Significant New Use Rules on Certain Chemical Substances, 25236-25282 [2012-9800]
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Federal Register / Vol. 77, No. 82 / Friday, April 27, 2012 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2011–0577; FRL–9343–4]
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 119 chemical substances
which were the subject of
premanufacture notices (PMNs). Four 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 119 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 June 26,
2012. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on May 11, 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 May 29, 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–2011–0577, 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–2011–0577.
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
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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–
2011–0577. 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,
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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
rules and orders under TSCA. Importers
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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 section
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
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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 119 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
119 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 four PMN
substances (P–10–470, P–10–471, P–10–
472, and P–11–217) 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 5(e) SNURs designate as a
‘‘significant new use’’ the absence of the
protective measures required in the
corresponding consent orders.
This rule also includes SNURs on 115
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.
Where EPA determined that the PMN
substance may present an unreasonable
risk of injury to human health via
inhalation exposure, the SNUR usually
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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
respirator requirements may request to
do so under § 721.30.
PMN Numbers P–00–2, P–00–5, and
P–00–6
Chemical names: Polymeric MDI
based polyurethanes (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as internal mold
release. Based on ecological structureactivity relationship (EcoSAR) analysis
of test data on analogous nonionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 part per
billion (ppb) of the PMN substances in
surface waters. As described in the
PMNs, 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
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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
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help characterize the environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.10299.
PMN Number P–00–85
Chemical name: Benzeneacetic acid,
.alpha.-chloro-.alpha.-phenyl-, ethyl
ester.
CAS number: 52460–86–3.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a reaction aid in
polymer synthesis. Based on EcoSAR
analysis of test data on analogous benzyl
halides, 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, 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
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
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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10300.
PMN Number P–00–317
Chemical name: Reaction products of
fatty alcohols,
(aminoethylaminopropyl)
dialkoxymethylsilane, glycidol, and
hydroxy-terminated
polydimethylsiloxane (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a silicone
textile treatment. Based on EcoSAR
analysis of test data on analogous
polycationic polymers, 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, releases of the
substance are not expected to result in
surface water concentrations that 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 determined, however, that
any use of the substance resulting in
surface water concentrations exceeding
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40 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10301.
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PMN Number P–00–442
Chemical name: Zinc ammonium
phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a fertilizer. Based
on EcoSAR analysis of test data on
analogous zinc salts and inorganic
phosphates, 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, 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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10302.
PMN Number P–00–833
Chemical name: Polyether modified
polysiloxane, acrylated (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a non-dispersive
additive. Based on test data on the PMN
substance, and EcoSAR analysis of test
data on analogous acrylates, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
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4 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 4 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in surface water
concentrations exceeding 4 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170 (b)(4)(i) and
(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10303.
PMN Number P–00–1099
Chemical name: Functionalized
polymethine (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an infra red
absorber. Based on EcoSAR analysis of
test data on analogous cationic dyes,
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
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,
tiers I and II (OPPTS Test Guideline
850.5400) would help to characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10304.
PMN Number P–00–1108
Chemical name: Modified
cyclohexane esters (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 plasticizer. Based
on EcoSAR analysis of test data on
analogous epoxides, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As
described in the PMN, 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
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 721.10305.
PMN Number P–01–114
Chemical name: Substituted
phenylepoxide (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a destructive use
(i.e., destroyed during process of
manufacturing) electric devices. Based
on test data on the PMN substance and
EcoSAR analysis of test data on
analogous epoxides, 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, 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 6 ppb may
cause significant adverse environmental
effects. Based on this information the
PMN substance meets the concern
criteria at § 721.170(b)(4)(i) and
(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10306.
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PMN Number P–01–343
Chemical name: Acrylate resin
(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
coating. Based on EcoSAR analysis of
test data on analogous acrylates, 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, 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
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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10307.
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PMN Numbers P–01–384, P–01–385,
P–01–386, P–01–387, and P–01–388
Chemical names: (P–01–384)
Ethoxylated, propoxylated diamine
diaryl substituted phenylmethane ester
with alkenylsuccinate,
dialkylethanolamine salt (generic);
(P–01–385) Ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate (generic); (P–01–386)
Ethoxylated, propoxylated diamine
diaryl substituted phenylmethane ester
with alkenylsuccinate, ammonium salt
(generic); (P–01–387) Ethoxylated,
propoxylated diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, sodium salt (generic);
and (P–01–388) Ethoxylated,
propoxylated diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, ethanolamine salt
(generic).
CAS numbers: Not available.
Basis for action: The consolidated
PMN states that the generic (nonconfidential) use of the substances will
be as colorants for aqueous ink
applications. Based on EcoSAR analysis
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of test data on analogous amphoteric
dyes, EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 70 ppb of the PMN
substances in surface waters. As
described in the PMNs, 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 70 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
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help to
characterize the environmental effects of
the PMN substances.
CFR citations: 40 CFR 721.10308 (P–
01–384); 40 CFR 721.10309 (P–01–385);
40 CFR 721.10310 (P–01–386); 40 CFR
721.10311 (P–01–387); and 40 CFR
721.10312 (P–01–388).
PMN Number P–02–249
Chemical name: Fatty acids, C16–18
and C18-unsatd., Me esters, epoxidized.
CAS number: 158318–67–3.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a raw material for
production of polyols. Based on EcoSAR
analysis of test data on analogous
polyepoxides, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 8 ppb of the
PMN substance in surface waters. As
described in the PMN, 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 8 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
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, tiers I and II (OPPTS Test
Guideline 850.5400) would help to
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characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10313.
PMN Numbers P–02–778, P–02–779,
and P–02–780
Chemical names: Dialkyl
dithiocarbamate esters (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be used as petroleum
additives. EPA identified environmental
concerns because the PMN substances
may be persistent, bio-accumulative,
and toxic (PBT) chemicals, based on
physical/chemical properties of the
PMN substances, as described in the
New Chemicals Program’s PBT category
(64 FR 60194, November 4, 1999) (FRL–
6097–7). EPA estimates that the PMN
substances will persist in the
environment for more than two months
and estimates a bioaccumulation factor
of greater than or equal to 1,000. Also,
based on EcoSAR analysis of test data
on analogous esters, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substances in surface waters.
As described in the PMNs, 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 purposeful or predictable release
containing the PMN substances into the
waters of the United States may cause
significant adverse environmental
effects since the PMN substances have
been characterized by EPA as PBTs.
Based on this information, the PMN
substances meet the concern criteria at
§ 721.170(b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help
characterize the PBT attributes of the
PMN substances.
CFR citation: 40 CFR 721.10314.
PMN Number P–02–833
Chemical name: 1,5-Dioxa-9azaspiro[5.5]undecane, 3,3,8,8,10,10hexamethyl-9-[1-[4-(2oxiranylmethoxy)phenyl]ethoxy]-.
CAS number: 434898–80–3.
Basis for action: The PMN states that
the substance will be used as a
polymerization initiator for
thermoplastics and elastomers. EPA
identified environmental concerns
because the substance may be a PBT
chemical, based on physical/chemical
properties of the PMN substance, as
described in the New Chemicals
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Program’s PBT category. EPA estimates
that the PMN substance will persist in
the environment more than two months
and estimates a bioaccumulation factor
of greater than or equal to 1,000. Also,
based on EcoSAR analysis of test data
on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
1ppb 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 purposeful or predictable release
containing the PMN substance into the
waters of the United States may cause
significant adverse environmental
effects since the PMN substance has
been characterized by EPA as a PBT.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170 (b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help to
characterize the PBT attributes of the
PMN substance.
CFR citation: 40 CFR 721.10315.
PMN Number P–02–872
Chemical name: Dicyclopentadiene
polymer with maleic anhydride and
alkyl alcohols (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an open-dispersive
use in molding operations. 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 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
determination of the partition
coefficient (n-octanol/water) by shake
flask method (OPPTS Test Guideline
830.7550), generator column method
(OPPTS Test Guideline 830.7560), or
estimation by liquid chromatography
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(OPPTS Test Guideline 830.7570); 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10316.
PMN Number P–02–1040
Chemical name: Alkyl phosphate
derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a processing aid.
Based on EcoSAR analysis of test data
on analogous soluble complexes of zinc,
such as zinc-phosphate salts, 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
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10317.
PMN Numbers P–02–1078 and
P–02–1080
Chemical names: Mannich bases
(generic).
CAS numbers: Not available.
Basis for action: The PMNs state that
the substances will be used as curatives
for epoxy resin to improve chemical
resistance. Based on EcoSAR analysis of
test data on analogous polycationic
polymers, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 40 ppb of the
PMN substances in surface waters. As
described in the PMNs, the substances
are not released to surface waters.
Therefore, EPA had not determined that
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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 40 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 porous
pot test (OPPTS Test Guideline
835.3220); a fish acute toxicity test,
freshwater and marine (OPPTS Test
Guideline 850.1075); a fish acute
toxicity 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help to
characterize the environmental effects of
the PMN substances.
CFR citation: 40 CFR 721.10318.
PMN Number P–03–42
Chemical name: Alkylamides,
ethoxylated (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a surfactant. Based
on EcoSAR analysis of test data on
analogous nonionic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
4 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
4 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10319.
PMN Number P–03–186
Chemical name: Fatty acid amide
(generic).
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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 EcoSAR analysis of
test data on analogous nonionic
surfactants and neutral organic
chemicals, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 8 ppb of the
PMN substance in surface waters. As
described in the PMN, 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 8 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10320.
PMN Number P–03–194
Chemical name: Bis[phenyl, 2H-1,3benzoxazine]derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a resin for
electronic laminates, adhesive resins,
encapsulant resins, and composite
resins. EPA has identified
environmental concerns because the
substance may be a PBT chemical, based
on physical/chemical properties of the
PMN substance, as described in the New
Chemicals Program’s PBT category.
Also, based on EcoSAR analysis of test
data on analogous neutral organic
chemicals, 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
purposeful or predictable release
containing the substance into the waters
of the United States may cause
significant adverse environmental
effects since the PMN substance has
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been characterized by EPA as a PBT.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help
characterize the PBT attributes of the
PMN substance. In addition, 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,
tiers I and II (OPPTS Test Guideline
850.5400) would help to characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10321.
PMN Number P–03–196
Chemical name: Metallic diol
(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 for
coatings, inks, adhesives, and
composites. Based on EcoSAR analysis
of test data on analogous zinc
compounds, 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, the substance is
not expected to be released to surface
waters in concentrations that exceed 6
ppb. Therefore, EPA has not determined
that the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in releases to
surface waters exceeding 6 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10322.
PMN Number P–03–248
Chemical name: Glycerol fatty acid
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 plastic film
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additive. Based on EcoSAR analysis of
test data on analogous nonionic
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, the substance is
not released to surface waters.
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 use
of the substance resulting in surface
water concentrations exceeding 6 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 study (OPPTS
Test Guideline 850.1400); a daphnid
chronic toxicity study (OPPTS Test
Guideline 850.1300); and an algal
toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10323.
PMN Number P–03–362
Chemical name: Thionocarbamate
derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a sulfide mineral
processing reagent. Based on test data
on the PMN substance, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 50 ppb of
the PMN substance in surface waters. As
described in the PMN, the substance is
not expected to be released to surface
waters in concentrations that exceed 50
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 50 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 porous
pot test (OPPTS Test Guideline
835.3220) would help to characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10324.
PMN Number P–03–442
Chemical name: Cyclosilazanes, diMe, Me hydrogen, polymers with di-Me,
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Me hydrogen silazanes, reaction
products with 3-(triethoxysilyl)-1propanamine.
CAS number: 475645–84–2.
Basis for action: The PMN states that
the substance will be used as a coating
material. 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
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10325.
PMN Number P–03–458
Chemical name: 2-Propenoic acid,
2-methyl-, methyl ester, polymer with
butyl 2-propenoate, ethyl 2-propenoate,
zinc 2-methyl-2-propenoate (1:2) and
zinc 2-propenoate (1:2), 2,2′-(1,2diazenediyl)bis[2-methylbutanenitrile]and 2,2′-(1,2-diazenediyl)bis[2methylpropanenitrile]-initiated.
CAS number: 460739–39–3.
Basis for action: The PMN states that
the substance will be used as a binder
polymer in paints. Based on EcoSAR
analysis of test data on analogous
soluble complexes of zinc, 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 water. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substance may present an
unreasonable risk. EPA has determined,
however, that any use of the substance
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).
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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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10326.
PMN Numbers P–03–529, P–03–530,
and P–03–531
Chemical names: (P–03–529) Salt of
mixed fatty amidoamines and
polyethylenepolyamines (generic); (P–
03–530) Salt of polyalkylenepolyamine
derivative (generic); and (P–03–531) Salt
of mixed fatty amidoamines (generic).
CAS numbers: Not available.
Basis for action: The consolidated
PMN states that the generic (nonconfidential) use of the substances will
be as processing aids. Based on EcoSAR
analysis of test data on analogous
cationic surfactants, 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 PMNs, 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 porous
pot test (OPPTS Test Guideline
835.3220) would help to characterize
the environmental fate of the PMN
substances.
CFR citations: 40 CFR 721.10327 (P–
03–529); 40 CFR 721.10328 (P–03–530);
and 40 CFR 721.10329 (P–03–531).
PMN Number P–03–722
Chemical name: Pyrazolone
derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a dye for use in
thermal transfer printing systems. EPA
has identified environmental concerns
because the substance may be a PBT
chemical, based on physical/chemical
properties of the PMN substance, as
described in the New Chemicals
Program’s PBT category. Also, based on
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test data on the PMN substance and
EcoSAR analysis of test data on
analogous hydrazines, EPA predicts
toxicity to aquatic organisms at surface
water 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 release to surface waters
may cause significant adverse
environmental effects since the PMN
substance has been characterized by
EPA as a PBT. Based on this
information, the PMN substance meets
the concern criteria at § 721.170 (b)(4)(i),
(b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help
characterize the PBT attributes of the
PMN substance. In addition, 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,
tiers I and II (OPPTS Test Guideline
850.5400) would help to characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10330.
PMN Number P–03–767
Chemical name: Aromatic isocyanate
methacrylate blocked (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a component in
composite formulations. Based on
EcoSAR analysis of test data on
analogous methacrylates and esters,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 1 ppb of the PMN substance
in surface waters. As described in the
PMN, 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
early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic
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toxicity test (OPPTS Test Guideline
850.1300); and an algal toxicity test,
tiers I and II (OPPTS Test Guideline
850.5400) would help to characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10331.
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PMN Number P–03–824
Chemical name: Lithium metal
phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an electrode
material. Based on EcoSAR analysis of
test data on analogous inorganic
phosphates, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 4 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 4 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10332.
PMN Number P–03–840
Chemical name: Substituted
benzamine thio-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 raw material.
Based on EcoSAR analysis of test data
on analogous anilines, 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 PMN substance resulting in surface
water concentrations exceeding 1 ppb
may cause significant adverse
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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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10333.
PMN Number P–03–861
Chemical name: Ethanol, 2,2′-[(3-[(2ethylhexyl)oxy]pentyl]imino]bis-.
CAS number: 284477–82–3.
Basis for action: The PMN states that
the substance will be used as an
intermediate, emulsifier for industrial
textile softening, and an industrial dye
additive. 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, 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 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 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10334.
PMN Number P–03–862
Chemical name: 1-Pentanamine, 3-[(2ethylhexyl)oxy]-.
CAS number: 174615–16–8.
Basis for action: The PMN states that
the substance will be used as a
surfactant intermediate. Based on
EcoSAR analysis of test data on
analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms
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may occur at concentrations that exceed
7 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 7 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in surface water
concentrations exceeding 7 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10335.
PMN Number P–04–1
Chemical name: Poly(oxy-1,2ethanediyl), .alpha.-(1-oxo-2-propen-1yl)-.omega.-([1,1′-biphenyl]-2-yloxy)-.
CAS number: 72009–86–0.
Basis for action: The PMN states that
the substance will be used as an ultra
violet (UV)-curable additive for optical
lens. 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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
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help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10336.
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PMN Number P–04–6
Chemical name: Copper,
iodotris(triphenylphosphine)-, (T-4)-.
CAS number: 15709–82–7.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an additive. EPA
has identified environmental concerns
because the substance may be a PBT
chemical, based on physical/chemical
properties of the PMN substance, as
described in the New Chemicals
Program’s PBT category. EPA estimates
that the PMN substance will persist in
the environment for more than six
months and estimates a
bioaccumulation factor of greater than
or equal to 1,000. In addition, based on
test data on the PMN substance and
EcoSAR analysis of analogous neutral
organics, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 60 ppb of the
PMN substance in surface water. 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
purposeful or predictable release
containing the PMN substance into the
waters of the United States may cause
serious significant adverse
environmental effects since the PMN
substance has been characterized by
EPA as a PBT. Based on this
information, the PMN substance meets
the concern criteria at § 721.170 (b)(4)(i),
(b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help
characterize the PBT attributes of the
PMN substance.
CFR citation: 40 CFR 721.10337.
PMN Number P–04–53
Chemical name: 2-Propenoic acid,
1,1′-(1,9-nonanediyl) ester.
CAS number: 107481–28–7.
Basis for action: The PMN states that
the substance will be used as a UVcurable monomer for optical lens. Based
on EcoSAR analysis of test data on
analogous acrylates, 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, the substance is
not released to surface waters.
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 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 a fish acute
toxicity study (OPPTS Test Guideline
850.1075); a daphnid acute toxicity
study (OPPTS Test Guideline 850.1010);
and an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10338.
PMN Number P–04–113
Chemical name: Adipic acid,
substituted propane, alkyldiol, acrylate
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an open nondispersive acrylate resin. Based on
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 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, tiers I and II (OPPTS
Test Guideline 850.5400) would help to
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10339.
PMN Number P–04–146
Chemical name: Potassium zinc
fluoride (KZnF3).
CAS number: 13827–02–6.
Basis for action: The PMN states that
the substance will be used as a flux for
brazing aluminum. Based on EcoSAR
analysis of test data on analogous zinc
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compounds, 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, 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 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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10340.
PMN Number P–04–338
Chemical name: Amino alkyl
organoborane (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a polymerization
catalyst/initiator for thermosetting
acrylic adhesive. Based on EcoSAR
analysis of test data on analogous
aminoborane, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 7 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 7 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
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CFR citation: 40 CFR 721.10341.
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PMN Number P–04–516
Chemical name: Quaternary
ammonium compounds, fatty alkyl
dialkyl hydroxide (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a fuel additive.
Based on EcoSAR analysis of test data
on analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
4 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
4 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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10342.
PMN Number P–04–563
Chemical name: Alkylated
aryloxyaniline thiourea (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a pesticide
intermediate. EPA identified
environmental concerns because the
PMN substance may be a PBTchemical
based on physical/chemical properties
of the PMN substance as described in
the New Chemicals Program’s PBT
category. EPA estimates that the PMN
substance will persist in the
environment for more than two months
and estimates a bioaccumulation factor
of greater than or equal to 5,000. Also,
based on EcoSAR analysis of test data
on analogous neutral organics and
isocyanates, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 2 ppb of the
substance in surface waters. According
to the scenario described in the PMN,
the substance is not released to surface
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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 purposeful or predictable release
containing the substance into the waters
of the United States may cause
significant environmental effects since
the PMN substance has been
characterized by EPA as a PBT. Based
on this information, the PMN substance
meets the concern criteria at
§ 721.170 (b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help
characterize the PBT attributes of the
PMN substance.
CFR citation: 40 CFR 721.10343.
PMN Number P–04–810
Chemical name: Alkylated aromatic
isothiocyanate (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as an
insecticide intermediate. EPA identified
environmental concerns because the
PMN substance may be a PBT chemical
based on physical/chemical properties
of the PMN substance, as described in
the New Chemicals Program’s PBT
category. EPA estimates that the PMN
substance will persist in the
environment for more than two months
and estimates a bioaccumulation factor
of greater than or equal to 5,000. Also,
based on EcoSAR analysis of test data
on analogous neutral organics and
isocyanates, EPA predicts toxicity to
aquatic organisms at concentrations that
exceed 1,000 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 purposeful or predictable release
containing the substance into the waters
of the United States may cause
significant environmental effects since
the PMN substance has been
characterized by EPA as a PBT. Based
on this information, the PMN substance
meets the concern criteria at § 721.170
(b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help
characterize the PBT attributes of the
PMN substance.
CFR citation: 40 CFR 721.10344.
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PMN Number P–05–110
Chemical name: 1,2Benzenedicarboxylic acid, 1,2bis(methylcyclohexyl) ester.
CAS number: 27987–25–3.
Basis for action: The PMN states that
the substance will be used as a plastic
softener. Based on EcoSAR analysis of
test data on analogous esters, EPA
predicts that 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
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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10345.
PMN Number P–05–599
Chemical name: 3H-Indolium, 2-[2-[2chloro-3-[2-(1,3-dihydro-3,3-dimethyl-1propyl-2H-indol-2-ylidene)ethylidene]1-cyclohexen-1-yl]ethenyl]-3,3dimethyl-1-propyl-, iodide (1:1).
CAS number: 207399–07–3.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an additive for
coating compositions. Based on EcoSAR
analysis of test data on analogous
cationic dyes, 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 will 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).
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Recommended testing: EPA had
determined that the results of a ZahnWellens/EMPA test (OPPTS Test
Guideline 835.3200); 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10346.
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PMN Number P–06–268
Chemical name:
Bicyclo[2.2.1]heptanedimethanamine,
N,N′-bis(1,2-dimethylpropylidene)-.
CAS number: 664980–30–7.
Basis for action: The PMN states that
the substance will be used as a curing
agent for epoxides and urethanes. 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 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
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 721.10347.
PMN Numbers P–06–623 and P–06–624
Chemical names: Aspartic acid, N,N′(iminodi-alkanediyl)bis, tetraalkane
esters (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 industrial coatings.
Based on EcoSAR analysis of test data
on analogous aliphatic amines and
esters, EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 3 ppb of the PMN
substances in surface waters. As
described in the PMN, the substances
are not released to surface waters.
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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 3 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 ready
biodegradation 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substances.
CFR citation: 40 CFR 721.10348.
PMN Number P–06–731
Chemical name: 1,4-Benzenediamine,
N′-(alkyl)-N-[4-[(alkyl)amino]phenyl]-Nphenyl- (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be used as an open, nondispersive resin. Based on EcoSAR
analysis of test data on analogous
cationic dyes, 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, 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 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,
tiers I and II (OPPTS Test Guideline
850.5400) would help to characterize
the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10349.
PMN Number P–06–742
Chemical name: Amines, C11-14branched and linear alkyl.
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CAS number: 863766–30–7.
Basis for action: The PMN states that
the substance will be used as a raw
material. EPA identified environmental
concerns because the PMN substance
may be a PBT chemical based on
physical/chemical properties of the
PMN substance as described in the New
Chemicals Program’s PBT category. EPA
estimates that the PMN substance will
persist in the environment for more than
two months and estimates a
bioaccumulation factor of greater than
or equal to 1,000. Also, 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 purposeful or predictable release
containing the PMN substance into the
waters of the United States may cause
significant adverse environmental
effects since the PMN substance has
been characterized by EPA has a PBT.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170 (b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of the tiered
testing described in the New Chemicals
Program’s PBT category would help
characterize the PBT attributes of the
PMN substance.
CFR citation: 40 CFR 721.10350.
PMN Number P–07–351
Chemical name: Carbomonocycle,
bis[(4-methylphenoxy)methyl](generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a component of a
manufactured consumer article. Based
on EcoSAR analysis of test data on
analogous neutral organic chemicals,
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 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 1 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 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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10351.
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PMN Number P–08–93
Chemical name: Dimethyl
terephthalate, polymer with alkyl diol
and substituted benzoates (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a binder in foundry
applications. Based on EcoSAR analysis
of test data on analogous esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
60 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 60 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 60 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 porous
pot test (Organisation for Economic Cooperation and Development (OECD)
Test Guideline 303A); an aquatic
invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10352.
PMN Number P–08–510
Chemical name: Organosulfide
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a co-stabilizer for
plastics. Based on EcoSAR analysis of
test data on analogous esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
1 ppb in surface waters. As described in
the PMN, releases of the PMN substance
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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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10353.
