Significant New Use Rules on Certain Chemical Substances, 24613-24628 [2012-9965]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 77, Number 80 (Wednesday, April 25, 2012)]
[Rules and Regulations]
[Pages 24613-24628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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

[[Page 24614]]

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: https://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: 
Docket ID Number EPA-HQ-OPPT-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 (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
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 https://www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through regulations.gov or email. The 
regulations.gov Web site is an ``anonymous access'' system, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email comment 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at https://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-9232; email address: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  721.5. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 
Sec.  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

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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

[[Page 24616]]

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.

[[Page 24617]]

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,

[[Page 24618]]

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

[[Page 24619]]

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).

[[Page 24620]]

    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

[[Page 24621]]

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 https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.  
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of 
this rule is June 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

[[Page 24622]]

provided for informational purposes. EPA strongly encourages persons, 
before performing any testing, to consult with the Agency pertaining to 
protocol selection and test reporting. To access the harmonized test 
guidelines referenced in this document electronically, please go to 
https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' 
The Organisation for Economic Co-operation and Development (OECD) test 
guidelines are available from the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org. To 
access EPA Method 8290A, please go to https://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 https://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances subject to this rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
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

[[Page 24623]]

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.


[[Page 24624]]



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

[[Page 24625]]

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

[[Page 24626]]

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

[[Page 24627]]

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.

[[Page 24628]]

    (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