[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Rules and Regulations]
[Pages 44079-44099]
[FR Doc No: 2017-20158]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2016-0331; FRL-9959-81]
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 37 chemical substances
which were the subject of premanufacture notices (PMNs). The applicable
review periods for the PMNs submitted for these 37 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). Six 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 37 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 November 20, 2017. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 5, 2017.
    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 October 23, 2017 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If EPA receives written adverse or critical
comments, or notice of intent to submit adverse or critical comments,
on one or more of these SNURs before October 23, 2017, 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-2016-0331, 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:
(202) 564-9232; email address: moss.kenneth @epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202)
554-1404; email address<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 October 23, 2017
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see Sec.  721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in

accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the agency taking?

    EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture or processing of a chemical substance for
any activity designated by these SNURs as a significant new use.
Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376). 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.  721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUN, EPA 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 37
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 37 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-
TSCA 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 6 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.  721.160, and are based on and consistent with the
provisions in the underlying consent orders. The TSCA section 5(e)
SNURs designate as a ``significant new use'' the absence of the
protective measures required in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) consent order usually requires, among
other things, that potentially exposed employees wear specified
respirators unless actual measurements of the workplace air show that
air-borne concentrations of the PMN substance are below a New Chemical
Exposure Limit (NCEL) that is established by EPA to provide adequate
protection to human health. In addition

to the actual NCEL concentration, the comprehensive NCELs provisions in
TSCA section 5(e) consent orders, which are modeled after Occupational
Safety and Health Administration (OSHA) Permissible Exposure Limits
(PELs) provisions, include requirements addressing performance criteria
for sampling and analytical methods, periodic monitoring, respiratory
protection, and recordkeeping. However, no comparable NCEL provisions
currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore,
for these cases, the individual SNURs in 40 CFR part 721, subpart E,
will state that persons subject to the SNUR who wish to pursue NCELs as
an alternative to the Sec.  721.63 respirator requirements may request
to do so under Sec.  721.30. EPA expects that persons whose Sec.
721.30 requests to use the NCELs approach for SNURs are approved by EPA
will be required to comply with NCELs provisions that are comparable to
those contained in the corresponding TSCA section 5(e) consent order
for the same chemical substance.
    This rule also includes SNURs on 31 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 promulgated pursuant to Sec.  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.  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-05-436

    Chemical name: Ethylene glycol ester of an aromatic substituted
propenoic acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a modifier for polyester
polymer. Based on structure activity relationship (SAR) analysis of
test data on structurally similar substances, EPA predicts toxicity to
aquatic organisms at concentrations that exceed 10 parts per billion
(ppb) of the PMN substance in surface waters. As described in the PMN,
releases to surface waters of the PMN substance are not expected to
exceed 10 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 10 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 (Office of Pollution
Prevention and Toxics (OPPTS) Test Guideline 850.1075); an acute
invertebrate toxicity test, freshwater daphnids (Office of Chemical
Safety and Pollution Prevention (OCSPP) 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 721.10961.

PMN Number P-10-504

    Chemical name: Phosphoric acid, metal salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a flame retardant for textiles. Based on SAR analysis of test data on
analogous substances, EPA identified eye and dermal irritation as well
as immunotoxicity concerns to workers from exposure to the PMN
substance via the inhalation route. Additionally, based on SAR analysis
of test data on analogous inorganic phosphates, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 5 ppb of
the PMN substance in surface waters. For the use described in the PMN,
significant releases of the substance are not expected, and worker
dermal and inhalation will be minimal. 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 substantial production volume increases, or use of the
PMN substance other than as described in the PMN, could change exposure
potential, which may cause significant adverse health and environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day oral toxicity test (OPPTS Test Guideline 870.3100); a fish acute
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075);
an acute invertebrate toxicity test, freshwater daphnids (OCSPP Test
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline
850.4500) would help characterize the human health and environmental
effects of the PMN substance. EPA also recommends that the guidance
document on aquatic toxicity testing of difficult substances and
mixtures (Organisation for Economic Co-operation and Development (OECD)
Test Guideline 23) be followed to facilitate solubility in the test
media.
    CFR citation: 40 CFR 721.10962.

PMN Number P-13-289

    Chemical name: Alkanoic acid, tetramethylheteromonocycle ester
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an additive component to
engine lubricants. Based on test data on the PMN substance, as well as
SAR analysis of test data on analogous aliphatic amines and esters, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 2 ppb of the PMN substance in surface waters. As described in
the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 2 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 2 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OCSPP Test Guideline 850.1400) and a
daphnid chronic toxicity test (OCSPP Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10963.

PMN Number P-13-908

    Chemical name: Polyether polyester urethane phosphate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an additive. Based on SAR
analysis of test data on analogous inorganic phosphates, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 5
ppb of the substance in surface waters for greater than 20 days per
year. This 20-day criterion is derived from partial life cycle tests
(daphnid chronic and fish early life stage tests) that typically range
from 21 to 28 days in duration. EPA predicts toxicity to aquatic
organisms may occur if releases of the substance to surface water
exceed releases from manufacturing, processing, and use levels
described in the PMN. For the manufacturing, processing, and use
operations 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. However, EPA has determined that, if
in the future there is domestic manufacture, the use changes from that
described in the PMN, or if the production volume increases
substantially, the potential for release to the environment may change
correspondingly and can result in significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of an
algal toxicity test (OCSPP Test Guideline 850.4500), with the PMN
substance substituted for the phosphate nutrient in the algal growth
medium, would help characterize the environmental effects of the PMN
substance.
    CFR citation: 40 CFR 721.10964.

