Significant New Use Rules on Certain Chemical Substances, 30451-30481 [2016-11121]
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Vol. 81
Monday,
No. 94
May 16, 2016
Part III
Environmental Protection Agency
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40 CFR Parts 9 and 721
Significant New Use Rules on Certain Chemical Substances; Final Rule
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Federal Register / Vol. 81, No. 94 / Monday, May 16, 2016 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2015–0810; FRL–9944–77]
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 55 chemical substances
which were the subject of
premanufacture notices (PMNs). Ten of
these chemical substances are subject to
TSCA section 5(e) consent orders issued
by EPA. This action requires persons
who intend to manufacture (defined by
statute to include import) or process any
of these 55 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 15,
2016. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on May 31, 2016.
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 15, 2016 (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 15,
2016, 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–2015–0810, 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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SUMMARY:
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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 (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
telephone number: (202) 564–9232;
email address: Moss.Kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture (defined
by statute to include import), 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
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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 § 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
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that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four bulleted TSCA
section 5(a)(2) factors listed in Unit III.
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.
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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.
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 55 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
55 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 10 PMN substances
(P–11–150, P–11–484, P–11–543, P–14–
67, P–15–59, P–15–60, P–15–104, P–15–
154, P–15–328, and P–15–502) 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
§ 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
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protective measures required in the
corresponding consent orders.
Where EPA determined that the PMN
substance may present an unreasonable
risk of injury to human health via
inhalation exposure, the underlying
TSCA section 5(e) consent order usually
requires, among other things, that
potentially exposed employees wear
specified respirators unless actual
measurements of the workplace air
show that air-borne concentrations of
the PMN substance are below a New
Chemical Exposure Limit (NCEL) that is
established by EPA to provide adequate
protection to human health. In addition
to the actual NCEL concentration, the
comprehensive NCELs provisions in
TSCA section 5(e) consent orders,
which are modeled after Occupational
Safety and Health Administration
(OSHA) Permissible Exposure Limits
(PELs) provisions, include requirements
addressing performance criteria for
sampling and analytical methods,
periodic monitoring, respiratory
protection, and recordkeeping.
However, no comparable NCEL
provisions currently exist in 40 CFR
part 721, subpart B, for SNURs.
Therefore, for these cases, the
individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject
to the SNUR who wish to pursue NCELs
as an alternative to the § 721.63
respirator requirements may request to
do so under § 721.30. EPA expects that
persons whose § 721.30 requests to use
the NCELs approach for SNURs are
approved by EPA will be required to
comply with NCELs provisions that are
comparable to those contained in the
corresponding TSCA section 5(e)
consent order for the same chemical
substance.
This rule also includes SNURs on 45
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,
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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 Number P–11–150
Chemical name: Alkali transition
metal oxide (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: April 14, 2015.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substance
will be as a battery material. Based on
test data on the PMN substance and
structural activity relationship (SAR)
analysis of test data on analogous
respirable, poorly soluble particulates,
subcategory titanium dioxide, EPA
identified concerns for lung, blood,
kidney, and adrenal toxicity,
neurotoxicity, developmental toxicity,
developmental neurotoxicity,
cardiovascular and gastrointestinal
effects, and immunosuppression. The
Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based
on a finding that the substance may
present an unreasonable risk of injury to
human health. To protect against these
risks, the consent order requires:
1. Hazard communication.
Establishment and use of a hazard
communication program, including
human health precautionary statements
on each label and the Material Safety
Data Sheet (MSDS).
2. Use of personal protective
equipment including a National
Institute of Occupational Safety and
Health (NIOSH)-certified respirator with
an assigned protection factor (APF) of at
least 10 or compliance with a New
Chemicals Exposure Limit (NCEL) of 2.4
milligrams/cubic meter (mg/m3) as an 8hour time-weighted average, when there
is potential inhalation exposure.
3. Submission of certain toxicity
testing on the PMN substance prior to
exceeding the confidential production
volume limit as specified in the consent
order of the PMN substance.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with special
attention to histopathology
(inflammation and cell proliferation) of
the lung tissues and various parameters
of the bronchoalveolar lavage fluid
(BALF) e.g., maker enzyme activities,
total protein content, total cell count,
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cell differential, and cell viability. It is
not necessary to look at internal organs.
EPA recommends that a recovery period
of 60 days be included to assess the
progression or regression of any lesions
would help characterize possible health
effects of the substance. The submitter
has agreed to complete this testing by
the confidential aggregate production
volume identified in the consent order.
In addition, EPA has determined that
the results of a carcinogenicity test
(OPPTS Test Guideline 870.4200) would
help characterize the potential human
health effects of the PMN substance.
The Order does not require this test 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 citation: 40 CFR 721.10875.
PMN Numbers P–11–484 and P–11–543
Chemical names: Perfluoroalkyl
substituted alkyl sulfonate (generic) (P–
11–484); and Polyfluorinated alkyl
quaternary ammonium chloride
(generic) (P–11–543).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: October 30, 2014.
Basis for TSCA section 5(e) consent
order: The PMNs state that the generic
(non-confidential) use of the substances
will be as surfactants. Based on physical
chemical properties data, as well as test
data on analogous perfluorinated
chemicals and potential perfluorinated
degradation products including
perfluorooctanoic acid (PFOA),
perfluorooctanesulfonate (PFOS),
perfluorohexane sulfonate (PFHS), and
1H,1H,2H,2H-perfluorooctanesulfonic
acid (6–2 FTSA), EPA identified
concerns for irritation to skin, eyes,
lungs, mucous membranes, lung
toxicity, liver toxicity, blood toxicity,
male reproductive toxicity,
immunosupression, and oncogenicity.
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.
Further, based on test data on P–11–484,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 2,800 and 1 part per billion
(ppb) respectively for PMN substances
P–11–484 and P–11–543 respectively in
surface waters. 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
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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 an
MSDS, within 90 days.
2. Submission of certain physical/
chemical property, human health and
environmental toxicity, and
environmental fate testing prior to
exceeding the confidential production
volume limits 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.
4. Use of the PMN substances only for
the confidential uses specified in the
consent order, where use in consumer
products that could be spray applied are
prohibited.
5. Disposal of the PMN substance
according to the incineration conditions
specified in the consent order.
6. Comply with the release to water
provisions specified in the consent
order.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of certain
environmental fate and human health
and environmental toxicity testing
would help characterize human health
and environmental effects of the PMN
substances. The submitter has agreed to
conduct the testing identified in the
consent agreement by the confidential
triggers identified in the consent order.
Further, EPA has determined that the
results of an acute inhalation toxicity
test (OPPTS Test Guideline 870.1300)
and a 90-day inhalation toxicity test
(OPPTS Test Guideline 870.3465) with
a post-exposure observation period of
up to 3 months and BALF analysis
would help characterize the human
health effects from spray application of
the PMN substances. The Order does
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not require this 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 721.10876 (P–
11–484) and 40 CFR 721.10877 (P–11–
543).
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PMN Number P–14–67
Chemical name:
Polyfluorinatedalkylsulfonyl substituted
alkane derivative (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: November 4, 2015.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substance
will be as a polymer additive. EPA has
concerns for potential incineration or
other decomposition products of the
PMN substance. These fluorinated
decomposition products may be
released to the environment from
incomplete incineration of the PMN
substance at low temperatures. EPA has
preliminary evidence, including data on
some fluorinated polymers which
suggest that under some conditions, the
PMN substance 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 PFOA and other
perfluorinated alkyls, including the
presumed environmental degradant.
EPA also has concerns that under some
conditions of use, particularly nonindustrial, commercial, or consumer
use, the PMN substance could cause
lung effects, based on limited data on
some perfluorinated compounds.
Concerns for the PMN substance are for
lung toxicity from waterproofing of lung
membrane, based on PMN properties.
The order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I),
based on a finding that these substances
and their potential degradation products
may present an unreasonable risk of
injury to the environment and human
health.
1. Risk notification. If as a result of
the test data required, the company
becomes aware that the PMN substance
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
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protecting against such risk into an
MSDS, within 90 days.
2. Submission of certain
environmental fate testing on the PMN
substance prior to exceeding the
confidential production volume limit as
specified in the consent order of the
PMN substance.
3. No use of the PMN substance in
consumer spray products.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of the
modified aerobic activated sludge
biodegradation test submitted by the
company for EPA review would help
characterize the possible degradation of
the PMN substance. The submitter has
agreed to submit the results of this test
by the confidential production volume
identified in the consent order. EPA had
determined that the results of a
phototransformation of chemicals on
soil surfaces (Organisation for Economic
Co-operation and Development (OECD)
Draft Document January 2002) would
help characterize the degradation
potential of the PMN substance. The
Order does not require this 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 citation: 40 CFR 721.10878.
PMN Number P–14–125
Chemical name: 1Octadecanaminium, N-(3-chloro-2hydroxypropyl)-N,N-dimethyl-, chloride
(1:1).
CAS number: 3001–63–6.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a chemical
intermediate for surfactant production.
Based on test data on the PMN
substance, as well as SAR analysis of
test data on analogous cationic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 2 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
2 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 resulting in surface water
concentrations exceeding 2 ppb may
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result in 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 721.10879.
PMN Numbers P–14–153, P–14–154,
P–15–79, and P–15–80
Chemical names: Fatty acid rxn
products with aminoalkylamines
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that
these substances will be used as
chemical intermediates, additives for
flotation products, and as adhesion
promoters for use in asphalt
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 the
uses described in the PMN, releases of
the substances 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
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances, excluding the
uses described in the PMNs, result in in
releases to surface water concentrations
exceeding 1 ppb may result in
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
toxicity test (OPPTS Test Guideline
850.1300); an algal toxicity test (Office
of Chemical Safety and Pollution
Prevention (OCSPP) Test Guideline
850.4500); log Kow and water solubility
measurements; as well as either the fish
acute toxicity mitigated by humic acid
test (OPPTS Test Guideline 850.1085) or
the whole sediment acute toxicity
invertebrates, freshwater test (OPPTS
Test Guideline 850.1735) would help
characterize the environmental effects of
the PMN substances. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substance and mixtures (OECD
Test Guideline 23) be consulted to
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PMN Number P–14–198
facilitate solubility in the test media.
Testing should be tiered, starting with
water solubility and log Kow
measurements before proceeding with
higher tier toxicity tests.
CFR citation: 40 CFR 721.10880.
asabaliauskas on DSK3SPTVN1PROD with RULES
PMN Numbers P–14–155 and P–14–156
Chemical names: Fatty acid amides
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the substances will be used as chemical
intermediates, additives for flotation
products, and adhesion promoters for
use in asphalt applications. Based on
SAR analysis of test data on analogous
amides and aliphatic amines, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
2 and 3 ppb respectively of the PMN
substances P–14–155 and P–14–156 in
surface waters. For the uses described in
the PMNs, releases of the substances are
not expected to result in surface water
concentrations that exceed 2 ppb and 3
ppb of the PMN substances respectively.
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, excluding uses
described in the PMNs, resulting in
surface water concentrations exceeding
2 ppb (P–14–155) or 3 ppb (P–14–156)
of the PMN substances may result in
significant adverse environmental
effects. Based on this information, the
PMN substances meet the concern
criteria at § 721.170(b)(3)(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); an algal toxicity test (OCSPP
Test Guideline 850.4500); log Kow and
water solubility measurements; as well
as either the fish acute toxicity
mitigated by humic acid test (OPPTS
Test Guideline 850.1085) or the whole
sediment acute toxicity invertebrates,
freshwater test (OPPTS Test Guideline
850.1735) would help characterize the
environmental effects of the PMN
substances. 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, because of the PMN’s
low water solubility. Testing should be
tiered, starting with water solubility and
log Kow measurements before
proceeding with higher tier toxicity
tests.
CFR citation: 40 CFR 721.10881.
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Chemical name: Trialkylammonium
borodibenzoate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a color developer
for general printing applications. Based
on test data on the PMN substance and
SAR analysis of test data on analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 47 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 domestic
manufacture or 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
47 ppb for more than 20 days per year.
Therefore, EPA has not determined that
the proposed manufacturing (defined by
statute to include import), processing or
use of the substance may present an
unreasonable risk. EPA has determined,
however, that any domestic
manufacture or use of the substance
other than as listed in the PMN may
result in 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 721.10882.
PMN Number P–14–324
Chemical name: Fatty ester
derivatives, reaction products with
alkanolamine, hydroxylated, borated
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as a
lubricating oil additive. Based on SAR
analysis of test data on analogous boron
compounds, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 2 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
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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 2
ppb for more than 20 days per year.
Therefore, EPA has not determined that
the proposed manufacturing (defined by
statute to include import), 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 lubricating oil additive
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 chronic
fish early-life stage toxicity test (OPPTS
Test Guideline 850.1400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10883.
PMN Number P–14–397
Chemical name: Benzenepropanol, 1benzoate.
CAS number: 60045–26–3.
Basis for action: The PMN states that
the substance will be used as a
plasticizer in adhesives for food-product
packaging, a diluents-type plasticizer in
plastisols, a coalescent in architectural
paints and coatings, and a fragrance
carrier in fragrances. Based on SAR
analysis of test data on analogous esters,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 5 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
uses described in the PMN. For the uses
described in the PMN, environmental
releases did not exceed 5 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
listed in the PMN may result in
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
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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.
CFR citation: 40 CFR 721.10884.
asabaliauskas on DSK3SPTVN1PROD with RULES
PMN Number P–14–448
Chemical name: Alcohols, C12–22,
distn. residues.
CAS number: 1476777–83–9.
Basis for action: The PMN states that
the use of the substance will be used in
formulation of defoamers used in the
production of paper. Based on structureactivity relationship SAR analysis of test
data on analogous neutral organics, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
7 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 waters
exceed releases from the use described
in the PMN. As described in the PMN,
releases of the substance are not
expected to result in surface water
concentrations that exceed 7 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, any use where the cumulative
molecular weights of the C12 and C14
components exceed 2 percent by weight
of the overall molecular weight of the
PMN substance 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. Before conducting these
aquatic toxicity testing, EPA
recommends chemical characterization
of the alkyl range for the alcohol moiety
and a water solubility test (OECD Test
Guideline 105) should be conducted.
CFR citation: 40 CFR 721.10885.
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PMN Number P–14–501 and P–14–502
Chemical names: Phosphoric acid,
mixed Bu and decyl and octyl and 2-(2phenoxyethoxy)ethyl and 2phenoxyethyl esters (P–14–501), and
Phosphoric acid, mixed Bu and decyl
and octyl and 2-(2-phenoxyethoxy)ethyl
and 2-phenoxyethyl esters, potassium
salts (P–14–502).
CAS numbers: 1502809–48–4 (P–14–
501) and 1502809–56–4 (P–14–502).
Basis for action: The PMN states that
substances will be used as gellants for
use in oil fracturing. Based on structureactivity relationship (SAR) analysis of
test data on analogous neutral organics,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 4 ppb of the PMN
substances in surface waters. As
described in the PMNs, releases of the
substances are not expected to result in
surface water concentrations that exceed
4 ppb. 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 substances resulting in
releases to surface water concentrations
exceeding 4 ppb may result in
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
(OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substances.
CFR citations: 40 CFR 721.10886 (P–
14–501) and 40 CFR 721.10887 (P–14–
502).
PMN Numbers P–15–59, P–15–60, and
P–15–104
Chemical names: Siloxanes and
Silicones, 3-[(2aminoethyl)amino)propyl Me, di-Me,
reaction products with cadmium zinc
selenide sulfide, lauric acid and
oleylamine (P–15–59); Dodecanoic acid,
reaction products with cadmium zinc
selenide sulfide and oleylamine (P–15–
60); and Phosphonic acid,
P-tetradecyl-, reaction products with
cadmium selenide (CdSe) (P–15–104).
CAS numbers: 1623456–05–2 (P–15–
59); 1773514–92–3 (P–15–60); and
1773514–66–1 (P–15–104).
Effective date of TSCA section 5(e)
consent order: May 5, 2015.
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Basis for TSCA section 5(e) consent
order: The PMNs state that the
substances will be used as a down
converter for an optical filter for light
emitting diodes used in displays (P–15–
59) and as chemical intermediates (P–
15–60 and P–15–104). Based on SAR
analysis of test data on analogous
respirable, poorly soluble particulates
and the presence of cadmium, EPA
identified concerns for lung effects,
kidney effects, and oncogenicity. In
addition, EPA predicts chronic toxicity
to aquatic organisms from exposure to
cadmium. The Order was issued under
TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that
the substances may present an
unreasonable risk of injury to human
health and the environment. To protect
against these risks, the consent order
requires:
1. Use of impervious gloves to prevent
dermal exposures, where there is a
potential for dermal exposures.
2. Submission of certain material
characterization data on P–15–59 by the
time triggers specified in the consent
order.
3. Manufacture, process, or use the
PMN substances only in a liquid
formulation.
4. Manufacture, process, and use P–
15–59 only as a down converter for an
optical filter for light emitting diodes
used in displays.
5. Manufacture, process, and use of P–
15–60 and P–15–104 only as chemical
intermediates.
6. Disposal of the PMN substances
only by incineration in a permitted
hazardous waste incinerator.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the development of
data on certain material characterization
data specified in the consent order on
PMN substance P–15–59 would help
characterize the possible effects of the
PMN substance. The submitter has
agreed to submit the results of these
studies prior to 3 and 18 month time
triggers identified in the consent order.
In addition, EPA determined that the
results of a metabolism and
pharmacokinetics test (OPPTS Test
Guideline 870.7485) would help
characterize the human health and
environmental effect of the PMN
substance. The Order does not require
this 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
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asabaliauskas on DSK3SPTVN1PROD with RULES
modified or revoked by EPA based on
submission of that or other relevant
information.
CFR citations: 40 CFR 721.10888 (P–
15–59), 40 CFR 721.10889 (P–15–60),
and 40 CFR 721.10890 (P–15–104).
