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[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Proposed Rules]
[Pages 12684-12701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04298]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 721

[EPA-HQ-OPPT-2012-0727; FRL-9376-7]
RIN 2070-AB27

Proposed Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for 37 chemical substances which 
were the subject of premanufacture notices (PMNs). Seventeen of these 
chemical substances are subject to TSCA section 5(e) consent orders 
issued by EPA. This action would require persons who intend to 
manufacture, import, or process any of these 37 chemical substances for 
an activity that is designated as a significant new use by this 
proposed rule to notify EPA at least 90 days before commencing that 
activity. The required notification would provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: Comments must be received on or before April 26, 2013.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2012-0727, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
ATTN: Docket ID Number EPA-HQ-OPPT-2012-0727. 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-
2012-0727. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through regulations.gov or email. The 
regulations.gov Web site is an ``anonymous access'' system, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email comment 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at http://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (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

[[Page 12685]]

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 in this proposed rule. 
The following list of North American Classification System (NAICS) 
codes is not intended to be exhaustive, but rather provides a guide to 
help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127; 
see also 19 CFR 127.28. Chemical importers must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA. Importers of chemicals subject to a final SNUR 
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 a proposed or final SNUR are 
subject to the export notification provisions of TSCA section 12(b) (15 
U.S.C. 2611(b)) (see Sec.  721.20) and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

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

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

II. Background

A. What action is the agency taking?

    These proposed SNURs would, when finalized, require persons to 
notify EPA at least 90 days before commencing the manufacture, import, 
or processing of the specific chemical substances identified in the 
PMNs 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 of April 24, 1990 
(55 FR 17376). 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) 
and 40 CFR part 721 require persons to submit a significant new use 
notice (SNUN) to EPA at least 90 days before they manufacture, import, 
or process the chemical substance for that use. Persons who must report 
are described in Sec.  [emsp14]721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700.
    According to Sec.  [emsp14]721.1(c), persons subject to these SNURs 
must comply with the same SNUN requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In 
particular, these requirements include the information submission 
requirements of TSCA section 5(b) and 5(d)(1), the exemptions 
authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (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.

[[Page 12686]]

     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 37 
chemical substances that are the subject of these proposed SNURs, EPA 
considered relevant information about the toxicity of the chemical 
substances, likely human exposures and environmental releases 
associated with possible uses, taking into consideration the four 
bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing to establish significant new use and recordkeeping 
requirements for 37 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 TSCA 
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 proposed rule.
    This proposed rule includes 14 PMN substances whose reported 
chemical names include the term ``carbon nanotube'' or ``carbon 
nanofibers.'' Because of a lack of established nomenclature for carbon 
nanotubes, the TSCA Inventory names for carbon nanotubes are currently 
in generic form, e.g., carbon nanotube (CNT), multi-walled carbon 
nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-
walled carbon nanotube (SWCNT). EPA uses the specific structural 
characteristics provided by the PMN submitter to more specifically 
characterize the TSCA Inventory listing for an individual CNT. All 
submitters of new chemical notices for CNTs have claimed those specific 
structural characteristics as CBI. EPA is publishing the generic 
chemical name along with the PMN number to identify that a distinct 
chemical substance was the subject of the PMN without revealing the 
confidential chemical identity of the PMN substance. Confidentiality 
claims preclude a more detailed description of the identity of these 
CNTs. If an intended manufacturer, importer, or processor of CNTs is 
unsure of whether its CNTs are subject to this proposed SNUR or any 
other SNUR, the company can either contact EPA or obtain a written 
determination from EPA pursuant to the bona fide procedures at Sec.  
721.11. EPA is using the specific structural characteristics for all 
CNTs submitted as new chemical substances under TSCA to help develop 
standard nomenclature for placing these chemical substances on the TSCA 
Inventory. EPA has compiled a generic list of those structural 
characteristics entitled ``Material Characterization of Carbon 
Nanotubes for Molecular Identity (MI) Determination & Nomenclature.'' A 
copy of this list is available in the docket for these proposed SNURs 
under docket ID number EPA-HQ-OPPT-2012-0727. If EPA develops a more 
specific generic chemical name for these materials, that name will be 
made publicly available.
    The regulatory text section of this proposed rule specifies the 
activities designated as significant new uses. Certain new uses, 
including exceeding production volume limits (i.e., limits on 
manufacture and importation volume) and other uses designated in this 
proposed rule, may be claimed as CBI.
    This proposed rule includes 17 PMN substances for which EPA 
determined, pursuant to TSCA section 5(e), that uncontrolled 
manufacture, import, processing, distribution in commerce, use, and 
disposal may present an unreasonable risk of injury to human health or 
the environment. Accordingly, these substances are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I). Those 
consent orders require protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``section 5(e) SNURs'' on these PMN substances are proposed pursuant to 
Sec.  721.160, and are based on and consistent with the provisions in 
the underlying consent orders. The section 5(e) SNURs designate as a 
``significant new use'' the absence of the protective measures required 
in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the 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 normally 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.  [emsp14]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 proposed rule also includes SNURs on 20 PMN substances that 
are not subject to consent orders under TSCA section 5(e). In these 
cases, for a variety of reasons, EPA did not find that the use scenario 
described in the PMN triggered the determinations set forth under TSCA 
section 5(e). However, EPA does believe that certain changes from the 
use scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
section 5(e) SNURs'' are promulgated pursuant to Sec.  [emsp14]721.170. 
EPA has determined that every activity designated as a ``significant 
new use'' in all non-section 5(e) SNURs issued under Sec.  
[emsp14]721.170 satisfies the two requirements stipulated in Sec.  
721.170(c)(2), i.e., these significant new use activities, ``(i) are 
different from those described in the premanufacture notice for the 
substance, including any amendments, deletions, and additions of 
activities to the premanufacture notice, and (ii) may be accompanied by 
changes in exposure or release levels that are significant in relation 
to the health or environmental concerns identified'' for the PMN 
substance.

