Significant New Use Rules on Certain Chemical Substances, 20296-20308 [2012-8092]
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Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations
restricted area as the Supervisor of
Shipbuilding, Conversion, and Repair
Gulf Coast (SUPSHIP Gulf Coast). After
the document was published, the
Department of the Navy revised the
mission, functions, and tasks of the
Supervisors of Shipbuilding,
Conversion and Repair organization.
This organizational revision changed
the administrative and enforcement
responsibilities for the subject restricted
area from SUPSHIP Gulf Coast to
SUPSHIP Bath, Maine. This document
corrects the final rule by revising
§ 334.815 (b) and (c) to reflect the
organizational change.
DATES:
Effective date: April 4, 2012.
Mr.
David Olson, Headquarters, Operations
and Regulatory Community of Practice,
Washington, DC at 202–761–4922 or by
email at david.b.olson@usace.army.mil
or Mr. Todd Vesperman, U.S. Army
Corps of Engineers, St. Paul District,
Regulatory Branch, at 920–448–2824 or
by email at todd.m.vesperman@
usace.army.mil.
FOR FURTHER INFORMATION CONTACT:
The U.S.
Army Corps of Engineers published a
final rule in the Federal Register on
May 24, 2011 (76 FR 30024), and later
determined that correcting amendments
need to be made to address
encroachment into a Federal navigation
channel and a change in the enforcing
authority that occurred as a result of the
Department of the Navy revising the
mission, functions, and tasks of the
Supervisors of Shipbuilding,
Conversion and Repair (SUPSHIPs)
organization. That organizational
revision changed administrative and
enforcement responsibilities for the
subject restricted area from SUPSHIP
Gulf Coast to SUPSHIP Bath, Maine.
This correcting amendment changes the
latitude and longitude coordinates in
§ 334.815(a) so that the restricted area
will not encroach into the Federal
navigation project. This correcting
amendment also changes the
administrative and enforcement
responsibilities in § 334.815(b) and (c)
for the subject restricted area from
SUPSHIP Gulf Coast to SUPSHIP Bath,
Maine.
SUPPLEMENTARY INFORMATION:
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List of Subjects in 33 CFR Part 334
Danger zones, Marine safety,
Navigation (water), Restricted areas,
Waterways.
For the reasons stated in the
preamble, 33 CFR part 334 is corrected
by making the following correcting
amendments:
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PART 334—DANGER ZONE AND
RESTRICTED AREA REGULATIONS
ENVIRONMENTAL PROTECTION
AGENCY
1. The authority citation for 33 CFR
part 334 continues to read as follows:
40 CFR Parts 9 and 721
Authority: 40 Stat. 266 (33 U.S.C. 1) and
40 Stat. 892 (33 U.S.C. 3).
RIN 2070–AB27
■
■
2. Revise § 334.815 to read as follows:
[EPA–HQ–OPPT–2011–0942; FRL–9333–3]
Significant New Use Rules on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
§ 334.815 Menominee River, at the
Marinette Marine Corporation Shipyard,
Marinette, Wisconsin; Naval Restricted
Area.
AGENCY:
(a) The area. The waters adjacent to
Marinette Marine Corporation’s pier
defined by a rectangular shaped area on
the south side of the river beginning on
shore at the eastern property line of
Marinette Marine Corporation at
latitude 45°5′58.7″ N, longitude
087°36′55.9″ W; thence northerly to
latitude 45°5′59.2″ N, longitude
087°36′55.8″ W; thence westerly to
latitude 45°5′59.6″ N, longitude
087°36′57.5″ W; thence westerly to
latitude 45°6′00.0″ N, longitude
087°36′58.7″ W; thence westerly to
latitude 45°6′1.7″ N, longitude
087°37′4.9″ W; thence westerly to
latitude 45°6′2.8″ N, longitude
087°37′9.8″ W; thence southerly to
latitude 45°6′2.2″ N, longitude
087°37′10.0″ W; thence easterly along
the Marinette Marine Corporation pier
to the point of origin. The restricted area
will be marked by a lighted and signed
floating buoy line.
(b) The regulation. All persons,
swimmers, vessels and other craft,
except those vessels under the
supervision or contract to a local
military or Naval authority, vessels of
the United States Coast Guard, and local
or state law enforcement vessels, are
prohibited from entering the restricted
area when marked by a signed floating
buoy line without permission from the
Supervisor of Shipbuilding, Conversion
and Repair, United States Navy, Bath,
Maine or his/her authorized
representative.
(c) Enforcement. The regulation in
this section shall be enforced by the
Supervisor of Shipbuilding, Conversion
and Repair, United States Navy, Bath,
Maine and/or such agencies or persons
as he/she may designate.
EPA is promulgating
significant new use rules (SNURs) under
the Toxic Substances Control Act
(TSCA) for 17 chemical substances
which were the subject of
premanufacture notices (PMNs). Two 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 17 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 4,
2012. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on April 18, 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 4, 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–2011–0942, 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–2011–0942.
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
Dated: March 29, 2012.
Richard C. Lockwood,
Chief, Operations and Regulatory, Directorate
of Civil Works.
[FR Doc. 2012–8120 Filed 4–3–12; 8:45 am]
BILLING CODE 3720–58–P
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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–
2011–0942. 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: 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
§ 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 and 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
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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.
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.
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B. What is the agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four bulleted TSCA
section 5(a)(2) factors listed in Unit III.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a significant new use
notice (SNUN) to EPA at least 90 days
before they manufacture, import, or
process the chemical substance for that
use. Persons who must report are
described in § 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. According to
§ 721.1(c), persons subject to these
SNURs must comply with the same
notice requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). In particular,
these requirements include the
information submission requirements of
TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA
sections 5(h)(1), 5(h)(2), 5(h)(3), and
5(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
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EPA may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control
the activities for which it has received
the SNUN. If EPA does not take action,
EPA is required under TSCA section
5(g) to explain in the Federal Register
its reasons for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorized EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the 17 chemical
substances that are the subject of these
SNURs, EPA considered relevant
information about the toxicity of the
chemical substances, likely human
exposures and environmental releases
associated with possible uses, and the
four bulleted TSCA section 5(a)(2)
factors listed in this unit.
IV. Substances Subject to This Rule
EPA is establishing significant new
use and recordkeeping requirements for
17 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 (i.e., SNURs without TSCA
section 5(e) consent orders), the basis
for the SNUR.
• Toxicity concerns.
• 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 two PMN
substances (P–10–486 and P–10–487)
that are subject to ‘‘risk-based’’ consent
orders under TSCA section
5(e)(1)(A)(ii)(I) in which EPA
determined that activities associated
with the PMN substances may present
unreasonable risk to human health or
the environment. Those consent orders
require protective measures to limit
exposures or otherwise mitigate the
potential unreasonable risk. The socalled ‘‘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 15
PMN substances (P–09–248, P–11–33,
P–11–34, P–11–188, P–11–316, P–11–
333, P–11–424, P–11–511, P–11–546, P–
11–578, P–11–580, P–11–591, P–11–
608, P–11–637, and P–11–662) 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.