PMN Number P-14-129

    Chemical name: Propanamide, 2-hydroxy-N,N-dimethyl-.
    CAS number: 35123-06-9.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a solvent in pesticide
formulations and solvent for fertilizers. Based on test data on the PMN
substance, EPA identified concerns for solvent neurotoxicity, blood and
liver toxicity, kidney effects, and developmental toxicity. For the
uses described in the PMN, EPA does not expect significant dermal or
inhalation occupational exposures, nor does it expect consumer
exposures. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however that any use of the
substance other than as described in the PMN, any use of the PMN
substance without the use of dermal protection, where there is a
potential for dermal exposures; or any use of the PMN substance in
consumer products may cause serious human 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
dermal penetration test (OPPTS Test Guideline 870.7600) would help
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10965.

PMN Number P-14-260

    Chemical name: 1-Propene, 2-bromo-3,3,3-trifluoro-.
    CAS number: 1514-82-5.
    Effective date of TSCA section 5(e) consent order: March 7, 2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the
PMN substance will be used as a fire extinguishing agent for: Portable
extinguishers (onboard aviation and all nonresidential); niche systems
(aircraft, normally unoccupied systems, self-contained automatic fire
extinguishing systems); and streaming systems for aircraft rescue fire
fighting vehicles. Based on test data on the PMN substance, EPA
predicts reproductive effects to unprotected workers from repeated
inhalation exposures. 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 1.0
parts per million (ppm) 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 Safety Data Sheet (SDS).
    3. No domestic manufacture of the PMN substance.
    4. Processing (including filling of hand-held fire extinguishers or
fire extinguishing systems) of the PMN substance in an enclosed
process.
    5. Use only as either (1) total flooding agent in unoccupied
spaces, specifically engine nacelles and auxiliary power units (APUs)
in aircraft; or (2) streaming fire extinguishing agent for use only in
handheld extinguishers in aircraft.
    The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
    Recommended testing: EPA has determined that inhalation monitoring
data, collected according to the EPA draft Inhalation Monitoring Data
Collection Guidelines (located in the docket under docket ID number
EPA-HQ-OPPT-2016-0331 would help characterize the human health effects
of the PMN substance. 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 721.10966.

PMN Number P-14-759

    Chemical name: Pyrolysis oil product (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: May 4, 2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance is as an on-site
coolant and petroleum feed-stock. Based on SAR analysis of test data on
analogous benzene and alkyl benzenes, EPA identified concerns for
oncogenicity, neurological effect, and blood toxicity to unprotected
workers from repeated inhalation exposures. Further, based on SAR
analysis of test data on analogous neutral organic chemicals, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 20 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. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposures) and a NIOSH-certified
respirator with an APF of at least 10 (where there is a potential for
dermal or inhalation exposures) or compliance with a NCEL of 0.5 ppm as
an 8-hour time-weighted average.
    2. Manufacture, processing, or use of the PMN substance only for
the use specified in the consent order.
    3. No use of the PMN substance resulting in releases to surface
waters concentrations that exceed 20 ppb.

    The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
    Recommended testing: EPA has determined that the results of a
developmental neurotoxicity test (OPPTS Test Guideline 870.6300) with a
complete blood count and differential for white blood cells; inhalation
monitoring data, collected according to the EPA draft Inhalation
Monitoring Data Collection Guidelines (located in the docket under
docket ID number EPA-HQ-OPPT-2016-0331; a fish acute toxicity test,
freshwater and marine (OPPTS Test Guideline 850.1075); an acute
invertebrate toxicity test, freshwater daphnids (OCSPP Test Guideline
850.1010) and an algal toxicity test (OCSPP Test Guideline 850.4500)
would help characterize the human health and environmental effects of
the PMN substance. 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 721.10967.

PMN Number P-15-279

    Chemical name: 1-Octanamine, 7 (or 8)-(aminomethyl)-.
    CAS number: 1613320-81-2.
    Basis for action: The PMN states that the substance is used as a
raw material for highly heat resistant plastic. Based on test 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 123 parts per billion of the PMN
substance in surface waters. As described in the PMN, releases of the
substance during the use described in the PMN are not expected to
result in surface water concentrations that exceed 123 ppb. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance for the use described in the PMN may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 123 ppb
may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OCSPP Test Guideline 850.1400) and a
daphnid chronic toxicity test (OCSPP Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10968.

PMN Number P-15-409

    Chemical name: Substituted alkanolamine ether (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: March 3, 2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as a hydrogen sulfide scavenger. The Order was
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(II) based
on a finding that 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. Based on this finding,
the consent order requires:
    1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into an SDS, within 90 days.
    2. Submission of certain toxicity, physical-chemical property, and
environmental fate testing on the PMN substance prior to exceeding the
confidential production volume limits as specified in the consent
order.
    The SNUR would designate as a ``significant new use'' the absence
of these measures.
    Recommended testing: EPA has determined that the results of certain
toxicity and environmental fate testing would help characterize the PMN
substance. The submitter has agreed to complete the testing identified
in the testing section of the consent order by the confidential limits
specified.
    CFR citation: 40 CFR 721.10969.