[[Page 12687]]

PMN Number P-00-835

    Chemical name: Substituted picolinate (generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the substance will be used as 
an intermediate in the manufacture of agricultural chemicals. Based on 
ecological structure activity relationship (EcoSAR) analysis of test 
data on analogous esters, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 90 parts per billion (ppb) of 
the PMN substance in surface waters. As described in the PMN, releases 
to surface water 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 resulting in surface water concentrations 
exceeding 90 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 
(Office of Chemical Safety and Pollution Prevention (OCSPP) Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10637.

PMN Number P-02-167

    Chemical name: Lithium metal phosphate (generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an electrode material. 
Based on EcoSAR analysis of test data on analogous inorganic 
phosphates, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, releases to water are not expected to 
exceed 1 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance presents an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 1 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10638.

PMN Number P-02-668

    Chemical name: Siloxanes and Silicones, di-Me, polymers with Ph 
silsesquioxanes, hydrolyzed, reaction products with 2-[[3-
(trimethoxysilyl)propoxy]methyl]oxirane.
    CAS number: 478823-10-8.
    Basis for action: The PMN substance will be used as a binder for 
silicone coatings. Based on structure activity relationship (SAR) 
analysis of test data on analogous epoxides and alkoxysilanes, EPA 
identified concerns for mutagenicity, oncogenicity, reproductive 
toxicity, developmental toxicity, lung toxicity, and sensitization from 
dermal and inhalation exposures to the PMN substance. For the use 
described in the PMN, significant occupational dermal and inhalation 
exposures are not expected due to the use of impervious gloves and a 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirator with an assigned protection factor (APF) of at least 10, and 
consumer exposures are not expected as the substance is not used in 
consumer products. Therefore, EPA has not determined that 
manufacturing, processing, and use of the substance may present an 
unreasonable risk. EPA has determined, however, that use of the 
substance without impervious gloves where there is a potential for 
dermal exposure; any use of the substance without a NIOSH-certified 
respirator with an APF of at least 10; or any use of the substance in 
consumer products may result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465), with 
attention to the pathology of the reproductive organs, and a 
carcinogenicity test (OPPTS Test Guideline 870.4200) would help to 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10639.

PMN Number P-03-135

    Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-(2-ethylhexyl) 
2-(2-methylpropyl) ester.
    CAS number: 252958-29-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a compressor lubricant. 
Based on EcoSAR analysis of test data on analogous esters, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. As described in the PMN, 
the substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. There are two other chemical substances 
identified in the PMN that are already on the TSCA Inventory. The SNUR 
does not apply to those chemical substances. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help to 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10640.

PMN Number P-03-255

    Chemical name: Phenol and vinyltoluene based hydrocarbon resin 
(generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a diluent for coatings. 
Based on EcoSAR analysis of test data on analogous neutral organics, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 1 ppb of the PMN substance in surface waters. As described 
in the PMN, releases to water 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 resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).

[[Page 12688]]

    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help to 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10641.

PMN Numbers P-03-762 and P-03-763

    Chemical name: Modified polyisocyanates (generic).
    CAS number: Claimed as confidential.
    Basis for action: The consolidated PMN states that the generic 
(non-confidential) use of the substances will be as hardeners. Based on 
SAR analysis of test data on analogous isocyanates, EPA has identified 
concerns for sensitization and irritation from dermal and inhalation 
exposure to the PMN substances. For the use described in the PMN, 
significant occupational inhalation and dermal exposures are not 
expected due to no domestic manufacture, use of impervious gloves, and 
no use of the substances involving an application method that generates 
a vapor, mist, or aerosol. Further, consumer exposures are not expected 
as the substance is not used in consumer products. Therefore, EPA has 
not determined that the proposed processing or use of the substances 
may present an unreasonable risk. EPA has determined, however, that any 
domestic manufacture of the substances; any use of the substances 
without impervious gloves where there is a potential for dermal 
exposures; any use of the substance in consumer products; or any use of 
the substances involving an application method that generates a vapor, 
mist, or aerosol may result in 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 skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10642.

PMN Number P-04-640

    Chemical name: Diisocyanate terminated polycarbodiimide (generic).
    CAS number: Claimed as confidential.
    Effective date of TSCA section 5(e) consent order: February 1, 
2006.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a 
crosslinking agent for solvent-based inks; a monomer for 
polymerization; and a water scavenger for producing anhydrous polymers. 
The PMN did not identify consumer uses for the PMN substance. Based on 
SAR analysis of test data on structurally similar diisocyanates, EPA 
identified concerns for dermal sensitization, respiratory 
sensitization, and pulmonary toxicity from exposure to the PMN 
substance by the inhalation and dermal routes. The order was issued 
under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a 
finding that this substance may present an unreasonable risk of injury 
to human health. To protect against these risks, the order requires:
    1. Use of personal protective equipment including impervious gloves 
(when there is potential dermal exposure) and either a NIOSH-certified 
respirator with an APF of at least 2,000, or compliance with a NCEL of 
0.05 mg/m\3\ as an 8-hour time-weighted average (when there is 
potential inhalation exposure).
    2. Establishment and use of a hazard communication program. The 
SNUR would designate as a ``significant new use'' the absence of these 
protective measures and consumer use of the PMN substance.
    Recommended testing: EPA has determined that data from worker 
exposure to the PMN substance (such as inhalation monitoring data 
generated according to the NCELs section of the consent order) or a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance. The order 
does not require submission of the testing at any specified time or 
production volume. However, the order's restrictions on manufacture, 
import, processing, distribution in commerce, use, and disposal of the 
PMN substance will remain in effect until the order is modified or 
revoked by EPA based on submission of that or other relevant 
information.
    CFR citation: 40 CFR 721.10643.

