Significant New Use Rules on Certain Chemical Substances, 39267-39288 [2014-15774]
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Vol. 79
Wednesday,
No. 131
July 9, 2014
Part VI
Environmental Protection Agency
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40 CFR Parts 9 and 721
Significant New Use Rules on Certain Chemical Substances; Direct Final
Rule
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Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2014–0166; FRL–9910–01]
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 43 chemical substances
which were the subject of
premanufacture notices (PMNs). Six of
these chemical substances are subject to
TSCA section 5(e) consent orders issued
by EPA. This action requires persons
who intend to manufacture (including
import) or process any of these 43
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
September 8, 2014. For purposes of
judicial review, this rule shall be
promulgated at 1 p.m. (e.s.t.) on July 23,
2014.
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 August 8, 2014 (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 August 8,
2014, EPA will withdraw the relevant
sections of this direct final rule before
its effective date.
For additional information on related
reporting requirement dates, see Units
I.A., VI., and VII. of the SUPPLEMENTARY
INFORMATION.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2014–0166, 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 (7405
M), Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–9232; email address:
moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this rule. The following list
of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to these SNURs
must certify their compliance with the
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
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intend to export a chemical substance
that is the subject of a proposed or final
SNUR, 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 submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
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
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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).
Consult that preamble for further
information on the objectives, rationale,
and procedures for SNURs and on the
basis for significant new use
designations, including provisions for
developing test data.
B. What is the Agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘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
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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 43 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
43 chemical substances in 40 CFR part
721, subpart E. In this unit, EPA
provides the following information for
each chemical substance:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS)
Registry number (if assigned for nonconfidential chemical identities).
• Basis for the 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 and
importation volume) and other uses
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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 6 PMN substances
(P-11-526, P-12-241, P-12-242, P-12-557,
P-12-558, and P-13-237) that are subject
to ‘‘risk-based’’ consent orders under
TSCA section 5(e)(1)(A)(ii)(I) where EPA
determined that activities associated
with the PMN substances may present
unreasonable risk to human health or
the environment. Those consent orders
require protective measures to limit
exposures or otherwise mitigate the
potential unreasonable risk. The socalled ‘‘TSCA section 5(e) SNURs’’ on
these PMN substances are promulgated
pursuant to § 721.160, and are based on
and consistent with the provisions in
the underlying consent orders. The
TSCA section 5(e) SNURs designate as
a ‘‘significant new use’’ the absence of
the protective measures required in the
corresponding consent orders.
This rule also includes SNURs on 36
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, ‘‘(i) are
different from those described in the
premanufacture notice for the
substance, including any amendments,
deletions, and additions of activities to
the premanufacture notice, and (ii) may
be accompanied by changes in exposure
or release levels that are significant in
relation to the health or environmental
concerns identified’’ for the PMN
substance.
PMN Numbers P-08-512 and P-08-513
Chemical names: (P-08-512) Alcohol
propoxylate (generic) and (P-05-513)
Alcohol propoxylate sulfate salt
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances are as a chemical
intermediate (P-08-512), and for
enhanced oil recovery applications (P-
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08-513). Based on structural activity
relationship (SAR) analysis of the test
data on analogous neutral organics (P08-512) and anionic surfactants (P-08513), EPA predicts toxicity to aquatic
organisms at concentrations that exceed
1 part per billion (ppb) of P-08-512 and
15 ppb of P-08-513 in surface waters.
However, based on test data submitted
on analogous chemical substances, EPA
expects the actual risk to aquatic
organisms in surface waters to be
significantly mitigated following
biological treatment at publicly owned
treatment works or at on-site waste
water treatment plants, injection to
Class I or II wells, or incineration. As
described in the PMN notices, releases
are either injected into Class I or II
wells, incinerated, or released to surface
waters after biological treatment.
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 nonindustrial use, or any release during
manufacturing, processing, or use other
than injection to Class I or II wells,
incineration, or release to water
following biological treatment and
clarification may cause significant
adverse environmental effects. Based on
this information, the PMN substances
meets the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
Modified Shake-Flask Biodegradation
Test (Cripe, C.R., Walker, W.W.,
Pritchard, P.H., Borquin, A.W. (1987).
Shake-Flask Test for Estimation of
Biodegradability of Toxic Organic
Substances in the Aquatic Environment.
Ecotoxicology and Environmental Safety
14:239–251) utilizing an algal toxicity
test (Office of Chemical Safety and
Pollution Prevention (OCSPP) Test
Guideline 850.4500); an aquatic
invertebrate toxicity test, freshwater
daphnids (OPPTS Test Guideline
850.1010); and a fish acute toxicity test,
freshwater and marine (OPPTS Test
Guideline 850.1075) with supplemental
analytics to identify degradation
products, would help to characterize the
environmental effects of the PMN
substances. Testing is recommended to
be conducted on P-08-513. EPA suggests
conducting the modified shake-flask
biodegradation test first as the results
may impact the ecotoxicity testing
recommendations.
CFR citation: 40 CFR 721.10725 (P-08512) and 40 CFR 721.10726 (P-08-513).
PMN Number P-11-526
Chemical name: Amphoteric
fluorinated surfactant (generic).
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CAS number: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: August 20, 2013.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substance
will be as a surface active agent. Based
on test data on the PMN substance and
data currently available to the Agency
on analogous perfluorooctanoic acid
(PFOA), EPA identified concerns for
potential incineration or other
decomposition products or degradants
of the PMN substance. EPA also has
concerns that exposures to the PMN
substance under certain conditions of
use—particularly non-industrial,
commercial, or consumer uses—could
cause lung effects, based on data on
analogous perfluorinated compounds.
PFOA is expected to persist for years in
the environment. Biodegradation and
photolysis tests of analogous substances
indicate little or no biodegradation or
photolysis of perfluoroalkyl
compounds. Bioaccumulation concerns
are based on the measured presence of
certain perfluoroalkyl compounds,
including PFOA, in wildlife and in
human blood samples. Toxicity studies
on PFOA indicate developmental,
reproductive and systemic toxicity in
various species, as well as cancer. These
factors taken together raise concerns for
potential adverse chronic effects in
humans and wildlife. The consent 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 human
health and the environment, these
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 risks, the consent order requires:
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 a
Material Safety Data Sheet (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 material impurities to
EPA; and (b) within the maximum
established limits of certain fluorinated
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impurities of the PMN substance as
stated in the consent order.
3. Use of the substance only as
described in the consent order.
4. Submission of certain testing prior
to exceeding the confidential
production volume limit of the PMN
substance 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 test data from
certain human health, environmental
fate, and ecotoxicity testing identified in
the consent order would help
characterize possible effects of the
substances and their degradation
products. The company has agreed not
to exceed the first production limit
without performing a Zahn-Wellens
biodegradation test (OPPTS Test
Guideline 835.5200) with analysis for
degradation products as specified, and a
hydrolysis test as a function of pH and
temperature (OPPTS Test Guideline
835.2130). The PMN submitter has also
agreed not to exceed the second
production limit without performing a
90-day repeated dose oral toxicity study
in rats with 1-generation reproduction
parallel study (must include
modifications) (OECD Test Guideline
421 modified) and a soil biodegradation
study (OECD Test Guideline 307). The
company has agreed not to exceed the
third production limit without
performing an ultraviolet (UV) visible
light absorption study (OPPTS Test
Guideline 830.7050), a direct photolysis
test, if wavelengths greater than 290
nautical miles (nm) are absorbed in the
previous test (OPPTS Test Guideline
830.7050) (OPPTS Test Guideline
835.2210), an indirect photolysis
screening test (OPPTS Test Guideline
835.5270), an anaerobic biodegradability
of organic compounds in digested
sludge test (OECD Test Guideline 311),
and an avian reproduction test (OPPTS
Test Guideline 850.2300) in bobwhite
quail. Further testing details are
available in the consent order located in
the docket under docket EPA–HQ–
OPPT–2014–0166. The consent order
does not require submission of the
additional pended testing detailed in
the consent order at any specified time
or production volume. However, the
consent order’s restrictions on
manufacture, processing, distribution in
commerce, use, and disposal of the
PMNs will remain in effect until the
consent order is modified or revoked by
EPA based on submission of that or
other relevant information.
CFR citation: 40 CFR 721.10727.
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PMN Numbers P-12-241 and P-12-242
Chemical names: (P-12-241) 2Propenoic acid, 2-methyl-, 2hydroxyethyl esters, telomers with C1826-alkyl acrylate, 1-dodecanethiol, N(hydroxymethyl)-2-methyl-2propenamide, polyfluorooctyl
methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated
(generic) and (P-12-242) 2-Propenoic
acid, 2-methyl-, C16-18 esters, telomers
with 3-chloro-2-hydroxypropyl
methacrylate, 1-dodecanethiol, N(hydroxymethyl)-2-methyl-2propenamide, polyfluorooctyl
methacrylate, and rel- (1R,2R,4R)-1,7,7trimethylbicyclo[2.2.1]hept-2-yl
methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated
(generic).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: June 5, 2013.
Basis for TSCA section 5(e) consent
order: The PMNs state that the generic
(non-confidential) use of these
substances is as a water and oil
repellant. Based on analogy to other
perfluorinated chemicals, including
PFOA, EPA has concerns for potential
fluorinated incineration or other
decomposition products of the PMN
substances. EPA has concerns that these
perfluorinated products may be released
to the environment from incomplete
incineration of the PMN substances at
low temperatures. EPA has preliminary
evidence that suggests that, under some
conditions, the PMN substances could
degrade in the environment. Based on
data on analogous chemicals, including
PFOA, EPA has concerns that these
degradation products will persist in the
environment, could bioaccumulate or
biomagnify, and could be toxic to
people, wild mammals, and birds.
PFOA is expected to persist for years in
the environment. Biodegradation and
photolysis tests of analogous substances
indicate little or no biodegradation or
photolysis of perfluoroalkyl
compounds. Bioaccumulation concerns
are based on the measured presence of
certain perfluoroalkyl compounds,
including PFOA, in wildlife and in
human blood samples. Toxicity studies
on PFOA indicate developmental,
reproductive and systemic toxicity in
various species, as well as possible
cancer concerns. These factors, taken
together, raise concerns for potential
adverse chronic effects in humans and
wildlife. The consent order was issued
under TSCA section 5(e)(1)(A) based on
a finding that these substances may
present an unreasonable risk of injury to
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human health and the environment,
these 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 risks, the consent order requires:
1. Risk notification. If as a result of
the test data required, the company
becomes aware that the PMN substances
may present a risk of injury to human
health or the environment, the company
must incorporate this new information,
and any information on methods for
protecting against such risk into a
Material Safety Data Sheet (MSDS),
within 90 days.
2. Manufacture of the PMN
substances: (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
substances as stated in the consent
order.
3. Use of the substances only as
described in the consent order.
4. Submission of certain
environmental fate and toxicity testing
prior to exceeding the confidential
production volume limit of the
aggregate amount of the PMN
substances described in P-12-241 and P12-242 specified in the consent order.
5. The individual annual manufacture
volume for P-12-241 and P-12-242 must
not reach the confidential annual
production volume 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 test data from
certain human health, environmental
fate, and ecotoxicity testing identified in
the consent order would help
characterize possible effects of the
substances and their degradation
products. The company has agreed not
to exceed the first production limit
without performing a hydrolysis as a
function of pH and temperature test
(OPPTS Test Guideline 835.2130), a
ready biodegradation test (OPPTS Test
Guideline 835.3110), a UV/Visible light
spectrum test (OPPTS Test Guideline
830.7050), a direct photolysis test
(OPPTS Test Guideline 835.2210) and
an indirect photolysis screening test
(OPPTS Test Guideline 835.5270). The
company has also agreed not to exceed
the second production limit without
performing a modified semi-continuous
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activated sludge (SCAS) with analysis of
degradation products test (OPPTS Test
Guideline 835.5045/), an aerobic/
anaerobic transformation in soil test
(OECD Test Guideline 307), an
anaerobic biodegradability of organic
compounds in digested sludge test
(OECD Test Guideline 311), a
phototransformation of chemicals in soil
test, 2002, surfaces—2 soils (draft
OECD, a simulation test—aerobic
sewage treatment (activated sludge
units) (OECD Test Guideline 303A), an
aerobic and anaerobic transformation in
aquatic sediment systems test (OECD
Test Guideline 308), and an acute
inhalation toxicity test (OPPTS Test
Guideline 870.1300). Further testing
details are available in the consent order
located in the docket under docket
EPA–HQ–OPPT–2014–0166. The
consent order does not require
submission of the pended testing
detailed in the consent order at any
specified time or production volume.
However, the consent order’s
restrictions on manufacture, processing,
distribution in commerce, use, and
disposal of the PMNs will remain in
effect until the consent order is
modified or revoked by EPA based on
submission of that or other relevant
information.
CFR citation: 40 CFR 721.10728 (P-12241) and 40 CFR 721.10729 (P-12-242).
PMN Numbers P-12-557 and P-12-558
Chemical names: (P-12-557) Tires,
wastes, pyrolyzed, C6-39 oil fraction
and (P-12-58) Tires, wastes, pyrolyzed,
C7-56 oil fraction.
CAS numbers: (P-12-557) 1410795–
89–9 and (P-12-558) 1410795-87-7.
Effective date of TSCA section 5(e)
consent order: July 22, 2013.
Basis for TSCA section 5(e) consent
order: The PMNs state that the
substances will be used as naphtha used
for high octane gas and cleaning fluids,
kerosene used for jet fuels, distillate fuel
oil used for off-highway diesel engines
and power generation, and vacuum gas
oil used for gasoline. Based on
structure-activity relationship analysis
of test data on analogous neutral organic
chemicals, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 360 ppb (for
P-12-557) and 170 ppb (for P-12-558) in
surface waters. The consent order was
issued under TSCA sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I) based on a finding
that uncontrolled manufacture,
processing, distribution in commerce,
use, and disposal of these substances
may present an unreasonable risk of
injury to the environment. To protect
against these risks, the consent order
requires:
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1. Establishment and use of a hazard
communication program, including
human health, environmental hazard
precautionary statements on each label
and the MSDS.