PMN Number P–15–81
Chemical name: Alkyl silicate,
polymer with 2-(chloromethyl)oxirane
and 4,4′0-(1methylethylidene)bis[phenol],
alkoxylated (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an ingredient in
liquid paint coating. Based on SAR
analysis of test data on analogous
epoxides, there were health concerns
regarding skin and lung sensitization,
mutagenicity, oncogenicity,
developmental toxicity, male
reproductive, liver, and kidney toxicity
based on the epoxide oxidation product
as well as irritation and lung toxicity
expected from the ethoxy silane
hydrolysis product from exposure to the
PMN substance via dermal exposure.
Further, based on SAR analysis of test
data on analogous epoxides, 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,
occupational exposures are expected to
be minimal due to use of adequate
dermal personal protection equipment
and 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
without the use of impervious gloves,
where there is a potential for dermal
exposure, or any use of the substance
resulting in surface water
concentrations exceeding 1 ppb may
result in serious human health or
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test (OECD Test
Guideline 422); a Zahn-Wellens/EMPA
test (OPPTS Test Guideline 835.3200); 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
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850.4500) would help characterize the
human health and environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.10891.
PMN Number P–15–109
Chemical name: Reaction product of a
mixture of aromatic dianhydrides and
aliphatic esters with an aromatic
diamine (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance is as an intermediate. Based
on SAR analysis of test data on
analogous anilines, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 11 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
11 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
11 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); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready
biodegradability test (OECD Test
Guideline 301) would help characterize
the environmental effects of the PMN
substance. EPA recommends that the
fate testing be performed first as the
results may mitigate the need for further
toxicity testing or change the testing
recommendations.
CFR citation: 40 CFR 721.10892.
PMN Number P–15–111
Chemical name: Fatty acids, tall-oil,
reaction products with an ether and
triethylenetetramine (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a hardener for
coating systems. 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 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
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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 1 ppb for more
than 20 days per year. Therefore, EPA
has not determined that the proposed
manufacturing (defined by statute to
include import), processing, or use of
the substance may present an
unreasonable risk. EPA has determined,
however, that any domestic
manufacture of the substance, or any
use of the PMN substance other than as
described in the PMN 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); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready
biodegradability test (OECD Test
Guideline 301) would help characterize
the environmental effects of the PMN
substance. EPA recommends that the
fate testing be performed first as the
results may mitigate the need for further
toxicity testing or change the testing
recommendations.
CFR citation: 40 CFR 721.10893.
PMN Number P–15–120
Chemical name: Substituted benzyl
acrylate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a resin for
industrial coating. Based on SAR
analysis of test data on analogous
acrylates, 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 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
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early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready
biodegradability test (OECD Test
Guideline 301) would help characterize
the environmental effects of the PMN
substance. EPA recommends that the
fate testing be performed first as the
results may mitigate the need for further
toxicity testing or change the testing
recommendations.
CFR citation: 40 CFR 721.10894.
PMN Number P–15–154
Chemical name: Fluoroalkyl acrylate
copolymer (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: May 14, 2015.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substance
will be as a textile treatment. 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
the substance may present an
unreasonable risk of injury to human
health and the environment. To protect
against these 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 an
MSDS, within 90 days.
2. Manufacture of the PMN substance:
(a) According to the chemical
composition section of the consent
order, including analyzing and reporting
certain starting raw material impurities
to EPA; and (b) within the maximum
established limits of certain fluorinated
impurities of the PMN substance as
stated in the consent order.
3. Submission of certain toxicity,
physical-chemical property, and
environmental fate testing on the PMN
substance prior to exceeding the
confidential production volume limits
as specified in the consent order.
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 and environmental fate testing
would help characterize the PMN
substance. The submitter has agreed to
complete the testing identified in the
testing section of the consent order by
the confidential limits specified. In
addition, EPA has determined that the
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results of a 90-day inhalation toxicity
test in rats (OPPTS Test Guideline
870.3465/OECD Test Guideline 413)
with a 60-day holding period, and
certain physical chemical property and
environmental fate testing identified in
the consent order would help
characterize the human health and fate
effects of the PMN substance. The Order
does not require this 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 citation: 40 CFR 721.10895.
PMN Number P–15–176
Chemical name: 1-Hexanol, 6mercapto-.
CAS number: 1633–78–9.
Basis for action: The PMN states that
the substance will be used as a chemical
intermediate to curable monomers.
Based on SAR analysis of test data on
analogous thiols, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 8 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
8 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
surface water concentrations exceeding
8 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, freshwater daphnids
(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 recommends
that the fate testing be performed first as
the results may mitigate the need for
further toxicity testing or change the
testing recommendations.
CFR citation: 40 CFR 721.10896.
PMN Number P–15–177
Chemical name: Phenol, 2,2′-[1,2disubstituted-1,2-ethanediyl]
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bis(iminomethylene)bis[substituted(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a catalyst in the
process to manufacture a crop
protection chemical. Based on test data
on the PMN substance, EPA identified
concerns for blood toxicity to workers
from dermal exposures to the PMN
substance. As described in the PMN,
occupational exposures are expected to
be minimal due to use of adequate
dermal personal protection equipment.
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 without the use of
chemical impervious gloves, where
there is a potential for dermal exposure,
or any use of the substance other than
as described in the PMN may cause
serious health effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(3)(i).
Recommended testing: EPA has
determined that the results of a skin
absorption, In vitro method (OECD Test
Guideline 428) would help characterize
the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10897.
PMN Number P–15–188
Chemical name: Carbomonocycles,
polymer with substituted
heteromonocycle, succinate, methyl
acrylate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as a pigmentwetting resin for Ultra Violet (UV)curable coatings. Based on SAR analysis
of test data on analogous methacrylates,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 7 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 7 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
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listed in the PMN 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 water
solubility test (OECD Test Guideline
105); 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. The water
solubility testing should be conducted
prior to conducting the ecotoxicity
testing as the results of the water
solubility may change the recommended
ecotoxicity testing.
CFR citation: 40 CFR 721.10898.
PMN Number P–15–190
Chemical name: Halogenated alkyl
trimethylaminium halide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be for cationization of
starch. Based on test data on analogous
alkylating agents, there were health
concerns regarding mutagenicity,
oncogenicity, developmental toxicity
and respiratory sensitization based from
exposure to the PMN substance via
inhalation exposure. In addition, based
on SAR analysis of test data on
analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
88 ppb of the PMN substance in surface
waters. As described in the PMN,
exposure is expected to be minimal due
to use of adequate respiratory personal
protection equipment and releases of
the substance are not expected to result
in surface water concentrations that
exceed 88 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 without the use of NIOSHcertified respirator with an APF of at
least 10, where there is a potential for
respiratory exposure, or any use of the
substance resulting in surface water
concentrations exceeding 88 ppb may
result in serious human health or
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a bacterial
reverse mutation test, (OPPTS Test
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Guideline 870.5100); a mammalian
erythrocyte micronucleus test (OPPTS
Test Guideline 870.5395); an acute oral
toxicity test (OPPTS Test Guideline
870.1100); a repeated dose 28-day oral
toxicity study in rodents (OPPTS Test
Guideline 870.3050); a fish acute
toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); a fish
acute toxicity mitigated by humic acid
test (OPPTS Test Guideline 850.1085);
an aquatic invertebrate acute toxicity
test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
human health and environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.10899.
PMN Number P–15–252
Chemical name: Titanium salt,
reaction products with silica (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a chemical
intermediate. Based on SAR analysis of
test data on analogous insoluble metal
oxides, EPA identified concerns for lung
toxicity if inhaled based on lung
overload for respirable, poorly soluble
particulates. For the use described in
the PMN, inhalation exposures are
expected to be minimal as the PMN is
handled in an enclosed process.
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 in a
non-enclosed process, or any use of the
substance other than listed in the PMN
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
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with 60-day
holding period and a particle size
distribution/fiber length and diameter
distributions (OECD Test Guideline 110)
would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10900.
PMN Number P–15–272
Chemical name: Formaldehyde,
reaction products with aniline and
aromatic mono- and di-phenol mixture
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a resin. Based on
SAR analysis of test data on analogous
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phenols, 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 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 (OECD
Test Guideline 301) would help
characterize the environmental effects of
the PMN substance. EPA recommends
that the fate testing be performed first as
the results may mitigate the need for
further toxicity testing or change the
testing recommendations.
CFR citation: 40 CFR 721.10901.
PMN Number P–15–276
Chemical name: Functionalized
carbon nanotubes (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as a thin film
for electronic device applications. Based
on SAR analysis of test data on
analogous carbon nanotubes and other
respirable poorly soluble particulates,
EPA identified potential lung effects
and skin penetration and toxicity
induction from inhalation and dermal
exposure to the PMN substance.
Further, EPA predicts toxicity to aquatic
organisms via releases of the PMN
substance to surface water. Although
there is potential for dermal exposure,
EPA does not expect significant
occupational exposures due to the use
of impervious gloves, and because the
PMN is used in a liquid and is not spray
applied except in a closed system.
Further, EPA does not expect
environmental releases during the use
identified in the PMN submission.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, and or use of the substance
may present an unreasonable risk to
human health or the environment. EPA
has determined, however, that any use
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of the substance without the use of
impervious gloves, where there is
potential for dermal exposure;
manufacturing the PMN substance for
use other than as a thin film for
electronic device applications;
manufacturing, processing, or using the
PMN substance in a form other than a
liquid; use of the PMN substance
involving an application method that
generates a mist, vapor, or aerosol
except in a closed system; or any release
of the PMN substance into surface
waters or disposal other than by landfill
or incineration may cause serious health
effects or significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(3)(ii)
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); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300); an algal toxicity test (OCSPP
Test Guideline 850.4500); a 90-day
inhalation toxicity test (OPPTS
870.3465) with additional testing
parameters beyond those noted at CFR
870.3465, for using the 90-day
subchronic protocol for nanomaterial
assessment; a two-year inhalation
bioassay (OPPTS Test Guideline
870.4200); and a surface charge by
electrophoresis (for example, using
ASTM E2865–12 or NCL Method PCC–
2—Measuring the Zeta Potential of
Nanoparticles) would help characterize
the health and environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10902.
PMN Number P–15–295
Chemical name: Acrylated mixed
metal oxides (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an intermediate.
Based on SAR analysis of test data on
respirable poorly soluble particulates,
EPA identified potential lung effects
and dermal toxicity from inhalation and
dermal exposure to the PMN substance.
Further, EPA predicts toxicity to aquatic
organisms via releases of the PMN
substance to surface water. Although
there is potential for dermal exposure,
EPA does not expect significant
occupational exposures due to the use
of impervious gloves, and because the
PMN is used in a liquid and is not spray
applied. Further, EPA does not expect
environmental releases during the use
identified in the PMN submission.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, and or use of the substance
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may present an unreasonable risk to
human health or the environment. EPA
has determined, however, that any use
of the substance without the use of
impervious gloves, where there is
potential for dermal exposure;
manufacturing, processing, or using the
PMN substance in a form other than as
a liquid; use of the PMN substance
involving an application method that
generates a mist, vapor, or aerosol; any
release of the PMN substance into
surface waters; or disposal other than by
landfill or incineration may cause
serious health effects or significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(ii) and (b))(ii).
Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with a 60-day
holding period; 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 and
health effects of the PMN substance.
CFR citation: 40 CFR 721.10903.
PMN Number P–15–306
Chemical name: Phenol, 1,1dimethylalkyl derivatives (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a process
intermediate. Based on SAR analysis of
test data on analogous phenols, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
13 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 13 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 13 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 acute invertebrate toxicity
test, freshwater daphnids (OPPTS Test
Guideline 850.1010); an algal toxicity
test (OCSPP Test Guideline 850.4500);
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and a Zahn-Wellens/EMPA test (OPPTS
Test Guideline 835.3200) would help
characterize the environmental effects of
the PMN substance. EPA recommends
that the fate testing be performed first as
the results may mitigate the need for
further toxicity testing or change the
testing recommendations.
CFR citation: 40 CFR 721.10904.
PMN Number P–15–319
Chemical name: Butanedioic acid, 2methylene-, dialkyl ester (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an intermediate for
production of a lubricant additive.
Based on SAR analysis of test data on
analogous acrylates and esters, 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 that resulting in surface
water concentrations 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 acute invertebrate toxicity
test, freshwater daphnids (OPPTS Test
Guideline 850.1010); an algal toxicity
test (OCSPP Test Guideline 850.4500);
and a ready biodegradability (OECD
Test Guideline 301) would help
characterize the environmental effects of
the PMN substance. EPA recommends
that the fate testing be performed first as
the results may mitigate the need for
further toxicity testing or change the
testing recommendations.
CFR citation: 40 CFR 721.10905.
PMN Number P–15–324
Chemical name: Magnesium alkaryl
sulfonate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the use of the substance will be as a
detergent additive in crankcase
lubricant applications. Based on
submitted test data on the PMN
substance, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb of the
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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 1
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 listed in the
PMN 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 daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10906.
PMN Number P–15–326
Chemical name:
Polyfluorohydrocarbon (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a specialty gas and
transfer fluid. Based on test data on the
PMN substance, EPA identified
concerns for neurotoxicity and
uncertain concern for cardiac
sensitization. Further, based on SAR
analysis of test data on analogous
substances, EPA identified concerns for
developmental toxicity. As described in
the PMN, EPA does not expect
significant occupational exposures due
to use of adequate personal protective
equipment, and consumer exposures are
not expected as the PMN substance is
not used in consumer products.
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 listed in the
PMN or any use in a consumer product
may result in significant adverse human
health effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170 (b)(3)(i)
and (b)(3)(ii).
Recommended testing: EPA has
determined that the results of 90-day
inhalation toxicity (OPPTS Test
Guideline 870.3465) would help
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characterize the health effects of the
PMN substance.
CFR citation: 40 CFR 721.10907.
PMN Number P–15–328
Chemical name: Aluminum calcium
oxide salt (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: June 2, 2015.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the PMN
substance will be as a cement additive.
Based on SAR analysis of test data on
analogous respirable, poorly soluble
particulates, EPA identified concerns for
lung toxicity based on lung overload.
The Order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I)
based on a finding that the substance
may present an unreasonable risk of
injury to human health. To protect
against these risks, the consent order
requires:
1. Hazard communication.
Establishment and use of a hazard
communication program, including
human health precautionary statements
on each label and the MSDS.
2. Use of personal protective
equipment including a NIOSH-certified
respirator with an APF of at least 10 or
compliance with a NCEL of 5 mg/m3 as
an 8-hour time-weighted average (when
there is potential inhalation exposure),
when there is potential inhalation
exposure.
3. Manufacture, processing or use of
the PMN substance only for the use
specified in the consent order.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465) in rats would help
characterize possible health effects of
the substance. The Order does not
require this 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 citation: 40 CFR 721.10908.
PMN Number P–15–332
Chemical name: Polyalkyltrisiloxane
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a site-limited
intermediate. Based on SAR analysis of
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test data on an analogous substance,
there were health concerns regarding
liver and kidney toxicity, thyroid
effects, and reproductive and
developmental toxicity from dermal and
inhalation exposures to the PMN
substance. Further, based on SAR
analysis of test data on analogous
neutral organics, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 4 ppb of the
PMN substance in surface waters. EPA
also 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. Further, as described in the
PMN, exposure is expected to be
minimal due to use of adequate
respiratory and dermal personal
protection equipment and releases of
the substance are not expected to result
in surface water concentrations
exceeding 4 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 4
ppb, any use other than that as a sitelimited intermediate, or any use without
the use of a NIOSH-certified respirator
with gas/vapor cartridges and an APF of
at least 10 and impervious gloves, may
result in serious human health or
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170 (b)(3)(ii) and
(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
sediment-water lumbriculus toxicity test
(OECD Test Guideline 225); a combined
repeated dose toxicity study with the
reproduction/developmental toxicity
screening test (OECD Test Guideline
422); a fish acute toxicity test,
freshwater and marine (OPPTS Test
Guideline 850.1075); an aquatic
invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
human health and environmental effects
of the PMN substance. All ecotoxicity
tests should analyze the PMN substance
as well as the hydrolysis products.
CFR citation: 40 CFR 721.10909.
PMN Number P–15–356
Chemical names: Oxirane, 2,2′-[[1-[4[1-methyl-1-[4-(2oxiranylmethoxy)phenyl]ethyl]phenyl]
ethylidene]bis(4,1phenyleneoxymethylene)]bis- (P–15–
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356, Chemical A); and 2-Propanol, 1,3bis[4-[1-[4-[1-methyl-1-[4-(2oxiranylmethoxy)phenyl]ethyl]phenyl]1-[4-(2-oxiranylmethoxy)phenyl]ethyl]
phenoxy]- (P–15–356, Chemical B).
CAS numbers: 115254–47–2 (P–15–
356, Chemical A) and 180063–56–3 (P–
15–356, Chemical B).
Basis for action: The PMN states that
the substances will be used as additives
in polymer formulation for electronics.
Based on test data on the PMN
substances and on SAR analysis of test
data on analogous epoxides, EPA
identified concerns for respiratory
sensitization and irritation,
mutagenicity, developmental toxicity,
male reproduction toxicity, liver and
kidney toxicity, and oncogenicity.
Additionally, based on SAR analysis of
test data on analogous polyepoxides,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 1 ppb of the PMN
substances in surface waters. Further,
EPA has concerns that the PMN
substances are potentially PBT
chemicals as described in the New
Chemical Program’s PBT category (64
FR 60194; November 4, 1999) (FRL–
6097–7). EPA estimates that the PMN
substances will persist in the
environment more than 2 months and
estimates a bioaccumulation factor of
greater than or equal to 1,000. For the
use described in the PMN, EPA expects
occupational exposures to be minimal
and does not expect releases to surface
waters. 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
additives in polymer formulation for
electronics or any use of the substances
resulting in releases to surface waters
may cause serious human health or
significant adverse environmental
effects. Based on this information, the
PMN substances meet the concern
criteria at § 721.170(b)(1)(i)(C), (b)(3)(i),
(b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
combined repeated dose toxicity study
with the reproduction/developmental
toxicity screening test (OECD Test
Guideline 422); a sediment-water
chironomid life-cycle toxicity test
(OECD Test Guideline 233), using
spiked water or spiked sediment; 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 human health and
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environmental effects of the PMN
substances.
