[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Rules and Regulations]
[Pages 81250-81274]
[FR Doc No: 2016-27326]

Vol. 81

Thursday,

No. 222

November 17, 2016

Part II

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. 222 / Thursday, November 17, 2016 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2016-0207; FRL-9953-41]
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 57 chemical substances
which were the subject of premanufacture notices (PMNs). The applicable
review periods for the PMNs submitted for these 57 chemical substances
all ended prior to June 22, 2016 (i.e., the date on which President
Obama signed into law the Frank R. Lautenberg Chemical Safety for the
21st Century Act which amends TSCA). Thirty-four 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 57 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 initiates EPA's evaluation of the
intended use within the applicable review period. Manufacture and
processing for the significant new use is unable to commence until EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and take such actions as are required with that
determination.

DATES: This rule is effective on January 17, 2017. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
December 1, 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 December 19, 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 December 19, 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-2016-0207, 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,
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 this rule on or after December 19,
2016 are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see Sec.  [emsp14]721.20), and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.

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

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

II. Background

A. What action is the Agency taking?

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

Consult that preamble for further information on the objectives,
rationale, and procedures for SNURs and on the basis for significant
new use designations, including provisions for developing test data.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore
prohibits such manufacturing or processing from commencing until EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and taken such actions as are required in association
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in
Unit V., the general SNUR provisions are found at 40 CFR part 721,
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  [emsp14]721.1(c), persons subject to these SNURs must comply
with the same SNUN requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA must either determine that the
significant new use is not likely to present an unreasonable risk of
injury or take such regulatory action as is associated with an
alternative determination before the manufacture or processing for the
significant new use can commence. If EPA determines that the
significant new use is not likely to present an unreasonable risk, EPA
is required under TSCA section 5(g) to make public, and submit for
publication in the Federal Register, a statement of EPA's findings.

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 57
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 57 chemical substances in 40 CFR part 721, subpart E.
In this unit, EPA provides the following information for each chemical
substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA
section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
     CFR citation assigned in the regulatory text section of
this 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 34 PMN substances 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.  [emsp14]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.  [emsp14]721.30. EPA expects that persons whose Sec.  721.30
requests to use the NCELs approach for SNURs are approved by EPA will
be required to comply with NCELs provisions that are comparable to
those contained in the corresponding TSCA section 5(e) consent order
for the same chemical substance.

    This rule also includes SNURs on 23 PMN substances that are not
subject to consent orders under TSCA section 5(e). These cases
completed Agency review prior to June 22, 2016. Under TSCA, prior to
the enactment of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act on June 22, 2016, EPA did not find that the use scenario
described in the PMN triggered the determinations set forth under TSCA
section 5(e). However, EPA does believe that certain changes from the
use scenario described in the PMN could result in increased exposures,
thereby constituting a ``significant new use.'' These so-called ``non-
TSCA section 5(e) SNURs'' are consistent with the determination made at
the time and are promulgated pursuant to Sec.  [emsp14]721.170. EPA has
determined that every activity designated as a ``significant new use''
in all non-TSCA section 5(e) SNURs issued under Sec.  [emsp14]721.170
satisfies the two requirements stipulated in Sec.  721.170(c)(2), i.e.,
these significant new use activities, ``(i) are different from those
described in the premanufacture notice for the substance, including any
amendments, deletions, and additions of activities to the
premanufacture notice, and (ii) may be accompanied by changes in
exposure or release levels that are significant in relation to the
health or environmental concerns identified'' for the PMN substance.

PMN Number P-11-482

    Chemical name: Bimodal mixture consisting of multi-walled carbon
nanotubes and other classes of carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: September 30,
2015.
    The PMN states that the generic use of the PMN substance will be as
a specialty additive. Based on test data on analogous respirable,
poorly soluble particulates and nanocarbon materials, EPA identified
concerns for pulmonary toxicity and oncogenicity. Based on test data
for other nanocarbon materials EPA identified concerns for
environmental toxicity. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the consent order
requires:
    1. Use of personal protective equipment involving impervious gloves
and protective clothing (where there is a potential for dermal
exposures) and a National Institute for Occupational Safety and Health
(NIOSH)-certified air purifying, tight-fitting full-face respirator
equipped with N-100, P-100, or R-100 cartridges, or power air purifying
particulate respirator with an Assigned Protection Factor (APF) of at
least 50 (where there is a potential for inhalation exposures).
    2. Submission of a dustiness test within six months of notice of
commencement of manufacture (NOC).
    3. Submission of certain physical-chemical properties data within
the time limits specified in the consent order.
    4. Processing and use of the PMN substance only for the use
specified in the consent order, including no application method that
generates a vapor, mist or aerosol unless the application method occurs
in an enclosed process.
    5. No use of the PMN substance resulting in releases to surface
waters and disposal of the PMN substance only by landfill or
incineration.
    The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
    Recommended testing: EPA has determined that the development of
data on certain physical-chemical properties, as well as certain human
health and environmental toxicity testing would help characterize
possible effects of the substance. The submitter has agreed to provide
a dustiness test (European Standard EU 15051) by six months from
commencement of manufacture. In addition, the submitter has agreed to
provide certain physical-chemical property testing as required in the
consent order after the commencement of manufacture. Although the order
does not require a 90-day inhalation toxicity test (OPPTS Test
Guideline 870.3465 or Organisation for Economic Co-operation and
Development (OECD) Test Guideline 413) in rats with a post-exposure
observation period of up to 9 months (including BALF analysis, a
determination of cardiovascular toxicity (clinically-based blood/plasma
protein analyses), and histopathology of the heart), a two-year
inhalation bioassay (OPPTS Test Guideline 870.4200), a daphnid chronic
toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage
toxicity test (OPPTS Test Guideline 850.1400), or an algal toxicity
test (OCSPP Test Guideline 850.4500), the Order's restrictions on
manufacture, processing, distribution in commerce, and disposal will
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10927.