2. Use of the substances only as
described in the consent order.
3. No use of the substances resulting
in surface water concentrations
exceeding the concentrations of concern
identified in the releases to water
section of the consent order.
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 text, 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. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be followed. The
order does not require the submission of
these tests 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 721.10730 (P-12557) and 40 CFR 721.10731 (P-12-558).
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PMN Number P-13-60
Chemical name: Neodymium,
butadiene iso-Bu neodecanoate
complexes.
CAS number: 1386395–00–1.
Basis for action: The PMN states that
the use of the substance is as a precursor
to polymerization catalyst. Based on
SAR analysis of test data on analogous
neodymium complexes, 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 exceeding
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 resulting in
releases to surface waters exceeding 8
ppb may cause 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 (OPPT Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPT 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 721.10732.
PMN Number P-13-237
Chemical name: Tires, wastes,
pyrolyzed, C5-15 condensate oil
fraction.
CAS number: Claimed confidential.
Chemical substance definition: A
complex combination of hydrocarbons
obtained from the substance produced
by the pyrolysis of rubber-based tires
after removal of the carbon black
fraction. It consists predominantly of
hydrocarbons having carbon numbers in
the range of C5 through C15. It boils in
the range of approximately 36 °C to 265
°C (97 °F to 509 °F).
Effective date of TSCA section 5(e)
consent order: August 8, 2013.
Basis for TSCA section 5(e) consent
order: The PMN states that the use of
the substance will be as a raw feed stock
for refineries. Based on data for benzene
which comprises 6% of the PMN
substance, EPA identified concerns for
oncogenicity, immunotoxicity, and liver
and blood toxicity. Based on data for
limonene, which constitutes 13% of the
PMN substance, EPA identified
concerns for dermal sensitization. Based
on SAR analysis for neutral organic
chemicals the PMN substance may be
toxic to aquatic organisms at
concentrations as low as 4 ppb. The
order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based
on a finding that this substance may
present an unreasonable risk of injury to
human health or the environment. To
protect against this risk, the consent
order requires:
1. An 8-hour time-weighted-average
(TWA) inhalation exposure limit of 1
part per million (ppm) to the PMN
substance.
2. Use of the PMN substance only as
a raw feed stock for refineries.
3. No use of the substance resulting in
surface water concentrations that exceed
4 ppb.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of inhalation
monitoring data, collected according to
the EPA draft Inhalation Monitoring
Data Collection Guidelines (located in
the docket to this rule); a fish acute
toxicity test, freshwater and marine
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(OPPTS Test Guideline 850.1075); an
aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.l010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
human health and environmental effects
of the PMN substance. The order does
not require submission of these tests at
any specified time or production
volume. However, the order’s
restrictions on manufacture, processing,
distribution in commerce, use, and
disposal of the PMN substance 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 721.10733.
PMN Number P-13-248
Chemical name: Lithium salt of
substituted imide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an electrolyte.
Based on test data on the PMN
substance, and SAR analysis of test data
on analogous lithium salts, the EPA
identified concerns for irritation,
possible corrosion, acute toxicity, blood
and thyroid effects, neurotoxicity, and
immunotoxicity from exposure to the
PMN substance via inhalation and
dermal exposures. As described in the
PMN, occupational exposures are
expected to be minimal due to the use
of a National Institute of Occupational
Safety and Health (NIOSH)-certified
particulate respirator with an assigned
protection factor (APF) of at least 10.
Further, general population exposures
are not expected as the PMN 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 PMN substance without
a NIOSH-certified particulate respirator
with an APF of at least 10, where there
is a potential for inhalation exposures;
or any use in a consumer product may
cause serious 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 inhalation
monitoring data, collected according to
the EPA draft Inhalation Monitoring
Data Collection Guidelines (located in
the docket to this rule) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10734.
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PMN Number P-13-270
Chemical name: Aromatic dibenzoate
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance is as a catalyst component.
Based on SAR analysis of test data on
analogous esters, EPA predicts chronic
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substance in surface waters.
Based on uses 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 should there
be any new use of the substance
resulting in releases to surface waters
exceeding 1 ppb significant adverse
environmental effects could occur.
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
sediment-water chironomid life-cycle
toxicity test using spiked water or
spiked sediment (OECD Test Guideline
233); a hydrolysis test (OECD Test
Guideline 111); and a Zahn-Wellens
inherent biodegradation test (OECD Test
Guideline 302B) would help
characterize the potential for chronic
aquatic toxicity of the PMN substance.
EPA also recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be followed to
facilitate solubility in the test media,
because of the PMN substance’s low
water solubility.
CFR citation: 40 CFR 721.10735.
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PMN Number P-13-309
Chemical name: Alcohols, C9–11branched, ethoxylated propoxylated.
CAS number: 1400790–00–2.
Basis for action: The PMN states that
the use of the substance will be as a
component of a pigment dispersant
blend for inks and coatings. Based on
SAR analysis of test data on analogous
nonionic surfactants, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 170 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
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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
170 ppb for more than 20 days per year.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance other than as a component
of a pigment dispersant blend for inks
and coatings may cause 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 (OPPT Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would
help characterize the environmental
effects of the PMN substance. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be followed to
facilitate solubility in the test media,
because of the PMN substance’s low
water solubility.
CFR citation: 40 CFR 721.10736.
PMN Number P-13-378
Chemical name: Carboxylic
anhydride, polymer with -hydrohydroxypoly(oxy-1,2-diethanediyl),
compd. with 2,3,4,6,7,8,9,10octahydropyrimido-[1,2-a]azepine
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the use of the substance is as a
polyurethane catalyst. Based on SAR
analysis of test data on analogous
aliphatic amines, 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
releases to surface waters exceeding 24
ppb may cause 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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acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); a fish acute toxicity test
mitigated by humic acid (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
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10737.
PMN Number P-13-453
Chemical name: Formaldehyde,
polymer with 2,3-dimethylphenol, 2,4dimethylphenol, 2,5-dimethylphenol,
3,5-dimethylphenol, 3-ethylphenol, 4ethylphenol, 3-methylphenol, 4methylphenol and phenol.
CAS number: 1415313–86–8.
Basis for action: The PMN states that
the substance will be used as a coating
for electronic components. Based on
SAR analysis of test data on analogous
phenols, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 5 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
5 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
releases to surface waters exceeding 5
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); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substance. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be followed to
facilitate solubility in the test media,
because of the PMN substance’s low
water solubility.
CFR citation: 40 CFR 721.10738.
PMN Number P-13-465
Chemical name: Caprolactone
homopolymer of substituted
benzotriazole (generic).
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CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a UV stabilizer.
Based on SAR analysis of test data on
analogous benzotriazoles, esters,
phenols, and amides, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations that exceed
1 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance resulting in
surface water concentrations exceeding
1 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a water
solubility test (OECD Test Guideline
105); a fish early life stage toxicity test
(OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance. EPA also recommends that
the guidance document on aquatic
toxicity testing of difficult substances
and mixtures (OECD Test Guideline 23)
be followed to facilitate solubility in the
test media, due to the low water
solubility of the PMN material. EPA
suggests conducting the water solubility
test first as the results may impact the
ecotoxicity testing recommendations.
CFR citation: 40 CFR 721.10739.
PMN Number P-13-473
Chemical name: Tin(2+) salt of
alkylcarboxylic acid (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a catalyst. Based on
test data on the PMN, as well as SAR
analysis of test data on analogous tin
compounds, the EPA identified
potential human health concerns
regarding eye corrosion, dermal
sensitization, and asthma, from the
PMN substance via dermal exposure.
Further, based on SAR analysis of test
data on analogous tin salts and anionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 27 ppb of the
PMN substance in surface waters for
greater than 20 days per year. This 20day criterion is derived from partial life
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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, exceed releases from the
use and production volume described in
the PMN. For the use and production
volume described in the PMN,
environmental releases did not exceed
27 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 use of the
substance without the use of impervious
gloves and goggles, when there is a
potential dermal exposure; use of the
substance other than as described in the
PMN; or any increase in the annual
confidential production volume could
result in exposures which may cause
serious human health and significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(i), (b)(3)(ii), and
(b)(4)(ii).
Recommended testing: EPA has
determined that a fish early-life stage
toxicity test (OPPTS Test Guideline
850.1400); a daphnid chronic toxicity
test (OPPTS Test Guideline 850.1300);
and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substance. EPA also
recommends filtration should be
avoided and that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) followed to facilitate
solubility in the test media, because of
the PMN substance’s low water
solubility. Repeated dose health tests
are not recommended because of the
PMN substance’s corrosive nature.
CFR citation: 40 CFR 721.10740.
PMN Number P-13-563
Chemical name: Propylene glycol,
alpha isocyanate, omega silane
(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 for polyurethane polymers.
Based on SAR analysis of analogous
diisocyanates, EPA identified concerns
for oncogenicity, mutagenicity,
respiratory and dermal sensitization and
lung and mucous membrane irritation
from exposure to the PMN substance via
inhalation and dermal exposures. For
the use described in the PMN, EPA does
not expect significant occupational or
consumer exposure. Therefore, EPA has
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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 a
NIOSH-certified particulate respirator
with an APF of at least 10, where there
is a potential for inhalation exposures;
any use other than as an intermediate;
or any use of the substance in consumer
products, may cause serious health
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 test (OPPTS Test Guideline
870.2600); a 90-day inhalation toxicity
test (OPPTS Test Guideline 870.3465);
and a carcinogenicity test (OPPTS Test
Guideline 870.4200) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10741.
PMN Numbers P-13-617, P-13-618, and
P-13-619
Chemical names: (P-13-617) Aromatic
dicarboxylic acid polymer with
alkanediol, alkyl alkyl-2-alkenoate,1,4dialkyl aromatic dicarboxylate,
alkanedioic acid, alkanediol, .alpha.hydro-.omega.-hydroxypoly[oxy(alkylalkanediyl)], hydroxyalkyl 2-alkyl-2alkenoate, aromatic diisocyanate, alkyl
2-alkyl-2-alkenoate and 2-alkyl-2alkenoic acid (generic), (P-13-618)
Alkanedioic acid, polymer with alkyl 2alkyl-2-alkenoate, alkanedioic acid,
alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1 2-alkanediyl)],
hydroxyalkyl 2-alkyl-2-alkenoate,
aromatic diisocyanate, alkyl 2-alkyl-2alkenoate and 2-alkyl-2-alkenoic acid
(generic); and (P-13-619) Alkanedioic
acid, polymer with alkyl alkylalkenoate, alkanedioic acid, alkanediol,
.alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1,2-alkanediyl)],
aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substances will be as an adhesive. Based
on SAR analysis of test data on
analogous diisocyanates, EPA identified
concerns for respiratory sensitization.
For the use described in the PMN, EPA
does not expect significant occupational
or consumer inhalation exposure as the
substances are not applied using a
method that generates a vapor, mist, or
aerosol, nor are they used in a consumer
product. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
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substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances without a
NIOSH-certified particulate respirator
with an APF of at least 10, where there
is a potential for inhalation exposures;
any use in consumer products; or any
use of the substances involving an
application method that generates a
vapor, mist, or aerosol may cause
serious health 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 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) would help
characterize the human health effects of
the PMN substances.
CFR citation: 40 CFR 721.10742 (P-13617); 40 CFR 721.10743 (P-03-618) and
40 CFR 721.10744 (P-13-619).
PMN Number P-13-722
Chemical name: Alkoxylated
quaternary alkyl ammonium
fluoroalkylsulfonimide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a polymer additive.
Based on SAR analysis of test data on
analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
9 ppb of the PMN substance in surface
waters. For the use described in the
PMN, environmental releases are not
expected to result in surface water
concentrations that exceed 9 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 9 ppb may
cause 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, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal
toxicity test (OPPTS Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance. EPA also recommends that
the guidance document on aquatic
toxicity testing of difficult substances
and mixtures (OECD Test Guideline 23)
be followed to facilitate solubility in the
test media, due to the low water
solubility of the PMN material.
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CFR citation: 40 CFR 721.10745.
PMN Number P-13-753
Chemical name: Isocyanate
terminated urethane polymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an adhesive and
sealant. Based on SAR analysis of test
data on analogous isocyanates, EPA
identified concerns for respiratory and
dermal sensitization to workers from
exposure to the PMN substance. In
addition, based on test data submitted
under the TSCA section 8(e) program,
the Agency identified concern for
mutagenicity. For the uses described in
the PMN, significant occupational
dermal and inhalation exposures are not
expected. Further, general population
exposures are not expected as the PMN
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 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 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 721.10746.
PMN Number P-13-773
Chemical name: 4-Pyrimidianamine,
2,5 dimethoxy-.
CAS number: 6960–17–4.
Basis for action: The PMN states that
the substance will be used as an
herbicide intermediate. Based on test
data of the PMN substance, as well as
SAR analysis of test data on analogous
aromatic amines, EPA identified
concerns for mutagenicity, oncogenicity,
and developmental toxicity to workers
exposed to the PMN substance. Further,
based on SAR analysis of test data on
analogous anilines, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 7 ppb of
the PMN substance in surface water. As
described in the PMN, EPA does not
expect significant occupational
exposures and releases of the PMN
substance are not expected to result in
surface water concentrations that exceed
7 ppb. Therefore, EPA has not
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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 a
NIOSH-certified respirator with an APF
of at least 10, where there is potential
inhalation exposure; any use without
impervious gloves, where there is
potential for dermal exposure; or any
use other than as an herbicide
intermediate may cause serious health
and environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(1)(i)(B), (b)(1)(i)(C),
(b)(3)(ii), (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
combined repeated dose toxicity test
(OECD Test Guideline 422), with the
reproduction/development toxicity
screening test; a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465); and an aquatic invertebrate
acute toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010) would
help characterize the human health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10747.