PMN Number P–08–623
Chemical name: 1,1′-Biphenyl,
3,3′,4,4′-tetramethyl-.
CAS number: 4920–95–0.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a raw material for
production of biphenyl dianhydride.
Based on EcoSAR analysis of test data
on analogous neutral organic chemicals,
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 PMN 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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10354.
PMN Number P–08–722
Chemical name: Poly(oxy-1,2ethanediyl), .alpha.-(1-oxododecyl).omega.-[3-triethoxysilyl)propoxy]-.
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CAS number: 1041420–54–5.
Basis for action: The PMN states that
the substance will be used as a pigment
treatment and surface treatment agent.
Based on EcoSAR analysis of test data
on analogous esters, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As
described in the PMN, the substance
will not 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
hydrolysis test (OPPTS Test Guideline
835.2120); 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10355.
PMN Number P–09–98
Chemical name: Zinc, bis[3-(acetyl.kappa.O)-6-methyl-2H-pyran-2,4(3H)dionato-.kappa.O4]diaqua-.
CAS number: 171884–15–4.
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 zinc compounds and allyl/
vinyl esters, with molecular weight
adjustments, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 4 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 4 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
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aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10356.
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PMN Number P–09–382
Chemical name: Iron, citrate
phosphate potassium complexes.
CAS number: 120579–31–9.
Basis for action: The PMN states that
the substance will be used as a nutrient
for agriculture, and as an intermediate
used to manufacture agricultural soil
amendments. Based on EcoSAR analysis
of test data on analogous inorganic
phosphates, 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 described
use in the PMN, where the substance
will only be transported in drums with
a maximum capacity of 20 gallons, or in
bottom-loading totes, 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
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); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10357.
PMN Number P–09–546
Chemical name: Formaldehyde
reaction products with aryl amine
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an intermediate.
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 water, from uses other than as
described in the PMN, exceed the
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releases expected from the use
described in the PMN. For the
intermediate 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
any use other than as an intermediate
that has been manufactured using the
process described in the premanufacture
notice 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10358.
PMN Number P–09–613
Chemical name: Cardanol-based alkyl
phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a sitelimited polymer modifier for nonconsumer products. Based on EcoSAR
analysis of test data on analogous
anionic surfactants and organic
phosphates, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 18 ppb of the
PMN substance in surface waters. For
the use described in the PMN, general
population exposure is limited 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 resulting in
surface water concentrations exceeding
18 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii). EPA has also
determined, however, in accordance
with TSCA section 5(a)(2)(A) and
5(a)(2)(C) and with § 721.170(a), that
uses other than as described in the PMN
may result in significant human
exposures.
Recommended testing: EPA has
determined that the results of an acute
oral toxicity study (OPPTS Test
Guideline 870.1100) or an acute oral
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toxicity up-and-down procedure (OECD
Test Guideline 425); a bacterial reverse
mutation test (OPPTS Test Guideline
870.5100); a mammalian erythrocyte
micronucleus test via the intraperitoneal
route (OPPTS Test Guideline 870.5395);
a repeated dose 28-day oral toxicity test
in rodents (OPPTS Test Guideline
870.3050 or OECD Test Guideline 407)
with a neurotoxicity functional
observational screening battery (OPPTS
Test Guideline 870.6200) for all test
doses; 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the human health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10359.
PMN Number P–09–628
Chemical name: 1–Substituted
propane, 3-(triethoxysilyl)-, reaction
products with polyethylene glycol
mono-(branched tridecyl) 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 cross-linking,
coupling agent. Based on test data on
the PMN substance, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 4 ppb of
the PMN substance in surface waters. As
described in the PMN, the substance
will not 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 4 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) 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 721.10360.
PMN Number P–10–15
Chemical name:
Anthraquinonedicarboximide, diaminoN-alkyl- (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a fuel additive.
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Based on EcoSAR analysis of test data
on analogous imides and anilines, 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 PMN 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) with sheepshead
minnows; a mysid chronic toxicity test
(OPPTS Test Guideline 850.1350); and
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) with
diatom Skeletonema costatum would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10361.
PMN Number P–10–44
Chemical name: Oils, callitropsis
nootkatensis.
CAS number: 1069136–34–0.
Basis for action: The PMN states that
the substance will be used as a fragrance
ingredient. Based on EcoSAR analysis of
test data on analogous neutral organic
compounds (hydrocarbons), 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 PMN 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
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, tiers I and II
(OPPTS Test Guideline 850.5400) would
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help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10362.
PMN Number P–10–47
Chemical name: Alkenoic acid,
2-methyl-, 2-oxiranylmethyl ester,
reaction products with 4,4′methylenebis (cyclohexanamine)
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance is as a curing
agent for epoxy resin in protective
coatings. Based on EcoSAR analysis of
test data on analogous aliphatic amines,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 44 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 release of
manufacturing or processing streams
containing the PMN substance resulting
in surface water concentrations
exceeding 44 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10363.
PMN Number P–10–53
Chemical name: Halogenated
aromatic amine (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a reactant
for the manufacture of a pesticide.
Based on EcoSAR analysis of test data
on analogous aromatic amines, 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, 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
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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 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10364.
PMN Number P–10–56
Chemical name: Butanoic acid, 3mercapto-2-methyl-, ethyl ester.
CAS number: 888021–82–7.
Basis for action: The PMN states that
the substance will be used as an
ingredient in fragrance compounds.
Based on EcoSAR analysis of test data
on analogous esters and thiols, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
8 ppb of the PMN substance in surface
waters. At the maximum annual
manufacturing and importation
production levels described in the PMN,
releases of the PMN substance are not
expected to result in surface water
concentrations that exceed 8 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in surface water
concentrations exceeding 8 ppb, or
exceedance of the annual maximum
manufacturing and importation limit of
100 kilograms 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 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10365.
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PMN Number P–10–76
Chemical name: Benzene, 4-bromo1,2-dimethyl-.
CAS number: 583–71–1.
Basis for action: The PMN states that
the substance will be used as a raw
material used for production of 1,1biphenyl,3,3′,4,4′-tetramethyl. Based on
EcoSAR analysis of test data on
analogous neutral organic chemicals,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 30 ppb of the PMN
substance in surface waters. As
described in the PMN, releases of the
PMN substance are not expected to
result in surface water concentrations
that exceed 30 ppb. Therefore, EPA has
not determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance resulting in
surface water concentrations exceeding
30 ppb may 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
simulation test to assess the
biodegradability of chemicals
discharged in wastewater (OECD Test
Guideline 314); 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10366.
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PMN Number P–10–83
Chemical name: Hydroxy-aryl,
polymer with substituted benzene,
cyanate (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 component.
Based on EcoSAR analysis of test data
on analogous neutral organic chemicals,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 3 ppb of the PMN substance
in surface waters. As described in the
PMN, releases of the substance are not
expected to result in surface water
concentrations that exceed 3 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
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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 water
solubility test (OECD Test Guideline
105); 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 721.10367.
PMN Number P–10–84
Chemical name: Triphenodioxazine
derivatives (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a dispersion
additive for printing ink. Based on
EcoSAR analysis of test data on
analogous aliphatic amines and
diamines, 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
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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10368.
PMN Number P–10–88
Chemical name: Carbonic acid,
diphenyl ester, polymer with diphenyl
P-methylphosphonate and 4,4′-(1methylethylidene)bis[phenol].
CAS number: 77226–90–5.
Basis for action: The PMN states that
the substance will be used as a flame
retardant and flame retardant additive
where the particle size is greater than 10
microns. Based on analysis of test data
on analogous respirable, poorly soluble
particulates, EPA identified concerns for
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lung overload from inhalation exposures
of the PMN substance. For the uses
described in the PMN, significant
worker and general population exposure
is unlikely, as exposure to respirable
particles is 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 as a flame retardant and flame
retardant additive where the particle
size is greater than 10 microns, may
result in significant human exposures to
the respirable form of the PMN
substance. Based on this information,
the PMN substance meets the concern
criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with a 60-day
holding period would help characterize
the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10369.
PMN Number P–10–99
Chemical name: Phosphonic acid, poctyl-, lanthanum (3+) salt (2:1).
CAS number: 1186211–38–0.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a modifier for
polymers. Based on EcoSAR analysis of
test data on analogous lanthanum salts,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 8 ppb of the PMN substance
in surface waters. As described in the
PMN, releases of the PMN substance are
not expected to result in surface water
concentrations that exceed 8 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance resulting in surface water
concentrations exceeding 8 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a
simulated biodegradability test (OECD
Test Guideline 314); 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10370.
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PMN Number P–10–136
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Chemical names: (P–10–136,
Chemical A) Butanoic acid, 3-mercapto,1,1′-[2,2-bis[(substituted-1oxoalkoxy)methyl]-1,3-propanediyl]
ester (generic) and (P–10–136, Chemical
B) Butanoic acid, 3-mercapto-,1,1′-[2(hydroxymethyl)-2-(substituted-1oxoalkoxy)methyl)-1,3-propanediyl]
ester (generic).
CAS numbers: Not available.
Basis for action: The PMN states that
the substance will be used as a
monomer for acryl-based UV-curing
coatings, inks, and adhesives. Based on
test data on the PMN substance, EPA
identified concerns for systemic
toxicity, mutagenic effects, dermal
sensitization and neurotoxicity from
dermal and inhalation exposures to the
PMN substance. Further, based on test
data on the PMN substance, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
2 ppb of the PMN substance in surface
waters. For the uses described in the
PMN, significant worker exposure is
unlikely, as dermal and inhalation
exposures are low, and the substance is
not released to surface waters.
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, use other than as
described in the PMN, or any use of the
substance resulting in surface water
concentrations exceeding 2 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)(i) and (b)(4)(i).
Recommended testing: EPA has
determined that the results of a
mammalian bone marrow chromosomal
aberration test (OPPTS Test Guideline
870.5385) by the intraperitoneal route; a
reproduction/developmental toxicity
screening test (OECD Test Guideline
421); 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 citations: 40 CFR 721.10371 (P–
10–136, Chemical A) and 40 CFR
721.10372 (P–10–136, Chemical B).
PMN Number P–10–153
Chemical name: 1H–Imidazole, 1-(1methylethyl)-.
CAS number: 4532–96–1.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a chemical
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intermediate. Based on test data on the
PMN substance, and EcoSAR analysis of
test data on analogous imidazoles, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
70 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 other than as
a chemical intermediate, or any use of
the substance resulting in surface water
concentrations exceeding 70 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 ready
biodegradability test—CO2 in sealed
vessels (OPPTS Test Guideline 835.3140
or OECD Test Guideline 310); 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10373.
PMN Number P–10–163
Chemical name: Silane, (3-chloropropoxy)dimethyl(l-methylethyl)-.
CAS number: 1191036–21–1.
Basis for action: The PMN states that
the substance will be used as an isolated
intermediate in the preparation of a
lithium reagent. Based on the expected
alkylating agent potential of the PMN
substance, and analysis of test data on
analogous substances, EPA identified
concerns for oncogenicity, mutagenicity,
developmental toxicity, liver toxicity,
irritation, and possible corrosion to all
tissues to workers exposed to the PMN
substance. Further, 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, worker
inhalation and dermal exposures are not
expected due to the use of organic vapor
respirators, impervious gloves and
goggles, and environmental releases to
surface waters are not expected.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
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determined, however, that any use of
the substance without the use of
impervious gloves, goggles, and organic
vapor respirators, where there is a
potential of dermal or inhalation
exposure; or any use of the substance
resulting in surface water
concentrations exceeding 2 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)(1)(i)(C), (b)(3)(ii),
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a bacterial
reverse mutation test (OPPTS Test
Guideline 870.5100); a mammalian
erythrocyte micronucleus test (OPPTS
Test Guideline 870.5395) via the
intraperitoneal route; an acute dermal
irritation test (OPPTS Test Guideline
870.2500); a skin sensitization test
(OPPTS Test Guideline 870.2600); a
repeated dose 28-day oral toxicity test
(OPPTS Test Guideline 870.3050) in
rodents; a fish acute toxicity test
(OPPTS Test Guideline 850.1075); an
aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the human health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10374.
PMN Number P–10–200
Chemical name: Hydroxypropyl
methacrylate, reaction products with
propylene oxide and ethylene oxide,
copolymer with N-vinyl caprolactam
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an oilfield polymer.
Based on test data on the PMN
substance, and EcoSAR analysis of test
data on analogous nonionic polymers,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 155 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 155 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
155 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)(i)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10375.
PMN Number P–10–222
Chemical name: Alkyltin halide
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an alkylating agent.
Based on test data on a structurally
similar substance, EPA identified
concerns for immunotoxicity, asthma,
and sensitization from exposure to the
PMN substance via the inhalation and
dermal route. Further, based on EcoSAR
analysis of test data on analogous tin
compounds, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 22 ppb of the
PMN substance in surface waters. For
the use described in the PMN, worker
inhalation and dermal exposures are
expected to be minimal and releases of
the PMN substance to surface waters are
not expected to result in surface water
concentrations that exceed 22 ppb.
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 described
in the PMN, or any release of the
substance resulting in surface water
concentrations exceeding 22 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 ready
biodegradability test (OPPTS Test
Guideline 835.3110); a fish acute
toxicity test (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the human health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10376.
PMN Number P–10–247
Chemical names: (P–10–247,
Chemical A) 1,2–
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Cyclohexanedicarboxylic acid, benzyl
C8-10-isoalkyl esters, C9-rich and (P–
10–247, Chemical B) 1,2Cyclohexanedicarboxylic acid, benzyl
nonyl ester, branched and linear.
CAS numbers: (P–10–247, Chemical
A) 1190265–49–6 and (P–10–247,
Chemical B) 1190264–82–4.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an additive for
polymers. Based on test data on the
PMN substance, EPA identified
concerns for skin and eye irritation via
the dermal route. In addition, based on
test data on a structurally similar
compound, EPA identified concerns for
systemic health effects. Further, based
on EcoSAR analysis of test data on
analogous esters, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. As
described in the PMN, worker exposure
to the substance is expected to be
minimal due to the use of impervious
gloves, and releases of the substance are
not expected to result in surface water
concentrations that exceed 1 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance without the use of
impervious gloves where there is a
potential for dermal exposure, or any
use of the substance resulting in surface
water concentrations exceeding 1 ppb,
may 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 ready
biodegradability test (OPPTS Test
Guideline 835.3110); a porous pot test
(OPPTS Test Guideline 835.3220); a
combined chronic toxicity/
carcinogenicity test (OPPTS Test
Guideline 870.4300); 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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
human health and environmental effects
of the PMN substance.
CFR citations: 40 CFR 721.10377 (P–
10–247, Chemical A) and 40 CFR
721.10378 (P–10–247, Chemical B).
PMN Number P–10–266
Chemical name: Propanoic acid, 3(dodecylthio)-, 2-(1,1-dimethylethyl)-4[[5-(1,1-dimethylethyl)-4-hydroxy-2-
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methylphenyl]thio]-5-methylphenyl
ester.
CAS number: 69075–62–3.
Basis for action: The PMN states that
the substance will be used as an
antioxidant for plastic articles. Based on
test data on the PMN substance, EPA
identified health concerns to workers
from exposure to the PMN substance via
inhalation, which include long-term
effects to the liver, heart, blood, and
possible immunotoxicity. As described
in the PMN, and at the production level
stated in the PMN, worker inhalation
exposure will be minimal. 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 if the production volume
increases substantially, the potential for
exposure could change correspondingly,
and may result in serious health effects.
Based on this information, the PMN
substance meets the concern criteria at
§ 721.170(b)(3)(i).
Recommended testing: EPA has
determined that the results of a
reproductive/developmental toxicity
screening test, via the oral route (OPPTS
Test Guideline 870.3550 or OECD Test
Guideline 421) would help characterize
the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10379.
PMN Number P–10–285
Chemical name: Benzoic acid, 3amino-2-mercapto-.
CAS number: 71807–60–8.
Basis for action: The PMN states that
the substance will be used as an
intermediate. Based on EcoSAR analysis
of test data on analogous thiols, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
33 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
33 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
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Guideline 850.1010); and an algal
toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10380.
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PMN Number P–10–290
Chemical name: Cyclic carboxylic
acid, polymer with dihydroxy dialkyl
ether, hydroxy substituted alkane and
carboxylic acid anhydride, methacrylate
terminated polyester (generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance is a base resin
for gel coat compounds. Based on
EcoSAR analysis of test data on
analogous esters, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 8 ppb of the
PMN substance in surface waters. As
described in the PMN, 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 8 ppb may
cause significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10381.
PMN Number P–10–313
Chemical name: Diphosphoric acid,
calcium salt (1:1).
CAS number: 14866–19–4.
Basis for action: The PMN states that
the substance will be used as an
opacifying agent for ceramic whiteware.
Based on test data on analogous
respirable, poorly soluble particulates,
EPA identified concerns for lung effects
if respirable particles are inhaled.
Further, based on EcoSAR analysis of
test data on analogous inorganic
phosphates, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 60 ppb of the
PMN substance in surface waters. For
the use described in the PMN, no
significant inhalation exposures are
expected and the substance is not
released to surface waters. Therefore,
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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 opacifying pigment for
ceramic whiteware, or any use resulting
in releases to surface waters that
produce surface water concentrations
that exceed 60 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 water
solubility test, shake flask method
(OPPTS Test Guideline 830.7840) using
mass spectrometry as the analytical
method; 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the human health and
environmental effect of the PMN
substance. Depending on the results of
the water solubility test, a 90-day
inhalation toxicity test (OPPTS Test
Guideline 870.3465) with a 60-day
holding period may be necessary.
CFR citation: 40 CFR 721.10382.
PMN Number P–10–324
Chemical name: Urea, N, N′-(methyl1,3-phenylene)bis[N′, N′-bis[3polyalkyleneamino]-, compd. with
formaldehyde polymer with phenol
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a curing
agent or accelerator for epoxy resin.
Based on EcoSAR analysis of test data
on analogous polycationic polymers,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 43 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 43 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
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toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10383.
PMN Number P–10–332
Chemical name: Substituted
alkanolamine phenol (generic).
CAS number: Not available.
Basis for action: The PMN states that
the substance will be used as a polyol
for rigid foam. Based on EcoSAR
analysis of test data on analogous
aliphatic amines, phenols, and phenolamines, 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 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 water
solubility test: Column elution method;
shake flask method (OPPTS Test
Guideline 830.7840); either a simulation
test—aerobic sewage treatment:
Activated sludge units (OECD Test
Guideline 303A) or an aerobic aquatic
biodegradation 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10384.
PMN Number P–10–344
Chemical name: Phenoxy 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 plasticizing
component of a two part coating
containing a flexibilizer at a maximum
concentration of 10 percent. Based on
test data on the hydrolysis product of
the PMN substance, EPA identified
concerns for blood effects,
developmental effects, and reproductive
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effects to workers exposed to the PMN
substance. For the use described in the
PMN, significant worker exposure is
unlikely, as the substance is imported,
and significant dermal and inhalation
exposures 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 a plasticizing
component of a two part coating
containing a flexibilizer at a maximum
PMN concentration of 10 percent, may
cause serious health effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(iii).
Recommended testing: Based on the
test data available to EPA on the
hydrolysis product of the PMN
substance, EPA does not recommend
additional testing at this time.
CFR citation: 40 CFR 721.10385.
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PMN Number P–10–361
Chemical name: Substituted phenol
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance will be as an
organic intermediate in substituted bisphenol manufacturing. 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, 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 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10386.
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PMN Number P–10–362
Chemical name: Substituted bisphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance will be as an
organic intermediate in bis-phosphite
synthesis. Based on EcoSAR analysis of
test data on analogous polyphenols,
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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10387.
PMN Number P–10–364
Chemical name: Bisphospite nickel
cyanoalkyl complex (generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance will be as a
soluble metal catalyst for organic
synthesis. Based on EcoSAR analysis of
test data on analogous inorganic nickel
compounds, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 5 ppb of the
PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations that exceed
5 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance resulting in
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
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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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10388.
PMN Number P–10–401
Chemical name: Styrene, copolymer
with acrylic acid, salt with alkoxylated
alkenylamine (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a non-dispersive
additive. Based on EcoSAR analysis of
test data on analogous polycationic
polymers, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 27 ppb of the
PMN substance in surface waters. Based
on the wastewater treatment processes
described in the PMN, releases of the
PMN substance are not expected to
result in surface water concentrations
that exceed 27 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
27 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10389.
PMN Number P–10–403
Chemical name: Acetoacetanilide
reaction product with multifunctional
acrylate (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
composite. Based on EcoSAR analysis of
test data on analogous acrylates, esters,
and amides, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. As
described in the PMN, the substance is
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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
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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10390.
PMN Number P–10–424
Chemical name: Copper gallium
indium selenide.
CAS number: 144972–86–1.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a copper indium
metal selenide deposited on a substrate
as a part of manufacturing copper
indium metal selenide solar panel.
Based on analysis of test data on
analogous respirable, poorly soluble
particulates (subcategory titanium
dioxide), EPA identified concerns for
lung effects and lung tumors to workers
exposed to the PMN substance. As
described in the PMN, worker exposure
will be minimal due to the use of
adequate respiratory protection and
adequate hazard communication
warnings in the Material Safety Data
Sheet (MSDS). Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance without a
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirator with an Assigned Protection
Factor (APF) of at least 10, or the
equivalent NCEL of 1.5 mg/m3 as an 8hour time weighted average, where
there is a potential for inhalation
exposure, may cause serious health
effects. EPA has also determined that
any use of the substance without
adequate hazard communication 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
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Guideline 870.3465) in rats would help
characterize the human health effects of
the PMN substance. Testing should
include a 60-day recovery.
CFR citation: 40 CFR 721.10391.
PMN Number P–10–426
Chemical name: Halo substituted
sulfamidylbenzyluracil (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an intermediate.
Based on test data on structurally
similar chemicals, EPA identified
concerns for developmental toxicity via
the inhalation route. Further, based on
test data for a close structural analog of
the PMN substance and EcoSAR
analysis of test data on analogous
neutral organics, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. As
described in the PMN, worker
inhalation exposures are expected to be
minimal due to manufacturing in an
enclosed system and use as a chemical
intermediate, and releases to surface
waters 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 manufacture of the
substance in a non-enclosed system, use
of the substance other than as a
chemical intermediate, or 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)(ii), (b)(4)(i),
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a prenatal
developmental toxicity test (OPPTS Test
Guideline 870.3700); 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the human health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10392.
PMN Number P–10–433
Chemical name: Sodium bromide
MDA 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 chemical
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intermediate for manufacturing
polyurethane rubber elastomer for tires,
wheels, rolls, screens, belts, and other
specialty urethane articles. Based on
EcoSAR analysis of test data on
analogous anilines, 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 ready
biodegradability test (OPPTS Test
Guideline 835.3110); a dissociation
constant in water test (OECD Test
Guideline 112); 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10393.
PMN Number P–10–436
Chemical name: Copolymer of
anhydride, a diol and a disubstituted
diol (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 additive.
Based on EcoSAR analysis of test data
on analogous acrylates, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 55 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
55 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
55 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
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acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10394.
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PMN Number P–10–458
Chemical name: Fatty acids, C14–18
and C16–18 unsatd., polymers with
adipic acid and triethanolamine, di-Me
sulfate-quaternized.
CAS number: 1211825–32–9.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an adjuvant in the
production of paper. Based on test data
on the PMN substance and EcoSAR
analysis of test data on analogous
polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 5 ppb of
the PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations that exceed
5 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance resulting in
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)
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 721.10395.
PMN Number P–10–470
Chemical name: Dimethyl siloxypolyfluoro methyl siloxypoly(oxyalkylenediyl) methyl siloxy
copolymer (generic).
CAS number: Not available.
