[Federal Register Volume 81, Number 94 (Monday, May 16, 2016)]
[Rules and Regulations]
[Pages 30451-30481]
[FR Doc No: 2016-11121]

Vol. 81

Monday,

No. 94

May 16, 2016

Part III

Environmental Protection Agency

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40 CFR Parts 9 and 721

 Significant New Use Rules on Certain Chemical Substances; Final Rule

Federal Register / Vol. 81 , No. 94 / Monday, May 16, 2016 / Rules
and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2015-0810; FRL-9944-77]
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 55 chemical substances
which were the subject of premanufacture notices (PMNs). Ten of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture
(defined by statute to include import) or process any of these 55
chemical substances for an activity that is designated as a significant
new use by this rule to notify EPA at least 90 days before commencing
that activity. The required notification will provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it occurs.

DATES: This rule is effective on July 15, 2016. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
May 31, 2016.
    Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before June 15, 2016 (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 June 15, 2016, EPA will withdraw the relevant
sections of this direct final rule before its effective date.
    For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2015-0810, 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, is available at http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

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

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at 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) (FRL-3658-5). Consult that preamble for further
information on the objectives, rationale, and procedures for SNURs and
on the basis for significant new use designations, including provisions
for developing test data.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine

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

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities for which it has received
the SNUN. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 55
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 55 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (assigned
for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or the basis
for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section
5(e) consent orders).
     Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
     CFR citation assigned in the regulatory text section of
this rule.
    The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture volume) and other
uses designated in this rule, may be claimed as CBI. Unit IX. discusses
a procedure companies may use to ascertain whether a proposed use
constitutes a significant new use.
    This rule includes 10 PMN substances (P-11-150, P-11-484, P-11-543,
P-14-67, P-15-59, P-15-60, P-15-104, P-15-154, P-15-328, and P-15-502)
that are subject to ``risk-based'' consent orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined that activities associated with
the PMN substances may present unreasonable risk to human health or the
environment. Those consent orders require protective measures to limit
exposures or otherwise mitigate the potential unreasonable risk. The
so-called ``TSCA section 5(e) SNURs'' on these PMN substances are
promulgated pursuant to Sec.  721.160, and are based on and consistent
with the provisions in the underlying consent orders. The TSCA section
5(e) SNURs designate as a ``significant new use'' the absence of the
protective measures required in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
consent orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec.  721.63 respirator requirements may request to do so under
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to
use the NCELs approach for SNURs are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) consent order for the same
chemical substance.
    This rule also includes SNURs on 45 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, for
a variety of reasons, EPA did not find that the use scenario described
in the PMN triggered the determinations set forth under TSCA section
5(e). However, EPA does believe that certain changes from the use
scenario described in the PMN could result in increased exposures,
thereby constituting a ``significant new use.'' These so-called ``TSCA
non-section 5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA
has determined that every activity designated as a ``significant new
use'' in all TSCA non-section 5(e) SNURs issued under Sec.  721.170
satisfies the two requirements stipulated in Sec.  721.170(c)(2), i.e.,
these significant new use activities are different from those described
in the premanufacture notice for the substance, including any
amendments,

deletions, and additions of activities to the premanufacture notice,
and may be accompanied by changes in exposure or release levels that
are significant in relation to the health or environmental concerns
identified'' for the PMN substance.

PMN Number P-11-150

    Chemical name: Alkali transition metal oxide (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: April 14, 2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a battery
material. Based on test data on the PMN substance and structural
activity relationship (SAR) analysis of test data on analogous
respirable, poorly soluble particulates, subcategory titanium dioxide,
EPA identified concerns for lung, blood, kidney, and adrenal toxicity,
neurotoxicity, developmental toxicity, developmental neurotoxicity,
cardiovascular and gastrointestinal effects, and immunosuppression. 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. To protect against these
risks, the consent order requires:
    1. Hazard communication. Establishment and use of a hazard
communication program, including human health precautionary statements
on each label and the Material Safety Data Sheet (MSDS).
    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 New Chemicals Exposure Limit (NCEL) of 2.4
milligrams/cubic meter (mg/m\3\) as an 8-hour time-weighted average,
when there is potential inhalation exposure.
    3. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the consent order of the PMN substance.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with
special attention to histopathology (inflammation and cell
proliferation) of the lung tissues and various parameters of the
bronchoalveolar lavage fluid (BALF) e.g., maker enzyme activities,
total protein content, total cell count, cell differential, and cell
viability. It is not necessary to look at internal organs. EPA
recommends that a recovery period of 60 days be included to assess the
progression or regression of any lesions would help characterize
possible health effects of the substance. The submitter has agreed to
complete this testing by the confidential aggregate production volume
identified in the consent order. In addition, EPA has determined that
the results of a carcinogenicity test (OPPTS Test Guideline 870.4200)
would help characterize the potential human health effects of the PMN
substance. The Order does not require this test at any specified time
or production volume. However, the Order's restrictions on manufacture,
processing, distribution in commerce, use, and disposal of the PMN
substances will remain in effect until the Order is modified or revoked
by EPA based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10875.

