Document ID: EPA-HQ-OPPT-2013-0100-0001
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2013-05-09T04:00Z

[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Rules and Regulations]
[Pages 27048-27057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11061]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2013-0100 FRL-9384-8]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct Final Rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 15 chemical substances 
which were the subject of premanufacture notices (PMNs). This action 
requires persons who intend to manufacture, import, or process any of 
these 15 chemical substances for an activity that is designated as a 
significant new use by this rule to notify EPA at least 90 days before 
commencing that activity. The required notification will provide EPA 
with the opportunity to evaluate the intended use and, if necessary, to 
prohibit or limit that activity before it occurs.

DATES: This rule is effective on July 8, 2013. For purposes of judicial 
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 23, 
2013.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before June 10, 2013 (see Unit VI. of the SUPPLEMENTARY 
INFORMATION).
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2013-0100, 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-2013-0100. 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-
2013-0100. 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 Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-9232; email address: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
The following list of North American Industrial 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.

[[Page 27049]]

    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after June 10, 2013 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

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

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

II. Background

A. What action is the agency taking?

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

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

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

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  721.1(c), persons subject to these SNURs must comply with the 
same 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 sections 5(b) 
and 5(d)(1), the exemptions authorized by TSCA sections 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 
sections 5(e), 5(f), 6, or 7 to control the activities for which it has 
received the SNUN. If EPA does not take action, EPA is required under 
TSCA section 5(g) to explain in the Federal Register its reasons for 
not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 15 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 15 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).

[[Page 27050]]

     Basis for the SNUR.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.
    This rule includes a PMN substance whose reported chemical name 
includes the term ``carbon nanotube'' or ``CNT''. 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 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 
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 SNURs under 
docket ID number EPA-HQ-OPPT-2013-0100. 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 rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture and importation 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    None of the 15 PMN substances included in this rule are subject to 
consent orders under TSCA section 5(e). In these cases, for a variety 
of reasons, EPA did not find that the use scenario described in the PMN 
triggered the determinations set forth under TSCA section 5(e). 
However, EPA does believe that certain changes from the use scenario 
described in the PMN could result in increased exposures, thereby 
constituting a ``significant new use.'' These so-called ``non-5(e) 
SNURs'' are promulgated pursuant to Sec.  721.170. EPA has determined 
that every activity designated as a ``significant new use'' in all non-
5(e) SNURs issued under Sec.  721.170 satisfies the two requirements 
stipulated in Sec.  721.170(c)(2), i.e., these significant new use 
activities, ``(i) are different from those described in the 
premanufacture notice for the substance, including any amendments, 
deletions, and additions of activities to the premanufacture notice, 
and (ii) may be accompanied by changes in exposure or release levels 
that are significant in relation to the health or environmental 
concerns identified'' for the PMN substance.

PMN Number P-11-60

    Chemical name: Methylenebis[isocyanatobenzene], polymer with 
alkanedoic acid, alkylene glycols, alkoxylated alkanepolyol and 
substituted trialkoxysilane (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an adhesive system component. 
Based on structural activity relationship (SAR) analysis of test data 
on analogous diisocyanates, EPA identified concerns for dermal and 
respiratory sensitization and for pulmonary toxicity to workers exposed 
to free isocyanates. Also, based on ecological structural activity 
relationship (EcoSAR) analysis on analogous polycationic polymers, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 61 parts per billion (ppb) of the PMN substance in surface 
waters. As described in the PMN, significant worker exposure or 
releases of the PMN substance to surface waters are not expected. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance other than 
as described in the PMN (manufacture with all isocyanate groups reacted 
within the polymer), or any use of the substance resulting in surface 
water concentrations exceeding 61 ppb could result in exposures which 
may cause serious health effects or significant adverse environmental 
effects.
    Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a water 
solubility: Column elution method; shake flask method test (OPPTS 
830.7840), an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010), a fish acute toxicity test, 
freshwater and marine test (OPPTS Test Guideline 850.1075), and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10661.

