Document ID: EPA-HQ-OPPT-2014-0714-0001
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2015-02-02T05:00Z

[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Rules and Regulations]
[Pages 5457-5471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01721]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2014-0714; FRL-9919-68]
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 27 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 27 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 April 3, 2015. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
February 17, 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 March 4, 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 March 4, 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.

[[Page 5458]]

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2014-0714, by one of the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, are available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
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.  [emsp14]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 http://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). 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.  [emsp14]721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA may take regulatory action under 
TSCA sections 5(e), 5(f), 6, or 7 to control the activities for which 
it has received the SNUN. If EPA does not take action, EPA is required 
under TSCA section 5(g) to explain in the Federal Register its reasons 
for not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human

[[Page 5459]]

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 27 
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 27 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 (if 
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).
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.

    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture and importation 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    This rule includes two PMN substances (P-12-17 and P-13-573) 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 ``section 5(e) SNURs'' on these PMN substances are 
promulgated pursuant to Sec.  [emsp14]721.160, and are based on and 
consistent with the provisions in the underlying consent orders. The 
section 5(e) SNURs designate as a ``significant new use'' the absence 
of the protective measures required in the corresponding consent 
orders.
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) consent order usually requires, among 
other things, that potentially exposed employees wear specified 
respirators unless actual measurements of the workplace air show that 
air-borne concentrations of the PMN substance are below a New Chemical 
Exposure Limit (NCEL) that is established by EPA to provide adequate 
protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
consent orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions currently exist 
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, 
the individual SNURs in 40 CFR part 721, subpart E, will state that 
persons subject to the SNUR who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  [emsp14]721.30. EPA expects that persons whose Sec.  721.30 
requests to use the NCELs approach for SNURs are approved by EPA will 
be required to comply with NCELs provisions that are comparable to 
those contained in the corresponding TSCA section 5(e) consent order 
for the same chemical substance.
    This rule also includes SNURs on 25 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, for 
a variety of reasons, EPA did not find that the use scenario described 
in the PMN triggered the determinations set forth under TSCA section 
5(e). However, EPA does believe that certain changes from the use 
scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
section 5(e) SNURs'' are promulgated pursuant to Sec.  [emsp14]721.170. 
EPA has determined that every activity designated as a ``significant 
new use'' in all non-section 5(e) SNURs issued under Sec.  
[emsp14]721.170 satisfies the two requirements stipulated in Sec.  
721.170(c)(2), i.e., these significant new use activities 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-12-17
    Chemical name: Phosphoric acid, iron (2+) lithium salt (1:1:1).
    CAS number: 15365-14-7.
    Effective date of TSCA section 5(e) consent order: May 27, 2014.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the PMN will be as electrode 
components. Based on test data on analogous respirable, poorly soluble 
particulates, EPA identified concerns for lung overload. Further, based 
on lithium (about 5 percent of the molecular weight of the PMN), EPA 
identified concerns for neurotoxicity, developmental toxicity, and 
immunotoxicity. 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 human health, the substance may be 
produced in substantial quantities and may reasonably be anticipated to 
enter the environment in substantial quantities, and there may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the consent order requires:
    1. Risk notification. If as a result of the test data required, the 
company becomes aware that the PMN substance may present a risk of 
injury to human health, the company must incorporate this new 
information, and any information on methods for protecting against such 
risk into a Material Safety Data Sheet (MSDS), within 90 days.
    2. Use of personal protective equipment including a National 
Institute of Occupational Safety and Health (NIOSH)-certified 
respirator with an assigned protection factor (APF) of at least 10 or 
compliance with a NCEL of 2.4 milligram/meter\3\ (mg/m\3\) as an 8-hour 
time-weighted average (when there is potential inhalation exposure), 
when there is potential inhalation exposure.
    3. Submission of certain testing prior to exceeding the 
confidential

