[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Rules and Regulations]
[Pages 24613-24628]
[FR Doc No: 2012-9965]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0182; FRL-9345-4]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 23 chemical substances
which were the subject of premanufacture notices (PMNs). Nine 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 23 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 25, 2012. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
May 9, 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 25, 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-2012-0182, by one of the following methods:
     Federal eRulemaking Portal: http://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-2012-0182. 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<PHONE_NUMBER>. Such deliveries are only accepted
during the DCO's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0182. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://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 http://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 http://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<PHONE_NUMBER>, 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<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
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.  721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a

copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public docket. Information
so marked will not be disclosed except in accordance with procedures
set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What action is the agency taking?

    EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of a chemical
substance for any activity designated by these SNURs as a significant
new use. Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for
further information on the objectives, rationale, and procedures for
SNURs and on the basis for significant new use designations, including
provisions for developing test data.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Persons who must report are described
in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  721.1(c), persons subject to these SNURs must comply with the
same notice requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA 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 23
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 23 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) number (if assigned for
non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA
section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
     CFR citation assigned in the regulatory text section of
this rule.
    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 nine PMN substances (P-07-537, P-07-706, P-10-
135, P-10-358, P-11-264, P-11-561, P-11-567, P-11-568, and P-11-569)
that are subject to ``risk-based'' consent orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined that activities associated with
the PMN substances may present unreasonable risk to human health or the
environment. Those consent orders require protective measures to limit
exposures or otherwise mitigate the potential unreasonable risk. The
so-called ``5(e) SNURs'' on these PMN substances are promulgated
pursuant to Sec.  721.160, and are based on and consistent with the
provisions in the underlying consent orders. The 5(e) SNURs designate
as a ``significant new use'' the absence of the protective

measures required in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec.  721.63 respirator requirements may request to do so under
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to
use the NCELs approach for SNURs are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) consent order for the same
chemical substance.
    This rule also includes SNURs on 14 PMN substances (P-05-714, P-11-
128, P-11-338, P-11-481, P-11-594, P-11-654, P-12-22, P-12-23, P-12-24,
P-12-25, P-12-26, P-12-33, P-12-51, and P-12-52) 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 or releases,
thereby constituting a ``significant new use.'' These so-called ``non-
5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA has
determined that every activity designated as a ``significant new use''
in all non-5(e) SNURs issued under Sec.  721.170 satisfies the two
requirements stipulated in Sec.  721.170(c)(2), i.e., these significant
new use activities, ``(i) are different from those described in the
premanufacture notice for the substance, including any amendments,
deletions, and additions of activities to the premanufacture notice,
and (ii) may be accompanied by changes in exposure or release levels
that are significant in relation to the health or environmental
concerns identified'' for the PMN substance.

PMN Number P-05-714

    Chemical name: Polyether ester acid compound with a polyamine amide
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
an additive for industrial paints, industrial coatings, and
architectural coatings. 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
use described in the PMN, significant environmental releases are not
expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use 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
acute toxicity mitigated by humic acid test (Office of Pollution
Prevention, Pesticides and Toxic Substances (OPPTS) Test Guideline
850.1085) would help characterize the environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.10410.

PMN Number P-07-537

    Chemical name: Alkanenitrile, bis(cyanoalkyl)amino (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: June 19, 2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as a
chemical intermediate. Based on test data on the PMN substance, EPA
identified concerns for neurotoxicity to workers from dermal and
inhalation exposures. The NCEL is 70 microgram/cubic meter ([mu]g/m\3\)
as an 8-hour time-weighted average. In addition, based on ecological
structure-activity relationship (EcoSAR) analysis of test data on
structurally similar aliphatic amines, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 700 parts per billion
(ppb). The consent order was issued under TSCA sections 5(e)(1)(A)(i)
and 5(e)(1)(A)(ii)(I) based on a finding that this substance may
present an unreasonable risk of injury to human health and the
environment. To protect against these risks, the consent order
requires:
    1. Use of personal protective equipment including impervious gloves
(when there is potential dermal exposure) and either a National
Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an assigned protection factor (APF) of at least 5, or
compliance with a NCEL of 70 [mu]g/m\3\ as an 8-hour time-weighted
average (when there is potential inhalation exposure).
    2. Establishment and use of a hazard communication program.
    3. Manufacture and use of the PMN substance only as a site-limited
intermediate.
    4. Submission of certain human health testing prior to exceeding
the confidential production volume limit specified in the consent
order.
    5. Disposal of the PMN substance only by incineration or landfill.
    6. No release of the PMN substance into the waters of the United
States.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of a
neurotoxicity study in rodents (Organisation for Economic Co-operation
and Development (OECD) Test Guideline 424); a fish early-life stage
toxicity test (OPPTS Test Guideline 850.1085); and a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300) would help characterize
the human health and environmental effects of the PMN substance. The
PMN submitter has agreed not to exceed the confidential production
volume limit specified in the consent order without performing the
neurotoxicity test. The consent order does not require the submission
of the fish and daphnid testing at any specified time or production
volume. However, the order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMN will
remain in effect until the consent order is modified or revoked by EPA
based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10411.