PMN Number P-11-204

    Chemical name: Acetaldehyde, substituted-, reaction products with 
2-butyne-1, 4-diol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance is 
as a brightener for nickel electroplating. Based on EcoSAR analysis of 
test data on analogous halo alcohols, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 7 ppb of the 
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 exceed releases from 
the use described in the PMN. For the use described in the PMN, 
environmental releases did not exceed 7 ppb for more than 20 days per 
year. Therefore, EPA has not determined that the proposed processing or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that use of the substance other than as described 
in the PMN could result in exposures which may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
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 
characterize the environmental effects of the PMN substance.

[[Page 27051]]

    CFR citation: 40 CFR 721.10662.

PMN Number P-12-44

    Chemical name: Functionalized multi-walled carbon nanotubes 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an additive for rubber and 
batteries. Based on available information on analogous chemical 
substances, EPA identified concerns for lung effects to workers exposed 
to the PMN substance. As described in the PMN, no significant 
inhalation exposures are expected to workers due to the manufacturing, 
processing, and use processes described in the PMN and the use of 
adequate personal protective equipment. EPA expects that some fraction 
of the carbon nanotubes, if released into the environment, will 
eventually become suspended in water. Sublethal effects have been 
observed for carbon nanotubes in fish at levels as low as 100 ppb. 
Observed effects included respiratory stress, ventilation rate, gill 
mucus secretion, gill damage, and aggressive behavior. As described in 
the PMN, no environmental exposures are expected, because the PMN 
substance is not released to surface water. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that use of the substance other than as described in the PMN; 
manufacturing, processing, or use in a powder form; or any use of the 
substance resulting in surface water releases may cause serious health 
effects or significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of the 
following tests would help characterize the health and environmental 
effects of the PMN substance: (1) A 90-day inhalation toxicity test 
(OPPTS Test Guideline 870.3465) with a post-exposure observation period 
of up to 3 months, bronchoalveolar lavage fluid (BALF) analysis, 
particle size distribution information and other toxicologically 
relevant properties, data on histopathology of pulmonary and ex-
pulmonary organs/tissues (cardiovascular, central nervous system, 
liver, kidney, etc.), pulmonary deposition (lung burden), clearance 
half-life (biopersistence) and translocation of the test material, and 
a determination of cardiovascular toxicity; (2) analysis by Scanning 
Transmission Electron Microscopy (STEM), Transmission Electron 
Microscopy (TEM), or Scanning Electron Microscopy (SEM) of number of 
walls (range and average), tube ends (open, capped, circular, other), 
tube width/diameter (measure inner and outer diameters or range), tube 
length (range) including a description of any deformities found in the 
tubes (bumps, branching, gaps, etc.); (3) percent (range) of functional 
groups found on the tubes (include the method of determination); and 
(4) particle size determined by count not by weight or volume 
(preferably using STEM).
    CFR citation: 40 CFR 721.10663.

PMN Numbers P-12-408, P-12-409, P-12-410, P-12-411, P-12-412, and P-12-
413

    Chemical name: Alkenedioic acid dialkyl ester, reaction products 
with alkenoic acid alkyl esters and diamine (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of these substances are as binders. Based on EcoSAR 
analysis of test data on analogous aliphatic amines, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb for the aggregate of the PMN substances in surface waters. As 
described in the PMNs, releases to surface waters 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 resulting 
in surface water concentrations exceeding 1 ppb for the aggregate of 
the PMN substances 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 an 
aquatic invertebrate acute toxicity test (OPPTS Test Guideline 
850.1010), fish acute toxicity test, freshwater and marine (OPPTS Test 
Guideline 850.1075), and an algal toxicity test (OCSPP Test Guideline 
850.4500) would help characterize the environmental effects of the PMN 
substance. The tests should be conducted on either the P-12-411 or P-
12-413 substance.
    CFR citation: 40 CFR 721.10664.