[[Page 5460]]

production volume limits of the PMN substance specified in the consent 
order.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the test data from 
certain human health testing identified in the consent order would help 
characterize possible health effects of the substance. The company has 
agreed not to exceed the first confidential production limit without 
performing a 90-day inhalation toxicity test (OPPTS Test Guideline 
870.3465) in rats, with special attention to histopathology as 
described in the consent order. If the results of the 90-day inhalation 
toxicity test indicates the potential for carcinogenicity, then the 
submitter has agreed not to exceed the second confidential production 
limit without performing a carcinogenicity test (OPPTS Test Guideline 
870.4200) in rats via the inhalation route.
    CFR citation: 40 CFR 721.10793.
PMN Numbers P-13-212 and P-13-213
    Chemical names: Alkenyl succinate, amine salts (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the use of the substances 
will be as metalworking fluid additives. Based on test data on 
analogous anionic surfactants, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 3 parts per billion 
(ppb) in aggregate of the PMN substances 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 substances to 
surface water exceed releases from the use described in the PMNs. For 
the use described in the PMNs, environmental releases of the substances 
did not exceed 3 ppb 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 use of the substances other than as described in the PMNs 
may result in 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 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 environmental effects 
of the PMN substances.
    CFR citation: 40 CFR 721.10794.
PMN Number P-13-559
    Chemical name: Amine salt of vegetable oil, polymer with 
cycloaliphatic glycol, hydroxy substituted carboxylic acid, aliphatic 
diisocyanate and tetra hydroxyalkane (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be as a wood sealer or concrete sealer. Based on ecological structure 
activity relationship (SAR) analysis of test data on polyamphoteric 
polymers, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 60 ppb of the PMN substance in surface 
waters for greater than 20 days per year. This 20-day criterion is 
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration. 
EPA predicts toxicity to aquatic organisms may occur if releases of the 
PMN substance to surface water exceed releases from the use described 
in the PMN. For the use described in the PMN, environmental releases of 
the substances did not exceed 60 ppb for more than 20 days per year. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance other than 
as described in the PMN may result in significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test (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 721.10795.
PMN Number P-13-573
    Chemical name: Polymer of terephthalic acid and ethyl benzene with 
multi-walled carbon nanotube (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: April 16, 2014.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the PMN will be as dispersing agents 
for various resin systems, such as thermosets, elastomers, 
thermoplastics and solvents and water. Based on test data on analogous 
respirable, poorly soluble particulates, EPA identified concerns for 
immunotoxicity, oncogenicity, and mutagenicity. Further, based on the 
agglomeration potential of carbon nanotubes, EPA identified concerns 
for environmental releases to water where the PMN may combine with 
dissolved organic matter to form stable aqueous suspensions. 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 human health and the environment, the substance may be 
produced in substantial quantities and may reasonably be anticipated to 
enter the environment in substantial quantities, and there may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the consent order requires:
    1. 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 N-100, P-100, or R-100 
cartridges (where there is a potential for inhalation exposure).
    2. Submission of certain physical-chemical data for the PMN 
substance within nine months of signing of the consent order.
    3. Submission of certain human health testing prior to exceeding 
the confidential production volume limit specified in the consent 
order.
    4. Processing and use of the PMN substance only for the 
confidential use specified in the consent order.
    5. No use of the substance resulting in releases to surface waters.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the development of 
data on certain physical-chemical properties, as well as certain human 
health and environmental toxicity testing would help characterize 
possible effects of the substance. The submitter has agreed to provide 
the physical/chemical properties data within the specified time limit. 
In addition, the submitter has agreed not to exceed the confidential 
production limit without performing a 90-day inhalation toxicity test 
(OPPTS Test Guideline 870.3465 or

[[Page 5461]]