Effective date of TSCA section 5(e)
consent order: April 20, 2011.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the PMN
substance will be as an open, nondispersive carpet treatment. EPA has
concerns for potential incineration or
other decomposition products of the
PMN substance. These perfluorinated
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products may be released to the
environment from incomplete
incineration of the PMN substance at
low temperatures. EPA has preliminary
evidence, including data on some
fluorinated polymers that suggests that,
under some conditions, the PMN
substance could degrade in the
environment. EPA has concerns that
these degradation products will persist
in the environment, could
bioaccumulate or biomagnify, and could
be toxic to people, wild mammals, and
birds. These concerns are based on data
on analog chemicals, including
perfluorooctanoic acid (PFOA) and
other perfluorinated alkyls, which
include the presumed environmental
degradant of the PMN substance. There
is pharmacokinetic and toxicological
data in animals on PFOA, as well as
epidemiological and blood monitoring
data in humans. Toxicity studies on
PFOA indicate developmental,
reproductive, and systemic toxicity in
various species, as well as cancer. These
factors, taken together, raise concerns
for potential adverse chronic effects
from the presumed degradation product
in humans and wildlife. 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 present an
unreasonable risk of injury to the
environment and human health, the
substance 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
substance and its potential degradation
products. To protect against these risks,
the consent order requires: No
manufacture of the substance beyond an
annual aggregate manufacture and
importation volume; recording and
reporting of certain fluorinated
impurities in the starting raw material;
and manufacture of the PMN substance
not to exceed the maximum established
impurity levels of certain fluorinated
impurities. The SNUR designates as a
‘‘significant new use’’ the absence of
these protective measures.
Recommended testing: EPA has
determined that the results of certain
fate and physical/chemical property
testing identified in the TSCA 5(e)
consent order would help characterize
possible effects of the substance and its
degradation products. The order does
not require submission of the testing at
any specified time or production
volume. However, the order’s
restrictions on manufacture, import,
processing, distribution in commerce,
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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 721.10396.
PMN Numbers P–10–471 and P–10–472
Chemical names: Alkyl acrylatepolyfluoro methacrylatepoly(oxyalkylenediyl)- methacrylates
(generic).
CAS numbers: Not available.
Effective date of TSCA section 5(e)
consent order: April 20, 2011.
Basis for TSCA section 5(e) consent
order: The consolidated PMN states that
the generic (non-confidential) use of the
PMN substances will be as open, nondispersive additives. EPA has concerns
for potential incineration or other
decomposition products of the PMN
substances. These perfluorinated
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 be PBT
chemicals, based on data on analog
chemicals, including PFOA and other
perfluorinated alkyls, which include the
presumed environmental degradant of
the PMN substances. There is
pharmacokinetic and toxicological data
in animals on PFOA, as well as
epidemiological and blood monitoring
data in humans. Toxicity studies on
PFOA indicate developmental,
reproductive, and systemic toxicity in
various species, as well as cancer. These
factors, taken together, raise concerns
for potential adverse chronic effects
from the presumed degradation product
in humans and wildlife. 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 risks, the consent order requires:
No manufacture of the substances
beyond an annual aggregate
manufacture and importation volume;
recording and reporting of certain
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fluorinated impurities in the starting
raw materials; and manufacture of the
PMN substances not to exceed the
maximum established impurity levels of
certain fluorinated impurities. The
SNUR designates as a ‘‘significant new
use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of certain
fate and physical/chemical property
testing identified in the TSCA 5(e)
consent order would help characterize
possible effects of the substances and
their degradation products. The order
does not require submission of the
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
PMNs 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 721.10397.
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PMN Number P–10–495
Chemical name: Poly(oxy-1,2ethanediyl),.alpha., -monoalkyl ethers.omega.-mono (hydrogen maleate)(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a coating additive.
Based on test data submitted with the
PMN, EPA identified concerns for
dermal sensitization to workers and
consumers exposed to the PMN
substance. For the industrial uses
described in the PMN, significant
worker exposures will be minimal due
to the use of protective equipment.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance other than for industrial
applications may result in consumer
exposures which may cause serious
health effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(3)(i).
Recommended testing: EPA has
determined that the results of a dermal
sensitization test (OPPTS Test Guideline
870.2600) at varying concentrations or
different formulations would help
characterize human health effects of the
PMN substance.
CFR citation: 40 CFR 721.10398.
PMN Number P–10–501
Chemical name: Benzoic acid azosubstituted pyridine (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 site-limited
intermediate. Based on EcoSAR analysis
of test data on analogous vinyl/allyl
nitriles, 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
PMN 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,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10399.
PMN Numbers P–10–517 and P–10–518
Chemical names: (P–10–517) Oxirane,
2-ethyl-, polymer with oxirane, monoC12-14-sec-alkyl ethers and (P–10–518)
Oxirane, 2-ethyl-, polymer with oxirane,
mono-C11-15-sec-alkyl ethers.
CAS numbers: (P–10–517) 1013910–
41–2 and (P–10–518) 1022990–65–3.
Basis for action: The consolidated
PMN states that the substances will be
used as surfactants for architectural
coatings and industrial metal cleaning
solutions. Based on test data on the
PMN substances, and EcoSAR analysis
of test data on analogous nonionic
surfactants, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 14 ppb of the
PMN substance P–10–517, and 20 ppb
of the PMN substance P–10–518, in
surface waters. As described in the
consolidated PMN notice, releases to
surface waters are not expected to
exceed 14 ppb or 20 ppb, respectively,
due to pretreatment of wastes prior to
release. 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
14 ppb of P–10–517, or 20 ppb of P–10–
518, may cause significant adverse
environmental effects. Based on this
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information, the PMN substances meet
the concern criteria at § 721.170(b)(4)(i)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of an
activated sludge simulation study
(OECD Test Guideline 303A); 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 citations: 40 CFR 721.10400
(P–10–517) and 40 CFR 721.10401
(P–10–518).
PMN Number: P–10–548
Chemical name: Vegetable oil,
modified products (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 EcoSAR analysis
of test data on analogous neutral organic
compounds, 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
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citations: 40 CFR 721.10402.
PMN Number P–10–550
Chemical name: Vegetable oil,
modified products, esters (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 EcoSAR analysis
of test data on analogous esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
8 ppb of the PMN substance in surface
waters. As described in the PMN,
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releases of the substance are not
expected to result in surface water
concentrations that exceed 8 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
any of the substance resulting in surface
water concentrations exceeding 8 ppb
may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citations: 40 CFR 721.10403.
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PMN Numbers P–10–551 and P–10–552
Chemical names: Olefins (generic)
(P–10–551 and P–10–552).
CAS numbers: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as chemical
intermediates. Based on EcoSAR
analysis of test data on analogous
neutral organics, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 6 ppb of the
PMN substances in surface waters. As
described in the PMNs, releases of the
substances are not expected to result in
surface water concentrations that exceed
6 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
any use of any of the substances
resulting in surface water
concentrations exceeding 6 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); an aquatic invertebrate acute
toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and
an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substances.
CFR citations: 40 CFR 721.10404.
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PMN Number P–10–553
Chemical name: Olefins (generic)
(P–10–553).
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 EcoSAR analysis of
test data on analogous neutral organic
compounds, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. For
the specific use and production limit
described in the PMN, releases of the
PMN 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
use of the substance other than as
described in the PMN, any use of the
substance resulting in surface water
concentrations exceeding 1 ppb, or use
beyond the annual aggregate production
limit may 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 a fish earlylife stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300); and an algal toxicity test,
tiers I and II (OPPTS Test Guideline
850.5400) would help characterize the
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10405.
PMN Number P–10–554
Chemical name: Fatty acid methyl
esters (generic) (P–10–554).
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 EcoSAR analysis
of test data on analogous esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
8 ppb of the PMN substance in surface
waters. As described in the PMN,
releases of the substance are not
expected to result in surface water
concentrations that exceed 8 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
any of the substance resulting in surface
water concentrations exceeding 8 ppb
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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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citations: 40 CFR 721.10406.
PMN Number: P–10–555
Chemical name: Fatty acid methyl
esters (generic) (P–10–555).
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 EcoSAR analysis
of test data on analogous esters, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
1 ppb of the PMN substance in surface
waters. As described in the PMN, 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citations: 40 CFR 721.10407.
PMN Number P–10–556
Chemical name: Poly[oxy(methyl-1,2ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3[(1-oxododecyl)oxy]
propylidene]amino]methylethyl].omega.-[2-[[2,2-dimethyl-3-[(1oxododecyl)oxy]propylidene]
amino]methylethoxy]-.
CAS number: 613246–75–6.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a latent curing
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agent in polyurethane adhesives. 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, tiers I and II
(OPPTS Test Guideline 850.5400) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10408.
PMN Number P–11–217
Chemical name:
Poly(oxyalkylenediyl), .alpha.-[[[methyl3-[[[(polyfluoroalkyl)oxy]carbonyl]
amino]phenyl]amino]carbonyl]-.omega.methoxy-(generic).
CAS number: Not available.
Effective date of TSCA section 5(e)
consent order: June 24, 2011.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the PMN
substance will be as an open, nondispersive carpet treatment. EPA has
concerns for potential incineration or
other decomposition products of the
PMN substance. These perfluorinated
products may be released to the
environment from incomplete
incineration of the PMN substance at
low temperatures. EPA has preliminary
evidence, including data on some
fluorinated polymers that suggests that,
under some conditions, the PMN
substance could degrade in the
environment. EPA has concerns that
these degradation products will persist
in the environment, could be PBT
chemicals, based on data on analog
chemicals, including PFOA and other
perfluorinated alkyls, which include the
presumed environmental degradant.
There is pharmacokinetic and
toxicological data in animals on PFOA,
as well as epidemiological and blood
monitoring data in humans. Toxicity
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studies on PFOA indicate
developmental, reproductive, and
systemic toxicity in various species, as
well as cancer. These factors, taken
together, raise concerns for potential
adverse chronic effects from the
presumed degradation product in
humans and wildlife. 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 present an
unreasonable risk of injury to the
environment and human health, the
substance 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
substance and its potential degradation
products. To protect against these risks,
the consent order requires: No
manufacture of the substance beyond an
annual aggregate manufacture and
importation volume; recording and
reporting of certain fluorinated
impurities in the starting raw material;
and manufacture of the PMN substance
not to exceed the maximum established
impurity levels of certain fluorinated
impurities. The SNUR designates as a
‘‘significant new use’’ the absence of
these protective measures.
Recommended testing: EPA has
determined that the results of certain
fate and physical/chemical property
testing identified in the TSCA 5(e)
consent order would help characterize
possible effects of the substance and its
degradation products. The order does
not require submission of the 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 order is
modified or revoked by EPA based on
submission of that or other relevant
information.
CFR citation: 40 CFR 721.10409.
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 four of the 119 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
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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 117 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.
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 June 26, 2012 without
further notice, unless EPA receives
written adverse or critical comments, or
notice of intent to submit adverse or
critical comments before May 29, 2012.
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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 May
29, 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 April 27, 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
four 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, 83 of the 119 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 April 24, 1990
SNUR, EPA has decided that the intent
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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
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 pertaining to protocol
selection and test reporting. To access
the harmonized test guidelines
referenced in this document
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electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’ The
Organisation for Economic Co-operation
and Development (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org.
In the TSCA section 5(e) consent
orders for four 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.
• Potential benefits of the chemical
substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing
certain significant new uses which have
been claimed as CBI subject to Agency
confidentiality regulations at 40 CFR
part 2 and 40 CFR part 720, subpart E.
Absent a final determination or other
disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is
required to keep this information
confidential. EPA promulgated a
procedure to deal with the situation
where a specific significant new use is
CBI, at 40 CFR 721.1725(b)(1).
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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.
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
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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–2011–0577.
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
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Sfmt 4700
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, and (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: (1) A significant
number of SNUNs would not be
submitted by small entities in response
to the SNUR and (2) submission of the
SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
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D. Unfunded Mandates Reform Act
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 RULES2
G. Executive Order 13045
This action is not subject to Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive
Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
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I. National Technology Transfer and
Advancement Act
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
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: April 12, 2012.
Ward Penberthy,
Acting Director, Chemical Control Division,
Office of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are
amended as follows:
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
■
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
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2. The table in § 9.1 is amended by
adding the following sections in
numerical order under the heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
OMB control
No.
40 CFR citation
*
*
*
*
*
Significant New Uses of Chemical
Substances
*
721.10299
721.10300
721.10301
721.10302
721.10303
721.10304
721.10305
721.10306
721.10307
721.10308
721.10309
721.10310
721.10311
721.10312
721.10313
721.10314
721.10315
721.10316
721.10317
721.10318
721.10319
721.10320
721.10321
721.10322
721.10323
721.10324
721.10325
721.10326
721.10327
721.10328
721.10329
721.10330
721.10331
721.10332
721.10333
721.10334
721.10335
721.10336
721.10337
721.10338
721.10339
721.10340
721.10341
721.10342
721.10343
721.10344
721.10345
721.10346
721.10347
721.10348
721.10349
721.10350
E:\FR\FM\27APR2.SGM
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OMB control
No.
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721.10351
721.10352
721.10353
721.10354
721.10355
721.10356
721.10357
721.10358
721.10359
721.10360
721.10361
721.10362
721.10363
721.10364
721.10365
721.10366
721.10367
721.10368
721.10369
721.10370
721.10371
721.10372
721.10373
721.10374
721.10375
721.10376
721.10377
721.10378
721.10379
721.10380
721.10381
721.10382
721.10383
721.10384
721.10385
721.10386
721.10387
721.10388
721.10389
721.10390
721.10391
721.10392
721.10393
721.10394
721.10395
721.10396
721.10397
721.10398
721.10399
721.10400
721.10401
721.10402
721.10403
721.10404
721.10405
721.10406
721.10407
721.10408
721.10409
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2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
mstockstill on DSK4VPTVN1PROD with RULES2
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 § 721.10299 to subpart E to
read as follows:
■
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§ 721.10299 Polymeric MDI based
polyurethanes (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as polymeric MDI based
polyurethanes (PMNs P–00–2, P–00–5,
and P–00–6) are subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(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.
5. Add § 721.10300 to subpart E to
read as follows:
■
§ 721.10300 Benzeneacetic acid, .alpha.chloro-.alpha.-phenyl-, ethyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzeneacetic acid, .alpha.-chloro.alpha.-phenyl-, ethyl ester (PMN P–00–
85; CAS No. 52460–86–3) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (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.
6. Add § 721.10301 to subpart E to
read as follows:
■
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Fmt 4701
Sfmt 4700
§ 721.10301 Reaction products of fatty
alcohols, (aminoethylaminopropyl)
dialkoxymethylsilane, glycidol, and
hydroxy-terminated polydimethylsiloxane
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as reaction products of fatty
alcohols, (aminoethylaminopropyl)
dialkoxymethylsilane, glycidol, and
hydroxy-terminated
polydimethylsiloxane (PMN P–00–317)
is subject to 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.
■ 7. Add § 721.10302 to subpart E to
read as follows:
§ 721.10302
(generic).
Zinc ammonium phosphate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as zinc ammonium
phosphate (PMN P–00–442) is subject to
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.
■ 8. Add § 721.10303 to subpart E to
read as follows:
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§ 721.10303 Polyether modified
polysiloxane, acrylated (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyether modified
polysiloxane, acrylated (PMN P–00–
833) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 9. Add § 721.10304 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10304
(generic).
Functionalized polymethine
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as functionalized
polymethine (PMN P–00–1099) is
subject to 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.
■ 10. Add § 721.10305 to subpart E to
read as follows:
§ 721.10305
(generic).
Modified cyclohexane esters
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as modified cyclohexane
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esters (PMN P–00–1108) is subject to
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.
■ 11. Add § 721.10306 to subpart E to
read as follows:
§ 721.10306
(generic).
Substituted phenylepoxide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted
phenylepoxide (PMN P–01–114) is
subject to 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=6).
(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.
■ 12. Add § 721.10307 to subpart E to
read as follows:
§ 721.10307
Acrylate resin (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acrylate resin (PMN P–
01–343) is subject to 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).
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25265
(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 § 721.10308 to subpart E to
read as follows:
§ 721.10308 Ethoxylated, propoxylated
diamine diaryl substituted phenylmethane
ester with alkenylsuccinate,
dialkylethanolamine salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, dialkylethanolamine
salt (PMN P–01–384) 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=70).
(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.
■ 14. Add § 721.10309 to subpart E to
read as follows:
§ 721.10309 Ethoxylated, propoxylated
diamine diaryl substituted phenylmethane
ester with alkenylsuccinate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate (PMN P–01–385) is
subject to 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=70).
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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.
■ 15. Add § 721.10310 to subpart E to
read as follows:
§ 721.10310 Ethoxylated, propoxylated
diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, ammonium salt
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, ammonium salt as
(PMN P–01–386) is subject to 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=70).
(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.
■ 16. Add § 721.10311 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10311 Ethoxylated, propoxylated
diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, sodium salt
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, sodium salt (PMN P–
01–387) is subject 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=70).
(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.
■ 17. Add § 721.10312 to subpart E to
read as follows:
§ 721.10312 Ethoxylated, propoxylated
diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, ethanolamine
salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethoxylated, propoxylated
diamine diaryl substituted
phenylmethane ester with
alkenylsuccinate, ethanolamine salt
(PMN P–01–388) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=70).
(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.
■ 18. Add § 721.10313 to subpart E to
read as follows:
§ 721.10313 Fatty acids, C16–18 and C18unsatd., Me esters, epoxidized.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
fatty acids, C16–18 and C18-unsatd., Me
esters, epoxidized (PMN P–02–249; CAS
No. 158318–67–3) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
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(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, 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 § 721.10314 to subpart E to
read as follows:
§ 721.10314
(generic).
Dialkyl dithiocarbamate esters
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as dialkyl dithiocarbamate
esters (PMNs P–02–778, P–02–779, and
P–02–780) 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)(1), (b)(1), and
(c)(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.
■ 20. Add § 721.10315 to subpart E to
read as follows:
§ 721.10315 1,5–Dioxa-9azaspiro[5.5]undecane, 3,3,8,8,10,10hexamethyl-9-[1-[4-(2oxiranylmethoxy)phenyl]ethoxy]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,5-dioxa-9-azaspiro[5.5]undecane,
3,3,8,8,10,10-hexamethyl-9-[1-[4-(2oxiranylmethoxy)phenyl]ethoxy]- (PMN
P–02–833; CAS No. 434898–80–3) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(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.
■ 21. Add § 721.10316 to subpart E to
read as follows:
§ 721.10316 Dicyclopentadiene polymer
with maleic anhydride and alkyl alcohols
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dicyclopentadiene
polymer with maleic anhydride and
alkyl alcohols (PMN P–02–872) is
subject to 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.
■ 22. Add § 721.10317 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10317
(generic).
Alkyl phosphate derivative
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyl phosphate
derivative (PMN P–02–1040) is subject
to 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.
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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.
■ 23. Add § 721.10318 to subpart E to
read as follows:
§ 721.10318
Mannich bases (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as mannich bases (PMNs P–
02–1078 and P–02–1080) 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=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.
■ 24. Add § 721.10319 to subpart E to
read as follows:
§ 721.10319
(generic).
Alkylamides, ethoxylated
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylamides, ethoxylated
(PMN P–03–42) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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25. Add § 721.10320 to subpart E to
read as follows:
■
§ 721.10320
Fatty acid amide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid amide (PMN P–
03–186) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, 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 § 721.10321 to subpart E to
read as follows:
§ 721.10321 Bis[phenyl, 2H-1,3benzoxazine]derivative (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as bis[phenyl, 2H-1,3benzoxazine]derivative (PMN P–03–
194) is subject to 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)(1), (b)(1), and
(c)(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.
■ 27. Add § 721.10322 to subpart E to
read as follows:
§ 721.10322
Metallic diol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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generically as metallic diol (PMN P–03–
196) is subject to 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=6).
(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.
■ 28. Add § 721.10323 to subpart E to
read as follows:
§ 721.10323
(generic).
Glycerol fatty acid ester
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as glycerol fatty acid ester
(PMN P–03–248) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=6).
(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 § 721.10324 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10324
(generic).
Thionocarbamate derivative
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as thionocarbamate
derivative (PMN P–03–362) is subject 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=50).
(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.
■ 30. Add § 721.10325 to subpart E to
read as follows:
§ 721.10325 Cyclosilazanes, di-Me, Me
hydrogen, polymers with di-Me, Me
hydrogen silazanes, reaction products with
3-(triethoxysilyl)-1-propanamine.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclosilazanes, di-Me, Me hydrogen,
polymers with di-Me, Me hydrogen
silazanes, reaction products with 3(triethoxysilyl)-1-propanamine (PMN P–
03–442; CAS No. 475645–84–2) 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=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 this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 31. Add § 721.10326 to subpart E to
read as follows:
§ 721.10326 2-Propenoic acid, 2-methyl-,
methyl ester, polymer with butyl 2propenoate, ethyl 2-propenoate, zinc 2methyl-2-propenoate (1:2) and zinc 2propenoate (1:2), 2,2’-(1,2-diazenediyl)bis[2methylbutanenitrile]- and 2,2’-(1,2diazenediyl)bis[2-methylpropanenitrile]initiated.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2-methyl-, methyl
ester, polymer with butyl 2-propenoate,
ethyl 2-propenoate, zinc 2-methyl-2-
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propenoate (1:2) and zinc 2-propenoate
(1:2), 2,2′-(1,2-diazenediyl)bis[2methylbutanenitrile]- and 2,2′-(1,2diazenediyl)bis[2methylpropanenitrile]-initiated (PMN
P–03–458; CAS No. 460739–39–3) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (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 this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 32. Add § 721.10327 to subpart E to
read as follows:
§ 721.10327 Salt of mixed fatty
amidoamines and polyethylenepolyamines
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as salt of mixed fatty
amidoamines and
polyethylenepolyamines (PMN P–03–
529) is subject to 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
§ 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.
■ 33. Add § 721.10328 to subpart E to
read as follows:
§ 721.10328 Salt of polyalkylenepolyamine
derivative (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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generically as salt of
polyalkylenepolyamine derivative (PMN
P–03–530) is subject to 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
§ 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.
■ 34. Add § 721.10329 to subpart E to
read as follows:
§ 721.10329 Salt of mixed fatty
amidoamines (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as salt of mixed fatty
amidoamines (PMN P–03–531) is
subject to 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
§ 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 § 721.10330 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10330
(generic).
Pyrazolone derivative
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as pyrazolone derivative
(PMN P–03–722) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
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(i) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(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.
■ 36. Add § 721.10331 to subpart E to
read as follows:
§ 721.10331 Aromatic isocyanate
methacrylate blocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as aromatic isocyanate
methacrylate blocked (PMN P–03–767)
is subject to 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.
■ 37. Add § 721.10332 to subpart E to
read as follows:
§ 721.10332
(generic).
Lithium metal phosphate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as lithium metal phosphate
(PMN P–03–824) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
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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.
■ 38. Add § 721.10333 to subpart E to
read as follows:
§ 721.10333 Substituted benzamine thioether (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted benzamine
thio-ether (PMN P–03–840) is subject to
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.
■ 39. Add § 721.10334 to subpart E to
read as follows:
§ 721.10334 Ethanol, 2,2′-[(3-[(2ethylhexyl)oxy]pentyl]imino]bis-].
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
ethanol, 2,2′-[(3-[(2ethylhexyl)oxy]pentyl]imino]bis- (PMN
P–03–861; CAS No. 284477–82–3) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=20).
(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
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§ 721.10337 Copper,
iodotris(triphenylphosphine)-, (T-4)-.
provisions of § 721.185 apply to this
section.
■ 40. Add § 721.10335 to subpart E to
read as follows:
§ 721.10335 1-Pentanamine, 3-[(2ethylhexyl)oxy]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-pentanamine, 3-[(2-ethylhexyl)oxy](PMN P–03–862; CAS No. 174615–16–8)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=7).
(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.
■ 41. Add § 721.10336 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10336 Poly(oxy-1,2-ethanediyl),
.alpha.-(1-oxo-2-propen-1-yl)-.omega.-([1,1′biphenyl]-2-yloxy)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
poly(oxy-1,2-ethanediyl), .alpha.-(1-oxo2-propen-1-yl)-.omega.-([1,1′-biphenyl]2-yloxy)- (PMN P–04–1; CAS No.
72009–86–0) 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) 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.
■ 42. Add § 721.10337 to subpart E to
read as follows:
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
copper, iodotris(triphenylphosphine)-,
(T-4)- (PMN P–04–6; CAS No. 15709–
82–7) 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)(1), (b)(1), and
(c)(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.