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PMN Number P–09–248
Chemical name: Ethyleneamine
polyphosphates (generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance will be as a
flame retardant added to polymers.
Based on test data on the PMN
substance, EPA predicts toxicity to
aquatic organisms may occur if releases
of the PMN substance to surface water
from uses other than described in the
PMN exceed the releases expected from
the use described in the PMN. For the
described use 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 of the substance other than as
described in the PMN may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(i).
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 721.10282.
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PMN Numbers P–10–486 and P–10–487
Chemical names: (P–10–486)
Poly[oxy(methyl-1,2-ethanediyl)],
.alpha.-sulfo-.omega.-hydroxy-, C12–13branched and linear alkyl ethers,
sodium salts and (P–10–487)
Poly[oxy(methyl-1,2-ethanediyl)],
.alpha.-sulfo-.omega.-hydroxy-, C14–15branched and linear alkyl ethers,
sodium salts.
CAS numbers: (P–10–486) 958238–
81–8 and (P–10–487) 958238–82–9.
Effective date of TSCA section 5(e)
consent order: July 22, 2011.
Basis for TSCA section 5(e) consent
order: The PMNs state that the use of
the substances will be for downhole
injection for enhanced oil recovery. The
order was issued under TSCA sections
5(e)(1)(A)(i), (e)(1)(A)(ii)(I), and
(e)(1)(A)(ii)(II) based on a finding that
these substances may present an
unreasonable risk of injury to the
environment and will be produced in
substantial quantities and may
reasonably be anticipated to enter the
environment in substantial quantities.
To protect against the risk, the order
requires certain hazard communication
requirements, specific disposal
requirements for processing and use,
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and prohibits releases from manufacture
of the PMN substances resulting in
surface water concentrations exceeding
28 parts per billion (ppb) for P–10–486
and 4 ppb for P–10–487. The SNUR
designates as a ‘‘significant new use’’
the absence of these protective
measures.
Toxicity concern: Based on ecological
structure activity relationship (EcoSAR)
analysis of test data on analogous
anionic surfactants, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 28 ppb for
P–10–486 and 4 ppb for P–10–487 in
surface waters.
Recommended testing: EPA has
determined that the results of 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) on P–10–487
would help characterize the
environmental effects of the PMN
substances. The PMN submitter agreed
not to exceed the production volume
limit in the consent order before
conducting these tests.
CFR citations: 40 CFR 721.10283 (P–
10–486) and 40 CFR 721.10284 (P–10–
487).
PMN Number P–11–33
Chemical name: Formaldehyde,
polymer with 4-(1,1dimethylethyl)phenol, reaction products
with 1-piperazineethanamine.
CAS number: 1191244–16–2.
Basis for action: The PMN states that
the PMN substance will be used as a
hardener for epoxy resin laminating
systems. Based on ecological structure
activity relationship (EcoSAR) analysis
of test data on analogous aliphatic
amines and phenol-amines, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
17 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
manufacture, 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
17 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 (OPPTS
Test Guideline 850.1075); an aquatic
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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 721.10285.
PMN Number P–11–34
Chemical name: Formaldehyde,
polymer with .alpha.-(2aminomethylethyl)-.omega.-(2aminomethylethoxy)poly[oxy(methyl1,2-ethanediyl)] and 4-(1,1dimethylethyl)phenol.
CAS number: 1192146–78–3.
Basis for action: The PMN states that
the PMN substance will be used as a
hardener for epoxy resin laminating
systems. Based on EcoSAR analysis of
test data on analogous aliphatic amines
and phenol-amines, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 21 ppb of
the PMN substance in surface waters. As
described in the PMNs, the substances
are not released to surface waters.
Therefore, EPA has not determined that
the proposed manufacture, processing,
or use of the substance may present an
unreasonable risk. EPA has determined,
however, that any use of the substance
resulting in surface water
concentrations exceeding 21 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 (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 721.10286.
PMN Number P–11–188
Chemical name: Infused carbon
nanostructures (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance is as an additive to provide
conductive properties to reinforcements
used in composites. Based on available
information on analogous chemical
substances, the PMN substance may
cause lung effects. For the use described
in the PMN, no significant inhalation
exposures are expected. Therefore, EPA
has not determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
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risk. EPA has determined, however, that
a manufacturing process other than as
described in the PMN (the
manufacturing process described in the
PMN includes incorporation of the PMN
substance into pellets) may cause
serious health effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of the
following information would help
characterize the health effects of the
PMN substance: The dimensions,
characteristics, and physical-chemical
properties of the carbon nanostructures.
These properties should be determined
once a year for three consecutive years.
CFR citation: 40 CFR 721.10287.
PMN Number P–11–316
Chemical name: Cyclohexane,
oxidized, by-products from, distn.
residues.
CAS number: 1014979–92–0.
Basis for action: The PMN states that
the generic (non-confidential) uses of
the substance are as an industrial
solvent in closed and open systems, and
as an accelerant in permitted industrial
explosives. Based on EcoSAR analysis
of test data on analogous esters, 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, fresh water 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 721.10288.
PMN Number P–11–333
Chemical name: Hexanedioic acid
polymer with aliphatic polyol
dihydrogen phosphate aromatic ester
(generic).
CAS number: Not available.
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Basis for action: The PMN states that
the generic (non-confidential) use will
be as a component of industrial
coatings. Based on EcoSAR analysis of
test data on analogous organic
phosphates, EPA predicts toxicity to
aquatic organisms may occur if releases
of the PMN substance to surface water
from uses other than described in the
PMN exceed the releases expected from
the use described in the PMN. For the
described use 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 of the substance other than as
described in the PMN may cause
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a ready
biodegradability test (OPPTS Test
Guideline 835.3110); 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 721.10289.
PMN Number P–11–424
Chemical name: Alkenoyloxy
arylphenone (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance is as a monomer for polymer
applications. Based on test data on the
PMN substance, and EcoSAR analysis of
test data on analogous methacrylates,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 26 ppb of the PMN
substance in surface waters. As
described in the PMN, releases to
surface waters are not expected to
exceed 26 ppb. Therefore, EPA has not
determined that the proposed
manufacture, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance resulting in
surface water concentrations exceeding
26 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
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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 721.10290.
PMN Number P–11–511
Chemical name: C15 olefins (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a petroleum
substitute base. Based on 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, 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 721.10291.
PMN Number P–11–546
Chemical name: Silicate (2-),
hexafluoro-, cesium (1:2).
CAS number: 16923–87–8.
Basis for action: The PMN states that
the PMN substance will be used as a
brazing (metal joining) agent. Based on
submitted test data for an analogous
PMN substance, EPA identified
concerns for degeneration of the
kidneys, necrosis of the heart muscle,
and effects on the male reproductive
organs to workers from inhalation
exposure to the PMN substance. For the
uses described in the PMN, significant
dermal or inhalation exposure 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, use
of the substance other than as a brazing
(metal joining) agent may cause serious
health effects. Based on this
information, the PMN substance meets
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the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a repeated
dose 28-day oral toxicity test (OPPTS
Test Guideline 870.3050) in rodents
would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10292.