PMN Number P-12-292

    Chemical name: Coke (coal), secondary pitch.
    Definition: A carbon-containing residue from the coking of air
blown pitch coke oil and/or pitch distillate. Composed primarily of
isotropic carbon, it contains small amounts of sulfur and ash
constituents.
    CAS number: 94113-91-4.
    Effective date of TSCA section 5(e) consent order: July 1. 2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be in the carbon
graphite industry. Based on SAR analysis of test data on analogous
respirable, poorly soluble particulates, subcategory carbon black, EPA
identified concerns for lung effects and cancer to workers exposed to
the PMN substance by the inhalation route. 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. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 50 or compliance with a NCEL of
0.0025 mg/m\3\ as an 8-hour time-weighted average, when there is a
potential for inhalation exposures.
    2. Hazard communication. Establishment and use of a hazard
communication program, including human health precautionary statements
on each label and in the Material Safety Data Sheet (MSDS).
    3. No domestic manufacture of the PMN substance.
    4. Use of the PMN substances only for the confidential uses
specified in the consent order.
    5. 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 development of
data on certain physical-chemical properties, as well as certain human
health toxicity testing would help characterize possible effects of the
substance. The submitter has agreed to provide the physical/chemical
properties data and a 90-day inhalation toxicity test (OPPTS Test
Guideline 870.3465) in rats with a post-exposure observation period of
60 days (including BALF analysis) before exceeding the

production volume limits in the consent order. Although the order does
not require a two-year inhalation bioassay (OPPTS Test Guideline
870.4200), the Order's restrictions on manufacture, processing,
distribution in commerce, and disposal will remain in effect until the
Order is modified or revoked by EPA based on submission of this or
other relevant information
    CFR citation: 40 CFR 721.10928.

PMN Numbers P-13-718, P-13-719, P-13-720, P-13-721, P-14-655, P-14-656,
P-14-657, and P-14-658

    Chemical name: Single-walled carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: July 1. 2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
use of the PMN substances will be as: a semi-conductor, conductive, or
resistive element in electronic circuitry and devices; an electro-
mechanical switch in electronic circuitry and devices; a film laminate
to improve structural, electrical or electro-chemical properties of
composite materials; a film laminate to improve conductivity in
batteries, capacitors and fuels cells; with composite materials to
improve their mechanical properties and electrical conductivities;
catalyst support for use in fuel cells; in a nanoporous network in gas
diffusion layers; for separation of chemicals; an additive to improve
corrosion resistance of metals; an additive in lubricants and greases
to improve wear resistance; an additive for transparency and
conductivity in electronic devices; an additive for fibers in
structural and electrical applications; an additive for fibers in
fabrics and as a chemical intermediate. Based on test data on analogous
respirable, poorly soluble particulates and other carbon nanotubes, EPA
identified concerns for pulmonary toxicity and oncogenicity. Based on
test data for other carbon nanotubes, EPA identified concerns for
environmental toxicity. 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 personal protective equipment involving impervious gloves
and protective clothing (where there is a potential for dermal
exposures) and a National Institute for Occupational Safety and Health
(NIOSH)-certified air purifying, tight-fitting full-face respirator
equipped with N-100, P-100, or R-100 cartridges, or power air purifying
particulate respirator with an Assigned Protection Factor (APF) of at
least 50 (where there is a potential for inhalation exposures).
    2. Submission of certain physical-chemical data for the PMN
substances within the time triggers specified in the consent order.
    3. Submission of certain human health testing prior to exceeding
the confidential production volume limit specified in the consent
order.
    4. Establishment of a medical surveillance program as specified in
the consent order.
    5. Processing and use of the PMN substances only for the uses
specified in the consent order, including no application method that
generates a vapor, mist or aerosol unless the application method occurs
in an enclosed process.
    6. No use of the PMN substances resulting in releases to surface
waters and disposal of the PMN substances only by landfill or
incineration.
    The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
    Recommended testing: EPA has determined that the development of
data on certain physical-chemical properties, as well as certain human
health and environmental toxicity testing would help characterize
possible effects of the substance. The submitter has agreed to provide
the physical/chemical properties data within the specified time limits.
In addition, the submitter has agreed not to exceed the confidential
production limit without performing a 90-day inhalation toxicity test
(OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) in rats with
a post-exposure observation period of up to 9 months (including BALF
analysis, a determination of cardiovascular toxicity (clinically-based
blood/plasma protein analyses), and histopathology of the heart).
Although the order does not require a two-year inhalation bioassay
(OPPTS Test Guideline 870.4200), a daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300), a fish early-life stage toxicity test (OPPTS
Test Guideline 850.1400), or an algal toxicity test (OCSPP Test
Guideline 850.4500), the Order's restrictions on manufacture,
processing, distribution in commerce, and disposal will remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10929.

PMN Numbers P-14-150, P-14-151, P-14-152, P-14-165, and P-14-166

    Chemical name: Fatty acid amides (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMNs states that these 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
expects toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb of PMNs P-14-150 and P-14-165, 2 ppb of PMN P-16-166, and
4 ppb of PMNs P-14-151 and P-14-152 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 their respective
concern concentration levels. 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, resulting
in releases to surface waters exceeding 1 ppb (P-15-150 and P-14-165),
2 ppb (P-16-166), or 4 ppb (P-15-151 and P-15-152) 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 (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 P-14-150, P-14-151, and P-14-152. Further, EPA has
determined 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 P-14-165 and P-14-166.
EPA also recommends that the guidance document on aquatic toxicity
testing of difficult substances and mixtures (OECD Test Guideline 23)
be followed to

facilitate solubility in the test media, because of the low water
solubility of the PMNs. EPA recommends conducting the water solubility
and log Kow measurements testing first as the results may mitigate the
need for further toxicity testing or change the testing
recommendations.
    CFR citation: 40 CFR 721.10930.

