Significant New Use Rules on Certain Chemical Substances, 32003-32017 [2015-13670]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Rules and Regulations]
[Pages 32003-32017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13670]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2015-0220; FRL-9927-67]
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 22 chemical substances 
which were the subject of premanufacture notices (PMNs). Two of these 
chemical substances are subject to TSCA section 5(e) consent orders 
issued by EPA. This action requires persons who intend to manufacture 
(including import) or process any of these 22 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 August 4, 2015. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
June 19, 2015.
    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 July 6, 2015 (see Unit VI. of the SUPPLEMENTARY 
INFORMATION). 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 July 6, 2015, EPA will withdraw the relevant 
sections of this direct final rule before its effective date.
    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-2015-0220, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     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: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

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:

[[Page 32004]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
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 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 
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 a proposed or final rule are subject 
to the export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.

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 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) (FRL-3658-5). 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 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 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.
     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 22 
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 22 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) Registry number (assigned 
for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, the 
basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA 
section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information 
to

[[Page 32005]]

evaluate the chemical substance (see Unit VIII. for more information).
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture volume) and other 
uses designated in this rule, may be claimed as CBI. Unit IX. discusses 
a procedure companies may use to ascertain whether a proposed use 
constitutes a significant new use.
    This rule includes 2 PMN substances (P-13-930 and P-14-763) that 
are subject to ``risk-based'' consent orders under TSCA section 
5(e)(1)(A)(ii)(I) where EPA determined that activities associated with 
the PMN substances may present unreasonable risk to human health or the 
environment. Those consent orders require protective measures to limit 
exposures or otherwise mitigate the potential unreasonable risk. The 
so-called ``TSCA section 5(e) SNURs'' on these PMN substances are 
promulgated pursuant to Sec.  721.160, and are based on and consistent 
with the provisions in the underlying consent orders. The TSCA section 
5(e) SNURs designate as a ``significant new use'' the absence of the 
protective measures required in the corresponding consent orders.
    This rule also includes SNURs on 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 ``TSCA 
non-section 5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA 
has determined that every activity designated as a ``significant new 
use'' in all TSCA non-section 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 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 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-11-549

    Chemical name: 2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-.
    CAS number: 692-49-9.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a heat transfer fluid. 
Based on test data on the PMN substance as well as structure activity 
relationship (SAR) analysis of analogous small fluorinated compounds, 
EPA identified concerns for cardiac sensitization, developmental 
toxicity, neurotoxicity, reproductive toxicity and oncogenicity from 
inhalation exposures to the PMN substance. As described in the PMN, 
occupational exposures are expected to be minimal due to no domestic 
manufacture and consumer exposure is not expected due to no use of the 
substance in a consumer product. Therefore, EPA has not determined that 
the proposed processing or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any domestic 
manufacture, any use other than as described in the PMN, or any use of 
the substance in a consumer product may cause serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(i) and (b)(3)(ii).
    Recommended testing: EPA has determined that inhalation monitoring 
data, collected according to the EPA draft Inhalation Monitoring Data 
Collection Guidelines (located in the docket under docket ID number 
EPA-HQ-OPPT-2015-0220) would help characterize the human health effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10830.

PMN Number P-13-690

    Chemical name: Aluminum phosphate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as 
a flame retardant for industrial plastics. Based on SAR analysis of 
test data on analogous respirable, poorly soluble particulates, EPA 
identified concerns for lung effects, blood toxicity, hypersensitivity, 
developmental neurotoxicity, and immunotoxicity from inhalation 
exposures to the PMN substance. Further, based on ecological SAR 
analysis of test data on analogous aluminum salts, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
87 parts per billion (ppb) of the PMN substance in surface waters. As 
described in the PMN, occupational exposures are expected to be minimal 
due to use of respiratory protection, and releases of the substance are 
not expected to result in surface water concentrations that exceed 87 
ppb. 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 PMN substance without 
the use of National Institute of Occupational Safety and Health 
(NIOSH)-certified respirator with an assigned protection factor (APF) 
of at least 10, where inhalation exposures are expected, or any use of 
the substance resulting in surface water concentrations exceeding 87 
ppb may cause serious human health effects and significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at 40 CFR 721.170(b)(3)(ii) and (b)(4)(ii).
    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); 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 (Office of Chemical 
Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) would 
help characterize the human health and environmental effects of the PMN 
substance. EPA also recommends that the guidance document on aquatic 
toxicity testing of difficult substance and mixtures (OECD Test 
Guideline 23) be consulted to facilitate solubility of the PMN 
substance in the test media.
    CFR citation: 40 CFR 721.10831.