PMN Number P-12-414

    Chemical name: 2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-
yl)methyl ester.
    CAS number: 69701-99-1.
    Basis for action: The PMN states that the use of the substance is 
as a reactive intermediate for use in ultraviolet (UV), electron beam 
(EB) and conventionally cured coating and ink formulations. Based on 
test data submitted on the PMN substance and EcoSAR analysis of test 
data on analogous acrylates, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 26 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 exceed releases from the 
use described in the PMN. For the use described in the PMN, 
environmental releases did not exceed 26 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 use of the 
substance other than as described in the PMN or any increase of the 
annual production volume of 50,000 kilograms could result in exposures 
which may cause significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early life-stage toxicity test (OPPTS Test Guidelines 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10665.

PMN Number P-12-437

    Chemical name: Quaternary ammonium compounds, bis(fattyalkyl) 
dimethyl, salts with tannins (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a component in drilling fluid. 
Based on EcoSAR analysis of test data on analogous cationic 
surfactants, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 11 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the PMN substance to 
surface waters are not expected.
    Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of

[[Page 27052]]

the substance other than as described in the PMN or resulting in 
surface water concentrations exceeding 11 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 an 
activated sludge sorption isotherm test (OPPTS Test Guideline 
835.1110), a fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075), a fish acute toxicity test mitigated by humic 
acid (OPPTS Test Guidelines 850.1085), 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 fate and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10666.

PMN Number P-12-560

    Chemical name: Slimes and sludges, aluminum and iron casting, 
wastewater treatment, solid waste.
    CAS number: 1391739-82-4.
    Chemical substance definition: The waste solids produced from the 
treatment of wastewaters during aluminum and iron casting, machining 
and finishing operations. It may contain aluminum, barium, chromium, 
copper, iron, lead, manganese, nickel, and zinc.
    Basis for action: The PMN states that the use of the substance is 
as a feedstock to provide mineral content for cement manufacturing. 
Based on test data on analogous respirable, poorly soluble 
particulates, EPA identified concerns for lung effects from lung 
overload associated with inhalation of the PMN substance when in powder 
form. EPA also identified concerns for neurotoxicity, immunotoxicity, 
and blood effects from any lead that is bioavailable; respiratory 
sensitization and immunotoxicity from any nickel, lead, aluminum, 
copper, and iron that is bioavailable; and digestive system effects 
from any copper that reaches the gastrointestinal tract. These concerns 
are for effects to workers from inhalation exposure to the PMN 
substance. For the uses described in the PMN, significant inhalation 
worker exposure is not expected as the PMN substance is not 
manufactured, processed, or used in powder form. 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 the manufacture, processing, or use of the substance in 
powder form 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 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 60-
day holding period would help characterize the human health effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10667.

PMN Number P-13-18

    Chemical name: Trisodium diethylene triaminepolycarboxylate 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a stabilizing agent for 
polymers. Based on the PMN substance's chelating potential of calcium, 
magnesium, iron, and other divalent cations and test data on analogous 
chemical substances such as pentacarboxylic acid chelators (TSCA 
section 8(e) submission  10980, CAS No. 140-01-2), 
ethylenediamine tetramethylene phosphonic acid, ethylene diamine 
tetramethylene phosphonic acid (EDTMPA), ethylenediaminetetraacetic 
acid (EDTA), and nitrilotriacetic acid (NTA), EPA identified concerns 
for blood toxicity, effects on the heart, inhibited muscle functioning, 
bone toxicity, bone cancer, developmental toxicity, and kidney 
toxicity. These concerns are for effects to workers from inhalation 
exposure to the PMN. EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, use of the substance 
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)(1)(i)(c), (b)(3)(i), and (b)(3)(ii).
    Recommended testing: EPA has determined that a 90-day oral toxicity 
in rodents test (OPPTS Test Guideline 870.3100) would help characterize 
the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10668.

PMN Number P-13-78

    Chemical name: Tertiary amine alkyl ether (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a catalyst for producing polyurethane foam. Based on test data on 
analogous chemical substances, EPA identified concerns for acute 
toxicity, irritation/corrosion to all exposed tissues, kidney toxicity, 
liver toxicity, effects to the adrenal system, and male reproductive 
toxicity to workers and the general population exposed to the PMN 
substance. For the use described in the PMN, significant worker and 
general population exposure is not expected.
    Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that use of the PMN substance other than 
for the use described in the PMN may result in 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 
combined repeated dose toxicity with the reproduction/development 
toxicity screening test (OPPTS Test Guideline 870.3650) would help 
characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.10669.