PMN Number P-14-413

    Chemical name: Kaolin, reaction products with polysiloxane
(generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: October 22,
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as an
insulator. Based on SAR analysis of test data on analogous respirable,
poorly soluble particulates, EPA identified concerns for lung effects
to workers exposed to the PMN substance by the inhalation route. 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. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 1,000 or compliance with a NCEL of
0.1 mg/m\3\ as an 8-hour time-weighted average, when there is a
potential for inhalation exposures.
    2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the MSDS.
    3. Submission of a 90-day inhalation study 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: The submitter has agreed to provide a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with a
post-exposure observation period of 60 days (including BALF analysis)
before exceeding the production volume limit in the consent order.
Although the order does not require a two-year inhalation bioassay
(OPPTS Test Guideline 870.4200), the Order's restrictions on
manufacture, processing, distribution in commerce, and disposal will
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10931.

PMN Numbers P-14-428, P-14-429, P-14-430, and P-14-431

    Chemical name: Fatty acid amides (generic).
    CAS number: Claimed confidential.
    Basis for Action: The consolidated PMN states that the substances
will be used as adhesion promoters and emulsifier intermediates 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 P-14-428 and P-14-430,
and 2 ppb of P-14-429 and P-14-431 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 their respective
concentration values. 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, resulting
in releases to surface waters exceeding 1 ppb of P-14-428 and P-14-430,
and 2 ppb of P-14-429 and P-14-431, may cause significant adverse
environmental effects. Based on this information, the PMN substances
meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 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 substances.
    CFR citation: 40 CFR 721.10932.

PMN Numbers P-14-523, P-14-524, P-14-525, P-14-526, and P-14-527

    Chemical name: Copolymers of perfluorinated and alkyl methacrylates
(generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: August 24, 2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of the substances will be as additives
for textile finishing. Based on physical-chemical properties data, as
well as test data on analogous perfluorinated chemicals and potential
perfluorinated degradation products, 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. 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 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. Use of personal protective equipment including a NIOSH-certified
respirator when there is a potential for inhalation exposures.
    2. 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.
    3. Manufacture of the PMN substances: (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.
    4. 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.
    5. Use of the PMN substances only for water and oil repellent use
on military protective clothing.
    6. No distribution of the PMN substances for consumer use.
    7. No manufacture of the PMN substances in the United States.
    8. No water releases of the PMN substances exceeding 17 ppb.
    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 an avian reproduction test (OECD Test
Guideline 206) in mallard ducks would help characterize potential human
health and environmental effects 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 citation: 40 CFR 721.10933.

PMN Number P-14-580

    Chemical name: Alkenoic acid, polymer with alkyl alkenoate,
alkylalkylalkenoate, alkenoic acid and tridecafluoro alkylalkenoate,
compds. with alkylaminoalcanol (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: October 21,
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 coating
additive. Based on physical chemical properties data, as well as test
data on analogous perfluorinated chemicals and potential perfluorinated
degradation products, 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. 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 the environment and human health, the
substance may be produced in substantial quantities and may reasonably
be anticipated to enter the environment in substantial quantities, and
there may be significant (or substantial) human exposure to the
substance and its potential degradation products. To protect against
these exposures and risks, the consent order requires:
    1. Use of a NIOSH-certified respirator when there is a potential
for inhalation exposures.
    2. Use of impervious gloves where there is a potential for dermal
exposures.
    3. 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.
    4. 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.
    5. 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.
    6. Use of the PMN substance only for the confidential uses
specified in the consent order.
    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
hydrolysis as a function of pH and temperature (OPPTS Test Guideline
835.2130); an indirect photolysis screening test (OPPTS Test Guideline
835.5270); a modified semi-continuous activated sludge (SCAS) test
(OPPTS Test Guideline 835.5045 or OECD Test Guideline 302A) with
analysis of degradation products; a simulation test-aerobic sewage
treatment (activated sludge units) OECD Test Guideline OECD 303A); a
phototransformation of chemicals in soils surfaces (Draft OECD Test
Guideline Jan. 2002); an acute inhalation toxicity test (OPPTS Test
Guideline 870.1300); and a fish short-term reproduction test (OPPTS
Test Guideline 890.1350) would help characterize potential human health
and environmental effects 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 citation: 40 CFR 721.10934.

PMN Number P-14-643

    Chemical name: Titanium oxide compound (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: July 15, 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 physical
characteristics modifier for composite articles. Based on SAR analysis
of test data on analogous respirable, poorly soluble particulates, EPA
identified concerns for lung effects to workers exposed to the PMN
substance by the inhalation route. 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. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 10 or compliance with a NCEL of 2.4
mg/m\3\ as an 8-hour time-weighted average, when there is a potential
for inhalation exposures.
    2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the MSDS.
    3. Submission of a 90-day inhalation study on the PMN substance
prior to exceeding the production volume limit 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: The submitter has agreed to provide a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats with a
post-exposure observation period of 60 days (including BALF analysis)
before exceeding the production volume limit in the consent order.
Although the order does not require a two-year inhalation bioassay
(OPPTS Test Guideline 870.4200), the Order's restrictions on
manufacture, processing, distribution in commerce, and disposal will
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10935.