PMN Number P-15-583

    Chemical name: Butanedioic acid, alkyl amine, dimethylbutyl ester
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: February 8,
2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as an additive to engine motor oil. Based on
physical-chemical properties data, EPA predicts that the PMN substance
will persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. Further, based
on test data on the PMN, as well as SAR analysis of analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substance in surface
waters. The Order was issued under TSCA sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that 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. To protect against these
exposures and risks, the consent order requires:
    1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into an SDS, within 90 days.
    2. 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.
    3. No releases of the PMN substance into the waters of the United
States.
    The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
    Recommended testing: EPA has determined that the results of certain
toxicity and environmental fate testing would help characterize the PMN
substance. The submitter has agreed to complete the testing identified
in the testing section of the consent order by the confidential limits
specified. In addition, EPA has determined that the results of a fish
early-life stage toxicity test (OCSPP Test Guideline 850.1400) and a
daphnid chronic toxicity test (OCSPP Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance. 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 721.10970.

PMN Number P-15-672

    Chemical name: Carbon nanotube (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: January 15,
2016.

    Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the PMN substance will be in
filtration media. 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
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 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
exposure) and a NIOSH-certified respirator with N-100, P-100, or R-100
cartridges (where there is a potential for inhalation exposure).
    2. Processing and use of the PMN substance only for the use
specified in the consent order.
    3. Processing and use of the PMN substance only as an aqueous
slurry, wet form, or a contained dry form as described in the PMN.
    4. 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 a two-year inhalation
bioassay (OPPTS 870.4200); a fish early-life stage toxicity test (OCSPP
Test Guideline 850.1400); a daphnid chronic toxicity test (OCSPP Test
Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline
850.4500) would help characterize possible health and environmental
effects of the substance. Although the Order does not require these
tests, 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 721.10971.

PMN Number P-15-678

    Chemical name: Metal salt of mineral acid, reaction products with
alumina, aluminum hydroxide, aluminum hydroxide oxide (Al(OH)O),
silica, titanium oxide (TiO2) and 3-(triethoxysilyl)-1-propanamine
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an industrial paper additive.
Based on SAR analysis of test data on analogous respirable, poorly
soluble particulates, EPA identified concerns for lung toxicity if
inhaled based on lung overload. As described in the PMN, inhalation is
expected to be minimal for this use. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance other than as identified in the PMN may result in
serious health effects. Based on this information, the PMN meets the
concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10972.

PMN Numbers P-15-766 and P-15-767

    Chemical names: Halogenated bisphenol A, polymer with
epichlorohydrin, alkenoate (generic) (P-15-766) and Halogenated
bisphenol A, polymer with bisphenol A diglycidyl ether and epoxidized
phenol-formaldehyde resin, alkenoate (generic) (P-15-767).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as resins for flame
retardant polyester. Based on test data on the confidential impurity of
the PMN substance, EPA identified concerns for chronic toxicity effects
to workers and the general population exposed to the PMN substances.
Further, based on the confidential impurity, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 20 ppb of the
impurity in surface waters. As described in the PMNs, EPA does not
expect significant occupational exposures, general population
exposures, nor releases of the substance to result in surface water
concentrations that exceed 20 ppb of the impurity in surface waters.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substances may present an unreasonable risk.
EPA has determined, however, that any consumer use, any use other than
as described in the PMNs, or any increase in production volume over
10,000 kg/yr may result in serious human health and significant adverse
environmental effects. Based on this information, the PMN substances
meet the concern criteria at Sec.  721.170(b)(5)(ii).
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity test (OECD Test Guideline 422) with the
reproduction/developmental toxicity screening test; a fish early-life
stage toxicity test (OCSPP Test Guideline 850.1400); a daphnid chronic
toxicity test (OCSPP Test Guideline 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the human
health and environmental effects of the PMN substances.
    CFR citations: 40 CFR 721.10973 (P-15-766) and 40 CFR 721.10974 (P-
15-767).

PMN Number P-16-14

    Chemical name: Silicon, tris[dialkyl phenyl]-dialkyl-dioxoalkane-
naphthalene disulfonate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an ink additive. Based on test
data on the PMN substance, as well as SAR analysis of test data on
analogous diketones, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 6 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the substance
during the use described in the PMN are not expected to result in
surface water concentrations that exceed 6 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance for the use described in the PMN may present an unreasonable
risk. EPA has determined, however, that any use of the substance
resulting in surface water concentrations exceeding 6 ppb may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.  721.170(b)(4)(i)
and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready
biodegradability test (OECD Test Guideline 301); a fish early-life
state toxicity test (OCSPP Test Guideline 850.1400); and a daphnid
chronic toxicity test (OCSPP Test Guideline 850.1300) would help
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10975.