PMN Number P-07-706

    Chemical name: Phosphonic acid ester (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: April 8, 2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a chemical
intermediate. Based on test data on the PMN substance and an analogous
chemical, EPA identified concerns for oncogenicity, mutagenicity,
reproductive/developmental toxicity, skin irritation, and sensitization
to workers from dermal and inhalation exposures. The NCEL is 1.0
milligram (mg)/m\3\ as an 8-hour time-weighted average. The consent
order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that this substance may present an
unreasonable risk of injury to human health. To protect against this
risk, the consent order requires:
    1. Use of personal protective equipment including dermal protection
(when there is potential dermal exposure) and a NIOSH-certified
respirator with an assigned protection factor (APF) of at least 15, or
compliance with a NCEL of 1.0 mg/m\3\ as an 8-hour time-weighted
average (when there is potential inhalation exposure).
    2. Establishment and use of a hazard communication program.
    3. Submission of certain human health testing prior to exceeding
the confidential production volume limit specified in the consent
order.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity with the reproduction/developmental
toxicity screening test (OECD Test Guideline 422) and a mammalian
erythrocyte micronucleus test (OECD Test Guideline 474) would help
characterize possible human health risks of the PMN substance. The PMN
submitter has agreed not to exceed the confidential production volume
limit specified in the consent order without performing these tests.
The consent order does not require the submission of a genetic
toxicology: rodent dominant lethal assay test (OECD Test Guideline 478)
at any specified time or production volume. However, the consent
order's restrictions on manufacture, import, processing, distribution
in commerce, use, and disposal of the PMN will remain in effect until
the consent order is modified or revoked by EPA based on submission of
that or other relevant information.
    CFR citation: 40 CFR 721.10412.

PMN Number P-10-135

    Chemical name: Fluorinated dialkyl ketone (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: October 21,
2011.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a heat
transfer fluid. Based on test data on the PMN substance and analogs,
EPA identified concerns for oncogenicity and liver effects from dermal
and inhalation exposures. The consent order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that
this substance may present an unreasonable risk of injury to human
health. To protect against this risk, the consent order prohibits
exceedance of the confidential annual production volume limit specified
in the consent order. The SNUR designates as a ``significant new use''
the absence of this protective measure.
    Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) and a reproduction/
developmental toxicity screening test (OECD Test Guideline 421, with
modifications) would help characterize the human health effects of the
PMN substance. The consent order does not require the submission of
this testing at any specified time or production volume. However, the
consent order's restrictions on manufacture, import, processing,
distribution in commerce, use, and disposal of the PMN will remain in
effect until the consent order is modified or revoked by EPA based on
submission of that or other relevant information.
    CFR citation: 40 CFR 721.10413.

PMN Number P-10-358

    Chemical name: Iron(1+), chloro[rel-1,5-dimethyl (1R,2S,4R,5S)-
9,9-dihydroxy-3-methyl-2,4-di(2-pyridinyl-.kappa.N)-7-[(2-
pyridinyl-.kappa.N)methyl]-3,7-diazabicyclo[3.3.1]nonane-1,5-
dicarboxylate-.kappa.N3,.kappa.N7]-, chloride (1:1), (OC-6-63)-.
    CAS number: 478945-46-9.
    Effective date of TSCA section 5(e) consent order: February 7,
2011.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a coatings
additive at concentrations not to exceed 1.0 percent. Based on test
data on the PMN substance, EPA identified concerns for systemic
toxicity, neurotoxicity, dermal sensitization, acute toxicity and
immunotoxicity from dermal exposure. The consent order was issued under
TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding
that this substance may present an unreasonable risk of injury to human
health. To protect against these risks, the consent order requires:
    1. Use of personal protective equipment including dermal protection
(when there is potential dermal exposure).
    2. Establishment and use of a hazard communication program.
    3. Use of the PMN substance only as described in the PMN.
    4. That annual manufacture and importation volume not exceed the
confidential limit specified in the consent order.
    5. No manufacture, processing, or use of the PMN substance in the
form of a powder or a solid.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of an
acute oral toxicity test (OPPTS Test Guideline 870.1100) in rabbits
would help characterize the human health effects of the substance. The
consent order does not require submission of the testing at any
specified time or production volume. However, the consent order's
restrictions on manufacture, import, processing, distribution in
commerce, use, and disposal of the PMNs will remain in effect until the
consent order is modified or revoked by EPA based on submission of that
or other relevant information.
    CFR citation: 40 CFR 721.10414.