■ 43. Add § 721.10338 to subpart E to
read as follows:
§ 721.10338 2-Propenoic acid, 1,1′-(1,9nonanediyl) ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 1,1′-(1,9-nonanediyl)
ester (PMN P–04–53; CAS No. 107481–
28–7) 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=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.
■ 44. Add § 721.10339 to subpart E to
read as follows:
§ 721.10339 Adipic acid, substituted
propane, alkyldiol, acrylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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generically as adipic acid, substituted
propane, alkyldiol, acrylate (PMN P–04–
113) is subject to 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.
■ 45. Add § 721.10340 to subpart E to
read as follows:
§ 721.10340
(KZnF3).
Potassium zinc fluoride
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
potassium zinc fluoride (KZnF3) (PMN
P–04–146; CAS No. 13827–02–6) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 46. Add § 721.10341 to subpart E to
read as follows:
§ 721.10341
(generic).
Amino alkyl organoborane
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as amino alkyl organoborane
(PMN P–04–338) is subject 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=7).
(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.
■ 47. Add § 721.10342 to subpart E to
read as follows:
§ 721.10342 Quaternary ammonium
compounds, fatty alkyl dialkyl hydroxide
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as quaternary ammonium
compounds, fatty alkyl dialkyl
hydroxide (PMN P–04–516) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 48. Add § 721.10343 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10343 Alkylated aryloxyaniline
thiourea (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylated aryloxyaniline
thiourea (PMN P–04–563) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(1), (b)(1), and
(c)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
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apply to this section except as modified
by this paragraph.
(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.
■ 49. Add § 721.10344 to subpart E to
read as follows:
§ 721.10344 Alkylated aromatic
isothiocyanate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylated aromatic
isothiocyanate (PMN P–04–810) is
subject to 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)(1), (b)(1), and
(c)(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.
■ 50. Add § 721.10345 to subpart E to
read as follows:
§ 721.10345 1,2-Benzenedicarboxylic acid,
1,2-bis(methylcyclohexyl) ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2-benzenedicarboxylic acid, 1,2bis(methylcyclohexyl) ester (PMN P–
05–110; CAS No. 27987–25–3) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (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.
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(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 51. Add § 721.10346 to subpart E to
read as follows:
§ 721.10346 3H-Indolium, 2-[2-[2-chloro-3[2-(1,3-dihydro-3,3-dimethyl-1-propyl-2Hindol-2-ylidene)ethylidene]-1-cyclohexen-1yl]ethenyl]-3,3-dimethyl-1-propyl-, iodide
(1:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
3H-indolium, 2-[2-[2-chloro-3-[2-(1,3dihydro-3,3-dimethyl-1-propyl-2Hindol-2-ylidene)ethylidene]-1cyclohexen-1-yl]ethenyl]-3,3-dimethyl1-propyl-, iodide (1:1) (PMN P–05–599;
CAS No. 207399–07–3) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (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.
■ 52. Add § 721.10347 to subpart E to
read as follows:
§ 721.10347 Bicyclo[2.2.1]
heptanedimethanamine, N,N′-bis(1,2dimethylpropylidene)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
bicyclo[2.2.1]heptanedimethanamine,
N,N′-bis(1,2-dimethylpropylidene)(PMN P–06–268; CAS No. 664980–30–7)
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
§ 721.125(a), (b), (c), and (k) 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.
■ 53. Add § 721.10348 to subpart E to
read as follows:
§ 721.10348 Aspartic acid, N,N′-(iminodialkanediyl)bis, tetraalkane esters (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as aspartic acid, N,N′(iminodi-alkanediyl)bis, tetraalkane
esters (PMNs P–06–623 and P–06–624)
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=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.
■ 54. Add § 721.10349 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10349 1,4-Benzenediamine, N′(alkyl)-N-[4-[(alkyl)amino]phenyl]-N-phenyl(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 1,4-benzenediamine, N′(alkyl)-N-[4-[(alkyl)amino]phenyl]-Nphenyl- (PMN P–06–731) is subject to
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
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provisions of § 721.185 apply to this
section.
■ 55. Add § 721.10350 to subpart E to
read as follows:
§ 721.10350 Amines, C11–14-branched
and linear alkyl.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
amines, C11–14-branched and linear
alkyl (PMN P–06–742; CAS No. 863766–
30–7) 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)(1), (b)(1), and
(c)(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.
■ 56. Add § 721.10351 to subpart E to
read as follows:
§ 721.10351 Carbomonocycle, bis[(4methylphenoxy)methyl]- (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as carbomonocycle, bis[(4methylphenoxy)methyl]- (PMN P–07–
351) is subject to 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.
■ 57. Add § 721.10352 to subpart E to
read as follows:
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§ 721.10352 Dimethyl terephthalate,
polymer with alkyl diol and substituted
benzoates (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dimethyl terephthalate,
polymer with alkyl diol and substituted
benzoates (PMN P–08–93) is subject to
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=60).
(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.
■ 58. Add § 721.10353 to subpart E to
read as follows:
§ 721.10353
Organosulfide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as organosulfide (PMN P–
08–510) is subject to 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.
■ 59. Add § 721.10354 to subpart E to
read as follows:
§ 721.10354 1,1′-Biphenyl, 3,3′,4,4′tetramethyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,1′-biphenyl, 3,3′,4,4′-tetramethyl-
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(PMN P–08–623; CAS No. 4920–95–0) 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) 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.
■ 60. Add § 721.10355 to subpart E to
read as follows:
§ 721.10355 Poly[oxy-1,2-ethanediyl),
.alpha.-(1-oxododecyl)-.omega.-[3triethoxysilyl)propoxy]-.
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
poly[oxy-1,2-ethanediyl), .alpha.-(1oxododecyl)-.omega.-[3triethoxysilyl)propoxy]- (PMN P–08–
722; CAS No. 1041420–54–5) 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) 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.
■ 61. Add § 721.10356 to subpart E to
read as follows:
§ 721.10356 Zinc, bis[3-(acetyl-.kappa.O)-6methyl-2H-pyran-2,4(3H)-dionato.kappa.O4]diaqua-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
zinc, bis[3-(acetyl-.kappa.O)-6-methyl2H-pyran-2,4(3H)-dionato.kappa.O4]diaqua- (PMN P–09–98; CAS
No. 171884–15–4) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, 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 § 721.10357 to subpart E to
read as follows:
§ 721.10357 Iron, citrate phosphate
potassium complexes.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
iron, citrate phosphate potassium
complexes (PMN P–09–382; CAS No.
120579–31–9) 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) (micronutrient in
fertilizer or soil amendment which will
only be transported in containers with
a maximum capacity of 20 gallons or in
bottom-loading totes).
(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.
■ 63. Add § 721.10358 to subpart E to
read as follows:
§ 721.10358 Formaldehyde reaction
products with aryl amine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as formaldehyde reaction
products with aryl amine (PMN P–09–
546) is subject to reporting under this
section for the significant new uses
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described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g) and (j) (use other
than as an intermediate that has been
manufactured using the process
described in the premanufacture notice).
(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 § 721.10359 to subpart E to
read as follows:
§ 721.10359 Cardanol-based alkyl
phosphate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as cardanol-based alkyl
phosphate (PMN P–09–613) is subject to
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) (site-limited
polymer modifier in non-consumer
products).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=18).
(b) Specific requirements. The
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.
■ 65. Add § 721.10360 to subpart E to
read as follows:
§ 721.10360 1-Substituted propane, 3(triethoxysilyl)-, reaction products with
polyethylene glycol mono-(branched
tridecyl) ether (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 1-substituted propane, 3-
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(triethoxysilyl)-, reaction products with
polyethylene glycol mono-(branched
tridecyl) ether (PMN P–09–628) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, 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 § 721.10361 to subpart E to
read as follows:
§ 721.10361 Anthraquinonedicarboximide,
diamino-N-alkyl- (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as
anthraquinonedicarboximide, diaminoN-alkyl- (PMN P–10–15) is subject to
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.
■ 67. Add § 721.10362 to subpart E to
read as follows:
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§ 721.10362
Oils, callitropsis nootkatensis.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oils, callitropsis nootkatensis (PMN P–
10–44; CAS No. 1069136–34–0) 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:
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(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.
■ 68. Add § 721.10363 to subpart E to
read as follows:
§ 721.10363 Alkenoic acid, 2-methyl-, 2oxiranylmethyl ester, reaction products with
4,4′ -methylenebis (cyclohexanamine)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkenoic acid, 2-methyl-,
2-oxiranylmethyl ester, reaction
products with 4,4′ -methylenebis
(cyclohexanamine) (PMN P–10–47) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4) and (b)(4)
(N=44).
(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.
■ 69. Add § 721.10364 to subpart E to
read as follows:
§ 21.10364
(generic).
Halogenated aromatic amine
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated aromatic
amine (PMN P–10–53) is subject to
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).
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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 § 721.10365 to subpart E to
read as follows:
§ 721.10365 Butanoic acid, 3-mercapto-2methyl-, ethyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
butanoic acid, 3-mercapto-2-methyl-,
ethyl ester (PMN P–10–56; CAS No.
888021–82–7) 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(s) (100 kilograms).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(b) Specific requirements. The
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.
■ 71. Add § 721.10366 to subpart E to
read as follows:
§ 721.10366
dimethyl-.
Benzene, 4-bromo-1,2-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzene, 4-bromo-1,2-dimethyl-(PMN
P–10–76; CAS No. 583–71–1) 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=30).
(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 § 721.10367 to subpart E to
read as follows:
§ 721.10367 Hydroxy-aryl, polymer with
substituted benzene, cyanate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as hydroxy-aryl, polymer
with substituted benzene, cyanate (PMN
P–10–83) is subject to 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.
■ 73. Add § 721.10368 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10368
(generic).
Triphenodioxazine derivatives
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as triphenodioxazine
derivatives (PMN P–10–84) is subject to
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
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provisions of § 721.185 apply to this
section.
■ 74. Add § 721.10369 to subpart E to
read as follows:
provisions of § 721.185 apply to this
section.
■ 76. Add § 721.10371 to subpart E to
read as follows:
§ 721.10369 Carbonic acid, diphenyl ester,
polymer with diphenyl Pmethylphosphonate and 4,4′-(1methylethylidene) bis[phenol].
§ 721.10371 Butanoic acid, 3-mercapto,1,1′-[2-(hydroxymethyl)-2-(substituted-1oxoalkoxy)methyl)-1,3-propanediyl] ester
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
carbonic acid, diphenyl ester, polymer
with diphenyl P-methylphosphonate
and 4,4′-(1-methylethylidene)
bis[phenol] (PMN P–10–88; CAS No.
77226–90–5) 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(j) (flame retardant
and flame retardant additive, where the
particle size is greater than 10 microns).
(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.
■ 75. Add § 721.10370 to subpart E to
read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as butanoic acid, 3mercapto-,1,1′-[2-(hydroxymethyl)-2(substituted-1-oxoalkoxy)methyl)-1,3propanediyl] ester (PMN P–10–136,
Chemical A) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (j) (monomer
for acryl-based ultra-violet (UV)-curing
coatings, inks, and adhesives).
(ii) Release to water. Requirements as
specified in § 721.90(b)(4) and (c)(4)
(N=2).
(b) Specific requirements. The
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.
■ 77. Add § 721.10372 to subpart E to
read as follows:
§ 721.10370 Phosphonic acid, p-octyl-,
lanthanum (3+) salt (2:1).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphinic acid, p-octyl-, lanthanum
(3+) salt (2:1) (PMN P–10–99; CAS No.
1186211–38–0) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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§ 721.10372 Butanoic acid, 3-mercapto,1,1′-[2,2-bis[(substituted-1oxoalkoxy)methyl]-1,3-propanediyl] ester
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as butanoic acid, 3mercapto-,1,1′-[2,2-bis[(substituted-1oxoalkoxy)methyl]-1,3-propanediyl]
ester (PMN P–10–136, Chemical B) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (j) (monomer
for acryl-based UV-curing coatings, inks,
and adhesives).
(ii) Release to water. Requirements as
specified in § 721.90(b)(4) and (c)(4)
(N=2).
(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.
■ 78. Add § 721.10373 to subpart E to
read as follows:
§ 721.10373 1H-Imidazole, 1-(1methylethyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1H-imidazole, 1-(1-methylethyl)- (PMN
P–10–153; CAS No. 4532–96–1) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=70).
(b) Specific requirements. The
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.
■ 79. Add § 721.10374 to subpart E to
read as follows:
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§ 721.10374 Silane, (3chloropropoxy)dimethyl(1-methylethyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
silane, (3-chloropropoxy)dimethyl(1methylethyl)-(PMN P–10–163; CAS No.
1191036–21–1) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(2)(iii) (gloves
and goggles), (a)(3), (a)(4). The following
National Institute for Occupational
Safety and Health (NIOSH)-certified
respirator with an assigned protection
factor (APF) of at least 10 meets the
minimum requirements for
§ 721.63(a)(4): NIOSH-certified organic
vapor respirator.
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(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=2).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (d), (e), and (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 § 721.10375 to subpart E to
read as follows:
§ 721.10375 Hydroxypropyl methacrylate,
reaction products with propylene oxide and
ethylene oxide, copolymer with N-vinyl
caprolactam (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as hydroxypropyl
methacrylate, reaction products with
propylene oxide and ethylene oxide,
copolymer with N-vinyl caprolactam
(PMN P–10–200) is subject to 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=155).
(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.
■ 81. Add § 721.10376 to subpart E to
read as follows:
§ 721.10376
Alkyltin halide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyltin halide (PMN P–
10–222) is subject to 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).
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(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=22).
(b) Specific requirements. The
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.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
■ 82. Add § 721.10377 to subpart E to
read as follows:
§ 721.10377 1,2-Cyclohexanedicarboxylic
acid, benzyl C8-10-isoalkyl esters, C9-rich.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2-cyclohexanedicarboxylic acid,
benzyl C8-10-isoalkyl esters, C9-rich
(PMN P–10–247, Chemical A; CAS No.
1190265–49–6) 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), and (a)(3).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (d), (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.
■ 83. Add § 721.10378 to subpart E to
read as follows:
§ 721.10378 1,2-Cyclohexanedicarboxylic
acid, benzyl nonyl ester, branched and
linear.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2-cyclohexanedicarboxylic acid,
benzyl nonyl ester, branched and linear
(PMN P–10–247, Chemical B; CAS No.
1190264–82–4) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
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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=33).
(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.
■ 86. Add § 721.10381 to subpart E to
read as follows:
§ 721.10379 Propanoic acid, 3(dodecylthio)-, 2-(1,1-dimethylethyl)-4-[[5(1,1-dimethylethyl)-4-hydroxy-2methylphenyl]thio]-5-methylphenyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propanoic acid, 3-(dodecylthio)-, 2-(1,1dimethylethyl)-4-[[5-(1,1dimethylethyl)-4-hydroxy-2methylphenyl]thio]-5-methylphenyl
ester (PMN P–10–266; CAS No. 69075–
62–3) 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(s) (10,000
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.
■ 85. Add § 721.10380 to subpart E to
read as follows:
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(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), and (a)(3).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (d), (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.
■ 84. Add § 721.10379 to subpart E to
read as follows:
§ 721.10381 Cyclic carboxylic acid,
polymer with dihydroxy dialkyl ether,
hydroxy substituted alkane and carboxylic
acid anhydride, methacrylate terminated
polyester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as cyclic carboxylic acid,
polymer with dihydroxy dialkyl ether,
hydroxy substituted alkane and
carboxylic acid anhydride, methacrylate
terminated polyester (PMN P–10–290) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 87. Add § 721.10382 to subpart E to
read as follows:
§ 721.10380
mercapto-.
Benzoic acid, 3-amino-2-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzoic acid, 3-amino-2-mercapto(PMN P–10–285; CAS No. 71807–60–8)
is subject to reporting under this section
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§ 721.10382
salt (1:1).
Diphosphoric acid, calcium
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
diphosphoric acid, calcium salt (1:1)
(PMN P–10–313; CAS No. 14866–19–4)
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(j) (opacifying agent
for ceramic whiteware).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=60).
(b) Specific requirements. The
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.
■ 88. Add § 721.10383 to subpart E to
read as follows:
§ 721.10383 Urea, N,N′-(methyl-1,3phenylene)bis[N′,N′-bis[3polyalkyleneamino]-, compd. with
formaldehyde polymer with phenol
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as urea, N,N′-(methyl-1,3phenylene)bis[N′,N′-bis[3polyalkyleneamino]-, compd. with
formaldehyde polymer with phenol
(PMN P–10–324) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=43).
(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.
■ 89. Add § 721.10384 to subpart E to
read as follows:
§ 721.10384 Substituted alkanolamine
phenol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted alkanolamine
phenol (PMN P–10–332) is subject to
reporting under this section for the
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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.
■ 90. Add § 721.10385 to subpart E to
read as follows:
§ 721.10385
Phenoxy alkyl ether (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as phenoxy alkyl ether (PMN
P–10–344) is subject to 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 this section.
■ 91. Add § 721.10386 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10386
Substituted phenol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted phenol (PMN
P–10–361) is subject to 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.
■ 92. Add § 721.10387 to subpart E to
read as follows:
§ 721.10387
(generic).
Substituted bis-phenol
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted bis-phenol
(PMN P–10–362) is subject to 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.
■ 93. Add § 721.10388 to subpart E to
read as follows:
§ 721.10388 Bisphospite nickel cyanoalkyl
complex (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as bisphospite nickel
cyanoalkyl complex (PMN P–10–364) is
subject to 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
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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.
■ 94. Add § 721.10389 to subpart E to
read as follows:
§ 721.10389 Styrene, copolymer with
acrylic acid, salt with alkoxylated
alkenylamine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as styrene, copolymer with
acrylic acid, salt with alkoxylated
alkenylamine (PMN P–10–401) is
subject to 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=27). Where primary,
secondary, and tertiary waste treatment
will occur, or treatment in a lined selfcontained solar evaporation pond where
UV light will degrade the substance, the
number of kilograms per day per site is
calculated after wastewater treatment.
(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.
■ 95. Add § 721.10390 to subpart E to
read as follows:
§ 721.10390 Acetoacetanilide reaction
product with multifunctional acrylate
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acetoacetanilide reaction
product with multifunctional acrylate
(PMN P–10–403) is subject to 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.
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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.
■ 96. Add § 721.10391 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10391
selenide.
Copper gallium indium
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
copper gallium indium selenide (PMN
P–10–424; CAS No. 144972–86–1) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4), (a)(6)(i), (b)
(concentration set at 0.1 percent), and
(c). The following NIOSH-certified
respirators with an assigned protection
factor (APF) of at least 10 meet the
minimum requirements for
§ 721.63(a)(4):
(A) NIOSH-certified air-purifying,
tight-fitting half-face respirator
equipped with N100 (if oil aerosols
absent), R100, or P100 filters;
(B) NIOSH-certified air-purifying,
tight-fitting full-face respirator equipped
with N100 (if oil aerosols absent), R100,
or P100 filters;
(C) NIOSH-certified powered airpurifying respirator equipped with a
loose- fitting hood or helmet and high
efficiency particulate air (HEPA) filters;
(D) NIOSH-certified powered airpurifying respirator equipped with a
tight-fitting facepiece (either half-face or
full-face) and HEPA filters; or
(E) 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).
(1) 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) of 1.5
mg/m3 as an 8-hour time-weightedaverage. Persons who wish to pursue
NCELs as an alternative to the § 721.63
respirator requirements may request to
do so under § 721.30.
(2) [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)(ii), (g)(2)(ii), (g)(2)(iv) (use
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respiratory protection or maintain
workplace airborne concentrations at or
below an 8-hour time-weighted average
of 1.5 mg/m3), and (g)(5).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (d), (f), (g), and (h)
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.
■ 97. Add § 721.10392 to subpart E to
read as follows:
§ 721.10392 Halo substituted
sulfamidylbenzyluracil (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halo substituted
sulfamidylbenzyluracil (PMN P–10–
426) is subject to 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(b) and (g).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (i), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 98. Add § 721.10393 to subpart E to
read as follows:
§ 721.10393 Sodium bromide MDA
complex (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sodium bromide MDA
complex (PMN P–10–433) is subject to
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).
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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.
■ 99. Add § 721.10394 to subpart E to
read as follows:
§ 721.10394 Copolymer of anhydride, a
diol and a disubstituted diol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as copolymer of anhydride,
a diol and a disubstituted diol (PMN P–
10–436) 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=55).
(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.
■ 100. Add § 721.10395 to subpart E to
read as follows:
§ 721.10395 Fatty acids, C14–18 and C16–
18 unsatd., polymers with adipic acid and
triethanolamine, di-Me sulfate-quaternized.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
fatty acids, C14–18 and C16–18 unsat.,
polymers with adipic acid and
triethanolamine, di-Me sulfatequaternized (PMN P–10–458; CAS No.
1211825–32–9) 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=5).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
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apply to this section except as modified
by this paragraph.
(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.
■ 101. Add § 721.10396 to subpart E to
read as follows:
§ 721.10396 Dimethyl siloxy-polyfluoro
methyl siloxy-poly(oxyalkylenediyl) methyl
siloxy copolymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dimethyl siloxypolyfluoro methyl siloxypoly(oxyalkylenediyl) methyl siloxy
copolymer (PMN P–10–470) 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) (recording and
reporting of certain fluorinated
impurities in the starting raw material,
and manufacture of the PMN substance
not to exceed the maximum established
impurity levels of certain fluorinated
impurities) and (t).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (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 this section.
■ 102. Add § 721.10397 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10397 Alkyl acrylate-polyfluoro
methacrylate-poly(oxyalkylenediyl)methacrylates (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as alkyl acrylate-polyfluoro
methacrylate-poly(oxyalkylenediyl)methacrylates (PMNs P–10–471 and P–
10–472) are 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(k) (recording and
reporting of certain fluorinated
impurities in the starting raw material,
and manufacture of the PMN substances
not to exceed the maximum established
impurity levels of certain fluorinated
impurities) and (t).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (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 this section.
■ 103. Add § 721.10398 to subpart E to
read as follows:
§ 721.10398 Poly(oxy-1,2-ethanediyl),.
alpha., -monoalkyl ethers-.omega.-mono
(hydrogen maleate)- (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as poly(oxy-1,2-ethanediyl),
.alpha., -monoalkyl ethers-.omega.mono (hydrogen maleate)- (PMN P–10–
495) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(l).
(ii) [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.
■ 104. Add § 721.10399 to subpart E to
read as follows:
§ 721.10399 Benzoic acid azo-substituted
pyridine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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Fmt 4701
Sfmt 4700
generically as benzoic acid azosubstituted pyridine (PMN P–10–501) 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=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.
■ 105. Add § 721.10400 to subpart E to
read as follows:
§ 721.10400 Oxirane, 2-ethyl-, polymer with
oxirane, mono-C12–14-sec-alkyl ethers.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-ethyl-, polymer with oxirane,
mono-C12-14-sec-alkyl ethers (PMN
P–10–517; CAS No. 1013910–41–2) 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=14), where the amount of
substance reasonably likely to be
removed during waste pretreatment
prior to release may be subtracted in
calculating the number of kilograms
released.
(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.
■ 106. Add § 721.10401 to subpart E to
read as follows:
§ 721.10401 Oxirane, 2-ethyl-, polymer with
oxirane, mono-C11-15-sec-alkyl ethers.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-ethyl-, polymer with oxirane,
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mono C11-15-sec-alkyl ethers (PMN P–
10–518; CAS No. 1022990–65–3) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=20), where the amount of
substance reasonably likely to be
removed during waste pretreatment
prior to release may be subtracted in
calculating the number of kilograms
released.
(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.
■ 107. Add § 721.10402 to subpart E to
read as follows:
mstockstill on DSK4VPTVN1PROD with RULES2
§ 721.10402 Vegetable oil, modified
products (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as vegetable oil, modified
products (PMN P–10–548) is subject to
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
§ 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.
■ 108. Add § 721.10403 to subpart E to
read as follows:
§ 721.10403 Vegetable oil, modified
products, esters (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as vegetable oil, modified
products, esters (PMN P–10–550) is
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subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 109. Add § 721.10404 to subpart E to
read as follows:
§ 721.10404 Olefins (generic) (P–10–551
and P–10–552).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as olefins (PMNs P–10–551
and P–10–552) 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=6).