PMN Numbers P-14-688, P-14-689, P-14-690, and P-14-691

    Chemical name: Fatty acid amide hydrochlorides (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMNs state that the substances will be used
as surfactants for use in asphalt emulsions. 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 for P-14-688, P-14-689, P-14-690, and 2 ppb for P-14-691 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 their respective concern concentration levels. 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, resulting in releases to surface waters
exceeding 1 ppb for P-14-688, P-14-689, P-14-690, and 2 ppb for P-14-
691, 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
characterize the environmental effects of the PMN substances. EPA
recommends that testing be conducted on P-14-688.
    CFR citation: 40 CFR 721.10936.

PMN Numbers P-14-712, P-14-713, P-14-714, and P-14-715

    Chemical names: Plastics, wastes, pyrolyzed, bulk pyrolysate
(generic) (P-14-712); Plastics, wastes, pyrolyzed, light distillate
(generic) (P-14-713); Plastics, wastes, pyrolyzed, middle distillate
(generic) (P-14-714); and Plastics, wastes, pyrolyzed, heavy distillate
(generic) (P-14-715).
    CAS numbers: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: July 27, 2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of P-14-712 is a petroleum blend stock,
of P-14-713 and P-14-714 is a fuel blend stock, and of P-14-715 is a
component of grease or wax products. Based on the presence of benzene
and naphthalene, EPA identified concerns for oncogenicity,
immunotoxicity, liver toxicity, and blood toxicity. There is also a
concern that polychlorinated dibenzo-p-dioxins and dibenzofurans could
be present in the PMN substances. 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 a NIOSH-certified respirator with an APF of at least 10
(where there is a potential for inhalation exposures) or, as an
alternative, maintaining workplace airborne concentrations of the
chemical substances identified in the consent order at a level below
the specified Exposure Limit (EL) of 0.1 ppm and 10 ppm respectively
for an 8-hour time weighted average.
    2. Use of the PMN substances only for the uses specified in the
consent order.
    3. Manufacture P-14-712 only as described in the PMN.
    4. Provide personal protective equipment to workers to prevent
dermal exposure, where there is a potential for dermal exposures.
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the MSDS.
    6. Record and report on a quarterly basis polychlorinated dibenzo-
p-dioxin and dibenzofuran levels for P-14-712.
    Recommended testing: EPA has determined that quarterly testing of
polychlorinated dibenzo-p-dioxin and dibenzofuran levels for P-14-712
will characterize potential health effects of the PMN substances.
    CFR citations: 40 CFR 721.10937 (P-14-712); 40 CFR 721.10938 (P-14-
713); 40 CFR 721.10939 (P-14-714); and 40 CFR 721.10940 (P-14-715).

PMN Number P-15-28

    Chemical name: Carbon silicon oxide.
    CAS number: 39345-87-4.
    Effective date of TSCA section 5(e) consent order: September 22,
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of P-15-28 is a colorant for industrial,
architecture, plastics, inks and automotive applications. Based on the
presence on data on structurally analogous poorly soluble particulates,
EPA identified concerns for lung overload. 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 that the substance will be produced in
substantial quantities and may reasonably be anticipated to enter the
environment in substantial quantities, and there may be significant (or
substantial) human exposure to the substance. To protect against these
risks, the consent order requires:
    1. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 10 or compliance with a NCEL of 6
mg/m\3\ as an 8-hour time-weighted average, when there is a potential
for inhalation exposures.
    2. Hazard communication. Establishment and use of a hazard
communication program, including human health precautionary statements
on each label and in the MSDS.
    3. Manufacture of the PMN substance only as described in the
Consent Order.
    4. Submission of certain toxicity testing on the PMN substance
within two years of submission of the NOC, as specified in the consent
order of the PMN substance.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity study, with a 60-day holding period (OPPTS Test
Guideline 870.3465), would help characterize human health and
environmental effects of the PMN substance. The submitter has agreed to
conduct this test within two years of submission of the Notice of
Commencement of Manufacture (NOC). EPA has also determined that the
results of a Chronic Toxicity test (OPPTS Test Guideline 870.4100) via
the inhalation route would further help characterize human health
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 substance will remain in effect until the Order
is modified or revoked by EPA based on submission of that or other
relevant information.
    CFR citation: 40 CFR 721.10941.

PMN Number P-15-54

    Chemical name: Carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: August 31, 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
chemical intermediate. Based on test data on analogous respirable,
poorly soluble particulates and carbon nanotubes, EPA identified
concerns for pulmonary toxicity and oncogenicity. Based on test data
for other nanocarbon materials EPA identified concerns for
environmental toxicity. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the consent order
requires:
    1. Use of personal protective equipment involving impervious gloves
and protective clothing (where there is

a potential for dermal exposures) and a National Institute for
Occupational Safety and Health (NIOSH)-certified air purifying, tight-
fitting full-face respirator equipped with N-100, P-100, or R-100
cartridges, or power air purifying particulate respirator with an
Assigned Protection Factor (APF) of at least 50 (where there is a
potential for inhalation exposures).
    2. Submission of certain physical chemical properties according to
the time limits described in the order.
    3. Submission of a 90-day inhalation study within one year of
notice of commencement.
    4. Use of the PMN substance only as a chemical intermediate.
    5. No use of the PMN substance resulting in releases to surface
waters and disposal of the PMN substance only by landfill or
incineration.
    The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
    Recommended testing: EPA has determined that the development of
data on certain physical-chemical properties, as well as certain human
health and environmental toxicity testing would help characterize
possible effects of the substance. The submitter has agreed to provide
the results of certain physical-chemical property testing annually for
at least three years after the commencement of manufacture. The
submitter has also agreed to provide the results of a 90-day inhalation
toxicity study already being conducted. Although the order does not
require a daphnid chronic toxicity test (OPPTS Test Guideline
850.1300), a fish early-life stage toxicity test (OPPTS Test Guideline
850.1400), or an algal toxicity test (OCSPP Test Guideline 850.4500),
the Order's restrictions on manufacture, processing, distribution in
commerce, and disposal will remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
    CFR citation: 40 CFR 721.10942.