PMN Number P-11-128

    Chemical name: 3H-indolium, 2-[2-[3-[2-(1,3-dihydro-1,3,3-
trimethyl-2H-indol-2-ylidene)ethylidene]-2-[(1-phenyl-1H-tetrazol-5-
yl)thio]-1-cyclohexen-1-yl]ethenyl]-1,3, 3-trimethyl-, chloride (1:1).
    CAS number: 440102-72-7.
    Basis for action: The PMN states that the substance will be used as
a dye used in the manufacture of imaging media/products. Based on
EcoSAR analysis of test data on cationic dyes, EPA predicts toxicity to
aquatic organisms may occur as a result of releases of the PMN
substance to surface water from manufacture or import in quantities
greater than the 10,000 kilograms (kg) per year production volume
stated in the PMN. At the annual production volume of 10,000 kg stated
in the PMN,

there were no significant environmental concerns. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substance may present an unreasonable risk. EPA has determined,
however, that exceeding an annual manufacturing and importation volume
of 10,000 kg 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 721.10415.

PMN Number P-11-264

    Chemical name: Brominated polyphenyl ether (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: November 22,
2011.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as a flame
retardant. EPA expects that brominated dibenzodioxins (BDD) and
dibenzofurans (BDF) may be generated during manufacture of the PMN
substance and may be potential decomposition products of the PMN
substance in the environment. Human health concerns from exposure to
BDD and BDF include cancer, reproductive and developmental toxicity,
and immunotoxicity. EPA expects the PMN to be highly persistent in the
environment and that it may be bioavailable based on data on related
substances. EPA also has environmental concerns based on the high
degree of bromination of the PMN substance and the potential presence
of BDD/BDF impurities that may form during manufacturing and may be
decomposition products in the environment. Current knowledge of the
ecotoxicity of BDD and BDF indicate adverse effects may occur in the
parts per trillion range in rainbow trout embryos and juveniles. The
consent order was issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this
substance and potential impurities and degradants may present an
unreasonable risk of injury to human health and the environment, the
substance may be produced in substantial quantities and may reasonably
be anticipated to enter the environment in substantial quantities, and
there may be significant (or substantial) human exposure to the
substance. To protect against these risks the consent order requires:
    1. No exceedance of the maximum levels of BDD and BDF in the PMN
substance as specified in the consent order.
    2. Manufacture of the PMN substance only at the site specified in
the PMN and only using the process described in the PMN unless the
dioxin/furan testing required in the consent order is conducted and the
test results submitted to EPA within 16 months of commencement of
manufacture at the additional site or process.
    3. The molecular weight of the manufactured PMN substance be equal
to or greater than the weight reported in the PMN.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of the
following tests would help characterize the possible health and
environmental effects of the PMN substance, its impurities and its
degradation products. The consent order contains two (confidential)
production limits. The PMN submitter has agreed not to exceed the first
production limit without performing an anaerobic aquatic metabolism
test (OPPTS Test Guideline 835.4400) and an amphibian metamorphosis
assay (OECD Test Guideline 231). The PMN submitter has also agreed not
to exceed a second production limit without performing a dietary
exposure bioaccumulation fish test (OECD Test Guideline 305, draft
dated October 14, 2011) and a test of the PMN substance for BDD and BDF
content by high-resolution gas chromatography/high-resolution mass
spectrometry (HRGC/HRMS) (EPA Test Method 8290A). EPA has also
determined that the following tests would help characterize the
environmental effects of the PMN substance. The consent order does not
require the submission of the following information at any specified
time or production volume: 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, tiers I and II test (OPPTS
Test Guideline 850.5400). However, the consent order's restrictions on
manufacture, import, processing, distribution in commerce, use, and
disposal of the PMN will remain in effect until the consent order is
modified or revoked by EPA based on submission of that or other
relevant information.
    CFR citation: 40 CFR 721.10416.

PMN Number P-11-338

    Chemical name: Biphenyl alkyl morpholino ketone (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a photo initiator. Based on EcoSAR analysis of test data on analogous
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 2 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 2 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS
Test Guideline 850.1010); and an algal toxicity test, tiers I and II
test (OPPTS Test Guideline 850.5400) would help characterize the
environmental effects of the PMN substance. EPA also recommends that
the special considerations for conducting laboratory studies (OPPTS
Test Guideline 850.1000) be followed to facilitate solubility in the
test media, because of the PMN's low water solubility.
    CFR citation: 40 CFR 721.10417.