Organisation for Economic Co-operation and Development (OECD) Test 
Guideline 413) in rats with a post-exposure observation period of up to 
3 months (including BALF analysis, a determination of cardiovascular 
toxicity (clinically-based blood/plasma protein analyses), and 
histopathology of the heart). Although the order does not require the 
results of a fish early-life stage toxicity test (OPPTS Test Guideline 
850.1400), a chronic daphnid toxicity test (OPPTS Test Guideline 
850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) 
at any specified time or volume, the Order's restrictions on 
manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10796.
PMN Number P-13-674
    Chemical name: Polycarbamoylsulfonic acid sodium salt (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be for leather processing. Based on test data of the PMN substance, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 11 ppb of the PMN substance in surface waters. As described in 
the PMN, releases of the substance are not expected to result in 
surface water concentrations exceeding 11 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 releases to 
surface waters exceeding 11 ppb may result in significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(i).
    Recommended testing: EPA has determined that the results of a fish 
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 721.10797.
PMN Number P-13-864
    Chemical name: Phosphonic acid chloride, diester (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic use of the 
substance will be as a chemical intermediate. Based on ecological SAR 
analysis of test data on analogous esters, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 5 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 exceeding 5 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 releases to surface waters exceeding 5 
ppb may result in significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test (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 721.10798.
PMN Numbers P-13-874, P-13-875, P-13-876, and P-13-877
    Chemical names: Substituted dimethyl phenols (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the generic use of the 
substances will be as chemical intermediates. Based on ecological SAR 
analysis of test data on analogous phenols, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 10 ppb of the 
PMN substances P-13-874 or P-13-875, and 5 ppb of the PMN substances P-
13-876 or P-13-877, in surface waters. As described in the PMNs, 
releases of the substances are not expected to result in surface water 
concentrations exceeding 10 ppb in aggregate of the PMN P-13-874 and P-
13-875 substances or 5 ppb in aggregate of the PMN P-13-876 and P-13-
877 substances. 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 that results in releases to surface waters exceeding 10 ppb 
in aggregate of the PMN P-13-874 and P-13-875 substances or 5 ppb in 
aggregate of the PMN P-13-876 and P-13-877 substances may result in 
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 fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); an 
algal toxicity test (OCSPP Test Guideline 850.4500); and a ready 
biodegradability test (OECD Test Guideline 301) on either P-13-874 or 
P-13-875, would help characterize the environmental effects of these 
two PMN substances. Further, 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); an algal 
toxicity test (OCSPP Test Guideline 850.4500); and a ready 
biodegradability test (OECD Test Guideline 301) on P-13-877 would help 
characterize the environmental effects of P-13-876 and P-13-877.
    CFR citation: 40 CFR 721.10799.
PMN Number P-13-931
    Chemical name: 2-propenoic acid, 4-phenoxybutyl ester.
    CAS number: 103969-85-3.
    Basis for action: The PMN states that the use of the substance will 
be a polymerizable component in adhesive formulations. Based on 
ecological SAR analysis of test data on analogous acrylates, 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 exceeding 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 releases to 
surface waters exceeding 1 ppb may result in 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 test (OECD Test Guideline 105) and a partition coefficient 
(n-octanol/water) test, HPLC Method (OECD Test Guideline 117) would 
help to characterize the physical-chemical properties of the PMN 
substance. EPA recommends that this testing be performed first as the 
results may mitigate the need for further testing or change the testing 
recommendations. Depending upon the results of these data, EPA has 
determined that the results of a fish acute toxicity test (OPPTS Test 
Guideline 850.1075); an aquatic invertebrate acute toxicity test (OPPTS 
Test Guideline 850.1010); and

[[Page 5462]]

an algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10800.
PMN Number P-13-936
    Chemical name: Organic phosphonate salt (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic use of the 
substance will be a contained use in energy production. Based on 
ecological SAR analysis of test data on analogous polyanionic monomers, 
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 exceeding 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 that results in 
releases to surface waters exceeding 130 ppb may result in 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 
algal toxicity test (OCSPP Test Guideline 850.4500) and a modified 
algal toxicity test with equivalent calcium ion amendments (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10801.
PMN Number P-14-39
    Chemical name: Quaternized protein/silicone copolymer (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic use of the 
substance will be as a fabric softener additive. Based on test data on 
the PMN substance, as well as ecological SAR analysis of test data on 
analogous amphoteric surfactants, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 31 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 
exceeding 31 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 releases to surface waters exceeding 31 ppb 
may result in significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test (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 721.10802.
PMN Number P-14-70
    Chemical name: 1,5-Pentanediamine.
    CAS number: 462-94-2.
    Basis for action: The PMN states that the uses of the substance 
will be as a monomer for polyamides and as an ingredient to produce 
metamethylene 1,5 diisocyanate. Based on ecological SAR analysis of 
test data on analogous aliphatic amines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 300 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 exceeding 300 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 releases to surface waters 
exceeding 300 ppb may result in significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test (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 721.10803.
PMN Number P-14-110
    Chemical name: Cashew-nutshell-liquid, polymer with formaldehyde, 
reaction products with diethanolamine and diisopropanol amine.
    CAS number: 1462343-28-7.
    Basis for action: The PMN states that the generic use of the 
substance will be as a polyol to be reacted with polyisocyanates to 
create polyurethane foam. Based on ecological SAR analysis of test data 
on analogous aliphatic amines, 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 
exceeding 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 releases to surface waters exceeding 1 ppb 
may result in 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 test (OECD Test Guideline 105) and a partition coefficient 
(n-octanol/water) test, high performance liquid chromotography (HPLC) 
Method (OECD Test Guideline 117) would help to characterize the 
physical-chemical properties of the PMN substance. EPA recommends that 
this testing be performed first as the results may mitigate the need 
for further testing or change the testing recommendations. Depending on 
the results of these tests, EPA has determined that the results of a 
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) OR the sediment-
water chironomid life-cycle toxicity test using spiked water or spiked 
sediment (OECD Test Guideline 233) and the ready biodegradability test 
(OECD Test Guideline 301) would help characterize the environmental 
effects of the PMN substance.
    CFR citation: 40 CFR 721.10804.
PMN Numbers P-14-202, P-14-203, P-14-204, P-14-205, and P-14-206
    Chemical names: Fatty acid imidazolines (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the generic use of the 
substances will be as emulsifiers. Based on ecological SAR analysis of 
test data on analogous aliphatic amines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb in 
aggregate of the PMN substances P-14-202 and P-14-203 or 1 ppb in 
aggregate of PMNs P-14-204, P-14-205, and P-14-206 in surface waters. 
As described in the PMNs, releases of the substances are not expected 
to result in surface water concentrations exceeding 1 ppb in aggregate 
of P-14-202 and P-14-203 or

[[Page 5463]]

1 ppb in aggregate of PMNs P-14-204, P-14-205, and P-14-206. 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 that results in 
releases to surface waters exceeding 1 ppb in aggregate of the PMN 
substances P-14-202 and P-14-203 or 1 ppb in aggregate of PMNs P-14-
204, P-14-205, and P-14-206 may result in 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 a water solubility 
test (OECD Test Guideline 105) and a partition coefficient (n-octanol/
water) test, HPLC Method (OECD Test Guideline 117) for P-14-202 and P-
14-204 would help to characterize the physical-chemical properties of 
the PMN substances. EPA recommends that this testing be performed first 
as the results may mitigate the need for further testing or change the 
testing recommendations. Depending on the results of these tests, 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); an algal toxicity test (OCSPP Test 
Guideline 850.4500); as well as either the fish acute toxicity 
mitigated by humic acid test (OPPTS Test Guideline 850.1085) or the 
whole sediment acute toxicity invertebrates, freshwater test (OPPTS 
Test Guideline 850.1735) on P-14-202 and P-14-204 may help characterize 
the environmental effects of the PMN substances. EPA also recommends 
that the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed to 
facilitate solubility in the test media.
    CFR citation: 40 CFR 721.10805.
PMN Number P-14-341
    Chemical name: Trimellitic anhydride, polymer with alkanolamine and 
tetrahydrophthalic anhydride (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will 
be as a binder for gluing the individual mineral fibres together to 
form a firm product, used industrially in a closed system. Based on 
test data on the PMN substance, the EPA identified human health 
concerns regarding blood toxicity and uncertain concerns for liver and 
kidney toxicity from exposure to the PMN substance via inhalation 
exposure. As described in the PMN, exposure is expected to be minimal 
for this use. 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 may result in serious health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity study with the reproductive/
developmental toxicity screening test (OECD Test Guideline 422) would 
help characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10806.
PMN Number P-14-417
    Chemical name: Aliphatic ether ethyl alcohol (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a solvent for ink. Based 
on test data on analogous ethylene glycol ethers, EPA identified 
concerns for blood, liver, and kidney toxicity, immunotoxicity, 
neurotoxicity, and developmental and reproductive toxicity to humans 
exposed to the PMN substance. Because of the use described in the PMN, 
significant dermal, inhalation and drinking water exposures are not 
expected for the worker, the general population, or consumer. 
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 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 the 
combined repeated dose toxicity study, with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422) would 
help characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.10807.
PMN Number P-14-513
    Chemical name: Bisxylenol diglycidyl ether polymer (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate. 
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 721.10808.
PMN Number P-14-518
    Chemical name: Cyclotetrasiloxane, 2,4,6,8-tetrakis[3-[2-(2-
methoxyethoxy)ethoxy]propyl]-2,4,6,8-tetramethyl-.
    CAS number: 17232-95-0.
    Basis for action: The PMN states that the substance will be used in 
the preparation of a triethyleneoxy-terminated polymer. Based on 
ecological SAR analysis of test data on analogous neutral organic 
chemicals, 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, however, 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. EPA also