PMN Number P-13-872

    Chemical name: Alkyl triazine (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used in 
the removal of hydrogen sulfide. Based on test data on the PMN 
substance, as well as ecological SAR analysis of test data on analogous 
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 130 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the substance are not 
expected to result in surface water concentrations that exceed 130 ppb. 
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 130 ppb may

[[Page 32006]]

cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10832.

PMN Number P-13-930

    Chemical name: Substituted bis 2,6-xylenol (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: December 10, 
2014.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a reactant 
in polymerization reactions. Based on SAR analysis of test data on 
structurally similar substances, EPA identified concerns for liver, 
kidney and developmental toxicity; blood effects, sensitization, and 
endocrine disruption. Further, based on test data on the PMN substance, 
EPA predicts toxicity to aquatic organisms at concentrations that 
exceed 6 ppb of the PMN substance in surface waters. The order was 
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based 
on a finding that the substance may present an unreasonable risk of 
injury to the environment and human health, and there may be 
significant (or substantial) human exposure to the substance. To 
protect against these exposures and risks, the consent order requires:
    1. Use of personal protective equipment involving impervious gloves 
and protective clothing (where there is a potential for dermal 
exposure) and a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for inhalation exposure).
    2. Establishment and use of a hazard communication program, 
including human health, environmental hazard precautionary statements 
on each label and the MSDS.
    3. Manufacturing, processing, or use of the PMN substance only as 
an intermediate.
    4. Submission of certain toxicity testing prior to exceeding the 
confidential production volume limits of the PMN substance specified in 
the consent order.
    5. No predictable or purposeful release of the PMN substance from 
manufacturing, processing or use into the waters of the United States 
that result in surface water concentrations exceeding 6 ppb.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
toxicity testing, identified in the TSCA 5(e) consent order would help 
characterize possible effects of the substance. The submitter has 
agreed not to exceed the first confidential volume limit without 
performing an aromatase (human recombinant) test (OCSPP Test Guideline 
890.1200) and a steroidogenesis (human cell line-H295R) test (OCSPP 
Test Guideline 890.1550 or OECD Test Guideline 456). Further, the Order 
prohibits the Company from exceeding the second confidential production 
volume limit unless the Company submits the Tier 2 testing described in 
the Testing section of this Order in accordance with the conditions 
specified in the Testing section.
    CFR citation: 40 CFR 721.10833.

PMN Number P-14-20

    Chemical name: Heteropolycyclic diacrylate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating resin. Based on 
test data on the PMN, EPA identified concerns for dermal and ocular 
irritation, and systemic toxicity from the dermal, ocular, and oral 
routes. Further, based on ecological SAR analysis of test data on 
analogous acrylates, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 120 ppb of the PMN substance in 
surface waters. As described in the PMN, occupational exposures are 
expected to be minimal due to the use of impervious gloves, goggles, 
and a NIOSH-certified particulate respirator with an APF of at least 
10. Further, releases of the substance are not expected to result in 
surface water concentrations that exceed 120 ppb. 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 the use of impervious 
gloves and goggles, when there is a potential dermal exposure; any use 
of the substance without a NIOSH-certified particulate respirator with 
an APF of at least 10, where there is a potential for inhalation 
exposures; or any use of the substance resulting in surface water 
concentrations exceeding 120 ppb may cause serious health effects and 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  721.170(b)(3)(i) 
and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity with the reproduction/developmental 
toxicity screening test (OPPTS Test Guideline 870.3650); a 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 human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10834.

PMN Number P-14-66

    Chemical name: 1,6-Hexanediamine, N1-(6-aminohexyl)-, polymer with 
2-(chloromethyl)oxirane, N-(dithiocarboxy) derivs., sodium salts.
    CAS number: 1459738-70-5.
    Basis for action: The PMN states that the substance will be used as 
a water clarifier intermediate. Based on ecological SAR analysis of 
test data on analogous dithiocarbamates, 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 of 
the substance are not expected to result in surface water 
concentrations that exceed 1 ppb. 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 that results 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 mysid 
acute toxicity test (OCSPP Test Guideline 850.1035); a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 
an acute invertebrate 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 721.10835.