PMN Numbers P-13-796, P-13-797, P-13798, P-13-799, and P-13-800
Chemical names: (P-13-796, P-13-797,
and P-13-798) Dicarbomonocyclesubstituted
carbomonocycledicarboxamide
(generic); (P-13-799)
Dicarboheterocycle-substituted
carbomonocycledicarboxamide
(generic); and (P-13-800)
Tricarbomonocycle-substituted
carbomonocycletricarboxamide
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substances are as additives for polymer
manufacturing. Based on SAR analysis
of test data on analogous amides, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
4 ppb (for P-13-796 and P-13-797); 14
ppb (for P-13-798); 1 ppb (for P-13-799);
and 2 ppb (for P-13-800) of the PMN
substance in surface waters. For the use
described in the PMNs, releases of the
substances are not expected to result in
surface water concentrations that exceed
the respective concentrations for
concern. 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
use of the substance resulting in releases
to surface waters exceeding the
respective concentrations of concern
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may result in significant adverse
environmental effects. Based on this
information, the PMN substances meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (OECD Test
Guideline 301); a fish early-life stage
toxicity test (OPPTS Test Guideline
850.1400); a daphnid chronic toxicity
test (OPPTS Test Guideline 850.1300);
and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substance. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be followed to
facilitate solubility in the test media,
because of the PMN substance’s low
water solubility. EPA suggests
conducting the biodegradation test first
as the results may impact the
ecotoxicity testing recommendations.
CFR citation: 40 CFR 721.10748 (P-13796, P-13-797, and P-13-798); 40 CFR
721.10749 (P-13-799); and 40 CFR
721.10750 (P-13-800).
PMN Number P-13-810, P-13-811, P-13812, P-13-813, P-13-814, and P-13-815
Chemical names: Cycloalkylamino
oleyl alkylamide acid salts (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the generic (non-confidential) use of
these substances are as inhibitors for oil
field applications. Based on SAR
analysis of test data on analogous
aliphatic amines, EPA predicts chronic
toxicity to aquatic organisms may occur
at concentrations that exceed 1 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
exceeding 1 ppb of the aggregate of
these PMN substances. 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
use of the substances resulting in
releases to surface waters exceeding 1
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substances meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a water
solubility: Column elution method;
shake flask method test (OPPTS Test
Guideline 830.7840) or a water
solubility: Generator column method
test (OPPTS Test Guideline 830.7860); a
determination of the partition
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coefficient (n-octanol/water) by shake
flask method (OPPTS Test Guideline
830.7550), generator column method
(OPPTS Test Guideline 830.7560), or
estimation by liquid chromatography
(OPPTS Test Guideline 830.7570); and
log Koc determination by adsorptiondesorption using a batch equilibrium
method (OECD Test Guideline 106) in
representative salt water conditions
would help characterize the
environmental effects of the PMN
substances. Based on the results of these
studies, EPA would recommend either
of the following as additional testing:
(A) Fish acute toxicity test, freshwater
and marine (OPPTS Test Guideline
850.1075); a mysid acute toxicity test
(OPPTS Test Guideline 850.1350); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) or;
(B) the whole sediment acute toxicity
test, invertebrates, marine (OPPTS Test
Guideline 850.1740).
CFR citation: 40 CFR 721.10751.
PMN Numbers P-13-816, P-13-817, P-13818, P-13-819, P-13-820, and P-13-821
Chemical names: Cycloalkylamino
cocoalkyl alkylamide acid salts
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the generic (non-confidential) use of
these substances is as inhibitors for oil
field applications. Based on SAR
analysis of test data on analogous
aliphatic amines, EPA predicts chronic
toxicity to aquatic organisms may occur
at concentrations that exceed 1 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
exceeding 1 ppb of the aggregate of
these PMN substances. 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
use of the substances resulting in
releases to surface waters exceeding 1
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substances meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a water
solubility: Column elution method;
shake flask method test (OPPTS Test
Guideline 830.7840) or a water
solubility: Generator column method
test (OPPTS Test Guideline 830.7860); a
determination of the partition
coefficient (n-octanol/water) by shake
flask method (OPPTS Test Guideline
830.7550), generator column method
(OPPTS Test Guideline 830.7560), or
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estimation by liquid chromatography
(OPPTS Test Guideline 830.7570); and
log Koc determination by adsorptiondesorption using a batch equilibrium
method (OECD Test Guideline 106) in
representative salt water conditions
would help characterize the
environmental effects of the PMN
substances. Based on the results of these
studies, EPA would recommend either
of the following as additional testing:
(A) Fish acute toxicity test, freshwater
and marine (OPPTS Test Guideline
850.1075); a mysid acute toxicity test
(OPPTS Test Guideline 850.1350); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) or;
(B) the whole sediment acute toxicity
test, invertebrates, marine (OPPTS Test
Guideline 850.1740).
CFR citation: 40 CFR 721.10752.
PMN Number P-13-839
Chemical name: Methanamine, N,Ndimethyl-, reaction products with
alkylamine-epichlorohydrin polymer,
chlorides (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 of
pre-coat solution. Based on the test data
submitted with this PMN as well as the
structural activity relationships analysis
for analogous polycationic polymers,
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 to
surface waters are not expected.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in surface water
concentrations exceeding 1 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(i) and (ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a fish acute
toxicity mitigated by humic acid
(OPPTS Test Guideline 850.1085); a
daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance. EPA also recommends that
the guidance document on aquatic
toxicity testing of difficult substances
and mixtures (OECD Test Guideline 23)
be followed to facilitate solubility in the
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test media, because of the PMN
substance’s low water solubility.
CFR citation: 40 CFR 721.10753.
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PMN Number P-13-882
Chemical name: Mixture of alkylated
benzene, brominated (generic) and
alkylated benzene, dibrominated
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that
the use of the substance will be as a feed
for a bromine recovery unit. Based on
analogous chemical substances that
contain bromine and alkylation
potential of the PMN substance, EPA
identified concerns for neurotoxicity,
liver and kidney toxicities,
mutagenicity, and oncogenicity, as well
as concerns for developmental toxicity
and dermal sensitization to workers
exposed to the PMN substance. The
Agency also identified the potential for
human health risk due to the possible
formation of dioxins. Further, based on
test data on analogous benzyl halides,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 5 ppb of the PMN substance
in surface water. For the use described
in the PMN, EPA does not expect
significant occupational inhalation or
dermal exposures; significant general
population inhalation or drinking water
exposures; or releases of the PMN
substance that result in surface water
concentrations that exceed 5 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 use other
than for use other than as feed for a
bromine recovery unit may cause
serious health and significant
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(1)(i)(D), (b)(3)(ii) and
(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465); 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 721.10754.
PMN Number: P-14-42
Chemical name: Substituted
perfluoroether (generic).
CAS Number: Claimed confidential.
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Basis for Action: The PMN states that
the generic (non-confidential) use of the
substance is as a surfactant for
laboratory use fluid. Based on SAR
analysis of test data on analogous high
molecular weight polymers, EPA
identified concerns for lung toxicity if
respirable droplets of the PMN
substance are inhaled. Further, based on
analogy to perfluorooctanoic acid
(PFOA) and perfluorooctane sulfonate
(PFOS), EPA identified concerns for
liver toxicity, acute toxicity,
developmental and reproductive
toxicity, and cancer, for the PMN
substance, when the mean moles of each
perfluoro propylene (PPO) unit is less
than 5. The low molecular weight
species have been identified as having
the potential to be persistent,
bioaccumulative, and toxic (PBT)
chemicals. EPA does not have
comparable toxicity information on the
low molecular weight fraction of the
PMN substance and unreacted starting
material. EPA has concerns that this
PMN substance will persist in the
environment. In addition, the perfluoro
degradation products could persist,
bioaccumulate, and be toxic to people,
wild mammals, and birds. EPA’s
concerns are based on analogy to other
perfluoro chemicals, including PFOA
and PFOS, which are both currently
under review by EPA for PBT concerns.
PFOA and PFOS are expected to persist
for years in the environment.
Biodegradation and photolysis tests of
analogous substances indicate little or
no biodegradation or photolysis of
perfluoroalkyl compounds.
Bioaccumulation concerns are based on
the measured presence of certain
perfluoroalkyl compounds, including
PFOA, in wildlife and in human blood
samples. In addition, EPA expects the
PMN substance and the perfluoro
degradation products to be highly
persistent, and the low molecular
weight fraction is expected to be mobile
and bioaccumulate in the environment.
No ecotoxicological concerns were
raised for the PMN substance itself.
However, there is high concern for
possible environmental effects to
mammals and wild birds from the
perfluoro degradation products of the
PMN substance. As stated previously,
the analog PFOA is persistent in the
environment; has a long bioretention
time in various species; has been
detected in a number of species of
wildlife, including marine mammals;
and is considered toxic to mammalian
and other species. The toxicological
properties and presence of PFOA in the
environment continue to be
investigated. For the use described in
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the PMN, EPA does not expect
occupational, general population, or
environmental exposures to the PMN
substance. 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 other than as
described in the PMN, or any
manufacture of the PMN substance
where the mean number of moles of
each perfluoro propylene oxide unit is
less than 5, may result in serious health
effects or significant adverse
environmental effects. Based on this
information, the PMN meets the concern
criteria at 721.170(b)(3)(i), (b)(3)(ii),
(b)(4)(ii), and (b)(4)(iii).
Recommended Testing: EPA has
determined that the results of the
following testing on the presumed
perfluoro degradation products of the
PMN substance would be necessary to
evaluate the potential human health
effects of the PMN substance: a repeated
dose metabolism and pharmacokinetics
test (OPPTS Test Guideline 870.7485) in
rats and mice; a 1-generation
reproduction study (OECD Test
Guideline 421), modified; a 90-day oral
toxicity test (OPPTS Test Guideline
870.3100) in rats; a combined chronic
toxicity/carcinogenicity test (OPPTS
Test Guideline 870.4300 or OECD Test
Guideline 453) in rats; and an avian
reproduction test (OPPTS Test
Guideline 850.2300 or OECD Test
Guideline 206). EPA recommends that
the Company conduct the
pharmacokinetics testing first to confirm
species acceptability and to provide a
reliable half-life for this substance.
Further, EPA has determined that the
results of the following physical/
chemical properties and fate and
transport tests on the PMN substance
would be necessary to evaluate the
environmental fate and transport: A UV
visible light absorption test (OPPTS Test
Guideline 830.7050); a hydrolysis as a
function of pH test (OPPTS Test
Guideline 835.2130); a semi-continuous
activated sludge (‘‘SCAS’’) test (OPPTS
Test Guideline 835.5045, OPPTS Test
Guideline 835.3210, or OECD Test
Guideline 302A) modified for analysis
for perfluoro degradation products; an
aerobic transformation in soil test
(OECD Test Guideline 307); an aerobic
and anaerobic transformations test
(OECD Test Guideline 308) in aquatic
sediment systems; a direct photolysis
test (OPPTS Test Guideline 835.2210);
an indirect photolysis screening test
(OPPTS Test Guideline 835.5270);
phototransformation of chemicals on
soil surfaces (Draft OECD Test Guideline
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January 2002) using 2 soils, a simulation
test-aerobic sewage treatment (OECD
Test Guideline 303A) activated sludge
units; and an anaerobic biodegradability
test (OECD Test Guideline 311) on
organic compounds in digested sludge.
CFR Citation: 40 CFR 721.10764.
V. Rationale and Objectives of the Rule
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A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these SNURs, EPA concluded
that for 6 of the 43 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 36 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.
• 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.
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Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Chemical Substance Inventory
(TSCA Inventory). Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
Internet at https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
VI. Direct Final Procedures
EPA is issuing these SNURs as a
direct final rule, as described in
§ 721.160(c)(3) and § 721.170(d)(4). In
accordance with § 721.160(c)(3)(ii) and
§ 721.170(d)(4)(i)(B), the effective date
of this rule is September 8, 2014
without further notice, unless EPA
receives written adverse or critical
comments, or notice of intent to submit
adverse or critical comments before
August 8, 2014.
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
August 8, 2014, 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,
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TSCA section 5(e) consent orders have
been issued for 6 of the 43 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
39 of the 43 chemical substances subject
to this rule have been claimed as
confidential and EPA has received no
post-PMN bona fide submissions (per 40
CFR 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 July 9,
2014 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.
lists those tests. Unit IV. also lists
recommended testing for TSCA nonsection 5(e) SNURs. Descriptions of tests
are provided for informational purposes.
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EPA strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’ The
Organisation for Economic Co-operation
and Development (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org.
In the TSCA section 5(e) consent
orders for several of the chemical
substances regulated under this rule,
EPA has established production volume
limits in view of the lack of data on the
potential health and environmental
risks that may be posed by the
significant new uses or increased
exposure to the chemical substances.
These limits cannot be exceeded unless
the PMN submitter first submits the
results of toxicity tests that would
permit a reasoned evaluation of the
potential risks posed by these chemical
substances. Under recent TSCA section
5(e) consent orders, each PMN submitter
is required to submit each study before
reaching the specified production limit.
Listings of the tests specified in the
TSCA section 5(e) consent orders are
included in Unit IV. The SNURs contain
the same production volume limits as
the TSCA section 5(e) consent orders.
Exceeding these production limits is
defined as a significant new use.
Persons who intend to exceed the
production limit must notify the Agency
by submitting a SNUN at least 90 days
in advance of commencement of nonexempt commercial manufacture or
processing.
The recommended tests specified in
Unit IV. may not be the only means of
addressing the potential risks of the
chemical substance. However,
submitting a SNUN without any test
data may increase the likelihood that
EPA will take action under TSCA
section 5(e), particularly if satisfactory
test results have not been obtained from
a prior PMN or SNUN submitter. EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
• Potential benefits of the chemical
substances.
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• 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 § 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
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
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submitting a PMN, including
submission of test data on health and
environmental effects as described in 40
CFR 720.50. SNUNs must be submitted
on EPA Form No. 7710–25, generated
using e-PMN software, and submitted to
the Agency in accordance with the
procedures set forth in 40 CFR 720.40
and § 721.25. E-PMN software is
available electronically at https://
www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this rule. EPA’s complete economic
analysis is available in the docket under
docket ID number EPA–HQ–OPPT–
2014–0166.
XII. Statutory and Executive Order
Reviews
A. Executive Order 12866
This rule 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 rule.
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.
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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)
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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 rule.
This rule is within the scope of the
February 18, 2012 certification. Based
on the Economic Analysis discussed in
Unit XI. and EPA’s experience
promulgating SNURs (discussed in the
certification), EPA believes that the
following are true:
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $8,300.
Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
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D. Unfunded Mandates Reform Act
(UMRA)
I. National Technology Transfer and
Advancement Act (NTTAA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
rule. As such, EPA has determined that
this rule does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any effect
on small governments subject to the
requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).
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).
F. Executive Order 13175
This rule does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This rule 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 rule.
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.
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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).
XIV. 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: June 27, 2014.
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:
■
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§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
40 CFR citation
*
*
OMB control No.
*
*
*
Significant New Uses of Chemical
Substances
*
*
721.10725
721.10726
721.10727
721.10728
721.10729
721.10730
721.10731
721.10732
721.10733
721.10734
721.10735
721.10736
721.10737
721.10738
721.10739
721.10740
721.10741
721.10742
721.10743
721.10744
721.10745
721.10746
721.10747
721.10748
721.10749
721.10750
721.10751
721.10752
721.10753
721.10754
721.10764
*
*
*
*
*
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
*
*
*
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 § 721.10725 to subpart E to
read as follows:
■
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§ 721.10725
Alcohol propoxylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alcohol propoxylate (PMN
P-08-512) 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(l)
(ii) Disposal. Requirements as
specified in § 721.85(a)(1), (a)(3) (Class I
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or II wells), (b)(1), (b)(3) (Class I or II
wells), (c)(1), and (c)(3) (Class I or II
wells).
(iii) Release to water. Requirements as
specified in § 721.90(a)(2)(ii), (b)(2)(ii),
and (c)(2)(ii).
(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 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.
■ 5. Add § 721.10726 to subpart E to
read as follows:
§ 721.10726 Alcohol propoxylate sulfate
salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alcohol propoxylate
sulfate salt (PMN P-08-513) 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(l)
(ii) Disposal. Requirements as
specified in § 721.85(a)(1), (a)(3) (Class I
or II wells), (b)(1), (b)(3) (Class I or II
wells), (c)(1), and (c)(3) (Class I or II
wells).
(iii) Release to water. Requirements as
specified in § 721.90(a)(2)(ii), (b)(2)(ii),
and (c)(2)(ii).
(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 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.
■ 6. Add § 721.10727 to subpart E to
read as follows:
§ 721.10727 Amphoteric fluorinated
surfactant (generic).
(a) Chemical substance and significant
new uses subject to reporting. (1) The
chemical substance identified
generically as amphoteric fluorinated
surfactant (PMN P-11-526) 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) Hazard communication program. A
significant new use of this substance is
any manner or method of manufacture
or processing associated with any use of
this substance without providing risk
notification as follows:
(A) If as a result of the test data
required under the TSCA section 5(e)
consent order for this substance, the
employer becomes aware that this
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 this substance is not
being manufactured, processed, or used
in the employer’s workplace, the
employer must add the new information
to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that
persons who will receive the PMN
substance from the employer, or who
have received the PMN substance from
the employer within 5 years from the
date the employer becomes aware of the
new information described in paragraph
(a)(2)(i)(A) of this section, are provided
an MSDS containing the information
required under paragraph (a)(2)(i)(A) of
this section within 90 days from the
time the employer becomes aware of the
new information.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k)(a significant
new use is any use other than as
allowed by the section 5(e) consent
order which includes analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities), and (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.
7. Add § 721.10728 to subpart E to
read as follows:
■
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§ 721.10728 2-Propenoic acid, 2-methyl-, 2hydroxyethyl esters, telomers with C18–26alkyl acrylate, 1-dodecanethiol, N(hydroxymethyl)-2-methyl-2-propenamide,
polyfluorooctyl methacrylate, 2,2′-[1,2diazenediylbis(1-methylethylidene)]bis[4,5dihydro-1H-imidazole]hydrochloride (1:2)initiated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2-propenoic acid, 2methyl-, 2-hydroxyethyl esters, telomers
with C18-26-alkyl acrylate, 1dodecanethiol, N-(hydroxymethyl)-2methyl-2-propenamide, polyfluorooctyl
methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated
(PMN P-12-241) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication program. A
significant new use of this substance is
any manner or method of manufacture
or processing associated with any use of
this substance without providing risk
notification as follows:
(A) If as a result of the test data
required under the TSCA section 5(e)
consent order for this substance, the
employer becomes aware that this
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 this substance is not
being manufactured, processed, or used
in the employer’s workplace, the
employer must add the new information
to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that
persons who will receive the PMN
substance from the employer, or who
have received the PMN substance from
the employer within 5 years from the
date the employer becomes aware of the
new information described in paragraph
(a)(2)(i)(A) of this section, are provided
an MSDS containing the information
required under paragraph (a)(2)(i)(A) of
this section within 90 days from the
time the employer becomes aware of the
new information.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (a significant
new use is any use other than as
allowed by the section 5(e) consent
order which includes analysis and
reporting and limitations of maximum
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impurity levels of certain fluorinated
impurities), (q), and (t).
(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), (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 § 721.10729 to subpart E to
read as follows:
§ 721.10729 2-Propenoic acid, 2-methyl-,
C16-18 esters, telomers with 3-chloro-2hydroxypropyl methacrylate, 1dodecanethiol, N-(hydroxymethyl)-2-methyl2-propenamide, polyfluorooctyl
methacrylate, and rel- (1R,2R,4R)-1,7,7trimethylbicyclo[2.2.1]hept-2-yl
methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2-propenoic acid, 2methyl-, C16-18 esters, telomers with 3chloro-2-hydroxypropyl methacrylate,
1-dodecanethiol, N-(hydroxymethyl)-2methyl-2-propenamide, polyfluorooctyl
methacrylate, and rel-(1R,2R,4R)-1,7,7trimethylbicyclo[2.2.1]hept-2-yl
methacrylate, 2,2′-[1,2-diazenediylbis(1methylethylidene)]bis[4,5-dihydro-1Himidazole]hydrochloride (1:2)-initiated
(PMN P-12-242) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication program. A
significant new use of this substance is
any manner or method of manufacture
or processing associated with any use of
this substance without providing risk
notification as follows:
(A) If as a result of the test data
required under the TSCA section 5(e)
consent order for this substance, the
employer becomes aware that this
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 this substance is not
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being manufactured, processed, or used
in the employer’s workplace, the
employer must add the new information
to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that
persons who will receive the PMN
substance from the employer, or who
have received the PMN substance from
the employer within 5 years from the
date the employer becomes aware of the
new information described in paragraph
(a)(2)(i)(A) of this section, are provided
an MSDS containing the information
required under paragraph (a)(2)(i)(A) of
this section within 90 days from the
time the employer becomes aware of the
new information.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (a significant
new use is any use other than as
allowed by the section 5(e) consent
order which includes analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities), (q), and (t).
(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), (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.
■ 9. Add § 721.10730 to subpart E to
read as follows:
§ 721.10730 Tires, wastes, pyrolyzed, C639 oil fraction.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
tires, wastes, pyrolyzed, C6-39 oil
fraction (P-12-557; CAS No. 1410795–
89–9) 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 chemical
substance that has been blended into
finished petroleum products or sent to
a petroleum refinery for use as a
chemical intermediate.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 1.0 percent), (f),
(g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
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(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=360).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (f), (g), (h), (i), and
(k) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(1) of this section.
■ 10. Add § 721.10731 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10731 Tires, wastes, pyrolyzed, C756 oil fraction.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
tires, wastes, pyrolyzed, C7–56 oil
fraction (P-12-558; CAS No. 1410795–
87–7) 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 chemical
substance that has been blended into
finished petroleum products or sent to
a petroleum refinery for use as a
chemical intermediate.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 1.0 percent), (f),
(g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k).
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=170).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (f), (g), (h), (i), and
(k) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
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of § 721.1725(b)(1) apply to paragraph
(a)(1) of this section.
■ 11. Add § 721.10732 to subpart E to
read as follows:
§ 721.10732 Neodymium, butadiene iso-Bu
neodecanoate complexes.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
neodymium, butadiene iso-Bu
neodecanoate complexes (PMN P-13-60;
CAS No. 1386395–00–1) 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) Releases 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), (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.
■ 12. Add § 721.10733 to subpart E to
read as follows:
§ 721.10733 Tires, wastes, pyrolyzed, C515 condensate oil fraction.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
tires, wastes, pyrolyzed, C5-15
condensate oil fraction (PMN P-13-237;
chemical substance definition: A
complex combination of hydrocarbons
obtained from the substance produced
by the pyrolysis of rubber-based tires
after removal of the carbon black
fraction. It consists predominantly of
hydrocarbons having carbon numbers in
the range of C5 through C15. It boils in
the range of approximately 36 °C to 265
°C (97 °F to 509 °F).) 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 substances that
have been blended into finished
petroleum products or sent to a
petroleum refinery for use as a chemical
intermediate, or stored as described in
the Distribution section of the order.
(2) The significant new uses are:
(i) Protection in the workplace. The
significant new use is any exposure
exceeding an 8 hour time weighted
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average (TWA) exposure limit of 1 part
per million (ppm).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is any use other than as a raw
feedstock for refineries.
(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), (b), (c), (i), (k), and records
documenting that exposures do not
exceed an 8 hour time weighted average
(TWA) exposure limit of 1 part per
million 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
significant new use rule.
■ 13. Add § 721.10734 to subpart E to
read as follows:
§ 721.10734 Lithium salt of substituted
imide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as lithium salt of substituted
imide (PMN P-13-248) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4), (a)(6)(i), (b)
(concentration set at 1.0 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):
(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), (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.
■ 14. Add § 721.10735 to subpart E to
read as follows:
§ 721.10735
(generic).
Aromatic dibenzoate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic dibenzoate
(PMN P-13-270) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Releases to water. Requirements as
specified in § 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.
■ 15. Add § 721.10736 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10736 Alcohols, C9-11-branched,
ethoxylated propoxylated.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
alcohols, C9–11-branched, ethoxylated
propoxylated (PMN P-13-309; CAS No.
1400790–00–2) 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 § 721.80. A significant new
use is any use other than as a
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component of a pigment dispersant
blend for inks and 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 (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 § 721.10737 to subpart E to
read as follows:
§ 721.10737 Carboxylic anhydride,
polymer with -hydro—hydroxypoly(oxy-1,2diethanediyl), compd. with 2,3,4,6,7,8,9,10octahydropyrimido-[1,2-a]azepine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as carboxylic anhydride,
polymer with -hydro—
hydroxypoly(oxy-1,2-diethanediyl),
compd. with 2,3,4,6,7,8,9,10octahydropyrimido-[1,2-a]azepine (PMN
P-13-378) 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) Releases 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.
■ 17. Add § 721.10738 to subpart E to
read as follows:
§ 721.10738 Formaldehyde, polymer with
2,3-dimethylphenol, 2,4-dimethylphenol,
2,5-dimethylphenol, 3,5-dimethylphenol, 3ethylphenol, 4-ethylphenol, 3-methylphenol,
4-methylphenol and phenol.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
formaldehyde, polymer with 2,3dimethylphenol, 2,4-dimethylphenol,
2,5-dimethylphenol, 3,5dimethylphenol, 3-ethylphenol, 4ethylphenol, 3-methylphenol, 4-
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methylphenol and phenol (PMN P-13453; CAS No. 1415313–86–8) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=5).
(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.
■ 18. Add § 721.10739 to subpart E to
read as follows:
§ 721.10739 Caprolactone homopolymer of
substituted benzotriazole (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as caprolactone
homopolymer of substituted
benzotriazole (PMN P-13-465) 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.
■ 19. Add § 721.10740 to subpart E to
read as follows:
§ 721.10740 Tin(2+) salt of alkylcarboxylic
acid (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as tin(2+) salt of
alkylcarboxylic acid (PMN P-13-473) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
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(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s).
(ii) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii), and
(a)(3).
(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)(1) of this section.
■ 20. Add § 721.10741 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10741 Polyalkylene glycol, alpha
isocyanate, omega silane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyalkylene glycol, alpha
isocyanate, omega silane (PMN P-13563) 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), (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 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.
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(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g) and (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), (b), (c), (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.
■ 21. Add § 721.10742 to subpart E to
read as follows:
§ 721.10742 Aromatic dicarboxylic acid
polymer with alkanediol, alkyl alkyl-2alkenoate, 1,4-dialkyl aromatic
dicarboxylate, alkanedioic acid, alkanedioic
acid. alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-alkanediyl)],
hydroxyalkyl 2-alkyl-2-alkenoate, aromatic
diisocyanate, alkyl 2-alkyl-2-alkenoate and
2-alkyl-2-alkenoic acid (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic dicarboxylic
acid polymer with alkanediol, alkyl
alkyl-2-alkenoate,1,4-dialkyl aromatic
dicarboxylate, alkanedioic acid,
alkanedioic acid. alkanediol, .alpha.hydro-.omega.-hydroxypoly[oxy(alkylalkanediyl)], hydroxyalkyl 2-alkyl-2alkenoate, aromatic diisocyanate, alkyl
2-alkyl-2-alkenoate and 2-alkyl-2alkenoic acid (PMN P-13-617) 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), (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 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.
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(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(o) and (y)(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), (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.
■ 22. Add § 721.10743 to subpart E to
read as follows:
§ 721.10743 Alkanedioic acid, polymer
with alkyl 2-alkyl-2-alkenoate, alkanedioic
acid, alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1 2-alkanediyl)],
hydroxyalkyl 2-alkyl-2-alkenoate, aromatic
diisocyanate, alkyl 2-alkyl-2-alkenoate and
2-alkyl-2-alkenoic acid (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkanedioic acid, polymer
with alkyl 2-alkyl-2-alkenoate,
alkanedioic acid, alkanediol, .alpha.hydro-.omega.-hydroxypoly[oxy(alkyl-1
2-alkanediyl)], hydroxyalkyl 2-alkyl-2alkenoate, aromatic diisocyanate, alkyl
2-alkyl-2-alkenoate and 2-alkyl-2alkenoic acid (PMN P-13-618) 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), (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 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
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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(o) and (y)(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), (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.