(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.
■ 110. Add § 721.10405 to subpart E to
read as follows:
§ 721.10405
Olefins (generic) (P–10–553).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as olefins (PMN P–10–553)
is subject to 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).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
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25281
(b) Specific requirements. The
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.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to this section.
■ 111. Add § 721.10406 to subpart E to
read as follows:
§ 721.10406 Fatty acid methyl esters
(generic) (P–10–554).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid methyl esters
(PMN P–10–554) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 112. Add § 721.10407 to subpart E to
read as follows:
§ 721.10407 Fatty acid methyl esters
(generic) (P–10–555).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid methyl esters
(PMN P–10–555) is subject to 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.
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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.
■ 113. Add § 721.10408 to subpart E to
read as follows:
§ 721.10408 Poly[oxy(methyl-1,2ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1oxododecyl) oxy]propylidene] amino]
methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1oxododecyl)oxy]propylidene] amino]methyl
ethoxy]-.
mstockstill on DSK4VPTVN1PROD with RULES2
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
poly[oxy(methyl-1,2-ethanediyl)],
.alpha.-[2-[[2,2-dimethyl-3-[(1oxododecyl)oxy]propylidene] amino]
methylethyl]-.omega.-[2-[[2,2-dimethyl3-[(1-oxododecyl)oxy]propy
lidene]amino] methylethoxy]- (PMN P–
10–556; CAS No. 613246–75–6) 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:
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Jkt 226001
(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.
■ 114. Add § 721.10409 to subpart E to
read as follows:
§ 721.10409 Poly(oxyalkylenediyl), .alpha.[[[methyl-3-[[[(polyfluoroalkyl)oxy]
carbonyl]amino]phenyl]amino]carbonyl].omega.-methoxy-(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as poly(oxyalkylenediyl),
.alpha.-[[[methyl-3-[[[(polyfluoroalkyl)
oxy]carbonyl]amino]phenyl]amino] car
bonyl]-.omega.-methoxy- (PMN P–11–
217) is subject to reporting under this
section for the significant new uses
PO 00000
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Fmt 4701
Sfmt 9990
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) (recording and
reporting of certain fluorinated
impurities in the starting raw material,
and manufacture of the PMN substance
not to exceed the maximum established
impurity levels of certain fluorinated
impurities) and (t).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (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 this section.
[FR Doc. 2012–9800 Filed 4–26–12; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 77, Number 82 (Friday, April 27, 2012)]
[Rules and Regulations]
[Pages 25236-25282]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9800]
[[Page 25235]]
Vol. 77
Friday,
No. 82
April 27, 2012
Part II
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Parts 9 and 721
Significant New Use Rules on Certain Chemical Substances; Final Rule
Federal Register / Vol. 77 , No. 82 / Friday, April 27, 2012 / Rules
and Regulations
[[Page 25236]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2011-0577; FRL-9343-4]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 119 chemical substances
which were the subject of premanufacture notices (PMNs). Four 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 119 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 June 26, 2012. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
May 11, 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 May 29, 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-2011-0577, 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-2011-0577. 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-
2011-0577. 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 rules
and orders under TSCA. Importers
[[Page 25237]]
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. 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. 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 section 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
119 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 119 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 25238]]
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 four PMN substances (P-10-470, P-10-471, P-10-
472, and P-11-217) 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
5(e) SNURs designate as a ``significant new use'' the absence of the
protective measures required in the corresponding consent orders.
This rule also includes SNURs on 115 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.
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.
PMN Numbers P-00-2, P-00-5, and P-00-6
Chemical names: Polymeric MDI based polyurethanes (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as internal mold release.
Based on ecological structure-activity relationship (EcoSAR) analysis
of test data on analogous nonionic surfactants, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 1 part per
billion (ppb) of the PMN substances in surface waters. As described in
the PMNs, 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 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 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10299.
PMN Number P-00-85
Chemical name: Benzeneacetic acid, .alpha.-chloro-.alpha.-phenyl-,
ethyl ester.
CAS number: 52460-86-3.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a reaction aid in polymer
synthesis. Based on EcoSAR analysis of test data on analogous benzyl
halides, 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, 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 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
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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10300.
PMN Number P-00-317
Chemical name: Reaction products of fatty alcohols,
(aminoethylaminopropyl)dialkoxymethylsilane, glycidol, and hydroxy-
terminated polydimethylsiloxane (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a silicone textile treatment. Based on EcoSAR analysis of test data on
analogous polycationic polymers, 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, releases of the
substance are not expected to result in surface water concentrations
that 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 determined, however, that any use of the
substance resulting in surface water concentrations exceeding
[[Page 25239]]
40 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10301.
PMN Number P-00-442
Chemical name: Zinc ammonium phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a fertilizer. Based on
EcoSAR analysis of test data on analogous zinc salts and inorganic
phosphates, 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, 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 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10302.
PMN Number P-00-833
Chemical name: Polyether modified polysiloxane, acrylated
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a non-dispersive
additive. Based on test data on the PMN substance, and EcoSAR analysis
of test data on analogous acrylates, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 4 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 4 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 4 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10303.
PMN Number P-00-1099
Chemical name: Functionalized polymethine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an infra red absorber.
Based on EcoSAR analysis of test data on analogous cationic dyes, 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
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, tiers I and II (OPPTS Test Guideline 850.5400)
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10304.
PMN Number P-00-1108
Chemical name: Modified cyclohexane esters (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
EcoSAR analysis of test data on analogous epoxides, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. As described in the PMN,
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
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 721.10305.
PMN Number P-01-114
Chemical name: Substituted phenylepoxide (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a destructive use (i.e.,
destroyed during process of manufacturing) electric devices. Based on
test data on the PMN substance and EcoSAR analysis of test data on
analogous epoxides, 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, 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 6 ppb may
cause significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10306.
[[Page 25240]]
PMN Number P-01-343
Chemical name: Acrylate resin (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 coating.
Based on EcoSAR analysis of test data on analogous acrylates, 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, 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 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10307.
PMN Numbers P-01-384, P-01-385, P-01-386, P-01-387, and P-01-388
Chemical names: (P-01-384) Ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate,
dialkylethanolamine salt (generic); (P-01-385) Ethoxylated,
propoxylated diamine diaryl substituted phenylmethane ester with
alkenylsuccinate (generic); (P-01-386) Ethoxylated, propoxylated
diamine diaryl substituted phenylmethane ester with alkenylsuccinate,
ammonium salt (generic); (P-01-387) Ethoxylated, propoxylated diamine
diaryl substituted phenylmethane ester with alkenylsuccinate, sodium
salt (generic); and (P-01-388) Ethoxylated, propoxylated diamine diaryl
substituted phenylmethane ester with alkenylsuccinate, ethanolamine
salt (generic).
CAS numbers: Not available.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as colorants for
aqueous ink applications. Based on EcoSAR analysis of test data on
analogous amphoteric dyes, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 70 ppb of the PMN substances in
surface waters. As described in the PMNs, 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
70 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
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help to characterize the environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10308 (P-01-384); 40 CFR 721.10309 (P-01-
385); 40 CFR 721.10310 (P-01-386); 40 CFR 721.10311 (P-01-387); and 40
CFR 721.10312 (P-01-388).
PMN Number P-02-249
Chemical name: Fatty acids, C16-18 and C18-unsatd., Me esters,
epoxidized.
CAS number: 158318-67-3.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for
production of polyols. Based on EcoSAR analysis of test data on
analogous polyepoxides, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 8 ppb of the PMN substance in
surface waters. As described in the PMN, 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 8 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10313.
PMN Numbers P-02-778, P-02-779, and P-02-780
Chemical names: Dialkyl dithiocarbamate esters (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be used as petroleum
additives. EPA identified environmental concerns because the PMN
substances may be persistent, bio-accumulative, and toxic (PBT)
chemicals, based on physical/chemical properties of the PMN substances,
as described in the New Chemicals Program's PBT category (64 FR 60194,
November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substances
will persist in the environment for more than two months and estimates
a bioaccumulation factor of greater than or equal to 1,000. Also, based
on EcoSAR analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substances in surface waters. As described in the PMNs,
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 purposeful or predictable release containing the PMN
substances into the waters of the United States may cause significant
adverse environmental effects since the PMN substances have been
characterized by EPA as PBTs. Based on this information, the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(ii) and
(b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help characterize the PBT attributes of the PMN substances.
CFR citation: 40 CFR 721.10314.
PMN Number P-02-833
Chemical name: 1,5-Dioxa-9-azaspiro[5.5]undecane, 3,3,8,8,10,10-
hexamethyl-9-[1-[4-(2-oxiranylmethoxy)phenyl]ethoxy]-.
CAS number: 434898-80-3.
Basis for action: The PMN states that the substance will be used as
a polymerization initiator for thermoplastics and elastomers. EPA
identified environmental concerns because the substance may be a PBT
chemical, based on physical/chemical properties of the PMN substance,
as described in the New Chemicals
[[Page 25241]]
Program's PBT category. EPA estimates that the PMN substance will
persist in the environment more than two months and estimates a
bioaccumulation factor of greater than or equal to 1,000. Also, based
on EcoSAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1ppb 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 purposeful or predictable release containing the PMN
substance into the waters of the United States may cause significant
adverse environmental effects since the PMN substance has been
characterized by EPA as a PBT. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(4)(ii) and
(b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help to characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10315.
PMN Number P-02-872
Chemical name: Dicyclopentadiene polymer with maleic anhydride and
alkyl alcohols (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an open-dispersive use in
molding operations. 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 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
determination of the partition coefficient (n-octanol/water) by shake
flask method (OPPTS Test Guideline 830.7550), generator column method
(OPPTS Test Guideline 830.7560), or estimation by liquid chromatography
(OPPTS Test Guideline 830.7570); 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, tiers I and II (OPPTS Test
Guideline 850.5400) would help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10316.
PMN Number P-02-1040
Chemical name: Alkyl phosphate derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a processing aid. Based
on EcoSAR analysis of test data on analogous soluble complexes of zinc,
such as zinc-phosphate salts, 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10317.
PMN Numbers P-02-1078 and P-02-1080
Chemical names: Mannich bases (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that the substances will be used
as curatives for epoxy resin to improve chemical resistance. Based on
EcoSAR analysis of test data on analogous polycationic polymers, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 40 ppb of the PMN substances in surface waters. As described in
the PMNs, the substances are not released to surface waters. Therefore,
EPA had 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 40 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
porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity
test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish
acute toxicity 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help to characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10318.
PMN Number P-03-42
Chemical name: Alkylamides, ethoxylated (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a surfactant. Based on
EcoSAR analysis of test data on analogous nonionic surfactants, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 4 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 4 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10319.
PMN Number P-03-186
Chemical name: Fatty acid amide (generic).
[[Page 25242]]
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 EcoSAR analysis of test data on analogous nonionic surfactants
and neutral organic chemicals, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 8 ppb of the PMN
substance in surface waters. As described in the PMN, 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 8
ppb may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10320.
PMN Number P-03-194
Chemical name: Bis[phenyl, 2H-1,3-benzoxazine]derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a resin for electronic laminates, adhesive resins, encapsulant resins,
and composite resins. EPA has identified environmental concerns because
the substance may be a PBT chemical, based on physical/chemical
properties of the PMN substance, as described in the New Chemicals
Program's PBT category. Also, based on EcoSAR analysis of test data on
analogous neutral organic chemicals, 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
purposeful or predictable release containing the substance into the
waters of the United States may cause significant adverse environmental
effects since the PMN substance has been characterized by EPA as a PBT.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help characterize the PBT attributes of the PMN substance. In
addition, 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10321.
PMN Number P-03-196
Chemical name: Metallic diol (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 for coatings,
inks, adhesives, and composites. Based on EcoSAR analysis of test data
on analogous zinc compounds, 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, the substance is not expected
to be released to surface waters in concentrations that exceed 6 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
releases to surface waters exceeding 6 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10322.
PMN Number P-03-248
Chemical name: Glycerol fatty acid 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 plastic film additive.
Based on EcoSAR analysis of test data on analogous nonionic
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, the substance is not released to
surface waters. 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 use of the
substance resulting in surface water concentrations exceeding 6 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 study (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity study (OPPTS Test Guideline 850.1300); and an
algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400)
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10323.
PMN Number P-03-362
Chemical name: Thionocarbamate derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a sulfide mineral
processing reagent. Based on test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 50 ppb of the PMN substance in surface waters. As described in
the PMN, the substance is not expected to be released to surface waters
in concentrations that exceed 50 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 50 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
porous pot test (OPPTS Test Guideline 835.3220) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10324.
PMN Number P-03-442
Chemical name: Cyclosilazanes, di-Me, Me hydrogen, polymers with
di-Me,
[[Page 25243]]
Me hydrogen silazanes, reaction products with 3-(triethoxysilyl)-1-
propanamine.
CAS number: 475645-84-2.
Basis for action: The PMN states that the substance will be used as
a coating material. 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10325.
PMN Number P-03-458
Chemical name: 2-Propenoic acid, 2-methyl-, methyl ester, polymer
with butyl 2-propenoate, ethyl 2-propenoate, zinc 2-methyl-2-propenoate
(1:2) and zinc 2-propenoate (1:2), 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]- and 2,2'-(1,2-diazenediyl)bis[2-
methylpropanenitrile]-initiated.
CAS number: 460739-39-3.
Basis for action: The PMN states that the substance will be used as
a binder polymer in paints. Based on EcoSAR analysis of test data on
analogous soluble complexes of zinc, 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 water. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10326.
PMN Numbers P-03-529, P-03-530, and P-03-531
Chemical names: (P-03-529) Salt of mixed fatty amidoamines and
polyethylenepolyamines (generic); (P-03-530) Salt of
polyalkylenepolyamine derivative (generic); and (P-03-531) Salt of
mixed fatty amidoamines (generic).
CAS numbers: Not available.
Basis for action: The consolidated PMN states that the generic
(non-confidential) use of the substances will be as processing aids.
Based on EcoSAR analysis of test data on analogous cationic
surfactants, 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 PMNs, 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
porous pot test (OPPTS Test Guideline 835.3220) would help to
characterize the environmental fate of the PMN substances.
CFR citations: 40 CFR 721.10327 (P-03-529); 40 CFR 721.10328 (P-03-
530); and 40 CFR 721.10329 (P-03-531).
PMN Number P-03-722
Chemical name: Pyrazolone derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a dye for use in thermal
transfer printing systems. EPA has identified environmental concerns
because the substance may be a PBT chemical, based on physical/chemical
properties of the PMN substance, as described in the New Chemicals
Program's PBT category. Also, based on test data on the PMN substance
and EcoSAR analysis of test data on analogous hydrazines, EPA predicts
toxicity to aquatic organisms at surface water 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 release
to surface waters may cause significant adverse environmental effects
since the PMN substance has been characterized by EPA as a PBT. Based
on this information, the PMN substance meets the concern criteria at
Sec. 721.170 (b)(4)(i), (b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help characterize the PBT attributes of the PMN substance. In
addition, 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, tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10330.
PMN Number P-03-767
Chemical name: Aromatic isocyanate methacrylate blocked (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a component in composite
formulations. Based on EcoSAR analysis of test data on analogous
methacrylates and esters, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. As described in the PMN, 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
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic
[[Page 25244]]
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test, tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10331.
PMN Number P-03-824
Chemical name: Lithium metal phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an electrode material.
Based on EcoSAR analysis of test data on analogous inorganic
phosphates, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 4 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 4 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10332.
PMN Number P-03-840
Chemical name: Substituted benzamine thio-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 raw material. Based on
EcoSAR analysis of test data on analogous anilines, 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 PMN 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10333.
PMN Number P-03-861
Chemical name: Ethanol, 2,2'-[(3-[(2-
ethylhexyl)oxy]pentyl]imino]bis-.
CAS number: 284477-82-3.
Basis for action: The PMN states that the substance will be used as
an intermediate, emulsifier for industrial textile softening, and an
industrial dye additive. 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, 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 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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10334.
PMN Number P-03-862
Chemical name: 1-Pentanamine, 3-[(2-ethylhexyl)oxy]-.
CAS number: 174615-16-8.
Basis for action: The PMN states that the substance will be used as
a surfactant intermediate. Based on EcoSAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 7 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 7
ppb. Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 7 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10335.
PMN Number P-04-1
Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxo-2-propen-1-
yl)-.omega.-([1,1'-biphenyl]-2-yloxy)-.
CAS number: 72009-86-0.
Basis for action: The PMN states that the substance will be used as
an ultra violet (UV)-curable additive for optical lens. 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 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,
tiers I and II (OPPTS Test Guideline 850.5400) would
[[Page 25245]]
help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10336.
PMN Number P-04-6
Chemical name: Copper, iodotris(triphenylphosphine)-, (T-4)-.
CAS number: 15709-82-7.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive. EPA has
identified environmental concerns because the substance may be a PBT
chemical, based on physical/chemical properties of the PMN substance,
as described in the New Chemicals Program's PBT category. EPA estimates
that the PMN substance will persist in the environment for more than
six months and estimates a bioaccumulation factor of greater than or
equal to 1,000. In addition, based on test data on the PMN substance
and EcoSAR analysis of analogous neutral organics, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
60 ppb of the PMN substance in surface water. 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 purposeful or predictable release containing the PMN
substance into the waters of the United States may cause serious
significant adverse environmental effects since the PMN substance has
been characterized by EPA as a PBT. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(4)(i),
(b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10337.
PMN Number P-04-53
Chemical name: 2-Propenoic acid, 1,1'-(1,9-nonanediyl) ester.
CAS number: 107481-28-7.
Basis for action: The PMN states that the substance will be used as
a UV-curable monomer for optical lens. Based on EcoSAR analysis of test
data on analogous acrylates, 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, 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 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 a fish
acute toxicity study (OPPTS Test Guideline 850.1075); a daphnid acute
toxicity study (OPPTS Test Guideline 850.1010); and an algal toxicity
test, tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10338.
PMN Number P-04-113
Chemical name: Adipic acid, substituted propane, alkyldiol,
acrylate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an open non-dispersive
acrylate resin. Based on 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 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, tiers
I and II (OPPTS Test Guideline 850.5400) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10339.
PMN Number P-04-146
Chemical name: Potassium zinc fluoride (KZnF3).
CAS number: 13827-02-6.
Basis for action: The PMN states that the substance will be used as
a flux for brazing aluminum. Based on EcoSAR analysis of test data on
analogous zinc compounds, 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, 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 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 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, tiers I and II (OPPTS
Test Guideline 850.5400) would help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10340.
PMN Number P-04-338
Chemical name: Amino alkyl organoborane (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymerization
catalyst/initiator for thermosetting acrylic adhesive. Based on EcoSAR
analysis of test data on analogous aminoborane, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 7 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 7 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help to
characterize the environmental effects of the PMN substance.
[[Page 25246]]
CFR citation: 40 CFR 721.10341.
PMN Number P-04-516
Chemical name: Quaternary ammonium compounds, fatty alkyl dialkyl
hydroxide (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a fuel additive. Based on
EcoSAR analysis of test data on analogous cationic surfactants, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 4 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 4 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 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, tiers I and II (OPPTS Test Guideline 850.5400) would
help to characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10342.
PMN Number P-04-563
Chemical name: Alkylated aryloxyaniline thiourea (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a pesticide intermediate. EPA identified environmental concerns because
the PMN substance may be a PBTchemical based on physical/chemical
properties of the PMN substance as described in the New Chemicals
Program's PBT category. EPA estimates that the PMN substance will
persist in the environment for more than two months and estimates a
bioaccumulation factor of greater than or equal to 5,000. Also, based
on EcoSAR analysis of test data on analogous neutral organics and
isocyanates, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb of the substance in surface waters.
According to the scenario 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 purposeful
or predictable release containing the substance into the waters of the
United States may cause significant environmental effects since the PMN
substance has been characterized by EPA as a PBT. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10343.
PMN Number P-04-810
Chemical name: Alkylated aromatic isothiocyanate (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
an insecticide intermediate. EPA identified environmental concerns
because the PMN substance may be a PBT chemical based on physical/
chemical properties of the PMN substance, as described in the New
Chemicals Program's PBT category. EPA estimates that the PMN substance
will persist in the environment for more than two months and estimates
a bioaccumulation factor of greater than or equal to 5,000. Also, based
on EcoSAR analysis of test data on analogous neutral organics and
isocyanates, EPA predicts toxicity to aquatic organisms at
concentrations that exceed 1,000 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 purposeful or
predictable release containing the substance into the waters of the
United States may cause significant environmental effects since the PMN
substance has been characterized by EPA as a PBT. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(4)(ii) and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10344.
PMN Number P-05-110
Chemical name: 1,2-Benzenedicarboxylic acid, 1,2-
bis(methylcyclohexyl) ester.
CAS number: 27987-25-3.
Basis for action: The PMN states that the substance will be used as
a plastic softener. Based on EcoSAR analysis of test data on analogous
esters, EPA predicts that 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
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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10345.
PMN Number P-05-599
Chemical name: 3H-Indolium, 2-[2-[2-chloro-3-[2-(1,3-dihydro-3,3-
dimethyl-1-propyl-2H-indol-2-ylidene)ethylidene]-1-cyclohexen-1-
yl]ethenyl]-3,3-dimethyl-1-propyl-, iodide (1:1).
CAS number: 207399-07-3.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for coating
compositions. Based on EcoSAR analysis of test data on analogous
cationic dyes, 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 will 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).
[[Page 25247]]
Recommended testing: EPA had determined that the results of a Zahn-
Wellens/EMPA test (OPPTS Test Guideline 835.3200); 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10346.
PMN Number P-06-268
Chemical name: Bicyclo[2.2.1]heptanedimethanamine, N,N'-bis(1,2-
dimethylpropylidene)-.
CAS number: 664980-30-7.
Basis for action: The PMN states that the substance will be used as
a curing agent for epoxides and urethanes. 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 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
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 721.10347.
PMN Numbers P-06-623 and P-06-624
Chemical names: Aspartic acid, N,N'-(iminodi-alkanediyl)bis,
tetraalkane esters (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
industrial coatings. Based on EcoSAR analysis of test data on analogous
aliphatic amines and esters, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 3 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 3
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 ready
biodegradation 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10348.
PMN Number P-06-731
Chemical name: 1,4-Benzenediamine, N'-(alkyl)-N-[4-
[(alkyl)amino]phenyl]-N-phenyl- (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be used as an open, non-
dispersive resin. Based on EcoSAR analysis of test data on analogous
cationic dyes, 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, 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 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, tiers I and II (OPPTS Test Guideline 850.5400)
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10349.
PMN Number P-06-742
Chemical name: Amines, C11-14-branched and linear alkyl.
CAS number: 863766-30-7.
Basis for action: The PMN states that the substance will be used as
a raw material. EPA identified environmental concerns because the PMN
substance may be a PBT chemical based on physical/chemical properties
of the PMN substance as described in the New Chemicals Program's PBT
category. EPA estimates that the PMN substance will persist in the
environment for more than two months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Also, 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 purposeful or predictable release containing the PMN
substance into the waters of the United States may cause significant
adverse environmental effects since the PMN substance has been
characterized by EPA has a PBT. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(4)(ii) and
(b)(4)(iii).
Recommended testing: EPA has determined that the results of the
tiered testing described in the New Chemicals Program's PBT category
would help characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10350.
PMN Number P-07-351
Chemical name: Carbomonocycle, bis[(4-methylphenoxy)methyl]-
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a component of a
manufactured consumer article. Based on EcoSAR analysis of test data on
analogous neutral organic chemicals, 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
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 1 ppb may
cause significant adverse environmental effects. Based on this
information the PMN substance meets
[[Page 25248]]
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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10351.
PMN Number P-08-93
Chemical name: Dimethyl terephthalate, polymer with alkyl diol and
substituted benzoates (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a binder in foundry
applications. Based on EcoSAR analysis of test data on analogous
esters, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 60 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 60 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 60 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
porous pot test (Organisation for Economic Co-operation and Development
(OECD) Test Guideline 303A); an aquatic invertebrate acute toxicity
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity, tiers I and II (OPPTS Test Guideline 850.5400) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10352.