PMN Number P-16-40

    Chemical name: Tar acids fraction (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a polymer. Based on test data
on the PMN substance, as well as SAR analysis of test data on analogous
phenols, EPA predicts toxicity to

aquatic organisms may occur at concentrations that exceed 45 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance during the use described in the PMN are not expected to
result in surface water concentrations that exceed 45 ppb. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance for the use described in the PMN may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 45 ppb
may cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life state toxicity test (OCSPP Test Guideline 850.1400); a
daphnid chronic toxicity test (OCSPP Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10976.

PMN Numbers P-16-59 and P-16-60

    Chemical names: Dialkyl fattyalkylamino propanamide alkylamine
(generic) (P-16-59) and Fattyalkylaminopropanoate ester (generic) (P-
16-60).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the substances will be used
as chemical intermediates. Based on data on the PMN substances, 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 substances in surface waters. As described in
the PMNs, 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 substances resulting in 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 (OCSPP Test Guideline 850.1400); a
daphnid chronic toxicity test (OCSPP 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 citations: 40 CFR 721.10977 (P-16-59) and 40 CFR 721.10978 (P-
16-60).

PMN Number P-16-70

    Chemical Name: Boron sodium oxide (B5NaO8), labeled with boron-10.
    CAS Number: 200443-98-7.
    Basis for Action: The PMN states that this substance is to be used
as an emergency shutdown coolant in boiling water reactors. Based on
test data for boron compounds, the EPA identified potential human
health concerns regarding reproductive effects, developmental toxicity,
neurotoxicity, and blood effects from exposure to the PMN substance via
inhalation exposure. Further, based on SAR analysis of test data on
boron compounds, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 1,240 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, inhalation and dermal exposures are expected to
be minimal and environmental releases did not exceed 1,240 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 serious human
health and significant adverse environmental effects. Based on this
information, the PMN substance meet the concern criteria at Sec.
721.170(b)(3)(ii) and (b)(4)(ii).
    Recommended Testing: EPA has determined that the results of a
reproductive/developmental toxicity screening test (OPPTS 870.3550/OECD
Test Guideline 421); 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 algal toxicity
test (OCSPP Test Guideline 850.4500) would help characterize the human
health and environmental effects of the PMN substance.
    CFR Citation: 40 CFR 721.10979.

PMN Number P-16-94

    Chemical name: Perfluoropolyether modified organosilane (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as
a stain-proof coating agent for touch panel. Based on physical-chemical
properties data on the PMN substance, as well as SAR analysis of 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. EPA predicts
adverse effects to human health and the environment may occur if
releases of the PMN substance to surface water at production volumes
higher than described in the PMN exceed the releases expected from the
production volume described in the PMN. For the described production
volume in the PMN, significant environmental releases are not expected.
    Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any substantial combined production
volume increase could result in exposures which may cause serious human
health and significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(1)(i)(D), (b)(3)(iii), and (b)(4)(iv).
    Recommended testing: EPA has determined that the results of an
indirect photolysis screening test: Sunlight photolysis in waters
containing dissolved humic substances (OPPTS Test Guideline 835.5270),
and simulation tests to assess the primary and ultimate
biodegradability of chemicals discharged to wastewater (OPPTS Test
Guideline 835.3280/OECD Test Guideline 314) would help characterize the
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10980.

PMN Number P-16-95

    Chemical name: Modified phenol-formaldehyde resin (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a flame retardant

additive. Based on SAR analysis of test data on analogous neutral
organics, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 96 ppb of the PMN substance in surface
waters. Further, based on the alcohol groups, EPA has concern for
irritation to eyes, lungs, and mucous membranes. As described in the
PMN, releases of the substance are not expected to result in surface
water concentrations that exceed 96 ppb and exposures to workers and
general population are minimal due to the use as a flame retardant
additive. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the
substance other than as stated in the PMN or any use of the substance
resulting in surface water concentrations exceeding 96 ppb may result
in serious human health and significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170(b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of an
acute toxicity test (OPPTS Test Guideline 870.1000); a repeated dose
28-day oral toxicity study (OPPTS Test Guideline 870.3050) in rodents;
a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline
870.5395); a fish early-life stage toxicity test (OCSPP Test Guideline
850.1400); a daphnid chronic toxicity test (OCSPP Test Guideline
850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500)
would help characterize the human health and environmental effects of
the PMN substance.
    CFR citation: 40 CFR 721.10981.

PMN Number P-16-101

    Chemical name: Disubstituted benzene alkanal (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a component for household
products, including cleaning, fabric and air care. Based on SAR
analysis of test data on analogous structurally similar substances, EPA
identified concerns for developmental toxicity from dermal exposures of
the PMN substance to workers and consumers. For the use described in
the PMN, dermal exposures are not expected based on the use of
impervious gloves, and consumer dermal exposures are expected to be
minimal. 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 PMN
substance without the use of dermal protection, where there is a
potential for dermal exposures, or any use of the PMN substance other
than for the use specified in the PMN may result in serious human
health effects. Based on this information, the PMN substance meet the
concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that results of a 90-day
oral toxicity test (OPPTS Test Guideline 870.3100) in rats via the
gavage route, and a developmental toxicity test OPPTS Test Guideline
870.3650) in rats via the gavage route would help characterize the
effects of the PMN substance.
    CFR citation: 40 CFR 721.10982.