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PMN Number P–11–578
Chemical name: Benzoic acid, 4-(1,1dimethylethyl)-, hydrazide.
CAS number: 43100–38–5.
Basis for action: The PMN states that
the use of this substance will be as an
intermediate. Based on SAR analysis of
test data on analogous hydrazines, EPA
identified concerns for mutagenicity,
oncogenicity, developmental toxicity,
dermal sensitization, and respiratory
sensitization from exposure to the PMN
substance via the inhalation route. In
addition, based on EcoSAR analysis of
analogous hydrazines, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 2 ppb of
the PMN substance in surface waters.
For the intermediate use described in
the PMN, inhalation exposures 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 other than as
an intermediate, or any use 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 90-day
oral toxicity test in rodents (OPPTS Test
Guideline 870.3100) by the inhalation
route; a carcinogenicity test (OPPTS
Test Guideline 870.4200) by the
inhalation route, in two species of
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 721.10293.
PMN Number P–11–580
Chemical name: Cyclohexanol, 2,6bis(1,1-dimethylethyl)-4-methyl-.
CAS number: 163119–16–2.
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Basis for action: The PMN states that
the use of this substance will be as an
intermediate. Based on EcoSAR analysis
of test data on analogous neutral
organics, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 2 ppb of the
PMN substance in surface waters. As
described in the PMN, releases 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
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 (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 721.10294.
PMN Number P–11–591
Chemical name: IPDI modified
isophthalic acid, neopentyl glycol and
adipic acid (generic).
CAS numbers: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a lamination
adhesive. Based on test data on
analogous substances, EPA identified
concerns for oncogenicity, if the PMN
substance is inhaled, as well as
concerns for irritation to the eyes, skin,
mucous membranes, and dermal and
respiratory sensitization to workers from
dermal and inhalation exposure to the
PMN. For the industrial uses described
in the PMN, and due to the use of
personal protective equipment,
significant worker exposure is unlikely,
as dermal or inhalation exposure is not
expected. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of this
substance may present an unreasonable
risk. EPA has determined, however, that
substantial production volume
increases, or use of the substance in
consumer products may cause serious
health effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has
determined that the results of a dermal
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sensitization test (OPPTS Test Guideline
870.2600) and a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10295.
PMN Number P–11–608
Chemical name: 1,3-Benzenediol, 4[1-[[3-(1H-imidazol-1yl)propyl]imino]ethyl]-.
CAS number: 1313999–39–1.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an epoxy catalyst.
Based on EcoSAR analysis of test data
on polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As
described in the PMN, 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 (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. Additionally, EPA
recommends that OPPTS Test Guideline
850.1000, ‘‘Special Considerations for
Conducting Aquatic Laboratory
Studies’’ be consulted for materials,
such as this PMN substance, that are
water insoluble or of low water
solubility.
CFR citation: 40 CFR 721.10296.
PMN Number P–11–637
Chemical name: Tin, C16-18 and C18unsatd. fatty acids castor-oil fatty acids
complexes.
CAS number: 1315588–63–6.
Basis for action: The PMN states that
the use of the substance will be as a
polyurethane foam catalyst. Based on
test data on the PMN substance, EPA
identified concerns for dermal
sensitization and blood and liver
toxicity to workers from exposure to the
PMN substance. For the industrial use
described in the PMN, and due to the
use of personal protective equipment,
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significant worker exposure is unlikely,
as dermal or inhalation exposure is not
expected. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of this
substance may present an unreasonable
risk. EPA has determined, however, that
domestic manufacture of the substance
or use of the substance in consumer
products may cause serious health
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(3)(i).
Recommended testing: EPA has
determined that the results of a 28-day
dermal toxicity study (OPPTS Test
Guideline 870.3200) would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10297.
PMN Number P–11–662
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Chemical name: MDI terminated
polyester polyurethane polymer
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a liquid moisture
cure adhesive. Based on test data on
analogous diisocyanates, EPA identified
concerns for mutagenicity, irritation to
lungs and mucous membranes, and
dermal and respiratory sensitization to
workers from dermal and inhalation
exposure to the PMN substance. For the
industrial uses described in the PMN,
and due to the use of personal
protective equipment, significant
worker exposure is unlikely, as dermal
or inhalation exposure 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 in consumer products may
cause serious health effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a dermal
sensitization test (OPPTS Test Guideline
870.2600) and a 90-day inhalation
toxicity test (OPPTS Test Guideline
870.3465) would help characterize the
human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10298.
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 two of the 17 chemical
substances, regulation was warranted
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under TSCA section 5(e), pending the
development of information sufficient to
make reasoned evaluations of the health
or environmental effects of the chemical
substances. The basis for such findings
is outlined in Unit IV. Based on these
findings, TSCA section 5(e) consent
orders requiring the use of appropriate
exposure controls were negotiated with
the PMN submitters. The SNUR
provisions for these chemical
substances are consistent with the
provisions of the TSCA section 5(e)
consent orders. These SNURs are
promulgated pursuant to § 721.160 (see
Unit II.).
In the other 15 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
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§ 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 4, 2012 without
further notice, unless EPA receives
written adverse or critical comments, or
notice of intent to submit adverse or
critical comments before May 4, 2012.
If EPA receives written adverse or
critical comments, or notice of intent to
submit adverse or critical comments, on
one or more of these SNURs before May
4, 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 4, 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
two 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, 7 of the 17 chemical
substances contained in this rule have
CBI chemical identities, and since EPA
has received a limited number of post-
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PMN 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
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. Thus, 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 all 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.
lists those tests. Unit IV. also lists
recommended testing for non-5(e)
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SNURs. Descriptions of tests are
provided for informational purposes.
EPA strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. To access the harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
In the TSCA section 5(e) consent
orders for two of the chemical
substances regulated under this rule,
EPA has established production volume
limits in view of the lack of data on the
potential health and environmental
risks that may be posed by the
significant new uses or increased
exposure to the chemical substances.
These limits cannot be exceeded unless
the PMN submitter first submits the
results of toxicity tests that would
permit a reasoned evaluation of the
potential risks posed by these chemical
substances. Under recent TSCA section
5(e) consent orders, each PMN submitter
is required to submit each study at least
14 weeks (earlier TSCA section 5(e)
consent orders required submissions at
least 12 weeks) before reaching the
specified production limit. Listings of
the tests specified in the TSCA section
5(e) consent orders are included in Unit
IV. The SNURs contain the same
production volume limits as the TSCA
section 5(e) consent orders. Exceeding
these production limits is defined as a
significant new use. Persons who intend
to exceed the production limit must
notify the Agency by submitting a
SNUN at least 90 days in advance of
commencement of non-exempt
commercial manufacture, import, or
processing.
The recommended tests specified in
Unit IV. may not be the only means of
addressing the potential risks of the
chemical substance. However,
submitting a SNUN without any test
data may increase the likelihood that
EPA will take action under TSCA
section 5(e), particularly if satisfactory
test results have not been obtained from
a prior PMN or SNUN submitter. EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
• Potential benefits of the chemical
substances.
