Significant New Use Rules on Certain Chemical Substances, 58665-58706 [2012-23235]
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Vol. 77
Friday,
No. 184
September 21, 2012
Part IV
Environmental Protection Agency
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40 CFR Parts 9 and 721
Significant New Use Rules on Certain Chemical Substances; Final Rule
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Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2011–0941; FRL–9357–2]
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 107 chemical substances
which were the subject of
premanufacture notices (PMNs). Eight of
these chemical substances are subject to
TSCA consent orders issued by EPA.
This action requires persons who intend
to manufacture, import, or process any
of these 107 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
November 20, 2012. For purposes of
judicial review, this rule shall be
promulgated at 1 p.m. (e.s.t.) on October
5, 2012.
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 October 22, 2012 (see Unit VI. of
the SUPPLEMENTARY INFORMATION).
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–2011–0941, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
• 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: OPPT Document
Control Office (DCO), EPA East, Rm.
6428, 1201 Constitution Ave. NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2011–0941.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
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SUMMARY:
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DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2011–0941. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
email. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through
regulations.gov, your email address will
be automatically captured and included
as part of the comment that is placed in
the docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave. NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
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to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Kenneth
Moss, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–9232; email address:
moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave. Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCAHotline@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, import,
process, or use the chemical substances
contained in this rule. Potentially
affected entities may include, but are
not limited to:
• Manufacturers, importers, or
processors of one or more subject
chemical substances (NAICS codes 325
and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
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; see also 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
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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 this rule are subject
to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b))
(see § 721.20), and must comply with
the export notification requirements in
40 CFR part 707, subpart D.
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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.
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II. Background
A. What action is the agency taking?
EPA is promulgating these SNURs
using direct final procedures. These
SNURs will require persons to notify
EPA at least 90 days before commencing
the manufacture, import, 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)
(April 24, 1990 SNUR). 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, import, or
process the chemical substance for that
use. Persons who must report are
described in § 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. According to
§ 721.1(c), persons subject to these
SNURs must comply with the same
notice 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
sections 5(h)(1), 5(h)(2), 5(h)(3), and
5(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
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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 107 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, taking
into consideration 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
107 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)
number (if assigned for non-confidential
chemical identities).
• Basis for the TSCA section 5(e)
consent order or, for non-section 5(e)
SNURs, the basis for the SNUR (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.
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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 8 PMN substances
(P–00–346, P–01–470, P–02–120, P–02–
285, P–04–834, P–10–58, P–10–59, and
P–10–60) for which EPA determined,
pursuant to TSCA section 5(e), that
uncontrolled manufacture, import,
processing, distribution in commerce,
use, and disposal may present an
unreasonable risk of injury to human
health and the environment.
Accordingly, these substances are
subject to ‘‘risk-based’’ consent orders
under TSCA section 5(e)(1)(A)(ii)(I).
Those consent orders require protective
measures to limit exposures or
otherwise mitigate the potential
unreasonable risk. The so-called ‘‘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 section 5(e) SNURs
designate as a ‘‘significant new use’’ the
absence of the protective measures
required in the corresponding consent
orders.
Where EPA determined that the PMN
substance may present an unreasonable
risk of injury to human health via
inhalation exposure, the SNUR usually
requires, among other things, that
potentially exposed employees wear
specified respirators unless actual
measurements of the workplace air
show that air-borne concentrations of
the PMN substance are below a New
Chemical Exposure Limit (NCEL) that is
established by EPA to provide adequate
protection to human health. In addition
to the actual NCEL concentration, the
comprehensive NCELs provisions,
which are modeled after Occupational
Safety and Health Administration
(OSHA) Permissible Exposure Limits
(PELs) provisions, include requirements
addressing performance criteria for
sampling and analytical methods,
periodic monitoring, respiratory
protection, and recordkeeping.
However, no comparable NCEL
provisions currently exist in 40 CFR
part 721, subpart B, for SNURs.
Therefore, for these cases, the
individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject
to the SNUR who wish to pursue NCELs
as an alternative to the § 721.63
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respirator requirements may request to
do so under § 721.30.
This rule also includes SNURs on 99
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 ‘‘non-5(e) SNURs’’ are
promulgated pursuant to § 721.170. EPA
has determined that every activity
designated as a ‘‘significant new use’’ in
all non-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 Number P–96–308
Chemical name: Aminoalkanol
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a chemical
intermediate. Based on structureactivity relationship (SAR) analysis of
the potential reaction of the PMN
substance with nitrosating agents, and
by analogy to monoethanolamine,
diethanolamine and
dimethylisopropylamine, EPA
identified concerns for skin, eye, liver,
kidney, lung, bone marrow, brain,
testes, heart, and blood toxicity from
exposure to the PMN substance via
inhalation and dermal exposures, and
the gastrointestinal (GI) tract. In
addition, based on ecological structureactivity relationship (EcoSAR) analysis
of test data on analogous aliphatic
amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 600 ppb of the PMN
substance in surface waters. For the use
described in the PMN, EPA does not
expect dermal or inhalation exposures
to manufacturing or processing workers
or other targeted populations, nor does
it expect releases to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
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determined, however, that any use of
the substance other than as described in
the PMN, or any use of the substance
resulting in surface water
concentrations exceeding 600 ppb may
cause serious health effects 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 the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with a functional
observational battery and
histopathology; a prenatal
developmental toxicity test (OPPTS Test
Guideline 870.3700); 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 to characterize
the human health and environmental
effect of the PMN substance.
CFR citation: 40 CFR 721.10427.
PMN Numbers P–96–1021 and P–96–
1022
Chemical names: (P–96–1021) Fatty
acids, C18-unsatd., dimers, reaction
products with 1-piperazineethanamine
and (P–96–1022) Fatty acids, C18unsatd., dimers, reaction products with
1-piperazineethanamine and tall-oil
fatty acids.
CAS numbers: (P–96–1021) 206565–
90–4 and (P–96–1022) 206565–89–1.
Basis for action: The consolidated
PMN states that the substances will be
used as water based epoxy curing
agents. Based on EcoSAR analysis of test
data on analogous aliphatic amines,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 1 ppb of the PMN
substances in surface waters. As
described in the PMN, the substances
are not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the PMN
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances resulting in
surface water concentrations exceeding
1 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substances meet
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
modified semi-continuous activated
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sludge (SCAS) test (OPPTS Test
Guideline 835.3210); 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) on PMN P–96–1022 would
help characterize the environmental
effects of the PMN substances.
CFR citations: 40 CFR 721.10428 (P–
96–1021) and 40 CFR 721.10429 (P–96–
1022).
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PMN Number P–97–823
Chemical name: Tetra alkyl
ammonium salt (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a curing agent for
coatings. Based on test data submitted
on the PMN substance at varying
concentrations, EPA identified concerns
for ocular lethality for occupational
exposures to the PMN substance at
concentrations greater than 25 percent.
For the use described in the PMN,
significant worker exposures are not
expected as the PMN substance is used
at concentrations no greater than 25
percent, and the material safety data
sheet (MSDS) provides the ocular
lethality results from the submitted eye
irritation studies. 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
including the hazard communication
warnings concerning the eye irritation
test results in the MSDS, or any use of
the substance in concentrations greater
than 25 percent may cause serious
health effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(3)(i).
Recommended testing: EPA has
determined that the results of an acute
eye irritation test (OPPTS Test
Guideline 870.2400) on the PMN
substance at concentrations greater than
25 percent would help characterize
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10430.
PMN Numbers P–98–141 and P–98–142
Chemical name: Phosphoric acid
esters (generic).
CAS number: Not available.
Basis for action: The consolidated
PMN states that the generic (nonconfidential) use of the substances will
be as metal extractants. Based on
EcoSAR analysis of test data on
analogous anionic surfactants, EPA
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predicts toxicity to aquatic organisms
may occur at concentrations that exceed
100 ppb of the PMN substance in
surface waters. As described in the
PMN, the substance is not released to
surface waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
PMN substance may present an
unreasonable risk. EPA has determined,
however, that any use of the substance
resulting in surface water
concentrations exceeding 100 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 test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) on the PMN
substances would help characterize the
environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.10431.
PMN Number P–98–1028
Chemical name: 1,2,4,5,7,8Hexoxonane, 3,6,9-triethyl-3,6,9trimethyl-.
CAS number: 24748–23–0.
Basis for action: The PMN states that
the substance will be used as a viscosity
modifier in the manufacture of
polypropylene, manufactured and
supplied as a solution in at least 40
percent mineral spirits. Based on
EcoSAR analysis of test data on
analogous peroxides, EPA predicts
toxicity to aquatic organisms may occur
if releases of the PMN 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, where the
PMN substance is supplied as a solution
of at least 40 percent mineral spirits,
significant environmental releases are
not expected. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
PMN substance may present an
unreasonable risk. EPA has determined,
however, that any use of the substance
other than as a viscosity modifier,
manufactured and supplied as a
solution in at least 40 percent mineral
spirits, in the manufacture of
polypropylene may cause significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(4)(ii).
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Recommended testing: EPA has
determined that the results of a porous
pot test (OPPTS Test Guideline
835.3220); 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.
CFR citation: 40 CFR 721.10432.
PMN Number P–99–184
Chemical name: Cyclopentene,
1,2,3,3,4,4,5,5-octafluoro-.
CAS number: 559–40–0.
Basis for action: The PMN states that
the substance will be used as a dry
etching agent and a chemical vapor
deposition (CVD) agent for the
production of semiconductors. Based on
test data on the PMN substance, EPA
identified concerns for acute toxicity,
systemic toxicity, developmental
toxicity, cardiac sensitization, and
mutagenicity from inhalation exposures.
As described in the PMN, the substance
will be imported and not manufactured
in the United States. As described in the
PMN, EPA does not expect significant
worker exposures during processing and
use activities for the uses described in
the PMN nor does it expect general
population exposures for the uses
described in the PMN. Therefore, EPA
has not determined that the proposed
processing or use may present an
unreasonable risk. EPA has determined,
however, that domestic manufacture, or
any use of the substance other than as
a dry etching agent and a CVD agent for
the production of semiconductors may
cause serious health effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(i).
Recommended testing: EPA has
determined that inhalation monitoring
data, collected according to the EPA
draft Inhalation Monitoring Data
Collection Guidelines (located in the
docket under docket ID number EPA–
HQ–OPPT–2011–0941), would help
characterize the human health effects of
the PMN substance.
CFR citations: 40 CFR 721.10433.
PMN Number P–99–214
Chemical name: Cyclopentane,
1,1,2,2,3,3,4-heptafluoro-.
CAS number: 15290–77–4.
Basis for action: The PMN states that
the substance will be used as a solvent
and a cleaning and drying agent. Based
on test data on the PMN substance, EPA
identified concerns for acute, systemic,
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and developmental toxicity, cardiac
sensitization, and mutagenicity from
inhalation exposures. As described in
the PMN, the substance will be
imported and not manufactured in the
United States. As described in the PMN,
EPA does not expect significant worker
exposures during processing and use
activities for the uses described in the
PMN nor does it expect general
population or consumer exposures for
the uses described in the PMN.
Therefore, EPA has not determined that
the proposed processing or use may
present an unreasonable risk. EPA has
determined, however, that any domestic
manufacture of the substance, use of the
substance other than as a solvent or a
cleaning and drying agent, or 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).
Recommended testing: EPA has
determined that inhalation monitoring
data, collected according to the EPA
draft Inhalation Monitoring Data
Collection Guidelines (located in the
docket under docket ID number EPA–
HQ–OPPT–2011–0941), would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10434.
PMN Number P–99–1179
Chemical name: Phenol, 2-(1-methyl1-phenylethyl)-4-(1,1,3,3tetramethylbutyl)-.
CAS number: 73936–80–8.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an ultraviolet (UV)
stabilizer for automotive coatings. Based
on EcoSAR analysis of test data on
analogous phenols, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations that exceed
1 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance resulting in
surface water concentrations exceeding
1 ppb may 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 (OPPTS Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300); and an algal toxicity test
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(OCSPP Test Guideline 850.4500) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10435.
PMN Numbers P–99–1217 and P–99–
1218
Chemical name: Amine neutralized
phosphated polyesters (generic).
CAS number: Not available.
Basis for action: The consolidated
PMN states that the generic (nonconfidential) use of the substances will
be as pigment dispersants. Based on
EcoSAR analysis of test data on
analogous anionic surfactants, EPA
predicts toxicity to aquatic organisms
may occur as a result of releases of the
PMN substances in quantities greater
than the combined 50,000 kilograms
(kgs) per year production volume stated
in the PMN. At the annual production
volume of 50,000 kgs stated in the
consolidated PMN, there were no
significant environmental releases.
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 exceeding an
annual aggregate manufacturing and
importation volume of 50,000 kgs may
cause significant adverse environmental
effects. Based on this information, the
PMN substances meet the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help
characterize the environmental effects of
the PMN substances.
CFR citation: 40 CFR 721.10436.
PMN Numbers P–99–1280, P–99–1281,
and P–99–1282
Chemical name: Sulfonic acid, linear
xylene alkylate, mono, sodium salts
(generic).
CAS number: Not available.
Basis for action: The consolidated
PMN states that the substances will be
used as enhanced oil recovery
surfactants. Based on EcoSAR analysis
of test data on analogous anionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 2 ppb of the
substances in surface waters for greater
than 20 days per year. This 20-day
criterion is derived from partial life
cycle tests (daphnid chronic and fish
early life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substances to surface water, from uses
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other than as described in the PMNs,
exceed releases from the use described
in the PMNs. For the use described in
the PMNs, environmental releases did
not exceed 2 ppb more than 20 days per
year. Therefore, EPA has not determined
that the proposed manufacturing,
processing, or use of the PMN
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances other than as
enhanced oil recovery surfactants may
cause significant adverse environmental
effects. Based on this information, the
PMN substances meet the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substances.
CFR citation: 40 CFR 721.10437.
PMN Number P–00–346
Chemical name: Dialkyl
hydroxybenzenealkanoic acid ester
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e)
consent order: August 16, 2001.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substance
will be as a petroleum additive. Based
on test data on the PMN substance and
SAR analysis of structurally similar
substances, EPA identified concerns for
liver and thyroid toxicity from dermal
exposures. 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
this substance may present an
unreasonable risk of injury to human
health, the substance may be produced
in substantial quantities, and there may
be significant (or substantial) human
exposure to the substance. To protect
against these risks, the consent order
requires:
1. Use of personal protective
equipment including impervious gloves
(when there is potential dermal
exposure).
2. Establishment and use of a hazard
communication program.
3. Submission of certain human
health testing prior to exceeding the
confidential production volume limit
specified in the consent order.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
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Recommended testing: EPA has
determined that the results of a 28-day
dermal toxicity test (The Organisation
for Economic Co-operation and
Development (OECD) Test Guideline
410) with emphasis on the thyroid (per
OPPTS Test Guideline 870.3465) would
help characterize the human health
effects of the PMN substance. The PMN
submitter has agreed not to exceed the
confidential production volume limit
specified in the consent order without
performing this test.
CFR citation: 40 CFR 721.10438.
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PMN Number P–00–635
Chemical name: 1,3-Dioxolan-2-one,
4-ethenyl.
CAS number: 4427–96–7.
Basis for action: The PMN states that
the generic (non-confidential) uses of
the substance will be as a chemical
intermediate and an industrial chemical
additive. Based on test data on the PMN
substance and SAR analysis of test data
on analogous vinylene carbonate, EPA
predicts acute toxicity, liver toxicity,
kidney toxicity, developmental toxicity,
immunotoxicity, and oncogenicity. For
the uses described in the PMN,
significant dermal exposures are not
expected due to the use of impervious
gloves. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance without the use
of impervious gloves where there is a
potential for dermal exposures, or any
use other than as described in the PMN
may cause serious human health effects.
Based on this information the PMN
substance meets the concern criteria at
§ 721.170(b)(1)(i)(C), (b)(3)(i), and
(b)(3)(ii).
Recommended testing: EPA has
determined that no additional testing is
recommended at this time as the health
effects have been adequately
characterized by the testing submitted
on the PMN substance.
CFR citation: 40 CFR 721.10439.
PMN Number P–00–1165
Chemical name: Diphosphoric acid,
polymers with ethoxylated reduced Me
esters of reduced polymd, oxidized
tetrafluoroethylene.
CAS number: 200013–65–6.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a surface active
agent. Based on analogous high
molecular weight polymers, EPA
identified concerns from inhalation
exposures. For the industrial uses
described in the PMN, worker
inhalation exposures are not expected as
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the substance is not applied by a
method that generates a vapor, mist, or
spray. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance in consumer products, or
any use involving an application
method that generates a vapor, mist, or
spray may cause serious health effects.
Based on the information, the PMN
substance meets the criteria at
721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of an acute
inhalation toxicity test (OPPTS Test
Guideline 870.1300) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10440.
PMN Numbers P–01–382 and P–01–383
Chemical names: (P–01–382) 1, 2Benzenedicarboxylic acid, di-C7–14branched and linear alkyl esters and (P–
01–383) 1,2-Benzenedicarboxylic acid,
di-C6–14-branched and linear alkyl
esters.
CAS numbers: (P–01–382) 309934–
68–7 and (P–01–383) 309934–69–8.
Basis for action: The consolidated
PMN states that the substances will be
used as plasticizers for flexible polyvinyl chloride. Based on SAR analysis
of the expected ester hydrolysis product
of the PMNs, EPA identified concerns
for liver, developmental, and
reproductive toxicity; and oncogenicity.
For the use described in the PMNs,
neither significant worker exposures nor
general population exposures are
expected. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances in children’s
toys (e.g., pacifiers, rattles, and teethers)
may cause serious health effects. Based
on this information, the PMN
substances meet the criteria at
§ 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has
determined that the results of an acute
oral toxicity test (OECD Test Guideline
401 or 420); an acute dermal toxicity
test (OECD Test Guideline 402); an
acute inhalation toxicity test (OECD
Test Guideline 403); a repeated dose 28day oral toxicity test in rodents (OECD
Test Guideline 407); a 28-day dermal
toxicity test (OECD Test Guideline 410);
a 28-day subacute inhalation toxicity
test (OECD Test Guideline 412); a
prenatal developmental toxicity test
(OECD Test Guideline 414); a 1generation reproduction test (OECD Test
Guideline 415); a reproduction and
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fertility effects test (OECD Test
Guideline 416); a reproduction/
development toxicity screening test
(OECD Test Guideline 421); a combined
repeated dose toxicity test with the
reproduction/development toxicity
screening test (OECD Test Guideline
422); a bacterial reverse mutation test
(OECD Test Guideline 471); an in vitro
mammalian chromosome aberration test
(OECD Test Guideline 473); a
mammalian erythrocyte micronucleus
test (OECD Test Guideline 474); and a
mammalian bone marrow chromosomal
aberration test (OECD Test Guideline
475) would help characterize the human
health effects of the PMN substances.
CFR citations: 40 CFR 721.10441 (P–
01–382) and 40 CFR 721.10442 (P–01–
383).
PMN Number P–01–470
Chemical name: Ethoxylated
alkylphenol sulfate, ammonium salt
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e)
consent order: August 26, 2002.
Basis for TSCA section 5(e) consent
order: The PMN states that the
substance will be used as a dispersant
for carbon black and organic pigments.
Based on test data on the PMN
substance, and EcoSAR analysis of test
data on analogous ethoxylated anionic
surfactants, EPA predicts environmental
toxicity that varies depending on the
average number of moles of ethoxylate.
As the number of ethoxylate decreases,
the aquatic toxicity of the substance
increases. For this PMN substance, the
average number of moles may vary.
Based on submitted test data on the
PMN—with an average number of 16.4
moles of ethoxylate—EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 200 ppb of
the PMN substance in surface waters.
When the average number of moles of
ethoxylate is less than or equal to 10,
EPA expects toxicity to aquatic
organisms may occur at concentrations
that exceed 60 ppb of the substance in
surface waters. 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
the substance may present an
unreasonable risk of injury to the
environment, may be produced in
substantial quantities, and may be
reasonably anticipated to enter the
environment in substantial quantities.
To protect against these risks, the
consent order prohibits the company
from manufacturing or importing the
PMN substance unless either: The mean
number of moles of the ethoxy group is
greater than or equal to 10, or the
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average number molecular weight is
greater than 950 daltons. The SNUR
designates as a ‘‘significant new use’’
the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of a fish
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 environmental effects of the
PMN substance. Testing should be
conducted on the PMN substance with
less than 10 moles of ethoxylate, or an
average number molecular weight of
less than 950 daltons. The consent order
does not require the submission of the
aforementioned testing at any specified
time or production volume. However,
the order’s restrictions on manufacture,
import, processing, distribution in
commerce, use, and disposal of the
PMN 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 721.10443.
PMN Number P–01–499 and P–01–500
Chemical name: (P–01–499) Propanol,
mercapto- and (P–01–500) 2-Propen-1ol, reaction products with hydrogen
sulfide, distn. residues.
CAS number: (P–01–499) 63947–56–8
and (P–01–500) 374078–75–8.
Basis for action: The PMNs state that
the substances will be used as chemical
intermediates. Based on SAR analysis of
test data on structurally similar 3mercaptopropanol, EPA identified
concerns for developmental and
maternal effects from dermal exposures
to the PMN substances. In addition,
based on test data on P–01–499 and
EcoSAR analysis of analogous thiols,
EPA predicts toxicity to aquatic
organisms may occur at surface water
concentrations that exceed 11 ppb for
P–01–499 and 1 ppb for P–01–500. For
the chemical intermediate use described
in the PMNs, significant worker
exposures are not expected due to the
use of impervious dermal protection,
and the substances are not released to
surface water. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances without
impervious dermal protection where
there is a potential for dermal
exposures, or any use of the substances
resulting in surface water
concentrations exceeding 11 ppb (P–01–
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499) or 1 ppb (P–01–500) may cause
serious health effects and significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(3)(ii), (b)(4)(i), and
(b)(4)(ii).
Recommended testing: EPA has
determined that the results of an aquatic
invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010) on P–01–500
would help to characterize the
environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.10444 (P–
01–499) and 40 CFR 721.10445 (P–01–
500).
PMN Number P–01–762
Chemical name: 1,9Cyclohexadecadiene.
CAS number: 4277–06–9.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as open, nondispersive use with limited employee
exposure. Based on test data on the
PMN substance, EPA identified
concerns for dermal sensitization and
irritation. In addition, based on test data
on the PMN substance and EcoSAR
analysis of test data on analogous
neutral organic chemicals, EPA predicts
toxicity to aquatic organisms at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. As
described in the PMN, significant
dermal exposures are not expected due
to the use of impervious gloves, and
releases of the substance to surface
waters are not expected in
concentrations that exceed 1 ppb.
Therefore, EPA has not determined that
manufacturing, processing, and use of
the substance may present an
unreasonable risk. EPA has determined,
however, that use of the substance
without impervious protective
equipment where there is a potential for
dermal exposures, or any use of the
substance resulting in surface water
concentrations exceeding 1 ppb may
cause serious health effects and
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria in § 721.170(b)(3)(i), (b)(4)(i),
and (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
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characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10446.
PMN Number P–01–829
Chemical name: 17Oxabicyclo[14.1.0]heptadec-8-ene.
CAS number: 34748–97–5.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as open, nondispersive with limited employee
exposure. Based on test data on the
PMN substance, EPA identified
concerns for dermal sensitization,
respiratory sensitization, mutagenicity,
developmental toxicity, male
reproductive toxicity, liver toxicity, and
kidney toxicity. In addition, based on
test data on the PMN substance and
EcoSAR analysis of test data on
analogous epoxides, EPA predicts
toxicity to aquatic organisms at
concentrations that exceed 1 ppb of the
substance in surface waters. As
described in the PMN, significant
exposures are not expected due to the
use of protective dermal and respiratory
equipment, and the substance is not
released to surface waters in
concentrations that exceed 1 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance without impervious
dermal and adequate respiratory
protection where there is a potential for
exposures, or any use of the substance
resulting in surface water
concentrations exceeding 1 ppb may
cause serious health effects and
significant adverse environmental
effects. Based on this information the
PMN substance meets the concern
criteria at § 721.170(b)(3)(i), (b)(4)(i),
and (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.
CFR citation: 40 CFR 721.10447.
PMN Number P–02–120
Chemical name: Acetic acid,
hydroxymethoxy-, methyl ester, reaction
products with substituted alkylamine
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e)
consent order: September 12, 2003.
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Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substance
will be as an emulsifier. Based on
EcoSAR analysis of test data on
analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms
may occur when the average number
molecular weight is below 850 daltons.
The order was issued under TSCA
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I) and
5(e)(1)(A)(ii)(II), based on a finding that
this substance may reasonably be
anticipated to enter the environment in
substantial quantities and may present
an unreasonable risk of injury to the
environment. The consent order for this
substance prohibits manufacturing or
importing of the PMN substance unless
the average number molecular weight is
greater than or equal to 850 daltons. The
SNUR designates as a ‘‘significant new
use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of a fish
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), on the PMN
substance where the average number
molecular weight is less than 850
daltons would help characterize
possible environmental effects of the
substance. The order does not require
submission of the aforementioned
information at any specified time or
production volume. However, the
order’s restrictions on manufacture,
import, 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 721.10448.
PMN Number P–02–172
Chemical name: Aromatic polyester
polyol (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an adhesive
component. Based on EcoSAR analysis
of test data on analogous esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
40 ppb of the PMN substance in surface
waters. As described in the PMN, EPA
does not expect releases to surface
waters to exceed 40 ppb. Therefore, EPA
has not determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has, however, determined that
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any use of the substance resulting in
surface water concentrations exceeding
40 ppb may cause significant adverse
environmental effects. Based on this
information, the 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.
CFR citation: 40 CFR 721.10449.
PMN Number P–02–285
Chemical name: Oxirane, 2-[[3(trimethoxysilyl)propoxy]methyl]-,
reaction products with wollastonite
(Ca(SiO3)).
CAS number: 100402–91–3.
Effective date of TSCA section 5(e)
consent order: October 14, 2002.
Basis for TSCA section 5(e) consent
order: The PMN states that the
substance will be used as functional
filler for polymer systems. Based on
SAR analysis of analogous respirable,
poorly soluble particulates, EPA
identified concerns for lung toxicity
based on lung overload, and concern for
carcinogenicity based on test data on the
starting raw material—wollastonite. 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 this substance
may present an unreasonable risk of
injury to human health. To protect
against this exposure and risk, the
consent order requires the company to
manufacture and process the PMN
substance with an average aspect ratio
of no greater than 5, and no more than
15 percent of the PMN substance shall
have an aspect ratio greater than 10. The
SNUR designates as a ‘‘significant new
use’’ the absence of these protective
measures.
Recommended testing: EPA had
determined that the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with a 60-day
holding period and a carcinogenicity
test (OPPTS Test Guideline 870.4200)
would help characterize the human
health effects of the PMN substance.
These tests should be conducted on the
PMN substance with an average aspect
ratio of greater than 5, and more than 15
percent of the PMN substance with an
aspect ratio of greater than 10. The order
does not require submission of the
aforementioned information at any
specified time or production volume.
However, the order’s restrictions on
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manufacture, import, 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 721.10450.
PMN Number P–02–436
Chemical name: Alkyd amide polyol
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as an
intermediate for polyurethane polymers.
Based on EcoSAR analysis of test data
on analogous nonionic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
3 ppb of the PMN substance in surface
waters. As described in the PMN, the
substance is not released to surface
waters. 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
3 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 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 721.10451.
PMN Number P–02–659
Chemical name: 9-Octadecenoic acid
(9Z)-, 1,1′-(dimethylstannylene) ester.