PMN Number P-14-209

    Chemical name: Dimethylaminoalkyl alkene amide (generic).
    CAS number: Claimed confidential.

[[Page 32007]]

    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adjuvant for non-
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated 
agricultural use products, an additive for pesticide formulations, and 
an additive for fertilizer formulations. Based on test data on the PMN 
substance, as well as ecological SAR analysis of test data on analogous 
amides and aliphatic amines, EPA predicts chronic toxicity to aquatic 
organisms may occur at concentrations that exceed 4 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 uses described in the PMN, 
environmental releases did not exceed the concentration of concern 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 may cause significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(i) and 
(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10836.

PMN Number P-14-452

    Chemical name: Substituted naphthalene polymer glycidyl ether 
(generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) uses of the substance will be as a matrix resin for 
composite materials and a binder resin for electronic materials. Based 
on ecological SAR analysis of test data on analogous polyepoxides, 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 of the substance are not expected to result in 
surface water concentrations that exceed 1 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10837.

PMN Number P-14-473

    Chemical name: Alkylpolycarboxylic acid, derivative, 
tris(fluorinatedalkoxy)alkyl ester salt (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be for coatings and printing 
applications. Based on ecological SAR analysis of test data on 
analogous anionic surfactants, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 6 ppb of the PMN 
substance in surface waters. As described in the PMN, releases of the 
substance are not expected to result in surface water concentrations 
that exceed 6 ppb. 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 6 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 water 
solubility study (OECD Test Guideline 105); a fish acute toxicity test, 
freshwater and marine (OPPTS Test Guideline 850.1075); a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10838.

PMN Number P-14-476

    Chemical name: Tricyclo[3.3.1.13,7]decan-1-amine, N,N-dimethyl-.
    CAS number: 3717-40-6.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an isolated intermediate. 
Based on ecological SAR analysis of test data on analogous aliphatic 
amines, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 8 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the substance are not 
expected to result in surface water concentrations that exceed 8 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined that any use of the substance resulting in surface 
water concentrations exceeding 8 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10839.

PMN Number P-14-510

    Chemical name: Sulfosuccinic acid ester, alkylamine derivs., sodium 
salt (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial leather 
softener. Based on test data on the PMN substance as well as SAR 
analysis of test data on analogous anionic surfactants, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
94 ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the substance are not expected to result in surface water 
concentrations that exceed 94 ppb. 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 94 ppb may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets

[[Page 32008]]

the concern criteria at Sec.  721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10840.

PMN Number P-14-603

    Chemical name: Bismuth nitrate oxide 
(Bi3(NO3)O4).
    CAS number: 1417164-49-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a proprietary degradation 
inhibitor additive in polymer-based insulation sheets. Based on test 
data on analogous respirable, poorly soluble particulates, EPA 
identified concerns for lung effects from inhalation exposures to the 
PMN substance. For the use described in the PMN, significant inhalation 
exposures are not expected. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that any use of the 
substance other than as listed in the PMN, or without respiratory 
protection, 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 study with a 60-day holding period (OPPTS Test 
Guideline 870.3465) would help characterize the human health effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10841.

PMN Number P-14-605

    Chemical name: Substituted cyclosiloxane (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be as a refractive index modifier component for light-emitting diode 
(LED) chips. Based on the physical/chemical properties of the PMN 
substance (as described in the New Chemical Program's PBT category at 
64 FR 60194; November 4, 1999) and test data on structurally similar 
substances, the PMN substance is a potentially persistent, 
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN 
substance will persist in the environment more than 2 months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
As described in the PMN notice, the PMN substance will not be released 
to water. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance other than as described in the PMN or resulting in releases 
to water 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)(3)(ii), (b)(4)(ii), and 
(b)(4)(iii).
    Recommended testing: EPA has determined that the results of a 
partition coefficient (n-octanol/water) test, estimation by liquid 
chromatography (OPPTS Test Guideline 830.7570 or OECD Test Guideline 
117); a ready biodegradability test (OPPTS Test Guideline 835.3110 or 
OECD Test Guideline 301); a fish bioconcentration factor (BCF) test 
(OPPTS Test Guideline 850.1730 or (OECD Test Guideline 305); and a 
water solubility test (OECD Test Guideline 111) would help characterize 
the health and environmental effects of the PMN substance. Depending on 
the results of these tests, additional testing as identified in the PBT 
category may be recommended.
    CFR citation: 40 CFR 721.10842.