PMN Number P-07-553

    Chemical name: Reaction product of aluminum hydroxide and modified 
alkoxysilane (generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the substance will be used as 
a flame retardant. Based on SAR analysis of test data on analogous 
respirable, poorly soluble particulates, EPA identified concerns for 
lung toxicity from inhalation exposures to the PMN substance. At an 
annual production volume of 100,000 kilograms (kgs), significant 
occupational inhalation exposures are not expected due to the use of a 
NIOSH-certified respirator with an APF of at least 10. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance without a NIOSH-certified 
respirator with an APF of at least 10, where there is a potential for 
inhalation exposure; or any increase of the annual 100,000 kg 
production volume may result in increased exposure to the PMN 
substance, which may cause serious human health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period would help characterize the health effects of the 
PMN substance.
    CFR citation: 40 CFR 721.10644.

PMN Number P-08-392

    Chemical name: Multi-walled carbon nanotube (generic) (P-08-392).
    CAS number: Claimed as confidential.
    Effective date of TSCA section 5(e) consent order: November 14, 
2008.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as an 
antistatic, reinforcement additive. Based on test data on the PMN 
substance, and SAR analysis of test data on structurally similar 
respirable, poorly soluble particulates, EPA identified concerns for 
pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and 
immunotoxicity. The order was issued under sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) of TSCA, based on a finding that the PMN substance 
may present an unreasonable risk of injury to human health. To protect 
against these risks, the order:
    1. Requires use of personal protective equipment including 
impervious gloves and protective clothing (when there is a potential 
dermal exposure) and a NIOSH-certified air-purifying, tight-fitting 
full-face respirator equipped with N100 filters with an APF of at least 
50 (when there is potential inhalation exposure).
    2. Prohibits manufacture of the PMN substance in the United States.
    3. Restricts processing and use of the PMN substance to those uses 
specified in the consent order.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.

[[Page 12689]]

    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465 or 
Organisation for Economic Co-operation and Development (OECD) Test 
Guideline 413) in rats with a post exposure observation period of up to 
3 months, including bronchoalveolar lavage fluid (BALF) analysis and 
certain material characterization data, would help characterize 
possible effects of the substance. In the consent order, the PMN 
submitter has agreed to perform these tests within 18 months of 
commencing non-exempt commercial manufacture.
    CFR citation: 40 CFR 721.10645.

PMN Number P-09-257

    Chemical name: Multi-walled carbon nanotube (generic) (P-09-257).
    CAS number: Claimed as confidential.
    Effective date of TSCA section 5(e) consent order: August 11, 2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) uses of the substance will be as an electric 
conductive filler to replace conventional material such as carbon black 
or carbon fiber in matrixes such as polymer resin for conductive 
applications, and an additive for elastomers, polymers, and resins to 
enhance mechanical properties. Based on SAR analysis of test data on 
analogous respirable, poorly soluble particulates and other CNTs, EPA 
identified concerns for pulmonary toxicity, fibrosis, carcinogenicity, 
mutagenicity, and immunotoxicity. Further, available data suggests that 
pulmonary deposition of some nanoparticles, including CNTs, may induce 
cardiovascular toxicity if inhaled. Although there are no environmental 
toxicity studies on CNTs available, EPA expects that some fraction of 
the CNTs, if released into the environment, will eventually be 
suspended in water. There have been sublethal effects observed for 
single walled CNTs in rainbow trout at levels as low as 100 ppb. The 
order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of 
TSCA 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 order:
    1. Requires use of personal protective equipment including 
impervious gloves and protective clothing (when there is a potential 
dermal exposure) and a NIOSH-certified air-purifying, tight-fitting 
full-face respirator equipped with N100 filters with an APF of at least 
50 (when there is potential inhalation exposure).
    2. Prohibits manufacture of the PMN substance in the United States.
    3. Restricts processing and use of the PMN substance to those uses 
specified in the consent order.
    4. Prohibits release to water during processing and use.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD 
Test Guideline 413) in rats with a post exposure observation period of 
up to 3 months (including BALF analysis, a determination of 
cardiovascular toxicity (clinically-based blood/plasma protein 
analyses), and histopathology of the heart) and development of data on 
certain physical/chemical properties would help characterize possible 
effects of the substance. In the consent order, the PMN submitter has 
agreed not to exceed a specified production volume/time limit 
(whichever comes first) without performing the 90-day test on the PMN 
substance. In addition, in the consent order, the PMN submitter agreed 
to provide the physical/chemical properties data within a specified 
time limit.
    CFR citation: 40 CFR 721.10646.

PMN Numbers P-10-115, P-10-116, P-10-117, P-10-118, P-10-119, P-10-120, 
P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, and P-10-126