CAS number: 3865–34–7.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a catalyst. Based on
EcoSAR analysis of test data on
analogous nonionic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
10 ppb of the substance in surface
waters. As described in the PMN, the
substance is not released to surface
waters. 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
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10 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 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 721.10452.
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PMN Number P–02–796
Chemical name: Polyglycerin alkyl
ether (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a lubricant
additive. Based on test data on the PMN
substance and EcoSAR analysis of test
data on analogous nonionic surfactants,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 3 ppb of the 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 PMN substance to
surface water, from uses other than as
described in the PMN, exceed releases
from the use described in the PMN. For
the use described in the PMN,
environmental releases did not exceed 3
ppb 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 described in
the PMN may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(4)(i)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (OPPTS Test
Guideline 835.3110) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10453.
PMN Number P–02–828
Chemical name: Propoxylated
ethoxylated alkylamine (generic).
CAS number: Not available.
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Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a concrete
admixture. Based on EcoSAR analysis of
analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
80 ppb of the PMN substance in surface
waters. As described in the PMN, the
substance is not released to surface
waters in concentrations that exceed 80
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 80 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 ready
biodegradability test (OPPTS Test
Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10454.
PMN Number P–03–61
Chemical name: Oxirane, 2,2′,2″[ethylidynetris(4,1phenyleneoxymethylene)]tris-.
CAS number: 87093–13–8.
Basis for action: The PMN states that
the substance will be used as a highdensity cross-linked polymer in resins,
composites, and adhesives. Based on
test data on the PMN substance and
SAR analysis of test data on analogous
epoxides, EPA identified concerns for
cancer, reproductive toxicity in males,
developmental toxicity, and
sensitization to lungs from worker and
consumer inhalation exposures. As
described in the PMN, significant
occupational and consumer inhalation
exposures are not expected, as the
substance is not spray applied.
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 involving an application
method that generates a mist, vapor, or
aerosol may cause serious health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(1)(i)(C), (b)(3)(i), and
(b)(3)(ii).
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Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) in rats would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10455.
PMN Number P–03–104
Chemical name: Tristyryl phenol
alkoxylate salt (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an agricultural
inert. Based on EcoSAR analysis of test
data on analogous cationic and anionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 2 ppb of the
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 PMN
substance to surface water, from uses
other than as described in the PMN,
exceed releases from the use described
in the PMN. For the use described in the
PMN, environmental releases did not
exceed 2 ppb 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 described in
the PMN 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 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 721.10456.
PMN Number P–03–154
Chemical name: 1,2Benzenedicarboxylic acid, mixed esters
with benzyl alc., cyclohexanol, 2-ethyl1-hexanol, fumaric acid and propylene
glycol.
CAS number: 464920–01–2.
Basis for action: The PMN states that
the substance will be used as a
monomer combined with styrene and
unsaturated polyester resins. Based on
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EcoSAR analysis of test data on
analogous acrylates and esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
1 ppb of the substance in surface waters.
As described in the PMN, the substance
is not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk to the
environment. 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 ready
biodegradability test (OPPTS Test
Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10457.
PMN Number P–03–238
Chemical name: Acrylate of
hydroxyimide (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be in adhesives. Based on
test data on the PMN substance and
SAR analysis of test data on analogous
acrylates, EPA identified concerns for
developmental toxicity and
sensitization from inhalation exposure
to the PMN substance. In addition,
based on EcoSAR analysis of test data
on analogous acrylates, EPA expects
toxicity to aquatic organisms may occur
at concentrations that exceed 20 ppb of
the PMN substance in surface waters. As
described in the PMN, significant
worker exposures are not expected as
the substance is used in the liquid form,
and the substance is not released to
surface waters. 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 manufacturing, processing, or use of
the substance in a solid form, or any use
resulting in surface water
concentrations exceeding 20 ppb may
cause serious health effects and
significant adverse environmental
effects. Based on this information the
PMN substance meets the concern
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criteria at § 721.170(b)(3)(i), (b)(3)(ii),
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a prenatal
developmental toxicity test (OPPTS Test
Guideline 870.3700) in rats; 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 to characterize
the human health and environmental
effects of the substance.
CFR citation: 40 CFR 721.10458.
PMN Number P–03–282
Chemical name: Amino-substituted
carbopolycycle (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a raw material.
Based on test data on the PMN
substance and SAR analysis of test data
on analogous alpha-naphthylamine,
aniline, aromatic amine, and
naphthalene, EPA identified concerns
for mutagenicity, oncogenicity,
sensitization, developmental toxicity,
blood effects, neurotoxicity, liver
effects, and cancer to workers exposed
to the PMN substance. As described in
the PMN, significant worker exposures
are not expected due to the use of
adequate personal protective
equipment. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance without the use
of impervious gloves where there is
potential for dermal exposure, use of the
substance without the use of a National
Institute for Occupational Safety and
Health (NIOSH)-certified respirator with
an assigned protection factor (APF) of at
least 50 where there is potential
inhalation exposure, domestic
manufacture, or use of the substance
other than as described in the PMN may
cause serious health effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(1)(i)(C), (b)(3)(i), and
(b)(3)(ii).
Recommended testing: EPA has
determined that inhalation monitoring
data, collected according to the EPA
draft Inhalation Monitoring Data
Collection Guidelines (located in the
docket under docket ID number EPA–
HQ–OPPT–2011–0941), would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10459.
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PMN Number P–03–307
Chemical name: Azo nickel complex
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a colorant. EPA
identified concerns for oncogenicity,
pulmonary sensitization,
immunotoxicity, developmental
toxicity, and neurotoxicity for released
nickel. In addition, test data for nickel
sulfate hexahydrate has shown effects
on the brain, kidney, liver, testes,
thymus, and spleen. For the use
described in the PMN, worker
inhalation exposures from the liquid
form of the PMN are not expected.
Therefore, EPA has not determined that
manufacturing, processing, and 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 use of the substance as a powder,
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 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465); a reproduction and
fertility effects test (OPPTS Test
Guideline 870.3800); and a
carcinogenicity study (OPPTS Test
Guideline 870.4200) would help to
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10460.
PMN Number P–03–325
Chemical name: Oxazolidine, 3,3′methylenebis[5-methyl-.
CAS number: 66204–44–2.
Basis for action: The PMN states that
the substance will be used as a
metalworking fluid. Based on test data
on the PMN substance, EPA identified
concerns for systemic toxicity and
severe skin and eye irritation. In
addition, based on test data on the PMN
substance and EcoSAR analysis of test
data on analogous aliphatic amines,
EPA predicts toxicity to aquatic
organisms may occur at surface water
concentrations that exceed 40 ppb of the
substance in saltwater, and 100 ppb of
the substance in freshwater. For the use
described in the PMN, worker exposures
are not expected as the substance is
used in an enclosed system, and the
substance is not released to surface
waters. Therefore, EPA has not
determined that manufacturing,
processing, and use of the substance
may present an unreasonable risk. EPA
has determined, however, that use of the
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substance other than as a metalworking
fluid, or any use of the substance
resulting in surface water
concentrations exceeding the freshwater
and saltwater concentrations of concern
may cause serious health effects and
significant adverse environmental
effects. Based on this information the
PMN substance meets the concern
criteria at § 721.170(b)(3)(i), (b)(4)(i),
and (b)(4)(ii).
Recommended testing: EPA has
determined that the no additional
testing is recommended at this time as
the human health and environmental
effects have been adequately
characterized by the testing submitted
on the PMN substance.
CFR citation: 40 CFR 721.10461.
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PMN Number P–03–354
Chemical name: 1-Penten-3-one, 1-(4chlorophenyl)-4,4-dimethyl-.
CAS number: 1577–03–3.
Basis for action: The PMN states that
the substance will be used as an
intermediate. Based on EcoSAR analysis
of test data on analogous vinyl ketones,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 30 ppb of the substance in
surface waters. For the use described in
the PMN, EPA does not expect releases
of the substance to surface waters in
concentrations that exceed 30 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. However,
EPA has determined that any use of the
substance other than as an intermediate,
or any use of the substance resulting in
surface water concentrations exceeding
30 ppb may cause significant adverse
environmental effects. Based on this
information, the substance meets the
concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a porous
pot test (OPPTS Test Guideline
835.3220); a fish early life-stage toxicity
test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10462.
PMN Number P–03–388
Chemical name: Fatty acid amides
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a paint and coating
additive. Based on EcoSAR analysis of
test data on analogous aliphatic amines,
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EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 1 ppb of the 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 PMN substance to
surface water, from uses other than as
described in the PMN, exceed releases
from the use described in the PMN. For
the use described in the PMN,
environmental releases did not exceed 1
ppb 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 other than as described in the
PMN 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 test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10463.
PMN Number P–03–461
Chemical name: Fatty acid, reaction
products with alkanolamine (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a petroleum
additive. Based on EcoSAR analysis of
test data on analogous aliphatic amines,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 6 ppb of the 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 PMN 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 6
ppb more than 20 days per year.
Therefore, EPA has not determined that
the proposed manufacturing,
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processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that use of the
substance other than as described in the
PMN 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 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 721.10464.
PMN Numbers P–03–561, P–03–563, P–
03–564, P–03–565, and P–03–566
Chemical names: (P–03–561) 2Propenoic acid, 2-methyl-, 3hydroxytricyclo[3.3.1.13,7]dec-1-yl
ester; (P–03–563) 2-Propenoic acid, 2methyl-, 2-ethyltricyclo[3.3.1.13,7]dec2-yl ester; (P–03–564) 2-Propenoic acid,
3-hydroxytricyclo [3.3.1.13,7] dec-1-yl
ester; (P–03–565) 2-Propenoic acid, 2methyltricyclo[3.3.1.13,7]dec-2-yl ester;
and (P–03–566) 2-Propenoic acid, 2ethyltricyclo[3.3.1.13,7]dec-2-yl ester.
CAS numbers: (P–03–561) 115372–
36–6; (P–03–563) 209982–56–9; (P–03–
564) 216581–76–9; (P–03–565) 249562–
06–9; and (P–03–566) 303186–14–3.
Basis for action: The consolidated
PMN states that the generic (nonconfidential) use of the substances will
be as monomers. Based on test data on
the PMN substances and SAR analysis
of test data on analogous acrylates and
methacrylates, EPA identified concerns
for systemic toxicity and pulmonary
sensitization. In addition, based on
EcoSAR analysis of test data on
analogous acrylates, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 3 ppb of
the PMN substances in surface waters.
For the uses described in the PMN,
significant worker exposures are not
expected due to the use of impervious
gloves, protective clothing, eye
protection, and adequate warnings in
the MSDS; and the substance is not
released to surface waters. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substances may present an
unreasonable risk. EPA has determined,
however, that any use of the substance
without worker protection where there
is a potential for dermal or inhalation
exposure, or any use of the substance
resulting in surface water
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concentrations exceeding 3 ppb may
cause serious health effects and
significant adverse environmental
effects. Based on this information the
PMN substances meet the concern
criteria at § 721.170(b)(3)(i), (b)(3)(ii),
and (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 to characterize
the environmental effects of the PMN
substances.
CFR citations: 40 CFR 721.10465 (P–
03–561); 40 CFR 721.10466; (P–03–563);
40 CFR 721.10467 (P–03–564); 40 CFR
721.10468 (P–03–565); and 40 CFR
721.10469 (P–03–566).
PMN Number P–03–567
Chemical name: Phosphonium,
tetrabutyl-, 1,1,2,2,3,3,4,4,4-nonafluoro1-butanesulfonate (1:1).
CAS number: 220689–12–3.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a polymer additive.
Based on test data on the PMN
substance, EPA identified concerns for
systemic toxicity and neurotoxicity from
inhalation exposures. In addition, EPA
identified concern for potential
degradation products, byproducts,
unreacted material, and low molecular
weight species. The PMN substance is a
derivative of perfluorobutanesulfonate
(PFBS) and may degrade to form PFBS.
Further, concerns for the substance are
based on analogous
perfluorooctanesulfonate (PFOS). For
the use described in the PMN,
significant exposures and
environmental releases are not
expected. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance other than as described in
the PMN may cause serious health
effects 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)(iii).
Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465); a 2 generation
reproduction and fertility effects test
(OPPTS Test Guideline 870.3200); a
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porous pot test (OPPTS Test Guideline
835.3220); and a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300) would help characterize the
human health and environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.10470.
PMN Number P–03–622
Chemical name: 2-Propenoic acid,
1,1′-(3-methyl-1,5-pentanediyl) ester.
CAS number: 64194–22–5.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a component of a
UV coating agent. Based on SAR
analysis of test data on analogous
acrylates, EPA identified concerns for
carcinogenicity and sensitization. In
addition, based on EcoSAR analysis of
test data on analogous acrylates, EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substance to surface waters, from uses
other than as described in the PMN,
exceed releases from the use described
in the PMN. As described in the PMN,
the substance will be imported and not
manufactured in the United States. For
the use described in the PMN,
significant worker exposures are not
expected during processing and use
activities for the uses described in the
PMN, and significant environmental
releases are not expected. Therefore,
EPA has not determined that the
proposed processing or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
domestic manufacture or use of the
substance other than as described in the
PMN may cause serious health effects
and significant adverse environmental
effects. Based on this information the
PMN substance meets the concern
criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii),
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
carcinogenicity test (OPPTS Test
Guideline 870.4200); 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 to characterize
the human health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10471.
PMN Number P–03–645
Chemical name: 1,3Benzenedimethanamine, polymers with
epichlorohydrin-polyethylene glycol
reaction products.
CAS number: 652968–34–8.
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Basis for action: The PMN states that
the substance will be used as a water
retention aid for ornamental plants.
Based on analogous swellable, high
molecular weight polymers, EPA
identified concerns for lung toxicity and
cancer. As described in the PMN, the
substance will be imported and not
manufactured in the United States. For
the use described in the PMN,
significant worker exposures are not
expected during processing and use
activities for the uses described in the
PMN. Therefore, EPA has not
determined that the proposed
processing or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any domestic
manufacture of the PMN substance 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 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with a 60-day
holding period, and a teabag test for
water retention capacity (see https://
www.epa.gov/oppt/newchems/pubs/
teabag.pdf) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10472.
PMN Number P–03–865
Chemical name: 1-Propanaminium, 3amino-N-(2-carboxyethyl)-N,Ndimethyl-, N-coco acyl derivs., inner
salts.
CAS number: 499781–63–4.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a non-corrosive
foamer in the oil and gas industry.
Based on test data on the PMN
substance, and EcoSAR analysis of test
data on analogous amphoteric and
cationic surfactants, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 85 ppb of
the PMN substance in surface waters. As
described in the PMN, EPA does not
expect releases of the substance to
surface waters in concentrations that
exceed 85 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
85 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(4)(i)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
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acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10473.
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PMN Number P–04–107
Chemical name: Substituted amino
ethane sulfonic acid salt (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be a contained use in
digital and imaging products. Based on
EcoSAR analysis of test data on
analogous anionic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
4 ppb of the 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
PMN substance to surface water, from
uses other than as described in the
PMN, exceed releases from the use
described in the PMN. For the use
described in the PMN, environmental
releases did not exceed 4 ppb 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
described in the PMN 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 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 721.10474.
PMN Number P–04–118
Chemical name: Hexanedioic acid,
compd. with N1-(6-aminohexyl)-N1methyl-1,6-hexanediamine (1:1).
CAS number: 659733–29–6.
Basis for action: The PMN states that
the substance will be used as an
intermediate for polymer manufacture.
Based on SAR analysis of test data on
analogous hexamethyl diamine, EPA
identified concerns for immunotoxicity,
systemic toxicity, developmental
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toxicity, and reproductive toxicity. In
addition, based on EcoSAR analysis of
test data on analogous aliphatic amines,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 20 ppb of the PMN
substance in surface waters. As
described in the PMN, EPA does not
expect significant worker exposures or
releases of the substance to surface
waters in concentrations that exceed 20
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 other than as intermediate
for polymer manufacture, or any use of
the substance resulting in surface water
concentrations exceeding 20 ppb may
cause serious health effects and
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(3)(ii) and
(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a prenatal
developmental toxicity test (OPPTS Test
Guideline 870.3700); a reproduction and
fertility effects test (OPPTS Test
Guideline 870.3800); an immunotoxicity
test (OPPTS Test Guideline 870.7800); a
fish early life-stage toxicity test (OPPTS
Test Guideline 850.1400); and a
daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300) would help
characterize the human health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10475.
PMN Number P–04–275
Chemical name: Oxetane, 3(bromomethyl)-3-methyl-.
CAS number: 78385–26–9.
Basis for action: The PMN substance
will be used as a chemical intermediate.
Based on SAR analysis of test data on
analogous chemical substances EPA
identified concerns for cancer for the
PMN material from dermal exposures.
For the use described in the PMN,
significant worker exposures are
unlikely due to the use of impervious
clothing. Therefore, EPA has not
determined that manufacturing,
processing, and use of the substance
may present an unreasonable risk. EPA
has determined, however, any use of the
substance without impervious clothing
where there is a potential for dermal
exposures, or any use of the substance
other than as an intermediate for the
pharmaceutical, photographic, and
other fine chemical industries may
cause serious health effects. Based on
this information the PMN substance
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meets the concern criteria at
§ 721.170(b)(1)(i)(C).
Recommended testing: EPA has
determined that an in vivo micronucleus
assay in erythrocytes (OPPTS Test
Guideline 870.5395 or OECD Test
Guideline 474), with exposure by the
intraperitoneal route, would help to
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10476.
PMN Number P–04–290
Chemical name: Acrylate ester
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a monomer in
radiation cured inks and coatings. Based
on EcoSAR analysis of test data on
analogous acrylates, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the 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 PMN
substance to surface water, from uses
other than as described in the PMN,
exceed releases from the use described
in the PMN. For the use described in the
PMN, environmental releases did not
exceed 1 ppb more than 20 days per
year. Therefore, EPA had 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 other than as
described in the PMN 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 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 721.10477.
PMN Number P–04–318
Chemical name: Polyether polyol
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as an
intermediate for urethane polymers.
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Based on SAR analysis of test data on
similar molecular structure chemicals,
EPA identified concerns for
developmental kidney and liver
toxicity. In addition, based on EcoSAR
analysis of test data on analogous
nonionic surfactants, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 30 ppb of
the substance in surface waters. For the
use described in the PMN, significant
worker exposures are not expected and
the substance is not released to surface
waters. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance other than as
an intermediate for urethane polymers,
or any use of the substance resulting in
surface water concentrations exceeding
30 ppb may cause serious health effects
and significant environmental effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of an acute
oral toxicity test (OPPTS Test Guideline
870.1100 or OECD Test Guideline 425);
a bacterial reverse mutation test (OPPTS
Test Guideline 870.5100); a mammalian
erythrocyte micronucleus test
(intraperitoneal route) (OPPTS Test
Guideline 870.5395); a repeated dose
28-day oral toxicity in rodents (OPPTS
Test Guideline 870.3050 or OECD Test
Guideline 407), which should include,
for all test doses, a neurotoxicity
functional observational battery, as
described in neurotoxicity screening
battery test (OPPTS Test Guideline
870.6200); a prenatal developmental
toxicity test (one species, oral route)
(OPPTS Test Guideline 870.3700); a
Zahn-Wellens/EMPA test (OPPTS Test
Guideline 835.3200); an aerobic aquatic
biodegredation test (OPPTS Test
Guideline 835.3100); a fish acute
toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an
aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
human health, environmental and fate
effects for PMN substance.
CFR citation: 40 CFR 721.10478.
PMN Number P–04–335
Chemical name: Quaternary
ammonium compounds,
tris(hydrogenated tallow alkyl)methyl,
chlorides.
CAS number: 308074–73–9.
Basis for action: The PMN states that
the generic (non-confidential) use of the
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substance will be as a rheology additive.
Based on EcoSAR analysis of test data
on analogous dialkyl cationic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb of the
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 PMN
substance to surface water, from uses
other than as described in the PMN,
exceed releases from the use described
in the PMN. For the use described in the
PMN, environmental releases did not
exceed 1 ppb 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 other than as described in the
PMN 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 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 721.10479.
PMN Number P–04–384
Chemical name: Trimethylolpropane
polyol, aminated (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a resin curing
agent. Based on EcoSAR analysis of test
data on analogous aliphatic amines,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 9 ppb of the PMN substance
in surface waters. As described in the
PMN, the substance is not released to
surface waters. Therefore, EPA has not
determined that the proposed
manufacturing and processing 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
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the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that results of a ready
biodegradability test (OPPTS Test
Guideline 835.3110); 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 721.10480.
PMN Numbers P–04–429, P–04–430, P–
04–431, and P–04–432
Chemical names: (P–04–429)
Siloxanes and Silicones, Me vinyl,
hydroxy-terminated, reaction products
with silica; (P–04–430) Siloxanes and
Silicones, di-Me, Me vinyl, hydroxyterminated, reaction products with
silica; (P–04–431) Siloxanes and
Silicones, di-Me, Me vinyl, hydroxyterminated, reaction products with
[(ethenyldimethylsilyl)oxy]-modified
silica; and (P–04–432) Siloxanes and
Silicones, Me vinyl, hydroxyterminated, reaction products with
[(ethenyldimethylsilyl)oxy]-modified
silica.
CAS numbers: (P–04–429) 630106–
01–3; (P–04–430) 630106–00–2; (P–01–
431) 630106–04–6; and (P–04–432)
630106–02–4.
Basis for action: The consolidated
PMN states that the substances will be
used as chemical fillers. Based on high
molecular weight polymers, EPA
identified concerns for lung overload.
Further, based on analogy to respirable,
poorly soluble particulates, under the
subcategory of crystalline silica, EPA
identified concerns for lung toxicity and
cancer. For the use described in the
PMN, significant worker inhalation
exposures are not expected as the
substance is used in a liquid form.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, and use of the substances
may present an unreasonable risk. EPA
has determined, however, that any use
of the substances in a powder form may
cause serious health effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has
determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465) in rats with special attention
to histopathology (inflammation and
cell proliferation) of the lung tissues and
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to various parameters of the
bronchoalveolar lavage fluid (BALF)
with a recovery period of 60 days; and
a carcinogenicity test (OPPTS Test
Guideline 870.4200) in rats would help
characterize the human health effects of
the PMN substance.
CFR citations: 40 CFR 721.10481 (P–
04–429); 40 CFR 721.10482 (P–04–430);
40 CFR 721.10483 (P–01–431); and 40
CFR 721.10484 (P–04–432).
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PMN Number P–04–479
Chemical name: Reaction products of
alcohols, alkyl alcohols, amino alcohols
and methanol sodium salts (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a cleaning agent.
Based on EcoSAR analysis of test data
on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
30 ppb of the 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 PMN 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 30 ppb 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 other than as
described in the PMN 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 (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10485.
PMN Number P–04–591
Chemical name: Alkyl substituted
amino-benzamide (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as an
acetaldehyde scavenger for plastic bottle
production. Based on EcoSAR analysis
of test data on analogous anilines, EPA
predicts toxicity to aquatic organisms
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may occur if releases of the PMN
substance to surface waters, 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, significant environmental releases
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
use of the substance other than as an
acetaldehyde scavenger for plastic bottle
production could result in exposures
which may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria as
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (OPPTS Test
Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10486.
PMN Numbers P–04–599, P–04–600, P–
04–605, and P–04–606
Chemical name: Alkylbenzenes
sulfonic acids, metal salts (generic).
CAS number: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as metalworking
detergents. Based on EcoSAR analysis of
test data on analogous anionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 60 ppb of the
substances in surface waters for greater
than 20 days per year. This 20-day
criterion is derived from partial life
cycle tests (daphnid chronic and fish
early life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substances to surface water, from uses
other than as described in the PMNs,
exceed releases from the use described
in the PMNs. For the use described in
the PMNs, environmental releases did
not exceed 60 ppb more than 20 days
per year. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
use of the substances other than as
described in the PMNs may cause
significant adverse environmental
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effects. Based on this information, the
PMN substances meet the concern
criteria as § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (OPPTS Test
Guideline 835.3110); a fish acute
toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an
aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.10487.
PMN Number P–04–636
Chemical name: Cuprate,
[[[[[[[(sulfonaphthalenyl)]azo](substitutedphenyl)]azo](substitutedsulfonaphthalenyl)]azo]substituted phenyl-substituted
heteromonocycle], sodium salts
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as an ink jet
dye. Based on SAR analysis of test data
on structurally similar substances, EPA
identified concerns for oncogenicity. As
described in the PMN, inhalation
exposures are not expected for the use
specified due to the use of a NIOSHcertified respirator with an APF of at
least 5. 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
uses of the substance without
respiratory protection where there is a
potential for inhalation exposure 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 an
unscheduled deoxyribonucleic acid
(DNA) synthesis in mammalian cells in
culture (OPPTS Test Guideline
870.5550), and if warranted by the
results of the first test, a carcinogenicity
test (OPPTS Test Guideline 870.4200)
would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10488.
PMN Number P–04–718
Chemical name: Substituted aryl
sulfonium polyfluorophosphate salts
(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
SAR analysis of test data on structurally
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similar substances, EPA identified
concerns for corrosion and ocular
lethality. In addition, based on EcoSAR
analysis of test data on analogous
cationic surfactants, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 6 ppb of
the PMN substance in surface waters. As
described in the PMN, significant
worker exposures are not expected as
the PMN is used in the form of a liquid
and releases of the substance to surface
waters are not expected. Therefore, EPA
has not determined that the proposed
manufacturing, processing, or use may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance in the form of a powder
or solid, or any use of the substance
resulting in surface water
concentrations exceeding 6 ppb may
cause serious health effects and
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(3)(ii) and
(b)(4)(ii).
Recommended testing: EPA has
determined that the results of an acute
eye irritation test (OPPTS Test
Guideline 870.2400); a fish acute
toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an
aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
human health and environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.10489.
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PMN Number P–04–834
Chemical name: HDI biuret,
hydroxyethyl methacrylate prepolymer
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e)
consent order: March 20, 2006.
Basis for TSCA section 5(e) consent
order: The PMN states that the
substance will be used as an ingredient
in 2-component polyurethane coatings.
Based on test data on analogous
diisocyanates, EPA identified concerns
for dermal and respiratory sensitization,
pulmonary toxicity, and carcinogenicity
from dermal and inhalation exposures.
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 this substance
may present an unreasonable risk of
injury to human health, the substance
may be produced in substantial
quantities, and there may be significant
(or substantial) human exposure to the
substance. To protect against this
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exposure and risk, the consent order
requires:
1. Use of personal protective
equipment including impervious gloves
(when there is potential dermal
exposure) and either a NIOSH-certified
respirator with an APF of at least 25, or
compliance with a NCEL of 0.05 mg/m3
as an 8-hour time-weighted average
(when there is potential inhalation
exposure).
2. Establishment and use of a hazard
communication program.
3. Submission of certain human
health testing prior to exceeding two
confidential production volume limits
specified in the consent order.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of a dermal
sensitization test (OPPTS Test Guideline
870.2600) and a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465) would help characterize the
human health effects of the PMN
substance. The PMN submitter has
agreed not to exceed the first
confidential production volume limit
specified in the consent order without
performing the dermal sensitization test,
and has agreed not to exceed the second
confidential production volume limit
without performing the 90-day toxicity
test. The order’s restrictions on
manufacture, import, processing,
distribution in commerce, use, and
disposal of the PMN 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 721.10490.
PMN Number P–05–55
Chemical name:
Benzenepropanal,.alpha.-methyl-.
CAS number: 5445–77–2.