PMN Number P-11-481

    Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-butyl 2-
(phenylmethyl) ester.
    CAS number: 1200806-67-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an additive for polymers.
Based on EcoSAR analysis of test data on analogous esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 2
ppb of the PMN substance in surface waters. As described in the PMN,
releases of the substance are not expected to result in surface water
concentrations that exceed 2 ppb. Therefore, EPA has not determined
that the proposed

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 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 721.10418.

PMN Number P-11-561

    Chemical name: Tetrafluoroethylene chlorotrifluoroethylene
copolymer (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 27,
2012.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a polymer used in automotive fuel hoses.
Based on EPA analysis of the potential content of the polymer, EPA is
concerned that some long-chain perfluorinated substances could be
present and if degraded, especially under thermal conditions, could be
released into the environment. EPA has concerns that the PMN substance
and its thermal degradation products will persist in the environment,
could bioaccumulate or biomagnify, and could be toxic to humans, wild
mammals, and birds. These concerns are based on data on analog
chemicals, including perfluorooctanoic acid (PFOA) and other
perfluorinated carboxylates, which include the presumed environmental
degradant of the PMN substance. There is pharmacokinetic and
toxicological data in animals on PFOA, as well as epidemiological and
blood monitoring data in humans. Toxicity studies on PFOA indicate
developmental, reproductive, and systemic toxicity in various species,
as well as cancer. These factors, taken together, raise concerns for
potential adverse chronic effects from the presumed degradation product
in humans and wildlife. The consent order was issued under TSCA
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II),
based on a finding that this substance may present an unreasonable risk
of injury to human health and the environment, the substance may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substance and its
potential degradation products. To protect against this exposure and
risk, the consent order requires the PMN substance be manufactured,
processed, distributed in commerce, and used only as a polymer in
automotive fuel hoses and the submitter has agreed to analyze, report,
and limit specific fluorinated impurities of the PMN substance where
the carbon chain meets or exceeds a specified length. The SNUR
designates as a ``significant new use'' the absence of these protective
measures.
    Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property testing identified in the consent
order would help characterize possible effects of the substances and
their degradation products. The consent order does not require
submission of the testing at any specified time or production volume.
However, the consent order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMN will
remain in effect until the consent order is modified or revoked by EPA
based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10419.

PMN Numbers P-11-567, P-11-568, and P-11-569

    Chemical name: Fluoropolymers (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 27,
2012.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of the PMN substances will be in the
manufacture of elastomer containing materials (P-11-567 and P-11-569),
and a component of film, wire, and cable (P-11-568). Based on SAR
analysis of test data on analogous high molecular weight polymers, EPA
identified concerns for lung effects through lung overload if
respirable particles of the intact PMN substances are inhaled. In
addition, EPA has concerns for the formation of potential incineration
or other decomposition products from the PMN substances. These
perfluorinated products may be released to the environment from
incomplete incineration of the PMN substances at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers,
suggesting that, under some conditions, the PMN substance could degrade
in the environment. EPA has concerns that these degradation products
will persist in the environment, could bioaccumulate or biomagnify, and
could be toxic to people, wild mammals, and birds. These concerns are
based on data on analog chemicals, including PFOA and other
perfluorinated carboxylates, which include the presumed environmental
degradant of the PMN substance. There is pharmacokinetic and
toxicological data in animals on PFOA, as well as epidemiological and
blood monitoring data in humans. Toxicity studies on PFOA indicate
developmental, reproductive, and systemic toxicity in various species,
as well as cancer. These factors, taken together, raise concerns for
potential adverse chronic effects from the presumed degradation product
in humans and wildlife. The consent order was issued under TSCA
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II),
based on a finding that this substance may present an unreasonable risk
of injury to human health and the environment, the substance may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substance and its
potential degradation products. To protect against these risks, the
consent order requires the submitter has agreed to analyze, report, and
limit specific fluorinated impurities of the PMN substances where the
carbon chain meets or exceeds a specified length and risk notification.
The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of certain
fate and physical/chemical property testing identified in the consent
order would help characterize possible effects of the substances and
their degradation products. The consent order does not require
submission of the testing at any specified time or production volume.
However, the consent order's restrictions on manufacture, import,
processing, distribution in commerce, use, and disposal of the PMNs
will remain in effect until the consent order is modified or revoked by
EPA based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10420.

PMN Number P-11-594

    Chemical name: Mercaptoalkoxysilane (generic).

    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
an epoxy catalyst. Based on EcoSAR analysis of test data on analogous
alkoxysilanes, esters, and phenols, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 2 ppb of the PMN
substance in surface waters. As described in the PMN, the substance
will not be released to water. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance resulting in surface water concentrations exceeding 2
ppb may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test,
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize
the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10421.