PMN Numbers P-11-484 and P-11-543

    Chemical names: Perfluoroalkyl substituted alkyl sulfonate
(generic) (P-11-484); and Polyfluorinated alkyl quaternary ammonium
chloride (generic) (P-11-543).
    CAS numbers: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: October 30,
2014.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of the substances will be as
surfactants. Based on physical chemical properties data, as well as
test data on analogous perfluorinated chemicals and potential
perfluorinated degradation products including perfluorooctanoic acid
(PFOA), perfluorooctanesulfonate (PFOS), perfluorohexane sulfonate
(PFHS), and 1H,1H,2H,2H-perfluorooctanesulfonic acid (6-2 FTSA), EPA
identified concerns for irritation to skin, eyes, lungs, mucous
membranes, lung toxicity, liver toxicity, blood toxicity, male
reproductive toxicity, immunosupression, and oncogenicity. EPA has
concerns that these degradation products will persist in the
environment, could bioaccumulate or biomagnify, and could be toxic
(PBT) to people, wild mammals, and birds. Further, based on test data
on P-11-484, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2,800 and 1 part per billion (ppb)
respectively for PMN substances P-11-484 and P-11-543 respectively in
surface waters. The Order was issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that these
substances may present an unreasonable risk of injury to the
environment and human health, the substances 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 substances and their potential
degradation products. To protect against these exposures and risks, the
consent order requires:
    1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into an MSDS, within 90 days.
    2. Submission of certain physical/chemical property, human health
and environmental toxicity, and environmental fate testing prior to
exceeding the confidential production volume limits specified in the
consent order.
    3. Recording and reporting of certain fluorinated impurities in the
starting raw material; and manufacture of the PMN substances not to
exceed the maximum established impurity levels of certain fluorinated
impurities.
    4. Use of the PMN substances only for the confidential uses
specified in the consent order, where use in consumer products that
could be spray applied are prohibited.
    5. Disposal of the PMN substance according to the incineration
conditions specified in the consent order.
    6. Comply with the release to water provisions specified in the
consent order.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of certain
environmental fate and human health and environmental toxicity testing
would help characterize human health and environmental effects of the
PMN substances. The submitter has agreed to conduct the testing
identified in the consent agreement by the confidential triggers
identified in the consent order. Further, EPA has determined that the
results of an acute inhalation toxicity test (OPPTS Test Guideline
870.1300) and a 90-day inhalation toxicity test (OPPTS Test Guideline
870.3465) with a post-exposure observation period of up to 3 months and
BALF analysis would help characterize the human health effects from
spray application of the PMN substances. The Order does

not require this testing at any specified time or production volume.
However, the Order's restrictions on manufacture, processing,
distribution in commerce, use, and disposal of the PMN substances will
remain in effect until the Order is modified or revoked by EPA based on
submission of that or other relevant information.
    CFR citations: 40 CFR 721.10876 (P-11-484) and 40 CFR 721.10877 (P-
11-543).

PMN Number P-14-67

    Chemical name: Polyfluorinatedalkylsulfonyl substituted alkane
derivative (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: November 4,
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a polymer
additive. EPA has concerns for potential incineration or other
decomposition products of the PMN substance. These fluorinated
decomposition products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers
which suggest that under some conditions, the PMN substance could
degrade in the environment. EPA has concerns that these degradation
products will persist in the environment, could bioaccumulate or
biomagnify, and could be toxic (PBT) to people, wild mammals, and
birds. These concerns are based on data on analogous chemical
substances, including PFOA and other perfluorinated alkyls, including
the presumed environmental degradant. EPA also has concerns that under
some conditions of use, particularly non-industrial, commercial, or
consumer use, the PMN substance could cause lung effects, based on
limited data on some perfluorinated compounds. Concerns for the PMN
substance are for lung toxicity from waterproofing of lung membrane,
based on PMN properties. The order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that these
substances and their potential degradation products may present an
unreasonable risk of injury to the environment and human health.
    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 or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into an MSDS, within 90 days.
    2. Submission of certain environmental fate testing on the PMN
substance prior to exceeding the confidential production volume limit
as specified in the consent order of the PMN substance.
    3. No use of the PMN substance in consumer spray products.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of the
modified aerobic activated sludge biodegradation test submitted by the
company for EPA review would help characterize the possible degradation
of the PMN substance. The submitter has agreed to submit the results of
this test by the confidential production volume identified in the
consent order. EPA had determined that the results of a
phototransformation of chemicals on soil surfaces (Organisation for
Economic Co-operation and Development (OECD) Draft Document January
2002) would help characterize the degradation potential of the PMN
substance. The Order does not require this testing at any specified
time or production volume. However, the Order's restrictions on
manufacture, processing, distribution in commerce, use, and disposal of
the PMN substances will remain in effect until the Order is modified or
revoked by EPA based on submission of that or other relevant
information.
    CFR citation: 40 CFR 721.10878.

PMN Number P-14-125

    Chemical name: 1-Octadecanaminium, N-(3-chloro-2-hydroxypropyl)-
N,N-dimethyl-, chloride (1:1).
    CAS number: 3001-63-6.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate
for surfactant production. Based on test data on the PMN substance, as
well as SAR analysis of test data on analogous cationic surfactants,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 2 ppb of the PMN substance in surface waters. As described
in the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 2 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use resulting in surface water concentrations
exceeding 2 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) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10879.

PMN Numbers P-14-153, P-14-154, P-15-79, and P-15-80

    Chemical names: Fatty acid rxn products with aminoalkylamines
(generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMN states that these substances will be used
as chemical intermediates, additives for flotation products, and as
adhesion promoters for use in asphalt applications. Based on 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 substances in surface waters. For the uses described in
the PMN, releases of the substances 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
substances may present an unreasonable risk. EPA has determined,
however, that any use of the substances, excluding the uses described
in the PMNs, result in in releases to surface water concentrations
exceeding 1 ppb 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
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal
toxicity test (Office of Chemical Safety and Pollution Prevention
(OCSPP) Test Guideline 850.4500); log Kow and water solubility
measurements; 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) would help characterize the environmental effects of the PMN
substances. EPA also recommends that the guidance document on aquatic
toxicity testing of difficult substance and mixtures (OECD Test
Guideline 23) be consulted to

facilitate solubility in the test media. Testing should be tiered,
starting with water solubility and log Kow measurements before
proceeding with higher tier toxicity tests.
    CFR citation: 40 CFR 721.10880.

PMN Numbers P-14-155 and P-14-156

    Chemical names: Fatty acid amides (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the substances will be used
as chemical intermediates, additives for flotation products, and
adhesion promoters for use in asphalt applications. Based on SAR
analysis of test data on analogous amides and aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 and 3 ppb respectively of the PMN substances P-14-155 and P-
14-156 in surface waters. For the uses described in the PMNs, releases
of the substances are not expected to result in surface water
concentrations that exceed 2 ppb and 3 ppb of the PMN substances
respectively. 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, excluding uses described in the PMNs, resulting in surface
water concentrations exceeding 2 ppb (P-14-155) or 3 ppb (P-14-156) of
the PMN substances may result in significant adverse environmental
effects. Based on this information, the PMN substances meet the concern
criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 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); log Kow and water
solubility measurements; 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) would help characterize the environmental
effects of the PMN substances. EPA also recommends that the guidance
document on aquatic toxicity testing of difficult substance and
mixtures (OECD Test Guideline 23) be consulted to facilitate solubility
in the test media, because of the PMN's low water solubility. Testing
should be tiered, starting with water solubility and log Kow
measurements before proceeding with higher tier toxicity tests.
    CFR citation: 40 CFR 721.10881.