Basis for action: The PMN states that
the substance will be used as a sitelimited intermediate. Based on SAR
analysis of test data on structurally
similar substances, EPA has identified
concerns for developmental toxicity. For
the use described in the PMN,
significant dermal and inhalation
exposures are not expected. Therefore,
EPA has not determined that proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
use of the PMN substance other than as
a site-limited intermediate may cause
serious health effects. Based on this
information the PMN substance meets
the concern criteria at
§ 721.170(b)(3)(ii).
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Recommended testing: EPA has
determined that the results of a prenatal
developmental toxicity test (OPPTS Test
Guideline 870.3700), by the dermal
route in mice, would help characterize
the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10491.
PMN Number P–05–301
Chemical name: Trisphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a hardener for
epoxy resin. Based on EcoSAR analysis
of test data on analogous phenols, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
20 ppb of the PMN substance in surface
waters. As described in the PMN,
releases of the PMN substance are not
expected to result in surface water
concentrations that exceed 20 ppb.
Therefore, EPA has not determined that
manufacturing, processing, and 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 20 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 test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10492.
PMN Number P–05–417
Chemical name: Tris-alkyl-alkoxy
melamine polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a crosslinking resin.
Based on test data on the PMN
substance, 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
PMN 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
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surface water concentrations exceeding
5 ppb may cause significant adverse
environmental effects. Based on this
information the PMN substance meets
the concern criteria at § 721.170(b)(4)(i).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300), and an algal toxicity test
(OCSPP Test Guideline 850.4500) on the
hydrolysis products of the PMN
substance would help to characterize
the environmental effects of the PMN
substance and its hydrolysis products.
CFR citation: 40 CFR 721.10493.
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PMN Number P–05–501
Chemical name: Reaction product of
trimethylolpropane triacrylate and
alkylene imine (generic).
CAS number: Not available.
Basis for action: The PMN substance
will be used as an amine synergist for
coatings and inks. Based on EcoSAR
analysis of test data on analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 5 ppb in
surface waters. As described in the
PMN, the substance is not released to
surface waters. 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
5 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); 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 to characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10494.
PMN Number P–05–634
Chemical name: Metal silicate
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an additive use
restricted to enclosed toner cartridges.
Based on SAR analysis of test data on
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analogous respirable, poorly soluble
particulates, EPA identified concerns for
lung effects for the PMN substance.
Based on physical properties, EPA
identified concerns for potential
systemic effects from dermal exposure
to the PMN substance. As described in
the PMN, the substance will be
imported and not manufactured in the
United States. For the use described in
the PMN, worker dermal and inhalation
exposures are not expected during
processing and use activities. Therefore,
EPA has not determined that the
proposed processing or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
domestic manufacture, or use of the
substance other than as described in the
PMN may cause serious health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465) in rats with special attention
to histopathology (inflammation and
cell proliferation) of the lung tissues and
to various parameters of the BALF with
a recovery period of 60 days would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10495.
PMN Number P–06–9
Chemical name: Amino alkoxy
polydimethylsiloxane, hydroxyterminated (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a textile additive.
Based on EcoSAR analysis of test data
on analogous polycationic polymers,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 10 ppb of the PMN
substance in surface waters. As
described in the PMN, the substance is
not released to surface waters.
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 10 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 test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
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an algal toxicity test (OCSPP Test
Guideline 850.4500) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10496.
PMN Numbers P–06–276, P–06–277, P–
06–278, P–06–279, P–06–280, and P–06–
281
Chemical names: (P–06–276 and P–
06–279) Substituted alkyl ester,
hydrolysis products with silica and
substituted silane (generic); (P–06–277
and P–06–280) Substituted alkyl ester,
hydrolysis products with silica
(generic); and (P–06–278 and P–06–281)
Substituted silane, hydrolysis products
with silica (generic).
CAS numbers: Not available.
Basis for action: The consolidated
PMN states that the generic (nonconfidential) use of the substances will
be as components of clearcoat. Based on
SAR analysis of test data on analogous
respirable, poorly soluble particulates,
EPA identified potential lung and
systemic effects from inhalation and
dermal exposures to the PMN
substances. For the use described in the
consolidated PMN, EPA does not expect
significant worker exposures to the
substances due to the use of appropriate
impervious gloves and clothing; use of
an appropriate NIOSH-certified
respirator with an APF of at least 5; and
no manufacturing, processing, or use in
the form of a powder. Therefore, EPA
has not determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances without
impervious gloves and clothing where
there is a potential for dermal
exposures; any use of the substances
without a NIOSH-certified respirator
with an APF of at least 5 where there
is a potential for inhalation exposures;
use of the substances other than as
described in the PMN; or
manufacturing, processing, or use of the
substances in the form of a powder may
cause serious adverse 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 citations: 40 CFR 721.10497 (P–
06–276 and P–06–279); 40 CFR
721.10498 (P–06–277 and P–06–280);
and 40 CFR 721.10499 (P–06–278 and
P–06–281).
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PMN Number P–06–341
Chemical name: Acrylated mixed
metal oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a film coating
additive. Based on SAR analysis of test
data on analogous respirable, poorly
soluble particulates, EPA identified
concerns for potential lung effects from
inhalation exposures and potential
systemic effects from dermal exposures.
For the use described in the PMN,
inhalation and dermal exposures are not
expected due to use of the substance as
a liquid and with impervious dermal
protection for exposed workers.
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
dermal protection where there is
potential for dermal exposures; any
manufacture, processing, or use of the
substance in the form of a powder; or
any use of the substance other than as
described in the PMN may cause serious
health effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(3)(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 721.10500.
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PMN Number P–06–542
Chemical name: Tridecyl phthalate
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a plasticizer. Based
on SAR analysis of test data on
analogous phthalates, EPA identified
concerns for developmental toxicity. For
the use stated in the PMN, significant
worker or consumer exposures are
unlikely. Therefore, EPA has not
determined that the proposed
manufacturing, processing, and use of
the substance may present an
unreasonable risk. EPA has determined,
however, that any other use of the
substance other than as described in the
PMN may cause serious adverse human
health effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of an oral
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reproduction and fertility effects test
(OPPTS Test Guideline 870.3800) would
help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10501.
PMN Number P–06–616
Chemical name: Modified triethylene
glycol dithiol (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a reactive
diluent/binder in aerospace sealants.
Based on EcoSAR analysis of test data
on analogous thiols, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 2 ppb of
the substance in surface waters. As
described in the PMN, the substance is
not expected to be released to surface
waters. 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
2 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 ready
biodegradability test (OPPTS Test
Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10502.
PMN Number P–06–622
Chemical name: 1,2-Ethanediol, 1carbamate.
CAS number: 5395–01–7.
Basis for action: The PMN states that
the substance will be used as an
intermediate monomer for polymer
synthesis. Based on test data on the
PMN substance, and SAR analysis of
test data on analogous urethanes and
carbamates, EPA identified concerns for
liver toxicity, developmental toxicity,
and oncogenicity. For the use described
in the PMN, EPA expects no significant
dermal exposures due to the use of
impervious gloves. 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
impervious gloves where there is a
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potential for dermal exposures may
cause serious adverse health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(1)(i)(C),(b)(3)(i), and
(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a prenatal
developmental toxicity test (OPPTS Test
Guideline 870.3700) and a
carcinogenicity test (OPPTS Test
Guideline 870.4200) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10503.
PMN Number P–06–682
Chemical name: Surface modified
magnesium hydroxide (generic).
CAS number: Not available.
Basis for action: The PMN states the
substance will be used as a
compatibilizer for flame retardant for
plastics. Based on SAR analysis of test
data on analogous respirable, poorly
soluble particulates, EPA identified
concerns for lung toxicity due to lung
overload from inhalation exposure to
the PMN substance. At the production
volume of 100,000 kgs per year and for
the specific use as a compatibilizer for
flame retardant for plastics, significant
worker exposures 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 other than as a
compatibilizer for flame retardant for
plastics, or any use of the substance in
quantities greater than 100,000 kgs per
year 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 a 90-day inhalation
toxicity test with a 60-day holding
period (OPPTS Test Guideline
870.3465) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10504.
PMN Number P–06–694
Chemical name: Phosphoric acid,
mixed mono- and diesters with 2-ethyl1-hexanol and polyethylene glycol
mono-C12–16-alkyl ethers.
CAS number: 882693–50–7.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a hydraulic fluid.
Based on test data on the PMN
substance and EcoSAR analysis of test
data on analogous anionic surfactants,
EPA predicts toxicity to aquatic
organisms may occur as a result of
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releases of the PMN substance to surface
waters from manufacture or import in
quantities greater than 75,000 kgs per
year, or from uses other than as stated
in the PMN. At the annual production
volume of 75,000 kgs per year, and for
the use stated in the PMN, no significant
environmental releases are 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 other than as stated in the
PMN, or exceeding an annual
manufacturing and importation volume
of 75,000 kgs may cause significant
adverse environmental effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075) and an aquatic invertebrate
acute toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10505.
PMN Numbers P–07–11 and P–08–29
Chemical name: Alkylated phenols
(generic).
CAS number: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substance will be as an antioxidant (P–
07–11) and an intermediate (P–08–29).
Based on test data on P–07–11 and SAR
analysis of test data on analogous
molecular structure chemicals, EPA
identified concerns for liver effects,
thyroid effects, and neurotoxicity. As
described in the PMNs, worker dermal
exposure to the PMN substances will be
minimal due to impervious gloves.
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 where there is potential for
dermal exposure may cause serious
adverse 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 a repeated dose 90-day
oral toxicity test in rodents (OPPTS Test
Guideline 870.3100) and a
developmental neurotoxicity test
(OPPTS Test Guideline 870.6300) would
help characterize the health effects of
the PMN substances.
CFR citation: 40 CFR 721.10506.
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PMN Number P–07–107
Chemical name: Biphenyl substituted
benzopyran (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a polymer additive.
Based on EcoSAR analysis of test data
on analogous neutral organic chemicals,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 2 ppb of the PMN substance
in surface waters. As described in the
PMN, releases of the PMN substance are
not expected to result in surface water
concentrations that exceed 2 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in surface water
concentrations exceeding 2 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 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 721.10507.
PMN Number P–07–161
Chemical name: Alkene substituted
Bis phenol (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a hardener for
epoxy resins. EPA identified human
health and environmental concerns
because the PMN substance may be a
persistent, bio-accumulative, and toxic
(PBT) chemical, based on the physical/
chemical properties of the PMN
substance, as described in the New
Chemicals Program’s PBT category (64
FR 60194, November 4, 1999) (FRL–
6097–7). EPA estimates that the
substance will persist in the
environment for more than 2 months
and estimates a bioaccumulation factor
of greater than or equal to 5,000. Also,
based on SAR analysis of test data on
analogous safrole, methyleugenal and
bisphenol A, EPA identified concerns
for carcinogenicity and mutagenicity,
systemic effects, and endocrine
disruption. Further, based on EcoSAR
analysis of test data on analogous
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phenols, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb of the
substance in surface waters. As
described in the PMN, significant
worker exposures are not expected due
to the use of impervious dermal
protective equipment, and the substance
is not released to surface waters.
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 impervious
dermal protection where there is a
potential for dermal exposures, or any
purposeful or predictable release of the
substance to surface waters may cause
serious health effects and significant
adverse environmental risks. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii),
and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (OPPTS Test
Guideline 835.3110); a fish
bioconcentration test (OPPTS Test
Guideline 850.1730); an oral combined
chronic toxicity/carcinogenicity study
(OPPTS Test Guideline 870.4300); 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 850.5400) would help to
characterize the human health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10508.
PMN Number P–07–204
Chemical name: Pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)-.
CAS number: 870778–34–0.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a heat transfer
fluid. Based on test data on the PMN
substance and SAR analysis of test data
on analogous perfluorinated substances,
EPA identified concerns for
neurotoxicity, liver effects, and cardiac
sensitization from exposures to the PMN
substance. For the use described in the
PMN, EPA does not expect significant
worker exposures due to the use of
impervious gloves. Therefore, EPA has
not determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use without impervious gloves
where there is a potential for dermal
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exposures, or any use of the substance
other than as described in the PMN may
cause serious adverse 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 a 28-day
dermal toxicity test (OPPTS Test
Guideline 870.3200) in rats; a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465), and a test using
the ‘‘Standard Test Method for
Permeation of Liquids and Gases
through Protective Clothing Materials
under Conditions of Continuous
Contact’’ (ASTM International standard
F739) as reported in the ‘‘Standard
Guide for Documenting the Results of
Chemical Permeation Testing of
Materials Used in Protective Clothing’’
(ASTM International standard F1194)
would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10509.
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PMN Number P–07–319
Chemical name: Alkylaminoalcohol
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a raw material for
a polymer paint additive. Based on
EcoSAR analysis of test data on
analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
1 ppb of the PMN substance in surface
waters. As described in the PMN, the
substance is not released to surface
waters. 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 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.
CFR citation: 40 CFR 721.10510.
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PMN Numbers P–07–320, P–07–321,
P–07–322, P–07–323, and P–07–324
Chemical name: Quaternary
ammonium salts (generic).
CAS number: Not available.
Basis for action: The consolidated
PMN states that the generic (nonconfidential) use of the substances will
be as inhibitors for oil field
applications. Based on EcoSAR analysis
of test data on analogous cationic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 20 ppb of the
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 PMN
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 20 ppb more than 20 days per
year. Therefore, EPA has not determined
that the proposed manufacturing,
processing, or use of the substances may
present an unreasonable risk. EPA has
determined, however, that use of the
substances other than as described in
the PMN could result in exposures
which 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); 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
substances.
CFR citations: 40 CFR 721.10511.
PMN Numbers P–07–563 and P–07–564
Chemical name: Fatty acid maleic
acid amides (generic).
CAS number: Not available.
Basis for action: The consolidated
PMN states that the substances will be
used as emulsifiers for oil well drilling
fluids. Based on EcoSAR analysis of test
data on analogous aliphatic amines,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 10 ppb of the PMN
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substances in surface waters. As
described in the PMN, the substances
are not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substances may
present an unreasonable risk. EPA has
determined, however, that any use of
the substances resulting in surface water
concentrations exceeding 10 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substances meet the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); 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
substances.
CFR citation: 40 CFR 721.10512.
PMN Number P–07–599
Chemical name: Aromatic acrylate
monomer (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be in the production of
polymers. Based on EcoSAR analysis of
test data on analogous acrylates, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
1 ppb of the PMN substance in surface
waters. As described in the PMN, the
substance is not expected to be released
to surface waters. 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 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.
CFR citation: 40 CFR 721.10513.
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PMN Number P–07–679
Chemical name: [1,1′-Biphenyl]-2,2′disulfonic acid, 4-[2-(4,5-dihydro-3methyl-5-oxo-1-phenyl-1H-pyrazol-4yl)diazenyl]-4′-[2-(2-hydroxy-1naphthalenyl)diazenyl]-, sodium salt
(1:2).
CAS number: 6470–20–8.
Basis for action: The PMN states that
substance will be used as a dye for
stationery ink. Based on SAR analysis of
test data on analogs of an azo reduction
product (pyrazole and methyl pyrazole),
EPA identified concerns for liver, blood,
and developmental toxicity;
neurotoxicity; mutagenicity; and
oncogenicity. As described in the PMN,
inhalation exposures to workers and
consumers are not expected as the PMN
substance will be imported in rollerball
pens and refills for rollerball pens.
Therefore, EPA has not determined that
the proposed processing or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
domestic manufacture, or any
processing or use of the substance in the
form of a solid may cause serious
adverse 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 bacterial
reverse mutation test (OPPTS Test
Guideline 870.5100); a mammalian
erythrocyte micronucleus test (OPPTS
Test Guideline 870.5395) via the
intraperitoneal route; a repeated dose
28-day oral toxicity test (OPPTS Test
Guideline 870.3050) in rodents; and an
acute oral toxicity test (OPPTS Test
Guideline 870.1100) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10514.
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PMN Numbers P–10–58, P–10–59, and
P–10–60
Chemical name: Partially fluorinated
alcohol substituted glycols (generic).
CAS number: Not available.
Effective date of TSCA section 5(e)
consent order: October 8, 2010.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) uses of the PMN
substances will be as an intermediate
(P–10–58 and P–10–59) and a surface
active agent (P–10–60). EPA has
concerns for potential incineration or
other decomposition products of the
PMN substances. These perfluorinated
decomposition products may be
released to the environment from
incomplete incineration of the PMN
substances at low temperatures. EPA
has preliminary evidence, including
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data on some fluorinated polymers, that
suggests that, under some conditions,
the PMN substances could degrade in
the environment. EPA has concerns that
these degradation products will persist
in the environment, could
bioaccumulate or biomagnify, and could
be toxic to people, wild mammals, and
birds. These concerns are based on data
on analog chemicals, including
perfluorooctanoic acid (PFOA) and
other perfluorinated alkyls, including
the presumed environmental degradant.
The order was issued under TSCA
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I),
and 5(e)(1)(A)(ii)(II), based on a finding
that these substances may present an
unreasonable risk of injury to the
environment and human health, the
substances may be produced in
substantial quantities and may
reasonably be anticipated to enter the
environment in substantial quantities,
and there may be significant (or
substantial) human exposure to the
substances and their potential
degradation products. To protect against
these exposures and risks, the consent
order requires submission of testing on
the PMN substance P–10–60 at five
identified aggregate manufacture and
importation volumes; requires analysis
of raw materials; and restricts the use of
P–10–58 and P–10–59 to use as
intermediates to manufacture P–10–60.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of certain
fate and physical/chemical property
testing identified in the TSCA section
5(e) consent order would help
characterize possible effects of the
substances and their degradation
products. The consent order contains
five production volume limits. The
PMN submitter has agreed not to exceed
the confidential production volume
limits without performing the specified
testing on the PMN substance P–10–60.
Additional testing is included in the
preamble to the consent order, but this
testing is not required at any specified
time or production volume. However,
the order’s restrictions on manufacture,
import, processing, distribution in
commerce, use, and disposal of the
PMN 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 721.10515.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
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subject to these SNURs, EPA concluded
that for 8 of the 107 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.
In the other 99 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, import,
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, importing, or
processing a listed chemical substance
for the described significant new use.
• EPA will be able to regulate
prospective manufacturers, importers,
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, importers, 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 Inventory. Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
Internet at https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
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VI. Direct Final Procedures
EPA is issuing these SNURs as a
direct final rule, as described in
§ 721.160(c)(3) and § 721.170(d)(4). In
accordance with § 721.160(c)(3)(ii) and
§ 721.170(d)(4)(i)(B), the effective date
of this rule is November 20, 2012
without further notice, unless EPA
receives written adverse or critical
comments, or notice of intent to submit
adverse or critical comments before
October 22, 2012.
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
October 22, 2012, 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.
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VII. Applicability of Rule to Uses
Occurring Before Effective Date of the
Rule
Significant new use designations for a
chemical substance are legally
established as of the date of publication
of this direct final rule (September 21,
2012).
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. TSCA section
5(e) consent orders have been issued for
eight chemical substances and the PMN
submitters are prohibited by the TSCA
section 5(e) consent orders from
undertaking activities which EPA is
designating as significant new uses. 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 other person
may commence such activities without
first submitting a PMN. For chemical
substances for which an NOC has not
been submitted at this time, EPA
concludes that the uses are not ongoing.
However, EPA recognizes that prior to
the effective date of the rule, when
chemical substances identified in this
SNUR are added to the TSCA Inventory,
other persons may engage in a
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significant new use as defined in this
rule before the effective date of the rule.
However, 67 of the 108 chemical
substances contained in this rule have
CBI chemical identities, and since EPA
has received a limited number of postPMN bona fide submissions (per
§§ 720.25 and 721.11), 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.
As discussed in the Federal Register
of April 24, 1990 (55 FR 17376), EPA
has decided that the intent of TSCA
section 5(a)(1)(B) is best served by
designating a use as a significant new
use as of the date of publication of this
direct final rule rather than as of the
effective date of the rule. If uses begun
after publication were considered
ongoing rather than new, it would be
difficult for EPA to establish SNUR
notice requirements because a person
could defeat the SNUR by initiating the
significant new use before the rule
became effective, and then argue that
the use was ongoing before the effective
date of the rule. Persons who begin
commercial manufacture, import, or
processing of the chemical substances
regulated through this SNUR will have
to cease any such activity before the
effective date of this rule. To resume
their activities, these persons would
have to comply with all applicable
SNUR notice requirements and wait
until the notice review period,
including any extensions, expires.
EPA has promulgated provisions to
allow persons to comply with this
SNUR before the effective date. If a
person meets the conditions of advance
compliance under § 721.45(h), the
person is considered exempt from the
requirements of the SNUR.
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
§ 720.50). However, upon review of
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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.
describes those tests. Unit IV. also lists
recommended testing for non-5(e)
SNURs. Descriptions of tests are
provided for informational purposes.
EPA strongly encourages persons, before
performing any testing, to consult with
the Agency about protocol selection and
test reporting. To access the harmonized
test guidelines referenced in this
document electronically, please go to
https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines’’ or for
guidelines that are not currently
available on the Web site EPA has
placed a copy of that guideline in the
public docket. 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. The ASTM
International standards are available at
https://www.astm.org/Standard/
index.shtml.
In the TSCA section 5(e) consent
orders for eight of the chemical
substances regulated under this rule,
EPA has established restrictions 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 restrictions will not
be removed until EPA determines that
the unrestricted use will not present an
unreasonable risk of injury, or result in
significant or substantial exposure or
environmental release. This
determination is usually made based on
the results of the required or
recommended toxicity tests.
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.
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• Potential benefits of the chemical
substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
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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, importer, or processor
may request that EPA determine
whether a proposed use would be a
significant new use under the rule. The
manufacturer, importer, or processor
must show that it has a bona fide intent
to manufacture, import, or process the
chemical substance and must identify
the specific use for which it intends to
manufacture, import, or process the
chemical substance. If EPA concludes
that the person has shown a bona fide
intent to manufacture, import, 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, importers, 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,
import, 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.
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X. SNUN Submissions
According to § 721.1(c), persons
submitting a SNUN must comply with
the same notice requirements and EPA
regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in
§ 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 §§ 721.25 and
720.40. 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, importers, 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–2011–0941.
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. 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
According to the Paperwork
Reduction Act (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
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comment to amend it is unnecessary. As
a result, EPA finds that there is ‘‘good
cause’’ under section 553(b)(3)(B) of the
Administrative Procedure Act, 5 U.S.C.
553(b)(3)(B), to amend this table without
further notice and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act
On February 18, 2012, EPA certified
pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA) (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 SNUN 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
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economic impact on a substantial
number of small entities.
D. Unfunded Mandates Reform Act
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 sections 202, 203, 204,
or 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L.
104–4).
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.
mstockstill on DSK4VPTVN1PROD with RULES4
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,
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distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
XIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and the Comptroller General of
the United States. 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 rule 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: September 13, 2012.
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,
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58689
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 § 14;9.1, add the following
sections in numerical order under the
undesignated center heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
40 CFR citation
*
*
OMB
Control No.
*
*
*
*
Significant New Uses of Chemical
Substances
*
721.10427
721.10428
721.10429
721.10430
721.10431
721.10432
721.10433
721.10434
721.10435
721.10436
721.10437
721.10438
721.10439
721.10440
721.10441
721.10442
721.10443
721.10444
721.10445
721.10446
721.10447
721.10448
721.10449
721.10450
721.10451
721.10452
721.10453
721.10454
721.10455
721.10456
721.10457
721.10458
721.10459
721.10460
721.10461
721.10462
721.10463
721.10464
721.10465
721.10466
721.10467
721.10468
721.10469
721.10470
721.10471
721.10472
721.10473
721.10474
721.10475
721.10476
721.10477
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*
*
*
*
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
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2070–0012
21SER4
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OMB
Control No.
40 CFR citation
721.10478
721.10479
721.10480
721.10481
721.10482
721.10483
721.10484
721.10485
721.10486
721.10487
721.10488
721.10489
721.10490
721.10491
721.10492
721.10493
721.10494
721.10495
721.10496
721.10497
721.10498
721.10499
721.10500
721.10501
721.10502
721.10503
721.10504
721.10505
721.10506
721.10507
721.10508
721.10509
721.10510
721.10511
721.10512
721.10513
721.10514
721.10515
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*
*
*
*
*
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
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 § 721.10427 to subpart E to
read as follows:
■
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10427
Aminoalkanol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aminoalkanol (PMN P–
96–308) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=600).
(b) Specific requirements. The
provisions of subpart A of this part
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apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 5. Add § 721.10428 to subpart E to
read as follows:
§ 721.10428 Fatty acids, C18-unsatd.,
dimers, reaction products with 1piperazineethanamine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
fatty acids, C18-unsatd., dimers, reaction
products with 1-piperazineethanamine
(PMN P–96–1021; CAS No. 206565–90–
4) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 6. Add § 721.10429 to subpart E to
read as follows:
§ 721.10429 Fatty acids, C18-unsatd.,
dimers, reaction products with 1piperazineethanamine and tall-oil fatty
acids.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
fatty acids, C18-unsatd., dimers, reaction
products with 1-piperazineethanamine
and tall-oil fatty acids (PMN P–96–1022;
CAS No. 206565–89–1) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
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(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 7. Add § 721.10430 to subpart E to
read as follows:
§ 721.10430
(generic).
Tetra alkyl ammonium salt
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as tetra alkyl ammonium salt
(PMN P–97–823) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72(a)
and (c)(2) (the following statement must
be included in the material safety data
sheet (MSDS): ‘‘The results of an eye
irritation test in rabbits resulted in
deaths at levels of the PMN substance
greater than 25 percent concentration’’).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (use of the
substance as described in the PMN at
concentrations less than or equal to 25
percent).
(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) and
are applicable to manufacturers,
importers, and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
■ 8. Add § 721.10431 to subpart E to
read as follows:
§ 721.10431
(generic).
Phosphoric acid esters
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as phosphoric acid esters
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(PMNs P–98–141 and P–98–142) 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=100).
(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, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 9. Add § 721.10432 to subpart E to
read as follows:
§ 721.10432 1,2,4,5,7,8-Hexoxonane, 3,6,9triethyl-3,6,9-trimethyl-.
mstockstill on DSK4VPTVN1PROD with RULES4
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2,4,5,7,8-hexoxonane, 3,6,9-triethyl3,6,9-trimethyl-. (PMN P–98–1028; CAS
No. 24748–23–0) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (viscosity
modifier in the manufacture of
polypropylene manufactured and
supplied as a solution in at least 40
percent mineral spirits).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 10. Add § 721.10433 to subpart E to
read as follows:
§ 721.10433
octafluoro-.
Cyclopentene, 1,2,3,3,4,4,5,5-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclopentene, 1,2,3,3,4,4,5,5-octafluoro(PMN P–99–184; CAS No. 559–40–0) 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) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (j) (dry
etching agent and chemical vapor
deposition agent for the production of
semiconductors).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 11. Add § 721.10434 to subpart E to
read as follows:
§ 721.10434 Cyclopentane, 1,1,2,2,3,3,4heptafluoro-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclopentane, 1,1,2,2,3,3,4-heptafluoro(PMN P–99–214; CAS No. 15290–77–4)
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) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (j) (solvent and
a cleaning and drying agent), and (o).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 12. Add § 721.10435 to subpart E to
read as follows:
§ 721.10435 Phenol, 2-(1-methyl-1phenylethyl)-4-(1,1,3,3-tetramethylbutyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phenol, 2-(1-methyl-1-phenylethyl)-4(1,1,3,3-tetramethylbutyl)- (PMN P–99–
1179; CAS No. 73936–80–8) 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) 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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 13. Add § 721.10436 to subpart E to
read as follows:
§ 721.10436 Amine neutralized phosphated
polyesters (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as amine neutralized
phosphated polyesters (PMN P–99–1217
and P–99–1218) are subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(s) (50,000
kilograms combined for the substances
identified in PMNs P–99–1217 and P–
99–1218).