■ 23. Add § 721.10744 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10744 Alkanedioic acid, polymer
with alkyl alkyl-alkenoate, alkanedioic acid,
alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1,2-alkanediyl)],
aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkanedioic acid, polymer
with alkyl alkyl-alkenoate, alkanedioic
acid, alkanediol, .alpha.-hydro-.omega.hydroxypoly[oxy(alkyl-1,2-alkanediyl)],
aromatic diisocyanate, alkyl alkylalkeneoate and alkyl-alkenoic acid
(PMN P-13-619) 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), (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 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
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(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(o) and (y)(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), (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.
■ 24. Add § 721.10745 to subpart E to
read as follows:
§ 721.10745 Alkoxylated quaternary alkyl
ammonium fluoroalkylsulfonimide
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkoxylated quaternary
alkyl ammonium
fluoroalkylsulfonimide (PMN P-13-722)
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=9).
(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.
■ 25. Add § 721.10746 to subpart E to
read as follows:
§ 721.10746 Isocyanate terminated
urethane polymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanate terminated
urethane polymer (PMN P-13-753) is
subject to reporting under this section
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for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4), (a)(6)(ii), (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 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(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), (b), (c), (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.
■ 26. Add § 721.10747 to subpart E to
read as follows:
§ 721.10747 4-Pyrimidianamine, 2,5
dimethoxy-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
4-pyrimidianamine, 2,5 dimethoxy(PMN P-13-773; CAS No. 6960–17–4) 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) 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), (b) (concentration set
at 0.1 percent) and (c). When
determining which persons are
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reasonably likely to be exposed as
required for § 721.63(a)(1) and (a)(4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. 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. A significant new
use is any use other than as an herbicide
intermediate.
(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.
■ 27. Add § 721.10748 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10748 Dicarbomonocyclesubstituted carbomonocycledicarboxamide
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as dicarbomonocyclesubstituted
carbomonocycledicarboxamide (PMNs
P-13-796, P-13-797, and P-13-798) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4 for P-13-796 and P-13-797;
and N=14 for P-13-798).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
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39287
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
significant new use rule.
■ 28. Add § 721.10749 to subpart E to
read as follows:
(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
significant new use rule.
■ 30. Add § 721.10751 to subpart E to
read as follows:
§ 721.10749 Dicarboheterocyclesubstituted carbomonocycledicarboxamide
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as cycloalkylamino oleyl
alkylamide acid salts (PMNs P-13-810,
P-13-811, P-13-812, P-13-813, P-13-814,
and P-13-815) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1, for the aggregate of the PMN
substances P-13-810, P-13-811, P-13812, P-13-813, P-13-814, and P-13-815).
(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 § 721.10752 to subpart E to
read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dicarboheterocyclesubstituted
carbomonocycledicarboxamide (PMN P13-799) 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
significant new use rule.
■ 29. Add § 721.10750 to subpart E to
read as follows:
§ 721.10750 Tricarbomonocyclesubstituted carbomonocycletricarboxamide
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as tricarbomonocyclesubstituted
carbomonocycletricarboxamide (PMN P13-800) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
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§ 721.10751 Cycloalkylamino oleyl
alkylamide acid salts (generic).
§ 721.10752 Cycloalkylamino cocoalkyl
alkylamide acid salts (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as cycloalkylamino
cocoalkyl alkylamide acid salts (PMNs
P-13-816, P-13-817, P-13-818, P-13-819,
P-13-820, and P-13-821) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1, for the aggregate of the PMN
substances P-13-816, P-13-817, P-13818, P-13-819, P-13-820, and P-13-821).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 32. Add § 721.10753 to subpart E to
read as follows:
§ 721.10753 Methanamine, N,N-dimethyl-,
reaction products with alkylamineepichlorohydrin polymer, chlorides
(generic).
mstockstill on DSK4VPTVN1PROD with RULES4
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as methanamine, N,Ndimethyl-, reaction products with
alkylamine-epichlorohydrin polymer,
chlorides (PMN P-13-839) 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
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20:52 Jul 08, 2014
Jkt 232001
provisions of § 721.185 apply to this
section.
■ 33. Add § 721.10754 to subpart E to
read as follows:
§ 721.10754 Mixture of alkylated benzene,
brominated (generic) and alkylated
benzene, dibrominated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as mixture of alkylated
benzene, brominated and alkylated
benzene, dibrominated (PMN P-13-882)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is any use other than as feed for a
bromine recovery unit.
(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.
34. Add § 721.10764 to subpart E to
read as follows:
■
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Sfmt 9990
§ 721.10764
(generic)
Substituted perfluoroether
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted perfluoroether
(PMN P-14-42) 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 this substance is: (1) Use of the
substance for any application other than
the confidential use identified in the
Premanufacture Notice (PMN) or (2)
Manufacture of the PMN substance
where the mean number of moles of
each perfluoro propylene oxide (‘‘PPO’’)
unit is less than 5.
(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 § 721.180 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
[FR Doc. 2014–15774 Filed 7–8–14; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Rules and Regulations]
[Pages 39267-39288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15774]
[[Page 39267]]
Vol. 79
Wednesday,
No. 131
July 9, 2014
Part VI
Environmental Protection Agency
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40 CFR Parts 9 and 721
Significant New Use Rules on Certain Chemical Substances; Direct Final
Rule
Federal Register / Vol. 79 , No. 131 / Wednesday, July 9, 2014 /
Rules and Regulations
[[Page 39268]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2014-0166; FRL-9910-01]
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 43 chemical substances
which were the subject of premanufacture notices (PMNs). Six of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture
(including import) or process any of these 43 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 September 8, 2014. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
July 23, 2014.
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 August 8, 2014 (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 August 8, 2014, EPA will withdraw the relevant
sections of this direct final rule before its effective date.
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0166, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405 M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of a proposed or final SNUR, 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 submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
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
[[Page 39269]]
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). Consult that preamble for further
information on the objectives, rationale, and procedures for SNURs and
on the basis for significant new use designations, including provisions
for developing test data.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``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.
[emsp14]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. [emsp14]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 43
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 43 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the 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 and importation
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 6 PMN substances (P-11-526, P-12-241, P-12-242,
P-12-557, P-12-558, and P-13-237) 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. [emsp14]721.160, and are based on and consistent with
the provisions in the underlying consent orders. The TSCA section 5(e)
SNURs designate as a ``significant new use'' the absence of the
protective measures required in the corresponding consent orders.
This rule also includes SNURs on 36 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.
[emsp14]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. [emsp14]721.170 satisfies the two requirements stipulated in
Sec. 721.170(c)(2), i.e., these significant new use activities, ``(i)
are different from those described in the premanufacture notice for the
substance, including any amendments, deletions, and additions of
activities to the premanufacture notice, and (ii) may be accompanied by
changes in exposure or release levels that are significant in relation
to the health or environmental concerns identified'' for the PMN
substance.
PMN Numbers P-08-512 and P-08-513
Chemical names: (P-08-512) Alcohol propoxylate (generic) and (P-05-
513) Alcohol propoxylate sulfate salt (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances are as a chemical intermediate (P-
08-512), and for enhanced oil recovery applications (P-
[[Page 39270]]
08-513). Based on structural activity relationship (SAR) analysis of
the test data on analogous neutral organics (P-08-512) and anionic
surfactants (P-08-513), EPA predicts toxicity to aquatic organisms at
concentrations that exceed 1 part per billion (ppb) of P-08-512 and 15
ppb of P-08-513 in surface waters. However, based on test data
submitted on analogous chemical substances, EPA expects the actual risk
to aquatic organisms in surface waters to be significantly mitigated
following biological treatment at publicly owned treatment works or at
on-site waste water treatment plants, injection to Class I or II wells,
or incineration. As described in the PMN notices, releases are either
injected into Class I or II wells, incinerated, or released to surface
waters after biological treatment. 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
non-industrial use, or any release during manufacturing, processing, or
use other than injection to Class I or II wells, incineration, or
release to water following biological treatment and clarification may
cause significant adverse environmental effects. Based on this
information, the PMN substances meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a
Modified Shake-Flask Biodegradation Test (Cripe, C.R., Walker, W.W.,
Pritchard, P.H., Borquin, A.W. (1987). Shake-Flask Test for Estimation
of Biodegradability of Toxic Organic Substances in the Aquatic
Environment. Ecotoxicology and Environmental Safety 14:239-251)
utilizing an algal toxicity test (Office of Chemical Safety and
Pollution Prevention (OCSPP) Test Guideline 850.4500); an aquatic
invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline
850.1010); and a fish acute toxicity test, freshwater and marine (OPPTS
Test Guideline 850.1075) with supplemental analytics to identify
degradation products, would help to characterize the environmental
effects of the PMN substances. Testing is recommended to be conducted
on P-08-513. EPA suggests conducting the modified shake-flask
biodegradation test first as the results may impact the ecotoxicity
testing recommendations.
CFR citation: 40 CFR 721.10725 (P-08-512) and 40 CFR 721.10726 (P-
08-513).
PMN Number P-11-526
Chemical name: Amphoteric fluorinated surfactant (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: August 20, 2013.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a surface
active agent. Based on test data on the PMN substance and data
currently available to the Agency on analogous perfluorooctanoic acid
(PFOA), EPA identified concerns for potential incineration or other
decomposition products or degradants of the PMN substance. EPA also has
concerns that exposures to the PMN substance under certain conditions
of use--particularly non-industrial, commercial, or consumer uses--
could cause lung effects, based on data on analogous perfluorinated
compounds. PFOA is expected to persist for years in the environment.
Biodegradation and photolysis tests of analogous substances indicate
little or no biodegradation or photolysis of perfluoroalkyl compounds.
Bioaccumulation concerns are based on the measured presence of certain
perfluoroalkyl compounds, including PFOA, in wildlife and in human
blood samples. Toxicity studies on PFOA indicate developmental,
reproductive and systemic toxicity in various species, as well as
cancer. These factors taken together raise concerns for potential
adverse chronic effects in humans and wildlife. The consent 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 human health and the environment,
these 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 risks, the consent order requires:
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 a Material Safety Data Sheet (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 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. Use of the substance only as described in the consent order.
4. Submission of certain testing prior to exceeding the
confidential production volume limit of the PMN substance 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 test data from
certain human health, environmental fate, and ecotoxicity testing
identified in the consent order would help characterize possible
effects of the substances and their degradation products. The company
has agreed not to exceed the first production limit without performing
a Zahn-Wellens biodegradation test (OPPTS Test Guideline 835.5200) with
analysis for degradation products as specified, and a hydrolysis test
as a function of pH and temperature (OPPTS Test Guideline 835.2130).
The PMN submitter has also agreed not to exceed the second production
limit without performing a 90-day repeated dose oral toxicity study in
rats with 1-generation reproduction parallel study (must include
modifications) (OECD Test Guideline 421 modified) and a soil
biodegradation study (OECD Test Guideline 307). The company has agreed
not to exceed the third production limit without performing an
ultraviolet (UV) visible light absorption study (OPPTS Test Guideline
830.7050), a direct photolysis test, if wavelengths greater than 290
nautical miles (nm) are absorbed in the previous test (OPPTS Test
Guideline 830.7050) (OPPTS Test Guideline 835.2210), an indirect
photolysis screening test (OPPTS Test Guideline 835.5270), an anaerobic
biodegradability of organic compounds in digested sludge test (OECD
Test Guideline 311), and an avian reproduction test (OPPTS Test
Guideline 850.2300) in bobwhite quail. Further testing details are
available in the consent order located in the docket under docket EPA-
HQ-OPPT-2014-0166. The consent order does not require submission of the
additional pended testing detailed in the consent order at any
specified time or production volume. However, the consent order's
restrictions on manufacture, processing, distribution in commerce, use,
and disposal of the PMNs will remain in effect until the consent order
is modified or revoked by EPA based on submission of that or other
relevant information.
CFR citation: 40 CFR 721.10727.
[[Page 39271]]
PMN Numbers P-12-241 and P-12-242
Chemical names: (P-12-241) 2-Propenoic acid, 2-methyl-, 2-
hydroxyethyl esters, telomers with C18-26-alkyl acrylate, 1-
dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide,
polyfluorooctyl methacrylate, 2,2'-[1,2-diazenediylbis(1-
methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-
initiated (generic) and (P-12-242) 2-Propenoic acid, 2-methyl-, C16-18
esters, telomers with 3-chloro-2-hydroxypropyl methacrylate, 1-
dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide,
polyfluorooctyl methacrylate, and rel- (1R,2R,4R)-1,7,7-
trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2'-[1,2-
diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-
imidazole]hydrochloride (1:2)-initiated (generic).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e) consent order: June 5, 2013.
Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of these substances is as a water and
oil repellant. Based on analogy to other perfluorinated chemicals,
including PFOA, EPA has concerns for potential fluorinated incineration
or other decomposition products of the PMN substances. EPA has concerns
that these perfluorinated products may be released to the environment
from incomplete incineration of the PMN substances at low temperatures.
EPA has preliminary evidence that suggests that, under some conditions,
the PMN substances could degrade in the environment. Based on data on
analogous chemicals, including PFOA, EPA has concerns that these
degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic to people, wild
mammals, and birds. PFOA is expected to persist for years in the
environment. Biodegradation and photolysis tests of analogous
substances indicate little or no biodegradation or photolysis of
perfluoroalkyl compounds. Bioaccumulation concerns are based on the
measured presence of certain perfluoroalkyl compounds, including PFOA,
in wildlife and in human blood samples. Toxicity studies on PFOA
indicate developmental, reproductive and systemic toxicity in various
species, as well as possible cancer concerns. These factors, taken
together, raise concerns for potential adverse chronic effects in
humans and wildlife. The consent order was issued under TSCA section
5(e)(1)(A) based on a finding that these substances may present an
unreasonable risk of injury to human health and the environment, these
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 risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into a Material Safety Data Sheet (MSDS), within 90
days.
2. Manufacture of the PMN substances: (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 substances as stated in the consent order.
3. Use of the substances only as described in the consent order.
4. Submission of certain environmental fate and toxicity testing
prior to exceeding the confidential production volume limit of the
aggregate amount of the PMN substances described in P-12-241 and P-12-
242 specified in the consent order.