PMN Number P-14-198

    Chemical name: Trialkylammonium borodibenzoate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a color developer for
general printing applications. Based on test data on the PMN substance
and SAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 47 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 substance to surface
water, from domestic manufacture or from uses other than as described
in the PMN, exceed releases from the use described in the PMN. For the
use described in the PMN, environmental releases did not exceed 47 ppb
for more than 20 days per year. Therefore, EPA has not determined that
the proposed manufacturing (defined by statute to include import),
processing or use of the substance may present an unreasonable risk.
EPA has determined, however, that any domestic manufacture or use of
the substance other than as listed 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)(i) and
(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10882.

PMN Number P-14-324

    Chemical name: Fatty ester derivatives, reaction products with
alkanolamine, hydroxylated, borated (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as
a lubricating oil additive. Based on SAR analysis of test data on
analogous boron compounds, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 2 ppb of the PMN substance in
surface waters for greater than 20 days per year. This 20-day criterion
is derived from partial life cycle tests (daphnid chronic and fish
early life stage tests) that typically range from 21 to 28 days in
duration. EPA predicts toxicity to aquatic organisms may occur if
releases of the substance to surface water, from uses other than as
described in the PMN, exceed releases from the use described in the
PMN. For the use described in the PMN, environmental releases did not
exceed 2 ppb for more than 20 days per year. Therefore, EPA has not
determined that the proposed manufacturing (defined by statute to
include import), processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance other than as a lubricating oil additive 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
chronic fish early-life stage toxicity test (OPPTS Test Guideline
850.1400) would help characterize the environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.10883.

PMN Number P-14-397

    Chemical name: Benzenepropanol, 1-benzoate.
    CAS number: 60045-26-3.
    Basis for action: The PMN states that the substance will be used as
a plasticizer in adhesives for food-product packaging, a diluents-type
plasticizer in plastisols, a coalescent in architectural paints and
coatings, and a fragrance carrier in fragrances. Based on 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 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 substance to surface water, from uses other than as
described in the PMN, exceed releases from the uses described in the
PMN. For the uses described in the PMN, environmental releases did not
exceed 5 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 listed 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
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 721.10884.

PMN Number P-14-448

    Chemical name: Alcohols, C12-22, distn. residues.
    CAS number: 1476777-83-9.
    Basis for action: The PMN states that the use of the substance will
be used in formulation of defoamers used in the production of paper.
Based on structure-activity relationship SAR analysis of test data on
analogous neutral organics, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 7 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 substance to surface waters exceed releases from the
use described in the PMN. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
that exceed 7 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, any use where the cumulative molecular weights of the
C12 and C14 components exceed 2 percent by weight
of the overall molecular weight of the PMN substance 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, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance. Before conducting these aquatic toxicity testing,
EPA recommends chemical characterization of the alkyl range for the
alcohol moiety and a water solubility test (OECD Test Guideline 105)
should be conducted.
    CFR citation: 40 CFR 721.10885.

PMN Number P-14-501 and P-14-502

    Chemical names: Phosphoric acid, mixed Bu and decyl and octyl and
2-(2-phenoxyethoxy)ethyl and 2-phenoxyethyl esters (P-14-501), and
Phosphoric acid, mixed Bu and decyl and octyl and 2-(2-
phenoxyethoxy)ethyl and 2-phenoxyethyl esters, potassium salts (P-14-
502).
    CAS numbers: 1502809-48-4 (P-14-501) and 1502809-56-4 (P-14-502).
    Basis for action: The PMN states that substances will be used as
gellants for use in oil fracturing. Based on structure-activity
relationship (SAR) analysis of test data on analogous neutral organics,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 4 ppb of the PMN substances in surface waters. As described
in the PMNs, releases of the substances are not expected to result in
surface water concentrations that exceed 4 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substances may present an unreasonable risk. EPA has determined,
however, that any use of substances resulting in releases to surface
water concentrations exceeding 4 ppb 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, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substances.
    CFR citations: 40 CFR 721.10886 (P-14-501) and 40 CFR 721.10887 (P-
14-502).

PMN Numbers P-15-59, P-15-60, and P-15-104

    Chemical names: Siloxanes and Silicones, 3-[(2-
aminoethyl)amino)propyl Me, di-Me, reaction products with cadmium zinc
selenide sulfide, lauric acid and oleylamine (P-15-59); Dodecanoic
acid, reaction products with cadmium zinc selenide sulfide and
oleylamine (P-15-60); and Phosphonic acid, P-tetradecyl-, reaction
products with cadmium selenide (CdSe) (P-15-104).
    CAS numbers: 1623456-05-2 (P-15-59); 1773514-92-3 (P-15-60); and
1773514-66-1 (P-15-104).
    Effective date of TSCA section 5(e) consent order: May 5, 2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
substances will be used as a down converter for an optical filter for
light emitting diodes used in displays (P-15-59) and as chemical
intermediates (P-15-60 and P-15-104). Based on SAR analysis of test
data on analogous respirable, poorly soluble particulates and the
presence of cadmium, EPA identified concerns for lung effects, kidney
effects, and oncogenicity. In addition, EPA predicts chronic toxicity
to aquatic organisms from exposure to cadmium. 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 substances may present an unreasonable risk of injury
to human health and the environment. To protect against these risks,
the consent order requires:
    1. Use of impervious gloves to prevent dermal exposures, where
there is a potential for dermal exposures.
    2. Submission of certain material characterization data on P-15-59
by the time triggers specified in the consent order.
    3. Manufacture, process, or use the PMN substances only in a liquid
formulation.
    4. Manufacture, process, and use P-15-59 only as a down converter
for an optical filter for light emitting diodes used in displays.
    5. Manufacture, process, and use of P-15-60 and P-15-104 only as
chemical intermediates.
    6. Disposal of the PMN substances only by incineration in a
permitted hazardous waste incinerator.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the development of
data on certain material characterization data specified in the consent
order on PMN substance P-15-59 would help characterize the possible
effects of the PMN substance. The submitter has agreed to submit the
results of these studies prior to 3 and 18 month time triggers
identified in the consent order. In addition, EPA determined that the
results of a metabolism and pharmacokinetics test (OPPTS Test Guideline
870.7485) would help characterize the human health and environmental
effect of the PMN substance. The Order does not require this testing at
any specified time or production volume. However, the Order's
restrictions on manufacture, processing, distribution in commerce, use,
and disposal of the PMN substances will remain in effect until the
Order is

modified or revoked by EPA based on submission of that or other
relevant information.
    CFR citations: 40 CFR 721.10888 (P-15-59), 40 CFR 721.10889 (P-15-
60), and 40 CFR 721.10890 (P-15-104).