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• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing
certain significant new uses which have
been claimed as CBI subject to Agency
confidentiality regulations at 40 CFR
part 2 and 40 CFR part 720, subpart E.
Absent a final determination or other
disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is
required to keep this information
confidential. EPA promulgated a
procedure to deal with the situation
where a specific significant new use is
CBI, at 40 CFR 721.1725(b)(1).
Under these procedures a
manufacturer, importer, or processor
may request EPA to determine whether
a proposed use would be a significant
new use under the rule. The
manufacturer, importer, or processor
must show that it has a bona fide intent
to manufacture, import, or process the
chemical substance and must identify
the specific use for which it intends to
manufacture, import, or process the
chemical substance. If EPA concludes
that the person has shown a bona fide
intent to manufacture, import, or
process the chemical substance, EPA
will tell the person whether the use
identified in the bona fide submission
would be a significant new use under
the rule. Since most of the chemical
identities of the chemical substances
subject to these SNURs are also CBI,
manufacturers, importers, and
processors can combine the bona fide
submission under the procedure in
§ 721.1725(b)(1) with that under
§ 721.11 into a single step.
If EPA determines that the use
identified in the bona fide submission
would not be a significant new use, i.e.,
the use does not meet the criteria
specified in the rule for a significant
new use, that person can manufacture,
import, or process the chemical
substance so long as the significant new
use trigger is not met. In the case of a
production volume trigger, this means
that the aggregate annual production
volume does not exceed that identified
in the bona fide submission to EPA.
Because of confidentiality concerns,
EPA does not typically disclose the
actual production volume that
constitutes the use trigger. Thus, if the
person later intends to exceed that
volume, a new bona fide submission
would be necessary to determine
whether that higher volume would be a
significant new use.
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X. SNUN Submissions
According to § 721.1(c), persons
submitting a SNUN must comply with
the same notice requirements and EPA
regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in
§ 720.50. SNUNs must be submitted on
EPA Form No. 7710–25, generated using
e-PMN software, and submitted to the
Agency in accordance with the
procedures set forth in §§ 721.25 and
720.40. E-PMN software is available
electronically at https://www.epa.gov/
opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substances
subject to this rule. EPA’s complete
economic analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2011–0942.
XII. Statutory and Executive Order
Reviews
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A. Executive Order 12866
This rule establishes SNURs for
several new chemical substances that
were the subject of PMNs, or TSCA
section 5(e) consent orders. The Office
of Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
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
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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
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economic impact on a substantial
number of small entities.
D. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
rule. As such, EPA has determined that
this rule does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any affect
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,
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distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act
In addition, since this action does not
involve any technical standards, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note), does not
apply to this action.
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
XIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to 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.
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
2. The table in § 9.1 is amended by
adding the following sections in
numerical order under the undesignated
center heading ‘‘Significant New Uses of
Chemical Substances’’ to read as
follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
OMB
control No.
40 CFR citation
*
*
*
*
*
Significant New Uses of Chemical
Substances
*
*
721.10282
721.10283
721.10284
721.10285
721.10286
721.10287
721.10288
721.10289
721.10290
721.10291
721.10292
721.10293
721.10294
721.10295
721.10296
721.10297
721.10298
*
*
*
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
*
*
*
*
*
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
PART 721—[AMENDED]
Dated: March 23, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office
of Pollution Prevention and Toxics.
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
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■
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345(d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
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4. Add § 721.10282 to subpart E to
read as follows:
■
Therefore, 40 CFR parts 9 and 721 are
amended as follows:
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3. The authority citation for part 721
continues to read as follows:
■
§ 721.10282 Ethyleneamine
polyphosphates (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as ethyleneamine
polyphosphates (PMN P–09–248) 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:
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20305
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 5. Add § 721.10283 to subpart E to
read as follows:
§ 721.10283 Poly[oxy(methyl-1,2ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-,
C12-13-branched and linear alkyl ethers,
sodium salts.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
poly[oxy(methyl-1,2-ethanediyl)],
.alpha.-sulfo-.omega.-hydroxy-, C12-13branched and linear alkyl ethers,
sodium salts (PMN P–10–486; CAS No.
958238–81–8) 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) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (f), (g)(3)(i),
(g)(3)(ii), (g)(4)(i), (g)(4)(ii), (g)(4)(iii),
and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(p) (330,000
kilograms for this substance and P–10–
487 combined).
(iii) Disposal. Requirements as
specified in § 721.85(b)(1) and (c)(1)
solvent rinsate resulting from cleaning
of storage and holding tanks, shipboard
tanks, iso containers, rail cars, and
trucks used to transport the substance
may only be disposed of by
incineration. Sampling wastes
containing the substance may only be
disposed of by incineration, and
§ 721.85(c)(3) for oilfield applications,
when the substance will no longer be
injected into a well at a particular site
for enhanced oil recovery, the water
rinsate of the field holding tank and any
remaining field water containing the
substance must be injected into a
designated disposal well, either a class
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(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (f), (g), (h), (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
significant new use rule.
*
*
*
*
*
■ 7. Add § 721.10285 to subpart E to
read as follows:
§ 721.10284 Poly[oxy(methyl-1,2ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-,
C14-15-branched and linear alkyl ethers,
sodium salts.
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I hazardous waste disposal well or
another class II well.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4) (N = 28).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (f), (g), (h), (i), and
(k) are applicable to manufacturers,
importers, and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
significant new use rule.
■ 6. Add § 721.10284 to subpart E to
read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
formaldehyde, polymer with 4-(1,1dimethylethyl)phenol, reaction products
with 1-piperazineethanamine (PMN
P–11–33; CAS No. 1191244–16–2) 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 = 17 parts per billion (ppb)).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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 § 721.10286 to subpart E to
read as follows:
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
poly[oxy(methyl-1,2-ethanediyl)],
.alpha.-sulfo-.omega.-hydroxy-, C14-15branched and linear alkyl ethers,
sodium salts (PMN P–10–487; CAS No.
958238–82–9) 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) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (f), (g)(3)(i),
(g)(3)(ii), (g)(4)(i), (g)(4)(ii), (g)(4)(iii),
and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(p) (330,000
kilograms for this substance and for
P–10–486 combined).
(iii) Disposal. Requirements as
specified in § 721.85(b)(1) and (c)(1)
solvent rinsate resulting from cleaning
of storage and holding tanks, shipboard
tanks, iso containers, rail cars, and
trucks used to transport the substance
may only be disposed of by
incineration. Sampling wastes
containing the substance may only be
disposed of by incineration, and
§ 721.85(c)(3) for oilfield applications,
when the substance will no longer be
injected into a well at a particular site
for enhanced oil recovery, the water
rinsate of the field holding tank and any
remaining field water containing the
substance must be injected into a
designated disposal well, either a class
I hazardous waste disposal well or
another class II well.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4) (N = 4).
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§ 721.10285 Formaldehyde, polymer with
4-(1,1-dimethylethyl)phenol, reaction
products with 1-piperazineethanamine.