PMN Number P-08-510
Chemical name: Organosulfide (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a co-stabilizer for
plastics. Based on EcoSAR analysis of test data on analogous esters,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 1 ppb in surface waters. As described in the PMN, releases
of the PMN 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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10353.
PMN Number P-08-623
Chemical name: 1,1'-Biphenyl, 3,3',4,4'-tetramethyl-.
CAS number: 4920-95-0.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for
production of biphenyl dianhydride. Based on EcoSAR analysis of test
data on analogous neutral organic chemicals, 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 PMN 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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10354.
PMN Number P-08-722
Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-(1-
oxododecyl)-.omega.-[3-triethoxysilyl)propoxy]-.
CAS number: 1041420-54-5.
Basis for action: The PMN states that the substance will be used as
a pigment treatment and surface treatment agent. Based on EcoSAR
analysis of test data on analogous esters, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substance in surface waters. As described in the PMN, the substance
will not 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
hydrolysis test (OPPTS Test Guideline 835.2120); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10355.
PMN Number P-09-98
Chemical name: Zinc, bis[3-(acetyl-.kappa.O)-6-methyl-2H-pyran-
2,4(3H)-dionato-.kappa.O4]diaqua-.
CAS number: 171884-15-4.
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 zinc compounds and allyl/
vinyl esters, with molecular weight adjustments, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 4 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 4 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
[[Page 25249]]
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10356.
PMN Number P-09-382
Chemical name: Iron, citrate phosphate potassium complexes.
CAS number: 120579-31-9.
Basis for action: The PMN states that the substance will be used as
a nutrient for agriculture, and as an intermediate used to manufacture
agricultural soil amendments. Based on EcoSAR analysis of test data on
analogous inorganic phosphates, 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 described use in the PMN, where the
substance will only be transported in drums with a maximum capacity of
20 gallons, or in bottom-loading totes, 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 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); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10357.
PMN Number P-09-546
Chemical name: Formaldehyde reaction products with aryl amine
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate. 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 water, from uses other than as described in the
PMN, exceed the releases expected from the use described in the PMN.
For the intermediate 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 any use other than as an intermediate that has been
manufactured using the process described in the premanufacture notice
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10358.
PMN Number P-09-613
Chemical name: Cardanol-based alkyl phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a site-limited polymer modifier for non-consumer products. Based on
EcoSAR analysis of test data on analogous anionic surfactants and
organic phosphates, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 18 ppb of the PMN substance in
surface waters. For the use described in the PMN, general population
exposure is limited 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 resulting in surface water concentrations exceeding 18 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). EPA has also determined, however, in accordance with
TSCA section 5(a)(2)(A) and 5(a)(2)(C) and with Sec. 721.170(a), that
uses other than as described in the PMN may result in significant human
exposures.
Recommended testing: EPA has determined that the results of an
acute oral toxicity study (OPPTS Test Guideline 870.1100) or an acute
oral toxicity up-and-down procedure (OECD Test Guideline 425); a
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test via the intraperitoneal route
(OPPTS Test Guideline 870.5395); a repeated dose 28-day oral toxicity
test in rodents (OPPTS Test Guideline 870.3050 or OECD Test Guideline
407) with a neurotoxicity functional observational screening battery
(OPPTS Test Guideline 870.6200) for all test doses; 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, tiers I and II (OPPTS Test Guideline 850.5400) would help
characterize the human health and environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10359.
PMN Number P-09-628
Chemical name: 1-Substituted propane, 3-(triethoxysilyl)-, reaction
products with polyethylene glycol mono-(branched tridecyl) 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 cross-linking, coupling
agent. Based on test data on the PMN substance, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 4 ppb of
the PMN substance in surface waters. As described in the PMN, the
substance will not 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 4 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) 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 721.10360.
PMN Number P-10-15
Chemical name: Anthraquinonedicarboximide, diamino-N-alkyl-
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a fuel additive.
[[Page 25250]]
Based on EcoSAR analysis of test data on analogous imides and anilines,
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 PMN 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) with
sheepshead minnows; a mysid chronic toxicity test (OPPTS Test Guideline
850.1350); and an algal toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) with diatom Skeletonema costatum would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10361.
PMN Number P-10-44
Chemical name: Oils, callitropsis nootkatensis.
CAS number: 1069136-34-0.
Basis for action: The PMN states that the substance will be used as
a fragrance ingredient. Based on EcoSAR analysis of test data on
analogous neutral organic compounds (hydrocarbons), 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 PMN 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
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10362.
PMN Number P-10-47
Chemical name: Alkenoic acid, 2-methyl-, 2-oxiranylmethyl ester,
reaction products with 4,4'-methylenebis (cyclohexanamine) (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is
as a curing agent for epoxy resin in protective coatings. Based on
EcoSAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 44 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 release of manufacturing or processing
streams containing the PMN substance resulting in surface water
concentrations exceeding 44 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10363.
PMN Number P-10-53
Chemical name: Halogenated aromatic amine (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a reactant for the manufacture of a pesticide. Based on EcoSAR analysis
of test data on analogous aromatic amines, 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, 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 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
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, tiers I and II (OPPTS
Test Guideline 850.5400) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10364.
PMN Number P-10-56
Chemical name: Butanoic acid, 3-mercapto-2-methyl-, ethyl ester.
CAS number: 888021-82-7.
Basis for action: The PMN states that the substance will be used as
an ingredient in fragrance compounds. Based on EcoSAR analysis of test
data on analogous esters and thiols, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 8 ppb of the PMN
substance in surface waters. At the maximum annual manufacturing and
importation production levels described in the PMN, releases of the PMN
substance are not expected to result in surface water concentrations
that exceed 8 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 8 ppb, or
exceedance of the annual maximum manufacturing and importation limit of
100 kilograms 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 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10365.
[[Page 25251]]
PMN Number P-10-76
Chemical name: Benzene, 4-bromo-1,2-dimethyl-.
CAS number: 583-71-1.
Basis for action: The PMN states that the substance will be used as
a raw material used for production of 1,1-biphenyl,3,3',4,4'-
tetramethyl. Based on EcoSAR analysis of test data on analogous neutral
organic chemicals, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 30 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the PMN substance are not
expected to result in surface water concentrations that exceed 30 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 30 ppb may 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
simulation test to assess the biodegradability of chemicals discharged
in wastewater (OECD Test Guideline 314); 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, tiers I and II (OPPTS
Test Guideline 850.5400) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10366.
PMN Number P-10-83
Chemical name: Hydroxy-aryl, polymer with substituted benzene,
cyanate (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 component. Based
on EcoSAR analysis of test data on analogous neutral organic chemicals,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 3 ppb of the PMN substance in surface waters. As described
in the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 3 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance 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 water
solubility test (OECD Test Guideline 105); 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 721.10367.
PMN Number P-10-84
Chemical name: Triphenodioxazine derivatives (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a dispersion additive for
printing ink. Based on EcoSAR analysis of test data on analogous
aliphatic amines and diamines, 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
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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10368.
PMN Number P-10-88
Chemical name: Carbonic acid, diphenyl ester, polymer with diphenyl
P-methylphosphonate and 4,4'-(1-methylethylidene)bis[phenol].
CAS number: 77226-90-5.
Basis for action: The PMN states that the substance will be used as
a flame retardant and flame retardant additive where the particle size
is greater than 10 microns. Based on analysis of test data on analogous
respirable, poorly soluble particulates, EPA identified concerns for
lung overload from inhalation exposures of the PMN substance. For the
uses described in the PMN, significant worker and general population
exposure is unlikely, as exposure to respirable particles is 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 as a flame retardant and flame retardant
additive where the particle size is greater than 10 microns, may result
in significant human exposures to the respirable form of the PMN
substance. Based on this information, the PMN substance meets the
concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period would help characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10369.
PMN Number P-10-99
Chemical name: Phosphonic acid, p-octyl-, lanthanum (3+) salt
(2:1).
CAS number: 1186211-38-0.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a modifier for polymers.
Based on EcoSAR analysis of test data on analogous lanthanum salts, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 8 ppb of the PMN substance in surface waters. As described in
the PMN, releases of the PMN substance are not expected to result in
surface water concentrations that exceed 8 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 8 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a
simulated biodegradability test (OECD Test Guideline 314); 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10370.
[[Page 25252]]
PMN Number P-10-136
Chemical names: (P-10-136, Chemical A) Butanoic acid, 3-mercapto-
,1,1'-[2,2-bis[(substituted-1-oxoalkoxy)methyl]-1,3-propanediyl] ester
(generic) and (P-10-136, Chemical B) Butanoic acid, 3-mercapto-,1,1'-
[2-(hydroxymethyl)-2-(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl]
ester (generic).
CAS numbers: Not available.
Basis for action: The PMN states that the substance will be used as
a monomer for acryl-based UV-curing coatings, inks, and adhesives.
Based on test data on the PMN substance, EPA identified concerns for
systemic toxicity, mutagenic effects, dermal sensitization and
neurotoxicity from dermal and inhalation exposures to the PMN
substance. Further, based on test data on the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 ppb of the PMN substance in surface waters. For the uses
described in the PMN, significant worker exposure is unlikely, as
dermal and inhalation exposures are low, and the substance is not
released to surface waters. 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, use other
than as described in the PMN, or any use of the substance resulting in
surface water concentrations exceeding 2 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)(i) and (b)(4)(i).
Recommended testing: EPA has determined that the results of a
mammalian bone marrow chromosomal aberration test (OPPTS Test Guideline
870.5385) by the intraperitoneal route; a reproduction/developmental
toxicity screening test (OECD Test Guideline 421); 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 citations: 40 CFR 721.10371 (P-10-136, Chemical A) and 40 CFR
721.10372 (P-10-136, Chemical B).
PMN Number P-10-153
Chemical name: 1H-Imidazole, 1-(1-methylethyl)-.
CAS number: 4532-96-1.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate.
Based on test data on the PMN substance, and EcoSAR analysis of test
data on analogous imidazoles, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 70 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 other than as a chemical intermediate, or any use of
the substance resulting in surface water concentrations exceeding 70
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 ready
biodegradability test--CO2 in sealed vessels (OPPTS Test
Guideline 835.3140 or OECD Test Guideline 310); 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, tiers I and II (OPPTS
Test Guideline 850.5400) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10373.
PMN Number P-10-163
Chemical name: Silane, (3-chloro- propoxy)dimethyl(l-methylethyl)-.
CAS number: 1191036-21-1.
Basis for action: The PMN states that the substance will be used as
an isolated intermediate in the preparation of a lithium reagent. Based
on the expected alkylating agent potential of the PMN substance, and
analysis of test data on analogous substances, EPA identified concerns
for oncogenicity, mutagenicity, developmental toxicity, liver toxicity,
irritation, and possible corrosion to all tissues to workers exposed to
the PMN substance. Further, 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, worker inhalation
and dermal exposures are not expected due to the use of organic vapor
respirators, impervious gloves and goggles, and environmental releases
to surface waters are not expected. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance without the use of impervious gloves, goggles, and
organic vapor respirators, where there is a potential of dermal or
inhalation exposure; or any use of the substance resulting in surface
water concentrations exceeding 2 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)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395)
via the intraperitoneal route; an acute dermal irritation test (OPPTS
Test Guideline 870.2500); a skin sensitization test (OPPTS Test
Guideline 870.2600); a repeated dose 28-day oral toxicity test (OPPTS
Test Guideline 870.3050) in rodents; a fish acute toxicity test (OPPTS
Test Guideline 850.1075); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would
help characterize the human health and environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10374.
PMN Number P-10-200
Chemical name: Hydroxypropyl methacrylate, reaction products with
propylene oxide and ethylene oxide, copolymer with N-vinyl caprolactam
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an oilfield polymer.
Based on test data on the PMN substance, and EcoSAR analysis of test
data on analogous nonionic polymers, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 155 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 155 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 155 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets
[[Page 25253]]
the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10375.
PMN Number P-10-222
Chemical name: Alkyltin halide (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an alkylating agent.
Based on test data on a structurally similar substance, EPA identified
concerns for immunotoxicity, asthma, and sensitization from exposure to
the PMN substance via the inhalation and dermal route. Further, based
on EcoSAR analysis of test data on analogous tin compounds, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 22 ppb of the PMN substance in surface waters. For the use
described in the PMN, worker inhalation and dermal exposures are
expected to be minimal and releases of the PMN substance to surface
waters are not expected to result in surface water concentrations that
exceed 22 ppb. 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 described in the PMN, or any release of the
substance resulting in surface water concentrations exceeding 22 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 ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute
toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate
acute toxicity test, freshwater daphnids (OPPTS Test Guideline
850.1010); and an algal toxicity test, tiers I and II (OPPTS Test
Guideline 850.5400) would help characterize the human health and
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10376.
PMN Number P-10-247
Chemical names: (P-10-247, Chemical A) 1,2-Cyclohexanedicarboxylic
acid, benzyl C8-10-isoalkyl esters, C9-rich and (P-10-247, Chemical B)
1,2-Cyclohexanedicarboxylic acid, benzyl nonyl ester, branched and
linear.
CAS numbers: (P-10-247, Chemical A) 1190265-49-6 and (P-10-247,
Chemical B) 1190264-82-4.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for polymers.
Based on test data on the PMN substance, EPA identified concerns for
skin and eye irritation via the dermal route. In addition, based on
test data on a structurally similar compound, EPA identified concerns
for systemic health effects. Further, based on EcoSAR analysis of test
data on analogous esters, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. As described in the PMN, worker exposure to the
substance is expected to be minimal due to the use of impervious
gloves, and releases of the substance are not expected to result in
surface water concentrations that exceed 1 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without the use of impervious
gloves where there is a potential for dermal exposure, or any use of
the substance resulting in surface water concentrations exceeding 1
ppb, may 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 ready
biodegradability test (OPPTS Test Guideline 835.3110); a porous pot
test (OPPTS Test Guideline 835.3220); a combined chronic toxicity/
carcinogenicity test (OPPTS Test Guideline 870.4300); 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, tiers I and II (OPPTS Test Guideline 850.5400) would help
characterize the human health and environmental effects of the PMN
substance.
CFR citations: 40 CFR 721.10377 (P-10-247, Chemical A) and 40 CFR
721.10378 (P-10-247, Chemical B).
PMN Number P-10-266
Chemical name: Propanoic acid, 3-(dodecylthio)-, 2-(1,1-
dimethylethyl)-4-[[5-(1,1-dimethylethyl)-4-hydroxy-2-
methylphenyl]thio]-5-methylphenyl ester.
CAS number: 69075-62-3.
Basis for action: The PMN states that the substance will be used as
an antioxidant for plastic articles. Based on test data on the PMN
substance, EPA identified health concerns to workers from exposure to
the PMN substance via inhalation, which include long-term effects to
the liver, heart, blood, and possible immunotoxicity. As described in
the PMN, and at the production level stated in the PMN, worker
inhalation exposure will be minimal. 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 if
the production volume increases substantially, the potential for
exposure could change correspondingly, and may result in serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of a
reproductive/developmental toxicity screening test, via the oral route
(OPPTS Test Guideline 870.3550 or OECD Test Guideline 421) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10379.
PMN Number P-10-285
Chemical name: Benzoic acid, 3-amino-2-mercapto-.
CAS number: 71807-60-8.
Basis for action: The PMN states that the substance will be used as
an intermediate. Based on EcoSAR analysis of test data on analogous
thiols, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 33 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 33 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
[[Page 25254]]
Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS
Test Guideline 850.5400) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10380.
PMN Number P-10-290
Chemical name: Cyclic carboxylic acid, polymer with dihydroxy
dialkyl ether, hydroxy substituted alkane and carboxylic acid
anhydride, methacrylate terminated polyester (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance is a
base resin for gel coat compounds. Based on EcoSAR analysis of test
data on analogous esters, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 8 ppb of the PMN substance in
surface waters. As described in the PMN, 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 8 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10381.
PMN Number P-10-313
Chemical name: Diphosphoric acid, calcium salt (1:1).
CAS number: 14866-19-4.
Basis for action: The PMN states that the substance will be used as
an opacifying agent for ceramic whiteware. Based on test data on
analogous respirable, poorly soluble particulates, EPA identified
concerns for lung effects if respirable particles are inhaled. Further,
based on EcoSAR analysis of test data on analogous inorganic
phosphates, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 60 ppb of the PMN substance in surface
waters. For the use described in the PMN, no significant inhalation
exposures are 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 opacifying pigment for ceramic whiteware, or
any use resulting in releases to surface waters that produce surface
water concentrations that exceed 60 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 water
solubility test, shake flask method (OPPTS Test Guideline 830.7840)
using mass spectrometry as the analytical method; 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, tiers I and II (OPPTS Test Guideline 850.5400) would help
characterize the human health and environmental effect of the PMN
substance. Depending on the results of the water solubility test, a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period may be necessary.
CFR citation: 40 CFR 721.10382.
PMN Number P-10-324
Chemical name: Urea, N, N'-(methyl-1,3-phenylene)bis[N', N'-bis[3-
polyalkyleneamino]-, compd. with formaldehyde polymer with phenol
(generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a curing agent or accelerator for epoxy resin. Based on EcoSAR analysis
of test data on analogous polycationic polymers, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 43 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 43 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10383.
PMN Number P-10-332
Chemical name: Substituted alkanolamine phenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
a polyol for rigid foam. Based on EcoSAR analysis of test data on
analogous aliphatic amines, phenols, and phenol-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 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 water
solubility test: Column elution method; shake flask method (OPPTS Test
Guideline 830.7840); either a simulation test--aerobic sewage
treatment: Activated sludge units (OECD Test Guideline 303A) or an
aerobic aquatic biodegradation 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10384.
PMN Number P-10-344
Chemical name: Phenoxy 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 plasticizing component
of a two part coating containing a flexibilizer at a maximum
concentration of 10 percent. Based on test data on the hydrolysis
product of the PMN substance, EPA identified concerns for blood
effects, developmental effects, and reproductive
[[Page 25255]]
effects to workers exposed to the PMN substance. For the use described
in the PMN, significant worker exposure is unlikely, as the substance
is imported, and significant dermal and inhalation exposures 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 a plasticizing component of a two part coating
containing a flexibilizer at a maximum PMN concentration of 10 percent,
may cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(iii).
Recommended testing: Based on the test data available to EPA on the
hydrolysis product of the PMN substance, EPA does not recommend
additional testing at this time.
CFR citation: 40 CFR 721.10385.
PMN Number P-10-361
Chemical name: Substituted phenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will
be as an organic intermediate in substituted bis-phenol manufacturing.
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, 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 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, tiers I and II
(OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10386.
PMN Number P-10-362
Chemical name: Substituted bis-phenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will
be as an organic intermediate in bis-phosphite synthesis. Based on
EcoSAR analysis of test data on analogous polyphenols, 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10387.
PMN Number P-10-364
Chemical name: Bisphospite nickel cyanoalkyl complex (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will
be as a soluble metal catalyst for organic synthesis. Based on EcoSAR
analysis of test data on analogous inorganic nickel compounds, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 5 ppb of the PMN substance in surface waters. As described in
the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 5 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in 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); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10388.
PMN Number P-10-401
Chemical name: Styrene, copolymer with acrylic acid, salt with
alkoxylated alkenylamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a non-dispersive
additive. Based on EcoSAR analysis of test data on analogous
polycationic polymers, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 27 ppb of the PMN substance in
surface waters. Based on the wastewater treatment processes described
in the PMN, releases of the PMN substance are not expected to result in
surface water concentrations that exceed 27 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 27 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10389.
PMN Number P-10-403
Chemical name: Acetoacetanilide reaction product with
multifunctional acrylate (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 composite.
Based on EcoSAR analysis of test data on analogous acrylates, esters,
and amides, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is
[[Page 25256]]
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
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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10390.
PMN Number P-10-424
Chemical name: Copper gallium indium selenide.
CAS number: 144972-86-1.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a copper indium metal
selenide deposited on a substrate as a part of manufacturing copper
indium metal selenide solar panel. Based on analysis of test data on
analogous respirable, poorly soluble particulates (subcategory titanium
dioxide), EPA identified concerns for lung effects and lung tumors to
workers exposed to the PMN substance. As described in the PMN, worker
exposure will be minimal due to the use of adequate respiratory
protection and adequate hazard communication warnings in the Material
Safety Data Sheet (MSDS). Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance without a National Institute for Occupational Safety and
Health (NIOSH)-certified respirator with an Assigned Protection Factor
(APF) of at least 10, or the equivalent NCEL of 1.5 mg/m\3\ as an 8-
hour time weighted average, where there is a potential for inhalation
exposure, may cause serious health effects. EPA has also determined
that any use of the substance without adequate hazard communication 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) in rats
would help characterize the human health effects of the PMN substance.
Testing should include a 60-day recovery.
CFR citation: 40 CFR 721.10391.
PMN Number P-10-426
Chemical name: Halo substituted sulfamidylbenzyluracil (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate. Based on
test data on structurally similar chemicals, EPA identified concerns
for developmental toxicity via the inhalation route. Further, based on
test data for a close structural analog of the PMN substance and EcoSAR
analysis of test data on analogous neutral organics, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. As described in the PMN,
worker inhalation exposures are expected to be minimal due to
manufacturing in an enclosed system and use as a chemical intermediate,
and releases to surface waters 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 manufacture of the substance in a non-enclosed
system, use of the substance other than as a chemical intermediate, or
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)(ii),
(b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a
prenatal developmental toxicity test (OPPTS Test Guideline 870.3700); 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10392.
PMN Number P-10-433
Chemical name: Sodium bromide MDA 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 chemical intermediate
for manufacturing polyurethane rubber elastomer for tires, wheels,
rolls, screens, belts, and other specialty urethane articles. Based on
EcoSAR analysis of test data on analogous anilines, 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 ready
biodegradability test (OPPTS Test Guideline 835.3110); a dissociation
constant in water test (OECD Test Guideline 112); 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, tiers I and II (OPPTS
Test Guideline 850.5400) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10393.
PMN Number P-10-436
Chemical name: Copolymer of anhydride, a diol and a disubstituted
diol (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 additive. Based
on EcoSAR analysis of test data on analogous acrylates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
55 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 55 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 55 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
[[Page 25257]]
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10394.
PMN Number P-10-458
Chemical name: Fatty acids, C14-18 and C16-18 unsatd., polymers
with adipic acid and triethanolamine, di-Me sulfate-quaternized.
CAS number: 1211825-32-9.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adjuvant in the
production of paper. Based on test data on the PMN substance and EcoSAR
analysis of test data on analogous polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 5
ppb of the PMN substance in surface waters. As described in the PMN,
releases of the substance are not expected to result in surface water
concentrations that exceed 5 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in 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) 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 721.10395.
PMN Number P-10-470
Chemical name: Dimethyl siloxy-polyfluoro methyl siloxy-
poly(oxyalkylenediyl) methyl siloxy copolymer (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: April 20, 2011.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as an open,
non-dispersive carpet treatment. EPA has concerns for potential
incineration or other decomposition products of the PMN substance.
These perfluorinated products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers
that suggests that, under some conditions, the PMN substance could
degrade in the environment. EPA has concerns that these degradation
products will persist in the environment, could bioaccumulate or
biomagnify, and could be toxic to people, wild mammals, and birds.
These concerns are based on data on analog chemicals, including
perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, which
include the presumed environmental degradant of the PMN substance.
There is pharmacokinetic and toxicological data in animals on PFOA, as
well as epidemiological and blood monitoring data in humans. Toxicity
studies on PFOA indicate developmental, reproductive, and systemic
toxicity in various species, as well as cancer. These factors, taken
together, raise concerns for potential adverse chronic effects from the
presumed degradation product in humans and wildlife. 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 present
an unreasonable risk of injury to the environment and human health, the
substance 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
substance and its potential degradation products. To protect against
these risks, the consent order requires: No manufacture of the
substance beyond an annual aggregate manufacture and importation
volume; recording and reporting of certain fluorinated impurities in
the starting raw material; and manufacture of the PMN substance not to
exceed the maximum established impurity levels of certain fluorinated
impurities. The SNUR designates as a ``significant new use'' the
absence of these protective measures.
Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property testing identified in the TSCA 5(e)
consent order would help characterize possible effects of the substance
and its degradation products. The order does not require submission of
the 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 order is modified or revoked by EPA based on submission of that or
other relevant information.