    Chemical name: Multi-walled carbon nanofibers (generic).
    CAS number: Claimed as confidential.
    Effective date of TSCA section 5(e) consent order: May 9, 2011.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
uses of the substances will be as electrical and thermal conductivity 
additives, mechanical reinforcement additives, energy storage 
additives, and chemical intermediates. Based on SAR analysis of test 
data on analogous respirable, poorly soluble particulates and other 
CNTs, EPA identified concerns for pulmonary toxicity, fibrosis, 
carcinogenicity, mutagenicity, and immunotoxicity. Further, available 
data suggests that pulmonary deposition of some nanoparticles, 
including CNTs may induce cardiovascular toxicity if inhaled. Although 
there are no environmental toxicity studies on CNTs available, EPA 
expects that some fraction of the CNTs, if released into the 
environment, will eventually be suspended in water. There have been 
sub-lethal effects observed for single walled CNTs in rainbow trout at 
levels as low as 100 ppb. The order was issued under sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that 
these substances may present an unreasonable risk of injury to human 
health and the environment. To protect against this risk, the order:
    1. Requires use of personal protective equipment including 
impervious gloves and protective clothing (when there is a potential 
dermal exposure) and a NIOSH-certified air-purifying, tight-fitting 
full-face respirator equipped with N100 filters with an APF of at least 
50 (when there is potential inhalation exposure).
    2. Restricts use of the PMN substances to use only as electrical 
and thermal conductivity additives, mechanical reinforcement additives, 
energy storage additives, and chemical intermediates as specified in 
the consent order.
    3. Restricts processing and use of the PMN substances to industrial 
settings.
    4. Prohibits release of the PMN substances into the waters of the 
United States during processing and use activities.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the results of certain 
physical/chemical properties data, workplace exposure monitoring and 
characterization testing, and a 90-day inhalation toxicity test (OPPTS 
Test Guideline 870.3465 or OECD Test Guideline 413) in rats would help 
characterize the human health effects of the PMN substances. The PMN 
submitter agreed to provide the physical/chemical properties data for 
the PMN substances within one year after submitting the notice of 
commencement. The consent order contains two additional production 
volume limits. The PMN submitter agreed not to exceed the first 
production volume limit without submitting workplace exposure 
monitoring and characterization testing (including byproducts) as well 
as quantification and characterization of substances that may be 
released during exposures typical during the use phase, such as 
handling, tearing and cutting the PMN substances. The PMN submitter has 
also agreed not to exceed the second production volume limit without 
performing two 90-day inhalation toxicity tests, with a post-exposure 
observation period of up to 3 months, BALF analysis, aggregation/
agglomeration state, shape, size/size particle distribution and surface 
properties of materials as administered, aggregation/agglomeration 
state, shape, size/size particle distribution and surface properties of 
materials of the

[[Page 12690]]

delivered materials after administration, determination of 
cardiovascular toxicity, heart histopathology, and data on pulmonary 
deposition. One 90-day inhalation toxicity test will be conducted from 
a representative PMN substance in the group P-10-115, P-10-116, P-10-
117, P-10-118, P-10-119, and the other 90-day inhalation toxicity test 
will be conducted from a representative PMN substance in the group P-
10-120, P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, and P-10-126.
    CFR citation: 40 CFR 721.10647.

PMN Numbers P-10-545 and P-10-546

    Chemical name: Modified lithium iron phosphates (generic).
    CAS number: Claimed as confidential.
    Effective date of TSCA section 5(e) consent order: December 10, 
2010.
    Basis for TSCA section 5(e) consent order: The consolidated PMN 
states that the generic (non-confidential) use of the substances will 
be as battery electrode components, contained use. Based on test data 
on analogous respirable, poorly soluble particulates, there is 
potential risk for adverse lung effects including cancer, lung 
fibrosis, lung inflammation and systemic effects, including 
immunotoxicity. EPA has identified concerns for these health effects 
from exposures to the PMN substances. Based on EcoSAR analysis of test 
data on analogous phosphates, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 2 ppb of the PMN 
substance in surface waters. The order was issued under sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that 
these substances may present an unreasonable risk of injury to human 
health or the environment. To protect against these risks, the consent 
order:
    1. Restricts manufacturing, processing, and use of the substances 
to a fully-enclosed and automated process, including all loading and 
unloading activities.
    2. Restricts use of the PMN substances to use only as specified in 
the consent order.
    3. Prohibits release of the PMN substances into the waters of the 
United States during processing and use activities.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats 
with a post-exposure observation period of up to 3 months, including 
BALF analysis; an algal toxicity test (OCSPP Test Guideline 850.5400); 
and physical/chemical properties testing for: Water solubility (OECD 
Test Guideline 105); surface chemistry, particle size distribution of 
the PMN substances, dustiness test (European Standard 15051); and 
particle size distribution, aggregation state, and porosity would help 
characterize the human health and environmental effects of the PMN 
substances. The PMN submitter has agreed not to exceed the confidential 
production volume in the consent order without performing the 90-day 
inhalation toxicity test and the physical/chemical properties tests.
    CFR citation: 40 CFR 721.10648.

PMN Number P-11-115

    Chemical name: MDI modified polyalkylene glycol adipate polyester 
(generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive. Based on SAR 
analysis of test data on analogous diisocyanates, EPA identified 
concerns for respiratory and dermal sensitization. For the use 
described in the PMN, significant occupational dermal and inhalation 
exposures are not expected due to the use of a NIOSH-certified 
respirator with an APF of at least 10, and consumer exposures are not 
expected as the substance is not used in consumer products. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that any use of the substance without a NIOSH-
certified respirator with an APF of at least 10, where there is a 
potential for inhalation exposures, or any use of the substance in 
consumer products may cause serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10649.

PMN Number P-11-155

    Chemical name: Polyether substituted anthraquinone derivative 
(generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be used as a colorant for 
cleaners and detergents. Based on EcoSAR analysis of test data on 
analogous aromatic amines and nonionic dyes, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 2 ppb of the 
PMN substance in surface waters for greater than 20 days per year. This 
20-day criterion is derived from partial life cycle tests (daphnid 
chronic and fish early life stage tests) that typically range from 21 
to 28 days in duration. EPA predicts toxicity to aquatic organisms may 
occur if releases of the PMN substance to surface water, from uses 
other than as described in the PMN, exceed releases from the use 
described in the PMN. For the use described in the PMN, environmental 
releases did not exceed 1 ppb for more than 20 days per year.
    Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance other than 
as a colorant for cleaners and detergents 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) and an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10650.