CFR citations: 40 CFR 721.10910 (P–
15–356, chemical A) and 40 CFR
721.10911 (P–15–356, chemical B).
PMN Number P–15–363
Chemical name: Aliphatic acrylate
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a monomer. Based
on SAR analysis of test data on
analogous acrylates, 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 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.
CFR citation: 40 CFR 721.10912.
PMN Number P–15–378
Chemical name: Diisocyanato hexane,
homopolymer, alkanoic acidpolyalkylene glycol ether with
substituted alkane (3:1) reaction
products-blocked (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as a dual
cure/UV cure adhesion/barrier coating
for wood substrates. Based on SAR
analysis of test data on analogous
diisocyanates, EPA identified concerns
for respiratory sensitization. As
described in the PMN, EPA does not
expect significant occupational dermal
or inhalation exposure due to use of
adequate personal protective equipment
and consumer exposures are not
expected as the PMN substance is not
used in consumer products. Therefore,
EPA has not determined that the
proposed manufacture, processing, or
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use of the substance may present an
unreasonable risk. EPA has determined,
however, that any use of the substance
without a NIOSH-certified particulate
respirator with an APF of at least 10
where there is a potential for inhalation
exposure, or any use in consumer
products may cause serious 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 skin
sensitization test (OPPTS Test Guideline
870.2600) and a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10913.
PMN Number P–15–382
Chemical name: Polyitaconic acid,
sodium zinc salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as an odor
neutralization for pet litter and cleaning
hard surface surfaces, fabrics, skin and
hair; an odor neutralization for air car;
and an odor neutralization for waste
processing and solid waste management
in paper, oil, gas, mining, agriculture,
food and municipal industries. Based on
SAR analysis of test data on analogous
zinc salts, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 4 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 4
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 listed in the
PMN 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
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(OCSPP Test Guideline 850.4500) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10914.
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PMN Number P–15–411
Chemical name: Fatty acid esters with
polyols polyalkyl ethers (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an anti-rust coating
solution additive. Based on SAR
analysis of test data on analogous
nonionic surfactants, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 30 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
30 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
30 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 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.
CFR citation: 40 CFR 721.10915.
PMN Number P–15–435
Chemical name: 2,7Naphthalenedisulfonic acid, 4-amino-3[substituted]-5-hydroxy-6-[(1E)-2phenyldiazenyl]-, lithium salt (1:3)
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a direct anionic
dyestuff for the printing industry. Based
on the results of a 28-day oral study for
the PMN substance, EPA predicts
anemia, effects on the adrenals, spleen,
kidney, lymph nodes and
immunotoxicity. In addition, based on
the lithium salt of the PMN, EPA
identified concerns for developmental
toxicity and neurotoxicity. Further,
based on SAR analysis of test data on
analogous azo reduction products, EPA
identified concerns for blood effects,
developmental toxicity, oncogenicity,
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and mutagenicity. As described in the
PMN, EPA does not expect significant
risk to workers due to use of adequate
personal protective equipment.
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 in a liquid
formulation could result in exposures
which may cause serious health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(1)(i)(C), (b)(3)(i) and
(b)(3)(ii).
Recommended testing: EPA has
determined that the results of an ames
assay (OPPTS Test Guideline 870.5100)
with the rival modification; a mouse
micronucleus assay conducted by the
oral route (OPPTS Test Guideline
870.5395); and a combined repeated
dose and developmental toxicity and
reproductive toxicity screening test
(OPPTS Test Guideline 870.3650) would
help to characterize the health effects of
the PMN substance.
CFR citation: 40 CFR 721.10916.
PMN Number P–15–492
Chemical name: Polymethylsiloxane,
distillation residues (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a site-limited
intermediate. Based on SAR analysis
test data on analogous silanes, EPA
identified concerns for mutagenicity,
liver and kidney toxicity, thyroid
effects, and reproductive and
developmental toxicity from dermal and
inhalation exposures to the PMN
substance. Further, based on SAR
analysis of test data on analogous
neutral organics, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. For
the intermediate use described in the
PMN, occupational exposures are
expected to be minimal due to the use
of adequate respiratory and dermal
personal protection equipment, and
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 without the use of a
NIOSH-certified respirator with gas/
vapor cartridges and an APF of at least
10, where there is a potential for
inhalation exposures, any use of the
substance without the use of impervious
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gloves, where there is a potential for
dermal exposures; any use of the
substance other than an intermediate; or
any use of the substance resulting in
surface water concentrations exceeding
1 ppb may result in serious human
health or significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(3)(ii)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
sediment-water lumbriculus toxicity test
(OECD Test Guideline 225) using spiked
sediment; a combined repeated dose
toxicity study with the reproduction/
developmental toxicity screening test
(OECD Test Guideline 422); a fish earlylife 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 human health and
environmental effects of the PMN
substance. All ecotoxicity tests should
analyze for the PMN substance as well
as the hydrolysis products.
CFR citation: 40 CFR 721.10917.
PMN Number P–15–502
Chemical name:
Perfluorobutanesulfonamide and
polyoxyalkylene containing
polyurethane (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: November 4, 2015.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substance
will be as a protective treatment. EPA
has concerns for potential incineration
or other decomposition products of the
PMN substance. These fluorinated
decomposition products may be
released to the environment from
incomplete incineration of the PMN
substance at low temperatures. EPA has
preliminary evidence, including data on
some fluorinated polymers which
suggest that under some conditions, the
PMN substance 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 PFOA and other
perfluorinated alkyls, including the
presumed environmental degradant.
EPA also has concerns that under some
conditions of use, particularly nonindustrial, commercial, or consumer
use, the PMN substance could cause
lung effects, based on limited data on
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some perfluorinated compounds.
Concerns for the PMN substance are for
lung toxicity from waterproofing of lung
membrane, based on PMN properties.
The order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I),
based on a finding that the substance
and its potential intermediate and/or
ultimate degradation products may
present an unreasonable risk of injury to
the environment and human health.
1. Risk notification. If as a result of
the test data required, the company
becomes aware that the PMN substance
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 an
MSDS, within 90 days.
2. Submission of certain
environmental fate testing on the PMN
substance prior to exceeding the
confidential production volume limit as
specified in the consent order of the
PMN substance.
3. No use of the PMN substance in
consumer spray products.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of an aerobic
and anaerobic transformation in soil test
(OECD Test Guideline 307) would help
characterize the possible degradation of
the PMN substance. The submitter has
agreed to submit the results of this test
by the confidential production volume
identified in the consent order. EPA had
determined that the results of a
phototransformation of chemicals on
soil surfaces (OECD Draft Document
January 2002) would help characterize
the degradation potential of the PMN
substance. The Order does not require
this 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 citation: 40 CFR 721.10918.
PMN Number P–15–542
Chemical name: Quaternary
ammonium compounds, (3-chloro-2hydroxypropyl)coco alkyldimethyl,
chlorides.
CAS number: 690995–44–9.
Basis for action: The PMN states that
the substance will be used as an
intermediate for surfactant production,
and as a chemical intermediate for sale
into commerce. Based on SAR analysis
of test data on analogous cationic
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(quaternary ammonium) surfactants,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 24 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
24 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
24 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.
CFR citation: 40 CFR 721.10919.
PMN Number P–15–559
Chemical name: Modified
diphenylmethane diisocyanate
prepolymer with polyol (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a raw material for
flexible foam. Based on SAR analysis of
analogous diisocyanates, EPA identified
concerns for potential dermal and
respiratory sensitization from dermal
and inhalation exposures, and for
pulmonary toxicity from inhalation
exposure, to the PMN substance where
the average molecular weight is below
7,500 daltons and any molecular weight
species is below 1,000 daltons. For the
molecular weight distribution described
in the PMN, significant occupational
exposures are not expected. Therefore,
EPA has not determined that the
proposed manufacture of the substance
may present an unreasonable risk. EPA
has determined, however, that any
manufacture of the PMN substance with
an average molecular weight below
7,500 daltons, and where any molecular
weight species is below 1,000 daltons
may cause serious 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 skin
sensitization test (OPPTS Test Guideline
870.2600) and a 90-day inhalation
toxicity test (OPPTS Test Guideline
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870.3465) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10920.
PMN Number P–15–573
Chemical name:
2-Furancarboxyaldehyde,
5-(chloromethyl)-.
CAS number: 1623–88–7.
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
aldehydes, the EPA identified human
health concerns for liver toxicity,
neurotoxicity, sensitization, and cancer
to workers exposed through dermal and
inhalation routes. For the chemical
intermediate use described in the PMN,
occupational exposures are expected to
be minimal due to the use of adequate
personal protective equipment and a
continuous reaction process such that
no greater than 50 kilograms of the PMN
substance is present in the workplace at
a given time 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 without the use of a NIOSHcertified respirator with an APF of at
least 50, where there is a potential for
inhalation exposures; any use without
the use of impervious gloves, where
there is a potential for dermal
exposures, any use of the substance
other than as a chemical intermediate;
or any use beyond the annual
production volume limit of 15,000
kilograms may result in serious human
health or significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has
determined that the results of a skin
sensitization (OECD Test Guideline 406)
would help characterize the human
health effects of the PMN substance; a
combined repeated dose toxicity test
with the reproduction/developmental
toxicity screening test (OECD Test
Guideline 422) with functional
observational battery (FOB); a standard
test method for permeation of liquids
and gases through protective clothing
materials under conditions of
continuous contact (ASTM Test
Guideline F739) using the format
specified in the standard guide for
documenting the results of chemical
permeation testing of materials used in
protective clothing materials (ASTM
Test Guideline F1194–99(2010)); and a
carcinogenicity test (OECD Test
Guideline 451) would help characterize
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the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10921.
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PMN Number P–15–607
Chemical name: 1,2,4,5,7,8Hexoxonane, 3,6,9-trimethyl-, 3,6,9tris(alkyl) derivs. (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an initiator for
polymerization. Based on data on the
PMN substance, as well as SAR analysis
of test data on analogous peroxides, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
56 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 56 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
listed in the PMN may result in
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) using a solvent
where the effects of the solvent are
already known or measured, would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10922.
PMN Number P–15–671
Chemical name: 9-Octadecen-1amine, hydrochloride (1:1), (9Z)-.
CAS number: 41130–29–4.
Basis for action: The PMN states that
the substance will be used as an
emulsifying agent used in the
production of asphalt emulsions for
chipsealing and other road maintenance
techniques. Based on test data for the
PMN substance, as well as 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 substance
in surface waters. As described in the
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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
result in 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 721.10923.
PMN Numbers P–15–689 and P–15–690
Chemical names: Vegetable fatty acid
alkyl esters (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the substances will be used as chemical
intermediates. Based on SAR analysis of
test data on analogous esters, 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 substances to surface water
exceeds releases from the use described
in the PMN. For the chemical
intermediate use 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 an
intermediate may result in 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
toxicity test (OPPTS Test Guideline
850.1300); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would
help to characterize the environmental
effects of the PMN substances.
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Depending on the results of these tests,
EPA has determined that the results of
an aerobic and anaerobic metabolism
test (OECD Test Guideline 308) in
aquatic sediment systems test; and a
sediment water chironomid life-cycle
toxicity test (OECD Test Guideline 233)
using spiked water or spiked sediment
would help to further characterize the
environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.10924.
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 10 of the 55 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
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 45 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.
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.
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• 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.
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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 15, 2016 without
further notice, unless EPA receives
written adverse or critical comments, or
notice of intent to submit adverse or
critical comments before June 15, 2016.
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
15, 2016, 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
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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 10 of the 55 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
41 of the 55 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 16,
2016 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 § 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.
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30467
lists those tests. Unit IV. also lists
recommended testing for non-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. ASTM
International standards are available at
https://www.astm.org/Standard/
index.shtml.
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
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
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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 § 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
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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–
2015–0810.
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,
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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
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.
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Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
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.).
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.
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).
asabaliauskas on DSK3SPTVN1PROD with RULES
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
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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 3, 2016.
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:
■
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.
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:
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
40 CFR citation
*
*
OMB control No.
*
*
Significant New Uses of Chemical
Substances
*
721.10875
721.10876
721.10877
721.10878
721.10879
721.10880
721.10881
721.10882
721.10883
721.10884
721.10885
721.10886
721.10887
721.10888
721.10889
721.10890
721.10891
721.10892
721.10893
721.10894
721.10895
721.10896
721.10897
721.10898
721.10899
721.10900
721.10901
721.10902
721.10903
721.10904
721.10905
721.10906
721.10907
721.10908
721.10909
721.10910
721.10911
721.10912
721.10913
721.10914
721.10915
721.10916
721.10917
721.10918
721.10919
721.10920
721.10921
721.10922
721.10923
721.10924
721.10925
*
*
*
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*
*
2070–0012
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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
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
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
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
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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 § 721.10875 to subpart E to
read as follows:
■
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§ 721.10875
(generic).
Alkali transition metal oxide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkali transition metal
oxide (PMN P–11–150) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this rule do not apply
to quantities of the PMN substance after
it has been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. (A)
Requirements as specified in
§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), (b)(concentration set at 0.1
percent), and (c). When determining
which persons are reasonably likely to
be exposed as required for
§ 721.63(a)(4), engineering control
measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an Assigned Protection
Factor (APF) of at least 10 meet the
requirements of § 721.63(a)(4):
(1) Any NIOSH-certified air-purifying
elastomeric half-mask respirator
equipped with N100 (if oil aerosols
absent), R100, or P100 filters.
(2) Any appropriate NIOSH-certified
N100 (if oil aerosols absent), R100, or
P100 filtering facepiece respirator.
(3) Any NIOSH-certified air-purifying
full facepiece respirator equipped with
N100 (if oil aerosols absent), R100, or
P100 filters.
(4) Any NIOSH-certified negative
pressure (demand) supplied air
respirator equipped with a half-mask.
(5) Any NIOSH-certified negative
pressure (demand) self-contained
breathing apparatus (SCBA) equipped
with a half-mask.
(B) As an alternative to the respiratory
requirements listed here, a manufacturer
or processor may choose to follow the
New Chemical Exposure Limit (NCEL)
provisions listed in the TSCA section
5(e) consent order for this substance.
The NCEL is 2.4 mg/m3 as an 8-hour
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time weighted average (TWA) verified
by actual monitoring data.
(ii) Hazard communication program.
Requirements as specified in § 721.72(a)
through (e)(concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii),
(g)(1)(iv), (g)(1)(viii), (g)(1)(ix), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv)(use respiratory
protection, or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 2.4 mg/
m3), and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 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) through (d) and (f) through
(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)(iii) of this section.
■ 5. Add § 721.10876 to subpart E to
read as follows:
§ 721.10876 Perfluoroalkyl substituted
alkyl sulfonate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as perfluoroalkyl substituted
alkyl sulfonate (PMN P–11–484) 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 (k)(analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities; and use other described in
the consent order), (o)(use in a
consumer product that could be spray
applied), and (q).
(ii) Disposal. Requirements as
specified in § 721.85. Incineration of
wastes in an incinerator operating at the
temperature of at least 1,000 degrees
Celsius and a residence time of
minimum of 2 seconds. Any tank or
vessel washings, residues from transport
vessels or tanks, and similar materials
that are captured and retained in the
normal course of manufacturing and
processing for re-use in manufacturing
of the PMN substance or products made
from the PMN substance are exempt
from this method of disposal.
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(iii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1) apply to the PMN substance
except under the terms specified in the
consent order.
(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), (j), 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 paragraphs
(a)(2)(i) and (iii) of this section.
■ 6. Add § 721.10877 to subpart E to
read as follows:
§ 721.10877 Polyfluorinated alkyl
quaternary ammonium chloride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyfluorinated alkyl
quaternary ammonium chloride (PMN
P–11–543) 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(k)(analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities; and use other described in
the consent order), (o)(use in a
consumer product that could be spray
applied), and (q).
(ii) Disposal. Requirements as
specified in § 721.85. Incineration of
wastes in an incinerator operating at the
temperature of at least 1,000 degrees
Celsius and a residence time of
minimum of 2 seconds. Any tank or
vessel washings, residues from transport
vessels or tanks, and similar materials
that are captured and retained in the
normal course of manufacturing and
processing for re-use in manufacturing
of the PMN substance or products made
from the PMN substance are exempt
from this method of disposal.
(iii) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1) apply to the PMN substance
except under the terms specified in the
consent order.
(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), (i), (j), 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 paragraphs
(a)(2)(i) and (iii) of this section.
■ 7. Add § 721.10878 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10878 Polyfluorinatedalkylsulfonyl
substituted alkane derivative (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as
polyfluorinatedalkylsulfonyl substituted
alkane derivative (PMN P–14–67) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this rule do not apply
to quantities of the PMN substance after
it has been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72. 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 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.
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(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) and (o)(use in
a consumer product that could be spray
applied), and (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), (h), 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.
■ 8. Add § 721.10879 to subpart E to
read as follows:
§ 721.10879 1-Octadecanaminium, N-(3chloro-2-hydroxypropyl)-N,N-dimethyl-,
chloride (1:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-octadecanaminium, N-(3-chloro-2hydroxypropyl)-N,N-dimethyl-, chloride
(1:1) (PMN P–14–125; CAS No. 3001–
63–6) 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=2).
(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.
■ 9. Add § 721.10880 to subpart E to
read as follows:
§ 721.10880 Fatty acid rxn products with
aminoalkylamines (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fatty acid rxn products
with aminoalkylamines (PMNs P–14–
153, P–14–154, P–15–79, and P–15–80)
are subject to reporting under this
section for the significant new uses
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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 of the substances is any use other
than as chemical intermediates,
additives for flotation products, or
adhesion promoters for use in asphalt
applications where the surface water
concentrations described under
paragraph (a)(3)(i) of this section are
exceeded.