(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, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 14. Add § 721.10437 to subpart E to
read as follows:
§ 721.10437 Sulfonic acid, linear xylene
alkylate, mono, sodium salts (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as sulfonic acid, linear
xylene alkylate, mono, sodium salts
(PMNs P–99–1280, P–99–1281, and P–
99–1282) 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:
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(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (enhanced oil
recovery surfactants).
(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, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 15. Add § 721.10438 to subpart E to
read as follows:
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§ 721.10438 Dialkyl
hydroxybenzenealkanoic acid ester
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dialkyl
hydroxybenzenealkanoic acid ester
(PMN P–00–346) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (b) (concentration
set at 1.0 percent), and (c).
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 1.0 percent), (f),
(g)(1)(iv), (g)(2)(i), (g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(q).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 16. Add § 721.10439 to subpart E to
read as follows:
§ 721.10439
1,3-Dioxolan-2-one, 4-ethenyl.
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance identified as
1,3-dioxolan-2-one, 4-ethenyl (PMN P–
00–635; CAS No. 4427–96–7) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (b) (concentration
set at 0.1 percent), and (c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
■ 17. Add § 721.10440 to subpart E to
read as follows:
§ 721.10440 Diphosphoric acid, polymers
with ethoxylated reduced Me esters of
reduced polymd. oxidized
tetrafluoroethylene.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
diphosphoric acid, polymers with
ethoxylated reduced Me esters of
reduced polymd. oxidized
tetrafluoroethylene (PMN P–00–1165;
CAS No. 200013–65–6) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o) and (y)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 18. Add § 721.10441 to subpart E to
read as follows:
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§ 721.10441 1,2-Benzenedicarboxylic acid,
di-C7–14-branched and linear alkyl esters.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2-benzenedicarboxylic acid, di-C7–14branched and linear alkyl esters (PMN
P–01–382; CAS No. 309934–68–7) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o) (use as
plasticizers for flexible polyvinyl
chloride not to include children’s toys
(e.g., pacifiers, rattles, and teethers)).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 19. Add § 721.10442 to subpart E to
read as follows:
§ 721.10442 1,2-Benzenedicarboxylic acid,
di-C6–14-branched and linear alkyl esters.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2-benzenedicarboxylic acid, di-C6–14branched and linear alkyl esters (PMN
P–01–383; CAS No. 309934–69–8) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o) (use as
plasticizers for flexible polyvinyl
chloride not to include children’s toys
(e.g., pacifiers, rattles, and teethers)).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 20. Add § 721.10443 to subpart E to
read as follows:
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§ 721.10443 Ethoxylated alkylphenol
sulfate, ammonium salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated alkylphenol
sulfate, ammonium salt (PMN P–01–
470) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (manufacture
and import of the PMN substance
according to the chemical composition
section of the consent order where the
substance must have either a mean
number of moles of ethoxy groups
greater than or equal to 10, or the
average number molecular weight is
greater than 950 daltons).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 21. Add § 721.10444 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10444
Propanol, mercapto-.
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provisions of § 721.185 apply to this
section.
■ 22. Add § 721.10445 to subpart E to
read as follows:
provisions of § 721.185 apply to this
section.
■ 24. Add § 721.10447 to subpart E to
read as follows:
§ 721.10445 2-Propen-1-ol, reaction
products with hydrogen sulfide, distn.
residues.
§ 721.10447 17Oxabicyclo[14.1.0]heptadec-8-ene.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propen-1-ol, reaction products with
hydrogen sulfide, distn. residues (PMN
P–01–500; CAS No. 374078–75–8) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (b) (concentration
set at 1.0 percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 23. Add § 721.10446 to subpart E to
read as follows:
§ 721.10446
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propanol, mercapto- (PMN P–01–499;
CAS No. 63947–56–8) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (b) (concentration
set at 1.0 percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=11).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
58693
1, 9-Cyclohexadecadiene.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,9-cyclohexadecadiene (PMN P–01–
762; CAS No. 4277–06–9) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (b) (concentration
set at 1.0 percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
17-oxabicyclo[14.1.0]heptadec-8-ene
(PMN P–01–829; CAS No. 34748–97–5)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (a)(4) (National
Institute for Occupational Safety and
Health (NIOSH)-certified air purifying
respirator equipped with a high
efficiency particulate filter including
disposable cartridge), (a)(5)(vii), (b)
(concentration set at 1.0 percent), and
(c).
(ii) Release to water. Requirement as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 25. Add § 721.10448 to subpart E to
read as follows:
§ 721.10448 Acetic acid, hydroxymethoxy-, methyl ester, reaction products
with substituted alkylamine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acetic acid,
hydroxymethoxy-, methyl ester, reaction
products with substituted alkylamine
(PMN P–02–120) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (manufacture
and import of the PMN substance
according to the average number
molecular weight section of the consent
order where the average molecular
weight is greater than or equal to 850
daltons).
(ii) [Reserved]
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(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 26. Add § 721.10449 to subpart E to
read as follows:
§ 721.10449
(generic).
Aromatic polyester polyol
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic polyester polyol
(PMN P–02–172) 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=40).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 27. Add § 721.10450 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10450 Oxirane, 2-[[3(trimethoxysilyl)propoxy]methyl]-, reaction
products with wollastonite (Ca(SiO3)).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-[[3(trimethoxysilyl)propoxy]methyl]-,
reaction products with wollastonite
(Ca(SiO3)) (PMN P–02–285; CAS No.
100402–91–3) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (manufacture
and process the PMN substance with an
average number aspect ratio no greater
than 5, and no more than 15 percent of
the PMN substance shall have an aspect
ratio greater than 10).
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(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 28. Add § 721.10451 to subpart E to
read as follows:
§ 721.10451
Alkyd amide polyol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyd amide polyol (PMN
P–02–436) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=3).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 29. Add § 721.10452 to subpart E to
read as follows:
§ 721.10452 9-Octadecenoic acid (9Z)-,
1,1′-(dimethylstannylene) ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
9-octadecenoic acid (9Z)-, 1,1′(dimethylstannylene) ester (PMN P–02–
659; CAS No. 3865–34–7) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=10).
(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
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§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 30. Add § 721.10453 to subpart E to
read as follows:
§ 721.10453
(generic).
Polyglycerin alkyl ether
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyglycerin alkyl ether
(PMN P–02–796) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 31. Add § 721.10454 to subpart E to
read as follows:
§ 721.10454 Propoxylated ethoxylated
alkylamine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as propoxylated ethoxylated
alkylamine (PMN P–02–828) 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=80).
(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, importers,
and processors of this substance.
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of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 34. Add § 721.10457 to subpart E to
read as follows:
§ 721.10455 Oxirane, 2,2′,2″[ethylidynetris(4,1phenyleneoxymethylene)]tris-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2,2′,2″-[ethylidynetris(4,1phenyleneoxymethylene)]tris- (PMN P–
03–61; CAS No. 87093–13–8) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(y)(1).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 33. Add § 721.10456 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10456 Tristyryl phenol alkoxylate
salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as tristyryl phenol
alkoxylate salt (PMN P–03–104) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
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provisions of § 721.185 apply to this
section.
■ 36. Add § 721.10459 to subpart E to
read as follows:
§ 721.10457 1,2-Benzenedicarboxylic acid,
mixed esters with benzyl alc., cyclohexanol,
2-ethyl-1-hexanol, fumaric acid and
propylene glycol.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 32. Add § 721.10455 to subpart E to
read as follows:
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§ 721.10459 Amino-substituted
carbopolycycle (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2-benzenedicarboxylic acid, mixed
esters with benzyl alc., cyclohexanol, 2ethyl-1-hexanol, fumaric acid and
propylene glycol (PMN P–03–154; CAS
No. 464920–01–2) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 35. Add § 721.10458 to subpart E to
read as follows:
§ 721.10458
(generic).
Acrylate of hydroxyimide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acrylate of hydroxyimide
(PMN P–03–238) 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(v)(2), (w)(2), and
(x)(2).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=20).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as amino-substituted
carbopolycycle (PMN P–03–282) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)
(respirators must provide a National
Institute for Occupational Safety and
Health (NIOSH) assigned protection
factor of at least 50), (a)(6), (b)
(concentration set at 0.1 percent), and
(c). Best’s Viton model 878, Best’s Butyl
model 878, Barrier Laminated Film, and
PVA Supported Polyvinyl Alcohol have
been demonstrated to satisfy the
requirements of § 721.63(a)(3)(i). Other
demonstrated impervious gloves that
satisfy § 721.63(a)(3)(i) are permissible.
The following respirators meet the
minimum requirements of
§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting, half-face
respirator equipment with N100 (if oil
aerosols absent), R100, or P100 filters;
NIOSH-certified air-purifying, tightfitting full-face respirator with N100 (if
oil aerosols absent), R100, or P100
filters; NIOSH-certified powered airpurifying respirator equipped with a
loose-fitting hood or helmet and high
efficiency particulate air (HEPA) filters;
NIOSH-certified powered air-purifying
respirator equipped with a tight-fitting
facepiece (either half-face or full-face)
and HEPA filters; or NIOSH-certified
supplied-air respirator operated in
pressure demand or continuous flow
mode and equipped with a hood or
helmet, or tight-fitting facepiece (either
half-face or full-face).
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 0.1 percent), (f),
(g)(1)(i), (g)(1)(vii), and (g)(2).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (j).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
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manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 37. Add § 721.10460 to subpart E to
read as follows:
§ 721.10460
Azo nickel complex (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as azo nickel complex (PMN
P–03–307) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j), (v)(1), (w)(1),
and (x)(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 (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 38. Add § 721.10461 to subpart E to
read as follows:
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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 39. Add § 721.10462 to subpart E to
read as follows:
§ 721.10462 1-Penten-3-one, 1-(4chlorophenyl)-4,4-dimethyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-penten-3-one, 1-(4-chlorophenyl)-4,4dimethyl- (PMN P–03–354; CAS No.
1577–03–3) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=30).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 40. Add § 721.10463 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10461 Oxazolidine, 3,3′methylenebis[5-methyl-.
§ 721.10463
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxazolidine, 3,3′-methylenebis[5methyl- (PMN P–03–325; CAS No.
66204–44–2) 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(j) (metalworking
fluid).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=40 (saltwater) and N=100
(freshwater)).
(b) Specific requirements. The
provisions of subpart A of this part
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid amides (PMN
P–03–388) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
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applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 41. Add § 721.10464 to subpart E to
read as follows:
§ 721.10464 Fatty acid, reaction products
with alkanolamine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid, reaction
products with alkanolamine (PMN P–
03–461) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 42. Add § 721.10465 to subpart E to
read as follows:
§ 721.10465 2-Propenoic acid, 2-methyl-, 3hydroxytricyclo[3.3.1.13,7]dec-1-yl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2-methyl-, 3hydroxytricyclo[3.3.1.13,7]dec-1-yl ester
(PMN P–03–561; CAS No. 115372–36–6)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3),
(a)(4) (National Institute for
Occupational Safety and Health
(NIOSH)-certified respirator with an
assigned protection factor (APF) of at
least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v),
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(a)(6)(vi), (b) (concentration set at 1.0
percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=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) through (e) and (k) and are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 43. Add § 721.10466 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10466 2-Propenoic acid, 2-methyl-, 2ethyltricyclo[3.3.1.13,7]dec-2-yl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2-methyl-, 2ethyltricyclo[3.3.1.13,7]dec-2-yl ester
(PMN P–03–563; CAS No. 209982–56–9)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3),
(a)(4) (National Institute for
Occupational Safety and Health
(NIOSH)-certified respirator with an
assigned protection factor (APF) of at
least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), (b) (concentration set at 1.0
percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=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) through (e) and (k) and are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 44. Add § 721.10467 to subpart E to
read as follows:
§ 721.10467 2-Propenoic acid, 3hydroxytricyclo[3.3.1.13,7]dec-1-yl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 3hydroxytricyclo[3.3.1.13,7]dec-1-yl ester
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(PMN P–03–564; CAS No. 216581–76–9)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3),
(a)(4) (National Institute for
Occupational Safety and Health
(NIOSH)-certified respirator with an
assigned protection factor (APF) of at
least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), (b) (concentration set at 1.0
percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=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) through (e) and (k) and are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 45. Add § 721.10468 to subpart E to
read as follows:
§ 721.10468 2-Propenoic acid, 2methyltricyclo[3.3.1.13,7]dec-2-yl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2methyltricyclo[3.3.1.13,7]dec-2-yl ester
(PMN P–03–565; CAS No. 249562–06–9)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3),
(a)(4) (National Institute for
Occupational Safety and Health
(NIOSH)-certified respirator with an
assigned protection factor (APF) of at
least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), (b) (concentration set at 1.0
percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=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) through (e) and (k) and are
applicable to manufacturers, importers,
and processors of this substance.
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58697
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 46. Add § 721.10469 to subpart E to
read as follows:
§ 721.10469 2-Propenoic acid, 2ethyltricyclo[3.3.1.13,7]dec-2-yl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2ethyltricyclo[3.3.1.13,7]dec-2-yl ester
(PMN P–03–566; CAS No. 303186–14–3)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3),
(a)(4) (National Institute for
Occupational Safety and Health
(NIOSH)-certified respirator with an
assigned protection factor (APF) of at
least 10), (a)(6)(i), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), (b) (concentration set at 1.0
percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=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) through (e) and (k) and are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 47. Add § 721.10470 to subpart E to
read as follows:
§ 721.10470 Phosphonium, tetrabutyl-,
1,1,2,2,3,3,4,4,4-nonafluoro-1butanesulfonate (1:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphonium, tetrabutyl-,
1,1,2,2,3,3,4,4,4-nonafluoro-1butanesulfonate (1:1) (PMN P–03–567;
CAS No. 220689–12–3) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(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 (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 48. Add § 721.10471 to subpart E to
read as follows:
§ 721.10471 2-Propenoic acid, 1,1′-(3methyl-1,5-pentanediyl) ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 1,1′-(3-methyl-1,5pentanediyl) ester (PMN P–03–622; CAS
No. 64194–22–5) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (f) and (j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 49. Add § 721.10472 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10472 1,3-Benzenedimethanamine,
polymers with epichlorohydrin-polyethylene
glycol reaction products.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,3-benzenedimethanamine, polymers
with epichlorohydrin-polyethylene
glycol reaction products (PMN P–03–
645; CAS No. 652968–34–8) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f).
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(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 50. Add § 721.10473 to subpart E to
read as follows:
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 52. Add § 721.10475 to subpart E to
read as follows:
§ 721.10473 1-Propanaminium, 3-amino-N(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl
derivs., inner salts.
§ 721.10475 Hexanedioic acid, compd. with
N1-(6-aminohexyl)-N1-methyl-1,6hexanediamine (1:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-propanaminium, 3-amino-N-(2carboxyethyl)-N,N-dimethyl-, N-coco
acyl derivs., inner salts (PMN P–03–865;
CAS No. 499781–63–4) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=85).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 51. Add § 721.10474 to subpart E to
read as follows:
§ 721.10474 Substituted amino ethane
sulfonic acid salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted amino ethane
sulfonic acid salt (PMN P–04–107) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
hexanedioic acid, compd. with N1-(6aminohexyl)-N1-methyl-1,6hexanediamine (1:1) (PMN P–04–118;
CAS No. 659733–29–6) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (intermediate for
polymer manufacture).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=20).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply this
section.
■ 53. Add § 721.10476 to subpart E to
read as follows:
§ 721.10476
methyl-.
Oxetane, 3-(bromomethyl)-3-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxetane, 3-(bromomethyl)-3-methyl(PMN P–04–275; CAS No. 78385–26–9)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (b) (concentration
set at 1.0 percent), and (c).
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(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 54. Add § 721.10477 to subpart E to
read as follows:
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 56. Add § 721.10479 to subpart E to
read as follows:
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 58. Add § 721.10481 to subpart E to
read as follows:
§ 721.10479 Quaternary ammonium
compounds, tris(hydrogenated tallow
alkyl)methyl, chlorides.
§ 721.10481 Siloxanes and Silicones, Me
vinyl, hydroxy-terminated, reaction
products with silica.
§ 721.10477
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
quaternary ammonium compounds,
tris(hydrogenated tallow alkyl)methyl,
chlorides (PMN P–04–335; CAS No.
308074–73–9) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 57. Add § 721.10480 to subpart E to
read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
Siloxanes and Silicones, Me vinyl,
hydroxy-terminated, reaction products
with silica (PMN P–04–429; CAS No.
630106–01–3) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(v)(1), (w)(1), and
(x)(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 (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 59. Add § 721.10482 to subpart E to
read as follows:
§ 721.10480 Trimethylolpropane polyol,
aminated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
Siloxanes and Silicones, di-Me, Me
vinyl, hydroxy-terminated, reaction
products with silica (PMN P–04–430;
CAS No. 630106–00–2) 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 (v)(1), (w)(1), and
(x)(1).
Acrylate ester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acrylate ester (PMN P–04–
290) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 55. Add § 721.10478 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10478
Polyether polyol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyether polyol (PMN P–
04–318) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (intermediate for
making urethane polymer).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=30).
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as trimethylolpropane
polyol, aminated (PMN P–04–384) 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].
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§ 721.10482 Siloxanes and Silicones, diMe, Me vinyl, hydroxy-terminated, reaction
products with silica.
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(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 60. Add § 721.10483 to subpart E to
read as follows:
§ 721.10483 Siloxanes and Silicones, diMe, Me vinyl, hydroxy-terminated, reaction
products with [(ethenyldimethylsilyl)oxy]modified silica.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
Siloxanes and Silicones, di-Me, Me
vinyl, hydroxy-terminated, reaction
products with
[(ethenyldimethylsilyl)oxy]-modified
silica (PMN P–04–431; CAS No.
630106–04–6) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (v)(1), (w)(1), and
(x)(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 (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 61. Add § 721.10484 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10484 Siloxanes and Silicones, Me
vinyl, hydroxy-terminated, reaction
products with [(ethenyldimethylsilyl)oxy]modified silica.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
Siloxanes and Silicones, Me vinyl,
hydroxy-terminated, reaction products
with [(ethenyldimethylsilyl)oxy]modified silica (PMN P–04–432; CAS
No. 630106–02–4) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
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(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (v)(1), (w)(1), and
(x)(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 (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 62. Add § 721.10485 to subpart E to
read as follows:
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (acetaldehyde
scavenger for plastic bottle production).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 64. Add § 721.10487 to subpart E to
read as follows:
§ 721.10485 Reaction products of
alcohols, alkyl alcohols, amino alcohols
and methanol sodium salts (generic).
§ 721.10487 Alkylbenzenes sulfonic acids,
metal salts (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as reaction products of
alcohols, alkyl alcohols, amino alcohols
and methanol sodium salts (PMN P–04–
479) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 63. Add § 721.10486 to subpart E to
read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as alkylbenzenes sulfonic
acids, metal salts (PMNs P–04–599, P–
04–600, P–04–605, and P–04–606) are
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 65. Add § 721.10488 to subpart E to
read as follows:
§ 721.10486 Alkyl substituted aminobenzamide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyl substituted aminobenzamide (PMN P–04–591) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
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§ 721.10488 Cuprate,
[[[[[[[(sulfonaphthalenyl)]azo](substitutedphenyl)]azo](substitutedsulfonaphthalenyl)]azo]substituted phenyl-substituted
heteromonocycle], sodium salts (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as cuprate,
[[[[[[[(sulfonaphthalenyl)]azo]-
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(substitutedphenyl)]azo](substitutedsulfonaphthalenyl)]azo]substituted phenyl-substituted
heteromonocycle], sodium salts (PMN
P–04–636) 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)(4) (National Institute
for Occupational Safety and Health
(NIOSH)-certified respirator with an
assigned protection factor (APF) of at
least 5), (a)(6)(i), (a)(6)(ii), (a)(6)(v),
(a)(6)(vi), (b) (concentration set at 0.1
percent), and (c).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) are applicable
to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 66. Add § 721.10489 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10489 Substituted aryl sulfonium
polyfluorophosphate salts (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted aryl
sulfonium polyfluorophosphate salts
(PMN P–04–718) 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 (v)(1), (v)(2),
(w)(1), (w)(2), (x)(1), and (x)(2).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N = 6).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 67. Add § 721.10490 to subpart E to
read as follows:
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§ 721.10490 HDI biuret, hydroxyethyl
methacrylate prepolymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as HDI biuret, hydroxyethyl
methacrylate prepolymer (PMN P–04–
834) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section. The requirements of this section
do not apply to quantities of the PMN
substance that have been completely
reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2), (a)(3), (a)(4), (b)
(concentration set at 0.1 percent), and
(c). The following National Institute for
Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of at
least 25 meet the minimum
requirements for § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting halfface respirator equipped with N100 (if
oil aerosols absent), R100, or P100
filters; NIOSH-certified air-purifying,
tight-fitting full-face respirator equipped
with N100 (if oil aerosols absent), R100,
or P100 filters; NIOSH-certified
powered air-purifying respirator
equipped with a loose-fitting hood or
helmet and high efficiency particulate
air (HEPA) filters; NIOSH-certified
powered air-purifying respirator
equipped with a tight-fitting facepiece
(either half-face or full-face) and HEPA
filters; or NIOSH-certified supplied-air
respirator operated in pressure demand
or continuous flow mode and equipped
with a hood or helmet, or tight-fitting
facepiece (either half-face or full-face).
(A) As an alternative to the respiratory
requirements listed in paragraph
(a)(2)(i), a manufacturer, importer, or
processor may choose to follow the new
chemical exposure limit (NCEL)
provisions listed in the TSCA section
5(e) consent order for this substance.
The NCEL is 0.05 mg/m3 as an 8-hour
time-weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (e)
(concentration set at 0.1 percent), (f),
(g)(1)(i), (g)(1)(ii), (g)(1)(vii), (g)(2)(i),
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58701
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v),
and (g)(5).
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(q).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 68. Add § 721.10491 to subpart E to
read as follows:
§ 721.10491
methyl-.
Benzenepropanal,.alpha.-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenepropanal,.alpha.-methyl- (PMN
P–05–55; CAS No. 5445–77–2) 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(h).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 69. Add § 721.10492 to subpart E to
read as follows:
§ 721.10492
Trisphenol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as trisphenol (PMN P–05–
301) 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 = 20).
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(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 70. Add § 721.10493 to subpart E to
read as follows:
§ 721.10493 Tris-alkyl-alkoxy melamine
polymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as tris-alkyl-alkoxy
melamine polymer (PMN P–05–417) 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).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 71. Add § 721.10494 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10494 Reaction product of
trimethylolpropane triacrylate and alkylene
imine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as reaction product of
trimethylolpropane triacrylate and
alkylene imine (PMN P–05–501) 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).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 72. Add § 721.10495 to subpart E to
read as follows:
§ 721.10495
Metal silicate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as metal silicate (PMN P–
05–634) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (f) and (j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 73. Add § 721.10496 to subpart E to
read as follows:
§ 721.10496 Amino alkoxy
polydimethylsiloxane, hydroxy-terminated
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as amino alkoxy
polydimethylsiloxane, hydroxyterminated (PMN P–06–9) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N = 10).
(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
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§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 74. Add § 721.10497 to subpart E to
read as follows:
§ 721.10497 Substituted alkyl ester,
hydrolysis products with silica and
substituted silane (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as substituted alkyl ester,
hydrolysis products with silica and
substituted silane (PMNs P–06–276 and
P–06–279) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3),
(a)(4), (b) (concentration set 1.0 percent),
and (c). The following National Institute
for Occupational Safety and Health
(NIOSH)-certified respirators with an
assigned protection factor (APF) of at
least 5 meet the requirements of
§ 721.63(a)(4): NIOSH-certified airpurifying, tight-fitting full-face
respirator equipped with N100 (if oil
aerosols absent), R100, or P100 filters;
NIOSH-certified air-purifying respirator
equipped with a loose-fitting hood or
helmet and high efficiency particulate
air (HEPA) filters; NIOSH-certified
powered air-purifying respirator
equipped with a tightfitting facepiece
(full-face) and HEPA filters; or NIOSHcertified supplied-air respirator
operated in pressure demand or
continuous flow mode and equipped
with a hood or helmet, or tight-fitting
facepiece (full-face).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (j), (v)(1), (w)(1),
and (x)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (i) are
applicable to manufacturers, importers,
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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§ 721.10499 Substituted silane, hydrolysis
products with silica (generic).
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
75. Add § 721.10498 to subpart E to
read as follows:
■
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§ 721.10498 Substituted alkyl ester,
hydrolysis products with silica (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as substituted alkyl ester,
hydrolysis products with silica (PMNs
P–06–277 and P–06–280) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3),
(a)(4), (b) (concentration set at 1.0
percent), and (c). The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirators with an assigned protection
factor (APF) of at least 5 meet the
requirements of § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N100 (if
oil aerosols absent), R100, or P100
filters; NIOSH-certified air-purifying
respirator equipped with a loose-fitting
hood or helmet and high efficiency
particulate air (HEPA) filters; NIOSHcertified powered air-purifying
respirator equipped with a tightfitting
facepiece (full-face) and HEPA filters; or
NIOSH-certified supplied-air respirator
operated in pressure demand or
continuous flow mode and equipped
with a hood or helmet, or tight-fitting
facepiece (full-face).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (j), (v)(1), (w)(1),
and (x)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (i) are
applicable to manufacturers, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
76. Add § 721.10499 to subpart E to
read as follows:
■
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as substituted silane,
hydrolysis products with silica (PMNs
P–06–278 and P–06–281) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3),
(a)(4), (b) (concentration set at 1.0
percent), and (c). The following
National Institute for Occupational
Safety and Health NIOSH-certified
respirators with an assigned protection
factor (APF) of at least 5 meet the
requirements of § 721.63(a)(4): NIOSHcertified air-purifying, tight-fitting fullface respirator equipped with N100 (if
oil aerosols absent), R100, or P100
filters; NIOSH-certified air-purifying
respirator equipped with a loose-fitting
hood or helmet and high efficiency
particulate air (HEPA) filters; NIOSHcertified powered air-purifying
respirator equipped with a tight-fitting
facepiece (full-face) and HEPA filters; or
NIOSH-certified supplied-air respirator
operated in pressure demand or
continuous flow mode and equipped
with a hood or helmet, or tight-fitting
facepiece (full-face).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (j), (v)(1), (w)(1),
and (x)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (i) are
applicable to manufacturers, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
■ 77. Add § 721.10500 to subpart E to
read as follows:
§ 721.10500
(generic).
Acrylated mixed metal oxides
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acrylated mixed metal
oxides (PMN P–06–341) is subject to
reporting under this section for the
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58703
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b)
(concentration set at 1.0 percent), and
(c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (j), (v)(1), (w)(1),
and (x)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
■ 78. Add § 721.10501 to subpart E to
read as follows:
§ 721.10501
Tridecyl phthalate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as tridecyl phthalate (PMN
P–06–542) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 79. Add § 721.10502 to subpart E to
read as follows:
§ 721.10502 Modified triethylene glycol
dithiol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance identified
generically as modified triethylene
glycol dithiol (PMN P–06–616) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 80. Add § 721.10503 to subpart E to
read as follows:
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (j) (compatibilizer
for flame retardant for plastics) and (s)
(100,000 kilograms).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 82. Add § 721.10505 to subpart E to
read as follows:
§ 721.10503
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphoric acid, mixed mono- and
diesters with 2-ethyl-1-hexanol and
polyethylene glycol mono-C12–16-alkyl
ethers (PMN P–06–694; CAS No.