PMN Number P-11-290

    Chemical name: Carbide derived nanocarbon (generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a sensor element in an 
electrochemical sensor. Based on SAR analysis of test data on 
respirable, poorly soluble particulates, EPA identified concerns for 
pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and 
immunotoxicity if the substances were manufactured by a method other 
than described in the PMN. Further, available data suggests that 
pulmonary deposition of some carbon-based nanoparticles, may induce 
cardiovascular toxicity if inhaled. EPA identified concerns for lung 
toxicity to workers from inhalation exposures to the PMN substance. For 
the manufacture method described in the PMN, significant 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

[[Page 12691]]

unreasonable risk. EPA has determined, however, that manufacture of the 
substance by a method other than as described in the PMN may cause 
serious health effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that inhalation monitoring 
data collected during the manufacturing process according to the EPA 
draft Inhalation Monitoring Data Collection Guidelines (located in the 
docket under docket ID number EPA-HQ-OPPT-2012-0727) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10651.

PMN Numbers P-11-309, P-11-311, P-11-312, P-11-313, and P-11-314

    Chemical names: (P-11-309) Hexanedioic acid, polymer with polyether 
polyol, 1,1'-methylenebis[4-isocyanatobenzene] and dihydroxydialkyl 
ether (generic); (P-11-311) Hexanedioic acid, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether and dialkanol 
ether (generic); (P-11-312) Hexanedioic acid, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[isocyanatobenzene], dihydroxydialkyl ether and dialkanol 
ether (generic); (P-11-313) Hexanedioic acid, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether, reaction 
products with dialkylcarbinol (generic); and (P-11-314) Hexanedioic 
acid, polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-
ethanediyl)],1,1'-methylenebis[4-isocyanatobenzene], dihydroxydialkyl 
ether reaction products with dialkylcarbinol (generic).
    CAS numbers: Claimed as confidential.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as industrial adhesives. 
Based on SAR analysis of test data on analogous isocyanates, EPA 
identified concerns for sensitization from dermal and inhalation 
exposure to the PMN substances. For the use described in the PMNs, 
significant occupational dermal and inhalation exposures are not 
expected due to the use of a NIOSH-certified respirator with an APF of 
at least 10, and consumer exposures are 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, that any use of the substances without a NIOSH-certified 
respirator with an APF of at least 10, where there is a potential for 
inhalation exposures, or any use of the substances in consumer products 
may cause serious health effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substances.
    CFR citations: 40 CFR 721.10652 (P-11-309); 40 CFR 721.10653 (P-11-
311); 40 CFR 721.10654 (P-11-312); 40 CFR 721.10655 (P-11-313); and 40 
CFR 721.10656 (P-11-314).

PMN Number P-12-73

    Chemical name: Castor oil, polymer with hydrogenated vegetable oil, 
1,1'-methylenebis[isocyanatobenzene] and isocyanate (generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an industrial adhesive. Based 
on SAR analysis of test data on analogous diisocyanates, EPA identified 
concerns for sensitization. For the use described in the PMN, 
significant occupational dermal and inhalation exposures are not 
expected due to the use of a NIOSH-certified respirator with an APF of 
at least 10, and consumer exposures are not expected as the substance 
is not used in consumer products. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance without a NIOSH-certified respirator with an APF 
of at least 10, where there is a potential for inhalation exposures, or 
any use of the substances in consumer products may cause serious health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization (OPPTS Test Guideline 870.2600) and a 90-day subchronic 
inhalation toxicity test (OPPTS Test Guideline 870.3465) in rodents 
would help characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10657.

PMN Number P-12-133

    Chemical name: 2-Oxepanone, polymer with 1,6-diisocyanatohexane, 
2,2''dimethyl-1;3-propanediol and 2,2'-oxybis[ethanol].
    CAS number: 1313708-90-5.
    Basis for action: The PMN states that the substance will be used as 
a coating for wind craft wings. Based on SAR analysis of test data on 
structurally similar chemicals submitted under TSCA section 8(e), EPA 
identified concerns for oncogenicity and mutagenicity. Additionally, 
based on the isocyanate moiety, the Agency identified concerns for 
sensitization. For the use described in the PMN, significant 
occupational inhalation exposures are not expected due to the use of a 
NIOSH-certified respirator with an APF of at least 10, and consumer 
exposures are not expected as the substance is not used in consumer 
products. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance without a NIOSH-certified respirator with an APF of at least 
10, where there is a potential for inhalation exposures, or any use of 
the substance in consumer products may cause serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity study (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10658.

PMN Number P-12-143

    Chemical name: Poly(oxy-1,4-butanediyl), -hydro--hydroxy-, polymer 
with alkyldiisocyanates (generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a crosslinking resin. 
Based on SAR analysis of test data on analogous isocyanates, EPA 
identified concerns for sensitization from dermal and respiratory 
exposures to the PMN substance. For the use described in the PMN, 
significant occupational dermal and inhalation exposures are not 
expected due to the use of a NIOSH-certified respirator with an APF of 
at least 10, and consumer exposures are not expected as the substance 
is not used in consumer products. Therefore,

[[Page 12692]]

EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that any use of the substance without a NIOSH-
certified respirator with an APF of at least 10, where there is a 
potential for inhalation exposures, or any use of the substance in 
consumer products may cause serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10659.