[[Page 5464]]

recommends that the guidance document on aquatic toxicity testing of 
difficult substances and mixtures (OECD Test Guideline 23) be followed 
to facilitate solubility of the PMN substance in the test media.
    CFR citation: 40 CFR 721.10809.
PMN Number P-14-544
    Chemical name: Heterocyclic amine potassium salt (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a dishing reducer. Based 
on ecological SAR analysis of test data on structurally similar 
substances, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 250 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 either (1) 
releases of the PMN substance to surface water, from uses other than as 
described in the PMN, exceed releases from the use described in the PMN 
or (2) the production volume increases beyond the confidential 
production volume described in the PMN. For the use and production 
volume described in the PMN, environmental releases did not exceed 250 
ppb for more than 20 days per year. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance other than as described in the PMN, or any 
increase in the annual production volume could result in exposures 
which may cause significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OECD Test Guideline 301); a fish early-life-
stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic 
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity 
test (OCSPP Test Guideline 850.4500) would help to characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10810.
PMN Number P-14-618
    Chemical name: Heterocyclic amine substituted acrylamide (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as 
a monomer for use in the manufacture of a polymer or for export. Based 
on ecological SAR analysis of test data on analogous acrylamides, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 23 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 23 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 23 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); an algal 
toxicity test (OCSPP Test Guideline 850.4500); and a ready 
biodegradability test (OECD Test Guideline 301) would help characterize 
the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10811.

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 27 
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 25 cases, where the uses are not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  [emsp14]721.170 were met, as 
discussed in Unit IV.

B. Objectives

    EPA is 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 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.  
[emsp14]721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective 
date of this rule is April 3, 2015 without further notice, unless EPA 
receives written adverse or critical comments, or notice of intent to 
submit adverse or critical comments before March 4, 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 March 4, 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

[[Page 5465]]

comments, or notice of intent to submit adverse or critical comments, 
must identify the chemical substance and the new use to which it 
applies. EPA will not withdraw a SNUR for a chemical substance not 
identified in the comment.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) consent orders have 
been issued for 2 of the 27 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 22 of the 27 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 February 2, 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 http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at 
http://www.sourceoecd.org.
    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.
    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.  
[emsp14]721.1725(b)(1) with that under Sec.  [emsp14]721.11 into a 
single step.

[[Page 5466]]

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

X. SNUN Submissions

    According to Sec.  [emsp14]721.1(c), persons submitting a SNUN must 
comply with the same notification requirements and EPA regulatory 
procedures as persons submitting a PMN, including submission of test 
data on health and environmental effects as described in 40 CFR 720.50. 
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers 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-2014-0714.

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.

[[Page 5467]]

G. Executive Order 13045

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

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to 
this action.