PMN Number P-15-81

    Chemical name: Alkyl silicate, polymer with 2-(chloromethyl)oxirane
and 4,4'0-(1-methylethylidene)bis[phenol], alkoxylated (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient in liquid
paint coating. Based on SAR analysis of test data on analogous
epoxides, there were health concerns regarding skin and lung
sensitization, mutagenicity, oncogenicity, developmental toxicity, male
reproductive, liver, and kidney toxicity based on the epoxide oxidation
product as well as irritation and lung toxicity expected from the
ethoxy silane hydrolysis product from exposure to the PMN substance via
dermal exposure. Further, based on SAR analysis of test data on
analogous epoxides, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. As described in the PMN, occupational exposures are
expected to be minimal due to use of adequate dermal personal
protection equipment and 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 without the use of impervious gloves,
where there is a potential for dermal exposure, or any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
result in serious human health or significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422); a
Zahn-Wellens/EMPA test (OPPTS Test Guideline 835.3200); a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid
chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10891.

PMN Number P-15-109

    Chemical name: Reaction product of a mixture of aromatic
dianhydrides and aliphatic esters with an aromatic diamine (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an intermediate. Based on SAR
analysis of test data on analogous anilines, 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 that exceed 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 resulting in surface water concentrations
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)(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. EPA recommends that the
fate testing be performed first as the results may mitigate the need
for further toxicity testing or change the testing recommendations.
    CFR citation: 40 CFR 721.10892.

PMN Number P-15-111

    Chemical name: Fatty acids, tall-oil, reaction products with an
ether and triethylenetetramine (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a hardener for coating
systems. Based on 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
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
substance to surface water, from uses other than as described in the
PMN, exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 1 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing (defined by statute to include import),
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any domestic manufacture of the
substance, or any use of the PMN 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
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. EPA recommends that the
fate testing be performed first as the results may mitigate the need
for further toxicity testing or change the testing recommendations.
    CFR citation: 40 CFR 721.10893.

PMN Number P-15-120

    Chemical name: Substituted benzyl acrylate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a resin for industrial
coating. Based on 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 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 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

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. EPA recommends that the
fate testing be performed first as the results may mitigate the need
for further toxicity testing or change the testing recommendations.
    CFR citation: 40 CFR 721.10894.

PMN Number P-15-154

    Chemical name: Fluoroalkyl acrylate copolymer (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: May 14, 2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a textile
treatment. The Order was issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that the
substance may present an unreasonable risk of injury to human health
and the environment. 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 substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into an MSDS, within 90 days.
    2. Manufacture of the PMN substance: (a) According to the chemical
composition section of the consent order, including analyzing and
reporting certain starting raw material impurities to EPA; and (b)
within the maximum established limits of certain fluorinated impurities
of the PMN substance as stated in the consent order.
    3. Submission of certain toxicity, physical-chemical property, and
environmental fate testing on the PMN substance prior to exceeding the
confidential production volume limits as specified in the consent
order.

The SNUR designates as a ``significant new use'' the absence of these
protective measures.
    Recommended testing: EPA has determined that the results of certain
toxicity and environmental fate testing would help characterize the PMN
substance. The submitter has agreed to complete the testing identified
in the testing section of the consent order by the confidential limits
specified. In addition, EPA has determined that the results of a 90-day
inhalation toxicity test in rats (OPPTS Test Guideline 870.3465/OECD
Test Guideline 413) with a 60-day holding period, and certain physical
chemical property and environmental fate testing identified in the
consent order would help characterize the human health and fate effects
of the PMN substance. The Order does not require this testing at any
specified time or production volume. However, the Order's restrictions
on manufacture, processing, distribution in commerce, use, and disposal
of the PMN substances will remain in effect until the Order is modified
or revoked by EPA based on submission of that or other relevant
information.
    CFR citation: 40 CFR 721.10895.

PMN Number P-15-176

    Chemical name: 1-Hexanol, 6-mercapto-.
    CAS number: 1633-78-9.
    Basis for action: The PMN states that the substance will be used as
a chemical intermediate to curable monomers. Based on SAR analysis of
test data on analogous thiols, 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 that results in surface water concentrations exceeding 8 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, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready biodegradability test (OECD Test
Guideline 301B) would help characterize the environmental effects of
the PMN substance. EPA recommends that the fate testing be performed
first as the results may mitigate the need for further toxicity testing
or change the testing recommendations.
    CFR citation: 40 CFR 721.10896.

PMN Number P-15-177

    Chemical name: Phenol, 2,2'-[1,2-disubstituted-1,2-
ethanediyl]bis(iminomethylene)bis[substituted- (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst in the process
to manufacture a crop protection chemical. Based on test data on the
PMN substance, EPA identified concerns for blood toxicity to workers
from dermal exposures to the PMN substance. As described in the PMN,
occupational exposures are expected to be minimal due to use of
adequate dermal personal protection equipment. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without the use of chemical
impervious gloves, where there is a potential for dermal exposure, or
any 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)(i).
    Recommended testing: EPA has determined that the results of a skin
absorption, In vitro method (OECD Test Guideline 428) would help
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10897.

PMN Number P-15-188

    Chemical name: Carbomonocycles, polymer with substituted
heteromonocycle, succinate, methyl acrylate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as
a pigment-wetting resin for Ultra Violet (UV)-curable coatings. Based
on SAR analysis of test data on analogous methacrylates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 7
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 substance to surface water, from
uses other than as described in the PMN, exceed releases from the use
described in the PMN. For the use described in the PMN, environmental
releases did not exceed 7 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

listed 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 water
solubility test (OECD Test Guideline 105); a fish acute toxicity test,
freshwater and marine (OPPTS Test Guideline 850.1075); an acute
invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline
850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500)
would help characterize the environmental effects of the PMN substance.
The water solubility testing should be conducted prior to conducting
the ecotoxicity testing as the results of the water solubility may
change the recommended ecotoxicity testing.
    CFR citation: 40 CFR 721.10898.