882693–50–7) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (j) and (s) (75,000
kilograms).
(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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 83. Add § 721.10506 to subpart E to
read as follows:
1,2-Ethanediol, 1-carbamate.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2-ethanediol, 1-carbamate (PMN P–
06–622; CAS No. 5395–01–7) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(2)(i), (a)(3), (b)
(concentration set at 0.1 percent), and
(c).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) are applicable
to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 81. Add § 721.10504 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10504 Surface modified magnesium
hydroxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as surface modified
magnesium hydroxide (PMN P–06–682)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
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§ 721.10505 Phosphoric acid, mixed
mono- and diesters with 2-ethyl-1-hexanol
and polyethylene glycol mono-C12–16-alkyl
ethers.
§ 721.10506
Alkylated phenols (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as alkylated phenols (PMNs
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Sfmt 4700
P–07–11 and P–08–29) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b)
(concentration set at 1.0 percent), and
(c).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) are applicable
to manufacturers, importers, and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 84. Add § 721.10507 to subpart E to
read as follows:
§ 721.10507 Biphenyl substituted
benzopyran (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as biphenyl substituted
benzopyran (PMN P–07–107) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 85. Add § 721.10508 to subpart E to
read as follows:
§ 721.10508
(generic).
Alkene substituted Bis phenol
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkene substituted bis
phenol (PMN P–07–161) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3), (b) (concentration
set at 0.1 percent), and (c).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 86. Add § 721.10509 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES4
§ 721.10509 Pentane, 1,1,1,2,3,3hexafluoro-4-(1,1,2,3,3,3hexafluoropropoxy)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
pentane, 1,1,1,2,3,3-hexafluoro-4(1,1,2,3,3,3-hexafluoropropoxy)- (PMN
P–07–204; CAS No. 870778–34–0) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (b)
(concentration set at 1.0 percent), and
(c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e) and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
■ 87. Add § 721.10510 to subpart E to
read as follows:
§ 721.10510
Alkylaminoalcohol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylaminoalcohol (PMN
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P–07–319) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 88. Add § 721.10511 to subpart E to
read as follows:
§ 721.10511
(generic).
Quaternary ammonium salts
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as quaternary ammonium
salts (PMNs P–07–320, P–07–321, P–07–
322, P–07–323, and P–07–324) are
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 89. Add § 721.10512 to subpart E to
read as follows:
§ 721.10512
(generic).
Fatty acid maleic acid amides
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fatty acid maleic acid
amides (PMNs P–07–563 and P–07–564)
are subject to reporting under this
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58705
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=10).
(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, importers,
and processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 90. Add § 721.10513 to subpart E to
read as follows:
§ 721.10513
(generic).
Aromatic acrylate monomer
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic acrylate
monomer (PMN P–07–599) 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, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 91. Add § 721.10514 to subpart E to
read as follows:
§ 721.10514 [1,1’-Biphenyl]-2,2’-disulfonic
acid, 4-[2-(4,5-dihydro-3-methyl-5-oxo-1phenyl-1H-pyrazol-4-yl)diazenyl]-4’-[2-(2hydroxy-1-naphthalenyl)diazenyl]-, sodium
salt (1:2).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
[1,1’-Biphenyl]-2,2’-disulfonic acid, 4[2-(4,5-dihydro-3-methyl-5-oxo-1phenyl-1H-pyrazol-4-yl)diazenyl]-4’-[2(2-hydroxy-1-naphthalenyl)diazenyl]-,
sodium salt (1:2) (PMN P–07–679; CAS
No. 6470–20–8) is subject to reporting
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under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (f), (v)(2), and
(x)(2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 92. Add § 721.10515 to subpart E to
read as follows:
§ 721.10515 Partially fluorinated alcohol
substituted glycols (generic).
mstockstill on DSK4VPTVN1PROD with RULES4
(a) Chemical substance and
significant new uses subject to reporting.
VerDate Mar<15>2010
17:15 Sep 20, 2012
Jkt 226001
(1) The chemical substances identified
generically as partially fluorinated
alcohol substituted glycols (PMNs P–
10–58, P–10–59, and P–10–60) are
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) (manufacture
and import of the PMN substances
according to the chemical synthesis and
composition section of the consent
order, including analysis, reporting, and
limitations of maximum impurity levels
of certain fluorinated impurities;
manufacture and import of P–10–58 and
P–10–59 only as described in the
manufacturing section of the consent
order), (l) (compliance with the
maximum established percentage of the
PMN substances in a non-industrial
product or distributed for use as a nonindustrial product), (o) (use of P–10–60
in a consumer product that could be
spray applied), and (q).
(ii) [Reserved]
PO 00000
Frm 00042
Fmt 4701
Sfmt 9990
(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, importers,
and processors of these substances,
except the recordkeeping requirements
for § 721.125 (b) and (c) do not apply to
importers or processors when any one of
the substances are contained in a
formulation at less than 3 weight
percent.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
[FR Doc. 2012–23235 Filed 9–20–12; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\21SER4.SGM
21SER4
]]>Agencies
[Federal Register Volume 77, Number 184 (Friday, September 21, 2012)]
[Rules and Regulations]
[Pages 58665-58706]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23235]
[[Page 58665]]
Vol. 77
Friday,
No. 184
September 21, 2012
Part IV
Environmental Protection Agency
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40 CFR Parts 9 and 721
Significant New Use Rules on Certain Chemical Substances; Final Rule
Federal Register / Vol. 77 , No. 184 / Friday, September 21, 2012 /
Rules and Regulations
[[Page 58666]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2011-0941; FRL-9357-2]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 107 chemical substances
which were the subject of premanufacture notices (PMNs). Eight of these
chemical substances are subject to TSCA consent orders issued by EPA.
This action requires persons who intend to manufacture, import, or
process any of these 107 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 November 20, 2012. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 5, 2012.
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 October 22, 2012 (see Unit VI. of the
SUPPLEMENTARY INFORMATION).
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-2011-0941, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments.
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: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2011-0941. The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0941. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: moss.kenneth@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
Potentially affected entities may include, but are not limited to:
Manufacturers, importers, or processors of one or more
subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Sec. 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
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;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable
[[Page 58667]]
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 this rule are subject to the
export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec. [emsp14]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 EPA at least 90 days before
commencing the manufacture, import, 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) (April 24, 1990 SNUR). 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, import, or process the
chemical substance for that use. Persons who must report are described
in Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. [emsp14]721.1(c), persons subject to these SNURs must comply
with the same notice 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 sections
5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN, EPA 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
107 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, taking into consideration 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 107 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) number (if assigned for
non-confidential chemical identities).
Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (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.
[[Page 58668]]
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 8 PMN substances (P-00-346, P-01-470, P-02-120,
P-02-285, P-04-834, P-10-58, P-10-59, and P-10-60) for which EPA
determined, pursuant to TSCA section 5(e), that uncontrolled
manufacture, import, processing, distribution in commerce, use, and
disposal may present an unreasonable risk of injury to human health and
the environment. Accordingly, these substances are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I). Those
consent orders require protective measures to limit exposures or
otherwise mitigate the potential unreasonable risk. The so-called
``5(e) SNURs'' on these PMN substances are promulgated pursuant to
Sec. 721.160, and are based on and consistent with the provisions in
the underlying consent orders. The section 5(e) SNURs designate as a
``significant new use'' the absence of the protective measures required
in the corresponding consent orders.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the SNUR usually requires, among other things, that potentially exposed
employees wear specified respirators unless actual measurements of the
workplace air show that air-borne concentrations of the PMN substance
are below a New Chemical Exposure Limit (NCEL) that is established by
EPA to provide adequate protection to human health. In addition to the
actual NCEL concentration, the comprehensive NCELs provisions, which
are modeled after Occupational Safety and Health Administration (OSHA)
Permissible Exposure Limits (PELs) provisions, include requirements
addressing performance criteria for sampling and analytical methods,
periodic monitoring, respiratory protection, and recordkeeping.
However, no comparable NCEL provisions currently exist in 40 CFR part
721, subpart B, for SNURs. Therefore, for these cases, the individual
SNURs in 40 CFR part 721, subpart E, will state that persons subject to
the SNUR who wish to pursue NCELs as an alternative to the Sec. 721.63
respirator requirements may request to do so under Sec. 721.30.
This rule also includes SNURs on 99 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 ``non-
5(e) SNURs'' are promulgated pursuant to Sec. 721.170. EPA has
determined that every activity designated as a ``significant new use''
in all non-5(e) SNURs issued under Sec. 721.170 satisfies the two
requirements stipulated in Sec. 721.170(c)(2), i.e., these significant
new use activities, ``(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 Number P-96-308
Chemical name: Aminoalkanol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on structure-activity relationship (SAR) analysis of the
potential reaction of the PMN substance with nitrosating agents, and by
analogy to monoethanolamine, diethanolamine and dimethylisopropylamine,
EPA identified concerns for skin, eye, liver, kidney, lung, bone
marrow, brain, testes, heart, and blood toxicity from exposure to the
PMN substance via inhalation and dermal exposures, and the
gastrointestinal (GI) tract. In addition, based on ecological
structure-activity relationship (EcoSAR) analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 600 ppb of the PMN substance in
surface waters. For the use described in the PMN, EPA does not expect
dermal or inhalation exposures to manufacturing or processing workers
or other targeted populations, nor does it expect releases to surface
waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance other than as described in the PMN, or any use of the
substance resulting in surface water concentrations exceeding 600 ppb
may cause serious health effects 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 the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a
functional observational battery and histopathology; a prenatal
developmental toxicity test (OPPTS Test Guideline 870.3700); 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 to
characterize the human health and environmental effect of the PMN
substance.
CFR citation: 40 CFR 721.10427.
PMN Numbers P-96-1021 and P-96-1022
Chemical names: (P-96-1021) Fatty acids, C18-unsatd.,
dimers, reaction products with 1-piperazineethanamine and (P-96-1022)
Fatty acids, C18-unsatd., dimers, reaction products with 1-
piperazineethanamine and tall-oil fatty acids.
CAS numbers: (P-96-1021) 206565-90-4 and (P-96-1022) 206565-89-1.
Basis for action: The consolidated PMN states that the substances
will be used as water based epoxy curing agents. Based on EcoSAR
analysis of test data on analogous aliphatic amines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substances in surface waters. As described in the PMN,
the substances are not released to surface waters. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the PMN substances may present an unreasonable risk. EPA has
determined, however, that any use of the substances resulting in
surface water concentrations exceeding 1 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a
modified semi-continuous activated
[[Page 58669]]
sludge (SCAS) test (OPPTS Test Guideline 835.3210); 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) on PMN P-96-1022 would help characterize the
environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10428 (P-96-1021) and 40 CFR 721.10429
(P-96-1022).
PMN Number P-97-823
Chemical name: Tetra alkyl ammonium salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a curing agent for
coatings. Based on test data submitted on the PMN substance at varying
concentrations, EPA identified concerns for ocular lethality for
occupational exposures to the PMN substance at concentrations greater
than 25 percent. For the use described in the PMN, significant worker
exposures are not expected as the PMN substance is used at
concentrations no greater than 25 percent, and the material safety data
sheet (MSDS) provides the ocular lethality results from the submitted
eye irritation studies. 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 including the hazard communication warnings
concerning the eye irritation test results in the MSDS, or any use of
the substance in concentrations greater than 25 percent may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of an
acute eye irritation test (OPPTS Test Guideline 870.2400) on the PMN
substance at concentrations greater than 25 percent would help
characterize human health effects of the PMN substance.
CFR citation: 40 CFR 721.10430.
PMN Numbers P-98-141 and P-98-142
Chemical name: Phosphoric acid esters (generic).
CAS number: Not available.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as metal extractants.
Based on EcoSAR analysis of test data on analogous anionic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 100 ppb of the PMN substance in surface waters. As
described in the PMN, the substance is not released to surface waters.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the PMN substance may present an unreasonable
risk. EPA has determined, however, that any use of the substance
resulting in surface water concentrations exceeding 100 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 test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) on the PMN substances would help
characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10431.
PMN Number P-98-1028
Chemical name: 1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-
trimethyl-.
CAS number: 24748-23-0.
Basis for action: The PMN states that the substance will be used as
a viscosity modifier in the manufacture of polypropylene, manufactured
and supplied as a solution in at least 40 percent mineral spirits.
Based on EcoSAR analysis of test data on analogous peroxides, EPA
predicts toxicity to aquatic organisms may occur if releases of the PMN
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, where the PMN substance is supplied as a solution
of at least 40 percent mineral spirits, significant environmental
releases are not expected. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the PMN substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance other than as a viscosity modifier, manufactured and
supplied as a solution in at least 40 percent mineral spirits, in the
manufacture of polypropylene may cause significant adverse
environmental effects. Based on this information, the PMN substances
meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a
porous pot test (OPPTS Test Guideline 835.3220); 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.
CFR citation: 40 CFR 721.10432.
PMN Number P-99-184
Chemical name: Cyclopentene, 1,2,3,3,4,4,5,5-octafluoro-.
CAS number: 559-40-0.
Basis for action: The PMN states that the substance will be used as
a dry etching agent and a chemical vapor deposition (CVD) agent for the
production of semiconductors. Based on test data on the PMN substance,
EPA identified concerns for acute toxicity, systemic toxicity,
developmental toxicity, cardiac sensitization, and mutagenicity from
inhalation exposures. As described in the PMN, the substance will be
imported and not manufactured in the United States. As described in the
PMN, EPA does not expect significant worker exposures during processing
and use activities for the uses described in the PMN nor does it expect
general population exposures for the uses described in the PMN.
Therefore, EPA has not determined that the proposed processing or use
may present an unreasonable risk. EPA has determined, however, that
domestic manufacture, or any use of the substance other than as a dry
etching agent and a CVD agent for the production of semiconductors may
cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that inhalation monitoring
data, collected according to the EPA draft Inhalation Monitoring Data
Collection Guidelines (located in the docket under docket ID number
EPA-HQ-OPPT-2011-0941), would help characterize the human health
effects of the PMN substance.
CFR citations: 40 CFR 721.10433.
PMN Number P-99-214
Chemical name: Cyclopentane, 1,1,2,2,3,3,4-heptafluoro-.
CAS number: 15290-77-4.
Basis for action: The PMN states that the substance will be used as
a solvent and a cleaning and drying agent. Based on test data on the
PMN substance, EPA identified concerns for acute, systemic,
[[Page 58670]]
and developmental toxicity, cardiac sensitization, and mutagenicity
from inhalation exposures. As described in the PMN, the substance will
be imported and not manufactured in the United States. As described in
the PMN, EPA does not expect significant worker exposures during
processing and use activities for the uses described in the PMN nor
does it expect general population or consumer exposures for the uses
described in the PMN. Therefore, EPA has not determined that the
proposed processing or use may present an unreasonable risk. EPA has
determined, however, that any domestic manufacture of the substance,
use of the substance other than as a solvent or a cleaning and drying
agent, or 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).
Recommended testing: EPA has determined that inhalation monitoring
data, collected according to the EPA draft Inhalation Monitoring Data
Collection Guidelines (located in the docket under docket ID number
EPA-HQ-OPPT-2011-0941), would help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10434.
PMN Number P-99-1179
Chemical name: Phenol, 2-(1-methyl-1-phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)-.
CAS number: 73936-80-8.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an ultraviolet (UV)
stabilizer for automotive coatings. Based on EcoSAR analysis of test
data on analogous phenols, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the substance are
not expected to result in surface water concentrations that exceed 1
ppb. Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 1 ppb may 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 (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10435.
PMN Numbers P-99-1217 and P-99-1218
Chemical name: Amine neutralized phosphated polyesters (generic).
CAS number: Not available.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as pigment
dispersants. Based on EcoSAR analysis of test data on analogous anionic
surfactants, EPA predicts toxicity to aquatic organisms may occur as a
result of releases of the PMN substances in quantities greater than the
combined 50,000 kilograms (kgs) per year production volume stated in
the PMN. At the annual production volume of 50,000 kgs stated in the
consolidated PMN, there were no significant environmental releases.
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 exceeding an annual aggregate
manufacturing and importation volume of 50,000 kgs may cause
significant adverse environmental effects. Based on this information,
the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10436.
PMN Numbers P-99-1280, P-99-1281, and P-99-1282
Chemical name: Sulfonic acid, linear xylene alkylate, mono, sodium
salts (generic).
CAS number: Not available.
Basis for action: The consolidated PMN states that the substances
will be used as enhanced oil recovery surfactants. Based on EcoSAR
analysis of test data on analogous anionic surfactants, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 2
ppb of the substances in surface waters for greater than 20 days per
year. This 20-day criterion is derived from partial life cycle tests
(daphnid chronic and fish early life stage tests) that typically range
from 21 to 28 days in duration. EPA predicts toxicity to aquatic
organisms may occur if releases of the PMN substances to surface water,
from uses other than as described in the PMNs, exceed releases from the
use described in the PMNs. For the use described in the PMNs,
environmental releases did not exceed 2 ppb more than 20 days per year.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the PMN substances may present an unreasonable
risk. EPA has determined, however, that any use of the substances other
than as enhanced oil recovery surfactants may cause significant adverse
environmental effects. Based on this information, the PMN substances
meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10437.
PMN Number P-00-346
Chemical name: Dialkyl hydroxybenzenealkanoic acid ester (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 16, 2001.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a petroleum
additive. Based on test data on the PMN substance and SAR analysis of
structurally similar substances, EPA identified concerns for liver and
thyroid toxicity from dermal exposures. 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 this substance may present
an unreasonable risk of injury to human health, the substance may be
produced in substantial quantities, and there may be significant (or
substantial) human exposure to the substance. To protect against these
risks, the consent order requires:
1. Use of personal protective equipment including impervious gloves
(when there is potential dermal exposure).
2. Establishment and use of a hazard communication program.
3. Submission of certain human health testing prior to exceeding
the confidential production volume limit specified in the consent
order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
[[Page 58671]]
Recommended testing: EPA has determined that the results of a 28-
day dermal toxicity test (The Organisation for Economic Co-operation
and Development (OECD) Test Guideline 410) with emphasis on the thyroid
(per OPPTS Test Guideline 870.3465) would help characterize the human
health effects of the PMN substance. The PMN submitter has agreed not
to exceed the confidential production volume limit specified in the
consent order without performing this test.
CFR citation: 40 CFR 721.10438.
PMN Number P-00-635
Chemical name: 1,3-Dioxolan-2-one, 4-ethenyl.
CAS number: 4427-96-7.
Basis for action: The PMN states that the generic (non-
confidential) uses of the substance will be as a chemical intermediate
and an industrial chemical additive. Based on test data on the PMN
substance and SAR analysis of test data on analogous vinylene
carbonate, EPA predicts acute toxicity, liver toxicity, kidney
toxicity, developmental toxicity, immunotoxicity, and oncogenicity. For
the uses described in the PMN, significant dermal exposures are not
expected due to the use of impervious gloves. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without the use of impervious
gloves where there is a potential for dermal exposures, or any use
other than as described in the PMN may cause serious human health
effects. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that no additional testing
is recommended at this time as the health effects have been adequately
characterized by the testing submitted on the PMN substance.
CFR citation: 40 CFR 721.10439.
PMN Number P-00-1165
Chemical name: Diphosphoric acid, polymers with ethoxylated reduced
Me esters of reduced polymd, oxidized tetrafluoroethylene.
CAS number: 200013-65-6.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a surface active agent.
Based on analogous high molecular weight polymers, EPA identified
concerns from inhalation exposures. For the industrial uses described
in the PMN, worker inhalation exposures are not expected as the
substance is not applied by a method that generates a vapor, mist, or
spray. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use may present an unreasonable risk. EPA
has determined, however, that any use of the substance in consumer
products, or any use involving an application method that generates a
vapor, mist, or spray may cause serious health effects. Based on the
information, the PMN substance meets the criteria at 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of an
acute inhalation toxicity test (OPPTS Test Guideline 870.1300) would
help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10440.
PMN Numbers P-01-382 and P-01-383
Chemical names: (P-01-382) 1, 2-Benzenedicarboxylic acid, di-
C7-14-branched and linear alkyl esters and (P-01-383) 1,2-
Benzenedicarboxylic acid, di-C6-14-branched and linear alkyl
esters.
CAS numbers: (P-01-382) 309934-68-7 and (P-01-383) 309934-69-8.
Basis for action: The consolidated PMN states that the substances
will be used as plasticizers for flexible poly-vinyl chloride. Based on
SAR analysis of the expected ester hydrolysis product of the PMNs, EPA
identified concerns for liver, developmental, and reproductive
toxicity; and oncogenicity. For the use described in the PMNs, neither
significant worker exposures nor general population exposures are
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances in children's toys (e.g., pacifiers, rattles, and teethers)
may cause serious health effects. Based on this information, the PMN
substances meet the criteria at Sec. 721.170(b)(1)(i)(C) and
(b)(3)(ii).
Recommended testing: EPA has determined that the results of an
acute oral toxicity test (OECD Test Guideline 401 or 420); an acute
dermal toxicity test (OECD Test Guideline 402); an acute inhalation
toxicity test (OECD Test Guideline 403); a repeated dose 28-day oral
toxicity test in rodents (OECD Test Guideline 407); a 28-day dermal
toxicity test (OECD Test Guideline 410); a 28-day subacute inhalation
toxicity test (OECD Test Guideline 412); a prenatal developmental
toxicity test (OECD Test Guideline 414); a 1-generation reproduction
test (OECD Test Guideline 415); a reproduction and fertility effects
test (OECD Test Guideline 416); a reproduction/development toxicity
screening test (OECD Test Guideline 421); a combined repeated dose
toxicity test with the reproduction/development toxicity screening test
(OECD Test Guideline 422); a bacterial reverse mutation test (OECD Test
Guideline 471); an in vitro mammalian chromosome aberration test (OECD
Test Guideline 473); a mammalian erythrocyte micronucleus test (OECD
Test Guideline 474); and a mammalian bone marrow chromosomal aberration
test (OECD Test Guideline 475) would help characterize the human health
effects of the PMN substances.
CFR citations: 40 CFR 721.10441 (P-01-382) and 40 CFR 721.10442 (P-
01-383).
PMN Number P-01-470
Chemical name: Ethoxylated alkylphenol sulfate, ammonium salt
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 26, 2002.
Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a dispersant for carbon black and organic
pigments. Based on test data on the PMN substance, and EcoSAR analysis
of test data on analogous ethoxylated anionic surfactants, EPA predicts
environmental toxicity that varies depending on the average number of
moles of ethoxylate. As the number of ethoxylate decreases, the aquatic
toxicity of the substance increases. For this PMN substance, the
average number of moles may vary. Based on submitted test data on the
PMN--with an average number of 16.4 moles of ethoxylate--EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
200 ppb of the PMN substance in surface waters. When the average number
of moles of ethoxylate is less than or equal to 10, EPA expects
toxicity to aquatic organisms may occur at concentrations that exceed
60 ppb of the substance in surface waters. 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 the substance may present
an unreasonable risk of injury to the environment, may be produced in
substantial quantities, and may be reasonably anticipated to enter the
environment in substantial quantities. To protect against these risks,
the consent order prohibits the company from manufacturing or importing
the PMN substance unless either: The mean number of moles of the ethoxy
group is greater than or equal to 10, or the
[[Page 58672]]
average number molecular weight is greater than 950 daltons. The SNUR
designates as a ``significant new use'' the absence of these protective
measures.
Recommended testing: EPA has determined that the results of a fish
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 environmental
effects of the PMN substance. Testing should be conducted on the PMN
substance with less than 10 moles of ethoxylate, or an average number
molecular weight of less than 950 daltons. The consent order does not
require the submission of the aforementioned testing at any specified
time or production volume. However, the order's restrictions on
manufacture, import, processing, distribution in commerce, use, and
disposal of the PMN 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 721.10443.
PMN Number P-01-499 and P-01-500
Chemical name: (P-01-499) Propanol, mercapto- and (P-01-500) 2-
Propen-1-ol, reaction products with hydrogen sulfide, distn. residues.
CAS number: (P-01-499) 63947-56-8 and (P-01-500) 374078-75-8.
Basis for action: The PMNs state that the substances will be used
as chemical intermediates. Based on SAR analysis of test data on
structurally similar 3- mercaptopropanol, EPA identified concerns for
developmental and maternal effects from dermal exposures to the PMN
substances. In addition, based on test data on P-01-499 and EcoSAR
analysis of analogous thiols, EPA predicts toxicity to aquatic
organisms may occur at surface water concentrations that exceed 11 ppb
for P-01-499 and 1 ppb for P-01-500. For the chemical intermediate use
described in the PMNs, significant worker exposures are not expected
due to the use of impervious dermal protection, and the substances are
not released to surface water. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that any use
of the substances without impervious dermal protection where there is a
potential for dermal exposures, or any use of the substances resulting
in surface water concentrations exceeding 11 ppb (P-01-499) or 1 ppb
(P-01-500) may cause serious health effects and significant adverse
environmental effects. Based on this information, the PMN substances
meet the concern criteria at Sec. 721.170(b)(3)(ii), (b)(4)(i), and
(b)(4)(ii).
Recommended testing: EPA has determined that the results of an
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010) on P-01-500 would help to characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10444 (P-01-499) and 40 CFR 721.10445 (P-
01-500).
PMN Number P-01-762
Chemical name: 1,9-Cyclohexadecadiene.
CAS number: 4277-06-9.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as open, non-dispersive use
with limited employee exposure. Based on test data on the PMN
substance, EPA identified concerns for dermal sensitization and
irritation. In addition, based on test data on the PMN substance and
EcoSAR analysis of test data on analogous neutral organic chemicals,
EPA predicts toxicity to aquatic organisms at concentrations that
exceed 1 ppb of the PMN substance in surface waters. As described in
the PMN, significant dermal exposures are not expected due to the use
of impervious gloves, and releases of the substance to surface waters
are not expected in concentrations that exceed 1 ppb. Therefore, EPA
has not determined that manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that use of the substance without impervious protective
equipment where there is a potential for dermal exposures, or any use
of the substance resulting in surface water concentrations exceeding 1
ppb may cause serious health effects and significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria in Sec. 721.170(b)(3)(i), (b)(4)(i), and
(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.
CFR citation: 40 CFR 721.10446.
PMN Number P-01-829
Chemical name: 17-Oxabicyclo[14.1.0]heptadec-8-ene.
CAS number: 34748-97-5.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as open, non-dispersive with
limited employee exposure. Based on test data on the PMN substance, EPA
identified concerns for dermal sensitization, respiratory
sensitization, mutagenicity, developmental toxicity, male reproductive
toxicity, liver toxicity, and kidney toxicity. In addition, based on
test data on the PMN substance and EcoSAR analysis of test data on
analogous epoxides, EPA predicts toxicity to aquatic organisms at
concentrations that exceed 1 ppb of the substance in surface waters. As
described in the PMN, significant exposures are not expected due to the
use of protective dermal and respiratory equipment, and the substance
is not released to surface waters in concentrations that exceed 1 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance without
impervious dermal and adequate respiratory protection where there is a
potential for exposures, or any use of the substance resulting in
surface water concentrations exceeding 1 ppb may cause serious health
effects and significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(i), (b)(4)(i), and (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.
CFR citation: 40 CFR 721.10447.
PMN Number P-02-120
Chemical name: Acetic acid, hydroxymethoxy-, methyl ester, reaction
products with substituted alkylamine (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: September 12,
2003.