J. Executive Order 12898

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

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: January 21, 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.  [emsp14]9.1, add the following sections in numerical order 
under the undesignated center heading ``Significant New Uses of 
Chemical Substances'' to read as follows:

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

* * * * *

------------------------------------------------------------------------
                                                            OMB Control
                     40 CFR Citation                            No.
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
                                * * * * *
721.10793...............................................       2070-0012
721.10794...............................................       2070-0012
721.10795...............................................       2070-0012
721.10796...............................................       2070-0012
721.10797...............................................       2070-0012
721.10798...............................................       2070-0012
721.10799...............................................       2070-0012
721.10800...............................................       2070-0012
721.10801...............................................       2070-0012
721.10802...............................................       2070-0012
721.10803...............................................       2070-0012
721.10804...............................................       2070-0012
721.10805...............................................       2070-0012
721.10806...............................................       2070-0012
721.10807...............................................       2070-0012
721.10808...............................................       2070-0012
721.10809...............................................       2070-0012
721.10810...............................................       2070-0012
721.10811...............................................       2070-0012
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  [emsp14]721.10793 to subpart E to read as follows:

Sec.  [emsp14]721.10793  Phosphoric acid, iron (2+) lithium salt 
(1:1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphoric acid, 
iron (2+) lithium salt (1:1:1) (PMN P-12-17; CAS No. 15365-14-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The SNUR does not apply 
to the PMN substance when it is manufactured, pursuant to any of the 
exemptions in 40 CFR 720.30(h) with no commercial purpose separate from 
the substance, mixture, or article of which it is a part.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(3), (a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b), 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 face piece, hood, or helmet.
    (C) NIOSH-certified negative pressure (demand) supplied-air 
respirator with a full face piece.
    (1) As an alternative to the respiratory requirements listed here, 
a manufacturer or processor may choose to follow the New Chemical 
Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) 
consent order for this substance. The NCEL is 2.4 mg/m\3\ as an 8-hour 
time weighted average verified by actual monitoring data.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72.
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on

[[Page 5468]]

methods for protecting against such risk, into a MSDS as described in 
Sec.  721.72(c) within 90 days from the time the employer becomes aware 
of the new information. If this substance is not being manufactured, 
processed, or used in the employer's workplace, the employer must add 
the new information to a MSDS before the substance is reintroduced into 
the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substance from the employer, or who have received the PMN substance 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(i)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(i)(A) of this section within 90 days from the 
time the employer becomes aware of the new information.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k) and (q).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (f) 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)(iii) 
of this section.

0
5. Add Sec.  721.10794 to subpart E to read as follows:

Sec.  721.10794  Alkenyl succinate, amine salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkenyl succinate, amine salts (PMNs P-13-212 and P-13-213) 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. The significant new use is any use other 
than as a metalworking fluid additive.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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.

0
6. Add Sec.  721.10795 to subpart E to read as follows:

Sec.  721.10705  Amine salt of vegetable oil, polymer with 
cycloaliphatic glycol, hydroxy substituted carboxylic acid, aliphatic 
diisocyanate and tetra hydroxy alkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine 
salt of vegetable oil, polymer with cycloaliphatic glycol, hydroxy 
substituted carboxylic acid, aliphatic diisocyanate and tetra hydroxy 
alkane (PMN P-13-559) 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. The significant new use is any use other 
than as a wood sealer or concrete sealer.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
7. Add Sec.  721.10796 to subpart E to read as follows:

Sec.  [emsp14]721.10796  Polymer of terephthalic acid and ethyl benzene 
with multi-walled carbon nanotube (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as polymer 
of terephthalic acid and ethyl benzene with multi-walled carbon 
nanotube (PMN P-13-573) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The SNUR does not apply to the PMN substance when it is manufactured, 
pursuant to any of the exemptions in 40 CFR 720.30(h) with no 
commercial purpose separate from the substance, mixture, or article of 
which it is a part.
    (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)(particulate), (b), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63 (a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. A National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirators with an N-100, P-100, or R-100 cartridge meet the 
requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k)(a significant new use is any 
processing or use other than described in the consent order) and (q).
    (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 (b).
    (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)(iii) 
of this section.

0
8. Add Sec.  [emsp14]721.10797 to subpart E to read as follows:

Sec.  721.10797  Polycarbamoylsulfonic acid sodium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polycarbamoylsulfonic acid sodium salt (PMN P-13-674) 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=11).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 5469]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
9. Add Sec.  [emsp14]721.10798 to subpart E to read as follows:

Sec.  721.10798  Phosphonic acid chloride, diester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphonic acid chloride, diester (PMN P-13-864) 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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.  [emsp14]721.10799 to subpart E to read as follows:

Sec.  721.10799  Substituted dimethyl phenols (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
substituted dimethyl phenols (PMNs P-13-874, P-13-875, P-13-876, and P-
13-877) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=10 in aggregate for PMN substances P-13-
874 and P-13-875, and N=5 in aggregate for the PMN substances P-13-876 
and P-13-877).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) 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.