PMN Number P-13-108

    Chemical name: Bromine, manufacture of, by-products from, 
distillation residues.
    CAS number: Not available.
    Chemical substance definition: The complex residuum obtained during 
the production of bromine using brine and waste streams from the 
production of halogenated hydrocarbons. It consists predominantly of 
halogenated hydrocarbons and ketones, having carbon numbers 
predominantly in the range of C3-C17. The boiling point is 
approximately 98[deg]C to 350[deg]C (208[emsp14][deg]F to 
662[emsp14][deg]F).
    Basis for action: The PMN states that the use of the substance is 
as feed for bromine recovery. EPA identified health and environmental 
concerns because the substance may be a persistent, bio-accumulative, 
and toxic (PBT) chemical, based on physical/chemical properties of the 
PMN substance, as described in the New Chemical Program's PBT category 
(64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the 
substance will persist in the environment for more than 2 months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
Also, based on test data on analogous bromobenzene and derivatives and 
brominated organic compounds, EPA identified concerns for liver 
toxicity, reproductive toxicity, developmental toxicity, mutagenicity, 
neurotoxicity, oncogenicity, and endocrine disruption. Further, based 
on EcoSAR analysis of test data on analogous neutral organic 
substances, EPA predicts toxicity to

[[Page 27053]]

aquatic organisms may occur at concentrations that exceed 1 ppb of the 
substance in surface waters. As described in the PMN, significant 
worker exposures are not expected and the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water releases may cause serious health 
effects and significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C), (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
    Recommended testing: EPA has determined that the results of the 
following tests would help characterize the health and environmental 
effects of the PMN substance:
    (1) Modified semi-continuous activated sludge (SCAS) with analysis 
for degradation products (OPPTS Test Guideline 835.5045, or 
Organisation for Economic Co-operation and Development (OECD) Test 
Guideline 302A); (2) direct photolysis (OPPTS Test Guideline 835.2210), 
if wavelengths greater than 290 nano meters (nm) are absorbed, 
determined using OPPTS Test Guideline 830.7050; (3) indirect photolysis 
(OPPTS Test Guideline 835.5270); (4) hydrolysis as a function of pH and 
temperature (OPPTS Test Guideline 835.2130 or OECD Test Guideline 111); 
(5) aerobic and anaerobic transformation in soil (OECD Test Guideline 
307); (6) phototransformation on soil surfaces (Draft OECD Jan. 2002); 
(7) aerobic and anaerobic transformation in aquatic sediment systems 
(OECD Test Guideline 308); (8) fish BCF (OECD Test Guideline 305) or 
earthworm bioaccumulation (OECD Test Guideline 317); (9) combined 
repeated dose toxicity study with the reproduction/developmental 
toxicity screening test (OECD Test Guideline 422); (10) fish early 
life-stage toxicity test (OPPTS Test Guideline 850.1400); (11) daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300); and (12) algal 
toxicity test (OCSPP Test Guideline 850.4500). EPA also recommends that 
the special considerations for conducting aquatic laboratory studies 
(OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10670.