CFR citation: 40 CFR 721.10396.
PMN Numbers P-10-471 and P-10-472
Chemical names: Alkyl acrylate-polyfluoro methacrylate-
poly(oxyalkylenediyl)- methacrylates (generic).
CAS numbers: Not available.
Effective date of TSCA section 5(e) consent order: April 20, 2011.
Basis for TSCA section 5(e) consent order: The consolidated PMN
states that the generic (non-confidential) use of the PMN substances
will be as open, non-dispersive additives. EPA has concerns for
potential incineration or other decomposition products of the PMN
substances. These perfluorinated 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 be
PBT chemicals, based on data on analog chemicals, including PFOA and
other perfluorinated alkyls, which include the presumed environmental
degradant of the PMN substances. There is pharmacokinetic and
toxicological data in animals on PFOA, as well as epidemiological and
blood monitoring data in humans. Toxicity studies on PFOA indicate
developmental, reproductive, and systemic toxicity in various species,
as well as cancer. These factors, taken together, raise concerns for
potential adverse chronic effects from the presumed degradation product
in humans and wildlife. 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 risks, the
consent order requires: No manufacture of the substances beyond an
annual aggregate manufacture and importation volume; recording and
reporting of certain
[[Page 25258]]
fluorinated impurities in the starting raw materials; and manufacture
of the PMN substances not to exceed the maximum established impurity
levels of certain fluorinated impurities. The SNUR designates as a
``significant new use'' the absence of these protective measures.
Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property testing identified in the TSCA 5(e)
consent order would help characterize possible effects of the
substances and their degradation products. The order does not require
submission of the 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 PMNs 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 721.10397.
PMN Number P-10-495
Chemical name: Poly(oxy-1,2-ethanediyl),.alpha., -monoalkyl
ethers-.omega.-mono (hydrogen maleate)- (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating additive. Based
on test data submitted with the PMN, EPA identified concerns for dermal
sensitization to workers and consumers exposed to the PMN substance.
For the industrial uses described in the PMN, significant worker
exposures will be minimal due to the use of protective equipment.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance other than
for industrial applications may result in consumer exposures which may
cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of a
dermal sensitization test (OPPTS Test Guideline 870.2600) at varying
concentrations or different formulations would help characterize human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10398.
PMN Number P-10-501
Chemical name: Benzoic acid azo-substituted pyridine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as site-limited
intermediate. Based on EcoSAR analysis of test data on analogous vinyl/
allyl nitriles, 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 PMN 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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10399.
PMN Numbers P-10-517 and P-10-518
Chemical names: (P-10-517) Oxirane, 2-ethyl-, polymer with oxirane,
mono-C12-14-sec-alkyl ethers and (P-10-518) Oxirane, 2-ethyl-, polymer
with oxirane, mono-C11-15-sec-alkyl ethers.
CAS numbers: (P-10-517) 1013910-41-2 and (P-10-518) 1022990-65-3.
Basis for action: The consolidated PMN states that the substances
will be used as surfactants for architectural coatings and industrial
metal cleaning solutions. Based on test data on the PMN substances, and
EcoSAR analysis of test data on analogous nonionic surfactants, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 14 ppb of the PMN substance P-10-517, and 20 ppb of the PMN
substance P-10-518, in surface waters. As described in the consolidated
PMN notice, releases to surface waters are not expected to exceed 14
ppb or 20 ppb, respectively, due to pretreatment of wastes prior to
release. 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 14 ppb
of P-10-517, or 20 ppb of P-10-518, may cause significant adverse
environmental effects. Based on this information, the PMN substances
meet the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of an
activated sludge simulation study (OECD Test Guideline 303A); 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 citations: 40 CFR 721.10400 (P-10-517) and 40 CFR 721.10401 (P-
10-518).
PMN Number: P-10-548
Chemical name: Vegetable oil, modified products (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 EcoSAR analysis of test data on analogous neutral organic
compounds, 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citations: 40 CFR 721.10402.
PMN Number P-10-550
Chemical name: Vegetable oil, modified products, esters (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 EcoSAR analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 8
ppb of the PMN substance in surface waters. As described in the PMN,
[[Page 25259]]
releases of the substance are not expected to result in surface water
concentrations that exceed 8 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of any of the substance resulting in surface water concentrations
exceeding 8 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citations: 40 CFR 721.10403.
PMN Numbers P-10-551 and P-10-552
Chemical names: Olefins (generic) (P-10-551 and P-10-552).
CAS numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as chemical intermediates.
Based on EcoSAR analysis of test data on analogous neutral organics,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 6 ppb of the PMN substances in surface waters. As described
in the PMNs, releases of the substances are not expected to result in
surface water concentrations that exceed 6 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substances may present an unreasonable risk. EPA has determined,
however, that any use of any of the substances resulting in surface
water concentrations exceeding 6 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); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10404.
PMN Number P-10-553
Chemical name: Olefins (generic) (P-10-553).
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 EcoSAR analysis of test data on analogous neutral organic
compounds, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. For the specific use and production limit described in the PMN,
releases of the PMN 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 use of the substance other than as described in the PMN,
any use of the substance resulting in surface water concentrations
exceeding 1 ppb, or use beyond the annual aggregate production limit
may 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 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, tiers I and II (OPPTS Test Guideline 850.5400)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10405.
PMN Number P-10-554
Chemical name: Fatty acid methyl esters (generic) (P-10-554).
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 EcoSAR analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 8
ppb of the PMN substance in surface waters. As described in the PMN,
releases of the substance are not expected to result in surface water
concentrations that exceed 8 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of any of the substance resulting in surface water concentrations
exceeding 8 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citations: 40 CFR 721.10406.
PMN Number: P-10-555
Chemical name: Fatty acid methyl esters (generic) (P-10-555).
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 EcoSAR analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. As described in the PMN,
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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citations: 40 CFR 721.10407.
PMN Number P-10-556
Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-
dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethyl]-.omega.-
[2-[[2,2-dimethyl-3-[(1-
oxododecyl)oxy]propylidene]amino]methylethoxy]-.
CAS number: 613246-75-6.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a latent curing
[[Page 25260]]
agent in polyurethane adhesives. 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,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10408.
PMN Number P-11-217
Chemical name: Poly(oxyalkylenediyl), .alpha.-[[[methyl-3-
[[[(polyfluoroalkyl)oxy]carbonyl]amino]phenyl]amino]carbonyl]-.omega.-
methoxy-(generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: June 24, 2011.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as an open,
non-dispersive carpet treatment. EPA has concerns for potential
incineration or other decomposition products of the PMN substance.
These perfluorinated products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers
that suggests that, under some conditions, the PMN substance could
degrade in the environment. EPA has concerns that these degradation
products will persist in the environment, could be PBT chemicals, based
on data on analog chemicals, including PFOA and other perfluorinated
alkyls, which include the presumed environmental degradant. There is
pharmacokinetic and toxicological data in animals on PFOA, as well as
epidemiological and blood monitoring data in humans. Toxicity studies
on PFOA indicate developmental, reproductive, and systemic toxicity in
various species, as well as cancer. These factors, taken together,
raise concerns for potential adverse chronic effects from the presumed
degradation product in humans and wildlife. 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 present an unreasonable risk
of injury to the environment and human health, the substance 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 substance and its
potential degradation products. To protect against these risks, the
consent order requires: No manufacture of the substance beyond an
annual aggregate manufacture and importation volume; recording and
reporting of certain fluorinated impurities in the starting raw
material; and manufacture of the PMN substance not to exceed the
maximum established impurity levels of certain fluorinated impurities.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property testing identified in the TSCA 5(e)
consent order would help characterize possible effects of the substance
and its degradation products. The order does not require submission of
the 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 order is modified or revoked by EPA based on submission of that or
other relevant information.
CFR citation: 40 CFR 721.10409.
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 four of the 119
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 117 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/.
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 June 26, 2012 without further notice, unless EPA receives
written adverse or critical comments, or notice of intent to submit
adverse or critical comments before May 29, 2012.
[[Page 25261]]
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 May 29, 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 April 27, 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 four 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, 83 of the 119
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 April 24, 1990 SNUR, 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 pertaining to
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.''
The Organisation for Economic Co-operation and Development (OECD) test
guidelines are available from the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
In the TSCA section 5(e) consent orders for four 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.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
[[Page 25262]]
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-
2011-0577.
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, and (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: (1) A significant number of
SNUNs would not be submitted by small entities in response to the SNUR
and (2) submission of the SNUN would not cost any small entity
significantly more than $8,300. Therefore, the promulgation of the SNUR
would not have a significant economic impact on a substantial number of
small entities.
[[Page 25263]]
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: April 12, 2012.
Ward Penberthy,
Acting 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. The table in Sec. 9.1 is amended by adding the following sections
in numerical order under the heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10299............................................... 2070-0012
721.10300............................................... 2070-0012
721.10301............................................... 2070-0012
721.10302............................................... 2070-0012
721.10303............................................... 2070-0012
721.10304............................................... 2070-0012
721.10305............................................... 2070-0012
721.10306............................................... 2070-0012
721.10307............................................... 2070-0012
721.10308............................................... 2070-0012
721.10309............................................... 2070-0012
721.10310............................................... 2070-0012
721.10311............................................... 2070-0012
721.10312............................................... 2070-0012
721.10313............................................... 2070-0012
721.10314............................................... 2070-0012
721.10315............................................... 2070-0012
721.10316............................................... 2070-0012
721.10317............................................... 2070-0012
721.10318............................................... 2070-0012
721.10319............................................... 2070-0012
721.10320............................................... 2070-0012
721.10321............................................... 2070-0012
721.10322............................................... 2070-0012
721.10323............................................... 2070-0012
721.10324............................................... 2070-0012
721.10325............................................... 2070-0012
721.10326............................................... 2070-0012
721.10327............................................... 2070-0012
721.10328............................................... 2070-0012
721.10329............................................... 2070-0012
721.10330............................................... 2070-0012
721.10331............................................... 2070-0012
721.10332............................................... 2070-0012
721.10333............................................... 2070-0012
721.10334............................................... 2070-0012
721.10335............................................... 2070-0012
721.10336............................................... 2070-0012
721.10337............................................... 2070-0012
721.10338............................................... 2070-0012
721.10339............................................... 2070-0012
721.10340............................................... 2070-0012
721.10341............................................... 2070-0012
721.10342............................................... 2070-0012
721.10343............................................... 2070-0012
721.10344............................................... 2070-0012
721.10345............................................... 2070-0012
721.10346............................................... 2070-0012
721.10347............................................... 2070-0012
721.10348............................................... 2070-0012
721.10349............................................... 2070-0012
721.10350............................................... 2070-0012
[[Page 25264]]
721.10351............................................... 2070-0012
721.10352............................................... 2070-0012
721.10353............................................... 2070-0012
721.10354............................................... 2070-0012
721.10355............................................... 2070-0012
721.10356............................................... 2070-0012
721.10357............................................... 2070-0012
721.10358............................................... 2070-0012
721.10359............................................... 2070-0012
721.10360............................................... 2070-0012
721.10361............................................... 2070-0012
721.10362............................................... 2070-0012
721.10363............................................... 2070-0012
721.10364............................................... 2070-0012
721.10365............................................... 2070-0012
721.10366............................................... 2070-0012
721.10367............................................... 2070-0012
721.10368............................................... 2070-0012
721.10369............................................... 2070-0012
721.10370............................................... 2070-0012
721.10371............................................... 2070-0012
721.10372............................................... 2070-0012
721.10373............................................... 2070-0012
721.10374............................................... 2070-0012
721.10375............................................... 2070-0012
721.10376............................................... 2070-0012
721.10377............................................... 2070-0012
721.10378............................................... 2070-0012
721.10379............................................... 2070-0012
721.10380............................................... 2070-0012
721.10381............................................... 2070-0012
721.10382............................................... 2070-0012
721.10383............................................... 2070-0012
721.10384............................................... 2070-0012
721.10385............................................... 2070-0012
721.10386............................................... 2070-0012
721.10387............................................... 2070-0012
721.10388............................................... 2070-0012
721.10389............................................... 2070-0012
721.10390............................................... 2070-0012
721.10391............................................... 2070-0012
721.10392............................................... 2070-0012
721.10393............................................... 2070-0012
721.10394............................................... 2070-0012
721.10395............................................... 2070-0012
721.10396............................................... 2070-0012
721.10397............................................... 2070-0012
721.10398............................................... 2070-0012
721.10399............................................... 2070-0012
721.10400............................................... 2070-0012
721.10401............................................... 2070-0012
721.10402............................................... 2070-0012
721.10403............................................... 2070-0012
721.10404............................................... 2070-0012
721.10405............................................... 2070-0012
721.10406............................................... 2070-0012
721.10407............................................... 2070-0012
721.10408............................................... 2070-0012
721.10409............................................... 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. 721.10299 to subpart E to read as follows:
Sec. 721.10299 Polymeric MDI based polyurethanes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
polymeric MDI based polyurethanes (PMNs P-00-2, P-00-5, and P-00-6) are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(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
5. Add Sec. 721.10300 to subpart E to read as follows:
Sec. 721.10300 Benzeneacetic acid, .alpha.-chloro-.alpha.-phenyl-,
ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzeneacetic acid,
.alpha.-chloro-.alpha.-phenyl-, ethyl ester (PMN P-00-85; CAS No.
52460-86-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (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
6. Add Sec. 721.10301 to subpart E to read as follows:
Sec. 721.10301 Reaction products of fatty alcohols,
(aminoethylaminopropyl) dialkoxymethylsilane, glycidol, and hydroxy-
terminated polydimethylsiloxane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction products of fatty alcohols, (aminoethylaminopropyl)
dialkoxymethylsilane, glycidol, and hydroxy-terminated
polydimethylsiloxane (PMN P-00-317) is subject to 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
7. Add Sec. 721.10302 to subpart E to read as follows:
Sec. 721.10302 Zinc ammonium phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as zinc
ammonium phosphate (PMN P-00-442) is subject to 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
8. Add Sec. 721.10303 to subpart E to read as follows:
[[Page 25265]]
Sec. 721.10303 Polyether modified polysiloxane, acrylated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyether modified polysiloxane, acrylated (PMN P-00-833) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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
9. Add Sec. 721.10304 to subpart E to read as follows:
Sec. 721.10304 Functionalized polymethine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
functionalized polymethine (PMN P-00-1099) is subject to 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
10. Add Sec. 721.10305 to subpart E to read as follows:
Sec. 721.10305 Modified cyclohexane esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified cyclohexane esters (PMN P-00-1108) is subject to 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
11. Add Sec. 721.10306 to subpart E to read as follows:
Sec. 721.10306 Substituted phenylepoxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted phenylepoxide (PMN P-01-114) is subject to 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=6).
(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
12. Add Sec. 721.10307 to subpart E to read as follows:
Sec. 721.10307 Acrylate resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acrylate resin (PMN P-01-343) is subject to 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
13. Add Sec. 721.10308 to subpart E to read as follows:
Sec. 721.10308 Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, dialkylethanolamine salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, dialkylethanolamine salt (PMN P-01-384) 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=70).
(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
14. Add Sec. 721.10309 to subpart E to read as follows:
Sec. 721.10309 Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate (PMN P-01-385) is subject to 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=70).
[[Page 25266]]
(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
15. Add Sec. 721.10310 to subpart E to read as follows:
Sec. 721.10310 Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, ammonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, ammonium salt as (PMN P-01-386) is subject
to 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=70).
(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
16. Add Sec. 721.10311 to subpart E to read as follows:
Sec. 721.10311 Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, sodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, sodium salt (PMN P-01-387) is subject to
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=70).
(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
17. Add Sec. 721.10312 to subpart E to read as follows:
Sec. 721.10312 Ethoxylated, propoxylated diamine diaryl substituted
phenylmethane ester with alkenylsuccinate, ethanolamine salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated, propoxylated diamine diaryl substituted phenylmethane
ester with alkenylsuccinate, ethanolamine salt (PMN P-01-388) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=70).
(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
18. Add Sec. 721.10313 to subpart E to read as follows:
Sec. 721.10313 Fatty acids, C16-18 and C18-unsatd., Me esters,
epoxidized.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fatty acids, C16-18
and C18-unsatd., Me esters, epoxidized (PMN P-02-249; CAS No. 158318-
67-3) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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. 721.10314 to subpart E to read as follows:
Sec. 721.10314 Dialkyl dithiocarbamate esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
dialkyl dithiocarbamate esters (PMNs P-02-778, P-02-779, and P-02-780)
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)(1), (b)(1), and (c)(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
20. Add Sec. 721.10315 to subpart E to read as follows:
Sec. 721.10315 1,5-Dioxa-9-azaspiro[5.5]undecane, 3,3,8,8,10,10-
hexamethyl-9-[1-[4-(2-oxiranylmethoxy)phenyl]ethoxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,5-dioxa-9-
azaspiro[5.5]undecane, 3,3,8,8,10,10-hexamethyl-9-[1-[4-(2-
oxiranylmethoxy)phenyl]ethoxy]- (PMN P-02-833; CAS No. 434898-80-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
[[Page 25267]]
(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
21. Add Sec. 721.10316 to subpart E to read as follows:
Sec. 721.10316 Dicyclopentadiene polymer with maleic anhydride and
alkyl alcohols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dicyclopentadiene polymer with maleic anhydride and alkyl alcohols (PMN
P-02-872) is subject to 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
22. Add Sec. 721.10317 to subpart E to read as follows:
Sec. 721.10317 Alkyl phosphate derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
phosphate derivative (PMN P-02-1040) is subject to 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
23. Add Sec. 721.10318 to subpart E to read as follows:
Sec. 721.10318 Mannich bases (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
mannich bases (PMNs P-02-1078 and P-02-1080) 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=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
24. Add Sec. 721.10319 to subpart E to read as follows:
Sec. 721.10319 Alkylamides, ethoxylated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylamides, ethoxylated (PMN P-03-42) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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. 721.10320 to subpart E to read as follows:
Sec. 721.10320 Fatty acid amide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid amide (PMN P-03-186) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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. 721.10321 to subpart E to read as follows:
Sec. 721.10321 Bis[phenyl, 2H-1,3-benzoxazine]derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
bis[phenyl, 2H-1,3-benzoxazine]derivative (PMN P-03-194) is subject to
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)(1), (b)(1), and (c)(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
27. Add Sec. 721.10322 to subpart E to read as follows:
Sec. 721.10322 Metallic diol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified
[[Page 25268]]
generically as metallic diol (PMN P-03-196) is subject to 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=6).
(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
28. Add Sec. 721.10323 to subpart E to read as follows:
Sec. 721.10323 Glycerol fatty acid ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
glycerol fatty acid ester (PMN P-03-248) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=6).
(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. 721.10324 to subpart E to read as follows:
Sec. 721.10324 Thionocarbamate derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
thionocarbamate derivative (PMN P-03-362) is subject to 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=50).
(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. 721.10325 to subpart E to read as follows:
Sec. 721.10325 Cyclosilazanes, di-Me, Me hydrogen, polymers with di-
Me, Me hydrogen silazanes, reaction products with 3-(triethoxysilyl)-1-
propanamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclosilazanes, di-
Me, Me hydrogen, polymers with di-Me, Me hydrogen silazanes, reaction
products with 3-(triethoxysilyl)-1-propanamine (PMN P-03-442; CAS No.
475645-84-2) 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=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
31. Add Sec. 721.10326 to subpart E to read as follows:
Sec. 721.10326 2-Propenoic acid, 2-methyl-, methyl ester, polymer
with butyl 2-propenoate, ethyl 2-propenoate, zinc 2-methyl-2-propenoate
(1:2) and zinc 2-propenoate (1:2), 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]- and 2,2'-(1,2-diazenediyl)bis[2-
methylpropanenitrile]-initiated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethyl 2-
propenoate, zinc 2-methyl-2-propenoate (1:2) and zinc 2-propenoate
(1:2), 2,2'-(1,2-diazenediyl)bis[2-methylbutanenitrile]- and 2,2'-(1,2-
diazenediyl)bis[2-methylpropanenitrile]-initiated (PMN P-03-458; CAS
No. 460739-39-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (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
32. Add Sec. 721.10327 to subpart E to read as follows:
Sec. 721.10327 Salt of mixed fatty amidoamines and
polyethylenepolyamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as salt of
mixed fatty amidoamines and polyethylenepolyamines (PMN P-03-529) is
subject to 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
33. Add Sec. 721.10328 to subpart E to read as follows:
Sec. 721.10328 Salt of polyalkylenepolyamine derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified
[[Page 25269]]
generically as salt of polyalkylenepolyamine derivative (PMN P-03-530)
is subject to 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
34. Add Sec. 721.10329 to subpart E to read as follows:
Sec. 721.10329 Salt of mixed fatty amidoamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as salt of
mixed fatty amidoamines (PMN P-03-531) is subject to 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
35. Add Sec. 721.10330 to subpart E to read as follows:
Sec. 721.10330 Pyrazolone derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
pyrazolone derivative (PMN P-03-722) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(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
36. Add Sec. 721.10331 to subpart E to read as follows:
Sec. 721.10331 Aromatic isocyanate methacrylate blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic isocyanate methacrylate blocked (PMN P-03-767) is subject to
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
37. Add Sec. 721.10332 to subpart E to read as follows:
Sec. 721.10332 Lithium metal phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lithium
metal phosphate (PMN P-03-824) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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
38. Add Sec. 721.10333 to subpart E to read as follows:
Sec. 721.10333 Substituted benzamine thio-ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzamine thio-ether (PMN P-03-840) is subject to 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
39. Add Sec. 721.10334 to subpart E to read as follows:
Sec. 721.10334 Ethanol, 2,2'-[(3-[(2-ethylhexyl)oxy]pentyl]imino]bis-
].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanol, 2,2'-[(3-
[(2-ethylhexyl)oxy]pentyl]imino]bis- (PMN P-03-861; CAS No. 284477-82-
3) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=20).
(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
[[Page 25270]]
provisions of Sec. 721.185 apply to this section.
0
40. Add Sec. 721.10335 to subpart E to read as follows:
Sec. 721.10335 1-Pentanamine, 3-[(2-ethylhexyl)oxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-pentanamine, 3-
[(2-ethylhexyl)oxy]- (PMN P-03-862; CAS No. 174615-16-8) 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=7).
(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
41. Add Sec. 721.10336 to subpart E to read as follows:
Sec. 721.10336 Poly(oxy-1,2-ethanediyl), .alpha.-(1-oxo-2-propen-1-
yl)-.omega.-([1,1'-biphenyl]-2-yloxy)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-(1-oxo-2-propen-1-yl)-.omega.-([1,1'-biphenyl]-2-
yloxy)- (PMN P-04-1; CAS No. 72009-86-0) 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) 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
42. Add Sec. 721.10337 to subpart E to read as follows:
Sec. 721.10337 Copper, iodotris(triphenylphosphine)-, (T-4)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as copper,
iodotris(triphenylphosphine)-, (T-4)- (PMN P-04-6; CAS No. 15709-82-7)
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)(1), (b)(1), and (c)(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
43. Add Sec. 721.10338 to subpart E to read as follows:
Sec. 721.10338 2-Propenoic acid, 1,1'-(1,9-nonanediyl) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
1,1'-(1,9-nonanediyl) ester (PMN P-04-53; CAS No. 107481-28-7) 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=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
44. Add Sec. 721.10339 to subpart E to read as follows:
Sec. 721.10339 Adipic acid, substituted propane, alkyldiol, acrylate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as adipic
acid, substituted propane, alkyldiol, acrylate (PMN P-04-113) is
subject to 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
45. Add Sec. 721.10340 to subpart E to read as follows:
Sec. 721.10340 Potassium zinc fluoride (KZnF3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as potassium zinc
fluoride (KZnF3) (PMN P-04-146; CAS No. 13827-02-6) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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. 721.10341 to subpart E to read as follows:
Sec. 721.10341 Amino alkyl organoborane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amino
alkyl organoborane (PMN P-04-338) is subject 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 25271]]
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=7).