PMN Number P-12-274

    Chemical name: Aliphatic diisocyanate adduct with substituted amino 
alkyl silane (generic).
    CAS number: Claimed as confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive. Based on SAR 
analysis of test data on analogous isocyanates, EPA identified concern 
for sensitization from dermal and inhalation exposure to the PMN 
substance. Additionally, liquid and vapor contact with the eye can 
cause moderate to severe irritation. For the use described in the PMN, 
significant occupational dermal and inhalation exposures are not 
expected due to the use of a NIOSH-certified respirator with an APF of 
at least 10, and consumer exposures are not expected as the substance 
is not used in consumer products. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance without a NIOSH-certified respirator with an APF 
of at least 10, where there is a potential for inhalation exposures; or 
any use of the substance in consumer products may cause serious health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  [emsp14]721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10660.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these proposed SNURs, EPA concluded that for 17 of 
the 37 chemical substances regulation was warranted under TSCA section 
5(e) pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The proposed SNUR provisions for these chemical substances 
are consistent with the provisions of the TSCA section 5(e) consent 
orders. These SNURs are being proposed pursuant to Sec.  
[emsp14]721.160.
    In the other 20 cases, where the uses are not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  [emsp14]721.170 were met, as 
discussed in Unit IV.

B. Objectives

    EPA is proposing 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 proposed rule:
     EPA would 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 would 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 would 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 would 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 Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Notice and Comment Procedures

    EPA is issuing these SNURs by notice and comment procedure, as 
described in Sec.  [emsp14]721.170(d)(4). In accordance with Sec.  
[emsp14]721.170(d)(4)(ii)(A), persons are being given the opportunity 
to submit comments on or before April 26, 2013 on whether EPA should 
establish notification requirements.

VII. Applicability of Proposed Rule to Uses Occurring Before Effective 
Date of the Final Rule

    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances subject to this proposed 
rule have undergone premanufacture review. TSCA section 5(e) consent 
orders have been issued for 17 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. EPA is soliciting comments on whether any of the uses proposed as 
significant new uses are ongoing.
    As discussed in the Federal Register of 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 proposed rule rather than as of the effective date 
of the final rule. If uses begun after publication of the proposed rule 
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 
final, and then argue that the use was ongoing before the effective 
date of the final rule. Thus, persons who begin commercial manufacture, 
import, or processing of the chemical substances that would be 
regulated through these proposed SNURs will have to cease any such 
activity before the effective date of the rule if and when finalized. 
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 
these proposed SNURs before the effective date. If a person meets the 
conditions of advance compliance under Sec.  [emsp14]721.45(h), the 
person would be considered exempt from the requirements of the SNUR.

[[Page 12693]]

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. lists those tests. Unit IV. also lists recommended 
testing for non-5(e) SNURs. Descriptions of tests are provided for 
informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the OCSPP test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at http://www.oecdbookshop.org or Source OECD at 
http://www.sourceoecd.org. To access the European Standard, EN 15051 
method, issued by The European Committee for Standardization (CEN), 
please go to http://www.cen.eu/cen/products.
    In the TSCA section 5(e) consent orders for several of the chemical 
substances regulated under this proposed 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 volume limits as the 
TSCA section 5(e) consent orders. Exceeding these production limits is 
defined as a significant new use. Persons who intend to exceed the 
production limit must notify the Agency by submitting a SNUN at least 
90 days in advance of commencement of non-exempt commercial 
manufacture, import, or processing.
    When physical/chemical properties of test material and/or material 
characterization tests are recommended for nanoscale substances that 
are the subject of this proposed rule, you should take into 
consideration the characterizations identified in the Guidance Manual 
for the Testing of Manufactured Nanomaterials: OECD's Sponsorship 
Programme, which is available at http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev&doclanguage=en.
    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. SNUN Submissions

    According to Sec.  [emsp14]721.1(c), persons submitting a SNUN must 
comply with the same notification 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 40 CFR 720.40 and Sec.  721.25. E-PMN software is 
available electronically at http://www.epa.gov/opptintr/newchems.

X. 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 proposed rule. EPA's complete 
economic analysis is available in the docket under docket ID number 
EPA-HQ-OPPT-2012-0727.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for several new chemical 
substances that were the subject of PMNs, and, in some cases, 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 (PRA)

    According to 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 would amend the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this proposed rule, if the SNUR is subsequently issued as a final 
rule. This listing of the OMB control numbers and their subsequent 
codification in the CFR satisfies the display requirements of PRA and 
OMB's implementing regulations at 5 CFR part 1320. This Information 
Collection Request (ICR) was previously subject to public notice and 
comment prior to OMB approval, and given the technical nature of the 
table, EPA finds that further notice and comment to amend it is 
unnecessary. As a result, EPA finds that there is ``good cause'' under 
section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 
553(b)(3)(B)) to amend this table without further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action would not impose any burden 
requiring additional OMB approval. If an entity were to submit a

[[Page 12694]]

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 (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of these SNURS would 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 SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
proposed rule.
    This proposed rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit X. 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 (UMRA)

    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 would be impacted by this proposed 
rule. As such, EPA has determined that this proposed rule would not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect on small governments subject to the requirements of 
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action would 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 proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor would 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 proposed 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 (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA 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).

List of Subjects in 40 CFR Part 721

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

    Dated: February 15, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec.  721.10637 to subpart E to read as follows:

Sec.  721.10637  Substituted picolinate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted picolinate (PMN P-00-835) is subject to 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=90).
    (ii) [Reserved]
    (b) Specific requirements. The 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
3. Add Sec.  721.10638 to subpart E to read as follows:

Sec.  721.10638  Lithium metal phosphate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as lithium 
metal phosphate (PMN P-02-167) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.