[[Page 58673]]
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as an
emulsifier. Based on EcoSAR analysis of test data on analogous
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur
when the average number molecular weight is below 850 daltons. The
order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I)
and 5(e)(1)(A)(ii)(II), based on a finding that this substance may
reasonably be anticipated to enter the environment in substantial
quantities and may present an unreasonable risk of injury to the
environment. The consent order for this substance prohibits
manufacturing or importing of the PMN substance unless the average
number molecular weight is greater than or equal to 850 daltons. The
SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that the results of a fish
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), on the PMN substance where the average
number molecular weight is less than 850 daltons would help
characterize possible environmental effects of the substance. The order
does not require submission of the aforementioned information at any
specified time or production volume. However, the order's restrictions
on manufacture, import, 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 721.10448.
PMN Number P-02-172
Chemical name: Aromatic polyester polyol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive component.
Based on EcoSAR analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
40 ppb of the PMN substance in surface waters. As described in the PMN,
EPA does not expect releases to surface waters to exceed 40 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has, however, determined that any use of the substance resulting in
surface water concentrations exceeding 40 ppb may cause significant
adverse environmental effects. Based on this information, the 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.
CFR citation: 40 CFR 721.10449.
PMN Number P-02-285
Chemical name: Oxirane, 2-[[3-(trimethoxysilyl)propoxy]methyl]-,
reaction products with wollastonite (Ca(SiO3)).
CAS number: 100402-91-3.
Effective date of TSCA section 5(e) consent order: October 14,
2002.
Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as functional filler for polymer systems. Based
on SAR analysis of analogous respirable, poorly soluble particulates,
EPA identified concerns for lung toxicity based on lung overload, and
concern for carcinogenicity based on test data on the starting raw
material--wollastonite. 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
this substance may present an unreasonable risk of injury to human
health. To protect against this exposure and risk, the consent order
requires the company to manufacture and process the PMN substance with
an average aspect ratio of no greater than 5, and no more than 15
percent of the PMN substance shall have an aspect ratio greater than
10. The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA had determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period and a carcinogenicity test (OPPTS Test Guideline
870.4200) would help characterize the human health effects of the PMN
substance. These tests should be conducted on the PMN substance with an
average aspect ratio of greater than 5, and more than 15 percent of the
PMN substance with an aspect ratio of greater than 10. The order does
not require submission of the aforementioned information at any
specified time or production volume. However, the order's restrictions
on manufacture, import, 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 721.10450.
PMN Number P-02-436
Chemical name: Alkyd amide polyol (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
an intermediate for polyurethane polymers. Based on EcoSAR analysis of
test data on analogous nonionic surfactants, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 3 ppb of the
PMN substance in surface waters. As described in the PMN, the substance
is not released to surface waters. 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 3 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 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 721.10451.
PMN Number P-02-659
Chemical name: 9-Octadecenoic acid (9Z)-, 1,1'-(dimethylstannylene)
ester.
CAS number: 3865-34-7.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst. Based on
EcoSAR analysis of test data on analogous nonionic surfactants, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 10 ppb of the substance in surface waters. As described in the
PMN, the substance is not released to surface waters. 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
[[Page 58674]]
10 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 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 721.10452.
PMN Number P-02-796
Chemical name: Polyglycerin alkyl ether (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a lubricant additive.
Based on test data on the PMN substance and EcoSAR analysis of test
data on analogous nonionic surfactants, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 3 ppb of the
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 PMN substance to surface water, from uses other than
as described in the PMN, exceed releases from the use described in the
PMN. For the use described in the PMN, environmental releases did not
exceed 3 ppb 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 described in the
PMN may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10453.
PMN Number P-02-828
Chemical name: Propoxylated ethoxylated alkylamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a concrete admixture.
Based on EcoSAR analysis of analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 80 ppb of the PMN substance in surface waters. As described in
the PMN, the substance is not released to surface waters in
concentrations that exceed 80 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 80 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 ready
biodegradability test (OPPTS Test Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10454.
PMN Number P-03-61
Chemical name: Oxirane, 2,2',2''-[ethylidynetris(4,1-
phenyleneoxymethylene)]tris-.
CAS number: 87093-13-8.
Basis for action: The PMN states that the substance will be used as
a high-density cross-linked polymer in resins, composites, and
adhesives. Based on test data on the PMN substance and SAR analysis of
test data on analogous epoxides, EPA identified concerns for cancer,
reproductive toxicity in males, developmental toxicity, and
sensitization to lungs from worker and consumer inhalation exposures.
As described in the PMN, significant occupational and consumer
inhalation exposures are not expected, as the substance is not spray
applied. 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 involving an application method that generates a mist, vapor,
or aerosol may cause serious health effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10455.
PMN Number P-03-104
Chemical name: Tristyryl phenol alkoxylate salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an agricultural inert.
Based on EcoSAR analysis of test data on analogous cationic and anionic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb of the 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 PMN
substance to surface water, from uses other than as described in the
PMN, exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 2 ppb 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 described in the PMN 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 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 721.10456.
PMN Number P-03-154
Chemical name: 1,2-Benzenedicarboxylic acid, mixed esters with
benzyl alc., cyclohexanol, 2-ethyl-1-hexanol, fumaric acid and
propylene glycol.
CAS number: 464920-01-2.
Basis for action: The PMN states that the substance will be used as
a monomer combined with styrene and unsaturated polyester resins. Based
on
[[Page 58675]]
EcoSAR analysis of test data on analogous acrylates and esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb of the substance in surface waters. As described in the
PMN, the substance is not released to surface waters. Therefore, EPA
has not determined that the proposed manufacturing, processing, or use
of the substance may present an unreasonable risk to the environment.
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 ready
biodegradability test (OPPTS Test Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10457.
PMN Number P-03-238
Chemical name: Acrylate of hydroxyimide (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be in adhesives. Based on test
data on the PMN substance and SAR analysis of test data on analogous
acrylates, EPA identified concerns for developmental toxicity and
sensitization from inhalation exposure to the PMN substance. In
addition, based on EcoSAR analysis of test data on analogous acrylates,
EPA expects toxicity to aquatic organisms may occur at concentrations
that exceed 20 ppb of the PMN substance in surface waters. As described
in the PMN, significant worker exposures are not expected as the
substance is used in the liquid form, and the substance is not released
to surface waters. 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 manufacturing,
processing, or use of the substance in a solid form, or any use
resulting in surface water concentrations exceeding 20 ppb may cause
serious health effects 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 the results of a
prenatal developmental toxicity test (OPPTS Test Guideline 870.3700) in
rats; 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 to
characterize the human health and environmental effects of the
substance.
CFR citation: 40 CFR 721.10458.
PMN Number P-03-282
Chemical name: Amino-substituted carbopolycycle (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material. Based on
test data on the PMN substance and SAR analysis of test data on
analogous alpha-naphthylamine, aniline, aromatic amine, and
naphthalene, EPA identified concerns for mutagenicity, oncogenicity,
sensitization, developmental toxicity, blood effects, neurotoxicity,
liver effects, and cancer to workers exposed to the PMN substance. As
described in the PMN, significant worker exposures are not expected due
to the use of adequate personal protective equipment. Therefore, EPA
has not determined that the proposed manufacturing, processing, or use
of the substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without the use of impervious
gloves where there is potential for dermal exposure, use of the
substance without the use of a National Institute for Occupational
Safety and Health (NIOSH)-certified respirator with an assigned
protection factor (APF) of at least 50 where there is potential
inhalation exposure, domestic manufacture, or use of the substance
other than as described in the PMN may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that inhalation monitoring
data, collected according to the EPA draft Inhalation Monitoring Data
Collection Guidelines (located in the docket under docket ID number
EPA-HQ-OPPT-2011-0941), would help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10459.
PMN Number P-03-307
Chemical name: Azo nickel complex (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a colorant. EPA
identified concerns for oncogenicity, pulmonary sensitization,
immunotoxicity, developmental toxicity, and neurotoxicity for released
nickel. In addition, test data for nickel sulfate hexahydrate has shown
effects on the brain, kidney, liver, testes, thymus, and spleen. For
the use described in the PMN, worker inhalation exposures from the
liquid form of the PMN are not expected. Therefore, EPA has not
determined that manufacturing, processing, and 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 use of the
substance as a powder, 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 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465); a
reproduction and fertility effects test (OPPTS Test Guideline
870.3800); and a carcinogenicity study (OPPTS Test Guideline 870.4200)
would help to characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10460.
PMN Number P-03-325
Chemical name: Oxazolidine, 3,3'-methylenebis[5-methyl-.
CAS number: 66204-44-2.
Basis for action: The PMN states that the substance will be used as
a metalworking fluid. Based on test data on the PMN substance, EPA
identified concerns for systemic toxicity and severe skin and eye
irritation. In addition, based on test data on the PMN substance and
EcoSAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at surface water
concentrations that exceed 40 ppb of the substance in saltwater, and
100 ppb of the substance in freshwater. For the use described in the
PMN, worker exposures are not expected as the substance is used in an
enclosed system, and the substance is not released to surface waters.
Therefore, EPA has not determined that manufacturing, processing, and
use of the substance may present an unreasonable risk. EPA has
determined, however, that use of the
[[Page 58676]]
substance other than as a metalworking fluid, or any use of the
substance resulting in surface water concentrations exceeding the
freshwater and saltwater concentrations of concern may cause serious
health effects and significant adverse environmental effects. Based on
this information the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(i), (b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the no additional
testing is recommended at this time as the human health and
environmental effects have been adequately characterized by the testing
submitted on the PMN substance.
CFR citation: 40 CFR 721.10461.
PMN Number P-03-354
Chemical name: 1-Penten-3-one, 1-(4-chlorophenyl)-4,4-dimethyl-.
CAS number: 1577-03-3.
Basis for action: The PMN states that the substance will be used as
an intermediate. Based on EcoSAR analysis of test data on analogous
vinyl ketones, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 30 ppb of the substance in surface waters.
For the use described in the PMN, EPA does not expect releases of the
substance to surface waters in concentrations that exceed 30 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
However, EPA has determined that any use of the substance other than as
an intermediate, or any use of the substance resulting in surface water
concentrations exceeding 30 ppb may cause significant adverse
environmental effects. Based on this information, the substance meets
the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a
porous pot test (OPPTS Test Guideline 835.3220); a fish early life-
stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10462.
PMN Number P-03-388
Chemical name: Fatty acid amides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a paint and coating
additive. Based on EcoSAR analysis of test data on analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the 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 PMN
substance to surface water, from uses other than as described in the
PMN, exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 1 ppb 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 other than as described in the PMN 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 test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10463.
PMN Number P-03-461
Chemical name: Fatty acid, reaction products with alkanolamine
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a petroleum additive.
Based on EcoSAR analysis of test data on analogous aliphatic amines,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 6 ppb of the 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 PMN 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 6 ppb 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 other than as described in the PMN 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 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 721.10464.
PMN Numbers P-03-561, P-03-563, P-03-564, P-03-565, and P-03-566
Chemical names: (P-03-561) 2-Propenoic acid, 2-methyl-, 3-
hydroxytricyclo[3.3.1.13,7]dec-1-yl ester; (P-03-563) 2-Propenoic acid,
2-methyl-, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester; (P-03-564) 2-
Propenoic acid, 3-hydroxytricyclo [3.3.1.13,7] dec-1-yl ester; (P-03-
565) 2-Propenoic acid, 2-methyltricyclo[3.3.1.13,7]dec-2-yl ester; and
(P-03-566) 2-Propenoic acid, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester.
CAS numbers: (P-03-561) 115372-36-6; (P-03-563) 209982-56-9; (P-03-
564) 216581-76-9; (P-03-565) 249562-06-9; and (P-03-566) 303186-14-3.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as monomers. Based on
test data on the PMN substances and SAR analysis of test data on
analogous acrylates and methacrylates, EPA identified concerns for
systemic toxicity and pulmonary sensitization. In addition, based on
EcoSAR analysis of test data on analogous acrylates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 3
ppb of the PMN substances in surface waters. For the uses described in
the PMN, significant worker exposures are not expected due to the use
of impervious gloves, protective clothing, eye protection, and adequate
warnings in the MSDS; and the substance is not released to surface
waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substance without worker protection where there is a potential for
dermal or inhalation exposure, or any use of the substance resulting in
surface water
[[Page 58677]]
concentrations exceeding 3 ppb may cause serious health effects and
significant adverse environmental effects. Based on this information
the PMN substances meet the concern criteria at Sec. 721.170(b)(3)(i),
(b)(3)(ii), and (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 to
characterize the environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10465 (P-03-561); 40 CFR 721.10466; (P-
03-563); 40 CFR 721.10467 (P-03-564); 40 CFR 721.10468 (P-03-565); and
40 CFR 721.10469 (P-03-566).
PMN Number P-03-567
Chemical name: Phosphonium, tetrabutyl-, 1,1,2,2,3,3,4,4,4-
nonafluoro-1-butanesulfonate (1:1).
CAS number: 220689-12-3.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer additive. Based
on test data on the PMN substance, EPA identified concerns for systemic
toxicity and neurotoxicity from inhalation exposures. In addition, EPA
identified concern for potential degradation products, byproducts,
unreacted material, and low molecular weight species. The PMN substance
is a derivative of perfluorobutanesulfonate (PFBS) and may degrade to
form PFBS. Further, concerns for the substance are based on analogous
perfluorooctanesulfonate (PFOS). For the use described in the PMN,
significant exposures and environmental releases are not expected.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use may present an unreasonable risk. EPA has
determined, however, that any use of the substance other than as
described in the PMN may cause serious health effects 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)(iii).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465); a 2
generation reproduction and fertility effects test (OPPTS Test
Guideline 870.3200); a porous pot test (OPPTS Test Guideline 835.3220);
and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300)
would help characterize the human health and environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10470.
PMN Number P-03-622
Chemical name: 2-Propenoic acid, 1,1'-(3-methyl-1,5-pentanediyl)
ester.
CAS number: 64194-22-5.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a component of a UV
coating agent. Based on SAR analysis of test data on analogous
acrylates, EPA identified concerns for carcinogenicity and
sensitization. In addition, based on EcoSAR analysis of test data on
analogous acrylates, EPA predicts toxicity to aquatic organisms may
occur if releases of the PMN substance to surface waters, from uses
other than as described in the PMN, exceed releases from the use
described in the PMN. As described in the PMN, the substance will be
imported and not manufactured in the United States. For the use
described in the PMN, significant worker exposures are not expected
during processing and use activities for the uses described in the PMN,
and significant environmental releases are not expected. Therefore, EPA
has not determined that the proposed processing or use of the substance
may present an unreasonable risk. EPA has determined, however, that
domestic manufacture or use of the substance other than as described in
the PMN may cause serious health effects and significant adverse
environmental effects. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(1)(i)(C), (b)(3)(ii),
and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
carcinogenicity test (OPPTS Test Guideline 870.4200); 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 to characterize the human health and
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10471.
PMN Number P-03-645
Chemical name: 1,3-Benzenedimethanamine, polymers with
epichlorohydrin-polyethylene glycol reaction products.
CAS number: 652968-34-8.
Basis for action: The PMN states that the substance will be used as
a water retention aid for ornamental plants. Based on analogous
swellable, high molecular weight polymers, EPA identified concerns for
lung toxicity and cancer. As described in the PMN, the substance will
be imported and not manufactured in the United States. For the use
described in the PMN, significant worker exposures are not expected
during processing and use activities for the uses described in the PMN.
Therefore, EPA has not determined that the proposed processing or use
of the substance may present an unreasonable risk. EPA has determined,
however, that any domestic manufacture of the PMN substance 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 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period, and a teabag test for water retention capacity (see
https://www.epa.gov/oppt/newchems/pubs/teabag.pdf) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10472.
PMN Number P-03-865
Chemical name: 1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-
dimethyl-, N-coco acyl derivs., inner salts.
CAS number: 499781-63-4.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a non-corrosive foamer in
the oil and gas industry. Based on test data on the PMN substance, and
EcoSAR analysis of test data on analogous amphoteric and cationic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 85 ppb of the PMN substance in surface
waters. As described in the PMN, EPA does not expect releases of the
substance to surface waters in concentrations that exceed 85 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 85 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(i) and
(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
[[Page 58678]]
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10473.
PMN Number P-04-107
Chemical name: Substituted amino ethane sulfonic acid salt
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be a contained use in digital
and imaging products. Based on EcoSAR analysis of test data on
analogous anionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 4 ppb of the
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 PMN substance to surface water, from uses other than
as described in the PMN, exceed releases from the use described in the
PMN. For the use described in the PMN, environmental releases did not
exceed 4 ppb 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 described in the
PMN 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 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 721.10474.
PMN Number P-04-118
Chemical name: Hexanedioic acid, compd. with N1-(6-aminohexyl)-N1-
methyl-1,6-hexanediamine (1:1).
CAS number: 659733-29-6.
Basis for action: The PMN states that the substance will be used as
an intermediate for polymer manufacture. Based on SAR analysis of test
data on analogous hexamethyl diamine, EPA identified concerns for
immunotoxicity, systemic toxicity, developmental toxicity, and
reproductive toxicity. In addition, based on EcoSAR analysis of test
data on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 20 ppb of the PMN
substance in surface waters. As described in the PMN, EPA does not
expect significant worker exposures or releases of the substance to
surface waters in concentrations that exceed 20 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 other than as intermediate for
polymer manufacture, or any use of the substance resulting in surface
water concentrations exceeding 20 ppb may cause serious health effects
and significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
prenatal developmental toxicity test (OPPTS Test Guideline 870.3700); a
reproduction and fertility effects test (OPPTS Test Guideline
870.3800); an immunotoxicity test (OPPTS Test Guideline 870.7800); a
fish early life-stage toxicity test (OPPTS Test Guideline 850.1400);
and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300)
would help characterize the human health and environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10475.
PMN Number P-04-275
Chemical name: Oxetane, 3-(bromomethyl)-3-methyl-.
CAS number: 78385-26-9.
Basis for action: The PMN substance will be used as a chemical
intermediate. Based on SAR analysis of test data on analogous chemical
substances EPA identified concerns for cancer for the PMN material from
dermal exposures. For the use described in the PMN, significant worker
exposures are unlikely due to the use of impervious clothing.
Therefore, EPA has not determined that manufacturing, processing, and
use of the substance may present an unreasonable risk. EPA has
determined, however, any use of the substance without impervious
clothing where there is a potential for dermal exposures, or any use of
the substance other than as an intermediate for the pharmaceutical,
photographic, and other fine chemical industries may cause serious
health effects. Based on this information the PMN substance meets the
concern criteria at Sec. 721.170(b)(1)(i)(C).
Recommended testing: EPA has determined that an in vivo
micronucleus assay in erythrocytes (OPPTS Test Guideline 870.5395 or
OECD Test Guideline 474), with exposure by the intraperitoneal route,
would help to characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10476.
PMN Number P-04-290
Chemical name: Acrylate ester (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer in radiation
cured inks and coatings. Based on EcoSAR analysis of test data on
analogous acrylates, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 1 ppb of the 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
PMN substance to surface water, from uses other than as described in
the PMN, exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 1 ppb more
than 20 days per year. Therefore, EPA had 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 other than as described in the PMN 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 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 721.10477.
PMN Number P-04-318
Chemical name: Polyether polyol (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
an intermediate for urethane polymers.
[[Page 58679]]
Based on SAR analysis of test data on similar molecular structure
chemicals, EPA identified concerns for developmental kidney and liver
toxicity. In addition, based on EcoSAR analysis of test data on
analogous nonionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 30 ppb of the
substance in surface waters. For the use described in the PMN,
significant worker exposures are not expected and the substance is not
released to surface waters. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance other than as an intermediate for urethane polymers, or any
use of the substance resulting in surface water concentrations
exceeding 30 ppb may cause serious health effects and significant
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an
acute oral toxicity test (OPPTS Test Guideline 870.1100 or OECD Test
Guideline 425); a bacterial reverse mutation test (OPPTS Test Guideline
870.5100); a mammalian erythrocyte micronucleus test (intraperitoneal
route) (OPPTS Test Guideline 870.5395); a repeated dose 28-day oral
toxicity in rodents (OPPTS Test Guideline 870.3050 or OECD Test
Guideline 407), which should include, for all test doses, a
neurotoxicity functional observational battery, as described in
neurotoxicity screening battery test (OPPTS Test Guideline 870.6200); a
prenatal developmental toxicity test (one species, oral route) (OPPTS
Test Guideline 870.3700); a Zahn-Wellens/EMPA test (OPPTS Test
Guideline 835.3200); an aerobic aquatic biodegredation test (OPPTS Test
Guideline 835.3100); a fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the human health, environmental and fate effects for PMN substance.
CFR citation: 40 CFR 721.10478.
PMN Number P-04-335
Chemical name: Quaternary ammonium compounds, tris(hydrogenated
tallow alkyl)methyl, chlorides.
CAS number: 308074-73-9.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a rheology additive.
Based on EcoSAR analysis of test data on analogous dialkyl cationic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the 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 PMN
substance to surface water, from uses other than as described in the
PMN, exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 1 ppb 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 other than as described in the PMN 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 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 721.10479.
PMN Number P-04-384
Chemical name: Trimethylolpropane polyol, aminated (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a resin curing agent.
Based on EcoSAR analysis of test data on analogous aliphatic amines,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 9 ppb of the PMN substance in surface waters. As described
in the PMN, the substance is not released to surface waters. Therefore,
EPA has not determined that the proposed manufacturing and processing
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 results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); 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 721.10480.
PMN Numbers P-04-429, P-04-430, P-04-431, and P-04-432
Chemical names: (P-04-429) Siloxanes and Silicones, Me vinyl,
hydroxy-terminated, reaction products with silica; (P-04-430) Siloxanes
and Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products
with silica; (P-04-431) Siloxanes and Silicones, di-Me, Me vinyl,
hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-
modified silica; and (P-04-432) Siloxanes and Silicones, Me vinyl,
hydroxy-terminated, reaction products with [(ethenyldimethylsilyl)oxy]-
modified silica.
CAS numbers: (P-04-429) 630106-01-3; (P-04-430) 630106-00-2; (P-01-
431) 630106-04-6; and (P-04-432) 630106-02-4.
Basis for action: The consolidated PMN states that the substances
will be used as chemical fillers. Based on high molecular weight
polymers, EPA identified concerns for lung overload. Further, based on
analogy to respirable, poorly soluble particulates, under the
subcategory of crystalline silica, EPA identified concerns for lung
toxicity and cancer. For the use described in the PMN, significant
worker inhalation exposures are not expected as the substance is used
in a liquid form. Therefore, EPA has not determined that the proposed
manufacturing, processing, and use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances in a powder form may cause serious health effects. Based on
this information, the PMN substances meet the concern criteria at Sec.
721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) in rats with special
attention to histopathology (inflammation and cell proliferation) of
the lung tissues and
[[Page 58680]]
to various parameters of the bronchoalveolar lavage fluid (BALF) with a
recovery period of 60 days; and a carcinogenicity test (OPPTS Test
Guideline 870.4200) in rats would help characterize the human health
effects of the PMN substance.
CFR citations: 40 CFR 721.10481 (P-04-429); 40 CFR 721.10482 (P-04-
430); 40 CFR 721.10483 (P-01-431); and 40 CFR 721.10484 (P-04-432).
PMN Number P-04-479
Chemical name: Reaction products of alcohols, alkyl alcohols, amino
alcohols and methanol sodium salts (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a cleaning agent. Based
on EcoSAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 30 ppb of the 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 PMN 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 30 ppb 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 other than as described in the PMN 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 (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10485.
PMN Number P-04-591
Chemical name: Alkyl substituted amino-benzamide (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
an acetaldehyde scavenger for plastic bottle production. Based on
EcoSAR analysis of test data on analogous anilines, EPA predicts
toxicity to aquatic organisms may occur if releases of the PMN
substance to surface waters, 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, significant environmental releases 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 use of the
substance other than as an acetaldehyde scavenger for plastic bottle
production could result in exposures which may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria as Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10486.
PMN Numbers P-04-599, P-04-600, P-04-605, and P-04-606
Chemical name: Alkylbenzenes sulfonic acids, metal salts (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as metalworking detergents.
Based on EcoSAR analysis of test data on analogous anionic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 60 ppb of the substances in surface waters for greater than
20 days per year. This 20-day criterion is derived from partial life
cycle tests (daphnid chronic and fish early life stage tests) that
typically range from 21 to 28 days in duration. EPA predicts toxicity
to aquatic organisms may occur if releases of the PMN substances to
surface water, from uses other than as described in the PMNs, exceed
releases from the use described in the PMNs. For the use described in
the PMNs, environmental releases did not exceed 60 ppb more than 20
days per year. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that use of the
substances other than as described in the PMNs may cause significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria as Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substances.
CFR citation: 40 CFR 721.10487.
PMN Number P-04-636
Chemical name: Cuprate, [[[[[[[(sulfonaphthalenyl)]azo]-
(substitutedphenyl)]azo]-(substitutedsulfonaphthalenyl)]azo]-
substituted phenyl-substituted heteromonocycle], sodium salts
(generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
an ink jet dye. Based on SAR analysis of test data on structurally
similar substances, EPA identified concerns for oncogenicity. As
described in the PMN, inhalation exposures are not expected for the use
specified due to the use of a NIOSH-certified respirator with an APF of
at least 5. 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 uses of the
substance without respiratory protection where there is a potential for
inhalation exposure 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 an
unscheduled deoxyribonucleic acid (DNA) synthesis in mammalian cells in
culture (OPPTS Test Guideline 870.5550), and if warranted by the
results of the first test, a carcinogenicity test (OPPTS Test Guideline
870.4200) would help characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10488.
PMN Number P-04-718
Chemical name: Substituted aryl sulfonium polyfluorophosphate salts
(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 SAR
analysis of test data on structurally
[[Page 58681]]
similar substances, EPA identified concerns for corrosion and ocular
lethality. In addition, based on EcoSAR analysis of test data on
analogous cationic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 6 ppb of the PMN
substance in surface waters. As described in the PMN, significant
worker exposures are not expected as the PMN is used in the form of a
liquid and releases of the substance to surface waters are not
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use may present an unreasonable risk. EPA
has determined, however, that any use of the substance in the form of a
powder or solid, or any use of the substance resulting in surface water
concentrations exceeding 6 ppb may cause serious health effects and
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii)
and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an
acute eye irritation test (OPPTS Test Guideline 870.2400); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the human health and
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10489.
PMN Number P-04-834
Chemical name: HDI biuret, hydroxyethyl methacrylate prepolymer
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: March 20, 2006.
Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as an ingredient in 2-component polyurethane
coatings. Based on test data on analogous diisocyanates, EPA identified
concerns for dermal and respiratory sensitization, pulmonary toxicity,
and carcinogenicity from dermal and inhalation exposures. 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 this substance may
present an unreasonable risk of injury to human health, the substance
may be produced in substantial quantities, and there may be significant
(or substantial) human exposure to the substance. To protect against
this exposure and risk, the consent order requires:
1. Use of personal protective equipment including impervious gloves
(when there is potential dermal exposure) and either a NIOSH-certified
respirator with an APF of at least 25, or compliance with a NCEL of
0.05 mg/m\3\ as an 8-hour time-weighted average (when there is
potential inhalation exposure).
2. Establishment and use of a hazard communication program.
3. Submission of certain human health testing prior to exceeding
two confidential production volume limits specified in the consent
order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of a
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance. The PMN
submitter has agreed not to exceed the first confidential production
volume limit specified in the consent order without performing the
dermal sensitization test, and has agreed not to exceed the second
confidential production volume limit without performing the 90-day
toxicity test. The order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMN 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 721.10490.
PMN Number P-05-55
Chemical name: Benzenepropanal,.alpha.-methyl-.
CAS number: 5445-77-2.