PMN Number P-15-149

    Chemical name: Sulfonated alkylbenzene salts (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: September 15,
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be for enhanced
oil recovery. Based on test data on analogous surfactants, EPA
identified concerns for surfactant effects on the lung and irritation
to eyes and mucous membranes. Further, based on structural activity
relationship (SAR) analysis of test data on analogous anionic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb of the PMN substance in surface
waters. The Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that the substance may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the consent order requires:
    1. Hazard communication. Establishment and use of a hazard
communication program, including environmental and human health
precautionary statements on each label and in the MSDS.
    2. 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.
    3. Use of the PMN substance only for the confidential use specified
in the consent order.
    4. 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 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 submitter has agreed to complete this testing
by the confidential production volume identified in the consent order.
In addition, 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); acute inhalation
toxicity test (OPPTS Test Guideline 870.1300); acute eye irritation
test (OPPTS Test Guideline 870.2400); and acute dermal irritation test
(OPPTS Test Guideline OPPTS 870.2500) would help characterize the
potential environmental and human health effects of the PMN substance.
The Order does not require these tests at any specified time or
production volume. However, the Order's restrictions on manufacture,
processing, distribution in commerce, use, and disposal of the PMN
substance will remain in effect until the Order is modified or revoked
by EPA based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10943.

PMN Number P-15-267

    Chemical name: Substituted quinoline derivative (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substance will be as a pesticide additive.
Based on test data on the PMN substance, EPA identified concerns for
chronic toxicity including blood, kidney, and spleen toxicity. As
described in the PMN, occupational exposures are expected to be minimal
due to the 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 use of the substance without use of
impervious dermal protection where there is potential for dermal
exposures, use of a NIOSH-certified respirator with an APF of at least
10, where there is a potential for inhalation exposures, and use other
than as a pesticide additive may result in serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that the results of a 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 721.10944.

PMN Number P-15-470

    Chemical name: Algal oil amide (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 aliphatic amines, 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,
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
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 721.10945.

PMN Number P-15-485

    Chemical name: Bismuth compound (generic).
    CAS number: Claimed confidential.
    Effective date of TSCA section 5(e) consent order: December 21,
2015.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as an additive
for industrial coatings. Based on SAR analysis of test data on
analogous respirable, poorly soluble particulates, EPA identified
concerns for lung toxicity. 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. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 10 or compliance with a NCEL of 2.4
mg/m\3\ as an 8-hour time-weighted average, when there is a potential
for inhalation exposures.
    2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the MSDS.
    3. Submission of certain toxicity testing on the PMN substance
prior to exceeding the production volume limit 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 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) would help to characterize the health effects of the PMN
substance. The submitter has agreed to complete this testing by the
aggregate production volume identified in the consent order. In
addition, EPA has determined that the results of a 2-year inhalation
bioassay (OCSPP 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 substance will remain in effect
until the Order is modified or revoked by EPA based on submission of
that or other relevant information.
    CFR citation: 40 CFR 721.10946.

PMN Numbers P-15-612, P-15-613, P-15-614, P-15-615, P-15-616, P-15-617,
and P-15-618

    Chemical names: Sulfur thulium ytterbium yttrium oxide (P-15-612);
Gadolinium sulfur ytterbium yttrium oxide, erbium- and thulium-doped
(P-15-613); Neodymium sulfur yttrium oxide (P-15-614); Erbium
gadolinium neodymium sulfur ytterbium yttrium oxide (P-15-615); Erbium
gadolinium sulfur ytterbium yttrium oxide (P-15-616); Erbium gadolinium
ytterbium oxide (P-15-617); and Erbium gadolinium sulfur ytterbium
oxide (P-15-618).
    CAS numbers: 180189-40-6 (P-15-612); 1651187-84-6 (P-15-613);
1651158-45-5 (P-15-614); 1651152-96-3 (P-15-615); 1622295-07-1 (P-15-
616); 1651152-05-4 (P-15-617); and 934388-91-7 (P-15-618).
    Effective date of TSCA section 5(e) consent order: December 21,
2015.
    Basis for TSCA section 5(e) consent order: The PMNs state that the
use of the substances will be as additives for brand protection and
anti-counterfeiting inks and polymers. Based on SAR analysis of test
data on analogous respirable, poorly soluble particulates, EPA
identified concerns for lung toxicity. 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. Use of personal protective equipment including a NIOSH-certified
respirator with an APF of at least 10 or compliance with a NCEL of 0.07
mg/m\3\ as an 8-hour time-weighted average, when there is a potential
for inhalation exposures.
    2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the MSDS.
    3. Submission of certain toxicity testing on the PMN substances
prior to exceeding the production volume limit 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 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) would help to characterize the health effects of the PMN
substance. The submitter has agreed to complete this testing by the
aggregate production volume identified in the consent order. In
addition, EPA has determined that the results of a 2-year inhalation
bioassay (OCSPP Test Guideline 870.4200) would help characterize the
potential human health effects of the PMN substances. 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 citations: 40 CFR 721.10947 (P-15-612); 40 CFR 721.10948 (P-15-
613); 40 CFR 721.10949 (P-15-614); 40 CFR 721.10950 (P-15-615); 40 CFR
721.10951 (P-15-616); 40 CFR 721.10952 (P-15-617); and 40 CFR 721.10953
(P-15-618).