PMN Numbers P-14-666 and P-14-668

    Chemical names: Substituted amide aromatic carboxylic acid, metal 
salt (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as morphology modifiers for 
plastics. Based on ecological SAR analysis of test data on analogous 
amides, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 67 ppb of the PMN substance (P-14-666) and 
39 ppb of the PMN substance (P-14-668) 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 substances to surface 
water, from uses other than as described in the PMNs, exceed releases 
from the uses described in the PMNs. For the use described in the PMNs, 
environmental releases did not exceed 67 ppb (P-14-666) and 39 ppb (P-
14-668) for more than 20 days per year. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substances may present an unreasonable risk. EPA has determined, 
however, that any use of the substances other than as listed in the 
PMNs may cause significant adverse environmental effects. Based on this 
information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal 
toxicity test (OCSPP Test Guideline 850.4500) on each PMN substance 
would help characterize their environmental effects.
    CFR citation: 40 CFR 721.10843.

PMN Number P-14-763

    Chemical name: Graphene nanoplatelets having a predominant 
thickness of 1-10 layers with lateral dimension predominantly less than 
2 microns.
    CAS number: Not Available
    Effective date of TSCA section 5(e) consent order: December 30, 
2014.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be in printed 
electronics, solar energy, separations, and functional composites. 
Based on SAR analysis of test data on respirable, poorly soluble 
particulates and analogous carbon nanomaterials, EPA identified 
concerns for pulmonary toxicity, oncogenicity, immunotoxicity, 
fibrosis, and lung toxicity from lung overload. The order was issued 
under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a 
finding that these substance may present an unreasonable risk of injury 
to the environment and human health, and there may be significant (or 
substantial) human exposure to the substance. To protect against these 
exposures and risks, the consent order requires:
    1. Use of personal protective equipment involving impervious gloves 
and protective clothing (where there is a potential for dermal 
exposure) and a NIOSH-certified respirator (where there is a potential 
for inhalation exposure).
    2. Establishment and use of a hazard communication program, 
including human health, environmental hazard precautionary statements 
on each label and the MSDS.
    3. Manufacturing, processing, or use of the PMN substance only as 
described in the consent order.
    4. No use of the PMN substance using an application method that 
generates a vapor, mist, or aerosol.
    5. Submission of certain toxicity testing prior to exceeding the 
confidential production volume limits

[[Page 32009]]

of the PMN substances specified in the consent order.
    6. No predictable or purposeful release of the PMN substances from 
manufacturing, processing or use into the waters of the United States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
particle size distribution and material characterization testing would 
be needed for the PMN substance. The company has agreed to submit the 
full chemical characterization testing described in the testing section 
of the consent order within the timeframes identified in the order. 
Further, depending on the results of the characterization testing, 
additional toxicity testing may be required at a confidential aggregate 
manufacture volume, as detailed in the consent order.
    CFR citation: 40 CFR 721.10844.

PMN Number P-14-781

    Chemical name: Methanaminium, N-[4-[[4-
(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-
methyl-, ethanedioate, ethanedioate (2:2:1).
    CAS number: 2437-29-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a component of industrial 
inks and dyes. Based on test data on analogous malachite green 
chloride, pararosaniline, gentian violet, crystal violet, oxalic acid, 
and other analogous substances, EPA identified concerns for 
mutagenicity, carcinogenicity, eye irritation, as well as kidney, 
acute, and developmental toxicities for occupational inhalation 
exposures and general population exposures from drinking water 
exposures. In addition, based on ecological SAR analysis of test data 
on analogous cationic dyes, 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, occupational exposures during 
processing and use activities are expected to be minimal. Further, 
releases of the PMN substance are not expected to result in surface 
water concentrations that exceed 1 ppb. Therefore, EPA has not 
determined that the proposed processing or use of the substance may 
present an unreasonable risk. EPA has determined, however, that any 
domestic manufacture of the substance, or any release of the substance 
resulting in surface water concentrations exceeding 1 ppb may cause 
serious health effects and significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity with the reproduction/developmental 
toxicity screening test (OECD Test Guideline 422); a bacterial reverse 
mutation test (OECD Test Guideline 471); an in vitro mammalian 
chromosome aberration test (OECD Test Guideline 473); a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 
an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 
850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) 
would help characterize the human health an environmental effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10845.