§ 721.10286 Formaldehyde, polymer with
.alpha.-(2-aminomethylethyl)-.omega.-(2aminomethylethoxy)poly[oxy(methyl-1,2ethanediyl)] and 4-(1,1dimethylethyl)phenol.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
formaldehyde, polymer with .alpha.-(2aminomethylethyl)-.omega.-(2aminomethylethoxy)poly[oxy(methyl1,2-ethanediyl)] and 4-(1,1dimethylethyl)phenol) (PMN P–11–34;
CAS No. 1192146–78–3) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
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(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N = 21 ppb).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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 § 721.10287 to subpart E to
read as follows:
§ 721.10287 Infused carbon
nanostructures (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as infused carbon
nanostructures (PMN P–11–188) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (manufacturing
process described in the PMN; the
process described in the PMN includes
the incorporation of the PMN substance
into pellets).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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
significant new use rule.
■ 10. Add § 721.10288 to subpart E to
read as follows:
§ 721.10288 Cyclohexane, oxidized, byproducts from, distn. residues.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclohexane, oxidized, by-products
from, distn. residues (PMN P–11–316;
CAS No. 1014979–92–0) 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 = 4 ppb).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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
significant new use rule.
■ 11. Add § 721.10289 to subpart E to
read as follows:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N = 26).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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 § 721.10291 to subpart E to
read as follows:
§ 721.10289 Hexanedioic acid polymer
with aliphatic polyol dihydrogen phosphate
aromatic ester (generic).
§ 721.10291
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as hexanedioic acid polymer
with aliphatic polyol dihydrogen
phosphate aromatic ester (PMN P–11–
333) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 12. Add § 721.10290 to subpart E to
read as follows:
emcdonald on DSK29S0YB1PROD with RULES
§ 721.10290
(generic).
Alkenoyloxy arylphenone
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkenoyloxy arylphenone
(PMN P–11–424) is subject 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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C15 olefins (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as C15 olefins (PMN P–11–
511) is subject to reporting under this
section for the significant 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 ppb).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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 § 721.10292 to subpart E to
read as follows:
§ 721.10292 Silicate (2-), hexafluoro-,
cesium (1:2).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
silicate (2-) hexafluoro-cesium (1:2)
(PMN P–11–546; CAS No. 16923–87–8)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j) (use as brazing
(metal joining) agent).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 15. Add § 721.10293 to subpart E to
read as follows:
§ 721.10293 Benzoic acid, 4-(1,1dimethylethyl)-, hydrazide.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzoic acid, 4-(1,1-dimethylethyl)-,
hydrazide (PMN P–11–578; CAS No.
43100–38–5) 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(g).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N = 2 ppb).
(b) Specific requirements. The
provisions of subpart 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.
■ 16. Add § 721.10294 to subpart E to
read as follows:
§ 721.10294 Cyclohexanol, 2,6-bis(1,1dimethylethyl)-4-methyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclohexanol, 2,6-bis(1,1dimethylethyl)-4-methyl- (PMN P–11–
580; CAS No. 163119–16–2) 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 = 2 ppb).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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.
■ 17. Add new § 721.10295 to subpart E
to read as follows:
§ 721.10295 IPDI modified isophthalic acid,
neopentyl glycol and adipic acid (generic).
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as IPDI modified isophthalic
acid, neopentyl glycol and adipic acid
(PMN P–11–591) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o) and (s) (15,000
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.
■ 18. Add new § 721.10296 to subpart E
to read as follows:
emcdonald on DSK29S0YB1PROD with RULES
§ 721.10296 1,3-Benzenediol, 4-[1-[[3-(lHimidazol-1-yl)propyl]imino] ethyl]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,3-benzenediol, 4-[ 1-[[3-(lH-imidazol1-yl)propyl]imino[ethyl]- (PMN P–11–
608; CAS No. 1313999–39–1) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N = 1 ppb).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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.
■ 19. Add new § 721.10297 to subpart E
to read as follows:
ENVIRONMENTAL PROTECTION
AGENCY
§ 721.10297 Tin, C16-18 and C18-unsatd.
fatty acids castor-oil fatty acids complexes.
[EPA–R09–OAR–2011–0544; FRL–9633–3]
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substance identified as
tin, C16-18 and C18-unsatd. fatty acids
castor-oil fatty acids complexes (PMN
P–11–637; CAS No. 1315588–63–6) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (o).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 20. Add new § 721.10298 to subpart E
to read as follows:
§ 721.10298 MDI terminated polyester
polyurethane polymer (generic).
(a) Chemical substances and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as MDI terminated polyester
polyurethane polymer (P–11–662) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart 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.
[FR Doc. 2012–8092 Filed 4–3–12; 8:45 am]
BILLING CODE 6560–50–P
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40 CFR Part 52
Approval and Promulgation of
Implementations Plans; California Air
Resources Board—In-Use Heavy-Duty
Diesel-Fueled Truck and Bus
Regulation, and Drayage Truck
Regulation
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is taking final action to
approve a revision to the California
State Implementation Plan (SIP)
submitted by the California Air
Resources Board (CARB or Board). This
revision concerns two regulations that
reduce emissions of diesel particulate
matter (PM), oxides of nitrogen (NOX),
and other pollutants from in-use, heavyduty diesel-fueled trucks and buses, and
drayage trucks. EPA is approving this
SIP revision because the Agency has
determined that the regulations are
consistent with the relevant Clean Air
Act requirements, policies and
guidance. Final approval of the two
regulations and incorporation of them
into the California SIP makes them
federally enforceable.
DATES: Effective Date: This rule is
effective on May 4, 2012.
ADDRESSES: EPA has established docket
number EPA–R09–OAR–2011–0544 for
this action. The index to the docket is
available electronically at
www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street,
San Francisco, California. While all
documents in the docket are listed in
the index, some information may be
publicly available only at the hard copy
location (e.g., copyrighted material), and
some may not be publicly available in
either location (e.g., Confidential
Business Information). To inspect the
hard copy materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT:
Roxanne Johnson, EPA Region IX, (415)
947–4150, johnson.roxanne@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us’’
and ‘‘our’’ refer to EPA.
SUMMARY:
Table of Contents
I. EPA’s Proposed Action
II. Public Comments and EPA Responses
III. Final Action
IV. Statutory and Executive Order Reviews
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Agencies
[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Rules and Regulations]
[Pages 20296-20308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8092]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2011-0942; FRL-9333-3]
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 17 chemical substances
which were the subject of premanufacture notices (PMNs). Two 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 17 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 4, 2012. For purposes of judicial
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 18,
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 4, 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-2011-0942, 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-2011-0942. 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
[[Page 20297]]
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-
2011-0942. 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
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
Sec. [emsp14]721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
[[Page 20298]]
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. [emsp14]721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. [emsp14]721.1(c), persons subject to these SNURs must comply
with the same notice requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN, EPA may take regulatory action
under TSCA section 5(e), 5(f), 6, or 7 to control the activities for
which it has received the SNUN. If EPA does not take action, EPA is
required under TSCA section 5(g) to explain in the Federal Register its
reasons for not taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 17
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for 17 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 (i.e., SNURs without TSCA section 5(e) consent
orders), the basis for the SNUR.