PMN Number P-16-102

    Chemical name: Phthalic anhydride, polymer with alkylene glycol and
alkanepolyol, acrylate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a coating component. Based on
SAR analysis of test data on analogous acrylates, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As described in the PMN, releases
of the substance during the use described in the PMN 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 for the use described in the PMN may present an
unreasonable risk. EPA has determined, however, that any use of the
substance resulting in surface water concentrations exceeding 1 ppb may
cause significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a water
solubility test (OPPTS Test Guideline 830.7840, a fish acute toxicity
test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute
invertebrate toxicity test, freshwater daphnids (OCSPP Test Guideline
850.1010); and algal toxicity test (OCSPP Test Guideline 850.4500);
would help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10983.

PMN Number P-16-104

    Chemical name: 2-Pyridinecarboxylic acid, 4,5-dichloro-6-(4-chloro-
2-fluoro-3-methoxyphenyl)-.
    CAS number: 1546765-39-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a feed stock for an
intermediate. Based on SAR analysis of test data on analogous
halopyridines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 8 ppb of the PMN substance in surface
waters. Further, based on the acid moiety, EPA has concern for
irritation to eyes, lungs, and mucous membranes. As described in the
PMN, releases of the substance are not expected to result in surface
water concentrations that exceed 8 ppb and exposures to workers and
general population are minimal due to the use as an intermediate.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance other than as an
intermediate or any use of the substance resulting in surface water
concentrations exceeding 8 ppb may result in serious human health and
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.  721.170(b)(3)(ii)
and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of an
acute toxicity test (OPPTS Test Guideline 870.1000); a repeated dose
28-day oral toxicity study (OPPTS Test Guideline 870.3050) in rodents;
a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a
mammalian erythrocyte micronucleus test (OPPTS Test Guideline
870.5395); a fish acute toxicity test, freshwater and marine (OPPTS
Test Guideline 850.1075); an acute invertebrate toxicity test,
freshwater daphnids (OCSPP Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10984.

PMN Numbers P-16-136, P-16-139, and P-16-140

    Chemical names: Dialkylamino alkylamide inner salt (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of these 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 these 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 resulting in 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)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OCSPP Test Guideline 850.1400); a mysid
chronic toxicity test (OCSPP Test Guideline 850.1350); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the environmental effects of the PMN substances. Testing should be
conducted on PMN substance P-16-139.
    CFR citation: 40 CFR 721.10985.

PMN Number P-16-170

    Chemical name: Nanocarbon (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: June 21, 2016.
    Basis for TSCA section 5(e) consent order: The PMN states that the
substance will be used as an additive to composite materials. 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
exposure) and a NIOSH-certified respirator with N-100, P-100, or R-100
cartridges (where there is a potential for inhalation exposure).
    2. Submission of a dustiness test within six months of notice of
commencement.
    3. Submission of a 90-day chronic inhalation study prior to
exceeding the confidential production volume limit 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 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 (OCSPP 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 721.10986.

PMN Number P-16-177

    Chemical name: Barium molybdenum niobium tantalum tellurium
vanadium zinc oxide.
    CAS number: 1440529-21-4.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a glass coating. Based on SAR
analysis of test data on the analogous respirable, poorly soluble
particulates, EPA identified concerns for lung effects to workers
exposed to the PMN substance. As described in the PMN, worker exposure
will be minimal due to the use of adequate respiratory protection.
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 a
National Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an assigned protection factor (APF) of at least 10,
where there is potential respiratory exposure, any use other than in
the PMN, or domestic manufacture may result in serious human health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day subchronic toxicity test (OPPTS Test Guideline 870.3465) via the
inhalation route with a 60-day holding period would help characterize
the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10987.

PMN Number P-16-179

    Chemical name: Alkanoic acids, esters with alkanetriol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a grease. Based on SAR
analysis of test data on analogous esters, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance are not expected to result in surface water
concentrations that exceed 1 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 1 ppb may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OCSPP Test Guideline 850.1400); a
daphnid chronic toxicity test (OCSPP Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10988.

PMN Number P-16-182

    Chemical names: Manganese, tris[.mu.-(2-
ethylhexanoato-.kappa.O:.kappa.O')]bis(octahydro-1,4,7-trimethyl-1H-
1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (P-16-182, chemical
A); Manganese, [.mu.-(acetato-.kappa.O:.kappa.O')]bis[.mu.-(2-
ethylhexanoato-