PMN Number P-14-811

    Chemical name: Sulfurized hydrocarbon (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be as a lubricant additive. Based on ecological SAR analysis of test 
data on analogous neutral organics, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb of the low 
molecular weight components of PMN substance in surface waters. As 
described in the PMN, where 80 percent of the molecular weight species 
is greater than 1,000 daltons, releases of the substance are not 
expected to result in surface water concentrations that exceed 1 ppb of 
the low molecular weight components. 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 where less than 80 percent of the molecular weight 
species is greater than 1,000 daltons, 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 
inherent biodegradability Zahn-Wellens test (OECD Test Guideline 302); 
an aerobic and anaerobic transformation in soil test (OECD Test 
Guideline 307); a fish BCF test: Aqueous and dietary exposure (OECD 
Test Guideline 305); a bioaccumulation in sediment-dwelling benthic 
oligochaetes test (OECD Test Guideline 315); a sediment-water 
chironomid toxicity test using spiked sediment (OECD Test Guideline 
218); 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.
    CFR citation: 40 CFR 721.10846.

PMN Number P-14-821

    Chemical name: Oxiranemethanaminium, N,N,N-trimethyl-, bromide.
    CAS number: 13895-77-7.
    Basis for action: The PMN states that the substance will be used as 
an intermediate for polymer production. Based on test data on analogous 
epoxides, EPA identified concerns for skin and lung sensitization, 
mutagenicity, oncogenicity, developmental toxicity, male reproductive, 
liver, and kidney toxicity from dermal and inhalation exposures. 
Further, based on ecological SAR analysis of test data on analogous 
quaternary ammonium compounds, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 28 ppb of the PMN 
substance in surface waters. As described in the PMN, particulate 
exposures are not expected and releases of the substance are not 
expected to result in surface water concentrations that exceed 28 ppb. 
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 manufacture, processing, or use 
of the substance in the form of a powder or any use of the substance 
resulting in surface water concentrations exceeding 28 ppb may cause 
serious health effects and significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465); a 
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a 
ready biodegradability test (OECD Test Guideline 301D) closed bottle 
method; 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 human health and environmental effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10847.

[[Page 32010]]

PMN Number P-14-875

    Chemical name: Aryloxyalkyl amine (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as 
an intermediate. Based on test data on the PMN substance and SAR 
analysis of test data on analogous aliphatic amines, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
44 ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the substance are not expected to result in surface water 
concentrations that exceed 44 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use resulting in surface water concentrations exceeding 44 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OECD Test Guideline 301) and an algal toxicity 
test (OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10848.

PMN Numbers P-15-115 and P-15-116

    Chemical names: (P-15-115) Phenol-biphenyl-formaldehyde 
polycondensate (generic); (P-15-116) Polymer of phenol, biphenyl and 
resorcinol (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be in electric molding. Based 
on test data on the PMN substances as well as SAR analysis of test data 
on analogous phenols, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 5 ppb of the PMN substances in 
surface waters. As described in the PMNs, releases of the substances 
are not expected to result in surface water concentrations that exceed 
5 ppb. 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 resulting 
in surface water concentrations exceeding 5 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(i) and 
(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a water 
solubility test (OECD Test Guideline 105); a fish early-life stage 
toxicity test (OPPTS Test Guideline 850.1400); and a daphnid chronic 
toxicity test (OPPTS Test Guideline 850.1300) would help characterize 
the environmental effects of the PMN substances. Testing may be 
conducted on either P-15-115 or P-15-116 and results should include a 
GPC analysis of molecular weight distribution.
    CFR citations: 40 CFR 721.10849 (P-15-115) and 40 CFR 721.10850 (P-
15-116)

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for 2 of the 22 
chemical substances, regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The SNUR provisions for these chemical substances are 
consistent with the provisions of the TSCA section 5(e) consent orders. 
These SNURs are promulgated pursuant to Sec.  721.160 (see Unit VI.).
    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.  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 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 or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to regulate prospective manufacturers or 
processors of a listed chemical substance before the described 
significant new use of that chemical substance occurs, provided that 
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
     EPA will ensure that all manufacturers 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 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.  
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of 
this rule is August 4, 2015 without further notice, unless EPA receives 
written adverse or critical comments, or notice of intent to submit 
adverse or critical comments before July 6, 2015.
    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 July 6, 2015, 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