(ii) [Reserved].
(3) The significant new uses for any
use other than as chemical
intermediated, additives for flotation
products, or adhesion promoters for use
in asphalt applications 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), (i), and (k) 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.
■ 10. Add § 721.10881 to subpart E to
read as follows:
§ 721.10881
Fatty acid amides (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fatty acid amides (PMNs
P–14–155 and P–14–156) are subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use of the substances is any use other
than as chemical intermediates,
additives for flotation products, or
adhesion promoters for use in asphalt
applications where the surface water
concentrations described under
paragraph (a)(3)(i) of this section are
exceeded.
(ii) [Reserved].
(3) The significant new uses for any
use other than as chemical
intermediated, additives for flotation
products, or adhesion promoters for use
in asphalt applications are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
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(c)(4) (N=2 for P–14–155 and N=3 for P–
14–156).
(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), (i), and (k) 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.
■ 11. Add § 721.10882 to subpart E to
read as follows:
§ 721.10882 Trialkylammonium
borodibenzoate (generic).
§ 721.10884
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as trialkylammonium
borodibenzoate (PMN P–14–198) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (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 this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 12. Add § 721.10883 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10883 Fatty ester derivatives,
reaction products with alkanolamine,
hydroxylated, borated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty ester derivatives,
reaction products with alkanolamine,
hydroxylated, borated (PMN P–14–324)
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
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specified in § 721.80. A significant new
use of the substance is a use other than
as a lubricating oil additive.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 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.
■ 13. Add § 721.10884 to subpart E to
read as follows:
Benzenepropanol, 1-benzoate.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenepropanol, 1-benzoate (PMN P–
14–397; CAS No. 60045–26–3) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use of the substance is use other than as
a plasticizer in adhesives for foodproduct packaging; a diluents-type
plasticizer in plastisol; a coalescent in
architectural paints and coating; and a
fragrance carrier in fragrances.
(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.
■ 14. Add § 721.10885 to subpart E to
read as follows:
§ 721.10885
residues.
Alcohols, C12–22, distn.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
alcohols, C12–22, distn. residues (PMN P–
14–448; CAS No. 1476777–83–9) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and
consumer activities. Requirements as
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specified in § 721.80. A significant new
use of the substance is any use where
the cumulative molecular weights of the
C12 and C14 components exceed 2
percent by weight of the overall
molecular weight of the PMN substance.
(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.
■ 15. Add § 721.10886 to subpart E to
read as follows:
§ 721.10886 Phosphoric acid, mixed Bu
and decyl and octyl and 2-(2phenoxyethoxy)ethyl and 2-phenoxyethyl
esters.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphoric acid, mixed Bu and decyl
and octyl and 2-(2-phenoxyethoxy)ethyl
and 2-phenoxyethyl esters (PMN P–14–
501; CAS No. 1502809–48–4) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(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 § 721.10887 to subpart E to
read as follows:
§ 721.10887 Phosphoric acid, mixed Bu
and decyl and octyl and 2-(2phenoxyethoxy)ethyl and 2-phenoxyethyl
esters, potassium salts.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphoric acid, mixed Bu and decyl
and octyl and 2-(2-phenoxyethoxy)ethyl
and 2-phenoxyethyl esters, potassium
salts (PMN P–14–502; CAS No.
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1502809–56–4) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(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.
■ 17. Add § 721.10888 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10888 Siloxanes and Silicones,
3-[(2-aminoethyl)amino)propyl Me, di-Me,
reaction products with cadmium zinc
selenide sulfide, lauric acid and oleylamine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
siloxanes and silicones, 3-[(2aminoethyl)amino)propyl Me, di-Me,
reaction products with cadmium zinc
selenide sulfide, lauric acid and
oleylamine (PMN P–15–59; CAS No.
1623456–05–2) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63 (a)(1) engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(p) (three months
and eighteen months). A significant new
use of the substance is manufacture,
process, or use the chemical substance
other than as a down converter for an
optical filter for light emitting diodes
used in displays, or other than in a
liquid formulation.
(iii) Disposal. Requirements as
specified in § 721.85. It is a significant
new use to dispose of the chemical
substance other than by incineration in
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a permitted hazardous waste
incinerator.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (j) 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.
■ 18. Add § 721.10889 to subpart E to
read as follows:
§ 721.10889 Dodecanoic acid, reaction
products with cadmium zinc selenide
sulfide and oleylamine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
dodecanoic acid, reaction products with
cadmium zinc selenide sulfide and
oleylamine (PMN P–15–60; CAS No.
1773514–92–3) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. It is a significant
new use to manufacture, process, or use
the chemical substance other than as a
chemical intermediate or other than in
a liquid formulation.
(iii) Disposal. Requirements as
specified in § 721.85. It is a significant
new use to dispose of the chemical
substance other than by incineration in
a permitted hazardous waste
incinerator.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i) and (j) 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.
■ 19. Add § 721.10890 to subpart E to
read as follows:
§ 721.10890 Phosphonic acid, Ptetradecyl-, reaction products with cadmium
selenide (CdSe).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphonic acid, P-tetradecyl-, reaction
products with cadmium selenide (CdSe)
(PMN P–15–104; CAS No. 1773514–66–
1) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. It is a significant
new use to manufacture, process, or use
the chemical substance other than as a
chemical intermediate or other than in
a liquid formulation.
(iii) Disposal. Requirements as
specified in § 721.85 It is a significant
new use to dispose of the chemical
substance other than by incineration in
a permitted hazardous waste
incinerator.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (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.
■ 20. Add § 721.10891 to subpart E to
read as follows:
§ 721.10891 Alkyl silicate, polymer with 2(chloromethyl)oxirane and 4,4′-(1methylethylidene)bis[phenol], alkoxylated
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyl silicate, polymer
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with 2-(chloromethyl)oxirane and 4,4′(1-methylethylidene)bis[phenol],
alkoxylated (PMN P–15–81) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in 40 CFR
721.63(a)(1), (a)(2)(i), (a)(3), (b)
(concentration set at 0.1 percent), and
(c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=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
provisions of § 721.185 apply to this
section.
■ 21. Add § 721.108992 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10892 Reaction product of a mixture
of aromatic dianhydrides and aliphatic
esters with an aromatic diamine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as reaction product of a
mixture of aromatic dianhydrides and
aliphatic esters with an aromatic
diamine (PMN P–15–109) 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=11).
(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.
■ 22. Add § 721.10893 to subpart E to
read as follows:
§ 721.10893 Fatty acids, tall-oil, reaction
products with an ether and
triethylenetetramine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance identified
generically as fatty acids, tall-oil,
reaction products with an ether and
triethylenetetramine (PMN P–15–111) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (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 this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 23. Add § 721.10894 to subpart E to
read as follows:
§ 721.10894
(generic)
Substituted benzyl acrylate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted benzyl
acrylate (PMN P–15–120) 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.
■ 24. Add § 721.10895 to subpart E to
read as follows:
§ 721.10895 Fluoroalkyl acrylate
copolymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
fluoroalkyl acrylate copolymer (PMN
PO 00000
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P–15–154) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72. 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 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) (analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities), and (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) through (e) 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.
■ 25. Add § 721.10896 to subpart E to
read as follows:
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§ 721.10896
1-Hexanol, 6-mercapto-.
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§ 721.10897 Phenol, 2,2′-[1,2-disubstituted1,2-ethanediyl]
bis(iminomethylene)bis[substituted(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified generically as phenol, 2,2′[1,2-disubstituted-1,2-ethanediyl]
bis(iminomethylene)bis[substituted(PMN P–15–177) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(ii), and
(a)(3).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(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), (d), (e), 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.
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27. Add § 721.10898 to subpart E to
read as follows:
■
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-hexanol, 6-mercapto-. (PMN P–15–
176; CAS No.1633–78–9) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(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.
■ 26. Add § 721.10897 to subpart E to
read as follows:
§ 721.10898 Carbomonocycles, polymer
with substituted heteromonocycle,
succinate, methyl acrylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as carbomonocycles,
polymer with substituted
heteromonocycle, succinate, methyl
acrylate (PMN P–15–188) 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 of the substance is any use other
than as a pigment-wetting resin for UVcurable coatings.
(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.
■ 28. Add § 721.10899 to subpart E to
read as follows:
§ 721.10899 Halogenated alkyl
trimethylaminium halide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkyl
trimethylaminium halide (PMN P–15–
190) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4), (a)(6)(i), (b)(concentration
set at 0.1 percent) and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(4), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an assigned protection
PO 00000
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factor (APF) of at least 10 meet the
requirements of § 721.63(a)(4):
(A) NIOSH-certified power airpurifying respirator with a hood or
helmet and with appropriate gas/vapor
(acid gas, organic vapor, or substance
specific) cartridges in combination with
HEPA filters.
(B) NIOSH-certified continuous flow
supplied-air respirator equipped with a
loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure
(demand) supplied-air respirator with a
full facepiece.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=88).
(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), (d), 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.
■ 29. Add § 721.10900 to subpart E to
read as follows:
§ 721.10900 Titanium salt, reaction
products with silica (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as titanium salt, reaction
products with silica (PMN P–15–252) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4), (a)(6)(i), (a)(6)(ii), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(4), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an assigned protection
factor (APF) of at least 10 meet the
requirements of § 721.63(a)(4):
(A) NIOSH-certified air-purifying
elastomeric half-mask respirator
equipped with N100 (if oil aerosols
absent), R100, or P100 filters.
(B) NIOSH-certified N100 (if oil
aerosols absent), R100, or P100 filtering
facepiece respirator.
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(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d) 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.
■ 30. Add § 721.10901 to subpart E to
read as follows:
§ 721.10901 Formaldehyde, reaction
products with aniline and aromatic monoand di-phenol mixture (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as formaldehyde, reaction
products with aniline and aromatic
mono- and di-phenol mixture (PMN
P–15–272) 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.
■ 31. Add § 721.10902 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10902 Functionalized carbon
nanotubes (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as functionalized carbon
nanotubes (PMN P–15–276) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this rule do not apply
to quantities of the PMN substance after
it has been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
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Jkt 238001
§ 721.63(a)(1), (a)(2)(i), and (a)(3). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is manufacture, process, or use of
the PMN substance other than in a
liquid formulation. A significant new
use is use other than as a thin film for
electronic device applications or any
use involving an application method
that generates a vapor, mist, or aerosol
unless such application method occurs
in an enclosed process. An enclosed
process is defined as an operation that
is designed and operated so that there
is no release associated with normal or
routine production processes into the
environment of any substance present in
the operation. An operation with
inadvertent or emergency pressure relief
releases remains an enclosed process so
long as measures are taken to prevent
worker exposure to and environmental
contamination from the releases.
(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (a)(2), (b)(1),
(b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), (j), 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.
■ 32. Add § 721.10903 to subpart E to
read as follows:
§ 721.10903
(generic).
Acrylated mixed metal oxides
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acrylated mixed metal
oxides (PMN P–15–295) 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
PO 00000
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Sfmt 4700
substance after it has been completely
reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), and (a)(3). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(v)(1), (v)(2), (w)(1),
(w)(2), (x)(1), (x)(2), and (y)(1).
(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (a)(2), (b)(1),
(b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), (j), 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.
■ 33. Add § 721.10904 to subpart E to
read as follows:
§ 721.10904 Phenol, 1,1-dimethylalkyl
derivatives (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically phenol, 1,1-dimethylalkyl
derivatives (PMN P–15–306) 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=13).
(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.
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§ 721.10907
(generic).
34. Add § 721.10905 to subpart E to
read as follows:
■
§ 721.10905 Butanedioic acid, 2methylene-, dialkyl ester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as butanedioic acid, 2methylene-, dialkyl ester (PMN P–15–
319) 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.
■ 35. Add § 721.10906 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10906
(generic).
Magnesium alkaryl sulfonate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as magnesium alkaryl
sulfonate (PMN P–15–324) 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 of the substance is any use other
than as a detergent additive in crankcase
lubricant applications.
(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.
■ 36. Add § 721.10907 to subpart E to
read as follows:
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Polyfluorohydrocarbon
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyfluorohydrocarbon
(PMN P–15–326) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (o).
(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.
(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.
■ 37. Add § 721.10908 to subpart E to
read as follows:
§ 721.10908
(generic).
Aluminum calcium oxide salt
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aluminum calcium oxide
salt (PMN P–15–328) 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 after it has been completely
reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), (b), and (c). When determining
which persons are reasonably likely to
be exposed as required for § 721.63
(a)(4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. The
following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
Assigned Protection Factor (APF) of at
least 10 meet the requirements of
§ 721.63(a)(4):
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(A) NIOSH-certified power airpurifying respirator with a hood or
helmet and with appropriate gas/vapor
(acid gas, organic vapor, or substance
specific) cartridges in combination with
HEPA filters.
(B) NIOSH-certified continuous flow
supplied-air respirator equipped with a
loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure
(demand) supplied-air respirator with a
full face piece.
As an alternative to the respiratory
requirements listed here, a manufacturer
or processor may choose to follow the
New Chemical Exposure Limit (NCEL)
provisions listed in the TSCA section
5(e) consent order for this substance.
The NCEL is 5 mg/m3 as an 8-hour time
weighted average verified by actual
monitoring data.
(ii) Hazard communication program.
Requirements as specified in § 721.72(a)
trhough (f)(concentration set at 1.0
percent), (g)(1)(ii), (g)(2)(When using
this substance avoid breathing the
substance, and use respiratory
protection, or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 5 mg/
m3.) and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d) and (f) through
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)(iii) of this section.
■ 38. Add § 721.10909 to subpart E to
read as follows:
§ 721.10909
Polyalkyltrisiloxane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyalkyltrisiloxane
(PMN P–15–332) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
(a)(6)(i), (b)(concentration set at 1.0
percent), and (c). When determining
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which persons are reasonably likely to
be exposed as required for
§ 721.63(a)(4), engineering control
measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an assigned protection
factor (APF) of at least 10 meet the
requirements of § 721.63(a)(4):
(A) NIOSH-certified power airpurifying respirator with a hood or
helmet and with appropriate gas/vapor
(acid gas, organic vapor, or substance
specific) cartridges in combination with
HEPA filters.
(B) NIOSH-certified continuous flow
supplied-air respirator equipped with a
loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure
(demand) supplied-air respirator with a
full facepiece.
(ii) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80(h).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (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) through (e), (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.
■ 39. Add § 721.10910 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10910 Oxirane, 2,2′-[[1-[4-[1-methyl1-[4-(2-oxiranylmethoxy)phenyl]
ethyl]phenyl]ethylidene]bis(4,1phenyleneoxymethylene)]bis- (P–15–356,
Chemical A).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2,2′-[[1-[4-[1-methyl-1-[4-(2oxiranylmethoxy)phenyl]ethyl]phenyl]
ethylidene]bis(4,1phenyleneoxymethylene)]bis- (PMN
P–15–356, Chemical A; CAS No.
115254–47–2) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial and
consumer activities. Requirements as
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specified in § 721.80. A significant new
use of the substance is any use other
than as an additive in polymer
formulation for electronics.
(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
provisions of § 721.185 apply to this
section.
■ 40. Add § 721.10911 to subpart E to
read as follows:
§ 721.10911 2-Propanol, 1,3-bis[4-[1-[4-[1methyl-1-[4-(2oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4(2-oxiranylmethoxy)phenyl]ethyl]phenoxy](P–15–356, Chemical B).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propanol, 1,3-bis[4-[1-[4-[1-methyl-1[4-(2oxiranylmethoxy)phenyl]ethyl]phenyl]1-[4-(2-oxiranylmethoxy)phenyl]
ethyl]phenoxy]- (PMN P–15–356,
Chemical B; CAS No. 180063–56–3) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial and
consumer activities. Requirements as
specified in § 721.80. A significant new
use of the substance is any use other
than as an additive in polymer
formulation for electronics.
(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
provisions of § 721.185 apply to this
section.
■ 41. Add § 721.10912 to subpart E to
read as follows:
§ 721.10912
Aliphatic acrylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance identified
generically as aliphatic acrylate (PMN
P–15–363) 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.
■ 42. Add § 721.10913 to subpart E to
read as follows:
§ 721.10913 Diisocyanato hexane,
homopolymer, alkanoic acid-polyalkylene
glycol ether with substituted alkane (3:1)
reaction products-blocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as diisocyanato hexane,
homopolymer, alkanoic acidpolyalkylene glycol ether with
substituted alkane (3:1) reaction
products-blocked (PMN P–15–378) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4), (a)(6)(ii), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(4), engineering
control measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an assigned protection
factor (APF) of at least 10 meet the
requirements of § 721.63(a)(4):
(A) NIOSH-certified power airpurifying respirator with a hood or
helmet and with appropriate gas/vapor
(acid gas, organic vapor, or substance
specific) cartridges in combination with
HEPA filters.
(B) NIOSH-certified continuous flow
supplied-air respirator equipped with a
loose fitting facepiece, hood, or helmet.
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(C) NIOSH-certified negative pressure
(demand) supplied-air respirator with a
full facepiece.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d) 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.
■ 43. Add § 721.10914 to subpart E to
read as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
§ 721.10914 Polyitaconic acid, sodium zinc
salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyitaconic acid, sodium
zinc salt (PMN P–15–382) 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) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use of the substance is any use other
than as an odor neutralization for pet
litter and cleaning hard surface surfaces,
fabrics, skin and hair; an odor
neutralization for air car; and an odor
neutralization for waste processing and
solid waste management in paper, oil,
gas, mining, agriculture, food and
municipal industries.
(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.
■ 44. Add § 721.10915 to subpart E to
read as follows:
411) 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=30).
(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.