PMN Number P-15-190

    Chemical name: Halogenated alkyl trimethylaminium halide (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be for cationization of starch.
Based on test data on analogous alkylating agents, there were health
concerns regarding mutagenicity, oncogenicity, developmental toxicity
and respiratory sensitization based from exposure to the PMN substance
via inhalation exposure. In addition, based on SAR analysis of test
data on analogous cationic surfactants, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 88 ppb of the
PMN substance in surface waters. As described in the PMN, exposure is
expected to be minimal due to use of adequate respiratory personal
protection equipment and releases of the substance are not expected to
result in surface water concentrations that exceed 88 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 without the use of NIOSH-certified
respirator with an APF of at least 10, where there is a potential for
respiratory exposure, or any use of the substance resulting in surface
water concentrations exceeding 88 ppb may result in serious human
health or significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
bacterial reverse mutation test, (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline
870.5395); an acute oral toxicity test (OPPTS Test Guideline 870.1100);
a repeated dose 28-day oral toxicity study in rodents (OPPTS Test
Guideline 870.3050); a fish acute toxicity test, freshwater and marine
(OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by
humic acid test (OPPTS Test Guideline 850.1085); an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline
850.4500) would help characterize the human health and environmental
effects of the PMN substance.
    CFR citation: 40 CFR 721.10899.

PMN Number P-15-252

    Chemical name: Titanium salt, reaction products with silica
(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 SAR analysis of test data on analogous insoluble metal oxides,
EPA identified concerns for lung toxicity if inhaled based on lung
overload for respirable, poorly soluble particulates. For the use
described in the PMN, inhalation exposures are expected to be minimal
as the PMN is handled in an enclosed process. 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 in a non-enclosed process, or any use of the
substance other than listed in the PMN may result in significant
adverse human health effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 60-
day holding period and a particle size distribution/fiber length and
diameter distributions (OECD Test Guideline 110) would help
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10900.

PMN Number P-15-272

    Chemical name: Formaldehyde, reaction products with aniline and
aromatic mono- and di-phenol mixture (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a resin. Based on SAR
analysis of test data on analogous phenols, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substance in surface waters. As described in the PMN, 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 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, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test
Guideline 850.4500); and a ready biodegradability (OECD Test Guideline
301) would help characterize the environmental effects of the PMN
substance. EPA recommends that the fate testing be performed first as
the results may mitigate the need for further toxicity testing or
change the testing recommendations.
    CFR citation: 40 CFR 721.10901.

PMN Number P-15-276

    Chemical name: Functionalized carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as
a thin film for electronic device applications. Based on SAR analysis
of test data on analogous carbon nanotubes and other respirable poorly
soluble particulates, EPA identified potential lung effects and skin
penetration and toxicity induction from inhalation and dermal exposure
to the PMN substance. Further, EPA predicts toxicity to aquatic
organisms via releases of the PMN substance to surface water. Although
there is potential for dermal exposure, EPA does not expect significant
occupational exposures due to the use of impervious gloves, and because
the PMN is used in a liquid and is not spray applied except in a closed
system. Further, EPA does not expect environmental releases during the
use identified in the PMN submission. Therefore, EPA has not determined
that the proposed manufacturing, processing, and or use of the
substance may present an unreasonable risk to human health or the
environment. EPA has determined, however, that any use

of the substance without the use of impervious gloves, where there is
potential for dermal exposure; manufacturing the PMN substance for use
other than as a thin film for electronic device applications;
manufacturing, processing, or using the PMN substance in a form other
than a liquid; use of the PMN substance involving an application method
that generates a mist, vapor, or aerosol except in a closed system; or
any release of the PMN substance into surface waters or disposal other
than by landfill or incineration may cause serious health effects or
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.  721.170(b)(3)(ii)
and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 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); a 90-day inhalation
toxicity test (OPPTS 870.3465) with additional testing parameters
beyond those noted at CFR 870.3465, for using the 90-day subchronic
protocol for nanomaterial assessment; a two-year inhalation bioassay
(OPPTS Test Guideline 870.4200); and a surface charge by
electrophoresis (for example, using ASTM E2865-12 or NCL Method PCC-2--
Measuring the Zeta Potential of Nanoparticles) would help characterize
the health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10902.

PMN Number P-15-295

    Chemical name: Acrylated mixed metal oxides (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate. Based on
SAR analysis of test data on respirable poorly soluble particulates,
EPA identified potential lung effects and dermal toxicity from
inhalation and dermal exposure to the PMN substance. Further, EPA
predicts toxicity to aquatic organisms via releases of the PMN
substance to surface water. Although there is potential for dermal
exposure, EPA does not expect significant occupational exposures due to
the use of impervious gloves, and because the PMN is used in a liquid
and is not spray applied. Further, EPA does not expect environmental
releases during the use identified in the PMN submission. Therefore,
EPA has not determined that the proposed manufacturing, processing, and
or use of the substance may present an unreasonable risk to human
health or the environment. EPA has determined, however, that any use of
the substance without the use of impervious gloves, where there is
potential for dermal exposure; manufacturing, processing, or using the
PMN substance in a form other than as a liquid; use of the PMN
substance involving an application method that generates a mist, vapor,
or aerosol; any release of the PMN substance into surface waters; or
disposal other than by landfill or incineration may cause serious
health effects or significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii) and (b))(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period; 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 and health effects
of the PMN substance.
    CFR citation: 40 CFR 721.10903.

PMN Number P-15-306

    Chemical name: Phenol, 1,1-dimethylalkyl derivatives (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a process intermediate.
Based on SAR analysis of test data on analogous phenols, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
13 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 13 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 13 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, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test
Guideline 850.4500); and a Zahn-Wellens/EMPA test (OPPTS Test Guideline
835.3200) would help characterize the environmental effects of the PMN
substance. EPA recommends that the fate testing be performed first as
the results may mitigate the need for further toxicity testing or
change the testing recommendations.
    CFR citation: 40 CFR 721.10904.