.kappa.O:.kappa.O')]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-
triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (P-16-182, chemical B);
Manganese, bis[.mu.-(acetato-.kappa.O:.kappa.O')][.mu.-(2-
ethylhexanoato-.kappa.O:.kappa.O')]bis(octahydro-1,4,7-trimethyl-1H-
1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (P-16-182, chemical
C); and Manganese, tris[.mu.-
(acetato-.kappa.O:.kappa.O')]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-
triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (P-16-182, chemical D).
    CAS numbers: 2020407-62-7 (P-16-182, chemical A); 2020407-63-8 (P-
16-182, chemical B); 2020407-64-9 (P-16-182, chemical C); and 2020407-
65-0 (P-16-182, chemical D).
    Basis for action: The PMN states that the generic (non-
confidential) use of the substances will be as resins. Based on SAR
analysis of test data on analogous compounds, EPA identified concerns
for systemic effects to the thyroid and pituitary gland, liver
toxicity, developmental and reproductive toxicity, and mutagenicity.
There are also concerns for immunotoxicity, reproductive and
developmental toxicity, neurotoxicity, blood effects, and kidney
toxicity, and uncertain concerns for asthma and oncogenicity, based on
manganese, and concerns for developmental toxicity for branched acid
hydrolysis products, by analogy to valproic acid and other acids that
are branched on the carbon adjacent to the acid group, all based on
exposure to the PMN substances via inhalation or dermal exposure. As
described in the PMN, exposure is expected to be minimal due to
negligible inhalation exposures and use of adequate dermal personal
protection equipment. 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
domestic manufacture; any manufacture of the PMN substances at a
concentration greater than 10% in any formulation; or any use of the
PMN substances without the use of chemical impervious gloves, where
there is a potential for dermal exposures may result in serious human
health effects. Based on this information, the PMN substances meet the
concern criteria at 40 CFR 721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a
combined repeated dose toxicity reproduction/development toxicity
screening test (OECD Test Guideline 422) would help characterize the
human health effects of the PMN substances.
    CFR citations: 40 CFR 721.10989 (P-16-182, chemical A), 40 CFR
721.10990 (P-16-182, chemical B), 40 CFR 721.10991 (P-16-182, chemical
C), and 40 CFR 721.10992 (P-16-182, chemical D).

PMN Number P-16-190

    Chemical name: Aryl polyolefin (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a lubricant. Based on
analogy to C10-13 alkyl derivatives of benzene, EPA identified concerns
for reproductive and developmental toxicity to workers exposed to the
PMN substance based on exposure to the PMN substance via dermal
exposure. As described in the PMN, exposure is expected to be minimal
due to use of adequate dermal personal protection equipment. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance may present an unreasonable risk. EPA has
determined, however, that use of the substance other than as described
in the PMN, or any use without the use of dermal protection where there
is a potential for dermal exposures may cause serious human health
effects. Based on this information, the PMN substance meets the concern
criteria at 40 CFR 721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a two-
generation reproduction toxicity test (OECD Test Guideline 416) would
help characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10993.

PMN Number P-16-260

    Chemical name: Melamine nitrate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a gas generant for automobile
air bag inflators. Based on test data on the PMN substance, as well as
SAR analysis of test data on analogous melamines, 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 during the use described in the PMN 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 for the use described in the PMN
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)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OCSPP Test Guideline 850.1400) and a
daphnid chronic toxicity test (OCSPP Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10994.

PMN Number P-16-272

    Chemical name: Lecithins, soya, hydrogenated.
    CAS number: 308068-11-3.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is an ingredient in a formulated
product. Based on SAR analysis of test data on analogous amphoteric
surfactants, 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 during the
use described in the PMN 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
for the use described in the PMN may present an unreasonable risk. EPA
has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 1 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OCSPP Test Guideline 850.1010); an algal toxicity test (OCSPP
Test Guideline 850.4500); a fish early-life stage toxicity test (OCSPP
Test Guideline 850.1400); and a daphnid chronic toxicity test (OCSPP
Test Guideline 850.1300) would help characterize the environmental
effects of the PMN substance.
    CFR citation: 40 CFR 721.10995.

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 6 of the 37
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.  14;721.160 (see Unit
VI.).
    In the other 31 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.  14;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.  14;721.160(c)(3) and Sec.  14;721.170(d)(4). In accordance with
Sec.  14;721.160(c)(3)(ii) and Sec.  14;721.170(d)(4)(i)(B), the
effective date of this rule is November 20, 2017 without further
notice, unless EPA receives written adverse or critical comments, or
notice of intent to submit adverse or critical comments before October
23, 2017.
    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 October 23, 2017, EPA will withdraw the relevant sections
of this direct final rule before its effective date. EPA will then
issue a proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
    This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received a
notice of commencement (NOC) and the chemical substance has not been
added to the TSCA Inventory, no person may commence such activities
without first submitting a PMN. Therefore, for chemical substances for
which an NOC has not been submitted EPA concludes that the designated
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) consent orders have
been issued for 6 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 26 of the 37 chemical substances subject to this rule
have been claimed as confidential and EPA has received no post-PMN bona
fide submissions (per Sec. Sec.  720.25 and 721.11). Based on this, the
Agency believes that it is highly unlikely that any of the significant
new uses described in the regulatory text of this rule are ongoing.
    Therefore, EPA designates June 1, 2017 which is the date of public
release by posting on EPA's Web site, 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-TSCA
section 5(e) SNURs. Descriptions of tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development (OECD) test guidelines are available from
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at
http://www.sourceoecd.org.
    In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study 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 Sec.
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.
14;721.1725(b)(1) with that under Sec.  14;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.  14;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-2016-0331.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

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

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection

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

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

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

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

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

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

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

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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: April 5, 2017.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,

1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.

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

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                           OMB  control
                     40 CFR citation                            No.
------------------------------------------------------------------------

------------------------------------------------------------------------
                               * * * * *
Significant New Uses of Chemical Substances.............................