■ 45. Add § 721.10916 to subpart E to
read as follows:
§ 721.10916 2,7-Naphthalenedisulfonic
acid, 4-amino-3-[substituted]-5-hydroxy-6[(1E)-2-phenyldiazenyl]-, lithium salt (1:3)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2,7-naphthalenedisulfonic
acid, 4-amino-3-[substituted]-5-hydroxy6-[(1E)-2-phenyldiazenyl]-, lithium salt
(1:3) (PMN P–15–435) 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 of the substance is any use other
that in a liquid formulation.
(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.
■ 46. Add § 721.10917 to subpart E to
read as follows:
§ 721.10915 Fatty acid esters with polyols
polyalkyl ethers (generic).
§ 721.10917 Polymethylsiloxane,
distillation residues (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid esters with
polyols polyalkyl ethers (PMN P–15–
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polymethylsiloxane,
distillation residues (PMN P–15–492) is
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Sfmt 4700
30479
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
(a)(6)(ii), (a)(6)(v), (a)(6)(vi), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(4), engineering
control measures (e.g., enclosure or
confinement of the operations, general
and local ventilation) or administrative
control measure (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirator with an assigned protection
factor (APF) of at least 10 meets the
minimum requirements for
§ 721.63(a)(4): NIOSH-certified powered
air-purifying respirator with a hood or
helmet and with appropriate gas-vapor
(acid gas, organic vapor, or substance
specific) cartridges.
(ii) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (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.
■ 47. Add § 721.10918 to subpart E to
read as follows:
§ 721.10918 Perfluorobutanesulfonamide
and polyoxyalkylene containing
polyurethane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as
perfluorobutanesulfonamide and
polyoxyalkylene containing
polyurethane (PMN P–15–502) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this rule do not apply
to quantities of the PMN substance after
it has been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication program. A
significant new use of the substance is
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asabaliauskas on DSK3SPTVN1PROD with RULES
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 TSCA section 5(e)
consent order for the substance, 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 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).
(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), (h), 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.
■ 48. Add § 721.10919 to subpart E to
read as follows:
§ 721.10919 Quaternary ammonium
compounds, (3-chloro-2hydroxypropyl)coco alkyldimethyl,
chlorides.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
quaternary ammonium compounds,
(3-chloro-2-hydroxypropyl)coco
alkyldimethyl, chlorides (PMN P–15–
542; CAS No. 690995–44–9) is subject to
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Jkt 238001
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=24).
(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.
■ 49. Add § 721.10920 to subpart E to
read as follows:
§ 721.10920 Modified diphenylmethane
diisocyanate prepolymer with polyol
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as modified
diphenylmethane diisocyanate
prepolymer with polyol (PMN P–15–
559) 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 of the substance is manufacture of
the substance where the average
molecular weight is below 7,500
daltons, and where any molecular
weight species is below 1,000 daltons.
(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.
■ 50. Add § 721.10921 to subpart E to
read as follows:
§ 721.10921 2-Furancarboxyaldehyde,
5-(chloromethyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-furancarboxyaldehyde, 5-
PO 00000
Frm 00030
Fmt 4701
Sfmt 4700
(chloromethyl)- (PMN P–15–573; CAS
No. 1623–88–7) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
(a)(6)(v), and (c). When determining
which persons are reasonably likely to
be exposed as required for
§ 721.63(a)(4), engineering control
measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an assigned protection
factor (APF) of at least 50 meet the
requirements of § 721.63(a)(4):
(A) NIOSH-certified powered airpurifying respirator with a tight-fitting
half mask and HEPA filters.
(B) NIOSH-certified continuous flow
supplied-air respirator equipped with a
tight-fitting half mask.
(C) NIOSH-certified negative pressure
(demand) supplied-air respirator
equipped with a full facepiece.
(ii) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80(g) (chemical
intermediate use in a continuous
reaction process such that no greater
than 50 kilograms is present in the
workplace at a given time) and
(s)(15,000 kilograms).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) 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.
■ 51. Add § 721.10922 to subpart E to
read as follows:
§ 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9trimethyl-, 3,6,9-tris(alkyl) derivs. (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 11,2,4,5,7,8-hexoxonane,
3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs.
(PMN P–15–607) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
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(2) The significant new uses are:
(i) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(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.
(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.
■ 52. Add § 721.10923 to subpart E to
read as follows:
§ 721.10923 9-Octadecen-1-amine,
hydrochloride (1:1), (9Z)-.
asabaliauskas on DSK3SPTVN1PROD with RULES
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
9-octadecen-1-amine, hydrochloride
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(1:1), (9Z)- (PMN P–15–671; CAS No.
41130–29–4) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) 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.
■ 53. Add § 721.10924 to subpart E to
read as follows:
§ 721.10924 Vegetable fatty acid alkyl
esters (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
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30481
generically as vegetable fatty acid alkyl
esters (PMNs P–15–689 and P–15–690)
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(g).
(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.
[FR Doc. 2016–11121 Filed 5–13–16; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)]
[Rules and Regulations]
[Pages 30451-30481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11121]
[[Page 30451]]
Vol. 81
Monday,
No. 94
May 16, 2016
Part III
Environmental Protection Agency
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40 CFR Parts 9 and 721
Significant New Use Rules on Certain Chemical Substances; Final Rule
Federal Register / Vol. 81 , No. 94 / Monday, May 16, 2016 / Rules
and Regulations
[[Page 30452]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2015-0810; FRL-9944-77]
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 55 chemical substances
which were the subject of premanufacture notices (PMNs). Ten of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture
(defined by statute to include import) or process any of these 55
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 15, 2016. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
May 31, 2016.
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 15, 2016 (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 15, 2016, 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-2015-0810, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9232; email
address: Moss.Kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import), 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
[[Page 30453]]
that a use of a chemical substance is a ``significant new use.'' EPA
must make this determination by rule after considering all relevant
factors, including the four bulleted TSCA section 5(a)(2) factors
listed in Unit III. 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 55
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 55 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 10 PMN substances (P-11-150, P-11-484, P-11-543,
P-14-67, P-15-59, P-15-60, P-15-104, P-15-154, P-15-328, and P-15-502)
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.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec. 721.63 respirator requirements may request to do so under
Sec. 721.30. EPA expects that persons whose Sec. 721.30 requests to
use the NCELs approach for SNURs are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) consent order for the same
chemical substance.
This rule also includes SNURs on 45 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,
[[Page 30454]]
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 Number P-11-150
Chemical name: Alkali transition metal oxide (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: April 14, 2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a battery
material. Based on test data on the PMN substance and structural
activity relationship (SAR) analysis of test data on analogous
respirable, poorly soluble particulates, subcategory titanium dioxide,
EPA identified concerns for lung, blood, kidney, and adrenal toxicity,
neurotoxicity, developmental toxicity, developmental neurotoxicity,
cardiovascular and gastrointestinal effects, and immunosuppression. The
Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that the substance may present an
unreasonable risk of injury to human health. To protect against these
risks, the consent order requires:
1. Hazard communication. Establishment and use of a hazard
communication program, including human health precautionary statements
on each label and the Material Safety Data Sheet (MSDS).
2. Use of personal protective equipment including a National
Institute of Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10 or
compliance with a New Chemicals Exposure Limit (NCEL) of 2.4
milligrams/cubic meter (mg/m\3\) as an 8-hour time-weighted average,
when there is potential inhalation exposure.
3. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the consent order of the PMN substance.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with
special attention to histopathology (inflammation and cell
proliferation) of the lung tissues and various parameters of the
bronchoalveolar lavage fluid (BALF) e.g., maker enzyme activities,
total protein content, total cell count, cell differential, and cell
viability. It is not necessary to look at internal organs. EPA
recommends that a recovery period of 60 days be included to assess the
progression or regression of any lesions would help characterize
possible health effects of the substance. The submitter has agreed to
complete this testing by the confidential aggregate production volume
identified in the consent order. In addition, EPA has determined that
the results of a carcinogenicity test (OPPTS Test Guideline 870.4200)
would help characterize the potential human health effects of the PMN
substance. The Order does not require this test 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 citation: 40 CFR 721.10875.
PMN Numbers P-11-484 and P-11-543
Chemical names: Perfluoroalkyl substituted alkyl sulfonate
(generic) (P-11-484); and Polyfluorinated alkyl quaternary ammonium
chloride (generic) (P-11-543).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e) consent order: October 30,
2014.
Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of the substances will be as
surfactants. Based on physical chemical properties data, as well as
test data on analogous perfluorinated chemicals and potential
perfluorinated degradation products including perfluorooctanoic acid
(PFOA), perfluorooctanesulfonate (PFOS), perfluorohexane sulfonate
(PFHS), and 1H,1H,2H,2H-perfluorooctanesulfonic acid (6-2 FTSA), EPA
identified concerns for irritation to skin, eyes, lungs, mucous
membranes, lung toxicity, liver toxicity, blood toxicity, male
reproductive toxicity, immunosupression, and oncogenicity. 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. Further, based on test data
on P-11-484, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2,800 and 1 part per billion (ppb)
respectively for PMN substances P-11-484 and P-11-543 respectively in
surface waters. 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 an MSDS, within 90 days.
2. Submission of certain physical/chemical property, human health
and environmental toxicity, and environmental fate testing prior to
exceeding the confidential production volume limits 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.
4. Use of the PMN substances only for the confidential uses
specified in the consent order, where use in consumer products that
could be spray applied are prohibited.
5. Disposal of the PMN substance according to the incineration
conditions specified in the consent order.
6. Comply with the release to water provisions specified in the
consent order.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that the results of certain
environmental fate and human health and environmental toxicity testing
would help characterize human health and environmental effects of the
PMN substances. The submitter has agreed to conduct the testing
identified in the consent agreement by the confidential triggers
identified in the consent order. Further, EPA has determined that the
results of an acute inhalation toxicity test (OPPTS Test Guideline
870.1300) and a 90-day inhalation toxicity test (OPPTS Test Guideline
870.3465) with a post-exposure observation period of up to 3 months and
BALF analysis would help characterize the human health effects from
spray application of the PMN substances. The Order does
[[Page 30455]]
not require this 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 721.10876 (P-11-484) and 40 CFR 721.10877 (P-
11-543).
PMN Number P-14-67
Chemical name: Polyfluorinatedalkylsulfonyl substituted alkane
derivative (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: November 4,
2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a polymer
additive. EPA has concerns for potential incineration or other
decomposition products of the PMN substance. These fluorinated
decomposition products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers
which suggest that under some conditions, the PMN substance 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 PFOA and other perfluorinated alkyls, including
the presumed environmental degradant. EPA also has concerns that under
some conditions of use, particularly non-industrial, commercial, or
consumer use, the PMN substance could cause lung effects, based on
limited data on some perfluorinated compounds. Concerns for the PMN
substance are for lung toxicity from waterproofing of lung membrane,
based on PMN properties. The order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that these
substances and their potential degradation products may present an
unreasonable risk of injury to the environment and human health.
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substance 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 an MSDS, within 90 days.
2. Submission of certain environmental fate testing on the PMN
substance prior to exceeding the confidential production volume limit
as specified in the consent order of the PMN substance.
3. No use of the PMN substance in consumer spray products.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that the results of the
modified aerobic activated sludge biodegradation test submitted by the
company for EPA review would help characterize the possible degradation
of the PMN substance. The submitter has agreed to submit the results of
this test by the confidential production volume identified in the
consent order. EPA had determined that the results of a
phototransformation of chemicals on soil surfaces (Organisation for
Economic Co-operation and Development (OECD) Draft Document January
2002) would help characterize the degradation potential of the PMN
substance. The Order does not require this 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 citation: 40 CFR 721.10878.
PMN Number P-14-125
Chemical name: 1-Octadecanaminium, N-(3-chloro-2-hydroxypropyl)-
N,N-dimethyl-, chloride (1:1).
CAS number: 3001-63-6.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate
for surfactant production. Based on test data on the PMN substance, as
well as SAR analysis of test data on analogous cationic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 2 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 2 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 resulting in surface water concentrations
exceeding 2 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) 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 721.10879.
PMN Numbers P-14-153, P-14-154, P-15-79, and P-15-80
Chemical names: Fatty acid rxn products with aminoalkylamines
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that these substances will be used
as chemical intermediates, additives for flotation products, and as
adhesion promoters for use in asphalt 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 the uses described in
the PMN, releases of the substances 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
substances may present an unreasonable risk. EPA has determined,
however, that any use of the substances, excluding the uses described
in the PMNs, result in in releases to surface water concentrations
exceeding 1 ppb may result in 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 toxicity test (OPPTS Test Guideline 850.1300); an algal
toxicity test (Office of Chemical Safety and Pollution Prevention
(OCSPP) Test Guideline 850.4500); log Kow and water solubility
measurements; as well as either the fish acute toxicity mitigated by
humic acid test (OPPTS Test Guideline 850.1085) or the whole sediment
acute toxicity invertebrates, freshwater test (OPPTS Test Guideline
850.1735) would help characterize the environmental effects of the PMN
substances. EPA also recommends that the guidance document on aquatic
toxicity testing of difficult substance and mixtures (OECD Test
Guideline 23) be consulted to
[[Page 30456]]
facilitate solubility in the test media. Testing should be tiered,
starting with water solubility and log Kow measurements before
proceeding with higher tier toxicity tests.
CFR citation: 40 CFR 721.10880.
PMN Numbers P-14-155 and P-14-156
Chemical names: Fatty acid amides (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the substances will be used
as chemical intermediates, additives for flotation products, and
adhesion promoters for use in asphalt applications. Based on SAR
analysis of test data on analogous amides and aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 and 3 ppb respectively of the PMN substances P-14-155 and P-
14-156 in surface waters. For the uses described in the PMNs, releases
of the substances are not expected to result in surface water
concentrations that exceed 2 ppb and 3 ppb of the PMN substances
respectively. 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, excluding uses described in the PMNs, resulting in surface
water concentrations exceeding 2 ppb (P-14-155) or 3 ppb (P-14-156) of
the PMN substances may result in significant adverse environmental
effects. Based on this information, the PMN substances meet the concern
criteria at Sec. 721.170(b)(3)(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); an algal
toxicity test (OCSPP Test Guideline 850.4500); log Kow and water
solubility measurements; as well as either the fish acute toxicity
mitigated by humic acid test (OPPTS Test Guideline 850.1085) or the
whole sediment acute toxicity invertebrates, freshwater test (OPPTS
Test Guideline 850.1735) would help characterize the environmental
effects of the PMN substances. 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, because of the PMN's low water solubility. Testing
should be tiered, starting with water solubility and log Kow
measurements before proceeding with higher tier toxicity tests.
CFR citation: 40 CFR 721.10881.
PMN Number P-14-198
Chemical name: Trialkylammonium borodibenzoate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a color developer for
general printing applications. Based on test data on the PMN substance
and SAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 47 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 domestic manufacture or 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 47 ppb
for more than 20 days per year. Therefore, EPA has not determined that
the proposed manufacturing (defined by statute to include import),
processing or use of the substance may present an unreasonable risk.
EPA has determined, however, that any domestic manufacture or use of
the substance other than as listed in the PMN 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) 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 721.10882.
PMN Number P-14-324
Chemical name: Fatty ester derivatives, reaction products with
alkanolamine, hydroxylated, borated (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a lubricating oil additive. Based on SAR analysis of test data on
analogous boron compounds, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 2 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 2 ppb for more than 20 days per year. Therefore, EPA has not
determined that the proposed manufacturing (defined by statute to
include import), 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 lubricating oil additive 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
chronic fish early-life stage toxicity test (OPPTS Test Guideline
850.1400) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10883.
PMN Number P-14-397
Chemical name: Benzenepropanol, 1-benzoate.
CAS number: 60045-26-3.
Basis for action: The PMN states that the substance will be used as
a plasticizer in adhesives for food-product packaging, a diluents-type
plasticizer in plastisols, a coalescent in architectural paints and
coatings, and a fragrance carrier in fragrances. Based on SAR analysis
of test data on analogous esters, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 5 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 uses described in the
PMN. For the uses described in the PMN, environmental releases did not
exceed 5 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 listed in the PMN
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).
[[Page 30457]]
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.
CFR citation: 40 CFR 721.10884.
PMN Number P-14-448
Chemical name: Alcohols, C12-22, distn. residues.
CAS number: 1476777-83-9.
Basis for action: The PMN states that the use of the substance will
be used in formulation of defoamers used in the production of paper.
Based on structure-activity relationship SAR analysis of test data on
analogous neutral organics, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 7 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 waters exceed releases from the
use described in the PMN. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
that exceed 7 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, any use where the cumulative molecular weights of the
C12 and C14 components exceed 2 percent by weight
of the overall molecular weight of the PMN substance 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. Before conducting these aquatic toxicity testing,
EPA recommends chemical characterization of the alkyl range for the
alcohol moiety and a water solubility test (OECD Test Guideline 105)
should be conducted.
CFR citation: 40 CFR 721.10885.
PMN Number P-14-501 and P-14-502
Chemical names: Phosphoric acid, mixed Bu and decyl and octyl and
2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters (P-14-501), and
Phosphoric acid, mixed Bu and decyl and octyl and 2-(2-
phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts (P-14-
502).
CAS numbers: 1502809-48-4 (P-14-501) and 1502809-56-4 (P-14-502).
Basis for action: The PMN states that substances will be used as
gellants for use in oil fracturing. Based on structure-activity
relationship (SAR) analysis of test data on analogous neutral organics,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 4 ppb of the PMN substances in surface waters. As described
in the PMNs, releases of the substances are not expected to result in
surface water concentrations that exceed 4 ppb. 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 substances resulting in releases to surface
water concentrations exceeding 4 ppb may result in 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 Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10886 (P-14-501) and 40 CFR 721.10887 (P-
14-502).
PMN Numbers P-15-59, P-15-60, and P-15-104
Chemical names: Siloxanes and Silicones, 3-[(2-
aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc
selenide sulfide, lauric acid and oleylamine (P-15-59); Dodecanoic
acid, reaction products with cadmium zinc selenide sulfide and
oleylamine (P-15-60); and Phosphonic acid, P-tetradecyl-, reaction
products with cadmium selenide (CdSe) (P-15-104).