5. The individual annual manufacture volume for P-12-241 and P-12-
242 must not reach the confidential annual production volume 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 test data from
certain human health, environmental fate, and ecotoxicity testing
identified in the consent order would help characterize possible
effects of the substances and their degradation products. The company
has agreed not to exceed the first production limit without performing
a hydrolysis as a function of pH and temperature test (OPPTS Test
Guideline 835.2130), a ready biodegradation test (OPPTS Test Guideline
835.3110), a UV/Visible light spectrum test (OPPTS Test Guideline
830.7050), a direct photolysis test (OPPTS Test Guideline 835.2210) and
an indirect photolysis screening test (OPPTS Test Guideline 835.5270).
The company has also agreed not to exceed the second production limit
without performing a modified semi-continuous activated sludge (SCAS)
with analysis of degradation products test (OPPTS Test Guideline
835.5045/), an aerobic/anaerobic transformation in soil test (OECD Test
Guideline 307), an anaerobic biodegradability of organic compounds in
digested sludge test (OECD Test Guideline 311), a phototransformation
of chemicals in soil test, 2002, surfaces--2 soils (draft OECD, a
simulation test--aerobic sewage treatment (activated sludge units)
(OECD Test Guideline 303A), an aerobic and anaerobic transformation in
aquatic sediment systems test (OECD Test Guideline 308), and an acute
inhalation toxicity test (OPPTS Test Guideline 870.1300). Further
testing details are available in the consent order located in the
docket under docket EPA-HQ-OPPT-2014-0166. The consent order does not
require submission of the pended testing detailed in the consent order
at any specified time or production volume. However, the consent
order's restrictions on manufacture, processing, distribution in
commerce, use, and disposal of the PMNs will remain in effect until the
consent order is modified or revoked by EPA based on submission of that
or other relevant information.
CFR citation: 40 CFR 721.10728 (P-12-241) and 40 CFR 721.10729 (P-
12-242).
PMN Numbers P-12-557 and P-12-558
Chemical names: (P-12-557) Tires, wastes, pyrolyzed, C6-39 oil
fraction and (P-12-58) Tires, wastes, pyrolyzed, C7-56 oil fraction.
CAS numbers: (P-12-557) 1410795-89-9 and (P-12-558) 1410795-87-7.
Effective date of TSCA section 5(e) consent order: July 22, 2013.
Basis for TSCA section 5(e) consent order: The PMNs state that the
substances will be used as naphtha used for high octane gas and
cleaning fluids, kerosene used for jet fuels, distillate fuel oil used
for off-highway diesel engines and power generation, and vacuum gas oil
used for gasoline. Based on structure-activity relationship analysis of
test data on analogous neutral organic chemicals, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 360 ppb
(for P-12-557) and 170 ppb (for P-12-558) in surface waters. The
consent order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that uncontrolled manufacture,
processing, distribution in commerce, use, and disposal of these
substances may present an unreasonable risk of injury to the
environment. To protect against these risks, the consent order
requires:
[[Page 39272]]
1. Establishment and use of a hazard communication program,
including human health, environmental hazard precautionary statements
on each label and the MSDS.
2. Use of the substances only as described in the consent order.
3. No use of the substances resulting in surface water
concentrations exceeding the concentrations of concern identified in
the releases to water section of the consent order.
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 text, 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. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed. The order
does not require the submission of these tests 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 721.10730 (P-12-557) and 40 CFR 721.10731 (P-
12-558).
PMN Number P-13-60
Chemical name: Neodymium, butadiene iso-Bu neodecanoate complexes.
CAS number: 1386395-00-1.
Basis for action: The PMN states that the use of the substance is
as a precursor to polymerization catalyst. Based on SAR analysis of
test data on analogous neodymium complexes, 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 exceeding 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 resulting in releases to surface waters exceeding 8
ppb may cause 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 (OPPT Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPT 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 721.10732.
PMN Number P-13-237
Chemical name: Tires, wastes, pyrolyzed, C5-15 condensate oil
fraction.
CAS number: Claimed confidential.
Chemical substance definition: A complex combination of
hydrocarbons obtained from the substance produced by the pyrolysis of
rubber-based tires after removal of the carbon black fraction. It
consists predominantly of hydrocarbons having carbon numbers in the
range of C5 through C15. It boils in the range of approximately 36
[deg]C to 265 [deg]C (97[emsp14][deg]F to 509[emsp14][deg]F).
Effective date of TSCA section 5(e) consent order: August 8, 2013.
Basis for TSCA section 5(e) consent order: The PMN states that the
use of the substance will be as a raw feed stock for refineries. Based
on data for benzene which comprises 6% of the PMN substance, EPA
identified concerns for oncogenicity, immunotoxicity, and liver and
blood toxicity. Based on data for limonene, which constitutes 13% of
the PMN substance, EPA identified concerns for dermal sensitization.
Based on SAR analysis for neutral organic chemicals the PMN substance
may be toxic to aquatic organisms at concentrations as low as 4 ppb.
The order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that this substance may present an
unreasonable risk of injury to human health or the environment. To
protect against this risk, the consent order requires:
1. An 8-hour time-weighted-average (TWA) inhalation exposure limit
of 1 part per million (ppm) to the PMN substance.
2. Use of the PMN substance only as a raw feed stock for
refineries.
3. No use of the substance resulting in surface water
concentrations that exceed 4 ppb.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of
inhalation monitoring data, collected according to the EPA draft
Inhalation Monitoring Data Collection Guidelines (located in the docket
to this rule); 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.l010); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the human health and environmental effects of the PMN substance. The
order does not require submission of these tests at any specified time
or production volume. However, the order's restrictions on manufacture,
processing, distribution in commerce, use, and disposal of the PMN
substance 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 721.10733.
PMN Number P-13-248
Chemical name: Lithium salt of substituted imide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an electrolyte. Based on
test data on the PMN substance, and SAR analysis of test data on
analogous lithium salts, the EPA identified concerns for irritation,
possible corrosion, acute toxicity, blood and thyroid effects,
neurotoxicity, and immunotoxicity from exposure to the PMN substance
via inhalation and dermal exposures. As described in the PMN,
occupational exposures are expected to be minimal due to the use of a
National Institute of Occupational Safety and Health (NIOSH)-certified
particulate respirator with an assigned protection factor (APF) of at
least 10. Further, general population exposures are not expected as the
PMN 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 PMN substance without a NIOSH-certified particulate
respirator with an APF of at least 10, where there is a potential for
inhalation exposures; or any use in a consumer product may cause
serious 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
inhalation monitoring data, collected according to the EPA draft
Inhalation Monitoring Data Collection Guidelines (located in the docket
to this rule) would help characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.10734.
[[Page 39273]]
PMN Number P-13-270
Chemical name: Aromatic dibenzoate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a catalyst component. Based on
SAR analysis of test data on analogous esters, EPA predicts chronic
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. Based on uses 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 should there be any new use of the substance resulting in
releases to surface waters exceeding 1 ppb significant adverse
environmental effects could occur. 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
sediment-water chironomid life-cycle toxicity test using spiked water
or spiked sediment (OECD Test Guideline 233); a hydrolysis test (OECD
Test Guideline 111); and a Zahn-Wellens inherent biodegradation test
(OECD Test Guideline 302B) would help characterize the potential for
chronic aquatic toxicity of the PMN substance. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed to
facilitate solubility in the test media, because of the PMN substance's
low water solubility.
CFR citation: 40 CFR 721.10735.
PMN Number P-13-309
Chemical name: Alcohols, C9-11-branched, ethoxylated propoxylated.
CAS number: 1400790-00-2.
Basis for action: The PMN states that the use of the substance will
be as a component of a pigment dispersant blend for inks and coatings.
Based on SAR analysis of test data on analogous nonionic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 170 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 170 ppb for more than 20 days per
year. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance other than as a component of a pigment dispersant blend for
inks and coatings may cause 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 (OPPT Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed
to facilitate solubility in the test media, because of the PMN
substance's low water solubility.
CFR citation: 40 CFR 721.10736.
PMN Number P-13-378
Chemical name: Carboxylic anhydride, polymer with -hydro-
hydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10-
octahydropyrimido-[1,2-a]azepine (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance is
as a polyurethane catalyst. Based on SAR analysis of test data on
analogous aliphatic amines, 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
releases to surface waters exceeding 24 ppb may cause 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); a fish acute toxicity test mitigated by humic acid (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 environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10737.
PMN Number P-13-453
Chemical name: Formaldehyde, polymer with 2,3-dimethylphenol, 2,4-
dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol,
4-ethylphenol, 3-methylphenol, 4-methylphenol and phenol.
CAS number: 1415313-86-8.
Basis for action: The PMN states that the substance will be used as
a coating for electronic components. Based on SAR analysis of test data
on analogous phenols, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 5 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 5
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
releases to surface waters exceeding 5 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); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed to
facilitate solubility in the test media, because of the PMN substance's
low water solubility.
CFR citation: 40 CFR 721.10738.
PMN Number P-13-465
Chemical name: Caprolactone homopolymer of substituted
benzotriazole (generic).
[[Page 39274]]
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a UV stabilizer. Based on
SAR analysis of test data on analogous benzotriazoles, esters, phenols,
and amides, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the substance are not
expected to result in surface water concentrations that exceed 1 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 1 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a water
solubility test (OECD Test Guideline 105); a fish early life stage
toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed to
facilitate solubility in the test media, due to the low water
solubility of the PMN material. EPA suggests conducting the water
solubility test first as the results may impact the ecotoxicity testing
recommendations.
CFR citation: 40 CFR 721.10739.
PMN Number P-13-473
Chemical name: Tin(2+) salt of alkylcarboxylic acid (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst. Based on test
data on the PMN, as well as SAR analysis of test data on analogous tin
compounds, the EPA identified potential human health concerns regarding
eye corrosion, dermal sensitization, and asthma, from the PMN substance
via dermal exposure. Further, based on SAR analysis of test data on
analogous tin salts and anionic surfactants, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 27 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, exceed releases
from the use and production volume described in the PMN. For the use
and production volume described in the PMN, environmental releases did
not exceed 27 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 use of the substance without the use of impervious gloves
and goggles, when there is a potential dermal exposure; use of the
substance other than as described in the PMN; or any increase in the
annual confidential production volume could result in exposures which
may cause serious human health and significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. EPA also recommends
filtration should be avoided and that the guidance document on aquatic
toxicity testing of difficult substances and mixtures (OECD Test
Guideline 23) followed to facilitate solubility in the test media,
because of the PMN substance's low water solubility. Repeated dose
health tests are not recommended because of the PMN substance's
corrosive nature.
CFR citation: 40 CFR 721.10740.
PMN Number P-13-563
Chemical name: Propylene glycol, alpha isocyanate, omega silane
(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
for polyurethane polymers. Based on SAR analysis of analogous
diisocyanates, EPA identified concerns for oncogenicity, mutagenicity,
respiratory and dermal sensitization and lung and mucous membrane
irritation from exposure to the PMN substance via inhalation and dermal
exposures. For the use described in the PMN, EPA does not expect
significant occupational or consumer exposure. 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 a NIOSH-certified
particulate respirator with an APF of at least 10, where there is a
potential for inhalation exposures; any use other than as an
intermediate; or any use of the substance in consumer products, may
cause serious health 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 test (OPPTS Test Guideline 870.2600); a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465); and a carcinogenicity
test (OPPTS Test Guideline 870.4200) would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10741.
PMN Numbers P-13-617, P-13-618, and P-13-619
Chemical names: (P-13-617) Aromatic dicarboxylic acid polymer with
alkanediol, alkyl alkyl-2-alkenoate,1,4-dialkyl aromatic dicarboxylate,
alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate,
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic
acid (generic), (P-13-618) Alkanedioic acid, polymer with alkyl 2-
alkyl-2-alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-
alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-
alkyl-2-alkenoic acid (generic); and (P-13-619) Alkanedioic acid,
polymer with alkyl alkyl-alkenoate, alkanedioic acid, alkanediol,
.alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic
diisocyanate, alkyl alkyl-alkeneoate and alkyl-alkenoic acid (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substances will be as an adhesive. Based on
SAR analysis of test data on analogous diisocyanates, EPA identified
concerns for respiratory sensitization. For the use described in the
PMN, EPA does not expect significant occupational or consumer
inhalation exposure as the substances are not applied using a method
that generates a vapor, mist, or aerosol, nor are they used in a
consumer product. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the
[[Page 39275]]
substances may present an unreasonable risk. EPA has determined,
however, that any use of the substances without a NIOSH-certified
particulate respirator with an APF of at least 10, where there is a
potential for inhalation exposures; any use in consumer products; or
any use of the substances involving an application method that
generates a vapor, mist, or aerosol may cause serious health 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 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substances.
CFR citation: 40 CFR 721.10742 (P-13-617); 40 CFR 721.10743 (P-03-
618) and 40 CFR 721.10744 (P-13-619).
PMN Number P-13-722
Chemical name: Alkoxylated quaternary alkyl ammonium
fluoroalkylsulfonimide (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer additive. Based
on SAR analysis of test data on analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 9 ppb of the PMN substance in surface waters. For the use
described in the PMN, environmental releases are not expected to result
in surface water concentrations that exceed 9 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 9 ppb may cause 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, freshwater daphnids
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OPPTS Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance. EPA also recommends that the guidance document on
aquatic toxicity testing of difficult substances and mixtures (OECD
Test Guideline 23) be followed to facilitate solubility in the test
media, due to the low water solubility of the PMN material.
CFR citation: 40 CFR 721.10745.
PMN Number P-13-753
Chemical name: Isocyanate terminated urethane polymer (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive and sealant.
Based on SAR analysis of test data on analogous isocyanates, EPA
identified concerns for respiratory and dermal sensitization to workers
from exposure to the PMN substance. In addition, based on test data
submitted under the TSCA section 8(e) program, the Agency identified
concern for mutagenicity. For the uses described in the PMN,
significant occupational dermal and inhalation exposures are not
expected. Further, general population exposures are not expected as the
PMN 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 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 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 721.10746.
PMN Number P-13-773
Chemical name: 4-Pyrimidianamine, 2,5 dimethoxy-.