[[Page 32011]]

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. However, TSCA section 5(e) consent orders have 
been issued for 2 of the 22 chemical substances, and the PMN submitters 
are prohibited by the TSCA section 5(e) consent orders from undertaking 
activities which would be designated as significant new uses. The 
identities of 16 of the 22 chemical substances subject to this rule 
have been claimed as confidential and EPA has received no post-PMN bona 
fide submissions (per Sec. Sec.  720.25 and 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 June 5, 2015 as the cutoff date for 
determining whether the new use is ongoing. Persons who begin 
commercial manufacture 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 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 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 https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at 
https://www.sourceoecd.org.
    In the TSCA section 5(e) consent orders for several of the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or 
increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of toxicity 
tests that would permit a reasoned evaluation of the potential risks 
posed by these chemical substances. Under recent TSCA section 5(e) 
consent orders, each PMN submitter is required to submit each study 
before reaching the specified production limit. Listings of the tests 
specified in the TSCA section 5(e) consent orders are included in Unit 
IV. The SNURs contain the same production volume limits as the TSCA 
section 5(e) consent orders. Exceeding these production limits is 
defined as a significant new use. Persons who intend to exceed the 
production limit must notify the Agency by submitting a SNUN at least 
90 days in advance of commencement of non-exempt commercial 
manufacture, or processing.
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA section 5(e), 
particularly if satisfactory test results have not been obtained from a 
prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at 40 CFR 
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture 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 and processors can 
combine the bona fide submission under the procedure in Sec.  
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture 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

[[Page 32012]]

exceed that volume, a new bona fide submission would be necessary to 
determine whether that higher volume would be a significant new use.

X. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same 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 https://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers 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-2015-0220.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances 
that were the subject of PMNs, or TSCA section 5(e) consent orders. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (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 action. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (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 
action.
    This action 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 action. As 
such, EPA has determined that this action 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 action does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action 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 action.

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

[[Page 32013]]

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 28, 2015.
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.  9.1, add the following sections in numerical order under 
the undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                             OMB control
                      40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
721.10830..................................................    2070-0012
721.10831..................................................    2070-0012
721.10832..................................................    2070-0012
721.10833..................................................    2070-0012
721.10834..................................................    2070-0012
721.10835..................................................    2070-0012
721.10836..................................................    2070-0012
721.10837..................................................    2070-0012
721.10838..................................................    2070-0012
721.10839..................................................    2070-0012
721.10840..................................................    2070-0012
721.10841..................................................    2070-0012
721.10842..................................................    2070-0012
721.10843..................................................    2070-0012
721.10844..................................................    2070-0012
721.10845..................................................    2070-0012
721.10846..................................................    2070-0012
721.10847..................................................    2070-0012
721.10848..................................................    2070-0012
721.10849..................................................    2070-0012
721.10850..................................................    2070-0012
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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


0
4. Add Sec.  721.10830 to subpart E to read as follows:


Sec.  721.18030  2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-butene, 
1,1,1,4,4,4-hexafluoro-, (2Z)- (PMN P-11-549; CAS No. 692-49-9) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (j), and (o).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers 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.  721.10831 to subpart E to read as follows:


Sec.  721.18031  Aluminum phosphate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aluminum phosphate (PMN P-13-690) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the PMN substance that has been completely reacted 
(cured) or entrained into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4) and (a)(6)(1). 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. A National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirator with an Assigned Protection Factor (APF) of at least 10 meet 
the requirements of Sec.  721.63(a)(4).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=87).
    (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 (e), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 32014]]


0
6. Add Sec.  721.10832 to subpart E to read as follows:


Sec.  721.10832  Alkyl triazine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
triazine (PMN P-13-872) 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=130).
    (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) through (c), and (k) are applicable to manufacturers 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.  721.10833 to subpart E to read as follows:


Sec.  721.10833  Substituted bis 2,6-xylenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted bis 2,6-xylenol (PMN P-13-930) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the PMN substance that have been incorporated into an 
article or has been incorporated into a polymer matrix.
    (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)(i), (a)(6)(ii), 
(b)(concentration set at 1.0 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 50 meet the requirements of Sec.  
721.63(a)(4):
    (A) NIOSH-certified power air-purifying respirator with a hood or 
helmet and with appropriate gas/vapor (acid gas, organic vapor, or 
substance specific) cartridges in combination with HEPA filters.
    (B) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting facepiece, hood, or helmet.
    (C) NIOSH-certified negative pressure (demand) supplied-air 
respirator with a full facepiece.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a), (b), (c), (d), (e), (f)(concentration set at 1.0 percent), 
(g)(1)(The PMN substance may cause sensitization, eye irritation, 
internal organ effects, and developmental effects), (g)(2), (g)(3), 
(g)(4)(i), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g) and (q).
    (iv) Release to water. (A) Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) N=6. However the requirements of Sec.  
721.91(a)(4) do not apply. Instead, if control technologies are in 
place to treat the waste stream containing the PMN substance, the 
amount of the PMN substance reasonably likely to be removed from the 
waste stream by such treatment may be subtracted in calculating the 
number of kilograms releases. No more than 40 percent removal 
efficiency may be attributed to such treatment.
    (B) In lieu of calculating the quotient, monitoring or alternative 
calculations may be used to predict the surface water concentrations 
expected to result from the intended release of the substance, if the 
monitoring procedures or calculations have been approved for such 
purposes by EPA.
    (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), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
8. Add Sec.  721.10834 to subpart E to read as follows:


Sec.  721.10834  Heteropolycyclic diacrylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteropolycyclic diacrylate (PMN P-14-20) 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)(2)(iii), (a)(3), (a)(4), (a)(6)(i), 
(a)(6)(ii), (b) (concentration set at 1.0 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 power air-purifying respirator with a hood or 
helmet and with appropriate gas/vapor (acid gas, organic vapor, or 
substance specific) cartridges in combination with HEPA filters.
    (B) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting facepiece, hood, or helmet.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=120).
    (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 (e), and (k) are applicable to manufacturers 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.  721.10835 to subpart E to read as follows:


Sec.  721.10835  1,6-Hexanediamine, N1-(6-aminohexyl)-, polymer with 2-
(chloromethyl)oxirane, N-(dithiocarboxy) derivs., sodium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,6-Hexanediamine, 
N1-(6-aminohexyl)-, polymer with 2-(chloromethyl)oxirane, N-
(dithiocarboxy) derivs., sodium salts

[[Page 32015]]

(PMN P-14-66; CAS No. 1459738-70-5) 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) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.10836 to subpart E to read as follows:


Sec.  721.10836  Dimethylaminoalkyl alkene amide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dimethylaminoalkyl alkene amide (PMN P-14-209) 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) through (c), and (i) are applicable to manufacturers 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
11. Add Sec.  721.10837 to subpart E to read as follows:


Sec.  721.10837  Substituted naphthalene polymer glycidyl ether 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted naphthalene polymer glycidyl ether (PMN P-14-452) 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) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
12. Add Sec.  721.10838 to subpart E to read as follows:


Sec.  721.10838  Alkylpolycarboxylic acid, derivative, 
tris(fluorinatedalkoxy)alkyl ester salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylpolycarboxylic acid, derivative, tris(fluorinatedalkoxy)alkyl 
ester salt (PMN P-14-473) 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=6).
    (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) through (c), and (k) are applicable to manufacturers 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.  721.10839 to subpart E to read as follows:


Sec.  721.10839  Tricyclo[3.3.1.13,7]decan-1-amine, N,N-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
tricyclo[3.3.1.13,7]decan-1-amine, N,N-dimethyl- (PMN P-14-476; CAS No. 
3717-40-6) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=8).
    (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) through (c) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
14. Add Sec.  721.10840 to subpart E to read as follows:


Sec.  721.10840  Sulfosuccinic acid ester, alkylamine derivs., sodium 
salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfosuccinic acid ester, alkylamine derivs., sodium salt (PMN P-14-
510) 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=94).
    (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) through (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
15. Add Sec.  721.10841 to subpart E to read as follows:


Sec.  721.10841  Bismuth nitrate oxide (Bi3(NO3)O4).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as bismuth nitrate 
oxide (Bi3(NO3)O4) (PMN P-14-603; CAS 
No. 1417164-49-8) 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)(4), (a)(6)(i), 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 32016]]