PMN Number P-15-655

    Chemical names: 2-Ethylhexanoic acid, compound with alkyamino
cyclohexane (generic) (P-15-0655, chemical A); and 2-Ethylhexanoic
acid, compound with cyclohexylamine (generic) (P-15-0655, chemical B).
    CAS numbers: Claimed confidential.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substances will be as an epoxy curing agent.
Based on SAR analysis of test data on analogous aliphatic amines, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 34 ppb of the PMN substances in surface waters. As described in
the PMN, releases of the substances are not expected to result in
surface water concentrations that exceed 34 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 substances that results in releases to
surface water concentrations exceeding 34 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 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 substances.
    CFR citation: 40 CFR 721.10954.

PMN Number P-15-680

    Chemical name: Propenoic acid, alkyl ester, polymer with 1,3-
cyclohexanedialkylamine, reaction products with oxirane(alkoxyalkyl)
(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 data on 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 that results in releases to 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 an
activated sludge sorption isotherm test (OPPTS Test Guideline
835.1110); 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 721.10955.

PMN Number P-15-691

    Chemical name: Acrylic acid, polymer with polyalkylene polyamine
(generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the use of the substance will
be as a chemical intermediate. Based on data on the PMN substance and
SAR analysis of test data on analogous polycationic polymers, 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 use
described in the PMN. For the use 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)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a Zahn-
Wellens/EMPA Test (OPPTS Test Guideline 835.3200); a fish early-life
stage toxicity test (OPPTS Test Guideline 850.1400); a fish acute-
toxicity test (OPPTS Test Guideline 850.1085) mitigated by humic acid
test; and a daphnid chronic toxicity test (OPPTS Test Guideline
850.1300); 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 721.10956.

PMN Number P-16-30

    Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-(2-
phenylhydrazide).
    CAS number: 1807977-72-5.
    Basis for Action: The PMN states that the substance will be used as
a curing agent in anaerobic adhesive and sealant formulations. Based on
test data on analogous hydrazines, EPA identified concerns for blood
toxicity, neurotoxicity, oncogenicity, and mutagenicity. Hydrazides are
expected to be positive in the chromosome aberration test and positive
for lung sensitization. Based on the presence of a free acid,
irritation to moist tissue (eyes, lungs, and mucous membranes) is
expected. As described in the PMN, occupational exposures are expected
to be minimal due to the 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 use of the substance without use of
impervious gloves and impervious clothing where there is a potential
for dermal exposures, may result in serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day dermal toxicity test (OPPTS Test Guideline 870.3250) and a
carcinogenicity test (OPPTS Test Guideline 870.4200) by the expected
route of exposure in two species of rodents, would help characterize
the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10957.

PMN Number P-16-52

    Chemical name: 2,5-Furandione, dihydro-, polymer with 1,1'-
iminobis[2-propanol], benzoate (ester), N-benzoyl derivs.
    CAS number: 592479-38-4.
    Basis for Action: The PMN states that the generic (non-
confidential) use of the substance will be as printing ink. Based on
SAR analysis of test data on analogous esters and amides, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 5
ppb of the PMN substance in surface waters. As described in the PMN,
releases of the substance are not expected to result in surface water
concentrations that exceed 5 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 5 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline

850.1075); an 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 721.10958.

PMN Numbers P-16-56 and P-16-57

    Chemical name: Dialkyl fattyalkylamino propanamide alkylamine
acetates (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMNs state that the generic (non-
confidential) use of the substances is in oil production. 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. As described in the PMNs,
releases of the substances 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 substances
may present an unreasonable risk. EPA has determined, however, that any
use of the substances that results in releases to surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substances
meets the concern criteria at Sec.  721.170(b)(4)(i).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a mysid
chronic toxicity test (OPPTS Test Guideline 850.1350); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10959.

PMN Number P-16-58

    Chemical name: Dialkylaminopropylaminopropanoate ester (generic).
    CAS number: Claimed confidential.
    Basis for Action: The PMN states that the substance will be used as
a chemical intermediate. Based on SAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 14 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 14
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 14 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an 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 721.10960.

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 34 of the 57
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.  [emsp14]721.160 (see Unit
VI.).
    In the other 23 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec.  [emsp14]721.170 were met, as
discussed in Unit IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
     EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     EPA will be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
     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.  [emsp14]721.160(c)(3) and Sec.  [emsp14]721.170(d)(4). In
accordance with Sec.  [emsp14]721.160(c)(3)(ii) and Sec.
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is January
17, 2017 without further notice, unless EPA receives written adverse or
critical comments, or notice of intent to submit adverse or critical
comments before December 19, 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 December 19, 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 Rule to Uses Occurring Before Effective Date of
the Final Rule

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this 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 34 of the 57 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 46 of the 57 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 November 9, 2016 (the date of public
release/web posting of this rule) as the cutoff date for determining
whether the new use is ongoing. This designation varies slightly from
EPA's past practice of designating the date of Federal Register
publication as the date for making this determination. The objective of
EPA's approach has been to ensure that a person could not defeat a SNUR
by initiating a significant new use before the effective date of the
direct final rule. In developing this rule, EPA has recognized that,
given EPA's practice of now posting rules on its Web site a week or
more in advance of Federal Register publication, this objective could
be thwarted even before that publication. Thus, EPA has slightly
modified its approach in this rulemaking and plans to follow this
modified approach in future significant new use rulemakings.
    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. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information 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 at
least 14 weeks (earlier TSCA section 5(e) consent orders required
submissions at least 12 weeks) 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.  [emsp14]721.1(c), persons submitting a SNUN must
comply with the same notification requirements and EPA regulatory
procedures as persons submitting a PMN, including submission of test
data on health and environmental effects as described in 40 CFR 720.50.
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and Sec.  721.25. E-PMN software is
available electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers 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-2016-0207.