CAS numbers: 1623456-05-2 (P-15-59); 1773514-92-3 (P-15-60); and
1773514-66-1 (P-15-104).
Effective date of TSCA section 5(e) consent order: May 5, 2015.
Basis for TSCA section 5(e) consent order: The PMNs state that the
substances will be used as a down converter for an optical filter for
light emitting diodes used in displays (P-15-59) and as chemical
intermediates (P-15-60 and P-15-104). Based on SAR analysis of test
data on analogous respirable, poorly soluble particulates and the
presence of cadmium, EPA identified concerns for lung effects, kidney
effects, and oncogenicity. In addition, EPA predicts chronic toxicity
to aquatic organisms from exposure to cadmium. The Order was issued
under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a
finding that the substances may present an unreasonable risk of injury
to human health and the environment. To protect against these risks,
the consent order requires:
1. Use of impervious gloves to prevent dermal exposures, where
there is a potential for dermal exposures.
2. Submission of certain material characterization data on P-15-59
by the time triggers specified in the consent order.
3. Manufacture, process, or use the PMN substances only in a liquid
formulation.
4. Manufacture, process, and use P-15-59 only as a down converter
for an optical filter for light emitting diodes used in displays.
5. Manufacture, process, and use of P-15-60 and P-15-104 only as
chemical intermediates.
6. Disposal of the PMN substances only by incineration in a
permitted hazardous waste incinerator.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that the development of
data on certain material characterization data specified in the consent
order on PMN substance P-15-59 would help characterize the possible
effects of the PMN substance. The submitter has agreed to submit the
results of these studies prior to 3 and 18 month time triggers
identified in the consent order. In addition, EPA determined that the
results of a metabolism and pharmacokinetics test (OPPTS Test Guideline
870.7485) would help characterize the human health and environmental
effect of the PMN substance. The Order does not require this 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
[[Page 30458]]
modified or revoked by EPA based on submission of that or other
relevant information.
CFR citations: 40 CFR 721.10888 (P-15-59), 40 CFR 721.10889 (P-15-
60), and 40 CFR 721.10890 (P-15-104).
PMN Number P-15-81
Chemical name: Alkyl silicate, polymer with 2-(chloromethyl)oxirane
and 4,4'0-(1-methylethylidene)bis[phenol], alkoxylated (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient in liquid
paint coating. Based on SAR analysis of test data on analogous
epoxides, there were health concerns regarding skin and lung
sensitization, mutagenicity, oncogenicity, developmental toxicity, male
reproductive, liver, and kidney toxicity based on the epoxide oxidation
product as well as irritation and lung toxicity expected from the
ethoxy silane hydrolysis product from exposure to the PMN substance via
dermal exposure. Further, based on SAR analysis of test data on
analogous epoxides, 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, occupational exposures are
expected to be minimal due to use of adequate dermal personal
protection equipment and 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 without the use of impervious gloves,
where there is a potential for dermal exposure, or any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
result in serious human health or significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422); a
Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200); 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 human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10891.
PMN Number P-15-109
Chemical name: Reaction product of a mixture of aromatic
dianhydrides and aliphatic esters with an aromatic diamine (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an intermediate. Based on SAR
analysis of test data on analogous anilines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 11 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 11 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 11 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); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) would help characterize
the environmental effects of the PMN substance. EPA recommends that the
fate testing be performed first as the results may mitigate the need
for further toxicity testing or change the testing recommendations.
CFR citation: 40 CFR 721.10892.
PMN Number P-15-111
Chemical name: Fatty acids, tall-oil, reaction products with an
ether and triethylenetetramine (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a hardener for coating
systems. 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 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 1 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing (defined by statute to include import),
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any domestic manufacture of the
substance, or any use of the PMN substance other than as described in
the PMN 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); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) would help characterize
the environmental effects of the PMN substance. EPA recommends that the
fate testing be performed first as the results may mitigate the need
for further toxicity testing or change the testing recommendations.
CFR citation: 40 CFR 721.10893.
PMN Number P-15-120
Chemical name: Substituted benzyl acrylate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a resin for industrial
coating. Based on SAR analysis of test data on analogous acrylates, 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 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
[[Page 30459]]
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a ready
biodegradability test (OECD Test Guideline 301) would help characterize
the environmental effects of the PMN substance. EPA recommends that the
fate testing be performed first as the results may mitigate the need
for further toxicity testing or change the testing recommendations.
CFR citation: 40 CFR 721.10894.
PMN Number P-15-154
Chemical name: Fluoroalkyl acrylate copolymer (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: May 14, 2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a textile
treatment. 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 the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these 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 an MSDS, within 90 days.
2. Manufacture of the PMN substance: (a) According to the chemical
composition section of the consent order, including analyzing and
reporting certain starting raw material impurities to EPA; and (b)
within the maximum established limits of certain fluorinated impurities
of the PMN substance as stated in the consent order.
3. Submission of certain toxicity, physical-chemical property, and
environmental fate testing on the PMN substance prior to exceeding the
confidential production volume limits as specified in the consent
order.
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 and environmental fate testing would help characterize the PMN
substance. The submitter has agreed to complete the testing identified
in the testing section of the consent order by the confidential limits
specified. In addition, EPA has determined that the results of a 90-day
inhalation toxicity test in rats (OPPTS Test Guideline 870.3465/OECD
Test Guideline 413) with a 60-day holding period, and certain physical
chemical property and environmental fate testing identified in the
consent order would help characterize the human health and fate effects
of the PMN substance. The Order does not require this 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 citation: 40 CFR 721.10895.
PMN Number P-15-176
Chemical name: 1-Hexanol, 6-mercapto-.
CAS number: 1633-78-9.
Basis for action: The PMN states that the substance will be used as
a chemical intermediate to curable monomers. Based on SAR analysis of
test data on analogous thiols, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 8 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 8 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 surface water concentrations exceeding 8 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, freshwater
daphnids (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 recommends that the fate testing be performed
first as the results may mitigate the need for further toxicity testing
or change the testing recommendations.
CFR citation: 40 CFR 721.10896.
PMN Number P-15-177
Chemical name: Phenol, 2,2'-[1,2-disubstituted-1,2-
ethanediyl]bis(iminomethylene)bis[substituted- (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst in the process
to manufacture a crop protection chemical. Based on test data on the
PMN substance, EPA identified concerns for blood toxicity to workers
from dermal exposures to the PMN substance. As described in the PMN,
occupational exposures are expected to be minimal due to use of
adequate dermal personal protection equipment. 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 without the use of chemical
impervious gloves, where there is a potential for dermal exposure, or
any use of the substance other than as described in the PMN may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of a skin
absorption, In vitro method (OECD Test Guideline 428) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10897.
PMN Number P-15-188
Chemical name: Carbomonocycles, polymer with substituted
heteromonocycle, succinate, methyl acrylate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a pigment-wetting resin for Ultra Violet (UV)-curable coatings. Based
on SAR analysis of test data on analogous methacrylates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 7
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 7 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
[[Page 30460]]
listed in the PMN 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 water
solubility test (OECD Test Guideline 105); 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.
The water solubility testing should be conducted prior to conducting
the ecotoxicity testing as the results of the water solubility may
change the recommended ecotoxicity testing.
CFR citation: 40 CFR 721.10898.
PMN Number P-15-190
Chemical name: Halogenated alkyl trimethylaminium halide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be for cationization of starch.
Based on test data on analogous alkylating agents, there were health
concerns regarding mutagenicity, oncogenicity, developmental toxicity
and respiratory sensitization based from exposure to the PMN substance
via inhalation exposure. In addition, based on SAR analysis of test
data on analogous cationic surfactants, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 88 ppb of the
PMN substance in surface waters. As described in the PMN, exposure is
expected to be minimal due to use of adequate respiratory personal
protection equipment and releases of the substance are not expected to
result in surface water concentrations that exceed 88 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 without the use of NIOSH-certified
respirator with an APF of at least 10, where there is a potential for
respiratory exposure, or any use of the substance resulting in surface
water concentrations exceeding 88 ppb may result in serious human
health or significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
bacterial reverse mutation test, (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline
870.5395); an acute oral toxicity test (OPPTS Test Guideline 870.1100);
a repeated dose 28-day oral toxicity study in rodents (OPPTS Test
Guideline 870.3050); a fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by
humic acid test (OPPTS Test Guideline 850.1085); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline
850.4500) would help characterize the human health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10899.
PMN Number P-15-252
Chemical name: Titanium salt, reaction products with silica
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on SAR analysis of test data on analogous insoluble metal oxides,
EPA identified concerns for lung toxicity if inhaled based on lung
overload for respirable, poorly soluble particulates. For the use
described in the PMN, inhalation exposures are expected to be minimal
as the PMN is handled in an enclosed process. 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 in a non-enclosed process, or any use of the
substance other than listed in the PMN 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 inhalation toxicity test (OPPTS Test Guideline 870.3465) with 60-
day holding period and a particle size distribution/fiber length and
diameter distributions (OECD Test Guideline 110) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10900.
PMN Number P-15-272
Chemical name: Formaldehyde, reaction products with aniline and
aromatic mono- and di-phenol mixture (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a resin. Based on SAR
analysis of test data on analogous phenols, 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 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 (OECD Test Guideline
301) would help characterize the environmental effects of the PMN
substance. EPA recommends that the fate testing be performed first as
the results may mitigate the need for further toxicity testing or
change the testing recommendations.
CFR citation: 40 CFR 721.10901.
PMN Number P-15-276
Chemical name: Functionalized carbon nanotubes (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a thin film for electronic device applications. Based on SAR analysis
of test data on analogous carbon nanotubes and other respirable poorly
soluble particulates, EPA identified potential lung effects and skin
penetration and toxicity induction from inhalation and dermal exposure
to the PMN substance. Further, EPA predicts toxicity to aquatic
organisms via releases of the PMN substance to surface water. Although
there is potential for dermal exposure, EPA does not expect significant
occupational exposures due to the use of impervious gloves, and because
the PMN is used in a liquid and is not spray applied except in a closed
system. Further, EPA does not expect environmental releases during the
use identified in the PMN submission. Therefore, EPA has not determined
that the proposed manufacturing, processing, and or use of the
substance may present an unreasonable risk to human health or the
environment. EPA has determined, however, that any use
[[Page 30461]]
of the substance without the use of impervious gloves, where there is
potential for dermal exposure; manufacturing the PMN substance for use
other than as a thin film for electronic device applications;
manufacturing, processing, or using the PMN substance in a form other
than a liquid; use of the PMN substance involving an application method
that generates a mist, vapor, or aerosol except in a closed system; or
any release of the PMN substance into surface waters or disposal other
than by landfill or incineration may cause serious health effects or
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii)
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); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal
toxicity test (OCSPP Test Guideline 850.4500); a 90-day inhalation
toxicity test (OPPTS 870.3465) with additional testing parameters
beyond those noted at CFR 870.3465, for using the 90-day subchronic
protocol for nanomaterial assessment; a two-year inhalation bioassay
(OPPTS Test Guideline 870.4200); and a surface charge by
electrophoresis (for example, using ASTM E2865-12 or NCL Method PCC-2--
Measuring the Zeta Potential of Nanoparticles) would help characterize
the health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10902.
PMN Number P-15-295
Chemical name: Acrylated mixed metal oxides (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate. Based on
SAR analysis of test data on respirable poorly soluble particulates,
EPA identified potential lung effects and dermal toxicity from
inhalation and dermal exposure to the PMN substance. Further, EPA
predicts toxicity to aquatic organisms via releases of the PMN
substance to surface water. Although there is potential for dermal
exposure, EPA does not expect significant occupational exposures due to
the use of impervious gloves, and because the PMN is used in a liquid
and is not spray applied. Further, EPA does not expect environmental
releases during the use identified in the PMN submission. Therefore,
EPA has not determined that the proposed manufacturing, processing, and
or use of the substance may present an unreasonable risk to human
health or the environment. EPA has determined, however, that any use of
the substance without the use of impervious gloves, where there is
potential for dermal exposure; manufacturing, processing, or using the
PMN substance in a form other than as a liquid; use of the PMN
substance involving an application method that generates a mist, vapor,
or aerosol; any release of the PMN substance into surface waters; or
disposal other than by landfill or incineration may cause serious
health effects or significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii) and (b))(ii).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period; 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 and health effects
of the PMN substance.
CFR citation: 40 CFR 721.10903.
PMN Number P-15-306
Chemical name: Phenol, 1,1-dimethylalkyl derivatives (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a process intermediate.
Based on SAR analysis of test data on analogous phenols, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
13 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 13 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 13 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 acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test
Guideline 850.4500); and a Zahn-Wellens/EMPA test (OPPTS Test Guideline
835.3200) would help characterize the environmental effects of the PMN
substance. EPA recommends that the fate testing be performed first as
the results may mitigate the need for further toxicity testing or
change the testing recommendations.
CFR citation: 40 CFR 721.10904.
PMN Number P-15-319
Chemical name: Butanedioic acid, 2-methylene-, dialkyl ester
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate for
production of a lubricant additive. Based on SAR analysis of test data
on analogous acrylates and esters, 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 that resulting in surface water concentrations 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 acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test
Guideline 850.4500); and a ready biodegradability (OECD Test Guideline
301) would help characterize the environmental effects of the PMN
substance. EPA recommends that the fate testing be performed first as
the results may mitigate the need for further toxicity testing or
change the testing recommendations.
CFR citation: 40 CFR 721.10905.
PMN Number P-15-324
Chemical name: Magnesium alkaryl sulfonate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be as a detergent additive in crankcase lubricant applications. Based
on submitted test data on the PMN substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
[[Page 30462]]
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 1 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 listed in the PMN
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
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10906.
PMN Number P-15-326
Chemical name: Polyfluorohydrocarbon (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a specialty gas and
transfer fluid. Based on test data on the PMN substance, EPA identified
concerns for neurotoxicity and uncertain concern for cardiac
sensitization. Further, based on SAR analysis of test data on analogous
substances, EPA identified concerns for developmental toxicity. As
described in the PMN, EPA does not expect significant occupational
exposures due to use of adequate personal protective equipment, and
consumer exposures are not expected as the PMN substance is not used in
consumer products. 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 listed in the PMN or any use in a consumer
product 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)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of 90-day
inhalation toxicity (OPPTS Test Guideline 870.3465) would help
characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.10907.
PMN Number P-15-328
Chemical name: Aluminum calcium oxide salt (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: June 2, 2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as a cement
additive. Based on SAR analysis of test data on analogous respirable,
poorly soluble particulates, EPA identified concerns for lung toxicity
based on lung overload. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the consent order requires:
1. Hazard communication. Establishment and use of a hazard
communication program, including human health precautionary statements
on each label and the MSDS.
2. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 10 or compliance with a NCEL of 5
mg/m\3\ as an 8-hour time-weighted average (when there is potential
inhalation exposure), when there is potential inhalation exposure.
3. Manufacture, processing or use of the PMN substance only for the
use specified in the consent order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) in rats would help
characterize possible health effects of the substance. The Order does
not require this 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 citation: 40 CFR 721.10908.
PMN Number P-15-332
Chemical name: Polyalkyltrisiloxane (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a site-limited
intermediate. Based on SAR analysis of test data on an analogous
substance, there were health concerns regarding liver and kidney
toxicity, thyroid effects, and reproductive and developmental toxicity
from dermal and inhalation exposures to the PMN substance. Further,
based on SAR analysis of test data on analogous neutral organics, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 4 ppb of the PMN substance in surface waters. EPA also 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. Further, as described in
the PMN, exposure is expected to be minimal due to use of adequate
respiratory and dermal personal protection equipment and releases of
the substance are not expected to result in surface water
concentrations exceeding 4 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 4
ppb, any use other than that as a site-limited intermediate, or any use
without the use of a NIOSH-certified respirator with gas/vapor
cartridges and an APF of at least 10 and impervious gloves, may result
in serious human health or significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
sediment-water lumbriculus toxicity test (OECD Test Guideline 225); a
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422); a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the human
health and environmental effects of the PMN substance. All ecotoxicity
tests should analyze the PMN substance as well as the hydrolysis
products.
CFR citation: 40 CFR 721.10909.
PMN Number P-15-356
Chemical names: Oxirane, 2,2'-[[1-[4-[1-methyl-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1-
phenyleneoxymethylene)]bis- (P-15-
[[Page 30463]]
356, Chemical A); and 2-Propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenoxy]- (P-15-356, Chemical B).
CAS numbers: 115254-47-2 (P-15-356, Chemical A) and 180063-56-3 (P-
15-356, Chemical B).
Basis for action: The PMN states that the substances will be used
as additives in polymer formulation for electronics. Based on test data
on the PMN substances and on SAR analysis of test data on analogous
epoxides, EPA identified concerns for respiratory sensitization and
irritation, mutagenicity, developmental toxicity, male reproduction
toxicity, liver and kidney toxicity, and oncogenicity. Additionally,
based on SAR analysis of test data on analogous polyepoxides, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb of the PMN substances in surface waters. Further, EPA has
concerns that the PMN substances are potentially PBT chemicals as
described in the New Chemical Program's PBT category (64 FR 60194;
November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substances
will persist in the environment more than 2 months and estimates a
bioaccumulation factor of greater than or equal to 1,000. For the use
described in the PMN, EPA expects occupational exposures to be minimal
and does not expect releases to surface waters. 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 additives in
polymer formulation for electronics or any use of the substances
resulting in releases to surface waters may cause serious human health
or significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422); a
sediment-water chironomid life-cycle toxicity test (OECD Test Guideline
233), using spiked water or spiked sediment; 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 human
health and environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10910 (P-15-356, chemical A) and 40 CFR
721.10911 (P-15-356, chemical B).