PMN Number P-11-654

    Chemical name: Phenol, 2-[[[3-(1H-imidazol-1-
yl)propyl]imino]phenylmethyl]-5-(octyloxy)-.
    CAS number: 1332716-20-7.
    Basis for action: The PMN states that the substance will be used as
an epoxy catalyst. Based on EcoSAR analysis of test data on analogous
Schiff bases and phenols, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. As described in the PMN, the substance will not be
released to water. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 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 721.10422.

PMN Numbers: P-12-22, P-12-23, P-12-24, P-12-25, and P-12-26

    Chemical names: Complex strontium aluminum, rare earth doped
(generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the PMN substances will be
used as dye used in the manufacture of imaging media/products. Based on
analogous respirable and poorly soluble substances, in particular,
titanium dioxide, EPA identified concerns for potential lung overload
to workers from inhalation exposure to the PMN substances.
Specifically, the Agency predicts potential toxicity to workers from
inhalation when more than 5% of the PMN substances particles are less
than 10 microns. For the uses described in the PMNs, significant worker
exposure is unlikely, when no more than 5% of particles are less than
10 microns. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances other than as described in the PMNs may cause serious health
effects. Based on this information, the PMN substances meets the
concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) would help characterize
the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10423.

PMN Number P-12-33

    Chemical name: Benzoic acid, 4-(1,1-dimethylethyl)-, methyl.
    CAS number: 26537-19-9.
    Basis for action: The PMN states that the substance will be used as
an intermediate in the manufacture of an imaging product. Based on
submitted test data on p-tert-butyl benzoic acid, EPA identified
concerns for neurotoxicity; reproductive toxicity (male); and adverse
effects to the liver, kidney, and lung. In addition, based on data on
benzoic acid, EPA identified concerns for developmental toxicity and
hypersensitivity. These concerns are for effects to workers from
inhalation and dermal exposures to the PMN substance. For the chemical
intermediate use described in the PMN, significant worker exposure is
unlikely, as dermal and inhalation exposures are not expected.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, use of the substance other than as an
intermediate may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that a combined repeated
dose toxicity with the reproduction/developmental toxicity screening
test (OPPTS Test Guideline 870.3650) would help characterize the human
health effects of the PMN substance.
    CFR citation: 40 CFR 721.10424.

PMN Numbers: P-12-51 and P-12-52

    Chemical names: Substituted alkylamides (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as polymer foam additives.
Based on test data on analogous chemical substances and information on
the Material Safety Data Sheet (MSDS), the Agency identified concerns
for irritation to all exposed tissues, solvent irritation, and solvent
neurotoxicity to workers from dermal exposure to the PMN substances.
For the use described in the PMNs, significant worker exposure is
unlikely, as dermal exposure is not expected. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substances may present an unreasonable risk. EPA has determined,
however, use of the substances other than as described in the PMNs 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
combined repeated dose toxicity with the reproduction/developmental
toxicity screening test (OPPTS Test Guideline 870.3650); a bacterial
reverse mutation test (OPPTS Test Guideline 870.5100); and a mammalian
erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) would
help characterize the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10425.

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 9 of the 23
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development

of information sufficient to make reasoned evaluations of the health or
environmental effects of the chemical substances. The basis for such
findings is outlined in Unit IV. Based on these findings, TSCA section
5(e) consent orders requiring the use of appropriate exposure controls
were negotiated with the PMN submitters. The SNUR provisions for these
chemical substances are consistent with the provisions of the TSCA
section 5(e) consent orders. These SNURs are promulgated pursuant to
Sec.  721.160 (see Unit II.).
    In the other 14 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec.  721.170 were met, as discussed
in Unit IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
     EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
     EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
     EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a chemical substance is on the TSCA Inventory is
available on the Internet at http://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
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of
this rule is June 25, 2012 without further notice, unless EPA receives
written adverse or critical comments, or notice of intent to submit
adverse or critical comments before May 25, 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 25, 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 25, 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 9 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, 19 of the 23
chemical substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions (per 40 CFR 720.25 and Sec.  721.11), the Agency
believes that it is highly unlikely that any of the significant new
uses described in the regulatory text of this rule are ongoing.
    As discussed in the April 24, 1990 SNUR, EPA has decided that the
intent of TSCA section 5(a)(1)(B) is best served by designating a use
as a significant new use as of the date of publication of this direct
final rule rather than as of the effective date of the rule. If uses
begun after publication were considered ongoing rather than new, it
would be difficult for EPA to establish SNUR notice requirements
because a person could defeat the SNUR by initiating the significant
new use before the rule became effective, and then argue that the use
was ongoing before the effective date of the rule. Persons who begin
commercial manufacture, import, or processing of the chemical
substances regulated through this SNUR will have to cease any such
activity before the effective date of this rule. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
any extensions expires.
    EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person meets the conditions of
advance compliance under Sec.  721.45(h), the person is considered
exempt from the requirements of the SNUR.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
    1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. describes those tests. Unit IV. also lists
recommended testing for non-5(e) SNURs. Descriptions of tests are

provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection and test reporting. To access the harmonized test
guidelines referenced in this document electronically, please go to
http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
The Organisation for Economic Co-operation and Development (OECD) test
guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. To
access EPA Method 8290A, please go to http://www.epa.gov/osw/hazard/testmethods/sw846/pdfs/8290a.pdf.
    In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Listings of the tests specified in
the TSCA section 5(e) consent orders are included in Unit IV. The SNURs
contain the same production 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 Sec.
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.

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 40 CFR 720.50. SNUNs must be
submitted on EPA Form No. 7710-25, generated using e-PMN software, and
submitted to the Agency in accordance with the procedures set forth in
Sec.  721.25 and 40 CFR 720.40. e-PMN software is available
electronically at http://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-
2012-0182.

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.
    2. The SNUN submitted by any small entity would not cost
significantly more than $8300.
    A copy of that certification is available in the docket for this
rule.
    This rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity
significantly more than $8,300. Therefore, the promulgation of the SNUR
would not have a significant economic impact on a substantial number of
small entities.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this rule. As
such, EPA has determined that this rule does not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
small governments subject to the requirements of sections 202, 203,
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly nor uniquely affect the communities of Indian
Tribal governments, nor does it involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175, entitled ``Consultation and Coordination With Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), do not apply to this
rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions To Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., EPA
will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: April 19, 2012.
Ward Penberthy,
Acting Director, Chemical Control Division, Office of Pollution
Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB Control
                     40 CFR Citation                            No.
------------------------------------------------------------------------

                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------

                                * * * * *
721.10410...............................................       2070-0012
721.10411...............................................       2070-0012
721.10412...............................................       2070-0012
721.10413...............................................       2070-0012
721.10414...............................................       2070-0012
721.10415...............................................       2070-0012
721.10416...............................................       2070-0012
721.10417...............................................       2070-0012
721.10418...............................................       2070-0012
721.10419...............................................       2070-0012
721.10420...............................................       2070-0012
721.10421...............................................       2070-0012
721.10422...............................................       2070-0012
721.10423...............................................       2070-0012
721.10424...............................................       2070-0012
721.10425...............................................       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.  721.10410 to subpart E to read as follows:

Sec.  721.10410  Polyether ester acid compound with a polyamine amide
(generic) (P-05-714).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyether ester acid compound with a polyamine amide (PMN P-05-714) is
subject to 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) (additive for industrial paints,
industrial coatings, and architectural coatings).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10411 to subpart E to read as follows:

Sec.  721.10411  Alkanenitrile, bis(cyanoalkyl)amino (generic) (P-07-
537).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanenitrile, bis(cyanoalkyl)amino (PMN P-07-537) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the PMN substance after it has been
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6)(i), (a)(6)(ii),
(a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).
The following National Institute for Occupational Safety and Health
(NIOSH)-certified respirator with an assigned protection factor (APF)
of at least 5 meets the minimum requirements for Sec.  721.63(a)(4):
NIOSH-certified air-purifying, tight-fitting full-face respirator
equipped with N100 (if oil aerosols absent), R100, or P100 filters;
NIOSH-certified powered air-purifying respirator equipped with a loose-
fitting hood or helmet and high efficiency particulate air (HEPA)
filters; NIOSH-certified powered air-purifying respirator equipped with
a tight-fitting facepiece (full-face) and HEPA filters; or NIOSH-
certified supplied-air respirator operated in pressure demand or
continuous flow mode and equipped with a hood or helmet, or tight-
fitting facepiece (full-face) and HEPA filters.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is 70
microgram/cubic meter ([mu]g/m\3\) as an 8-hour time-weighted average.
Persons who wish to pursue NCELs as an alternative to the Sec.  721.63
respirator requirements may request to do so under Sec.  721.30.
Persons whose Sec.  721.30 requests to use the NCELs approach are
approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 1.0 percent),
(f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection, or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 70 [mu]g/m\3\), (g)(2)(v), (g)(3)(i), (g)(3)(ii),
(g)(4)(i), (g)(4)(iii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(h) and (q).
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (v) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers, importers, and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
6. Add Sec.  721.10412 to subpart E to read as follows:

Sec.  721.10412  Phosphonic acid ester (generic) (P-07-706).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphonic acid ester (PMN P-07-706) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the PMN substance after it has been completely reacted
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2), (a)(3), (a)(4), (a)(5), (a)(6)(i), (a)(6)(v),
(a)(6)(i), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set at
0.1 percent) and (c). The following National Institute for Occupational
Safety and Health (NIOSH)-approved respirators with an assigned
protection

factor (APF) of 15 meet the minimum requirements for Sec.  721.63
(a)(4): NIOSH-certified air-purifying, tight-fitting full-face
respirator equipped with the appropriate gas/vapor cartridges (organic
vapor, acid gas, or substance-specific); NIOSH-certified powered air-
purifying respirator equipped with a loose-fitting hood or helmet and
the appropriate gas/vapor cartridges (organic vapor, acid gas, or
substance-specific); NIOSH-certified powered air-purifying respirator
with a tight-fitting facepiece (full-face) and equipped with the
appropriate gas/vapor cartridges (organic vapor, acid gas, or
substance-specific); NIOSH-certified supplied-air respirator operated
in pressure demand or continuous flow mode and equipped with a hood or
helmet, or tight-fitting facepiece (full-face); or NIOSH-certified
supplied-air respirator operated in pressure demand or continuous flow
mode and equipped with a loose-fitting hood or helmet or a tight-
fitting facepiece (full-face) if no cartridge service life testing is
available.
    (A) As an alternative to the respiratory requirements listed in
paragraph (a)(2)(i), a manufacturer, importer, or processor may choose
to follow the new chemical exposure limit (NCEL) provisions listed in
the TSCA section 5(e) consent order for this substance. The NCEL is 1.0
millgram/cubic meter (mg/m\3\) as an 8-hour time-weighted-average.
Persons who wish to pursue NCELs as an alternative to the Sec.  721.63
respirator requirements may request to do so under Sec.  721.30.
Persons whose Sec.  721.30 requests to use the NCELs approach are
approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(i), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 1.0 mg/m\3\), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
7. Add Sec.  721.10413 to subpart E to read as follows:

Sec.  721.10413  Fluorinated dialkyl ketone (generic) (P-10-135).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorinated dialkyl ketone (PMN P-10-135) is subject to 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(t).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

0
8. Add Sec.  721.10414 to subpart E to read as follows:

Sec.  721.10414  Polycyclic polyamine diester organometallic compound
(generic) (P-10-358).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as iron(1+),
chloro[rel-1,5-dimethyl (1R,2S,4R,5S)-9,9-dihydroxy-3-methyl-2,4-di(2-
pyridinyl-.kappa.N)-7-[(2-pyridinyl-.kappa.N)methyl]-3,7-
diazabicyclo[3.3.1]nonane-1,5-dicarboxylate-.kappa.N3,.kappa.N7]-,
chloride (1:1), (OC-6-63)-(PMN P-10-358, CAS No. 478945-46-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the PMN substance after it has
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2), (a)(3), (a)(6)(i), (a)(6)(ii), (a)(6)(iv),
(a)(6)(v), (a)(6)(vi), (b) (concentration set at 1.0 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii), (g)(2)(i), (g)(2)(v),
(g)(3)(i), (g)(3)(ii), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j), (t), (v)(1), (v)(2), (w)(1), (w)(2),
(x)(1), and (x)(2).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
9. Add Sec.  721.10415 to subpart E to read as follows:

Sec.  721.10415  3H-indolium, 2-[2-[3-[2-(1,3-dihydro-1,3,3-trimethyl-
2H-indol-2-ylidene)ethylidene]-2-[(1-phenyl-1H-tetrazol-5-yl)thio]-1-
cyclohexen-1-yl]ethenyl]-1, 3, 3-trimethyl-, chloride (1:1).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3H-indolium, 2-[2-
[3-[2-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)ethylidene]-2-
[(1-phenyl-1H-tetrazol-5-yl)thio]-1-cyclohexen-1-yl]ethenyl]-1, 3, 3-
trimethyl-, chloride (1:1) (PMN P-11-128, CAS No. 440102-72-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(s) (10,000 kilogram (kg)).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance,
    (2) Limitations or revocation of certain notification requirements.
The

provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.10416 to subpart E to read as follows:

Sec.  721.10416  Brominated polyphenyl ether (generic) (P-11-264).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
brominated polyphenyl ether (PMN P-11-264) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the PMN substance after it has been completely reacted
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j) (manufacture of the substance at a
molecular weight greater than or equal to that described in PMN P-11-
264), Sec.  721.80 (k) (manufacture at the facility described in PMN P-
11-264 or by the process described in PMN P-11-264 (changes in
manufacturing processes include, but are not limited to, changes in
feedstock, reaction conditions, and/or product isolation and
purification) unless the brominated dibenzodioxin (BDD)/brominated
dibenzofuran (BDF) testing (EPA Test Method 8290A) required in the
consent order is conducted at the new facility or for the new
manufacturing method and the test results submitted to EPA within 16
months of changing the manufacturing process or commencement of
manufacture at a different facility; manufacture of the substance where
levels of the fifteen BDD/BDF congeners are detected at or below the
Levels of Quantification (LOQs) published in EPA's Dioxin test rule (40
CFR 766.27)).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  721.10417 to subpart E to read as follows:

Sec.  721.10417  Biphenyl alkyl morpholino ketone (generic) (P-11-338).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
biphenyl alkyl morpholino ketone (PMN P-11-338) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
12. Add Sec.  721.10418 to subpart E to read as follows:

Sec.  721.10418  1,2-Cyclohexanedicarboxylic acid, 1-butyl 2-
(phenylmethyl) ester.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance is identified as 1,2-
cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester (PMN P-11-
481, CAS No. 1200806-67-2) 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).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.10419 to subpart E to read as follows:

Sec.  721.10419  Tetrafluoroethylene chlorotrifluoroethylene copolymer
(generic) (P-11-561).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
tetrafluoroethylene chlorotrifluoroethylene copolymer (PMN P-11-561) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the PMN substance after it has
been completely reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (manufacture, processing, distribution
in commerce, and use of PMN P-11-561 substance only as a polymer in
automotive fuel hoses; analysis and reporting and limitations of
maximum impurity levels of certain fluorinated impurities).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A 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
14. Add Sec.  721.10420 to subpart E to read as follows:

Sec.  721.10420  Fluoropolymers (generic) (P-11-567, P-11-568, and P-
11-569).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
fluoropolymers (PMNs P-11-567, P-11-568, and P-11-569) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the PMN substances after it has been
completely reacted (cured). These PMN substances, which have been
molded into final articles and which are recycled into non-virgin raw
material are again subject to the requirements of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. A significant new use of this
substance is any manner or method of manufacture, import, or processing
associated with any use of this substance without providing risk
notification as follows:
    (A) If as a result of the test data required under the TSCA section
5(e) consent order for this substance, the employer becomes aware that
this substance may present a risk of injury to human health, the
employer must incorporate this new information, and

any information on methods for protecting against such risk, into a
Material Safety Data Sheet (MSDS) as described in Sec.  721.72(c)
within 90 days from the time the employer becomes aware of the new
information. If this substance is not being manufactured, imported,
processed, or used in the employer's workplace, the employer must add
the new information to a MSDS before the substance is reintroduced into
the workplace.
    (B) The employer must ensure that persons who will receive this
substance from the employer are provided a MSDS as described in Sec.
721.72(c) containing the information required under paragraph
(a)(2)(i)(A) of this section within 90 days from the time the employer
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (analysis and reporting and limitations
of maximum impurity levels of certain fluorinated impurities).
    (b) Specific requirements. The provisions of subpart A 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)(ii) of
this section.

0
15. Add Sec.  721.10421 to subpart E to read as follows:

Sec.  721.10421  Mercaptoalkoxysilane (generic) (P-11-594).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
mercaptoalkoxysilane (PMN P-11-594) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
16. Add Sec.  721.10422 to subpart E to read as follows:

Sec.  721.10422  Phenol, 2-[[[3-(1H-imidazol-1-
yl)propyl]imino]phenylmethyl]-5-(octyloxy)-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 2-[[[3-(1H-
imidazol-1-yl)propyl]imino]phenylmethyl]-5-(octyloxy)- (PMN P-11-654,
CAS No. 1332716-20-7) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
17. Add Sec.  721.10423 to subpart E to read as follows:

Sec.  721.10423  Complex strontium aluminum, rare earth doped (generic)
(P-12-22, P-12-23, P-12-24, P-12-25, and P-12-26).

    (a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
complex strontium aluminum, rare earth doped (PMNs P-12-22, P-12-23, P-
12-24, P-12-25, and P-12-26) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j) (manufacture, processing, or use where
no more than 5% of particles are less than 10 microns).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
18. Add Sec.  721.10424 to subpart E to read as follows:

Sec.  721.10424  Benzoic acid, 4-(1,1-dimethylethyl)-, methyl.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoic acid, 4-
(1,1-dimethylethyl)-, methyl (PMN P-12-33, CAS No. 26537-19-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
19. Add Sec.  721.10425 to subpart E to read as follows:

Sec.  721.10425  Substituted alkylamides (generic) (P-12-51 and P-12-
52).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted alkylamides (PMNs P-12-51 and P-12-52) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of 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.

[FR Doc. 2012-9965 Filed 4-24-12; 8:45 am]
BILLING CODE 6560-50-P