PMN Number P-15-319

    Chemical name: Butanedioic acid, 2-methylene-, dialkyl ester
(generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate for
production of a lubricant additive. Based on SAR analysis of test data
on analogous acrylates and esters, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb of the PMN
substance in surface waters. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
that exceed 1 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance that resulting in surface water concentrations 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 fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test
Guideline 850.4500); and a ready biodegradability (OECD Test Guideline
301) would help characterize the environmental effects of the PMN
substance. EPA recommends that the fate testing be performed first as
the results may mitigate the need for further toxicity testing or
change the testing recommendations.
    CFR citation: 40 CFR 721.10905.

PMN Number P-15-324

    Chemical name: Magnesium alkaryl sulfonate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the use of the substance will
be as a detergent additive in crankcase lubricant applications. Based
on submitted test data on the PMN substance, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 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 substance to surface water, from uses other
than as described in the PMN, exceed releases from the use described in
the PMN. For the use described in the PMN, environmental releases did
not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance other than as listed 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)(i).
    Recommended testing: EPA has determined that the results of a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10906.

PMN Number P-15-326

    Chemical name: Polyfluorohydrocarbon (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a specialty gas and
transfer fluid. Based on test data on the PMN substance, EPA identified
concerns for neurotoxicity and uncertain concern for cardiac
sensitization. Further, based on SAR analysis of test data on analogous
substances, EPA identified concerns for developmental toxicity. As
described in the PMN, EPA does not expect significant occupational
exposures due to use of adequate personal protective equipment, and
consumer exposures are not expected as the PMN substance is not used in
consumer products. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance other than as listed in the PMN or any use in a consumer
product may result in significant adverse human health effects. Based
on this information, the PMN substance meets the concern criteria at
Sec.  721.170 (b)(3)(i) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of 90-day
inhalation toxicity (OPPTS Test Guideline 870.3465) would help
characterize the health effects of the PMN substance.
    CFR citation: 40 CFR 721.10907.

PMN Number P-15-328

    Chemical name: Aluminum calcium oxide salt (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: June 2, 2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be as a cement
additive. Based on SAR analysis of test data on analogous respirable,
poorly soluble particulates, EPA identified concerns for lung toxicity
based on lung overload. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the consent order requires:
    1. Hazard communication. Establishment and use of a hazard
communication program, including human health precautionary statements
on each label and the MSDS.
    2. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 10 or compliance with a NCEL of 5
mg/m\3\ as an 8-hour time-weighted average (when there is potential
inhalation exposure), when there is potential inhalation exposure.
    3. Manufacture, processing or use of the PMN substance only for the
use 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 a 90-day inhalation
toxicity test (OPPTS Test Guideline 870.3465) in rats would help
characterize possible health effects of the substance. The Order does
not require this testing at any specified time or production volume.
However, the Order's restrictions on manufacture, processing,
distribution in commerce, use, and disposal of the PMN substances will
remain in effect until the Order is modified or revoked by EPA based on
submission of that or other relevant information.
    CFR citation: 40 CFR 721.10908.

PMN Number P-15-332

    Chemical name: Polyalkyltrisiloxane (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a site-limited
intermediate. Based on SAR analysis of test data on an analogous
substance, there were health concerns regarding liver and kidney
toxicity, thyroid effects, and reproductive and developmental toxicity
from dermal and inhalation exposures to the PMN substance. Further,
based on SAR analysis of test data on analogous neutral organics, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 4 ppb of the PMN substance in surface waters. EPA also predicts
toxicity to aquatic organisms may occur if releases of the substance to
surface water, from uses other than as described in the PMN, exceed
releases from the use described in the PMN. Further, as described in
the PMN, exposure is expected to be minimal due to use of adequate
respiratory and dermal personal protection equipment and releases of
the substance are not expected to result in surface water
concentrations exceeding 4 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 4
ppb, any use other than that as a site-limited intermediate, or any use
without the use of a NIOSH-certified respirator with gas/vapor
cartridges and an APF of at least 10 and impervious gloves, may result
in serious human health or significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
sediment-water lumbriculus toxicity test (OECD Test Guideline 225); a
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422); a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the human
health and environmental effects of the PMN substance. All ecotoxicity
tests should analyze the PMN substance as well as the hydrolysis
products.
    CFR citation: 40 CFR 721.10909.

PMN Number P-15-356

    Chemical names: Oxirane, 2,2'-[[1-[4-[1-methyl-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenyl]ethylidene]bis(4,1-
phenyleneoxymethylene)]bis- (P-15-

356, Chemical A); and 2-Propanol, 1,3-bis[4-[1-[4-[1-methyl-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenyl]-1-[4-(2-
oxiranylmethoxy)phenyl]ethyl]phenoxy]- (P-15-356, Chemical B).
    CAS numbers: 115254-47-2 (P-15-356, Chemical A) and 180063-56-3 (P-
15-356, Chemical B).
    Basis for action: The PMN states that the substances will be used
as additives in polymer formulation for electronics. Based on test data
on the PMN substances and on SAR analysis of test data on analogous
epoxides, EPA identified concerns for respiratory sensitization and
irritation, mutagenicity, developmental toxicity, male reproduction
toxicity, liver and kidney toxicity, and oncogenicity. Additionally,
based on 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 substances in surface waters. Further, EPA has
concerns that the PMN substances are potentially PBT chemicals as
described in the New Chemical Program's PBT category (64 FR 60194;
November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substances
will persist in the environment more than 2 months and estimates a
bioaccumulation factor of greater than or equal to 1,000. For the use
described in the PMN, EPA expects occupational exposures to be minimal
and does not expect releases to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substances may present an unreasonable risk. EPA has determined,
however, that any use of the substances other than as additives in
polymer formulation for electronics or any use of the substances
resulting in releases to surface waters may cause serious human health
or significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening test (OECD Test Guideline 422); a
sediment-water chironomid life-cycle toxicity test (OECD Test Guideline
233), using spiked water or spiked sediment; a fish early-life stage
toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the human
health and environmental effects of the PMN substances.
    CFR citations: 40 CFR 721.10910 (P-15-356, chemical A) and 40 CFR
721.10911 (P-15-356, chemical B).

PMN Number P-15-363

    Chemical name: Aliphatic acrylate (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer. Based on 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 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 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, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
    CFR citation: 40 CFR 721.10912.