                                * * * * *
721.10961...............................................       2070-0012
721.10962...............................................       2070-0012
721.10963...............................................       2070-0012
721.10964...............................................       2070-0012
721.10965...............................................       2070-0012
721.10966...............................................       2070-0012
721.10967...............................................       2070-0012
721.10968...............................................       2070-0012
721.10969...............................................       2070-0012
721.10970...............................................       2070-0012
721.10971...............................................       2070-0012
721.10972...............................................       2070-0012
721.10973...............................................       2070-0012
721.10974...............................................       2070-0012
721.10975...............................................       2070-0012
721.10976...............................................       2070-0012
721.10977...............................................       2070-0012
721.10978...............................................       2070-0012
721.10979...............................................       2070-0012
721.10980...............................................       2070-0012
721.10981...............................................       2070-0012
721.10982...............................................       2070-0012
721.10983...............................................       2070-0012
721.10984...............................................       2070-0012
721.10985...............................................       2070-0012
721.10986...............................................       2070-0012
721.10987...............................................       2070-0012
721.10988...............................................       2070-0012
721.10989...............................................       2070-0012
721.10990...............................................       2070-0012
721.10991...............................................       2070-0012
721.10992...............................................       2070-0012
721.10993...............................................       2070-0012
721.10994...............................................       2070-0012
721.10995...............................................       2070-0012

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

* * * * *

PART 721--[AMENDED]

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

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

0
 4. Add Sec.  721.10961 to subpart E to read as follows:

Sec.  721.10961  Ethylene glycol ester of an aromatic substituted
propenoic acid (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethylene glycol ester of an aromatic substituted propenoic acid (PMN P-
05-436) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=10).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
 5. Add Sec.  721.10962 to subpart E to read as follows:

Sec.  721.10962  Phosphoric acid, metal salt (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphoric acid, metal salt (PMN P-10-504) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j) and (s) (100,000 kilograms).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

0
 6. Add Sec.  721.10963 to subpart E to read as follows:

Sec.  721.10963  Alkanoic acid, tetramethylheteromonocycle ester
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, tetramethylheteromonocycle ester (PMN P-13-289) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  721.10964 to subpart E to read as follows:

Sec.  721.10964  Polyether polyester urethane phosphate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyether polyester urethane phosphate (PMN P-13-908) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (j) and (s) (1,000 kilograms).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

0
 8. Add Sec.  14;721.10965 to subpart E to read as follows:

Sec.  721.10965  Propanamide, 2-hydroxy-N,N-dimethyl-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanamide, 2-
hydroxy-N,N-dimethyl- (PMN P-14-129, CAS No. 35123-06-9) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), and (b) (concentration set at 1.0
percent).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j) and (o).
    (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
9. Add Sec.  14;721.10966 to subpart E to read as follows:

Sec.  721.10966  1-Propene, 2-bromo-3,3,3-trifluoro-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propene, 2-bromo-
3,3,3-trifluoro- (PMN P-14-260, CAS No. 1514-82-5) is 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 quantities of the PMN substance after they have been charged
into a fire extinguisher or fire extinguishing system.
    (2) The significant new uses are:
    (i) Protection in the workplace. (A) Requirements as specified in
Sec.  721.63(a)(1), (a)(3), (a)(4), (a)(6)(v), (a)(6)(vi), (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. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirator with an Applied
Protection Factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
    (1) NIOSH-certified air-purifying half mask respirator equipped
with a gas/vapor (organic vapor) cartridge.
    (2) NIOSH-certified powered air-purifying respirator with a hood or
helmet and with a gas/vapor (organic vapor) cartridge.
    (3) NIOSH-certified negative pressure (demand) supplied-air
respirator with a half-mask.
    (4) NIOSH-certified continuous flow supplied-air respirator with a
loose fitting facepiece, hood, or helmet.
    (5) NIOSH-certified negative pressure (demand) self-contained
breathing apparatus (SCBA) with a half-mask.
    (B) 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 1.0
parts per million (ppm) 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.
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a) through (e) (concentration set at 1.0 percent), (f),
(g)(1) (cardiac sensitization and reproductive effects), (g)(2)(i),
(g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(c), (f), and (k) (A significant new use is
any use other than as either a total flooding agent in unoccupied
spaces, specifically engine nacelles and auxiliary power units (APUs)
in aircraft; or as a streaming fire extinguishing agent for use only in
handheld extinguishers in aircraft).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  14;721.10967 to subpart E to read as follows:

Sec.  721.10967  Pyrolysis oil product (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
pyrolysis oil product (PMN P-14-759) 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. (A) Requirements as specified in
Sec.  721.63(a)(1), (a)(3), (a)(4), (a)(6) (particulate and gas/vapor),
(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. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirator with an Applied
Protection Factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
    (1) NIOSH-certified air-purifying half mask respirator equipped
with an organic vapor cartridge.
    (2) NIOSH-certified powered air-purifying respirator with a hood or
helmet and with an organic vapor cartridge.
    (3) NIOSH-certified negative pressure (demand) supplied-air
respirator with a half-mask.
    (4) NIOSH-certified continuous flow supplied-air respirator with a
loose fitting facepiece, hood, or helmet.
    (5) NIOSH-certified negative pressure (demand) self-contained
breathing apparatus (SCBA) with a half-mask.
    (B) 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 0.5
parts per million (ppm) 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.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k).
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=20).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