Basis for action: The PMN states that the substance will be used as
a site-limited intermediate. Based on SAR analysis of test data on
structurally similar substances, EPA has identified concerns for
developmental toxicity. For the use described in the PMN, significant
dermal and inhalation exposures are not expected. Therefore, EPA has
not determined that proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that use of the PMN substance other than as a site-limited
intermediate 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
prenatal developmental toxicity test (OPPTS Test Guideline 870.3700),
by the dermal route in mice, would help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.10491.
PMN Number P-05-301
Chemical name: Trisphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a hardener for epoxy
resin. Based on EcoSAR analysis of test data on analogous phenols, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 20 ppb of the PMN substance in surface waters. As described in
the PMN, releases of the PMN substance are not expected to result in
surface water concentrations that exceed 20 ppb. Therefore, EPA has not
determined that manufacturing, processing, and 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 20
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 test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10492.
PMN Number P-05-417
Chemical name: Tris-alkyl-alkoxy melamine polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a crosslinking resin.
Based on test data on the PMN substance, 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 PMN 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
[[Page 58682]]
surface water concentrations exceeding 5 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).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), and an
algal toxicity test (OCSPP Test Guideline 850.4500) on the hydrolysis
products of the PMN substance would help to characterize the
environmental effects of the PMN substance and its hydrolysis products.
CFR citation: 40 CFR 721.10493.
PMN Number P-05-501
Chemical name: Reaction product of trimethylolpropane triacrylate
and alkylene imine (generic).
CAS number: Not available.
Basis for action: The PMN substance will be used as an amine
synergist for coatings and inks. Based on EcoSAR analysis of test data
on analogous aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 5 ppb in surface
waters. As described in the PMN, the substance is not released to
surface waters. 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 5 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 to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10494.
PMN Number P-05-634
Chemical name: Metal silicate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive use
restricted to enclosed toner cartridges. Based on SAR analysis of test
data on analogous respirable, poorly soluble particulates, EPA
identified concerns for lung effects for the PMN substance. Based on
physical properties, EPA identified concerns for potential systemic
effects from dermal exposure to the PMN substance. As described in the
PMN, the substance will be imported and not manufactured in the United
States. For the use described in the PMN, worker dermal and inhalation
exposures are not expected during processing and use activities.
Therefore, EPA has not determined that the proposed processing or use
of the substance may present an unreasonable risk. EPA has determined,
however, that domestic manufacture, or use of the substance other than
as described in the PMN may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) in rats with special
attention to histopathology (inflammation and cell proliferation) of
the lung tissues and to various parameters of the BALF with a recovery
period of 60 days would help characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10495.
PMN Number P-06-9
Chemical name: Amino alkoxy polydimethylsiloxane, hydroxy-
terminated (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a textile additive. Based
on EcoSAR analysis of test data on analogous polycationic polymers, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 10 ppb of the PMN substance in surface waters. As described in
the PMN, the substance is not released to surface waters. 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 10 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 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 721.10496.
PMN Numbers P-06-276, P-06-277, P-06-278, P-06-279, P-06-280, and P-06-
281
Chemical names: (P-06-276 and P-06-279) Substituted alkyl ester,
hydrolysis products with silica and substituted silane (generic); (P-
06-277 and P-06-280) Substituted alkyl ester, hydrolysis products with
silica (generic); and (P-06-278 and P-06-281) Substituted silane,
hydrolysis products with silica (generic).
CAS numbers: Not available.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as components of
clearcoat. Based on SAR analysis of test data on analogous respirable,
poorly soluble particulates, EPA identified potential lung and systemic
effects from inhalation and dermal exposures to the PMN substances. For
the use described in the consolidated PMN, EPA does not expect
significant worker exposures to the substances due to the use of
appropriate impervious gloves and clothing; use of an appropriate
NIOSH-certified respirator with an APF of at least 5; and no
manufacturing, processing, or use in the form of a powder. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substances may present an unreasonable risk. EPA has
determined, however, that any use of the substances without impervious
gloves and clothing where there is a potential for dermal exposures;
any use of the substances without a NIOSH-certified respirator with an
APF of at least 5 where there is a potential for inhalation exposures;
use of the substances other than as described in the PMN; or
manufacturing, processing, or use of the substances in the form of a
powder may cause serious adverse 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 citations: 40 CFR 721.10497 (P-06-276 and P-06-279); 40 CFR
721.10498 (P-06-277 and P-06-280); and 40 CFR 721.10499 (P-06-278 and
P-06-281).
[[Page 58683]]
PMN Number P-06-341
Chemical name: Acrylated mixed metal oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a film coating additive.
Based on SAR analysis of test data on analogous respirable, poorly
soluble particulates, EPA identified concerns for potential lung
effects from inhalation exposures and potential systemic effects from
dermal exposures. For the use described in the PMN, inhalation and
dermal exposures are not expected due to use of the substance as a
liquid and with impervious dermal protection for exposed workers.
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 dermal protection where there is potential for dermal
exposures; any manufacture, processing, or use of the substance in the
form of a powder; or any use of the substance other than as described
in the PMN may cause serious health effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(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 721.10500.
PMN Number P-06-542
Chemical name: Tridecyl phthalate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a plasticizer. Based on
SAR analysis of test data on analogous phthalates, EPA identified
concerns for developmental toxicity. For the use stated in the PMN,
significant worker or consumer exposures are unlikely. Therefore, EPA
has not determined that the proposed manufacturing, processing, and use
of the substance may present an unreasonable risk. EPA has determined,
however, that any other use of the substance other than as described in
the PMN may cause serious adverse human health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of an oral
reproduction and fertility effects test (OPPTS Test Guideline 870.3800)
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10501.
PMN Number P-06-616
Chemical name: Modified triethylene glycol dithiol (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a reactive diluent/binder in aerospace sealants. Based on EcoSAR
analysis of test data on analogous thiols, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 2 ppb of the
substance in surface waters. As described in the PMN, the substance is
not expected to be released to surface waters. 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 2 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 ready
biodegradability test (OPPTS Test Guideline 835.3110); 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.
CFR citation: 40 CFR 721.10502.
PMN Number P-06-622
Chemical name: 1,2-Ethanediol, 1-carbamate.
CAS number: 5395-01-7.
Basis for action: The PMN states that the substance will be used as
an intermediate monomer for polymer synthesis. Based on test data on
the PMN substance, and SAR analysis of test data on analogous urethanes
and carbamates, EPA identified concerns for liver toxicity,
developmental toxicity, and oncogenicity. For the use described in the
PMN, EPA expects no significant dermal exposures due to the use of
impervious gloves. 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 impervious gloves where there is a potential for
dermal exposures may cause serious adverse health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C),(b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a
prenatal developmental toxicity test (OPPTS Test Guideline 870.3700)
and a carcinogenicity test (OPPTS Test Guideline 870.4200) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10503.
PMN Number P-06-682
Chemical name: Surface modified magnesium hydroxide (generic).
CAS number: Not available.
Basis for action: The PMN states the substance will be used as a
compatibilizer for flame retardant for plastics. Based on SAR analysis
of test data on analogous respirable, poorly soluble particulates, EPA
identified concerns for lung toxicity due to lung overload from
inhalation exposure to the PMN substance. At the production volume of
100,000 kgs per year and for the specific use as a compatibilizer for
flame retardant for plastics, significant worker exposures 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 other than as a compatibilizer for flame retardant for
plastics, or any use of the substance in quantities greater than
100,000 kgs per year 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 a 90-day inhalation
toxicity test with a 60-day holding period (OPPTS Test Guideline
870.3465) would help characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10504.
PMN Number P-06-694
Chemical name: Phosphoric acid, mixed mono- and diesters with 2-
ethyl-1-hexanol and polyethylene glycol mono-C12-16-alkyl
ethers.
CAS number: 882693-50-7.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a hydraulic fluid. Based
on test data on the PMN substance and EcoSAR analysis of test data on
analogous anionic surfactants, EPA predicts toxicity to aquatic
organisms may occur as a result of
[[Page 58684]]
releases of the PMN substance to surface waters from manufacture or
import in quantities greater than 75,000 kgs per year, or from uses
other than as stated in the PMN. At the annual production volume of
75,000 kgs per year, and for the use stated in the PMN, no significant
environmental releases are 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 other than as stated in the PMN, or exceeding an
annual manufacturing and importation volume of 75,000 kgs may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i)
and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075) and an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10505.
PMN Numbers P-07-11 and P-08-29
Chemical name: Alkylated phenols (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substance will be as an antioxidant (P-07-11)
and an intermediate (P-08-29). Based on test data on P-07-11 and SAR
analysis of test data on analogous molecular structure chemicals, EPA
identified concerns for liver effects, thyroid effects, and
neurotoxicity. As described in the PMNs, worker dermal exposure to the
PMN substances will be minimal due to impervious gloves. 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
where there is potential for dermal exposure may cause serious adverse
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 a repeated dose 90-day
oral toxicity test in rodents (OPPTS Test Guideline 870.3100) and a
developmental neurotoxicity test (OPPTS Test Guideline 870.6300) would
help characterize the health effects of the PMN substances.
CFR citation: 40 CFR 721.10506.
PMN Number P-07-107
Chemical name: Biphenyl substituted benzopyran (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer additive. Based
on EcoSAR analysis of test data on analogous neutral organic chemicals,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 2 ppb of the PMN substance in surface waters. As described
in the PMN, releases of the PMN substance are not expected to result in
surface water concentrations that exceed 2 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 2 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 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 721.10507.
PMN Number P-07-161
Chemical name: Alkene substituted Bis phenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a hardener for epoxy
resins. EPA identified human health and environmental concerns because
the PMN substance may be a persistent, bio-accumulative, and toxic
(PBT) chemical, based on the physical/chemical properties of the PMN
substance, as described in the New Chemicals Program's PBT category (64
FR 60194, November 4, 1999) (FRL-6097-7). EPA estimates that the
substance will persist in the environment for more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 5,000.
Also, based on SAR analysis of test data on analogous safrole,
methyleugenal and bisphenol A, EPA identified concerns for
carcinogenicity and mutagenicity, systemic effects, and endocrine
disruption. Further, based on EcoSAR analysis of test data on analogous
phenols, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the substance in surface waters. As
described in the PMN, significant worker exposures are not expected due
to the use of impervious dermal protective equipment, and the substance
is not released to surface waters. 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 impervious dermal protection where there
is a potential for dermal exposures, or any purposeful or predictable
release of the substance to surface waters may cause serious health
effects and significant adverse environmental risks. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish
bioconcentration test (OPPTS Test Guideline 850.1730); an oral combined
chronic toxicity/carcinogenicity study (OPPTS Test Guideline 870.4300);
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 850.5400) would help to characterize the human
health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10508.
PMN Number P-07-204
Chemical name: Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-
hexafluoropropoxy)-.
CAS number: 870778-34-0.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a heat transfer fluid.
Based on test data on the PMN substance and SAR analysis of test data
on analogous perfluorinated substances, EPA identified concerns for
neurotoxicity, liver effects, and cardiac sensitization from exposures
to the PMN substance. For the use described in the PMN, EPA does not
expect significant worker exposures due to the use of impervious
gloves. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use without
impervious gloves where there is a potential for dermal
[[Page 58685]]
exposures, or any use of the substance other than as described in the
PMN may cause serious adverse 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 a 28-
day dermal toxicity test (OPPTS Test Guideline 870.3200) in rats; a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465), and a
test using the ``Standard Test Method for Permeation of Liquids and
Gases through Protective Clothing Materials under Conditions of
Continuous Contact'' (ASTM International standard F739) as reported in
the ``Standard Guide for Documenting the Results of Chemical Permeation
Testing of Materials Used in Protective Clothing'' (ASTM International
standard F1194) would help characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.10509.
PMN Number P-07-319
Chemical name: Alkylaminoalcohol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for a
polymer paint additive. Based on EcoSAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. As described in the PMN, the substance is not released
to surface waters. 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 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.
CFR citation: 40 CFR 721.10510.
PMN Numbers P-07-320, P-07-321, P-07-322, P-07-323, and P-07-324
Chemical name: Quaternary ammonium salts (generic).
CAS number: Not available.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as inhibitors for oil
field applications. Based on EcoSAR analysis of test data on analogous
cationic surfactants, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 20 ppb of the 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
PMN 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 20 ppb more
than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that use of
the substances other than as described in the PMN could result in
exposures which 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 substances.
CFR citations: 40 CFR 721.10511.
PMN Numbers P-07-563 and P-07-564
Chemical name: Fatty acid maleic acid amides (generic).
CAS number: Not available.
Basis for action: The consolidated PMN states that the substances
will be used as emulsifiers for oil well drilling fluids. Based on
EcoSAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 10 ppb of the PMN substances in surface waters. As described in
the PMN, the substances are not released to surface waters. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substances may present an unreasonable risk. EPA has
determined, however, that any use of the substances resulting in
surface water concentrations exceeding 10 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); 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 substances.
CFR citation: 40 CFR 721.10512.
PMN Number P-07-599
Chemical name: Aromatic acrylate monomer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be in the production of
polymers. Based on EcoSAR analysis of test data on analogous acrylates,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 1 ppb of the PMN substance in surface waters. As described
in the PMN, the substance is not expected to be released to surface
waters. 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 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.
CFR citation: 40 CFR 721.10513.
[[Page 58686]]
PMN Number P-07-679
Chemical name: [1,1'-Biphenyl]-2,2'-disulfonic acid, 4-[2-(4,5-
dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)diazenyl]-4'-[2-(2-
hydroxy-1-naphthalenyl)diazenyl]-, sodium salt (1:2).
CAS number: 6470-20-8.
Basis for action: The PMN states that substance will be used as a
dye for stationery ink. Based on SAR analysis of test data on analogs
of an azo reduction product (pyrazole and methyl pyrazole), EPA
identified concerns for liver, blood, and developmental toxicity;
neurotoxicity; mutagenicity; and oncogenicity. As described in the PMN,
inhalation exposures to workers and consumers are not expected as the
PMN substance will be imported in rollerball pens and refills for
rollerball pens. Therefore, EPA has not determined that the proposed
processing or use of the substance may present an unreasonable risk.
EPA has determined, however, that domestic manufacture, or any
processing or use of the substance in the form of a solid may cause
serious adverse 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
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395)
via the intraperitoneal route; a repeated dose 28-day oral toxicity
test (OPPTS Test Guideline 870.3050) in rodents; and an acute oral
toxicity test (OPPTS Test Guideline 870.1100) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10514.
PMN Numbers P-10-58, P-10-59, and P-10-60
Chemical name: Partially fluorinated alcohol substituted glycols
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: October 8, 2010.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) uses of the PMN substances will be as an
intermediate (P-10-58 and P-10-59) and a surface active agent (P-10-
60). EPA has concerns for potential incineration or other decomposition
products of the PMN substances. These perfluorinated decomposition
products may be released to the environment from incomplete
incineration of the PMN substances at low temperatures. EPA has
preliminary evidence, including data on some fluorinated polymers, that
suggests that, under some conditions, the PMN substances could degrade
in the environment. EPA has concerns that these degradation products
will persist in the environment, could bioaccumulate or biomagnify, and
could be toxic to people, wild mammals, and birds. These concerns are
based on data on analog chemicals, including perfluorooctanoic acid
(PFOA) and other perfluorinated alkyls, including the presumed
environmental degradant. The order was issued under TSCA sections
5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a
finding that these substances may present an unreasonable risk of
injury to the environment and human health, the substances may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substances and their
potential degradation products. To protect against these exposures and
risks, the consent order requires submission of testing on the PMN
substance P-10-60 at five identified aggregate manufacture and
importation volumes; requires analysis of raw materials; and restricts
the use of P-10-58 and P-10-59 to use as intermediates to manufacture
P-10-60. The SNUR designates as a ``significant new use'' the absence
of these protective measures.
Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property testing identified in the TSCA
section 5(e) consent order would help characterize possible effects of
the substances and their degradation products. The consent order
contains five production volume limits. The PMN submitter has agreed
not to exceed the confidential production volume limits without
performing the specified testing on the PMN substance P-10-60.
Additional testing is included in the preamble to the consent order,
but this testing is not required at any specified time or production
volume. However, the order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMN 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 721.10515.
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 8 of the 107
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.
In the other 99 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, import, 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,
importing, or processing a listed chemical substance for the described
significant new use.
EPA will be able to regulate prospective manufacturers,
importers, 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, importers, 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 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/.
[[Page 58687]]
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 November 20, 2012 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before October 22, 2012.
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 October 22, 2012, 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 Rule to Uses Occurring Before Effective Date of
the Rule
Significant new use designations for a chemical substance are
legally established as of the date of publication of this direct final
rule (September 21, 2012).
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. TSCA section 5(e) consent orders have
been issued for eight chemical substances and the PMN submitters are
prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. 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 other
person may commence such activities without first submitting a PMN. For
chemical substances for which an NOC has not been submitted at this
time, EPA concludes that the uses are not ongoing. However, EPA
recognizes that prior to the effective date of the rule, when chemical
substances identified in this SNUR are added to the TSCA Inventory,
other persons may engage in a significant new use as defined in this
rule before the effective date of the rule. However, 67 of the 108
chemical substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions (per Sec. Sec. 720.25 and 721.11), 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.
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of this direct final rule rather than as of the
effective date of the rule. If uses begun after publication were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could defeat the
SNUR by initiating the significant new use before the rule became
effective, and then argue that the use was ongoing before the effective
date of the rule. Persons who begin commercial manufacture, import, or
processing of the chemical substances regulated through this SNUR will
have to cease any such activity before the effective date of this rule.
To resume their activities, these persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including any extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec. 721.45(h), the person is considered
exempt from the requirements of the SNUR.
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 Sec.
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. describes those tests. Unit IV. also lists
recommended testing for non-5(e) SNURs. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency about
protocol selection and test reporting. To access the harmonized test
guidelines referenced in this document electronically, please go to
https://www.epa.gov/ocspp and select ``Test Methods and Guidelines'' or
for guidelines that are not currently available on the Web site EPA has
placed a copy of that guideline in the public docket. 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. The ASTM International
standards are available at https://www.astm.org/Standard/index.shtml.
In the TSCA section 5(e) consent orders for eight of the chemical
substances regulated under this rule, EPA has established restrictions
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 restrictions will not be
removed until EPA determines that the unrestricted use will not present
an unreasonable risk of injury, or result in significant or substantial
exposure or environmental release. This determination is usually made
based on the results of the required or recommended toxicity tests.
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.
[[Page 58688]]
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, importer, or processor may
request that EPA determine whether a proposed use would be a
significant new use under the rule. The manufacturer, importer, or
processor must show that it has a bona fide intent to manufacture,
import, or process the chemical substance and must identify the
specific use for which it intends to manufacture, import, or process
the chemical substance. If EPA concludes that the person has shown a
bona fide intent to manufacture, import, 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, importers, 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, import, 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 notice requirements and EPA regulatory procedures as
persons submitting a PMN, including submission of test data on health
and environmental effects as described in Sec. 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
Sec. Sec. 721.25 and 720.40. 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, importers, 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-
2011-0941.
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. 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
According to the Paperwork Reduction Act (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. 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
On February 18, 2012, EPA certified pursuant to section 605(b) of
the Regulatory Flexibility Act (RFA) (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 SNUN 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
[[Page 58689]]
economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act
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 sections 202, 203,
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).
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
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
XIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. 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 rule 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: September 13, 2012.
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. 14;9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB
40 CFR citation Control No.
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
* * * * *
721.10427.................................................. 2070-0012
721.10428.................................................. 2070-0012
721.10429.................................................. 2070-0012
721.10430.................................................. 2070-0012
721.10431.................................................. 2070-0012
721.10432.................................................. 2070-0012
721.10433.................................................. 2070-0012
721.10434.................................................. 2070-0012
721.10435.................................................. 2070-0012
721.10436.................................................. 2070-0012
721.10437.................................................. 2070-0012
721.10438.................................................. 2070-0012
721.10439.................................................. 2070-0012
721.10440.................................................. 2070-0012
721.10441.................................................. 2070-0012
721.10442.................................................. 2070-0012
721.10443.................................................. 2070-0012
721.10444.................................................. 2070-0012
721.10445.................................................. 2070-0012
721.10446.................................................. 2070-0012
721.10447.................................................. 2070-0012
721.10448.................................................. 2070-0012
721.10449.................................................. 2070-0012
721.10450.................................................. 2070-0012
721.10451.................................................. 2070-0012
721.10452.................................................. 2070-0012
721.10453.................................................. 2070-0012
721.10454.................................................. 2070-0012
721.10455.................................................. 2070-0012
721.10456.................................................. 2070-0012
721.10457.................................................. 2070-0012
721.10458.................................................. 2070-0012
721.10459.................................................. 2070-0012
721.10460.................................................. 2070-0012
721.10461.................................................. 2070-0012
721.10462.................................................. 2070-0012
721.10463.................................................. 2070-0012
721.10464.................................................. 2070-0012
721.10465.................................................. 2070-0012
721.10466.................................................. 2070-0012
721.10467.................................................. 2070-0012
721.10468.................................................. 2070-0012
721.10469.................................................. 2070-0012
721.10470.................................................. 2070-0012
721.10471.................................................. 2070-0012
721.10472.................................................. 2070-0012
721.10473.................................................. 2070-0012
721.10474.................................................. 2070-0012
721.10475.................................................. 2070-0012
721.10476.................................................. 2070-0012
721.10477.................................................. 2070-0012
[[Page 58690]]
721.10478.................................................. 2070-0012
721.10479.................................................. 2070-0012
721.10480.................................................. 2070-0012
721.10481.................................................. 2070-0012
721.10482.................................................. 2070-0012
721.10483.................................................. 2070-0012
721.10484.................................................. 2070-0012
721.10485.................................................. 2070-0012
721.10486.................................................. 2070-0012
721.10487.................................................. 2070-0012
721.10488.................................................. 2070-0012
721.10489.................................................. 2070-0012
721.10490.................................................. 2070-0012
721.10491.................................................. 2070-0012
721.10492.................................................. 2070-0012
721.10493.................................................. 2070-0012
721.10494.................................................. 2070-0012
721.10495.................................................. 2070-0012
721.10496.................................................. 2070-0012
721.10497.................................................. 2070-0012
721.10498.................................................. 2070-0012
721.10499.................................................. 2070-0012
721.10500.................................................. 2070-0012
721.10501.................................................. 2070-0012
721.10502.................................................. 2070-0012
721.10503.................................................. 2070-0012
721.10504.................................................. 2070-0012
721.10505.................................................. 2070-0012
721.10506.................................................. 2070-0012
721.10507.................................................. 2070-0012
721.10508.................................................. 2070-0012
721.10509.................................................. 2070-0012
721.10510.................................................. 2070-0012
721.10511.................................................. 2070-0012
721.10512.................................................. 2070-0012
721.10513.................................................. 2070-0012
721.10514.................................................. 2070-0012
721.10515.................................................. 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. 721.10427 to subpart E to read as follows:
Sec. 721.10427 Aminoalkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aminoalkanol (PMN P-96-308) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=600).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
5. Add Sec. 721.10428 to subpart E to read as follows:
Sec. 721.10428 Fatty acids, C18-unsatd., dimers, reaction products
with 1-piperazineethanamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fatty acids,
C18-unsatd., dimers, reaction products with 1-
piperazineethanamine (PMN P-96-1021; CAS No. 206565-90-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, 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. 721.10429 to subpart E to read as follows:
Sec. 721.10429 Fatty acids, C18-unsatd., dimers, reaction products
with 1-piperazineethanamine and tall-oil fatty acids.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fatty acids,
C18-unsatd., dimers, reaction products with 1-
piperazineethanamine and tall-oil fatty acids (PMN P-96-1022; CAS No.
206565-89-1) 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) Release to water. Requirements as specified in Sec.
[emsp14]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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.10430 to subpart E to read as follows:
Sec. [emsp14]721.10430 Tetra alkyl ammonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as tetra
alkyl ammonium salt (PMN P-97-823) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72(a) and (c)(2) (the following statement must be included in
the material safety data sheet (MSDS): ``The results of an eye
irritation test in rabbits resulted in deaths at levels of the PMN
substance greater than 25 percent concentration'').
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (use of the substance as described in
the PMN at concentrations less than or equal to 25 percent).
(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) and are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
8. Add Sec. 721.10431 to subpart E to read as follows:
Sec. 721.10431 Phosphoric acid esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
phosphoric acid esters
[[Page 58691]]
(PMNs P-98-141 and P-98-142) 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=100).
(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,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
9. Add Sec. [emsp14]721.10432 to subpart E to read as follows:
Sec. [emsp14]721.10432 1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-
trimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2,4,5,7,8-
hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl-. (PMN P-98-1028; CAS No.
24748-23-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (viscosity modifier in the manufacture
of polypropylene manufactured and supplied as a solution in at least 40
percent mineral spirits).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
10. Add Sec. [emsp14]721.10433 to subpart E to read as follows:
Sec. [emsp14]721.10433 Cyclopentene, 1,2,3,3,4,4,5,5-octafluoro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclopentene,
1,2,3,3,4,4,5,5-octafluoro- (PMN P-99-184; CAS No. 559-40-0) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (j) (dry etching agent and chemical
vapor deposition agent for the production of semiconductors).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
11. Add Sec. [emsp14]721.10434 to subpart E to read as follows:
Sec. [emsp14]721.10434 Cyclopentane, 1,1,2,2,3,3,4-heptafluoro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclopentane,
1,1,2,2,3,3,4-heptafluoro- (PMN P-99-214; CAS No. 15290-77-4) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (j) (solvent and a cleaning and drying
agent), and (o).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
12. Add Sec. [emsp14]721.10435 to subpart E to read as follows:
Sec. [emsp14]721.10435 Phenol, 2-(1-methyl-1-phenylethyl)-4-(1,1,3,3-
tetramethylbutyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 2-(1-
methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)- (PMN P-99-1179; CAS
No. 73936-80-8) 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=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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
13. Add Sec. 721.10436 to subpart E to read as follows:
Sec. 721.10436 Amine neutralized phosphated polyesters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as amine
neutralized phosphated polyesters (PMN P-99-1217 and P-99-1218) are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (50,000 kilograms combined for the
substances identified in PMNs P-99-1217 and P-99-1218).
(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,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
14. Add Sec. 721.10437 to subpart E to read as follows:
Sec. 721.10437 Sulfonic acid, linear xylene alkylate, mono, sodium
salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
sulfonic acid, linear xylene alkylate, mono, sodium salts (PMNs P-99-
1280, P-99-1281, and P-99-1282) 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:
[[Page 58692]]
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (enhanced oil recovery surfactants).
(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,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
15. Add Sec. 721.10438 to subpart E to read as follows:
Sec. 721.10438 Dialkyl hydroxybenzenealkanoic acid ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as dialkyl
hydroxybenzenealkanoic acid ester (PMN P-00-346) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(1)(iv), (g)(2)(i), (g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
16. Add Sec. 721.10439 to subpart E to read as follows:
Sec. 721.10439 1,3-Dioxolan-2-one, 4-ethenyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-dioxolan-2-one,
4-ethenyl (PMN P-00-635; CAS No. 4427-96-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b) (concentration set at 0.1 percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
17. Add Sec. 721.10440 to subpart E to read as follows:
Sec. 721.10440 Diphosphoric acid, polymers with ethoxylated reduced
Me esters of reduced polymd. oxidized tetrafluoroethylene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as diphosphoric acid,
polymers with ethoxylated reduced Me esters of reduced polymd. oxidized
tetrafluoroethylene (PMN P-00-1165; CAS No. 200013-65-6) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
18. Add Sec. 721.10441 to subpart E to read as follows:
Sec. 721.10441 1,2-Benzenedicarboxylic acid, di-C7-14-branched and
linear alkyl esters.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-
benzenedicarboxylic acid, di-C7-14-branched and linear alkyl
esters (PMN P-01-382; CAS No. 309934-68-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) (use as plasticizers for flexible
polyvinyl chloride not to include children's toys (e.g., pacifiers,
rattles, and teethers)).