CAS number: 6960-17-4.
Basis for action: The PMN states that the substance will be used as
an herbicide intermediate. Based on test data of the PMN substance, as
well as SAR analysis of test data on analogous aromatic amines, EPA
identified concerns for mutagenicity, oncogenicity, and developmental
toxicity to workers exposed to the PMN substance. Further, based on SAR
analysis of test data on analogous anilines, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 7 ppb of the
PMN substance in surface water. As described in the PMN, EPA does not
expect significant occupational exposures and releases of the PMN
substance are not expected to result in surface water concentrations
that exceed 7 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 a NIOSH-certified respirator with an APF of at least
10, where there is potential inhalation exposure; any use without
impervious gloves, where there is potential for dermal exposure; or any
use other than as an herbicide intermediate may cause serious health
and environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(1)(i)(B), (b)(1)(i)(C),
(b)(3)(ii), (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity test (OECD Test Guideline 422), with
the reproduction/development toxicity screening test; a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465); and an
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010) would help characterize the human health and
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10747.
PMN Numbers P-13-796, P-13-797, P-13-798, P-13-799, and P-13-800
Chemical names: (P-13-796, P-13-797, and P-13-798)
Dicarbomonocycle-substituted carbomonocycledicarboxamide (generic); (P-
13-799) Dicarboheterocycle-substituted carbomonocycledicarboxamide
(generic); and (P-13-800) Tricarbomonocycle-substituted
carbomonocycletricarboxamide (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substances are as additives for polymer
manufacturing. Based on SAR analysis of test data on analogous amides,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 4 ppb (for P-13-796 and P-13-797); 14 ppb (for P-13-798); 1
ppb (for P-13-799); and 2 ppb (for P-13-800) of the PMN substance in
surface waters. For the use described in the PMNs, releases of the
substances are not expected to result in surface water concentrations
that exceed the respective concentrations for concern. 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 use of the substance resulting in releases to surface
waters exceeding the respective concentrations of concern
[[Page 39276]]
may result in significant adverse environmental effects. Based on this
information, the PMN substances meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OECD Test Guideline 301); a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be followed to
facilitate solubility in the test media, because of the PMN substance's
low water solubility. EPA suggests conducting the biodegradation test
first as the results may impact the ecotoxicity testing
recommendations.
CFR citation: 40 CFR 721.10748 (P-13-796, P-13-797, and P-13-798);
40 CFR 721.10749 (P-13-799); and 40 CFR 721.10750 (P-13-800).
PMN Number P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-
815
Chemical names: Cycloalkylamino oleyl alkylamide acid salts
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-
confidential) use of these substances are as inhibitors for oil field
applications. Based on SAR analysis of test data on analogous aliphatic
amines, EPA predicts chronic toxicity to aquatic organisms may occur at
concentrations that exceed 1 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 exceeding 1 ppb of
the aggregate of these PMN substances. 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 use of the substances resulting in releases to surface
waters exceeding 1 ppb may result in significant adverse environmental
effects. Based on this information, the PMN substances meets the
concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a water
solubility: Column elution method; shake flask method test (OPPTS Test
Guideline 830.7840) or a water solubility: Generator column method test
(OPPTS Test Guideline 830.7860); a determination of the partition
coefficient (n-octanol/water) by shake flask method (OPPTS Test
Guideline 830.7550), generator column method (OPPTS Test Guideline
830.7560), or estimation by liquid chromatography (OPPTS Test Guideline
830.7570); and log Koc determination by adsorption-desorption using a
batch equilibrium method (OECD Test Guideline 106) in representative
salt water conditions would help characterize the environmental effects
of the PMN substances. Based on the results of these studies, EPA would
recommend either of the following as additional testing:
(A) Fish acute toxicity test, freshwater and marine (OPPTS Test
Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline
850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500)
or;
(B) the whole sediment acute toxicity test, invertebrates, marine
(OPPTS Test Guideline 850.1740).
CFR citation: 40 CFR 721.10751.
PMN Numbers P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-
821
Chemical names: Cycloalkylamino cocoalkyl alkylamide acid salts
(generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-
confidential) use of these substances is as inhibitors for oil field
applications. Based on SAR analysis of test data on analogous aliphatic
amines, EPA predicts chronic toxicity to aquatic organisms may occur at
concentrations that exceed 1 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 exceeding 1 ppb of
the aggregate of these PMN substances. 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 use of the substances resulting in releases to surface
waters exceeding 1 ppb may result in significant adverse environmental
effects. Based on this information, the PMN substances meets the
concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a water
solubility: Column elution method; shake flask method test (OPPTS Test
Guideline 830.7840) or a water solubility: Generator column method test
(OPPTS Test Guideline 830.7860); a determination of the partition
coefficient (n-octanol/water) by shake flask method (OPPTS Test
Guideline 830.7550), generator column method (OPPTS Test Guideline
830.7560), or estimation by liquid chromatography (OPPTS Test Guideline
830.7570); and log Koc determination by adsorption-desorption using a
batch equilibrium method (OECD Test Guideline 106) in representative
salt water conditions would help characterize the environmental effects
of the PMN substances. Based on the results of these studies, EPA would
recommend either of the following as additional testing:
(A) Fish acute toxicity test, freshwater and marine (OPPTS Test
Guideline 850.1075); a mysid acute toxicity test (OPPTS Test Guideline
850.1350); and an algal toxicity test (OCSPP Test Guideline 850.4500)
or;
(B) the whole sediment acute toxicity test, invertebrates, marine
(OPPTS Test Guideline 850.1740).
CFR citation: 40 CFR 721.10752.
PMN Number P-13-839
Chemical name: Methanamine, N,N-dimethyl-, reaction products with
alkylamine-epichlorohydrin polymer, chlorides (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 of pre-coat
solution. Based on the test data submitted with this PMN as well as the
structural activity relationships analysis for analogous polycationic
polymers, 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 to surface
waters are not expected. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a fish
acute toxicity mitigated by humic acid (OPPTS Test Guideline 850.1085);
a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substances and mixtures (OECD Test Guideline 23) be followed
to facilitate solubility in the
[[Page 39277]]
test media, because of the PMN substance's low water solubility.
CFR citation: 40 CFR 721.10753.
PMN Number P-13-882
Chemical name: Mixture of alkylated benzene, brominated (generic)
and alkylated benzene, dibrominated (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be as a feed for a bromine recovery unit. Based on analogous chemical
substances that contain bromine and alkylation potential of the PMN
substance, EPA identified concerns for neurotoxicity, liver and kidney
toxicities, mutagenicity, and oncogenicity, as well as concerns for
developmental toxicity and dermal sensitization to workers exposed to
the PMN substance. The Agency also identified the potential for human
health risk due to the possible formation of dioxins. Further, based on
test data on analogous benzyl halides, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 5 ppb of the PMN
substance in surface water. For the use described in the PMN, EPA does
not expect significant occupational inhalation or dermal exposures;
significant general population inhalation or drinking water exposures;
or releases of the PMN substance that result in surface water
concentrations that exceed 5 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 use
other than for use other than as feed for a bromine recovery unit may
cause serious health and significant environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(D), (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465); 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 721.10754.
PMN Number: P-14-42
Chemical name: Substituted perfluoroether (generic).
CAS Number: Claimed confidential.
Basis for Action: The PMN states that the generic (non-
confidential) use of the substance is as a surfactant for laboratory
use fluid. Based on SAR analysis of test data on analogous high
molecular weight polymers, EPA identified concerns for lung toxicity if
respirable droplets of the PMN substance are inhaled. Further, based on
analogy to perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate
(PFOS), EPA identified concerns for liver toxicity, acute toxicity,
developmental and reproductive toxicity, and cancer, for the PMN
substance, when the mean moles of each perfluoro propylene (PPO) unit
is less than 5. The low molecular weight species have been identified
as having the potential to be persistent, bioaccumulative, and toxic
(PBT) chemicals. EPA does not have comparable toxicity information on
the low molecular weight fraction of the PMN substance and unreacted
starting material. EPA has concerns that this PMN substance will
persist in the environment. In addition, the perfluoro degradation
products could persist, bioaccumulate, and be toxic to people, wild
mammals, and birds. EPA's concerns are based on analogy to other
perfluoro chemicals, including PFOA and PFOS, which are both currently
under review by EPA for PBT concerns. PFOA and PFOS are expected to
persist for years in the environment. Biodegradation and photolysis
tests of analogous substances indicate little or no biodegradation or
photolysis of perfluoroalkyl compounds. Bioaccumulation concerns are
based on the measured presence of certain perfluoroalkyl compounds,
including PFOA, in wildlife and in human blood samples. In addition,
EPA expects the PMN substance and the perfluoro degradation products to
be highly persistent, and the low molecular weight fraction is expected
to be mobile and bioaccumulate in the environment. No ecotoxicological
concerns were raised for the PMN substance itself. However, there is
high concern for possible environmental effects to mammals and wild
birds from the perfluoro degradation products of the PMN substance. As
stated previously, the analog PFOA is persistent in the environment;
has a long bioretention time in various species; has been detected in a
number of species of wildlife, including marine mammals; and is
considered toxic to mammalian and other species. The toxicological
properties and presence of PFOA in the environment continue to be
investigated. For the use described in the PMN, EPA does not expect
occupational, general population, or environmental exposures to the PMN
substance. 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 other than as described in the PMN, or any manufacture of the
PMN substance where the mean number of moles of each perfluoro
propylene oxide unit is less than 5, may result in serious health
effects or significant adverse environmental effects. Based on this
information, the PMN meets the concern criteria at 721.170(b)(3)(i),
(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Recommended Testing: EPA has determined that the results of the
following testing on the presumed perfluoro degradation products of the
PMN substance would be necessary to evaluate the potential human health
effects of the PMN substance: a repeated dose metabolism and
pharmacokinetics test (OPPTS Test Guideline 870.7485) in rats and mice;
a 1-generation reproduction study (OECD Test Guideline 421), modified;
a 90-day oral toxicity test (OPPTS Test Guideline 870.3100) in rats; a
combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline
870.4300 or OECD Test Guideline 453) in rats; and an avian reproduction
test (OPPTS Test Guideline 850.2300 or OECD Test Guideline 206). EPA
recommends that the Company conduct the pharmacokinetics testing first
to confirm species acceptability and to provide a reliable half-life
for this substance. Further, EPA has determined that the results of the
following physical/chemical properties and fate and transport tests on
the PMN substance would be necessary to evaluate the environmental fate
and transport: A UV visible light absorption test (OPPTS Test Guideline
830.7050); a hydrolysis as a function of pH test (OPPTS Test Guideline
835.2130); a semi-continuous activated sludge (``SCAS'') test (OPPTS
Test Guideline 835.5045, OPPTS Test Guideline 835.3210, or OECD Test
Guideline 302A) modified for analysis for perfluoro degradation
products; an aerobic transformation in soil test (OECD Test Guideline
307); an aerobic and anaerobic transformations test (OECD Test
Guideline 308) in aquatic sediment systems; a direct photolysis test
(OPPTS Test Guideline 835.2210); an indirect photolysis screening test
(OPPTS Test Guideline 835.5270); phototransformation of chemicals on
soil surfaces (Draft OECD Test Guideline
[[Page 39278]]
January 2002) using 2 soils, a simulation test-aerobic sewage treatment
(OECD Test Guideline 303A) activated sludge units; and an anaerobic
biodegradability test (OECD Test Guideline 311) on organic compounds in
digested sludge.
CFR Citation: 40 CFR 721.10764.
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 6 of the 43
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 36 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.
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 September 8, 2014 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before August 8, 2014.
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 August 8, 2014, 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 6 of the 43 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 39 of the 43 chemical substances subject to this rule
have been claimed as confidential and EPA has received no post-PMN bona
fide submissions (per 40 CFR 720.25 and Sec. 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 July 9, 2014 as the cutoff date for
determining whether the new use is ongoing. Persons who begin
commercial manufacture or processing of the chemical substances for a
significant new use identified as of that date would have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons would have to first comply with all
applicable SNUR notification requirements and wait until the notice
review period, including any extensions, expires. If such a person met
the conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR. Consult
the Federal Register document of April 24, 1990, for a more detailed
discussion of the cutoff date for ongoing uses.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for TSCA non-section 5(e) SNURs. Descriptions of tests are
provided for informational purposes.
[[Page 39279]]
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. To access the
OCSPP test guidelines referenced in this document electronically,
please go to https://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.'' The Organisation for Economic Co-operation and
Development (OECD) test guidelines are available from the OECD Bookshop
at https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study
before reaching the specified production limit. Listings of the tests
specified in the TSCA section 5(e) consent orders are included in Unit
IV. The SNURs contain the same production volume limits as the TSCA
section 5(e) consent orders. Exceeding these production limits is
defined as a significant new use. Persons who intend to exceed the
production limit must notify the Agency by submitting a SNUN at least
90 days in advance of commencement of non-exempt commercial manufacture
or processing.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at Sec.
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-2014-0166.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This rule 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 rule. 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.
[[Page 39280]]
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 rule.
This rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant
economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this rule. As
such, EPA has determined that this rule does not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
small governments subject to the requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 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 rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
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
rule.
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).
XIV. 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: June 27, 2014.
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:
[[Page 39281]]
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
40 CFR citation OMB control No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10725 2070-0012
721.10726 2070-0012
721.10727 2070-0012
721.10728 2070-0012
721.10729 2070-0012
721.10730 2070-0012
721.10731 2070-0012
721.10732 2070-0012
721.10733 2070-0012
721.10734 2070-0012
721.10735 2070-0012
721.10736 2070-0012
721.10737 2070-0012
721.10738 2070-0012
721.10739 2070-0012
721.10740 2070-0012
721.10741 2070-0012
721.10742 2070-0012
721.10743 2070-0012
721.10744 2070-0012
721.10745 2070-0012
721.10746 2070-0012
721.10747 2070-0012
721.10748 2070-0012
721.10749 2070-0012
721.10750 2070-0012
721.10751 2070-0012
721.10752 2070-0012
721.10753 2070-0012
721.10754 2070-0012
721.10764 2070-0012
* * * * *
------------------------------------------------------------------------
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.10725 to subpart E to read as follows:
Sec. 721.10725 Alcohol propoxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alcohol
propoxylate (PMN P-08-512) 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(l)
(ii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(a)(3) (Class I or II wells), (b)(1), (b)(3) (Class I or II wells),
(c)(1), and (c)(3) (Class I or II wells).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
(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 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.