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 respirator with an 
assigned protection factor (APF) of at least 10 meets the minimum 
requirements for Sec.  721.63(a)(4): NIOSH-certified air-purifying 
elastomeric half-mask respirator equipped with N100 (if oil aerosols 
absent), R100, or P100 filters.
    (ii) Industrial commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (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 (d), and (i) are applicable to manufacturers 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
16. Add Sec.  721.10842 to subpart E to read as follows:


Sec.  721.10842  Substituted cyclosiloxane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted cyclosiloxane (PMN P-14-605) 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. A significant 
new use is any use other than as a refractive index modifier component 
for light-emitting diode (LED) chips.
    (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) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
17. Add Sec.  721.10843 to subpart E to read as follows:


Sec.  721.10843  Substituted amide aromatic carboxylic acid, metal salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted amide aromatic carboxylic acid, metal salt (PMNs P-14-666 
and P-14-668) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial commercial, and consumer activities. Requirements as 
specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers 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
18. Add Sec.  721.10844 to subpart E to read as follows:


Sec.  721.10844  Graphene nanoplatelets having a predominant thickness 
of 1-10 layers with lateral dimension predominantly less than 2 
microns.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as graphene 
nanoplatelets having a predominant thickness of 1-10 layers with 
lateral dimension predominantly less than 2 microns (PMN P-14-763) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the PMN substance that have been 
embedded or incorporated into a polymer matrix that itself has been 
reacted (cured); embedded in a permanent solid polymer form that is not 
intended to undergo further processing, except mechanical processing; 
or imported 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), (a)(6)(i), 
(a)(6)(ii), (b) (concentration set at 1.0 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 meet the 
requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified power air-purifying, tight-fitting full-face 
respirator equipped with an N-100, P-100, or R-100 cartridge.
    (B) NIOSH-certified power air-purifying particulate respirator with 
an assigned protection factor (APF) of at least 50.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), (q), and (y)(1).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), and (k) are applicable to manufacturers 
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
19. Add Sec.  721.10845 to subpart E to read as follows:


Sec.  721.10845  Methanaminium, N-[4-[[4-
(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-
methyl-, ethanedioate, ethanedioate (2:2:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as methanaminium, N-
[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-
ylidene]-N-methyl-, ethanedioate, ethanedioate (2:2:1) (PMN P-14-781; 
CAS No. 2437-29-8) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial commercial, and consumer activities. Requirements as 
specified in Sec.  721.80(f).

[[Page 32017]]

    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
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.  721.10846 to subpart E to read as follows:


Sec.  721.10846  Sulfurized hydrocarbon (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfurized hydrocarbon (PMN P-14-811) 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. A significant new use is any use where less 
than 80 percent of the low molecular weight species are greater than 
1,000 daltons.
    (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) through (c), and (i) are applicable to manufacturers 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
21. Add Sec.  721.10847 to subpart E to read as follows:


Sec.  721.10847  Oxiranemethanaminium, N,N,N-trimethyl-, bromide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 
oxiranemethanaminium, N,N,N-trimethyl-, bromide (PMN P-14-821; CAS No. 
13895-77-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial commercial, and consumer activities. Requirements as 
specified in Sec.  721.80(v)(1), (w)(1), and (x)(1).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=28).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
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.  721.10848 to subpart E to read as follows:


Sec.  721.10848  Aryloxyalkyl amine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aryloxyalkyl amine (PMN P-14-875) 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=44).
    (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) through (c), and (k) are applicable to manufacturers 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.  721.10849 to subpart E to read as follows:


Sec.  721.10849  Phenol-biphenyl-formaldehyde polycondensate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as phenol-
biphenyl-formaldehyde polycondensate (PMN P-15-115) 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=5).
    (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) through (c), and (k) are applicable to manufacturers 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.  721.10850 to subpart E to read as follows:


Sec.  721.10850  Polymer of phenol, biphenyl and resorcinol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polymer 
of phenol, biphenyl and resorcinol (PMN P-15-116) 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=5).
    (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) through (c), and (k) are applicable to manufacturers 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. 2015-13670 Filed 6-4-15; 8:45 am]
 BILLING CODE 6560-50-P