XII. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the risk assessment documents included in the public docket. These
information sources supply information relevant to whether a particular
use would be a significant new use, based on relevant factors including
those listed under TSCA section 5(a)(2).
    The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
this significant new use rule, in Unit II and in the documents noted
above. EPA recognizes, based on the available information, that there
is variability and uncertainty in whether any particular significant
new use would actually present an unreasonable risk. For precisely this
reason, it is appropriate to secure a future notice and review process
for these uses, at such time as they are known more definitely. The
extent to which the various information, procedures, measures, methods,
protocols, methodologies or models used in EPA's decision have been
subject to independent verification or peer review is adequate to
justify their use, collectively, in the record for a significant new
use rule.

XIII. 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).

XIV. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: November 3, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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

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

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

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

* * * * *

------------------------------------------------------------------------
                                                           OMB  Control
                     40 CFR citation                            No.
------------------------------------------------------------------------

                                * * * * *
------------------------------------------------------------------------

               Significant New Uses of Chemical Substances
------------------------------------------------------------------------

                                * * * * *
721.10927...............................................       2070-0012
721.10928...............................................       2070-0012
721.10929...............................................       2070-0012
721.10930...............................................       2070-0012
721.10931...............................................       2070-0012
721.10932...............................................       2070-0012
721.10933...............................................       2070-0012
721.10934...............................................       2070-0012
721.10935...............................................       2070-0012
721.10936...............................................       2070-0012
721.10937...............................................       2070-0012
721.10938...............................................       2070-0012
721.10939...............................................       2070-0012
721.10940...............................................       2070-0012
721.10941...............................................       2070-0012
721.10942...............................................       2070-0012
721.10943...............................................       2070-0012
721.10944...............................................       2070-0012
721.10945...............................................       2070-0012
721.10946...............................................       2070-0012
721.10947...............................................       2070-0012
721.10948...............................................       2070-0012
721.10949...............................................       2070-0012
721.10950...............................................       2070-0012
721.10951...............................................       2070-0012
721.10952...............................................       2070-0012
721.10953...............................................       2070-0012
721.10954...............................................       2070-0012
721.10955...............................................       2070-0012
721.10956...............................................       2070-0012
721.10957...............................................       2070-0012
721.10958...............................................       2070-0012
721.10959...............................................       2070-0012
721.10960...............................................       2070-0012

                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  [emsp14]721.10927 to subpart E to read as follows:

Sec.  [emsp14]721.10927  Bimodal mixture consisting of multi-walled
carbon nanotubes and other classes of carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
bimodal mixture

consisting of multi-walled carbon nanotubes and other classes of carbon
nanotubes (PMN P-11-482) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)
(particulate), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. A National
Institute for Occupational Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator
with an Assigned Protection Factor (APF) of at least 50 meets the
requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) and (q). A significant new use is any
use involving an application method that generates a vapor, mist or
aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), (j), and (k) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

0
5. Add Sec.  [emsp14]721.10928 to subpart E to read as follows:

Sec.  [emsp14]721.10928  Coke (coal), secondary pitch; a carbon-
containing residue from the coking of air blown pitch coke oil and/or
pitch distillate; composed primarily of isotropic carbon, it contains
small amounts of sulfur and ash constituents.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as coke (coal),
secondary pitch. Definition: A carbon-containing residue from the
coking of air blown pitch coke oil and/or pitch distillate. Composed
primarily of isotropic carbon, it contains small amounts of sulfur and
ash constituents (PMN P-12-292; CAS No. 94113-91-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(4), (a)(6)(particulate), (b)(concentration set at 0.1
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. A National
Institute for Occupational Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator
with an Assigned Protection Factor (APF) of at least 50 meets the
requirements of Sec.  721.63(a)(4).
    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.0025
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec.  721.63 respirator requirements may
request to so under Sec.  721.30. Persons whose Sec.  721.30 requests
to use the NCELs approach are approved by EPA will be required to
follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a) through (e)(concentration set at 0.1 percent), (f),
(g)(1)(vii), (g)(2)(ii), (g)(2)(iv), (g)(1)(This substance may cause
lung effects), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k), and (q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), and (f) through (i) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
6. Add Sec.  [emsp14]721.10929 to subpart E to read as follows:

Sec.  [emsp14]721.10929  Single-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as single
walled carbon nanotubes (PMNs P-13-718, P-13-719, P-13-720, P-13-721,
P-14-655, P-14-656, P-14-657, and P-14-658) are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this rule do not apply to
the PMN substance when it is embedded or incorporated into a polymer
matrix that itself has been reacted (cured), embedded in a permanent
solid polymer form that is not intended to undergo further processing,
except mechanical processing, or incorporated into an article as
defined at 40 CFR 720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4),
(a)(6)(particulate), (b), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. A National
Institute for Occupational Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator
with an Assigned Protection Factor (APF) of at least 50 meets the
requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k)(A significant new use is use other than
as: A semi-conductor, conductive, or resistive element in electronic
circuitry and devices; an electro-mechanical switch in electronic
circuitry and devices; a film laminate to improve structural,

electrical or electro-chemical properties of composite materials; a
film laminate to improve conductivity in batteries, capacitors and
fuels cells; with composite materials to improve their mechanical
properties and electrical conductivities; catalyst support for use in
fuel cells; in a nanoporous network in gas diffusion layers; for
separation of chemicals; an additive to improve corrosion resistance of
metals; an additive in lubricants and greases to improve wear
resistance; an additive for transparency and conductivity in electronic
devices; an additive for fibers in structural and electrical
applications; an additive for fibers in fabrics and as a chemical
intermediate) and (q). A significant new use is any use involving an
application method that generates a vapor, mist or aerosol unless such
application method occurs in an enclosed process. An enclosed process
is defined as an operation that is designed and operated so that there
is no release associated with normal or routine production processes
into the environment of any substance present in the operation. An
operation with inadvertent or emergency pressure relief releases
remains an enclosed process so long as measures are taken to prevent
worker exposure to and environmental contamination from the releases.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), (j), and (k) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