Toxicity concerns.
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture and importation
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
This rule includes two PMN substances (P-10-486 and P-10-487) that
are subject to ``risk-based'' consent orders under TSCA section
5(e)(1)(A)(ii)(I) in which EPA determined that activities associated
with the PMN substances may present unreasonable risk to human health
or the environment. Those consent orders require protective measures to
limit exposures or otherwise mitigate the potential unreasonable risk.
The so-called ``5(e) SNURs'' on these PMN substances are promulgated
pursuant to Sec. [emsp14]721.160, and are based on and consistent with
the provisions in the underlying consent orders. The 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 15 PMN substances (P-09-248, P-11-
33, P-11-34, P-11-188, P-11-316, P-11-333, P-11-424, P-11-511, P-11-
546, P-11-578, P-11-580, P-11-591, P-11-608, P-11-637, and P-11-662)
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.
[emsp14]721.170. EPA has determined that every activity designated as a
``significant new use'' in all non-5(e) SNURs issued under Sec.
[emsp14]721.170 satisfies the two requirements stipulated in Sec.
721.170(c)(2), i.e., these significant new use activities, ``(i) are
different from those described in the premanufacture notice for the
substance, including any amendments, deletions, and additions of
activities to the premanufacture notice, and (ii) may be accompanied by
changes in exposure or release levels that are significant in relation
to the health or environmental concerns identified'' for the PMN
substance.
[[Page 20299]]
PMN Number P-09-248
Chemical name: Ethyleneamine polyphosphates (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will
be as a flame retardant added to polymers. Based on test data on the
PMN substance, EPA predicts toxicity to aquatic organisms may occur if
releases of the PMN substance to surface water from uses other than
described in the PMN exceed the releases expected from the use
described in the PMN. For the described use 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 of the substance other than as described in the
PMN may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i).
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 721.10282.
PMN Numbers P-10-486 and P-10-487
Chemical names: (P-10-486) Poly[oxy(methyl-1,2-ethanediyl)],
.alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl
ethers, sodium salts and (P-10-487) Poly[oxy(methyl-1,2-ethanediyl)],
.alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl
ethers, sodium salts.
CAS numbers: (P-10-486) 958238-81-8 and (P-10-487) 958238-82-9.
Effective date of TSCA section 5(e) consent order: July 22, 2011.
Basis for TSCA section 5(e) consent order: The PMNs state that the
use of the substances will be for downhole injection for enhanced oil
recovery. The order was issued under TSCA sections 5(e)(1)(A)(i),
(e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II) based on a finding that these
substances may present an unreasonable risk of injury to the
environment and will be produced in substantial quantities and may
reasonably be anticipated to enter the environment in substantial
quantities. To protect against the risk, the order requires certain
hazard communication requirements, specific disposal requirements for
processing and use, and prohibits releases from manufacture of the PMN
substances resulting in surface water concentrations exceeding 28 parts
per billion (ppb) for P-10-486 and 4 ppb for P-10-487. The SNUR
designates as a ``significant new use'' the absence of these protective
measures.
Toxicity concern: Based on ecological structure activity
relationship (EcoSAR) analysis of test data on analogous anionic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 28 ppb for P-10-486 and 4 ppb for P-10-487
in surface waters.
Recommended testing: EPA has determined that the results of 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) on P-10-487 would help characterize the
environmental effects of the PMN substances. The PMN submitter agreed
not to exceed the production volume limit in the consent order before
conducting these tests.
CFR citations: 40 CFR 721.10283 (P-10-486) and 40 CFR 721.10284 (P-
10-487).
PMN Number P-11-33
Chemical name: Formaldehyde, polymer with 4-(1,1-
dimethylethyl)phenol, reaction products with 1-piperazineethanamine.
CAS number: 1191244-16-2.
Basis for action: The PMN states that the PMN substance will be
used as a hardener for epoxy resin laminating systems. Based on
ecological structure activity relationship (EcoSAR) analysis of test
data on analogous aliphatic amines and phenol-amines, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
17 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 manufacture, 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 17 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 (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 721.10285.
PMN Number P-11-34
Chemical name: Formaldehyde, polymer with .alpha.-(2-
aminomethylethyl)-.omega.-(2-aminomethylethoxy)poly[oxy(methyl-1,2-
ethanediyl)] and 4-(1,1-dimethylethyl)phenol.
CAS number: 1192146-78-3.
Basis for action: The PMN states that the PMN substance will be
used as a hardener for epoxy resin laminating systems. Based on EcoSAR
analysis of test data on analogous aliphatic amines and phenol-amines,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 21 ppb of the PMN substance in surface waters. As described
in the PMNs, the substances are not released to surface waters.
Therefore, EPA has not determined that the proposed manufacture,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 21 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 (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 721.10286.
PMN Number P-11-188
Chemical name: Infused carbon nanostructures (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an additive to provide
conductive properties to reinforcements used in composites. Based on
available information on analogous chemical substances, the PMN
substance may cause lung effects. For the use described in the PMN, no
significant inhalation exposures are expected. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable
[[Page 20300]]
risk. EPA has determined, however, that a manufacturing process other
than as described in the PMN (the manufacturing process described in
the PMN includes incorporation of the PMN substance into pellets) may
cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of the
following information would help characterize the health effects of the
PMN substance: The dimensions, characteristics, and physical-chemical
properties of the carbon nanostructures. These properties should be
determined once a year for three consecutive years.
CFR citation: 40 CFR 721.10287.
PMN Number P-11-316
Chemical name: Cyclohexane, oxidized, by-products from, distn.
residues.
CAS number: 1014979-92-0.
Basis for action: The PMN states that the generic (non-
confidential) uses of the substance are as an industrial solvent in
closed and open systems, and as an accelerant in permitted industrial
explosives. Based on EcoSAR analysis of test data on analogous esters,
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, fresh water
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 721.10288.
PMN Number P-11-333
Chemical name: Hexanedioic acid polymer with aliphatic polyol
dihydrogen phosphate aromatic ester (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use will be as a component of industrial coatings. Based
on EcoSAR analysis of test data on analogous organic phosphates, EPA
predicts toxicity to aquatic organisms may occur if releases of the PMN
substance to surface water from uses other than described in the PMN
exceed the releases expected from the use described in the PMN. For the
described use 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 of the
substance other than as described in the PMN may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); 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 721.10289.
PMN Number P-11-424
Chemical name: Alkenoyloxy arylphenone (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a monomer for polymer
applications. Based on test data on the PMN substance, and EcoSAR
analysis of test data on analogous methacrylates, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 26 ppb of
the PMN substance in surface waters. As described in the PMN, releases
to surface waters are not expected to exceed 26 ppb. Therefore, EPA has
not determined that the proposed manufacture, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 26 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10290.
PMN Number P-11-511
Chemical name: C15 olefins (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a petroleum substitute
base. Based on 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, 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 721.10291.
PMN Number P-11-546
Chemical name: Silicate (2-), hexafluoro-, cesium (1:2).
CAS number: 16923-87-8.