0
11. Add Sec.  [emsp14]721.10800 to subpart E to read as follows:

Sec.  721.10800  2-Propenoic acid, 4-phenoxybutyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 
4-phenoxybutyl ester (PMN P-13-931; CAS No. 103969-85-3) 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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.  [emsp14]721.10801 to subpart E to read as follows:

Sec.  721.10801  Organic phosphonate salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organic 
phosphonate salt (PMN P-13-936) 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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.  [emsp14]721.10802 to subpart E to read as follows:

Sec.  721.10802  Quaternized protein/silicone copolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
quaternized protein/silicone copolymer (PMN P-14-39) 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=31).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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.  [emsp14]721.10803 to subpart E to read as follows:

Sec.  721.10803  1,5-Pentanediamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,5-pentanediamine 
(PMN P-14-70; CAS No. 462-94-2) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=300).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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.  [emsp14]721.10804 to subpart E to read as follows:

Sec.  721.10804  Cashew-nutshell-liquid, polymer with formaldehyde, 
reaction products with diethanolamine and diisopropanol amine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cashew-nutshell-
liquid, polymer with

[[Page 5470]]

formaldehyde, reaction products with diethanolamine and diisopropanol 
amine (PMN P-14-110; CAS No. 1462343-28-7) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
16. Add Sec.  [emsp14]721.10805 to subpart E to read as follows:

Sec.  721.10805  Fatty acid imidazolines (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid imidazolines. (PMNs P-14-202, P-14-203, P-14-204, P-14-205, and P-
14-206) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (where N=1 in aggregate for PMNs P-14-203 
and P-14-204; N=1 in aggregate for PMNs P-14-204, P-14-205, P-14-206).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) 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.

0
17. Add Sec.  [emsp14]721.10806 to subpart E to read as follows:

Sec.  721.10806  Trimellitic anhydride, polymer with alkanolamine and 
tetrahydrophthalic anhydride (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
trimellitic anhydride, polymer with alkanolamine and tetrahydrophthalic 
anhydride (PMN P-14-341) 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 of the PMN 
substance other than as a binder for gluing the individual mineral 
fibers together to form a firm product, used industrially in a closed 
system.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
18. Add Sec.  [emsp14]721.10807 to subpart E to read as follows:

Sec.  721.10807  Aliphatic ether ethyl alcohol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic ether ethyl alcohol (PMN P-14-417) 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 other 
than the confidential use as stated in the PMN.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
19. Add Sec.  [emsp14]721.10808 to subpart E to read as follows:

Sec.  721.10808  Bisxylenol diglycidyl ether polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bisxylenol diglycidyl ether polymer (PMN P-14-513) 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
20. Add Sec.  [emsp14]721.10809 to subpart E to read as follows:

Sec.  721.10809  Cyclotetrasiloxane, 2,4,6,8-tetrakis[3-[2-(2-
methoxyethoxy)ethoxy]propyl]-2,4,6,8-tetramethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cyclotetrasiloxane, 
2,4,6,8-tetrakis[3-[2-(2-methoxyethoxy)ethoxy]propyl]-2,4,6,8-
tetramethyl- (PMN P-14-518; CAS No. 17232-95-0) 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 (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
21. Add Sec.  [emsp14]721.10810 to subpart E to read as follows:

Sec.  721.10810  Heterocyclic amine potassium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The

[[Page 5471]]

chemical substance identified generically as heterocyclic amine 
potassium salt (PMN P-14-544) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (j)(a significant new use is any use other 
than the confidential use stated in the PMN) and (s).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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
22. Add Sec.  [emsp14]721.10811 to subpart E to read as follows:

Sec.  721.10811  Heterocyclic amine substituted acrylamide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heterocyclic amine substituted acrylamide (PMN P-14-618) 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=23).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (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. 2015-01721 Filed 1-30-15; 8:45 am]
BILLING CODE 6560-50-P