0
 11. Add Sec.  14;721.10968 to subpart E to read as follows:

Sec.  721.10968  1-Octanamine, 7 (or 8)-(aminomethyl)-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-octanamine, 7 (or
8)-(aminomethyl)- (PMN P-15-279, CAS No. 1613320-81-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=123).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
12. Add Sec.  721.10969 to subpart E to read as follows:

Sec.  721.10969  Substituted alkanolamine ether (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkanolamine ether (PMN P-15-409) 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) Hazard communication program. A significant new use of the
substance is any manner or method of manufacture or processing
associated with any use of the substance without providing risk
notification as follows:
    (A) If as a result of the test data required under TSCA section
5(e) consent order for the substance, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into an
SDS as described in Sec.  721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to an SDS before the substance is
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an SDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
    (ii) 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 (c), (h) 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
13. Add Sec.  721.10970 to subpart E to read as follows:

Sec.  721.10970  Butanedioic acid, alkyl amine, dimethylbutyl ester
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
butanedioic acid, alkyl amine, dimethylbutyl ester (PMN P-15-583) is
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 quantities of the PMN substance after they have
been added to engine oil.
    (i) Hazard communication program. A significant new use of the
substance is any manner or method of manufacture or processing
associated with any use of the substance without providing risk
notification as follows:
    (A) If as a result of the test data required under TSCA section
5(e) consent order for the substance, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into an
SDS as described in Sec.  721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to an SDS before the substance is
reintroduced into the workplace.
    (B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an SDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q).
    (iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
    (2) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (h), (i) and (k) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

0
 14. Add Sec.  721.10971 to subpart E to read as follows:

Sec.  721.10971  Carbon nanotube (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
nanotube (PMN P-15-672) 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
respirators with an N-100, P-100, or R-100 cartridge meet the
requirements of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to process or
use the chemical substance other than as an aqueous slurry, wet form,
or a contained dry form as described in the PMN.
    (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) and (i) through (k) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
 15. Add Sec.  721.10972 to subpart E to read as follows:

Sec.  721.10972  Metal salt of mineral acid, reaction products with
alumina, aluminum hydroxide, aluminum hydroxide oxide (Al(OH)O),
silica, titanium oxide (TiO2) and 3-(triethoxysilyl)-1-propanamine
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal
salt of mineral acid, reaction products with alumina, aluminum
hydroxide, aluminum hydroxide oxide (Al(OH)O), silica, titanium oxide
(TiO2) and 3-(triethoxysilyl)-1-propanamine (PMN P-15-678) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

0
16. Add Sec.  721.10973 to subpart E to read as follows:

Sec.  721.10973  Halogenated bisphenol A, polymer with epichlorohydrin,
alkenoate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated bisphenol A, polymer with epichlorohydrin, alkenoate (PMN
P-15-766) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j), (o) and (s) (10,000 kilograms).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

0
17. Add Sec.  721.10974 to subpart E to read as follows:

Sec.  721.10974  Halogenated bisphenol A, polymer with bisphenol A
diglycidyl ether and epoxidized phenol-formaldehyde resin, alkenoate
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
halogenated bisphenol A, polymer with bisphenol A diglycidyl ether and
epoxidized phenol-formaldehyde resin, alkenoate (PMN P-15-767) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j), (o) and (s) (10,000 kilograms).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.

0
18. Add Sec.  721.10975 to subpart E to read as follows:

Sec.  721.10975  Silicon, tris[dialkyl phenyl]-dialkyl-dioxoalkane-
naphthalene disulfonate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
silicon, tris[dialkyl phenyl]-dialkyl-dioxoalkane-naphthalene
disulfonate (PMN P-16-14) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j). The significant new use is use other
than as described in PMN-16-14 where the surface water concentrations
described in paragraph (a)(3)(i) are exceeded.
    (ii) [Reserved]
    (3) The significant new uses for any use other than as described in
PMN-16-14:

    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=6).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.

0
19. Add Sec.  721.10976 to subpart E to read as follows:

Sec.  721.10976  Tar acids fraction (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as tar
acids fraction (PMN P-16-40) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=45).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  721.10977 to subpart E to read as follows:

Sec.  721.10977  Dialkyl fattyalkylamino propanamide alkylamine
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as dialkyl
fattyalkylamino propanamide alkylamine (PMN P-16-59) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
21. Add Sec.  721.10978 to subpart E to read as follows:

Sec.  721.10978  Fattyalkylaminopropanoate ester (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fattyalkylaminopropanoate ester (PMN P-16-60) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
22. Add Sec.  721.10979 to subpart E to read as follows:

Sec.  721.10979  Boron sodium oxide (B5NaO8), labeled with boron-10.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as boron sodium oxide
(B5NaO8), labeled with boron-10 (PMN P-16-70, CAS No. 200443-98-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. A significant new use is any use of the
substance other than as an emergency shutdown coolant in boiler water
reactors.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.