Basis for action: The PMN states that the PMN substance will be
used as a brazing (metal joining) agent. Based on submitted test data
for an analogous PMN substance, EPA identified concerns for
degeneration of the kidneys, necrosis of the heart muscle, and effects
on the male reproductive organs to workers from inhalation exposure to
the PMN substance. For the uses described in the PMN, significant
dermal or inhalation exposure 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, use of the substance other than as a brazing (metal joining)
agent may cause serious health effects. Based on this information, the
PMN substance meets
[[Page 20301]]
the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a
repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050)
in rodents would help characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10292.
PMN Number P-11-578
Chemical name: Benzoic acid, 4-(1,1-dimethylethyl)-, hydrazide.
CAS number: 43100-38-5.
Basis for action: The PMN states that the use of this substance
will be as an intermediate. Based on SAR analysis of test data on
analogous hydrazines, EPA identified concerns for mutagenicity,
oncogenicity, developmental toxicity, dermal sensitization, and
respiratory sensitization from exposure to the PMN substance via the
inhalation route. In addition, based on EcoSAR analysis of analogous
hydrazines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb of the PMN substance in surface
waters. For the intermediate use described in the PMN, inhalation
exposures 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 other than as an intermediate, or any use 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 90-
day oral toxicity test in rodents (OPPTS Test Guideline 870.3100) by
the inhalation route; a carcinogenicity test (OPPTS Test Guideline
870.4200) by the inhalation route, in two species of 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 721.10293.
PMN Number P-11-580
Chemical name: Cyclohexanol, 2,6-bis(1,1-dimethylethyl)-4-methyl-.
CAS number: 163119-16-2.
Basis for action: The PMN states that the use of this substance
will be as an intermediate. Based on EcoSAR analysis of test data on
analogous neutral organics, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 2 ppb of the PMN substance in
surface waters. As described in the PMN, releases 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 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 (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 721.10294.
PMN Number P-11-591
Chemical name: IPDI modified isophthalic acid, neopentyl glycol and
adipic acid (generic).
CAS numbers: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a lamination adhesive.
Based on test data on analogous substances, EPA identified concerns for
oncogenicity, if the PMN substance is inhaled, as well as concerns for
irritation to the eyes, skin, mucous membranes, and dermal and
respiratory sensitization to workers from dermal and inhalation
exposure to the PMN. For the industrial uses described in the PMN, and
due to the use of personal protective equipment, significant worker
exposure is unlikely, as dermal or inhalation exposure is not expected.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of this substance may present an unreasonable risk.
EPA has determined, however, that substantial production volume
increases, or use of the substance in consumer products may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10295.
PMN Number P-11-608
Chemical name: 1,3-Benzenediol, 4-[1-[[3-(1H-imidazol-1-
yl)propyl]imino]ethyl]-.
CAS number: 1313999-39-1.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an epoxy catalyst. Based
on EcoSAR analysis of test data on polycationic polymers, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. As described in the PMN,
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 (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. Additionally, EPA recommends that OPPTS
Test Guideline 850.1000, ``Special Considerations for Conducting
Aquatic Laboratory Studies'' be consulted for materials, such as this
PMN substance, that are water insoluble or of low water solubility.
CFR citation: 40 CFR 721.10296.
PMN Number P-11-637
Chemical name: Tin, C16-18 and C18-unsatd. fatty acids castor-oil
fatty acids complexes.
CAS number: 1315588-63-6.
Basis for action: The PMN states that the use of the substance will
be as a polyurethane foam catalyst. Based on test data on the PMN
substance, EPA identified concerns for dermal sensitization and blood
and liver toxicity to workers from exposure to the PMN substance. For
the industrial use described in the PMN, and due to the use of personal
protective equipment,
[[Page 20302]]
significant worker exposure is unlikely, as dermal or inhalation
exposure is not expected. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of this substance may
present an unreasonable risk. EPA has determined, however, that
domestic manufacture of the substance or use of the substance in
consumer products may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of a 28-
day dermal toxicity study (OPPTS Test Guideline 870.3200) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10297.
PMN Number P-11-662
Chemical name: MDI terminated polyester polyurethane polymer
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a liquid moisture cure
adhesive. Based on test data on analogous diisocyanates, EPA identified
concerns for mutagenicity, irritation to lungs and mucous membranes,
and dermal and respiratory sensitization to workers from dermal and
inhalation exposure to the PMN substance. For the industrial uses
described in the PMN, and due to the use of personal protective
equipment, significant worker exposure is unlikely, as dermal or
inhalation exposure 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 in consumer products may cause serious health effects.
Based on this information, the PMN substances meet the concern criteria
at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10298.
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 two of the 17
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. [emsp14]721.160 (see Unit
II.).
In the other 15 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec. [emsp14]721.170 were met, as
discussed in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will receive notice of any person's intent to
manufacture, 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. [emsp14]721.160(c)(3) and Sec. [emsp14]721.170(d)(4). In
accordance with Sec. [emsp14]721.160(c)(3)(ii) and Sec.
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is June 4,
2012 without further notice, unless EPA receives written adverse or
critical comments, or notice of intent to submit adverse or critical
comments before May 4, 2012.
If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before May 4, 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 4, 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 two 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, 7 of the 17
chemical substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-
[[Page 20303]]
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. Thus, 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
all 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. lists those tests. Unit IV. also lists recommended
testing for non-5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the harmonized test guidelines referenced
in this document electronically, please go to https://www.epa.gov/ocspp
and select ``Test Methods and Guidelines.''
In the TSCA section 5(e) consent orders for two of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study at
least 14 weeks (earlier TSCA section 5(e) consent orders required
submissions at least 12 weeks) before reaching the specified production
limit. Listings of the tests specified in the TSCA section 5(e) consent
orders are included in Unit IV. The SNURs contain the same production
volume limits as the TSCA section 5(e) consent orders. Exceeding these
production limits is defined as a significant new use. Persons who
intend to exceed the production limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture, import, or processing.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer, importer, or processor may
request EPA to 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.
[[Page 20304]]
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-
2011-0942.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This rule establishes SNURs for several new chemical substances
that were the subject of PMNs, or TSCA section 5(e) consent orders. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
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.
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 affect 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,
[[Page 20305]]
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 to 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: March 23, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.
0
2. The table in Sec. 9.1 is amended by adding the following sections
in numerical order under the undesignated center heading ``Significant
New Uses of Chemical Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
721.10282............................................... 2070-0012
721.10283............................................... 2070-0012
721.10284............................................... 2070-0012
721.10285............................................... 2070-0012
721.10286............................................... 2070-0012
721.10287............................................... 2070-0012
721.10288............................................... 2070-0012
721.10289............................................... 2070-0012
721.10290............................................... 2070-0012
721.10291............................................... 2070-0012
721.10292............................................... 2070-0012
721.10293............................................... 2070-0012
721.10294............................................... 2070-0012
721.10295............................................... 2070-0012
721.10296............................................... 2070-0012
721.10297............................................... 2070-0012
721.10298............................................... 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. 721.10282 to subpart E to read as follows:
Sec. 721.10282 Ethyleneamine polyphosphates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethyleneamine polyphosphates (PMN P-09-248) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
5. Add Sec. 721.10283 to subpart E to read as follows:
Sec. 721.10283 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium
salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and
linear alkyl ethers, sodium salts (PMN P-10-486; CAS No. 958238-81-8)
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) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i),
(g)(4)(ii), (g)(4)(iii), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p) (330,000 kilograms for this substance
and P-10-487 combined).