PMN Number P-15-378

    Chemical name: Diisocyanato hexane, homopolymer, alkanoic acid-
polyalkylene glycol ether with substituted alkane (3:1) reaction
products-blocked (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as
a dual cure/UV cure adhesion/barrier coating for wood substrates. Based
on SAR analysis of test data on analogous diisocyanates, EPA identified
concerns for respiratory sensitization. As described in the PMN, EPA
does not expect significant occupational dermal or inhalation exposure
due to use of adequate personal protective equipment and consumer
exposures are not expected as the PMN substance is not used in consumer
products. Therefore, EPA has not determined that the proposed
manufacture, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance without a NIOSH-certified particulate respirator with an APF
of at least 10 where there is a potential for inhalation exposure, or
any use in consumer products may cause serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10913.

PMN Number P-15-382

    Chemical name: Polyitaconic acid, sodium zinc salt (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as
an odor neutralization for pet litter and cleaning hard surface
surfaces, fabrics, skin and hair; an odor neutralization for air car;
and an odor neutralization for waste processing and solid waste
management in paper, oil, gas, mining, agriculture, food and municipal
industries. Based on SAR analysis of test data on analogous zinc salts,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 4 ppb of the PMN substance in surface waters for greater
than 20 days per year. This 20-day criterion is derived from partial
life cycle tests (daphnid chronic and fish early life stage tests) that
typically range from 21 to 28 days in duration. EPA predicts toxicity
to aquatic organisms may occur if releases of the substance to surface
water, from uses other than as described in the PMN, exceed releases
from the use described in the PMN. For the use described in the PMN,
environmental releases did not exceed 4 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 listed 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
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 721.10914.

PMN Number P-15-411

    Chemical name: Fatty acid esters with polyols polyalkyl ethers
(generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an anti-rust coating
solution additive. Based on SAR analysis of test data on analogous
nonionic surfactants, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 30 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 30
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 30 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, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance.
    CFR citation: 40 CFR 721.10915.

PMN Number P-15-435

    Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-3-
[substituted]-5-hydroxy-6-[(1E)-2-phenyldiazenyl]-, lithium salt (1:3)
(generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a direct anionic dyestuff
for the printing industry. Based on the results of a 28-day oral study
for the PMN substance, EPA predicts anemia, effects on the adrenals,
spleen, kidney, lymph nodes and immunotoxicity. In addition, based on
the lithium salt of the PMN, EPA identified concerns for developmental
toxicity and neurotoxicity. Further, based on SAR analysis of test data
on analogous azo reduction products, EPA identified concerns for blood
effects, developmental toxicity, oncogenicity, and mutagenicity. As
described in the PMN, EPA does not expect significant risk to workers
due to use of adequate personal protective equipment. 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 in a liquid
formulation could result in exposures which may cause serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(1)(i)(C), (b)(3)(i) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of an ames
assay (OPPTS Test Guideline 870.5100) with the rival modification; a
mouse micronucleus assay conducted by the oral route (OPPTS Test
Guideline 870.5395); and a combined repeated dose and developmental
toxicity and reproductive toxicity screening test (OPPTS Test Guideline
870.3650) would help to characterize the health effects of the PMN
substance.
    CFR citation: 40 CFR 721.10916.

PMN Number P-15-492

    Chemical name: Polymethylsiloxane, distillation residues (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a site-limited
intermediate. Based on SAR analysis test data on analogous silanes, EPA
identified concerns for mutagenicity, liver and kidney toxicity,
thyroid effects, and reproductive and developmental toxicity from
dermal and inhalation exposures to the PMN substance. Further, based on
SAR analysis of test data on analogous neutral organics, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 1
ppb of the PMN substance in surface waters. For the intermediate use
described in the PMN, occupational exposures are expected to be minimal
due to the use of adequate respiratory and dermal personal protection
equipment, and 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 without the use of a NIOSH-
certified respirator with gas/vapor cartridges and an APF of at least
10, where there is a potential for inhalation exposures, any use of the
substance without the use of impervious gloves, where there is a
potential for dermal exposures; any use of the substance other than an
intermediate; or any use of the substance resulting in surface water
concentrations exceeding 1 ppb may result in serious human health or
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.  721.170(b)(3)(ii)
and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a
sediment-water lumbriculus toxicity test (OECD Test Guideline 225)
using spiked sediment; a combined repeated dose toxicity study with the
reproduction/developmental toxicity screening test (OECD Test Guideline
422); a fish early-life stage toxicity test (OPPTS Test Guideline
850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline
850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500)
would help characterize the human health and environmental effects of
the PMN substance. All ecotoxicity tests should analyze for the PMN
substance as well as the hydrolysis products.
    CFR citation: 40 CFR 721.10917.

PMN Number P-15-502

    Chemical name: Perfluorobutanesulfonamide and polyoxyalkylene
containing polyurethane (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: November 4,
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a protective
treatment. EPA has concerns for potential incineration or other
decomposition products of the PMN substance. These fluorinated
decomposition products may be released to the environment from
incomplete incineration of the PMN substance at low temperatures. EPA
has preliminary evidence, including data on some fluorinated polymers
which suggest that under some conditions, the PMN substance could
degrade in the environment. EPA has concerns that these degradation
products will persist in the environment, could bioaccumulate or
biomagnify, and could be toxic (PBT) to people, wild mammals, and
birds. These concerns are based on data on analogous chemical
substances, including PFOA and other perfluorinated alkyls, including
the presumed environmental degradant. EPA also has concerns that under
some conditions of use, particularly non-industrial, commercial, or
consumer use, the PMN substance could cause lung effects, based on
limited data on

some perfluorinated compounds. Concerns for the PMN substance are for
lung toxicity from waterproofing of lung membrane, based on PMN
properties. 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 and its
potential intermediate and/or ultimate degradation products may present
an unreasonable risk of injury to the environment and human health.
    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 or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into an MSDS, within 90 days.
    2. Submission of certain environmental fate testing on the PMN
substance prior to exceeding the confidential production volume limit
as specified in the consent order of the PMN substance.
    3. No use of the PMN substance in consumer spray products.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Recommended testing: EPA has determined that the results of an
aerobic and anaerobic transformation in soil test (OECD Test Guideline
307) would help characterize the possible degradation of the PMN
substance. The submitter has agreed to submit the results of this test
by the confidential production volume identified in the consent order.
EPA had determined that the results of a phototransformation of
chemicals on soil surfaces (OECD Draft Document January 2002) would
help characterize the degradation potential of the PMN substance. The
Order does not require this testing at any specified time or production
volume. However, the Order's restrictions on manufacture, processing,
distribution in commerce, use, and disposal of the PMN substances will
remain in effect until the Order is modified or revoked by EPA based on
submission of that or other relevant information.
    CFR citation: 40 CFR 721.10918.