0
5. Add Sec. 721.10726 to subpart E to read as follows:
Sec. 721.10726 Alcohol propoxylate sulfate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alcohol
propoxylate sulfate salt (PMN P-08-513) 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(l)
(ii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(a)(3) (Class I or II wells), (b)(1), (b)(3) (Class I or II wells),
(c)(1), and (c)(3) (Class I or II wells).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(2)(ii), (b)(2)(ii), and (c)(2)(ii).
(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 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.
0
6. Add Sec. 721.10727 to subpart E to read as follows:
Sec. 721.10727 Amphoteric fluorinated surfactant (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
amphoteric fluorinated surfactant (PMN P-11-526) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this 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 this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k)(a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and (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
7. Add Sec. 721.10728 to subpart E to read as follows:
[[Page 39282]]
Sec. 721.10728 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl esters,
telomers with C18-26-alkyl acrylate, 1-dodecanethiol, N-
(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate,
2,2'-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-
imidazole]hydrochloride (1:2)-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, 2-hydroxyethyl esters, telomers with C18-26-
alkyl acrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-methyl-2-
propenamide, polyfluorooctyl methacrylate, 2,2'-[1,2-diazenediylbis(1-
methylethylidene)]bis[4,5-dihydro-1H-imidazole]hydrochloride (1:2)-
initiated (PMN P-12-241) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this 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 this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), (q), and (t).
(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), (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. 721.10729 to subpart E to read as follows:
Sec. 721.10729 2-Propenoic acid, 2-methyl-, C16-18 esters, telomers
with 3-chloro-2-hydroxypropyl methacrylate, 1-dodecanethiol, N-
(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate,
and rel- (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl
methacrylate, 2,2'-[1,2-diazenediylbis(1-methylethylidene)]bis[4,5-
dihydro-1H-imidazole]hydrochloride (1:2)-initiated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, C16-18 esters, telomers with 3-chloro-2-
hydroxypropyl methacrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-
methyl-2-propenamide, polyfluorooctyl methacrylate, and rel-(1R,2R,4R)-
1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate, 2,2'-[1,2-
diazenediylbis(1-methylethylidene)]bis[4,5-dihydro-1H-
imidazole]hydrochloride (1:2)-initiated (PMN P-12-242) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this 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 this substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), (q), and (t).
(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), (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
9. Add Sec. 721.10730 to subpart E to read as follows:
Sec. 721.10730 Tires, wastes, pyrolyzed, C6-39 oil fraction.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as tires, wastes,
pyrolyzed, C6-39 oil fraction (P-12-557; CAS No. 1410795-89-9) 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 chemical substance that has been
blended into finished petroleum products or sent to a petroleum
refinery for use as a chemical intermediate.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
[[Page 39283]]
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=360).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), (i), and (k) are applicable to
manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(1) of
this section.
0
10. Add Sec. 721.10731 to subpart E to read as follows:
Sec. 721.10731 Tires, wastes, pyrolyzed, C7-56 oil fraction.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as tires, wastes,
pyrolyzed, C7-56 oil fraction (P-12-558; CAS No. 1410795-87-7) 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 chemical substance that has been
blended into finished petroleum products or sent to a petroleum
refinery for use as a chemical intermediate.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=170).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), (i), and (k) are applicable to
manufacturers and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(1) of
this section.
0
11. Add Sec. 721.10732 to subpart E to read as follows:
Sec. 721.10732 Neodymium, butadiene iso-Bu neodecanoate complexes.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as neodymium,
butadiene iso-Bu neodecanoate complexes (PMN P-13-60; CAS No. 1386395-
00-1) 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) Releases 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), (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
12. Add Sec. 721.10733 to subpart E to read as follows:
Sec. 721.10733 Tires, wastes, pyrolyzed, C5-15 condensate oil
fraction.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as tires, wastes,
pyrolyzed, C5-15 condensate oil fraction (PMN P-13-237; chemical
substance definition: A complex combination of hydrocarbons obtained
from the substance produced by the pyrolysis of rubber-based tires
after removal of the carbon black fraction. It consists predominantly
of hydrocarbons having carbon numbers in the range of C5 through C15.
It boils in the range of approximately 36 [deg]C to 265 [deg]C
(97[emsp14][deg]F to 509[emsp14][deg]F).) 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 substances that have been blended into finished
petroleum products or sent to a petroleum refinery for use as a
chemical intermediate, or stored as described in the Distribution
section of the order.
(2) The significant new uses are:
(i) Protection in the workplace. The significant new use is any
exposure exceeding an 8 hour time weighted average (TWA) exposure limit
of 1 part per million (ppm).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is any use other
than as a raw feedstock for refineries.
(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), (b), (c), (i), (k), and records documenting that exposures
do not exceed an 8 hour time weighted average (TWA) exposure limit of 1
part per million 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 significant new use rule.
0
13. Add Sec. 721.10734 to subpart E to read as follows:
Sec. 721.10734 Lithium salt of substituted imide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lithium
salt of substituted imide (PMN P-13-248) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(i), (b) (concentration set at 1.0 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.
[[Page 39284]]
(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), (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.
0
14. Add Sec. 721.10735 to subpart E to read as follows:
Sec. 721.10735 Aromatic dibenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic dibenzoate (PMN P-13-270) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (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
15. Add Sec. 721.10736 to subpart E to read as follows:
Sec. 721.10736 Alcohols, C9-11-branched, ethoxylated propoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alcohols, C9-11-
branched, ethoxylated propoxylated (PMN P-13-309; CAS No. 1400790-00-2)
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 is any use other
than as a component of a pigment dispersant blend for inks and
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 (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. 721.10737 to subpart E to read as follows:
Sec. 721.10737 Carboxylic anhydride, polymer with -hydro--
hydroxypoly(oxy-1,2-diethanediyl), compd. with 2,3,4,6,7,8,9,10-
octahydropyrimido-[1,2-a]azepine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carboxylic anhydride, polymer with -hydro--hydroxypoly(oxy-1,2-
diethanediyl), compd. with 2,3,4,6,7,8,9,10-octahydropyrimido-[1,2-
a]azepine (PMN P-13-378) 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) Releases 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
17. Add Sec. 721.10738 to subpart E to read as follows:
Sec. 721.10738 Formaldehyde, polymer with 2,3-dimethylphenol, 2,4-
dimethylphenol, 2,5-dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol,
4-ethylphenol, 3-methylphenol, 4-methylphenol and phenol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymer with 2,3-dimethylphenol, 2,4-dimethylphenol, 2,5-
dimethylphenol, 3,5-dimethylphenol, 3-ethylphenol, 4-ethylphenol, 3-
methylphenol, 4-methylphenol and phenol (PMN P-13-453; CAS No. 1415313-
86-8) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=5).
(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
18. Add Sec. 721.10739 to subpart E to read as follows:
Sec. 721.10739 Caprolactone homopolymer of substituted benzotriazole
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
caprolactone homopolymer of substituted benzotriazole (PMN P-13-465) 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
19. Add Sec. 721.10740 to subpart E to read as follows:
Sec. 721.10740 Tin(2+) salt of alkylcarboxylic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as tin(2+)
salt of alkylcarboxylic acid (PMN P-13-473) 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:
[[Page 39285]]
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s).
(ii) Protection in the workplace. Requirements as specified in
Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(iii), and (a)(3).
(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)(1) of
this section.
0
20. Add Sec. 721.10741 to subpart E to read as follows:
Sec. 721.10741 Polyalkylene glycol, alpha isocyanate, omega silane
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyalkylene glycol, alpha isocyanate, omega silane (PMN P-13-563) 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), (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 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(g) and (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), (b), (c), (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
21. Add Sec. 721.10742 to subpart E to read as follows:
Sec. 721.10742 Aromatic dicarboxylic acid polymer with alkanediol,
alkyl alkyl-2-alkenoate, 1,4-dialkyl aromatic dicarboxylate,
alkanedioic acid, alkanedioic acid. alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate,
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic
acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic dicarboxylic acid polymer with alkanediol, alkyl alkyl-2-
alkenoate,1,4-dialkyl aromatic dicarboxylate, alkanedioic acid,
alkanedioic acid. alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate,
aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic
acid (PMN P-13-617) 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), (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 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(o) and (y)(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), (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
22. Add Sec. 721.10743 to subpart E to read as follows:
Sec. 721.10743 Alkanedioic acid, polymer with alkyl 2-alkyl-2-
alkenoate, alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1 2-alkanediyl)], hydroxyalkyl 2-alkyl-2-
alkenoate, aromatic diisocyanate, alkyl 2-alkyl-2-alkenoate and 2-
alkyl-2-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymer with alkyl 2-alkyl-2-alkenoate, alkanedioic
acid, alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1 2-
alkanediyl)], hydroxyalkyl 2-alkyl-2-alkenoate, aromatic diisocyanate,
alkyl 2-alkyl-2-alkenoate and 2-alkyl-2-alkenoic acid (PMN P-13-618) 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), (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 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
[[Page 39286]]
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(o) and (y)(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), (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
23. Add Sec. 721.10744 to subpart E to read as follows:
Sec. 721.10744 Alkanedioic acid, polymer with alkyl alkyl-alkenoate,
alkanedioic acid, alkanediol, .alpha.-hydro-.omega.-
hydroxypoly[oxy(alkyl-1,2-alkanediyl)], aromatic diisocyanate, alkyl
alkyl-alkeneoate and alkyl-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanedioic acid, polymer with alkyl alkyl-alkenoate, alkanedioic acid,
alkanediol, .alpha.-hydro-.omega.-hydroxypoly[oxy(alkyl-1,2-
alkanediyl)], aromatic diisocyanate, alkyl alkyl-alkeneoate and alkyl-
alkenoic acid (PMN P-13-619) 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), (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 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(o) and (y)(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), (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
24. Add Sec. 721.10745 to subpart E to read as follows:
Sec. 721.10745 Alkoxylated quaternary alkyl ammonium
fluoroalkylsulfonimide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkoxylated quaternary alkyl ammonium fluoroalkylsulfonimide (PMN P-13-
722) 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=9).
(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
25. Add Sec. 721.10746 to subpart E to read as follows:
Sec. 721.10746 Isocyanate terminated urethane polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanate terminated urethane polymer (PMN P-13-753) 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), (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 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(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), (b), (c), (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
26. Add Sec. 721.10747 to subpart E to read as follows:
Sec. 721.10747 4-Pyrimidianamine, 2,5 dimethoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 4-pyrimidianamine,
2,5 dimethoxy- (PMN P-13-773; CAS No. 6960-17-4) 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) 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), (b)
(concentration set at 0.1 percent) and (c). When determining which
persons are
[[Page 39287]]
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. 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. A significant new use is any use other
than as an herbicide intermediate.
(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.
0
27. Add Sec. 721.10748 to subpart E to read as follows:
Sec. 721.10748 Dicarbomonocycle-substituted
carbomonocycledicarboxamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
dicarbomonocycle-substituted carbomonocycledicarboxamide (PMNs P-13-
796, P-13-797, and P-13-798) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4 for P-13-796 and P-13-797; and
N=14 for P-13-798).
(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 significant new use rule.
0
28. Add Sec. 721.10749 to subpart E to read as follows:
Sec. 721.10749 Dicarboheterocycle-substituted
carbomonocycledicarboxamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dicarboheterocycle-substituted carbomonocycledicarboxamide (PMN P-13-
799) 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 significant new use rule.
0
29. Add Sec. 721.10750 to subpart E to read as follows:
Sec. 721.10750 Tricarbomonocycle-substituted
carbomonocycletricarboxamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
tricarbomonocycle-substituted carbomonocycletricarboxamide (PMN P-13-
800) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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 significant new use rule.
0
30. Add Sec. 721.10751 to subpart E to read as follows:
Sec. 721.10751 Cycloalkylamino oleyl alkylamide acid salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
cycloalkylamino oleyl alkylamide acid salts (PMNs P-13-810, P-13-811,
P-13-812, P-13-813, P-13-814, and P-13-815) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN
substances P-13-810, P-13-811, P-13-812, P-13-813, P-13-814, and P-13-
815).
(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. 721.10752 to subpart E to read as follows:
Sec. 721.10752 Cycloalkylamino cocoalkyl alkylamide acid salts
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
cycloalkylamino cocoalkyl alkylamide acid salts (PMNs P-13-816, P-13-
817, P-13-818, P-13-819, P-13-820, and P-13-821) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1, for the aggregate of the PMN
substances P-13-816, P-13-817, P-13-818, P-13-819, P-13-820, and P-13-
821).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
[[Page 39288]]
(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
32. Add Sec. 721.10753 to subpart E to read as follows:
Sec. 721.10753 Methanamine, N,N-dimethyl-, reaction products with
alkylamine-epichlorohydrin polymer, chlorides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
methanamine, N,N-dimethyl-, reaction products with alkylamine-
epichlorohydrin polymer, chlorides (PMN P-13-839) 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
33. Add Sec. 721.10754 to subpart E to read as follows:
Sec. 721.10754 Mixture of alkylated benzene, brominated (generic) and
alkylated benzene, dibrominated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixture
of alkylated benzene, brominated and alkylated benzene, dibrominated
(PMN P-13-882) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is any use other
than as feed for a bromine recovery unit.
(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
34. Add Sec. 721.10764 to subpart E to read as follows:
Sec. 721.10764 Substituted perfluoroether (generic)
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted perfluoroether (PMN P-14-42) 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 this substance
is: (1) Use of the substance for any application other than the
confidential use identified in the Premanufacture Notice (PMN) or (2)
Manufacture of the PMN substance where the mean number of moles of each
perfluoro propylene oxide (``PPO'') unit is less than 5.
(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. 721.180 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
[FR Doc. 2014-15774 Filed 7-8-14; 8:45 am]
BILLING CODE 6560-50-P