(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,
importers, 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. 721.10442 to subpart E to read as follows:
Sec. 721.10442 1,2-Benzenedicarboxylic acid, di-C6-14-branched and
linear alkyl esters.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-
benzenedicarboxylic acid, di-C6-14-branched and linear alkyl
esters (PMN P-01-383; CAS No. 309934-69-8) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) (use as plasticizers for flexible
polyvinyl chloride not to include children's toys (e.g., pacifiers,
rattles, and teethers)).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
20. Add Sec. 721.10443 to subpart E to read as follows:
[[Page 58693]]
Sec. 721.10443 Ethoxylated alkylphenol sulfate, ammonium salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated alkylphenol sulfate, ammonium salt (PMN P-01-470) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacture and import of the PMN
substance according to the chemical composition section of the consent
order where the substance must have either a mean number of moles of
ethoxy groups greater than or equal to 10, or the average number
molecular weight is greater than 950 daltons).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, 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. 721.10444 to subpart E to read as follows:
Sec. 721.10444 Propanol, mercapto-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanol, mercapto-
(PMN P-01-499; CAS No. 63947-56-8) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=11).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
22. Add Sec. 721.10445 to subpart E to read as follows:
Sec. 721.10445 2-Propen-1-ol, reaction products with hydrogen
sulfide, distn. residues.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propen-1-ol,
reaction products with hydrogen sulfide, distn. residues (PMN P-01-500;
CAS No. 374078-75-8) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
23. Add Sec. 721.10446 to subpart E to read as follows:
Sec. 721.10446 1, 9-Cyclohexadecadiene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,9-
cyclohexadecadiene (PMN P-01-762; CAS No. 4277-06-9) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
24. Add Sec. 721.10447 to subpart E to read as follows:
Sec. 721.10447 17-Oxabicyclo[14.1.0]heptadec-8-ene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 17-
oxabicyclo[14.1.0]heptadec-8-ene (PMN P-01-829; CAS No. 34748-97-5) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4) (National Institute for Occupational
Safety and Health (NIOSH)-certified air purifying respirator equipped
with a high efficiency particulate filter including disposable
cartridge), (a)(5)(vii), (b) (concentration set at 1.0 percent), and
(c).
(ii) Release to water. Requirement as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
25. Add Sec. 721.10448 to subpart E to read as follows:
Sec. 721.10448 Acetic acid, hydroxy- methoxy-, methyl ester, reaction
products with substituted alkylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acetic
acid, hydroxymethoxy-, methyl ester, reaction products with substituted
alkylamine (PMN P-02-120) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacture and import of the PMN
substance according to the average number molecular weight section of
the consent order where the average molecular weight is greater than or
equal to 850 daltons).
(ii) [Reserved]
[[Page 58694]]
(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,
importers, 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. 721.10449 to subpart E to read as follows:
Sec. 721.10449 Aromatic polyester polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic polyester polyol (PMN P-02-172) 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=40).
(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,
importers, 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. 721.10450 to subpart E to read as follows:
Sec. [emsp14]721.10450 Oxirane, 2-[[3-
(trimethoxysilyl)propoxy]methyl]-, reaction products with wollastonite
(Ca(SiO3)).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-[[3-
(trimethoxysilyl)propoxy]methyl]-, reaction products with wollastonite
(Ca(SiO3)) (PMN P-02-285; CAS No. 100402-91-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacture and process the PMN
substance with an average number aspect ratio no greater than 5, and no
more than 15 percent of the PMN substance shall have an aspect ratio
greater than 10).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
28. Add Sec. 721.10451 to subpart E to read as follows:
Sec. 721.10451 Alkyd amide polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyd
amide polyol (PMN P-02-436) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
29. Add Sec. 721.10452 to subpart E to read as follows:
Sec. 721.10452 9-Octadecenoic acid (9Z)-, 1,1'-(dimethylstannylene)
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 9-octadecenoic acid
(9Z)-, 1,1'-(dimethylstannylene) ester (PMN P-02-659; CAS No. 3865-34-
7) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=10).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
30. Add Sec. 721.10453 to subpart E to read as follows:
Sec. 721.10453 Polyglycerin alkyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyglycerin alkyl ether (PMN P-02-796) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
31. Add Sec. 721.10454 to subpart E to read as follows:
Sec. 721.10454 Propoxylated ethoxylated alkylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propoxylated ethoxylated alkylamine (PMN P-02-828) 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=80).
(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,
importers, and processors of this substance.
[[Page 58695]]
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
32. Add Sec. 721.10455 to subpart E to read as follows:
Sec. 721.10455 Oxirane, 2,2',2''-[ethylidynetris(4,1-
phenyleneoxymethylene)]tris-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2,2',2''-
[ethylidynetris(4,1-phenyleneoxymethylene)]tris- (PMN P-03-61; CAS No.
87093-13-8) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
33. Add Sec. 721.10456 to subpart E to read as follows:
Sec. 721.10456 Tristyryl phenol alkoxylate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
tristyryl phenol alkoxylate salt (PMN P-03-104) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
34. Add Sec. 721.10457 to subpart E to read as follows:
Sec. 721.10457 1,2-Benzenedicarboxylic acid, mixed esters with benzyl
alc., cyclohexanol, 2-ethyl-1-hexanol, fumaric acid and propylene
glycol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-
benzenedicarboxylic acid, mixed esters with benzyl alc., cyclohexanol,
2-ethyl-1-hexanol, fumaric acid and propylene glycol (PMN P-03-154; CAS
No. 464920-01-2) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
35. Add Sec. 721.10458 to subpart E to read as follows:
Sec. 721.10458 Acrylate of hydroxyimide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acrylate of hydroxyimide (PMN P-03-238) 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(v)(2), (w)(2), and (x)(2).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=20).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
36. Add Sec. 721.10459 to subpart E to read as follows:
Sec. 721.10459 Amino-substituted carbopolycycle (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amino-
substituted carbopolycycle (PMN P-03-282) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned
protection factor of at least 50), (a)(6), (b) (concentration set at
0.1 percent), and (c). Best's Viton model 878, Best's Butyl model 878,
Barrier Laminated Film, and PVA Supported Polyvinyl Alcohol have been
demonstrated to satisfy the requirements of Sec. 721.63(a)(3)(i).
Other demonstrated impervious gloves that satisfy Sec. 721.63(a)(3)(i)
are permissible. The following respirators meet the minimum
requirements of Sec. 721.63(a)(4): NIOSH-certified air-purifying,
tight-fitting, half-face respirator equipment with N100 (if oil
aerosols absent), R100, or P100 filters; NIOSH-certified air-purifying,
tight-fitting full-face respirator with N100 (if oil aerosols absent),
R100, or P100 filters; NIOSH-certified powered air-purifying respirator
equipped with a loose-fitting hood or helmet and high efficiency
particulate air (HEPA) filters; NIOSH-certified powered air-purifying
respirator equipped with a tight-fitting facepiece (either half-face or
full-face) and HEPA filters; or NIOSH-certified supplied-air respirator
operated in pressure demand or continuous flow mode and equipped with a
hood or helmet, or tight-fitting facepiece (either half-face or full-
face).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(i), (g)(1)(vii), and (g)(2).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (j).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to
[[Page 58696]]
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
37. Add Sec. 721.10460 to subpart E to read as follows:
Sec. 721.10460 Azo nickel complex (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as azo
nickel complex (PMN P-03-307) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j), (v)(1), (w)(1), and (x)(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 (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
38. Add Sec. 721.10461 to subpart E to read as follows:
Sec. 721.10461 Oxazolidine, 3,3'-methylenebis[5-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxazolidine, 3,3'-
methylenebis[5-methyl- (PMN P-03-325; CAS No. 66204-44-2) 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(j) (metalworking fluid).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=40 (saltwater) and N=100
(freshwater)).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
39. Add Sec. 721.10462 to subpart E to read as follows:
Sec. 721.10462 1-Penten-3-one, 1-(4-chlorophenyl)-4,4-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-penten-3-one, 1-
(4-chlorophenyl)-4,4-dimethyl- (PMN P-03-354; CAS No. 1577-03-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=30).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
40. Add Sec. 721.10463 to subpart E to read as follows:
Sec. 721.10463 Fatty acid amides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid amides (PMN P-03-388) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
41. Add Sec. 721.10464 to subpart E to read as follows:
Sec. 721.10464 Fatty acid, reaction products with alkanolamine
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid, reaction products with alkanolamine (PMN P-03-461) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
42. Add Sec. 721.10465 to subpart E to read as follows:
Sec. 721.10465 2-Propenoic acid, 2-methyl-, 3-
hydroxytricyclo[3.3.1.13,7]dec-1-yl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl ester (PMN P-03-561;
CAS No. 115372-36-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10),
(a)(6)(i), (a)(6)(ii), (a)(6)(v),
[[Page 58697]]
(a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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) through (e) and (k) and are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
43. Add Sec. 721.10466 to subpart E to read as follows:
Sec. 721.10466 2-Propenoic acid, 2-methyl-, 2-
ethyltricyclo[3.3.1.13,7]dec-2-yl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester (PMN P-03-563; CAS
No. 209982-56-9) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10),
(a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at
1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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) through (e) and (k) and are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
44. Add Sec. 721.10467 to subpart E to read as follows:
Sec. [emsp14]721.10467 2-Propenoic acid, 3-
hydroxytricyclo[3.3.1.13,7]dec-1-yl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
3-hydroxytricyclo[3.3.1.13,7]dec-1-yl ester (PMN P-03-564; CAS No.
216581-76-9) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10),
(a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at
1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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) through (e) and (k) and are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
45. Add Sec. 721.10468 to subpart E to read as follows:
Sec. [emsp14]721.10468 2-Propenoic acid, 2-
methyltricyclo[3.3.1.13,7]dec-2-yl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyltricyclo[3.3.1.13,7]dec-2-yl ester (PMN P-03-565; CAS No.
249562-06-9) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10),
(a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at
1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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) through (e) and (k) and are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
46. Add Sec. [emsp14]721.10469 to subpart E to read as follows:
Sec. 721.10469 2-Propenoic acid, 2-ethyltricyclo[3.3.1.13,7]dec-2-yl
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-ethyltricyclo[3.3.1.13,7]dec-2-yl ester (PMN P-03-566; CAS No.
303186-14-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4) (National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 10),
(a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at
1.0 percent), and (c).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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) through (e) and (k) and are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
47. Add Sec. [emsp14]721.10470 to subpart E to read as follows:
Sec. [emsp14]721.10470 Phosphonium, tetrabutyl-, 1,1,2,2,3,3,4,4,4-
nonafluoro-1-butanesulfonate (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonium,
tetrabutyl-, 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfonate (1:1) (PMN
P-03-567; CAS No. 220689-12-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
[[Page 58698]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
48. Add Sec. 721.10471 to subpart E to read as follows:
Sec. 721.10471 2-Propenoic acid, 1,1'-(3-methyl-1,5-pentanediyl)
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
1,1'-(3-methyl-1,5-pentanediyl) ester (PMN P-03-622; CAS No. 64194-22-
5) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
49. Add Sec. 721.10472 to subpart E to read as follows:
Sec. 721.10472 1,3-Benzenedimethanamine, polymers with
epichlorohydrin-polyethylene glycol reaction products.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-
benzenedimethanamine, polymers with epichlorohydrin-polyethylene glycol
reaction products (PMN P-03-645; CAS No. 652968-34-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) [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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
50. Add Sec. 721.10473 to subpart E to read as follows:
Sec. 721.10473 1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-
dimethyl-, N-coco acyl derivs., inner salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanaminium, 3-
amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivs., inner
salts (PMN P-03-865; CAS No. 499781-63-4) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=85).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
51. Add Sec. 721.10474 to subpart E to read as follows:
Sec. 721.10474 Substituted amino ethane sulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted amino ethane sulfonic acid salt (PMN P-04-107) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
52. Add Sec. 721.10475 to subpart E to read as follows:
Sec. 721.10475 Hexanedioic acid, compd. with N1-(6-aminohexyl)-N1-
methyl-1,6-hexanediamine (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as hexanedioic acid,
compd. with N1-(6-aminohexyl)-N1-methyl-1,6-hexanediamine (1:1) (PMN P-
04-118; CAS No. 659733-29-6) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (intermediate for polymer manufacture).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=20).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply this section.
0
53. Add Sec. 721.10476 to subpart E to read as follows:
Sec. 721.10476 Oxetane, 3-(bromomethyl)-3-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxetane, 3-
(bromomethyl)-3-methyl- (PMN P-04-275; CAS No. 78385-26-9) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b) (concentration set at 1.0 percent), and (c).
[[Page 58699]]
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
54. Add Sec. 721.10477 to subpart E to read as follows:
Sec. 721.10477 Acrylate ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acrylate ester (PMN P-04-290) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
55. Add Sec. 721.10478 to subpart E to read as follows:
Sec. 721.10478 Polyether polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyether polyol (PMN P-04-318) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (intermediate for making urethane
polymer).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=30).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
56. Add Sec. 721.10479 to subpart E to read as follows:
Sec. 721.10479 Quaternary ammonium compounds, tris(hydrogenated
tallow alkyl)methyl, chlorides.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as quaternary ammonium
compounds, tris(hydrogenated tallow alkyl)methyl, chlorides (PMN P-04-
335; CAS No. 308074-73-9) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
57. Add Sec. 721.10480 to subpart E to read as follows:
Sec. 721.10480 Trimethylolpropane polyol, aminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trimethylolpropane polyol, aminated (PMN P-04-384) 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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
58. Add Sec. 721.10481 to subpart E to read as follows:
Sec. 721.10481 Siloxanes and Silicones, Me vinyl, hydroxy-terminated,
reaction products with silica.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Siloxanes and
Silicones, Me vinyl, hydroxy-terminated, reaction products with silica
(PMN P-04-429; CAS No. 630106-01-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(v)(1), (w)(1), and (x)(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 (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
59. Add Sec. 721.10482 to subpart E to read as follows:
Sec. 721.10482 Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-
terminated, reaction products with silica.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Siloxanes and
Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with
silica (PMN P-04-430; CAS No. 630106-00-2) 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 (v)(1), (w)(1), and (x)(1).
[[Page 58700]]
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
60. Add Sec. 721.10483 to subpart E to read as follows:
Sec. 721.10483 Siloxanes and Silicones, di-Me, Me vinyl, hydroxy-
terminated, reaction products with [(ethenyldimethylsilyl)oxy]-modified
silica.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Siloxanes and
Silicones, di-Me, Me vinyl, hydroxy-terminated, reaction products with
[(ethenyldimethylsilyl)oxy]-modified silica (PMN P-04-431; CAS No.
630106-04-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(1), (w)(1), and (x)(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 (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
61. Add Sec. 721.10484 to subpart E to read as follows:
Sec. 721.10484 Siloxanes and Silicones, Me vinyl, hydroxy-terminated,
reaction products with [(ethenyldimethylsilyl)oxy]-modified silica.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Siloxanes and
Silicones, Me vinyl, hydroxy-terminated, reaction products with
[(ethenyldimethylsilyl)oxy]-modified silica (PMN P-04-432; CAS No.
630106-02-4) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(1), (w)(1), and (x)(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 (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
62. Add Sec. 721.10485 to subpart E to read as follows:
Sec. 721.10485 Reaction products of alcohols, alkyl alcohols, amino
alcohols and methanol sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction products of alcohols, alkyl alcohols, amino alcohols and
methanol sodium salts (PMN P-04-479) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
63. Add Sec. 721.10486 to subpart E to read as follows:
Sec. 721.10486 Alkyl substituted amino-benzamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
substituted amino-benzamide (PMN P-04-591) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (acetaldehyde scavenger for plastic
bottle production).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
64. Add Sec. 721.10487 to subpart E to read as follows:
Sec. 721.10487 Alkylbenzenes sulfonic acids, metal salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkylbenzenes sulfonic acids, metal salts (PMNs P-04-599, P-04-600, P-
04-605, and P-04-606) are subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
65. Add Sec. 721.10488 to subpart E to read as follows:
Sec. 721.10488 Cuprate, [[[[[[[(sulfonaphthalenyl)]azo]-
(substitutedphenyl)]azo]-(substitutedsulfonaphthalenyl)]azo]-
substituted phenyl-substituted heteromonocycle], sodium salts
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cuprate, [[[[[[[(sulfonaphthalenyl)]azo]-
[[Page 58701]]
(substitutedphenyl)]azo]-(substitutedsulfonaphthalenyl)]azo]-
substituted phenyl-substituted heteromonocycle], sodium salts (PMN P-
04-636) 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)(4) (National Institute for Occupational Safety and
Health (NIOSH)-certified respirator with an assigned protection factor
(APF) of at least 5), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b)
(concentration set at 0.1 percent), and (c).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
66. Add Sec. 721.10489 to subpart E to read as follows:
Sec. 721.10489 Substituted aryl sulfonium polyfluorophosphate salts
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted aryl sulfonium polyfluorophosphate salts (PMN P-04-718) 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 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1),
and (x)(2).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 6).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
67. Add Sec. 721.10490 to subpart E to read as follows:
Sec. 721.10490 HDI biuret, hydroxyethyl methacrylate prepolymer
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as HDI
biuret, hydroxyethyl methacrylate prepolymer (PMN P-04-834) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the PMN substance that have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2), (a)(3), (a)(4), (b) (concentration set at 0.1
percent), and (c). The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of at least 25 meet the minimum requirements
for Sec. 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting
half-face respirator equipped with N100 (if oil aerosols absent), R100,
or P100 filters; NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters; NIOSH-certified powered air-purifying respirator equipped with
a loose-fitting hood or helmet and high efficiency particulate air
(HEPA) filters; NIOSH-certified powered air-purifying respirator
equipped with a tight-fitting facepiece (either half-face or full-face)
and HEPA filters; or NIOSH-certified supplied-air respirator operated
in pressure demand or continuous flow mode and equipped with a hood or
helmet, or tight-fitting facepiece (either half-face or full-face).
(A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is
0.05 mg/m\3\ as an 8-hour time-weighted average. Persons who wish to
pursue NCELs as an alternative to Sec. 721.63 respirator requirements
may request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(vii), (g)(2)(i), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
68. Add Sec. 721.10491 to subpart E to read as follows:
Sec. 721.10491 Benzenepropanal,.alpha.-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
benzenepropanal,.alpha.-methyl- (PMN P-05-55; CAS No. 5445-77-2) 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(h).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
69. Add Sec. 721.10492 to subpart E to read as follows:
Sec. 721.10492 Trisphenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trisphenol (PMN P-05-301) 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 = 20).
[[Page 58702]]
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
70. Add Sec. 721.10493 to subpart E to read as follows:
Sec. 721.10493 Tris-alkyl-alkoxy melamine polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as tris-
alkyl-alkoxy melamine polymer (PMN P-05-417) 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).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
71. Add Sec. 721.10494 to subpart E to read as follows:
Sec. 721.10494 Reaction product of trimethylolpropane triacrylate and
alkylene imine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of trimethylolpropane triacrylate and alkylene imine
(PMN P-05-501) 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).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
72. Add Sec. 721.10495 to subpart E to read as follows:
Sec. 721.10495 Metal silicate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal
silicate (PMN P-05-634) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
73. Add Sec. 721.10496 to subpart E to read as follows:
Sec. [emsp14]721.10496 Amino alkoxy polydimethylsiloxane, hydroxy-
terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amino
alkoxy polydimethylsiloxane, hydroxy-terminated (PMN P-06-9) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 10).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
74. Add Sec. 721.10497 to subpart E to read as follows:
Sec. 721.10497 Substituted alkyl ester, hydrolysis products with
silica and substituted silane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted alkyl ester, hydrolysis products with silica and
substituted silane (PMNs P-06-276 and P-06-279) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (b) (concentration
set 1.0 percent), and (c). The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
assigned protection factor (APF) of at least 5 meet the requirements of
Sec. 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting full-
face respirator equipped with N100 (if oil aerosols absent), R100, or
P100 filters; NIOSH-certified air-purifying respirator equipped with a
loose-fitting hood or helmet and high efficiency particulate air (HEPA)
filters; NIOSH-certified powered air-purifying respirator equipped with
a tightfitting facepiece (full-face) and HEPA filters; or NIOSH-
certified supplied-air respirator operated in pressure demand or
continuous flow mode and equipped with a hood or helmet, or tight-
fitting facepiece (full-face).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (i) are applicable to manufacturers,
importers, 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
[[Page 58703]]
of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
0
75. Add Sec. 721.10498 to subpart E to read as follows:
Sec. 721.10498 Substituted alkyl ester, hydrolysis products with
silica (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted alkyl ester, hydrolysis products with silica (PMNs P-06-277
and P-06-280) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (b) (concentration
set at 1.0 percent), and (c). The following National Institute for
Occupational Safety and Health (NIOSH)-certified respirators with an
assigned protection factor (APF) of at least 5 meet the requirements of
Sec. 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting full-
face respirator equipped with N100 (if oil aerosols absent), R100, or
P100 filters; NIOSH-certified air-purifying respirator equipped with a
loose-fitting hood or helmet and high efficiency particulate air (HEPA)
filters; NIOSH-certified powered air-purifying respirator equipped with
a tightfitting facepiece (full-face) and HEPA filters; or NIOSH-
certified supplied-air respirator operated in pressure demand or
continuous flow mode and equipped with a hood or helmet, or tight-
fitting facepiece (full-face).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (i) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
76. Add Sec. 721.10499 to subpart E to read as follows:
Sec. 721.10499 Substituted silane, hydrolysis products with silica
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted silane, hydrolysis products with silica (PMNs P-06-278 and
P-06-281) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3), (a)(4), (b) (concentration
set at 1.0 percent), and (c). The following National Institute for
Occupational Safety and Health NIOSH-certified respirators with an
assigned protection factor (APF) of at least 5 meet the requirements of
Sec. 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting full-
face respirator equipped with N100 (if oil aerosols absent), R100, or
P100 filters; NIOSH-certified air-purifying respirator equipped with a
loose-fitting hood or helmet and high efficiency particulate air (HEPA)
filters; NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (full-face) and HEPA filters; or NIOSH-
certified supplied-air respirator operated in pressure demand or
continuous flow mode and equipped with a hood or helmet, or tight-
fitting facepiece (full-face).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (i) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
77. Add Sec. 721.10500 to subpart E to read as follows:
Sec. 721.10500 Acrylated mixed metal oxides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acrylated mixed metal oxides (PMN P-06-341) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0
percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
78. Add Sec. 721.10501 to subpart E to read as follows:
Sec. 721.10501 Tridecyl phthalate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
tridecyl phthalate (PMN P-06-542) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
79. Add Sec. 721.10502 to subpart E to read as follows:
Sec. 721.10502 Modified triethylene glycol dithiol (generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 58704]]
(1) The chemical substance identified generically as modified
triethylene glycol dithiol (PMN P-06-616) 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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
80. Add Sec. 721.10503 to subpart E to read as follows:
Sec. 721.10503 1,2-Ethanediol, 1-carbamate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-ethanediol, 1-
carbamate (PMN P-06-622; CAS No. 5395-01-7) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and
(c).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
81. Add Sec. 721.10504 to subpart E to read as follows:
Sec. 721.10504 Surface modified magnesium hydroxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as surface
modified magnesium hydroxide (PMN P-06-682) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j) (compatibilizer for flame retardant
for plastics) and (s) (100,000 kilograms).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
82. Add Sec. 721.10505 to subpart E to read as follows:
Sec. [emsp14]721.10505 Phosphoric acid, mixed mono- and diesters with
2-ethyl-1-hexanol and polyethylene glycol mono-C12-16-alkyl
ethers.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphoric acid,
mixed mono- and diesters with 2-ethyl-1-hexanol and polyethylene glycol
mono-C12-16-alkyl ethers (PMN P-06-694; CAS No. 882693-50-7)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j) and (s) (75,000 kilograms).
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
83. Add Sec. 721.10506 to subpart E to read as follows:
Sec. 721.10506 Alkylated phenols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkylated phenols (PMNs P-07-11 and P-08-29) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0
percent), and (c).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) are applicable to manufacturers, importers, and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
84. Add Sec. 721.10507 to subpart E to read as follows:
Sec. 721.10507 Biphenyl substituted benzopyran (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
biphenyl substituted benzopyran (PMN P-07-107) 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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
85. Add Sec. 721.10508 to subpart E to read as follows:
Sec. 721.10508 Alkene substituted Bis phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkene
substituted bis phenol (PMN P-07-161) 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 58705]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (b) (concentration set at 0.1 percent), and (c).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
86. Add Sec. 721.10509 to subpart E to read as follows:
Sec. 721.10509 Pentane, 1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-
hexafluoropropoxy)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as pentane,
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)- (PMN P-07-
204; CAS No. 870778-34-0) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0
percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
87. Add Sec. 721.10510 to subpart E to read as follows:
Sec. 721.10510 Alkylaminoalcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylaminoalcohol (PMN P-07-319) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
88. Add Sec. 721.10511 to subpart E to read as follows:
Sec. 721.10511 Quaternary ammonium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
quaternary ammonium salts (PMNs P-07-320, P-07-321, P-07-322, P-07-323,
and P-07-324) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
89. Add Sec. [emsp14]721.10512 to subpart E to read as follows:
Sec. [emsp14]721.10512 Fatty acid maleic acid amides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid maleic acid amides (PMNs P-07-563 and P-07-564) 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=10).
(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,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
90. Add Sec. [emsp14]721.10513 to subpart E to read as follows:
Sec. [emsp14]721.10513 Aromatic acrylate monomer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic acrylate monomer (PMN P-07-599) 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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
91. Add Sec. [emsp14]721.10514 to subpart E to read as follows:
Sec. [emsp14]721.10514 [1,1'-Biphenyl]-2,2'-disulfonic acid, 4-[2-
(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)diazenyl]-4'-[2-
(2-hydroxy-1-naphthalenyl)diazenyl]-, sodium salt (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as [1,1'-Biphenyl]-
2,2'-disulfonic acid, 4-[2-(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-
pyrazol-4-yl)diazenyl]-4'-[2-(2-hydroxy-1-naphthalenyl)diazenyl]-,
sodium salt (1:2) (PMN P-07-679; CAS No. 6470-20-8) is subject to
reporting
[[Page 58706]]
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (v)(2), and (x)(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 (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
92. Add Sec. [emsp14]721.10515 to subpart E to read as follows:
Sec. [emsp14]721.10515 Partially fluorinated alcohol substituted
glycols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
partially fluorinated alcohol substituted glycols (PMNs P-10-58, P-10-
59, and P-10-60) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) (manufacture and import of the PMN
substances according to the chemical synthesis and composition section
of the consent order, including analysis, reporting, and limitations of
maximum impurity levels of certain fluorinated impurities; manufacture
and import of P-10-58 and P-10-59 only as described in the
manufacturing section of the consent order), (l) (compliance with the
maximum established percentage of the PMN substances in a non-
industrial product or distributed for use as a non-industrial product),
(o) (use of P-10-60 in a consumer product that could be spray applied),
and (q).
(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,
importers, and processors of these substances, except the recordkeeping
requirements for Sec. 721.125 (b) and (c) do not apply to importers or
processors when any one of the substances are contained in a
formulation at less than 3 weight percent.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
[FR Doc. 2012-23235 Filed 9-20-12; 8:45 am]
BILLING CODE 6560-50-P