[[Page 12695]]

    (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
4. Add Sec.  721.10639 to subpart E to read as follows:

Sec.  721.10639  Siloxanes and Silicones, di-Me, polymers with Ph 
silsesquioxanes, hydrolyzed, reaction products with 2-[[3-
(trimethoxysilyl)propoxy]methyl]oxirane.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as siloxanes and 
silicones, di-Me, polymers with Ph silsesquioxanes, hydrolyzed, 
reaction products with 2-[[3-(trimethoxysilyl)propoxy]methyl]oxirane 
(PMN P-02-668; CAS No. 478823-10-8) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (b) (concentration 
set at 0.1 percent), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63 (a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), and (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.  721.10640 to subpart E to read as follows:

Sec.  721.10640  11,2-Cyclohexanedicarboxylic acid, 1-(2-ethylhexyl) 2-
(2-methylpropyl) ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2-
cyclohexanedicarboxylic acid, 1-(2-ethylhexyl) 2-(2-methylpropyl) ester 
(PMN P-03-135; CAS Nos. 252958-29-5) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
6. Add Sec.  721.10641 to subpart E to read as follows:

Sec.  721.10641  Phenol and vinyltoluene based hydrocarbon resin 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as phenol 
and vinyltoluene based hydrocarbon resin (PMN P-03-255) is subject to 
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
7. Add Sec.  721.10642 to subpart E to read as follows:

Sec.  721.10642  Modified polyisocyanates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
modified polyisocyanates (PMNs P-03-762 and P-03-763) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 
percent), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (o), and (y)(l).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), and (i) are applicable to 
manufacturers, importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
8. Add Sec.  721.10643 to subpart E to read as follows:

Sec.  721.10643  Diisocyanate terminated polycarbodiimide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
diisocyanate terminated polycarbodiimide (PMN P-04-640) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The

[[Page 12696]]

requirements of this rule do not apply to quantities of the PMN 
substance that have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(3), (a)(4), and (a)(6)(ii). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63 (a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. A National Institute for Occupational Safety and Health 
(NIOSH)-certified supplied-air respirator operated in pressure demand 
or other positive pressure mode and equipped with a tight-fitting full 
facepiece with an assigned protection factor (APF) of at least 2,000 
meets the minimum requirements Sec.  721.63(a)(4). As an alternative to 
the respiratory requirements listed here, a manufacturer, importer, or 
processor may choose to follow the new chemical exposure limit (NCEL) 
provisions listed in the TSCA section 5(e) consent order for this 
substance. The NCEL is 0.05 mg/m\3\. 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 
section 5(e) consent order.
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), 
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection or 
maintain airborne concentrations at or below an 8-hour time-weighted 
average of 0.05 mg/m\3\), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The 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.
0
9. Add Sec.  721.10644 to subpart E to read as follows:

Sec.  721.10644  Reaction product of aluminum hydroxide and modified 
alkoxysilane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
reaction product of aluminum hydroxide and modified alkoxysilane (PMN 
P-07-553) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (b) (concentrations set at 0.1 percent), and 
(c). When determining which persons are reasonably likely to be exposed 
as required for Sec.  721.63(a)(4), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 10 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(s) (100,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
10. Add Sec.  [emsp14]721.10645 to subpart E to read as follows:

Sec.  [emsp14]721.10645  Multi-walled carbon nanotube (generic) (P-08-
392).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotube (PMN P-08-392) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this rule do not apply to 
quantities of the PMN substance that have been completely reacted 
(cured); incorporated or embedded into a polymer matrix that itself has 
been completely reacted (cured); or embedded in a permanent solid 
polymer form that is not intended to undergo further processing except 
for mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (a)(6) 
(particulate, including solids or liquid droplets). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63 (a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. A National Institute for Occupational Safety and Health 
(NIOSH)-certified air-purifying, tight-fitting full-face respirator 
equipped with N100 filters with an assigned protection factor (APF) of 
at least 50 meet the minimum requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (k), and (q) (within 18 months of 
commencing non-exempt commercial manufacture).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), and (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

[[Page 12697]]

of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.
0
11. Add Sec.  [emsp14]721.10646 to subpart E to read as follows:

Sec.  [emsp14]721.10646  Multi-walled carbon nanotube (generic) (P-09-
257).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotube (PMN P-09-257) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this rule do not apply to 
quantities of the PMN substance that have been completely reacted 
(cured); incorporated or embedded into a polymer matrix that itself has 
been completely reacted (cured); embedded in a permanent solid polymer 
form that is not intended to undergo further processing except for 
mechanical processing; or incorporated into an article as defined at 40 
CFR 720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (a)(6) 
(particulate, including solids or liquid droplets). When determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63 (a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. A National Institute for Occupational Safety and Health 
(NIOSH)-certified air-purifying, tight-fitting full-face respirator 
equipped with N100 filters with an assigned protection factor (APF) of 
at least 50 meets the minimum requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (k), and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(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), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.
0
12. Add Sec.  [emsp14]721.10647 to subpart E to read as follows:

Sec.  [emsp14]721.10647  Multi-walled carbon nanofibers (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanofibers (PMNs P-10-115, P-10-116, P-10-117, P-10-118, 
P-10-119, P-10-120, P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, 
and P-10-126) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this rule do not apply to quantities of the PMN 
substances after they have been completely reacted (cured); 
incorporated or embedded into a polymer matrix that itself has been 
reacted (cured); embedded into a permanent solid polymer form that is 
not intended to undergo further processing except for mechanical 
processing; or incorporated into an article as defined at 40 CFR 
720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (a)(6)(i). 
When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63 (a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. A National Institute for Occupational Safety 
and Health (NIOSH)-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 filters with an assigned protection 
factor (APF) of at least 50 meets the minimum requirements of Sec.  
721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k) (electrical and thermal conductivity 
additive in encapsulated thermoplastics, thermosets, elastomers, glass, 
metals, and ceramics; mechanical reinforcement additive in encapsulated 
thermoplastics, thermosets, elastomers, glass, metals, and ceramics; 
energy storage additive; or chemical intermediate), (l) and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(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), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers, importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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
13. Add Sec.  [emsp14]721.10648 to subpart E to read as follows:

Sec.  [emsp14]721.10648  Modified lithium iron phosphates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
modified lithium iron phosphates (PMNs P-10-545 and P-10-546) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
rule do not apply to quantities of the PMN substances after they have 
been completely reacted (cured), embedded or incorporated into a 
polymer matrix that has been reacted (cured), or embedded in a 
permanent solid polymer form that is not intended to undergo further 
processing, except mechanical.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (a), (b), (c), (k), and (q).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(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), (b), (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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.  [emsp14]721.10649 to subpart E to read as follows:

Sec.  [emsp14]721.10649  MDI modified polyalkylene glycol adipate 
polyester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as MDI 
modified polyalkylene glycol adipate polyester (PMN P-11-115) is 
subject to reporting under this section for the significant

[[Page 12698]]

new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63 (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
15. Add Sec.  [emsp14]721.10650 to subpart E to read as follows:

Sec.  [emsp14]721.10650  Polyether substituted anthraquinone derivative 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyether substituted anthraquinone derivative (PMN P-11-155) is 
subject to 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) (colorant for cleaners and detergents).
    (ii) [Reserved]
    (b) Specific requirements. The 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
16. Add Sec.  [emsp14]721.10651 to subpart E to read as follows:

Sec.  [emsp14]721.10651  Carbide derived nanocarbon (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as carbide 
derived nanocarbon (PMN P-11-290) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (manufacture of the substance by the 
method described in the premanufacture notice).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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
17. Add Sec.  [emsp14]721.10652 to subpart E to read as follows:

Sec.  [emsp14]721.10652  Hexanedioic acid, polymer with polyether 
polyol, 1,1'-methylenebis[4-isocyanatobenzene] and dihydroxydialkyl 
ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hexanedioic acid, polymer with polyether polyol, 1,1'-methylenebis[4-
isocyanatobenzene] and dihydroxydialkyl ether (PMN P-11-309) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), 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.  [emsp14]721.10653 to subpart E to read as follows:

[[Page 12699]]

Sec.  [emsp14]721.10653  Hexanedioic acid, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether and dialkanol 
ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hexanedioic acid, polymer with .alpha.-hydro-.omega.-
hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-methylenebis[4-
isocyanatobenzene], dihydroxydialkyl ether and dialkanol ether (PMN P-
11-311) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), 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.  [emsp14]721.10654 to subpart E to read as follows:

Sec.  [emsp14]721.10654  Hexanedioic acid, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[isocyanatobenzene], dihydroxydialkyl ether and dialkanol 
ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hexanedioic acid, polymer with .alpha.-hydro-.omega.-
hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[isocyanatobenzene], dihydroxydialkyl ether and dialkanol 
ether (PMN P-11-312) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63 (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
20. Add Sec.  [emsp14]721.10655 to subpart E to read as follows:

Sec.  [emsp14]721.10655  Hexanedioic acid, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether, reaction 
products with dialkylcarbinol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hexanedioic acid, polymer with .alpha.-hydro-.omega.-
hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-methylenebis[4-
isocyanatobenzene], dihydroxydialkyl ether, reaction products with 
dialkylcarbinol (PMN P-11-313) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a

[[Page 12700]]

loose-fitting hood or helmet and high efficiency particulate air (HEPA) 
filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
21. Add Sec.  [emsp14]721.10656 to subpart E to read as follows:

Sec.  [emsp14]721.10656  Hexanedioic acid, polymer with .alpha.-
hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-
methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether reaction 
products with dialkylcarbinol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hexanedioic acid, polymer with .alpha.-hydro-.omega.-
hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-methylenebis[4-
isocyanatobenzene], dihydroxydialkyl ether reaction products with 
dialkylcarbinol (PMN P-11-314) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), 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
22. Add Sec.  [emsp14]721.10657 to subpart E to read as follows:

Sec.  [emsp14]721.10657  Castor oil, polymer with hydrogenated 
vegetable oil, 1,1'-methylenebis[isocyanatobenzene] and isocyanate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as castor 
oil, polymer with hydrogenated vegetable oil, 1,1'-
methylenebis[isocyanatobenzene] and isocyanate (PMN P-12-73) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), 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
23. Add Sec.  [emsp14]721.10658 to subpart E to read as follows:

Sec.  [emsp14]721.10658  2-Oxepanone, polymer with 1,6-
diisocyanatohexane, 2,2-dimethyl-1,3-propanediol and 2,2'-
oxybis[ethanol].

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-oxepanone, 
polymer with 1,6-diisocyimatohexane, 2,2-dimethyl-1,3-propanediol and 
2,2'-oxybis[ethanol] (PMN P-12-133; CAS No. 1313708-90-5) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general

[[Page 12701]]

and local ventilation) or administrative control measures (e.g., 
workplace policies and procedures) shall be considered and implemented 
to prevent exposure, where feasible. The following National Institute 
for Occupational Safety and Health (NIOSH)-certified respirators with 
an assigned protection factor (APF) of at least 10 meet the 
requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), 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
24. Add Sec.  [emsp14]721.10659 to subpart E to read as follows:

Sec.  [emsp14]721.10659  Poly(oxy-1,4-butanediyl), -hydro--hydroxy-, 
polymer with alkyldiisocyanates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
poly(oxy-1,4-butanediyl), -hydro--hydroxy-, polymer with 
alkyldiisocyanates (PMN P-12-143) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), 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
25. Add Sec.  [emsp14]721.10660 to subpart E to read as follows:

Sec.  [emsp14]721.10660  Aliphatic diisocyanate adduct with substituted 
amino alkyl silane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic diisocyanate adduct with substituted amino alkyl silane (PMN 
P-12-274) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set 
at 0.1 percent), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible. The following National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an assigned protection factor (APF) of at least 10 
meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters;
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters;
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters; and
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2013-04298 Filed 2-22-13; 8:45 am]
BILLING CODE 6560-50-P
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