(iii) Disposal. Requirements as specified in Sec. 721.85(b)(1) and
(c)(1) solvent rinsate resulting from cleaning of storage and holding
tanks, shipboard tanks, iso containers, rail cars, and trucks used to
transport the substance may only be disposed of by incineration.
Sampling wastes containing the substance may only be disposed of by
incineration, and Sec. 721.85(c)(3) for oilfield applications, when
the substance will no longer be injected into a well at a particular
site for enhanced oil recovery, the water rinsate of the field holding
tank and any remaining field water containing the substance must be
injected into a designated disposal well, either a class
[[Page 20306]]
I hazardous waste disposal well or another class II well.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4) (N = 28).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
0
6. Add Sec. 721.10284 to subpart E to read as follows:
Sec. 721.10284 Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium
salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and
linear alkyl ethers, sodium salts (PMN P-10-487; CAS No. 958238-82-9)
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) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i),
(g)(4)(ii), (g)(4)(iii), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p) (330,000 kilograms for this substance
and for P-10-486 combined).
(iii) Disposal. Requirements as specified in Sec. 721.85(b)(1) and
(c)(1) solvent rinsate resulting from cleaning of storage and holding
tanks, shipboard tanks, iso containers, rail cars, and trucks used to
transport the substance may only be disposed of by incineration.
Sampling wastes containing the substance may only be disposed of by
incineration, and Sec. 721.85(c)(3) for oilfield applications, when
the substance will no longer be injected into a well at a particular
site for enhanced oil recovery, the water rinsate of the field holding
tank and any remaining field water containing the substance must be
injected into a designated disposal well, either a class I hazardous
waste disposal well or another class II well.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4) (N = 4).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), (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 significant new use rule.
* * * * *
0
7. Add Sec. 721.10285 to subpart E to read as follows:
Sec. 721.10285 Formaldehyde, polymer with 4-(1,1-
dimethylethyl)phenol, reaction products with 1-piperazineethanamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymer with 4-(1,1-dimethylethyl)phenol, reaction products with 1-
piperazineethanamine (PMN P-11-33; CAS No. 1191244-16-2) 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 = 17 parts per billion (ppb)).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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. 721.10286 to subpart E to read as follows:
Sec. 721.10286 Formaldehyde, polymer with .alpha.-(2-
aminomethylethyl)-.omega.-(2-aminomethylethoxy)poly[oxy(methyl-1,2-
ethanediyl)] and 4-(1,1-dimethylethyl)phenol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymer with .alpha.-(2-aminomethylethyl)-.omega.-(2-
aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl)] and 4-(1,1-
dimethylethyl)phenol) (PMN P-11-34; CAS No. 1192146-78-3) 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 = 21 ppb).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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. 721.10287 to subpart E to read as follows:
Sec. 721.10287 Infused carbon nanostructures (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as infused
carbon nanostructures (PMN P-11-188) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (manufacturing process described in the
PMN; the process described in the PMN includes the incorporation of the
PMN substance into pellets).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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 significant new use rule.
0
10. Add Sec. 721.10288 to subpart E to read as follows:
Sec. 721.10288 Cyclohexane, oxidized, by-products from, distn.
residues.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclohexane,
oxidized, by-products from, distn. residues (PMN P-11-316; CAS No.
1014979-92-0) 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:
[[Page 20307]]
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 4 ppb).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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 significant new use rule.
0
11. Add Sec. 721.10289 to subpart E to read as follows:
Sec. 721.10289 Hexanedioic acid polymer with aliphatic polyol
dihydrogen phosphate aromatic ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hexanedioic acid polymer with aliphatic polyol dihydrogen phosphate
aromatic ester (PMN P-11-333) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
12. Add Sec. 721.10290 to subpart E to read as follows:
Sec. 721.10290 Alkenoyloxy arylphenone (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoyloxy arylphenone (PMN P-11-424) is subject to reporting under
this section for the significant 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 = 26).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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. [emsp14]721.10291 to subpart E to read as follows:
Sec. [emsp14]721.10291 C15 olefins (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as C15
olefins (PMN P-11-511) is subject to reporting under this section for
the significant 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 ppb).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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. [emsp14]721.10292 to subpart E to read as follows:
Sec. [emsp14]721.10292 Silicate (2-), hexafluoro-, cesium (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silicate (2-)
hexafluoro-cesium (1:2) (PMN P-11-546; CAS No. 16923-87-8) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (use as brazing (metal joining) agent).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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
15. Add Sec. 721.10293 to subpart E to read as follows:
Sec. [emsp14]721.10293 Benzoic acid, 4-(1,1-dimethylethyl)-,
hydrazide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoic acid, 4-
(1,1-dimethylethyl)-, hydrazide (PMN P-11-578; CAS No. 43100-38-5) 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(g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 2 ppb).
(b) Specific requirements. The provisions of subpart A 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
16. Add Sec. [emsp14]721.10294 to subpart E to read as follows:
Sec. [emsp14]721.10294 Cyclohexanol, 2,6-bis(1,1-dimethylethyl)-4-
methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclohexanol, 2,6-
bis(1,1-dimethylethyl)-4-methyl- (PMN P-11-580; CAS No. 163119-16-2) 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 = 2 ppb).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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 20308]]
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 new Sec. 721.10295 to subpart E to read as follows:
Sec. 721.10295 IPDI modified isophthalic acid, neopentyl glycol and
adipic acid (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance identified generically as IPDI
modified isophthalic acid, neopentyl glycol and adipic acid (PMN P-11-
591) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (s) (15,000 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
18. Add new Sec. 721.10296 to subpart E to read as follows:
Sec. 721.10296 1,3-Benzenediol, 4-[1-[[3-(lH-imidazol-1-
yl)propyl]imino] ethyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-benzenediol, 4-
[ 1-[[3-(lH-imidazol-1-yl)propyl]imino[ethyl]- (PMN P-11-608; CAS No.
1313999-39-1) 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 = 1 ppb).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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 new Sec. 721.10297 to subpart E to read as follows:
Sec. 721.10297 Tin, C16-18 and C18-unsatd. fatty acids castor-oil
fatty acids complexes.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance identified as tin, C16-18 and
C18-unsatd. fatty acids castor-oil fatty acids complexes (PMN P-11-637;
CAS No. 1315588-63-6) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (o).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
20. Add new Sec. 721.10298 to subpart E to read as follows:
Sec. 721.10298 MDI terminated polyester polyurethane polymer
(generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance identified generically as MDI
terminated polyester polyurethane polymer (P-11-662) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A 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.
[FR Doc. 2012-8092 Filed 4-3-12; 8:45 am]
BILLING CODE 6560-50-P