0
7. Add Sec.  721.10930 to subpart E to read as follows:

Sec.  721.10930  Fatty acid amides (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid amides (PMNs P-14-150, P-14-151, P-14-152, P-14-165, and P-14-166)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use of the substances
is any use other than as chemical intermediates, additives for
flotation products, or adhesion promoters for use in asphalt
applications where the surface water concentrations described under
paragraph (a)(3)(i) of this section are exceeded.
    (ii) [Reserved]
    (3) The significant new uses for any use other than as chemical
intermediates, additives for flotation products, or adhesion promoters
for use in asphalt applications are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where (N=1 for PMNs P-15-150 and P-14-
165), (N=2 for PMN P-14-166), and (N=4 for PMNs P-14-151 and P-14-152).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and
processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.10931 to subpart E to read as follows:

Sec.  721.10931  Kaolin, reaction products with polysiloxane (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as kaolin,
reaction products with polysiloxane (PMN P-14-413) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(4), (a)(6) (particulate), (b) (concentration set at
1.0 percent), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. A NIOSH-certified
powered air purifying full facepiece respirator with an Assigned
Protection Factor (APF) of at least 1,000 equipped with an appropriate
gas/vapor (acid gas, organic vapor, or substance specific) cartridge in
combination with HEPA filters or a NIOSH-certified continuous flow
supplied air respirator equipped with a full facepiece meet the
requirements of Sec.  721.63(a)(4).
    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.1 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec.  721.63 respirator requirements may
request to do so under Sec.  721.30. Persons whose Sec.  721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), through (e) (concentration set at 1.0 percent), (f),
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), and (f), through (i) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
9. Add Sec.  721.10932 to subpart E to read as follows:

Sec.  721.10932  Fatty acid amides (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid amides (PMNs P-14-428, P-14-429, P-14-430, and P-14-431) are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as

specified in Sec.  721.80. A significant new use of the substances is
any use other than as emulsifier intermediates or adhesion promoters
for use in asphalt applications where the surface water concentrations
described under paragraph (a)(3)(i) of this section are exceeded.
    (ii) [Reserved]
    (3) The significant new uses for any use other than as emulsifier
intermediates or adhesion promoters for use in asphalt applications
are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where (N=1 for PMNs P-14-428 and P-14-
429) and (N=2 for PMNs P-14-429 and P-14-431).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and
processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.10933 to subpart E to read as follows:

Sec.  721.10933  Copolymers of perfluorinated and alkyl methacrylates
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
copolymers of perfluorinated and alkyl methacrylates (PMNs P-14-523, P-
14-524, P-14-525, P-14-526, and P-14-527) are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(4), (a)(6) (particulate, gas/vapor or a combination
gas/vapor and particulate)), and (c). When determining which persons
are reasonably likely to be exposed as required for Sec.  721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k) (analysis and reporting and
limitations of maximum impurity levels of certain impurities), (o) and
(q). It is a significant new use to use the PMN substance other than
for water and oil repellent use on military protective clothing.
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=17.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

0
11. Add Sec.  721.10934 to subpart E to read as follows:

Sec.  721.10934  Alkenoic acid, polymer with alkyl alkenoate,
alkylalkylalkenoate, alkenoic acid and tridecafluoro alkylalkenoate,
compds. with alkylaminoalcanol (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, polymer with alkyl alkenoate, alkylalkylalkenoate,
alkenoic acid and tridecafluoro alkylalkenoate, compds. with
alkylaminoalcanol (PMN P-14-580) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(4), (a)(6) (particulate, gas/vapor or a combination
gas/vapor and particulate), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec.  721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (analysis and reporting and limitations
of maximum impurity levels of certain impurities; and use other
described in the consent order) and (q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraphs (a)(2)(ii)
of this section.

0
12. Add Sec.  721.10935 to subpart E to read as follows:

Sec.  721.10935  Titanium oxide compound (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
titanium oxide compound (PMN P-14-643) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(4) (respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor of at
least 10), (a)(6) (particulate), (b) (concentration set at 1.0
percent), and (c). When determining which persons are reasonably likely
to be exposed as required for Sec.  721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 2.4 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec.  721.63 respirator requirements may
request to do so under Sec.  721.30. Persons whose Sec.  721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a), through (e) (concentration set at 1.0 percent), (f),
(g)(1)(ii), (g)(2)(ii), (g)(2)(iii), and (g)(2)(iv), and (g)(5).

    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(p) (4,300,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), and (f), through (i) are applicable to
manufacturers and processors of this.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  721.10936 to subpart E to read as follows:

Sec.  721.10936  Fatty acid amide hydrochlorides (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid amide hydrochlorides (PMNs P-14-688, P-14-689, P-14-690, and P-14-
691) are subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use of the substances
is any use other than as surfactants for use in asphalt applications
where the surface water concentrations described under paragraph
(a)(3)(i) of this section are exceeded.
    (ii) [Reserved]
    (3) The significant new uses for any use other than as surfactants
for use in asphalt applications are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1 for PMNs P-14-688, P-14-689, and
P-14-690) and (N=2 for PMN P-14-691).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.