PMN Number P-15-363
Chemical name: Aliphatic acrylate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer. Based on SAR
analysis of test data on analogous acrylates, 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 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.
CFR citation: 40 CFR 721.10912.
PMN Number P-15-378
Chemical name: Diisocyanato hexane, homopolymer, alkanoic acid-
polyalkylene glycol ether with substituted alkane (3:1) reaction
products-blocked (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a dual cure/UV cure adhesion/barrier coating for wood substrates. Based
on SAR analysis of test data on analogous diisocyanates, EPA identified
concerns for respiratory sensitization. As described in the PMN, EPA
does not expect significant occupational dermal or inhalation exposure
due to use of adequate personal protective equipment and consumer
exposures are not expected as the PMN substance is not used in consumer
products. Therefore, EPA has not determined that the proposed
manufacture, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance without a NIOSH-certified particulate respirator with an APF
of at least 10 where there is a potential for inhalation exposure, or
any use in consumer products may cause serious 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 skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10913.
PMN Number P-15-382
Chemical name: Polyitaconic acid, sodium zinc salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
an odor neutralization for pet litter and cleaning hard surface
surfaces, fabrics, skin and hair; an odor neutralization for air car;
and an odor neutralization for waste processing and solid waste
management in paper, oil, gas, mining, agriculture, food and municipal
industries. Based on SAR analysis of test data on analogous zinc salts,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 4 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 4 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 listed in the PMN 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
[[Page 30464]]
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10914.
PMN Number P-15-411
Chemical name: Fatty acid esters with polyols polyalkyl ethers
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an anti-rust coating
solution additive. Based on SAR analysis of test data on analogous
nonionic surfactants, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 30 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 30
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 30 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 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.
CFR citation: 40 CFR 721.10915.
PMN Number P-15-435
Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-3-
[substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3)
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a direct anionic dyestuff
for the printing industry. Based on the results of a 28-day oral study
for the PMN substance, EPA predicts anemia, effects on the adrenals,
spleen, kidney, lymph nodes and immunotoxicity. In addition, based on
the lithium salt of the PMN, EPA identified concerns for developmental
toxicity and neurotoxicity. Further, based on SAR analysis of test data
on analogous azo reduction products, EPA identified concerns for blood
effects, developmental toxicity, oncogenicity, and mutagenicity. As
described in the PMN, EPA does not expect significant risk to workers
due to use of adequate personal protective equipment. 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 in a liquid
formulation could result in exposures which may cause serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of an ames
assay (OPPTS Test Guideline 870.5100) with the rival modification; a
mouse micronucleus assay conducted by the oral route (OPPTS Test
Guideline 870.5395); and a combined repeated dose and developmental
toxicity and reproductive toxicity screening test (OPPTS Test Guideline
870.3650) would help to characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.10916.
PMN Number P-15-492
Chemical name: Polymethylsiloxane, distillation residues (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a site-limited
intermediate. Based on SAR analysis test data on analogous silanes, EPA
identified concerns for mutagenicity, liver and kidney toxicity,
thyroid effects, and reproductive and developmental toxicity from
dermal and inhalation exposures to the PMN substance. Further, based on
SAR analysis of test data on analogous neutral organics, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. For the intermediate use
described in the PMN, occupational exposures are expected to be minimal
due to the use of adequate respiratory and dermal personal protection
equipment, and 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 without the use of a NIOSH-
certified respirator with gas/vapor cartridges and an APF of at least
10, where there is a potential for inhalation exposures, any use of the
substance without the use of impervious gloves, where there is a
potential for dermal exposures; any use of the substance other than an
intermediate; or any use of the substance resulting in surface water
concentrations exceeding 1 ppb may result in serious human health or
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii)
and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
sediment-water lumbriculus toxicity test (OECD Test Guideline 225)
using spiked sediment; a combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test (OECD Test Guideline
422); 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 human health and environmental effects of
the PMN substance. All ecotoxicity tests should analyze for the PMN
substance as well as the hydrolysis products.
CFR citation: 40 CFR 721.10917.
PMN Number P-15-502
Chemical name: Perfluorobutanesulfonamide and polyoxyalkylene
containing polyurethane (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: November 4,
2015.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a protective
treatment. EPA has concerns for potential incineration or other
decomposition products of the PMN substance. These fluorinated
decomposition products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers
which suggest that under some conditions, the PMN substance 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 PFOA and other perfluorinated alkyls, including
the presumed environmental degradant. EPA also has concerns that under
some conditions of use, particularly non-industrial, commercial, or
consumer use, the PMN substance could cause lung effects, based on
limited data on
[[Page 30465]]
some perfluorinated compounds. Concerns for the PMN substance are for
lung toxicity from waterproofing of lung membrane, based on PMN
properties. The order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that the substance and its
potential intermediate and/or ultimate degradation products may present
an unreasonable risk of injury to the environment and human health.
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substance 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 an MSDS, within 90 days.
2. Submission of certain environmental fate testing on the PMN
substance prior to exceeding the confidential production volume limit
as specified in the consent order of the PMN substance.
3. No use of the PMN substance in consumer spray products.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of an
aerobic and anaerobic transformation in soil test (OECD Test Guideline
307) would help characterize the possible degradation of the PMN
substance. The submitter has agreed to submit the results of this test
by the confidential production volume identified in the consent order.
EPA had determined that the results of a phototransformation of
chemicals on soil surfaces (OECD Draft Document January 2002) would
help characterize the degradation potential of the PMN substance. The
Order does not require this 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 citation: 40 CFR 721.10918.
PMN Number P-15-542
Chemical name: Quaternary ammonium compounds, (3-chloro-2-
hydroxypropyl)coco alkyldimethyl, chlorides.
CAS number: 690995-44-9.
Basis for action: The PMN states that the substance will be used as
an intermediate for surfactant production, and as a chemical
intermediate for sale into commerce. Based on SAR analysis of test data
on analogous cationic (quaternary ammonium) surfactants, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
24 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 24 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 24 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.
CFR citation: 40 CFR 721.10919.
PMN Number P-15-559
Chemical name: Modified diphenylmethane diisocyanate prepolymer
with polyol (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for
flexible foam. Based on SAR analysis of analogous diisocyanates, EPA
identified concerns for potential dermal and respiratory sensitization
from dermal and inhalation exposures, and for pulmonary toxicity from
inhalation exposure, to the PMN substance where the average molecular
weight is below 7,500 daltons and any molecular weight species is below
1,000 daltons. For the molecular weight distribution described in the
PMN, significant occupational exposures are not expected. Therefore,
EPA has not determined that the proposed manufacture of the substance
may present an unreasonable risk. EPA has determined, however, that any
manufacture of the PMN substance with an average molecular weight below
7,500 daltons, and where any molecular weight species is below 1,000
daltons may cause serious 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 skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10920.
PMN Number P-15-573
Chemical name: 2-Furancarboxyaldehyde, 5-(chloromethyl)-.
CAS number: 1623-88-7.
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 aldehydes, the EPA identified human health concerns for liver
toxicity, neurotoxicity, sensitization, and cancer to workers exposed
through dermal and inhalation routes. For the chemical intermediate use
described in the PMN, occupational exposures are expected to be minimal
due to the use of adequate personal protective equipment and a
continuous reaction process such that no greater than 50 kilograms of
the PMN substance is present in the workplace at a given time 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 without the use of a NIOSH-
certified respirator with an APF of at least 50, where there is a
potential for inhalation exposures; any use without the use of
impervious gloves, where there is a potential for dermal exposures, any
use of the substance other than as a chemical intermediate; or any use
beyond the annual production volume limit of 15,000 kilograms may
result in serious human health or significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization (OECD Test Guideline 406) would help characterize the
human health effects of the PMN substance; a combined repeated dose
toxicity test with the reproduction/developmental toxicity screening
test (OECD Test Guideline 422) with functional observational battery
(FOB); a standard test method for permeation of liquids and gases
through protective clothing materials under conditions of continuous
contact (ASTM Test Guideline F739) using the format specified in the
standard guide for documenting the results of chemical permeation
testing of materials used in protective clothing materials (ASTM Test
Guideline F1194-99(2010)); and a carcinogenicity test (OECD Test
Guideline 451) would help characterize
[[Page 30466]]
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10921.
PMN Number P-15-607
Chemical name: 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-
tris(alkyl) derivs. (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an initiator for
polymerization. Based on data on the PMN substance, as well as SAR
analysis of test data on analogous peroxides, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 56 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 56 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 listed in the PMN
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) 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) using a
solvent where the effects of the solvent are already known or measured,
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10922.
PMN Number P-15-671
Chemical name: 9-Octadecen-1-amine, hydrochloride (1:1), (9Z)-.
CAS number: 41130-29-4.
Basis for action: The PMN states that the substance will be used as
an emulsifying agent used in the production of asphalt emulsions for
chipsealing and other road maintenance techniques. Based on test data
for the PMN substance, as well as 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 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 result in 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 721.10923.
PMN Numbers P-15-689 and P-15-690
Chemical names: Vegetable fatty acid alkyl esters (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the substances will be used
as chemical intermediates. Based on SAR analysis of test data on
analogous esters, 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
substances to surface water exceeds releases from the use described in
the PMN. For the chemical intermediate use 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 an intermediate may result in 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 toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help to
characterize the environmental effects of the PMN substances. Depending
on the results of these tests, EPA has determined that the results of
an aerobic and anaerobic metabolism test (OECD Test Guideline 308) in
aquatic sediment systems test; and a sediment water chironomid life-
cycle toxicity test (OECD Test Guideline 233) using spiked water or
spiked sediment would help to further characterize the environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.10924.
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 10 of the 55
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 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. 721.160 (see Unit VI.).
In the other 45 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. 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.
[[Page 30467]]
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. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec.
721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective date of
this rule is July 15, 2016 without further notice, unless EPA receives
written adverse or critical comments, or notice of intent to submit
adverse or critical comments before June 15, 2016.
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 15, 2016, 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 10 of the 55 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 41 of the 55 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 16, 2016 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 non-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. ASTM International standards are available
at https://www.astm.org/Standard/index.shtml.
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 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
[[Page 30468]]
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.
721.1725(b)(1) with that under Sec. 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. 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-2015-0810.
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 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.
[[Page 30469]]
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 3, 2016.
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. 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. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10875............................................ 2070-0012
721.10876............................................ 2070-0012
721.10877............................................ 2070-0012
721.10878............................................ 2070-0012
721.10879............................................ 2070-0012
721.10880............................................ 2070-0012
721.10881............................................ 2070-0012
721.10882............................................ 2070-0012
721.10883............................................ 2070-0012
721.10884............................................ 2070-0012
721.10885............................................ 2070-0012
721.10886............................................ 2070-0012
721.10887............................................ 2070-0012
721.10888............................................ 2070-0012
721.10889............................................ 2070-0012
721.10890............................................ 2070-0012
721.10891............................................ 2070-0012
721.10892............................................ 2070-0012
721.10893............................................ 2070-0012
721.10894............................................ 2070-0012
721.10895............................................ 2070-0012
721.10896............................................ 2070-0012
721.10897............................................ 2070-0012
721.10898............................................ 2070-0012
721.10899............................................ 2070-0012
721.10900............................................ 2070-0012
721.10901............................................ 2070-0012
721.10902............................................ 2070-0012
721.10903............................................ 2070-0012
721.10904............................................ 2070-0012
721.10905............................................ 2070-0012
721.10906............................................ 2070-0012
721.10907............................................ 2070-0012
721.10908............................................ 2070-0012
721.10909............................................ 2070-0012
721.10910............................................ 2070-0012
721.10911............................................ 2070-0012
721.10912............................................ 2070-0012
721.10913............................................ 2070-0012
721.10914............................................ 2070-0012
721.10915............................................ 2070-0012
721.10916............................................ 2070-0012
721.10917............................................ 2070-0012
721.10918............................................ 2070-0012
721.10919............................................ 2070-0012
721.10920............................................ 2070-0012
721.10921............................................ 2070-0012
721.10922............................................ 2070-0012
721.10923............................................ 2070-0012
721.10924............................................ 2070-0012
721.10925............................................ 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
[[Page 30470]]
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. 721.10875 to subpart E to read as follows:
Sec. 721.10875 Alkali transition metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkali
transition metal oxide (PMN P-11-150) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the PMN substance after it has been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. (A) Requirements as specified in
Sec. 721.63(a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi),
(b)(concentration set at 0.1 percent), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an Assigned
Protection Factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
(1) Any NIOSH-certified air-purifying elastomeric half-mask
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters.
(2) Any appropriate NIOSH-certified N100 (if oil aerosols absent),
R100, or P100 filtering facepiece respirator.
(3) Any NIOSH-certified air-purifying full facepiece respirator
equipped with N100 (if oil aerosols absent), R100, or P100 filters.
(4) Any NIOSH-certified negative pressure (demand) supplied air
respirator equipped with a half-mask.
(5) Any NIOSH-certified negative pressure (demand) self-contained
breathing apparatus (SCBA) equipped with a half-mask.
(B) As an alternative to the respiratory requirements listed here,
a manufacturer or processor may choose to follow the New Chemical
Exposure Limit (NCEL) provisions listed in the TSCA section 5(e)
consent order for this substance. The NCEL is 2.4 mg/m\3\ as an 8-hour
time weighted average (TWA) verified by actual monitoring data.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a) through (e)(concentration set at 0.1 percent), (f),
(g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii),
(g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv)(use respiratory
protection, or maintain workplace airborne concentrations at or below
an 8-hour time-weighted average of 2.4 mg/m\3\), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in 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) through (d) and (f) through (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)(iii)
of this section.
0
5. Add Sec. 721.10876 to subpart E to read as follows:
Sec. 721.10876 Perfluoroalkyl substituted alkyl sulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoroalkyl substituted alkyl sulfonate (PMN P-11-484) 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 (k)(analysis and reporting and limitations
of maximum impurity levels of certain fluorinated impurities; and use
other described in the consent order), (o)(use in a consumer product
that could be spray applied), and (q).
(ii) Disposal. Requirements as specified in Sec. 721.85.
Incineration of wastes in an incinerator operating at the temperature
of at least 1,000 degrees Celsius and a residence time of minimum of 2
seconds. Any tank or vessel washings, residues from transport vessels
or tanks, and similar materials that are captured and retained in the
normal course of manufacturing and processing for re-use in
manufacturing of the PMN substance or products made from the PMN
substance are exempt from this method of disposal.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1) apply to the PMN substance except
under the terms specified in the consent order.
(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), (j), 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 paragraphs (a)(2)(i)
and (iii) of this section.
0
6. Add Sec. 721.10877 to subpart E to read as follows:
Sec. 721.10877 Polyfluorinated alkyl quaternary ammonium chloride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorinated alkyl quaternary ammonium chloride (PMN P-11-543) 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(k)(analysis and reporting and limitations
of maximum impurity levels of certain fluorinated impurities; and use
other described in the consent order), (o)(use in a consumer product
that could be spray applied), and (q).
(ii) Disposal. Requirements as specified in Sec. 721.85.
Incineration of wastes in an incinerator operating at the temperature
of at least 1,000 degrees Celsius and a residence time of minimum of 2
seconds. Any tank or vessel washings, residues from transport vessels
or tanks, and similar materials that are captured and retained in the
normal course of manufacturing and processing for re-use in
manufacturing of the PMN substance or products made from the PMN
substance are exempt from this method of disposal.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1) apply to the PMN substance except
under the terms specified in the consent order.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
[[Page 30471]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), (j), 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 paragraphs (a)(2)(i)
and (iii) of this section.
0
7. Add Sec. 721.10878 to subpart E to read as follows:
Sec. 721.10878 Polyfluorinatedalkylsulfonyl substituted alkane
derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorinatedalkylsulfonyl substituted alkane derivative (PMN P-14-
67) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this rule do not apply to quantities of the PMN substance after it has
been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72. 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 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) and (o)(use in a consumer product that
could be spray applied), and (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), (h), 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
8. Add Sec. 721.10879 to subpart E to read as follows:
Sec. 721.10879 1-Octadecanaminium, N-(3-chloro-2-hydroxypropyl)-N,N-
dimethyl-, chloride (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-octadecanaminium,
N-(3-chloro-2-hydroxypropyl)-N,N-dimethyl-, chloride (1:1) (PMN P-14-
125; CAS No. 3001-63-6) 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=2).
(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
9. Add Sec. 721.10880 to subpart E to read as follows:
Sec. 721.10880 Fatty acid rxn products with aminoalkylamines
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid rxn products with aminoalkylamines (PMNs P-14-153, P-14-154, P-15-
79, and P-15-80) 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. A significant new use of the substances
is any use other than as chemical intermediates, additives for
flotation products, or adhesion promoters for use in asphalt
applications where the surface water concentrations described under
paragraph (a)(3)(i) of this section are exceeded.
(ii) [Reserved].
(3) The significant new uses for any use other than as chemical
intermediated, additives for flotation products, or adhesion promoters
for use in asphalt applications 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), (i), and (k) 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.
0
10. Add Sec. 721.10881 to subpart E to read as follows:
Sec. 721.10881 Fatty acid amides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid amides (PMNs P-14-155 and P-14-156) are subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use of the substances
is any use other than as chemical intermediates, additives for
flotation products, or adhesion promoters for use in asphalt
applications where the surface water concentrations described under
paragraph (a)(3)(i) of this section are exceeded.
(ii) [Reserved].
(3) The significant new uses for any use other than as chemical
intermediated, additives for flotation products, or adhesion promoters
for use in asphalt applications are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and
[[Page 30472]]
(c)(4) (N=2 for P-14-155 and N=3 for P-14-156).
(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), (i), and (k) 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.