V. Rationale and Objectives of the Rule

A. Rationale

    In these 15 cases, EPA determined that one or more of the criteria 
of concern established at Sec.  721.170 were met, as discussed in Unit 
IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA will be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.
    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. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.  
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of 
this rule is July 8, 2013 without further notice, unless EPA receives 
written adverse or critical comments, or notice of intent to submit 
adverse or critical comments before June 10, 2013.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before June 10, 2013, EPA will withdraw the relevant sections of 
this direct final rule before its effective date. EPA will then issue a 
proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse or critical comments, or notice of 
intent to submit adverse or critical comments, must identify the 
chemical substance and the new use to which it applies. EPA will not 
withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. The identities of 13 of the 15 chemical substances 
subject to this rule have been claimed as confidential and EPA has 
received no post-PMN bona fide submissions (per Sec.  720.25 and Sec.  
721.11). Based on this, the Agency believes that it is highly unlikely 
that any of the significant new uses described in the regulatory text 
of this rule are ongoing.
    Therefore EPA designates May 9, 2013 as the cutoff date for 
determining whether the new use is ongoing. Persons who begin 
commercial manufacture, import, or processing of the chemical 
substances for a significant new use identified as of that date would 
have to cease any such activity upon the effective date of the final 
rule. To resume their activities, these persons would have to first 
comply with all applicable SNUR notification requirements and wait 
until the notice review period, including any extensions, expires. If 
such a person met the conditions of advance compliance under Sec.  
721.45(h), the person would be considered exempt from the requirements 
of the SNUR. Consult the Federal Register document of April 24, 1990 
(55 FR 17376) for a more detailed discussion of the cutoff date for 
ongoing uses.

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

[[Page 27054]]

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. Unit IV. lists recommended 
testing for these 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 OECD test guidelines are 
available from the OECD Bookshop at http://www.oecdbookshop.org or 
SourceOECD at http://www.sourceoecd.org.
    When physical/chemical properties of test material and/or material 
characterization tests are recommended for nanoscale substances that 
are the subject of this 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. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at 40 CFR 
721.1725(b)(1).
    Under these procedures a manufacturer, importer, or processor may 
request EPA to determine whether a proposed use would be a significant 
new use under the rule. The manufacturer, importer, or processor must 
show that it has a bona fide intent to manufacture, import, or process 
the chemical substance and must identify the specific use for which it 
intends to manufacture, import, or process the chemical substance. If 
EPA concludes that the person has shown a bona fide intent to 
manufacture, import, or process the chemical substance, EPA will tell 
the person whether the use identified in the bona fide submission would 
be a significant new use under the rule. Since most of the chemical 
identities of the chemical substances subject to these SNURs are also 
CBI, manufacturers, importers, and processors can combine the bona fide 
submission under the procedure in Sec.  [emsp14]721.1725(b)(1) with 
that under Sec.  [emsp14]721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture, import, or process the chemical substance so 
long as the significant new use trigger is not met. In the case of a 
production volume trigger, this means that the aggregate annual 
production volume does not exceed that identified in the bona fide 
submission to EPA. Because of confidentiality concerns, EPA does not 
typically disclose the actual production volume that constitutes the 
use trigger. Thus, if the person later intends to exceed that volume, a 
new bona fide submission would be necessary to determine whether that 
higher volume would be a significant new use.

X. SNUN Submissions

    According to Sec.  [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.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances subject to this rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2013-0100.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This rule establishes SNURs for several new chemical substances 
that were the subject of PMNs. The Office of Management and Budget 
(OMB) has exempted these types of actions from review under Executive 
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993).

B. Paperwork Reduction Act (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 is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this rule. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As

[[Page 27055]]

a result, EPA finds that there is ``good cause'' under section 
553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 
553(b)(3)(B)) to amend this table without further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The 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 
rule.
    This rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.

Therefore, the promulgation of the SNUR would not have a significant 
economic impact on a substantial number of small entities.

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

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

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

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act (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).

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: May 2, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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

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

0
2. In Sec.  [emsp14]9.1, add the following sections in numerical order 
under the undesignated center heading ``Significant New Uses of 
Chemical Substances'' to read as follows:

[[Page 27056]]

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB Control
                     40 CFR Citation                            no.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10661...............................................      2070-0012.
721.10662...............................................      2070-0012.
721.10663...............................................      2070-0012.
721.10664...............................................      2070-0012.
721.10665...............................................      2070-0012.
721.10666...............................................      2070-0012.
721.10667...............................................      2070-0012.
721.10668...............................................      2070-0012.
721.10669...............................................      2070-0012.
721.10670...............................................      2070-0012.
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  [emsp14]721.10661 to subpart E to read as follows:

Sec.  [emsp14]721.10661  Methylenebis[isocyanatobenzene], polymer with 
alkanedoic acid, alkylene glycols, alkoxylated alkanepolyol and 
substituted trialkoxysilane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methylenebis[isocyanatobenzene], polymer with alkanedoic acid, alkylene 
glycols, alkoxylated alkanepolyol and substituted trialkoxysilane (PMN 
P-11-60) is subject to 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 with all isocyanate groups 
reacted within the polymer).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 61).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10662 to subpart E to read as follows:

Sec.  721.10662  Acetaldehyde, substituted-, reaction products with 2-
butyne-1, 4-diol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
acetaldehyde, substituted-, reaction products with 2-butyne-1, 4-diol 
(PMN P-11-204) is subject to 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) (brightener for nickel electroplating).
    (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
6. Add Sec.  721.10663 to subpart E to read as follows:

Sec.  721.10663  Functionalized multi-walled carbon nanotubes 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
functionalized multi-walled carbon nanotubes (PMN P-12-44) is subject 
to 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), (v)(1), (w)(1), and (x)(1).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
7. Add Sec.  721.10664 to subpart E to read as follows:

Sec.  721.10664  Alkenedioic acid dialkyl ester, reaction products with 
alkenoic acid alkyl esters and diamine (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkenedioic acid dialkyl ester, reaction products with alkenoic acid 
alkyl esters and diamine (PMNs P-12-408, P-12-409, P-12-410, P-12-411, 
P-12-412, and P-12-413) are subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (where N = 1 parts per billion (ppb) 
for the aggregate of the PMN substances, P-12-408, P-12-409, P-12-410, 
P-12-411, P-12-412, and P-12-413).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.10665 to subpart E to read as follows:

Sec.  721.10665  2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-
yl)methyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester (PMN 
P-12-414; CAS No. 69701-99-1) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (reactive intermediate for use in 
ultraviolet (UV), electron beam (EB), and conventionally cured coating 
and ink formulations) and (s) (50,000 kilograms).

[[Page 27057]]

    (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
9. Add Sec.  721.10666 to subpart E to read as follows:

Sec.  721.10666  Quaternary ammonium compounds, bis(fattyalkyl) 
dimethyl, salts with tannins (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
quaternary ammonium compounds, bis(fattyalkyl) dimethyl, salts with 
tannins (PMN P-12-437) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 11).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
10. Add Sec.  721.10667 to subpart E to read as follows:

Sec.  721.10667  Slimes and sludges, aluminum and iron casting, 
wastewater treatment, solid waste.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as slimes 
and sludges, aluminum and iron casting, wastewater treatment, solid 
waste (PMN P-12-560; CAS No. 1391739-82-4; chemical substance 
definition: The waste solids produced from the treatment of wastewaters 
during aluminum and iron casting, machining and finishing operations. 
It may contain aluminum, barium, chromium, copper, iron, lead, 
manganese, nickel, and zinc.) is subject to 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(v)(1), (w)(1), and (x)(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 (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  721.10668 to subpart E to read as follows:

Sec.  721.10668  Trisodium diethylene triaminepolycarboxylate 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
trisodium diethylene triaminepolycarboxylate (PMN P-13-18) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to this section.

0
12. Add Sec.  721.10669 to subpart E to read as follows:

Sec.  721.10669  Tertiary amine alkyl ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
tertiary amine alkyl ether (PMN P-13-78) is subject to 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) (a catalyst for producing polyurethane 
foam).
    (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
13. Add Sec.  721.10670 to subpart E to read as follows:

Sec.  721.10670  Bromine, manufacture of, by-products from, 
distillation residues.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bromine, manufacture of, by-products from, distillation residues (PMN 
P-13-108; chemical substance definition: The complex residuum obtained 
during the production of bromine using brine and waste streams from the 
production of halogenated hydrocarbons. It consists predominantly of 
halogenated hydrocarbons and ketones, having carbon numbers 
predominantly in the range of C3-C17. The boiling point is 
approximately 98[deg]C to 350[deg]C (208[deg]F to 662[deg]F).) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
[FR Doc. 2013-11061 Filed 5-8-13; 8:45 am]
BILLING CODE 6560-50-P