(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
47. Add Sec. 721.10342 to subpart E to read as follows:
Sec. 721.10342 Quaternary ammonium compounds, fatty alkyl dialkyl
hydroxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
quaternary ammonium compounds, fatty alkyl dialkyl hydroxide (PMN P-04-
516) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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
48. Add Sec. 721.10343 to subpart E to read as follows:
Sec. 721.10343 Alkylated aryloxyaniline thiourea (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylated aryloxyaniline thiourea (PMN P-04-563) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(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
49. Add Sec. 721.10344 to subpart E to read as follows:
Sec. 721.10344 Alkylated aromatic isothiocyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylated aromatic isothiocyanate (PMN P-04-810) is subject to
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)(1), (b)(1), and (c)(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
50. Add Sec. 721.10345 to subpart E to read as follows:
Sec. 721.10345 1,2-Benzenedicarboxylic acid, 1,2-
bis(methylcyclohexyl) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-
benzenedicarboxylic acid, 1,2-bis(methylcyclohexyl) ester (PMN P-05-
110; CAS No. 27987-25-3) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (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
51. Add Sec. 721.10346 to subpart E to read as follows:
Sec. 721.10346 3H-Indolium, 2-[2-[2-chloro-3-[2-(1,3-dihydro-3,3-
dimethyl-1-propyl-2H-indol-2-ylidene)ethylidene]-1-cyclohexen-1-
yl]ethenyl]-3,3-dimethyl-1-propyl-, iodide (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3H-indolium, 2-[2-
[2-chloro-3-[2-(1,3-dihydro-3,3-dimethyl-1-propyl-2H-indol-2-
ylidene)ethylidene]-1-cyclohexen-1-yl]ethenyl]-3,3-dimethyl-1-propyl-,
iodide (1:1) (PMN P-05-599; CAS No. 207399-07-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (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
52. Add Sec. 721.10347 to subpart E to read as follows:
Sec. 721.10347 Bicyclo[2.2.1] heptanedimethanamine, N,N'-bis(1,2-
dimethylpropylidene)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
bicyclo[2.2.1]heptanedimethanamine, N,N'-bis(1,2-dimethylpropylidene)-
(PMN P-06-268; CAS No. 664980-30-7) 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
[[Page 25272]]
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
53. Add Sec. 721.10348 to subpart E to read as follows:
Sec. 721.10348 Aspartic acid, N,N'-(iminodi-alkanediyl)bis,
tetraalkane esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
aspartic acid, N,N'-(iminodi-alkanediyl)bis, tetraalkane esters (PMNs
P-06-623 and P-06-624) 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=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
54. Add Sec. 721.10349 to subpart E to read as follows:
Sec. 721.10349 1,4-Benzenediamine, N'-(alkyl)-N-[4-
[(alkyl)amino]phenyl]-N-phenyl- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,4-
benzenediamine, N'-(alkyl)-N-[4-[(alkyl)amino]phenyl]-N-phenyl- (PMN P-
06-731) is subject to 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
55. Add Sec. 721.10350 to subpart E to read as follows:
Sec. 721.10350 Amines, C11-14-branched and linear alkyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines, C11-14-
branched and linear alkyl (PMN P-06-742; CAS No. 863766-30-7) 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)(1), (b)(1), and (c)(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
56. Add Sec. 721.10351 to subpart E to read as follows:
Sec. 721.10351 Carbomonocycle, bis[(4-methylphenoxy)methyl]-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbomonocycle, bis[(4-methylphenoxy)methyl]- (PMN P-07-351) is subject
to 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
57. Add Sec. [emsp14]721.10352 to subpart E to read as follows:
Sec. [emsp14]721.10352 Dimethyl terephthalate, polymer with alkyl
diol and substituted benzoates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dimethyl terephthalate, polymer with alkyl diol and substituted
benzoates (PMN P-08-93) is subject to 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=60).
(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. 721.10353 to subpart E to read as follows:
Sec. [emsp14]721.10353 Organosulfide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
organosulfide (PMN P-08-510) is subject to 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
59. Add Sec. 721.10354 to subpart E to read as follows:
Sec. 721.10354 1,1'-Biphenyl, 3,3',4,4'-tetramethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,1'-biphenyl,
3,3',4,4'-tetramethyl-
[[Page 25273]]
(PMN P-08-623; CAS No. 4920-95-0) 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) 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
60. Add Sec. 721.10355 to subpart E to read as follows:
Sec. 721.10355 Poly[oxy-1,2-ethanediyl), .alpha.-(1-
oxododecyl)-.omega.-[3-triethoxysilyl)propoxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy-1,2-
ethanediyl), .alpha.-(1-oxododecyl)-.omega.-[3-triethoxysilyl)propoxy]-
(PMN P-08-722; CAS No. 1041420-54-5) 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) 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
61. Add Sec. 721.10356 to subpart E to read as follows:
Sec. 721.10356 Zinc, bis[3-(acetyl-.kappa.O)-6-methyl-2H-pyran-
2,4(3H)-dionato-.kappa.O4]diaqua-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as zinc, bis[3-
(acetyl-.kappa.O)-6-methyl-2H-pyran-2,4(3H)-dionato-.kappa.O4]diaqua-
(PMN P-09-98; CAS No. 171884-15-4) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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. 721.10357 to subpart E to read as follows:
Sec. 721.10357 Iron, citrate phosphate potassium complexes.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as iron, citrate
phosphate potassium complexes (PMN P-09-382; CAS No. 120579-31-9) 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) (micronutrient in fertilizer or soil
amendment which will only be transported in containers with a maximum
capacity of 20 gallons or in bottom-loading totes).
(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
63. Add Sec. 721.10358 to subpart E to read as follows:
Sec. 721.10358 Formaldehyde reaction products with aryl amine
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde reaction products with aryl amine (PMN P-09-546) is
subject to 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) and (j) (use other than as an
intermediate that has been manufactured using the process described in
the premanufacture notice).
(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. 721.10359 to subpart E to read as follows:
Sec. 721.10359 Cardanol-based alkyl phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cardanol-based alkyl phosphate (PMN P-09-613) is subject to 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) (site-limited polymer modifier in non-
consumer products).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=18).
(b) Specific requirements. The 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
65. Add Sec. 721.10360 to subpart E to read as follows:
Sec. 721.10360 1-Substituted propane, 3-(triethoxysilyl)-, reaction
products with polyethylene glycol mono-(branched tridecyl) ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1-
substituted propane, 3-
[[Page 25274]]
(triethoxysilyl)-, reaction products with polyethylene glycol mono-
(branched tridecyl) ether (PMN P-09-628) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=4).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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. 721.10361 to subpart E to read as follows:
Sec. 721.10361 Anthraquinonedicarboximide, diamino-N-alkyl-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
anthraquinonedicarboximide, diamino-N-alkyl- (PMN P-10-15) is subject
to 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
67. Add Sec. [emsp14]721.10362 to subpart E to read as follows:
Sec. 721.10362 Oils, callitropsis nootkatensis.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oils, callitropsis
nootkatensis (PMN P-10-44; CAS No. 1069136-34-0) 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) 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
68. Add Sec. 721.10363 to subpart E to read as follows:
Sec. 721.10363 Alkenoic acid, 2-methyl-, 2-oxiranylmethyl ester,
reaction products with 4,4' -methylenebis (cyclohexanamine) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, 2-methyl-, 2-oxiranylmethyl ester, reaction products
with 4,4' -methylenebis (cyclohexanamine) (PMN P-10-47) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4) and (b)(4) (N=44).
(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
69. Add Sec. 721.10364 to subpart E to read as follows:
Sec. 21.10364 Halogenated aromatic amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated aromatic amine (PMN P-10-53) is subject to 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
70. Add Sec. 721.10365 to subpart E to read as follows:
Sec. 721.10365 Butanoic acid, 3-mercapto-2-methyl-, ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as butanoic acid, 3-
mercapto-2-methyl-, ethyl ester (PMN P-10-56; CAS No. 888021-82-7) 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(s) (100 kilograms).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(b) Specific requirements. The 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
71. Add Sec. 721.10366 to subpart E to read as follows:
Sec. 721.10366 Benzene, 4-bromo-1,2-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, 4-bromo-
1,2-dimethyl-(PMN P-10-76; CAS No. 583-71-1) 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.
721.90(a)(4), (b)(4), and (c)(4) (N=30).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
[[Page 25275]]
(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. 721.10367 to subpart E to read as follows:
Sec. 721.10367 Hydroxy-aryl, polymer with substituted benzene,
cyanate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydroxy-aryl, polymer with substituted benzene, cyanate (PMN P-10-83)
is subject to 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
73. Add Sec. 721.10368 to subpart E to read as follows:
Sec. 721.10368 Triphenodioxazine derivatives (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
triphenodioxazine derivatives (PMN P-10-84) is subject to 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
74. Add Sec. 721.10369 to subpart E to read as follows:
Sec. 721.10369 Carbonic acid, diphenyl ester, polymer with diphenyl
P-methylphosphonate and 4,4'-(1-methylethylidene) bis[phenol].
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbonic acid,
diphenyl ester, polymer with diphenyl P-methylphosphonate and 4,4'-(1-
methylethylidene) bis[phenol] (PMN P-10-88; CAS No. 77226-90-5) 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(j) (flame retardant and flame retardant
additive, where the particle size is greater than 10 microns).
(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
75. Add Sec. 721.10370 to subpart E to read as follows:
Sec. 721.10370 Phosphonic acid, p-octyl-, lanthanum (3+) salt (2:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphinic acid, p-
octyl-, lanthanum (3+) salt (2:1) (PMN P-10-99; CAS No. 1186211-38-0)
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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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
76. Add Sec. 721.10371 to subpart E to read as follows:
Sec. 721.10371 Butanoic acid, 3-mercapto-,1,1'-[2-(hydroxymethyl)-2-
(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
butanoic acid, 3-mercapto-,1,1'-[2-(hydroxymethyl)-2-(substituted-1-
oxoalkoxy)methyl)-1,3-propanediyl] ester (PMN P-10-136, Chemical A) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (j) (monomer for acryl-based ultra-
violet (UV)-curing coatings, inks, and adhesives).
(ii) Release to water. Requirements as specified in Sec.
721.90(b)(4) and (c)(4) (N=2).
(b) Specific requirements. The 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
77. Add Sec. 721.10372 to subpart E to read as follows:
Sec. 721.10372 Butanoic acid, 3-mercapto-,1,1'-[2,2-
bis[(substituted-1-oxoalkoxy)methyl]-1,3-propanediyl] ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
butanoic acid, 3-mercapto-,1,1'-[2,2-bis[(substituted-1-
oxoalkoxy)methyl]-1,3-propanediyl] ester (PMN P-10-136, Chemical B) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (j) (monomer for acryl-based UV-
curing coatings, inks, and adhesives).
(ii) Release to water. Requirements as specified in Sec.
721.90(b)(4) and (c)(4) (N=2).
(b) Specific requirements. The provisions of subpart A of this part
[[Page 25276]]
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
78. Add Sec. 721.10373 to subpart E to read as follows:
Sec. 721.10373 1H-Imidazole, 1-(1-methylethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-imidazole, 1-(1-
methylethyl)- (PMN P-10-153; CAS No. 4532-96-1) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=70).
(b) Specific requirements. The 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
79. Add Sec. 721.10374 to subpart E to read as follows:
Sec. 721.10374 Silane, (3-chloropropoxy)dimethyl(1-methylethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silane, (3-
chloropropoxy)dimethyl(1-methylethyl)-(PMN P-10-163; CAS No. 1191036-
21-1) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(iii) (gloves and goggles), (a)(3),
(a)(4). The following National Institute for Occupational Safety and
Health (NIOSH)-certified respirator with an assigned protection factor
(APF) of at least 10 meets the minimum requirements for Sec.
721.63(a)(4): NIOSH-certified organic vapor respirator.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=2).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), and (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. 721.10375 to subpart E to read as follows:
Sec. 721.10375 Hydroxypropyl methacrylate, reaction products with
propylene oxide and ethylene oxide, copolymer with N-vinyl caprolactam
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydroxypropyl methacrylate, reaction products with propylene oxide and
ethylene oxide, copolymer with N-vinyl caprolactam (PMN P-10-200) is
subject to 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=155).
(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
81. Add Sec. 721.10376 to subpart E to read as follows:
Sec. 721.10376 Alkyltin halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkyltin halide (PMN P-10-222) is subject to 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=22).
(b) Specific requirements. The 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 this section.
0
82. Add Sec. 721.10377 to subpart E to read as follows:
Sec. 721.10377 1,2-Cyclohexanedicarboxylic acid, benzyl C8-10-
isoalkyl esters, C9-rich.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-
cyclohexanedicarboxylic acid, benzyl C8-10-isoalkyl esters, C9-rich
(PMN P-10-247, Chemical A; CAS No. 1190265-49-6) 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), and (a)(3).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (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
83. Add Sec. 721.10378 to subpart E to read as follows:
Sec. 721.10378 1,2-Cyclohexanedicarboxylic acid, benzyl nonyl ester,
branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-
cyclohexanedicarboxylic acid, benzyl nonyl ester, branched and linear
(PMN P-10-247, Chemical B; CAS No. 1190264-82-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
[[Page 25277]]
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), and (a)(3).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (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
84. Add Sec. 721.10379 to subpart E to read as follows:
Sec. 721.10379 Propanoic acid, 3-(dodecylthio)-, 2-(1,1-
dimethylethyl)-4-[[5-(1,1-dimethylethyl)-4-hydroxy-2-
methylphenyl]thio]-5-methylphenyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanoic acid, 3-
(dodecylthio)-, 2-(1,1-dimethylethyl)-4-[[5-(1,1-dimethylethyl)-4-
hydroxy-2-methylphenyl]thio]-5-methylphenyl ester (PMN P-10-266; CAS
No. 69075-62-3) 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(s) (10,000 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
85. Add Sec. 721.10380 to subpart E to read as follows:
Sec. 721.10380 Benzoic acid, 3-amino-2-mercapto-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoic acid, 3-
amino-2-mercapto- (PMN P-10-285; CAS No. 71807-60-8) 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=33).
(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
86. Add Sec. 721.10381 to subpart E to read as follows:
Sec. 721.10381 Cyclic carboxylic acid, polymer with dihydroxy dialkyl
ether, hydroxy substituted alkane and carboxylic acid anhydride,
methacrylate terminated polyester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as cyclic
carboxylic acid, polymer with dihydroxy dialkyl ether, hydroxy
substituted alkane and carboxylic acid anhydride, methacrylate
terminated polyester (PMN P-10-290) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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
87. Add Sec. 721.10382 to subpart E to read as follows:
Sec. 721.10382 Diphosphoric acid, calcium salt (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as diphosphoric acid,
calcium salt (1:1) (PMN P-10-313; CAS No. 14866-19-4) 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(j) (opacifying agent for ceramic
whiteware).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=60).
(b) Specific requirements. The 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
88. Add Sec. 721.10383 to subpart E to read as follows:
Sec. 721.10383 Urea, N,N'-(methyl-1,3-phenylene)bis[N',N'-bis[3-
polyalkyleneamino]-, compd. with formaldehyde polymer with phenol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as urea,
N,N'-(methyl-1,3-phenylene)bis[N',N'-bis[3-polyalkyleneamino]-, compd.
with formaldehyde polymer with phenol (PMN P-10-324) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=43).
(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
89. Add Sec. 721.10384 to subpart E to read as follows:
Sec. 721.10384 Substituted alkanolamine phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkanolamine phenol (PMN P-10-332) is subject to reporting
under this section for the
[[Page 25278]]
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
90. Add Sec. 721.10385 to subpart E to read as follows:
Sec. 721.10385 Phenoxy alkyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenoxy
alkyl ether (PMN P-10-344) is subject to 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 this section.
0
91. Add Sec. 721.10386 to subpart E to read as follows:
Sec. 721.10386 Substituted phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted phenol (PMN P-10-361) is subject to 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
92. Add Sec. 721.10387 to subpart E to read as follows:
Sec. 721.10387 Substituted bis-phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted bis-phenol (PMN P-10-362) is subject to 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
93. Add Sec. 721.10388 to subpart E to read as follows:
Sec. 721.10388 Bisphospite nickel cyanoalkyl complex (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
bisphospite nickel cyanoalkyl complex (PMN P-10-364) is subject to
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
94. Add Sec. 721.10389 to subpart E to read as follows:
Sec. 721.10389 Styrene, copolymer with acrylic acid, salt with
alkoxylated alkenylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
styrene, copolymer with acrylic acid, salt with alkoxylated
alkenylamine (PMN P-10-401) is subject to 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=27). Where primary, secondary, and
tertiary waste treatment will occur, or treatment in a lined self-
contained solar evaporation pond where UV light will degrade the
substance, the number of kilograms per day per site is calculated after
wastewater treatment.
(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
95. Add Sec. 721.10390 to subpart E to read as follows:
Sec. 721.10390 Acetoacetanilide reaction product with multifunctional
acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acetoacetanilide reaction product with multifunctional acrylate (PMN P-
10-403) is subject to 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.
[[Page 25279]]
(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
96. Add Sec. 721.10391 to subpart E to read as follows:
Sec. 721.10391 Copper gallium indium selenide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as copper gallium
indium selenide (PMN P-10-424; CAS No. 144972-86-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(i), (b) (concentration set at 0.1 percent), and
(c). The following NIOSH-certified respirators with an assigned
protection factor (APF) of at least 10 meet the minimum requirements
for Sec. 721.63(a)(4):
(A) NIOSH-certified air-purifying, tight-fitting half-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
(B) NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
(C) NIOSH-certified powered air-purifying respirator equipped with
a loose- fitting hood or helmet and high efficiency particulate air
(HEPA) filters;
(D) NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (either half-face or full-face) and HEPA
filters; or
(E) 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).
(1) 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) of 1.5 mg/m\3\ as an
8-hour time-weighted-average. Persons who wish to pursue NCELs as an
alternative to the Sec. 721.63 respirator requirements may request to
do so under Sec. 721.30.
(2) [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)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 1.5 mg/m\3\), and (g)(5).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (f), (g), and (h) 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
97. Add Sec. 721.10392 to subpart E to read as follows:
Sec. 721.10392 Halo substituted sulfamidylbenzyluracil (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as halo
substituted sulfamidylbenzyluracil (PMN P-10-426) is subject to
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(b) and (g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers,
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
98. Add Sec. 721.10393 to subpart E to read as follows:
Sec. 721.10393 Sodium bromide MDA complex (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as sodium
bromide MDA complex (PMN P-10-433) is subject to 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
99. Add Sec. 721.10394 to subpart E to read as follows:
Sec. 721.10394 Copolymer of anhydride, a diol and a disubstituted
diol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
copolymer of anhydride, a diol and a disubstituted diol (PMN P-10-436)
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=55).
(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
100. Add Sec. 721.10395 to subpart E to read as follows:
Sec. 721.10395 Fatty acids, C14-18 and C16-18 unsatd., polymers with
adipic acid and triethanolamine, di-Me sulfate-quaternized.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fatty acids, C14-18
and C16-18 unsat., polymers with adipic acid and triethanolamine, di-Me
sulfate-quaternized (PMN P-10-458; CAS No. 1211825-32-9) 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=5).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 25280]]
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
101. Add Sec. 721.10396 to subpart E to read as follows:
Sec. 721.10396 Dimethyl siloxy-polyfluoro methyl siloxy-
poly(oxyalkylenediyl) methyl siloxy copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dimethyl siloxy-polyfluoro methyl siloxy-poly(oxyalkylenediyl) methyl
siloxy copolymer (PMN P-10-470) 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) (recording and reporting of certain
fluorinated impurities in the starting raw material, and manufacture of
the PMN substance not to exceed the maximum established impurity levels
of certain fluorinated impurities) and (t).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (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 this section.
0
102. Add Sec. 721.10397 to subpart E to read as follows:
Sec. 721.10397 Alkyl acrylate-polyfluoro methacrylate-
poly(oxyalkylenediyl)-methacrylates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as alkyl
acrylate-polyfluoro methacrylate-poly(oxyalkylenediyl)- methacrylates
(PMNs P-10-471 and P-10-472) 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) (recording and reporting of certain
fluorinated impurities in the starting raw material, and manufacture of
the PMN substances not to exceed the maximum established impurity
levels of certain fluorinated impurities) and (t).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (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 this section.
0
103. Add Sec. 721.10398 to subpart E to read as follows:
Sec. 721.10398 Poly(oxy-1,2-ethanediyl),. alpha., -monoalkyl
ethers-.omega.-mono (hydrogen maleate)- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxy-1,2-ethanediyl), .alpha., -monoalkyl ethers-.omega.-mono
(hydrogen maleate)- (PMN P-10-495) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(l).
(ii) [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
104. Add Sec. 721.10399 to subpart E to read as follows:
Sec. 721.10399 Benzoic acid azo-substituted pyridine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as benzoic
acid azo-substituted pyridine (PMN P-10-501) 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=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
105. Add Sec. 721.10400 to subpart E to read as follows:
Sec. 721.10400 Oxirane, 2-ethyl-, polymer with oxirane, mono-C12-14-
sec-alkyl ethers.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-ethyl-,
polymer with oxirane, mono-C12-14-sec-alkyl ethers (PMN P-10-517; CAS
No. 1013910-41-2) 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=14), where the amount of substance
reasonably likely to be removed during waste pretreatment prior to
release may be subtracted in calculating the number of kilograms
released.
(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
106. Add Sec. 721.10401 to subpart E to read as follows:
Sec. 721.10401 Oxirane, 2-ethyl-, polymer with oxirane, mono-C11-15-
sec-alkyl ethers.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-ethyl-,
polymer with oxirane,
[[Page 25281]]
mono C11-15-sec-alkyl ethers (PMN P-10-518; CAS No. 1022990-65-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=20), where the amount of substance
reasonably likely to be removed during waste pretreatment prior to
release may be subtracted in calculating the number of kilograms
released.
(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
107. Add Sec. 721.10402 to subpart E to read as follows:
Sec. 721.10402 Vegetable oil, modified products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, modified products (PMN P-10-548) is subject to 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
108. Add Sec. 721.10403 to subpart E to read as follows:
Sec. 721.10403 Vegetable oil, modified products, esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, modified products, esters (PMN P-10-550) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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
109. Add Sec. 721.10404 to subpart E to read as follows:
Sec. 721.10404 Olefins (generic) (P-10-551 and P-10-552).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
olefins (PMNs P-10-551 and P-10-552) 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=6).
(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
110. Add Sec. 721.10405 to subpart E to read as follows:
Sec. 721.10405 Olefins (generic) (P-10-553).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as olefins
(PMN P-10-553) is subject to 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).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers,
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 this section.
0
111. Add Sec. 721.10406 to subpart E to read as follows:
Sec. 721.10406 Fatty acid methyl esters (generic) (P-10-554).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid methyl esters (PMN P-10-554) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
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
112. Add Sec. 721.10407 to subpart E to read as follows:
Sec. 721.10407 Fatty acid methyl esters (generic) (P-10-555).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid methyl esters (PMN P-10-555) is subject to 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.
[[Page 25282]]
(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
113. Add Sec. 721.10408 to subpart E to read as follows:
Sec. 721.10408 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-
dimethyl-3-[(1-oxododecyl) oxy]propylidene] amino]
methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-
oxododecyl)oxy]propylidene] amino]methylethoxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-
oxododecyl)oxy]propylidene] amino] methylethyl]-.omega.-[2-[[2,2-
dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino] methylethoxy]- (PMN P-
10-556; CAS No. 613246-75-6) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=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
114. Add Sec. 721.10409 to subpart E to read as follows:
Sec. 721.10409 Poly(oxyalkylenediyl), .alpha.-[[[methyl-3-
[[[(polyfluoroalkyl)oxy] carbonyl]amino]phenyl]amino]carbonyl]-.omega.-
methoxy-(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxyalkylenediyl), .alpha.-[[[methyl-3-[[[(polyfluoroalkyl)
oxy]carbonyl]amino]phenyl]amino] carbonyl]-.omega.-methoxy- (PMN P-11-
217) is subject to 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) (recording and reporting of certain
fluorinated impurities in the starting raw material, and manufacture of
the PMN substance not to exceed the maximum established impurity levels
of certain fluorinated impurities) and (t).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (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 this section.
[FR Doc. 2012-9800 Filed 4-26-12; 8:45 am]
BILLING CODE 6560-50-P