0
11. Add Sec. 721.10882 to subpart E to read as follows:
Sec. 721.10882 Trialkylammonium borodibenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trialkylammonium borodibenzoate (PMN P-14-198) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80(f) and (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 this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
12. Add Sec. 721.10883 to subpart E to read as follows:
Sec. 721.10883 Fatty ester derivatives, reaction products with
alkanolamine, hydroxylated, borated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
ester derivatives, reaction products with alkanolamine, hydroxylated,
borated (PMN P-14-324) 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 of the substance is a
use other than as a lubricating oil additive.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (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
13. Add Sec. 721.10884 to subpart E to read as follows:
Sec. 721.10884 Benzenepropanol, 1-benzoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenepropanol, 1-
benzoate (PMN P-14-397; CAS No. 60045-26-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use of the substance is
use other than as a plasticizer in adhesives for food-product
packaging; a diluents-type plasticizer in plastisol; a coalescent in
architectural paints and coating; and a fragrance carrier in
fragrances.
(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
14. Add Sec. 721.10885 to subpart E to read as follows:
Sec. 721.10885 Alcohols, C12-22, distn. residues.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alcohols,
C12-22, distn. residues (PMN P-14-448; CAS No. 1476777-83-9)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use of the substance is
any use where the cumulative molecular weights of the C12
and C14 components exceed 2 percent by weight of the overall
molecular weight of the PMN substance.
(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
15. Add Sec. 721.10886 to subpart E to read as follows:
Sec. 721.10886 Phosphoric acid, mixed Bu and decyl and octyl and 2-
(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-
phenoxyethyl esters (PMN P-14-501; CAS No. 1502809-48-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(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. 721.10887 to subpart E to read as follows:
Sec. 721.10887 Phosphoric acid, mixed Bu and decyl and octyl and 2-
(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
mixed Bu and decyl and octyl and 2-(2-phenoxyethoxy)ethyl and 2-
phenoxyethyl esters, potassium salts (PMN P-14-502; CAS No.
[[Page 30473]]
1502809-56-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(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
17. Add Sec. 721.10888 to subpart E to read as follows:
Sec. 721.10888 Siloxanes and Silicones, 3-[(2-aminoethyl)amino)propyl
Me, di-Me, reaction products with cadmium zinc selenide sulfide, lauric
acid and oleylamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as siloxanes and
silicones, 3-[(2-aminoethyl)amino)propyl Me, di-Me, reaction products
with cadmium zinc selenide sulfide, lauric acid and oleylamine (PMN P-
15-59; CAS No. 1623456-05-2) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63 (a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p) (three months and eighteen months). A
significant new use of the substance is manufacture, process, or use
the chemical substance other than as a down converter for an optical
filter for light emitting diodes used in displays, or other than in a
liquid formulation.
(iii) Disposal. Requirements as specified in Sec. 721.85. It is a
significant new use to dispose of the chemical substance other than by
incineration in a permitted hazardous waste incinerator.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (j) 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
18. Add Sec. 721.10889 to subpart E to read as follows:
Sec. 721.10889 Dodecanoic acid, reaction products with cadmium zinc
selenide sulfide and oleylamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as dodecanoic acid,
reaction products with cadmium zinc selenide sulfide and oleylamine
(PMN P-15-60; CAS No. 1773514-92-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. It is a significant new use to
manufacture, process, or use the chemical substance other than as a
chemical intermediate or other than in a liquid formulation.
(iii) Disposal. Requirements as specified in Sec. 721.85. It is a
significant new use to dispose of the chemical substance other than by
incineration in a permitted hazardous waste incinerator.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i) and (j) 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. 721.10890 to subpart E to read as follows:
Sec. 721.10890 Phosphonic acid, P-tetradecyl-, reaction products with
cadmium selenide (CdSe).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonic acid, P-
tetradecyl-, reaction products with cadmium selenide (CdSe) (PMN P-15-
104; CAS No. 1773514-66-1) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. It is a significant new use to
manufacture, process, or use the chemical substance other than as a
chemical intermediate or other than in a liquid formulation.
(iii) Disposal. Requirements as specified in Sec. 721.85 It is a
significant new use to dispose of the chemical substance other than by
incineration in a permitted hazardous waste incinerator.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (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
20. Add Sec. 721.10891 to subpart E to read as follows:
Sec. 721.10891 Alkyl silicate, polymer with 2-(chloromethyl)oxirane
and 4,4'-(1-methylethylidene)bis[phenol], alkoxylated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
silicate, polymer
[[Page 30474]]
with 2-(chloromethyl)oxirane and 4,4'-(1-methylethylidene)bis[phenol],
alkoxylated (PMN P-15-81) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in 40
CFR 721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1
percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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 provisions of Sec. 721.185 apply to this section.
0
21. Add Sec. 721.108992 to subpart E to read as follows:
Sec. 721.10892 Reaction product of a mixture of aromatic dianhydrides
and aliphatic esters with an aromatic diamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of a mixture of aromatic dianhydrides and aliphatic
esters with an aromatic diamine (PMN P-15-109) 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=11).
(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
22. Add Sec. 721.10893 to subpart E to read as follows:
Sec. 721.10893 Fatty acids, tall-oil, reaction products with an ether
and triethylenetetramine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, tall-oil, reaction products with an ether and
triethylenetetramine (PMN P-15-111) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (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 this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
23. Add Sec. 721.10894 to subpart E to read as follows:
Sec. 721.10894 Substituted benzyl acrylate (generic)
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzyl acrylate (PMN P-15-120) 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
24. Add Sec. 721.10895 to subpart E to read as follows:
Sec. 721.10895 Fluoroalkyl acrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fluoroalkyl
acrylate copolymer (PMN P-15-154) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72. 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 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) (analysis and reporting and limitations
of maximum impurity levels of certain fluorinated impurities), and (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) through (e) 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
25. Add Sec. 721.10896 to subpart E to read as follows:
[[Page 30475]]
Sec. 721.10896 1-Hexanol, 6-mercapto-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-hexanol, 6-
mercapto-. (PMN P-15-176; CAS No.1633-78-9) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(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
26. Add Sec. 721.10897 to subpart E to read as follows:
Sec. 721.10897 Phenol, 2,2'-[1,2-disubstituted-1,2-
ethanediyl]bis(iminomethylene)bis[substituted- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified
generically as phenol, 2,2'-[1,2-disubstituted-1,2-
ethanediyl]bis(iminomethylene)bis[substituted- (PMN P-15-177) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii), and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(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), (d), (e), 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
27. Add Sec. 721.10898 to subpart E to read as follows:
Sec. 721.10898 Carbomonocycles, polymer with substituted
heteromonocycle, succinate, methyl acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbomonocycles, polymer with substituted heteromonocycle, succinate,
methyl acrylate (PMN P-15-188) 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 of the substance is
any use other than as a pigment-wetting resin for UV-curable coatings.
(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
28. Add Sec. 721.10899 to subpart E to read as follows:
Sec. 721.10899 Halogenated alkyl trimethylaminium halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkyl trimethylaminium halide (PMN P-15-190) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(i), (b)(concentration set at 0.1 percent) and (c).
When determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(4), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
assigned protection factor (APF) of at least 10 meet the requirements
of Sec. 721.63(a)(4):
(A) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=88).
(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), (d), 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
29. Add Sec. 721.10900 to subpart E to read as follows:
Sec. 721.10900 Titanium salt, reaction products with silica
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
titanium salt, reaction products with silica (PMN P-15-252) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(i), (a)(6)(ii), and (c). When determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified air-purifying elastomeric half-mask respirator
equipped with N100 (if oil aerosols absent), R100, or P100 filters.
(B) NIOSH-certified N100 (if oil aerosols absent), R100, or P100
filtering facepiece respirator.
[[Page 30476]]
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d) 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
30. Add Sec. 721.10901 to subpart E to read as follows:
Sec. 721.10901 Formaldehyde, reaction products with aniline and
aromatic mono- and di-phenol mixture (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, reaction products with aniline and aromatic mono- and di-
phenol mixture (PMN P-15-272) 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
31. Add Sec. 721.10902 to subpart E to read as follows:
Sec. 721.10902 Functionalized carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
functionalized carbon nanotubes (PMN P-15-276) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this rule do not apply to
quantities of the PMN substance after it has been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is manufacture,
process, or use of the PMN substance other than in a liquid
formulation. A significant new use is use other than as a thin film for
electronic device applications or any use involving an application
method that generates a vapor, mist, or aerosol unless such application
method occurs in an enclosed process. An enclosed process is defined as
an operation that is designed and operated so that there is no release
associated with normal or routine production processes into the
environment of any substance present in the operation. An operation
with inadvertent or emergency pressure relief releases remains an
enclosed process so long as measures are taken to prevent worker
exposure to and environmental contamination from the releases.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), (j), 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
32. Add Sec. 721.10903 to subpart E to read as follows:
Sec. 721.10903 Acrylated mixed metal oxides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acrylated mixed metal oxides (PMN P-15-295) 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 after it has been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), and (a)(3). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(v)(1), (v)(2), (w)(1), (w)(2), (x)(1),
(x)(2), and (y)(1).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), (j), 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
33. Add Sec. 721.10904 to subpart E to read as follows:
Sec. 721.10904 Phenol, 1,1-dimethylalkyl derivatives (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically phenol,
1,1-dimethylalkyl derivatives (PMN P-15-306) 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=13).
(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.
[[Page 30477]]
0
34. Add Sec. 721.10905 to subpart E to read as follows:
Sec. 721.10905 Butanedioic acid, 2-methylene-, dialkyl ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
butanedioic acid, 2-methylene-, dialkyl ester (PMN P-15-319) 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
35. Add Sec. 721.10906 to subpart E to read as follows:
Sec. 721.10906 Magnesium alkaryl sulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
magnesium alkaryl sulfonate (PMN P-15-324) 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 of the substance is
any use other than as a detergent additive in crankcase lubricant
applications.
(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
36. Add Sec. 721.10907 to subpart E to read as follows:
Sec. 721.10907 Polyfluorohydrocarbon (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyfluorohydrocarbon (PMN P-15-326) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80(j) and (o).
(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.
(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
37. Add Sec. 721.10908 to subpart E to read as follows:
Sec. 721.10908 Aluminum calcium oxide salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aluminum calcium oxide salt (PMN P-15-328) 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 after it has been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63 (a)(4), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
Assigned Protection Factor (APF) of at least 10 meet the requirements
of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting face piece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full face piece.
As an alternative to the respiratory requirements listed here, a
manufacturer or processor may choose to follow the New Chemical
Exposure Limit (NCEL) provisions listed in the TSCA section 5(e)
consent order for this substance. The NCEL is 5 mg/m\3\ as an 8-hour
time weighted average verified by actual monitoring data.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a) trhough (f)(concentration set at 1.0 percent),
(g)(1)(ii), (g)(2)(When using this substance avoid breathing the
substance, and use respiratory protection, or maintain workplace
airborne concentrations at or below an 8-hour time-weighted average of
5 mg/m\3\.) and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d) and (f) through 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)(iii)
of this section.
0
38. Add Sec. 721.10909 to subpart E to read as follows:
Sec. 721.10909 Polyalkyltrisiloxane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyalkyltrisiloxane (PMN P-15-332) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(i), (b)(concentration
set at 1.0 percent), and (c). When determining
[[Page 30478]]
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified power air- purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Industrial commercial, and consumer activities. Requirements
as specified in Sec. 721.80(h).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (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) through (e), (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
39. Add Sec. 721.10910 to subpart E to read as follows:
Sec. 721.10910 Oxirane, 2,2'-[[1-[4-[1-methyl-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1-
phenyleneoxymethylene)]bis- (P-15-356, Chemical A).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2,2'-[[1-
[4-[1-methyl-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1-
phenyleneoxymethylene)]bis- (PMN P-15-356, Chemical A; CAS No. 115254-
47-2) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use of the substance is
any use other than as an additive in polymer formulation for
electronics.
(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 provisions of Sec. 721.185 apply to this section.
0
40. Add Sec. 721.10911 to subpart E to read as follows:
Sec. 721.10911 2-Propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenoxy]- (P-15-356, Chemical B).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanol, 1,3-
bis[4-[1-[4-[1-methyl-1-[4-(2-oxiranylmethoxy)phenyl]ethyl]phenyl]-1-
[4-(2-oxiranylmethoxy)phenyl]ethyl]phenoxy]- (PMN P-15-356, Chemical B;
CAS No. 180063-56-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use of the substance is
any use other than as an additive in polymer formulation for
electronics.
(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 provisions of Sec. 721.185 apply to this section.
0
41. Add Sec. 721.10912 to subpart E to read as follows:
Sec. 721.10912 Aliphatic acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aliphatic acrylate (PMN P-15-363) 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
42. Add Sec. 721.10913 to subpart E to read as follows:
Sec. 721.10913 Diisocyanato hexane, homopolymer, alkanoic acid-
polyalkylene glycol ether with substituted alkane (3:1) reaction
products-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
diisocyanato hexane, homopolymer, alkanoic acid-polyalkylene glycol
ether with substituted alkane (3:1) reaction products-blocked (PMN P-
15-378) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(ii), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. The following
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of at least 10
meet the requirements of Sec. 721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet.
[[Page 30479]]
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d) 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
43. Add Sec. 721.10914 to subpart E to read as follows:
Sec. 721.10914 Polyitaconic acid, sodium zinc salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyitaconic acid, sodium zinc salt (PMN P-15-382) 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) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use of the substance is
any use other than as an odor neutralization for pet litter and
cleaning hard surface surfaces, fabrics, skin and hair; an odor
neutralization for air car; and an odor neutralization for waste
processing and solid waste management in paper, oil, gas, mining,
agriculture, food and municipal industries.
(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
44. Add Sec. 721.10915 to subpart E to read as follows:
Sec. 721.10915 Fatty acid esters with polyols polyalkyl ethers
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid esters with polyols polyalkyl ethers (PMN P-15-411) 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=30).
(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
45. Add Sec. 721.10916 to subpart E to read as follows:
Sec. 721.10916 2,7-Naphthalenedisulfonic acid, 4-amino-3-
[substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3)
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,7-
naphthalenedisulfonic acid, 4-amino-3-[substituted]-5-hydroxy-6-[(1E)-
2-phenyldiazenyl]-, lithium salt (1:3) (PMN P-15-435) 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 of the substance is
any use other that in a liquid formulation.
(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.
0
46. Add Sec. 721.10917 to subpart E to read as follows:
Sec. 721.10917 Polymethylsiloxane, distillation residues (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polymethylsiloxane, distillation residues (PMN P-15-492) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec. 721.63(a)(4), engineering
control measures (e.g., enclosure or confinement of the operations,
general and local ventilation) or administrative control measure (e.g.,
workplace policies and procedures) shall be considered and implemented
to prevent exposure, where feasible. The following National Institute
for Occupational Safety and Health (NIOSH)-certified respirator with an
assigned protection factor (APF) of at least 10 meets the minimum
requirements for Sec. 721.63(a)(4): NIOSH-certified powered air-
purifying respirator with a hood or helmet and with appropriate gas-
vapor (acid gas, organic vapor, or substance specific) cartridges.
(ii) Industrial commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (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
47. Add Sec. 721.10918 to subpart E to read as follows:
Sec. 721.10918 Perfluorobutanesulfonamide and polyoxyalkylene
containing polyurethane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluorobutanesulfonamide and polyoxyalkylene containing polyurethane
(PMN P-15-502) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this rule do not apply to quantities of the PMN
substance after it has been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substance is
[[Page 30480]]
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 TSCA section
5(e) consent order for the substance, 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 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).
(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), (h), 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
48. Add Sec. 721.10919 to subpart E to read as follows:
Sec. 721.10919 Quaternary ammonium compounds, (3-chloro-2-
hydroxypropyl)coco alkyldimethyl, chlorides.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as quaternary ammonium
compounds, (3-chloro-2-hydroxypropyl)coco alkyldimethyl, chlorides (PMN
P-15-542; CAS No. 690995-44-9) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=24).
(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
49. Add Sec. 721.10920 to subpart E to read as follows:
Sec. 721.10920 Modified diphenylmethane diisocyanate prepolymer with
polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified diphenylmethane diisocyanate prepolymer with polyol (PMN P-15-
559) 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 of the substance is
manufacture of the substance where the average molecular weight is
below 7,500 daltons, and where any molecular weight species is below
1,000 daltons.
(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
50. Add Sec. 721.10921 to subpart E to read as follows:
Sec. 721.10921 2-Furancarboxyaldehyde, 5-(chloromethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
furancarboxyaldehyde, 5-(chloromethyl)- (PMN P-15-573; CAS No. 1623-88-
7) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), and (c). When
determining which persons are reasonably likely to be exposed as
required for Sec. 721.63(a)(4), engineering control measures (e.g.,
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible. The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
assigned protection factor (APF) of at least 50 meet the requirements
of Sec. 721.63(a)(4):
(A) NIOSH-certified powered air-purifying respirator with a tight-
fitting half mask and HEPA filters.
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a tight-fitting half mask.
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator equipped with a full facepiece.
(ii) Industrial commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) (chemical intermediate use in a
continuous reaction process such that no greater than 50 kilograms is
present in the workplace at a given time) and (s)(15,000 kilograms).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) 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
51. Add Sec. 721.10922 to subpart E to read as follows:
Sec. 721.10922 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-
tris(alkyl) derivs. (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
11,2,4,5,7,8-hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs.
(PMN P-15-607) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
[[Page 30481]]
(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 this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
52. Add Sec. 721.10923 to subpart E to read as follows:
Sec. 721.10923 9-Octadecen-1-amine, hydrochloride (1:1), (9Z)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 9-octadecen-1-
amine, hydrochloride (1:1), (9Z)- (PMN P-15-671; CAS No. 41130-29-4) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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
53. Add Sec. 721.10924 to subpart E to read as follows:
Sec. 721.10924 Vegetable fatty acid alkyl esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
vegetable fatty acid alkyl esters (PMNs P-15-689 and P-15-690) 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(g).
(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.
[FR Doc. 2016-11121 Filed 5-13-16; 8:45 am]
BILLING CODE 6560-50-P