PMN Number P-15-542

    Chemical name: Quaternary ammonium compounds, (3-chloro-2-
hydroxypropyl)coco alkyldimethyl, chlorides.
    CAS number: 690995-44-9.
    Basis for action: The PMN states that the substance will be used as
an intermediate for surfactant production, and as a chemical
intermediate for sale into commerce. Based on SAR analysis of test data
on analogous cationic (quaternary ammonium) surfactants, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
24 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 24 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 24 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
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 721.10919.

PMN Number P-15-559

    Chemical name: Modified diphenylmethane diisocyanate prepolymer
with polyol (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for
flexible foam. Based on SAR analysis of analogous diisocyanates, EPA
identified concerns for potential dermal and respiratory sensitization
from dermal and inhalation exposures, and for pulmonary toxicity from
inhalation exposure, to the PMN substance where the average molecular
weight is below 7,500 daltons and any molecular weight species is below
1,000 daltons. For the molecular weight distribution described in the
PMN, significant occupational exposures are not expected. Therefore,
EPA has not determined that the proposed manufacture of the substance
may present an unreasonable risk. EPA has determined, however, that any
manufacture of the PMN substance with an average molecular weight below
7,500 daltons, and where any molecular weight species is below 1,000
daltons may cause serious health effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10920.

PMN Number P-15-573

    Chemical name: 2-Furancarboxyaldehyde, 5-(chloromethyl)-.
    CAS number: 1623-88-7.
    Basis for action: The PMN states that the use of the substance will
be as a chemical intermediate. Based on SAR analysis of test data on
analogous aldehydes, the EPA identified human health concerns for liver
toxicity, neurotoxicity, sensitization, and cancer to workers exposed
through dermal and inhalation routes. For the chemical intermediate use
described in the PMN, occupational exposures are expected to be minimal
due to the use of adequate personal protective equipment and a
continuous reaction process such that no greater than 50 kilograms of
the PMN substance is present in the workplace at a given time 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 without the use of a NIOSH-
certified respirator with an APF of at least 50, where there is a
potential for inhalation exposures; any use without the use of
impervious gloves, where there is a potential for dermal exposures, any
use of the substance other than as a chemical intermediate; or any use
beyond the annual production volume limit of 15,000 kilograms may
result in serious human health or significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin
sensitization (OECD Test Guideline 406) would help characterize the
human health effects of the PMN substance; a combined repeated dose
toxicity test with the reproduction/developmental toxicity screening
test (OECD Test Guideline 422) with functional observational battery
(FOB); a standard test method for permeation of liquids and gases
through protective clothing materials under conditions of continuous
contact (ASTM Test Guideline F739) using the format specified in the
standard guide for documenting the results of chemical permeation
testing of materials used in protective clothing materials (ASTM Test
Guideline F1194-99(2010)); and a carcinogenicity test (OECD Test
Guideline 451) would help characterize

the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10921.

PMN Number P-15-607

    Chemical name: 1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-
tris(alkyl) derivs. (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an initiator for
polymerization. Based on data on the PMN substance, as well as SAR
analysis of test data on analogous peroxides, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 56 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 substance to surface water, from uses other
than as described in the PMN, exceed releases from the use described in
the PMN. For the use described in the PMN, environmental releases did
not exceed 56 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 listed 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)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) using a
solvent where the effects of the solvent are already known or measured,
would help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10922.

PMN Number P-15-671

    Chemical name: 9-Octadecen-1-amine, hydrochloride (1:1), (9Z)-.
    CAS number: 41130-29-4.
    Basis for action: The PMN states that the substance will be used as
an emulsifying agent used in the production of asphalt emulsions for
chipsealing and other road maintenance techniques. Based on test data
for the PMN substance, as well as 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 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 result in significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170 (b)(4)(i) and
(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10923.

PMN Numbers P-15-689 and P-15-690

    Chemical names: Vegetable fatty acid alkyl esters (generic).
    CAS numbers: Claimed confidential.
    Basis for action: The PMNs state that the substances will be used
as chemical intermediates. Based on SAR analysis of test data on
analogous esters, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb 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
substances to surface water exceeds releases from the use described in
the PMN. For the chemical intermediate use described in the PMN,
environmental releases did not exceed 1 ppb for more than 20 days per
year. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that any use of the
substances other than as an intermediate 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
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 substances. Depending
on the results of these tests, EPA has determined that the results of
an aerobic and anaerobic metabolism test (OECD Test Guideline 308) in
aquatic sediment systems test; and a sediment water chironomid life-
cycle toxicity test (OECD Test Guideline 233) using spiked water or
spiked sediment would help to further characterize the environmental
effects of the PMN substances.
    CFR citation: 40 CFR 721.10924.

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 10 of the 55
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 45 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec.  721.170 were met, as discussed
in Unit IV.

B. Objectives

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

     EPA will ensure that all manufacturers and processors of
the same chemical substance that is subject to a TSCA section 5(e)
consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of
this rule is July 15, 2016 without further notice, unless EPA receives
written adverse or critical comments, or notice of intent to submit
adverse or critical comments before June 15, 2016.
    If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before June 15, 2016, EPA will withdraw the relevant sections of
this direct final rule before its effective date. EPA will then issue a
proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
    This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) consent orders have
been issued for 10 of the 55 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 41 of the 55 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 May 16, 2016 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. ASTM International standards are available
at http://www.astm.org/Standard/index.shtml.
    In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study
before reaching the specified production limit. Listings of the tests
specified in the TSCA section 5(e) consent orders are included in Unit
IV. The SNURs contain the same production volume limits as the TSCA
section 5(e) consent orders. Exceeding these production limits is
defined as a significant new use. Persons who intend to exceed the
production limit must notify the Agency by submitting a SNUN at least
90 days in advance of commencement of non-exempt commercial manufacture
or processing.
    The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate

SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

IX. Procedural Determinations

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

X. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and Sec.  721.25. E-PMN software is
available electronically at 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-2015-0810.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

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

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
    1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.

A copy of that certification is available in the docket for this
action.
    This action is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity
significantly more than $8,300.

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

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

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

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That 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.),