Document ID: EPA-HQ-OPPT-2016-0331-0001
Agency: epa
Document Type: Rule
Title: Significant New Use Rules: Certain Chemical Substances
Posted Date: 2017-09-21T04:00Z

[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Rules and Regulations]
[Pages 44079-44099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

[[Page 44080]]

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

[[Page 44081]]

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.

[[Page 44082]]

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.

[[Page 44083]]

    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.

[[Page 44084]]

    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

[[Page 44085]]

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

[[Page 44086]]

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

[[Page 44087]]

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-

[[Page 44088]]

.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.

[[Page 44089]]

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

[[Page 44090]]

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

[[Page 44091]]

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,

[[Page 44092]]

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.

[[Page 44093]]

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

[[Page 44094]]

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:

[[Page 44095]]

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:

[[Page 44096]]

    (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.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
 23. Add Sec.  721.10980 to subpart E to read as follows:

Sec.  721.10980  Perfluoropolyether modified organosilane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluoropolyether modified organosilane (PMN P-16-94) 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(s) (500 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.

0
24. Add Sec.  721.10981 to subpart E to read as follows:

Sec.  721.10981  Modified phenol-formaldehyde resin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
modified phenol-formaldehyde resin (PMN P-16-95) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=96).
    (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

[[Page 44097]]

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
25. Add Sec.  721.10982 to subpart E to read as follows:

Sec.  721.10982  Disubstituted benzene alkanal (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
disubstituted benzene alkanal (PMN P-16-101) 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)(2)(i), (a)(3), (b) (concentration set at 1.0 percent), and 
(c).
    (ii) Industrial commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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
 26. Add Sec.  721.10983 to subpart E to read as follows:

Sec.  721.10983  Phthalic anhydride, polymer with alkylene glycol and 
alkanepolyol, acrylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phthalic anhydride, polymer with alkylene glycol and alkanepolyol, 
acrylate (PMN P-16-102) 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
 27. Add Sec.  721.10984 to subpart E to read as follows:

Sec.  721.10984   2-Pyridinecarboxylic acid, 4,5-dichloro-6-(4-chloro-
2-fluoro-3-methoxyphenyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 4,5-dichloro-6-(4-chloro-2-fluoro-3-
methoxyphenyl)- (PMN P-16-104, CAS No. 1546765-39-2) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=8).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
 28. Add Sec.  721.10985 to subpart E to read as follows:

Sec.  721.10985  Dialkylamino alkylamide inner salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
dialkylamino alkylamide inner salt (PMNs P-16-136, P-16-139 and P-16-
140) are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=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 these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
 29. Add Sec.  721.10986 to subpart E to read as follows:

Sec.  721.10986  Nanocarbon (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
nanocarbon (PMN P-16-170) 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 when the PMN 
substance is incorporated into the composite material allowed by the 
section 5(e) consent order.
    (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(k) and (q). A significant new use is any 
use involving an application method that generates a vapor, mist or 
aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e) and (i) through (k) are applicable to 
manufacturers and processors of this substance.

[[Page 44098]]

    (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
 30. Add Sec.  721.10987 to subpart E to read as follows:

Sec.  721.10987  Barium molybdenum niobium tantalum tellurium vanadium 
zinc oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as barium molybdenum 
niobium tantalum tellurium vanadium zinc oxide (PMN P-16-177, CAS No. 
1440529-21-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 1.0 
percent) and (c). When determining which persons are reasonably likely 
to be exposed as required for Sec.  721.63(a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 10 meet the requirements 
of Sec.  721.63(a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in 721.80(f) and (j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
 31. Add Sec.  721.10988 to subpart E to read as follows:

Sec.  721.10988  Alkanoic acids, esters with alkanetriol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanoic acids, esters with alkanetriol (PMN P-16-179) 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
 32. Add Sec.  721.10989 to subpart E to read as follows:

Sec.  721.10989  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).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 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- (PMN P-
16-182, chemical A; CAS No. 2020407-62-7) 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) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (b) (concentration set at 1.0 percent).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (j) (a significant new use is any 
manufacture at a concentration of greater than 10% of the PMN substance 
in any formulation).
    (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.

0
33. Add Sec.  721.10990 to subpart E to read as follows:

Sec.  721.10990  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).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 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- (PMN P-16-182, 
chemical B; CAS No. 2020407-63-8) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (b) (concentration set at 1.0 percent).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (j) (a significant new use is any 
manufacture at a concentration of greater than 10% of the PMN substance 
in any formulation).
    (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.

0
 34. Add Sec.  721.10991 to subpart E to read as follows:

Sec.  721.10991  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).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 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- (PMN P-16-182, 
chemical C; CAS No. 2020407-64-9) is subject to reporting

[[Page 44099]]

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)(3), and (b) (concentration set at 1.0 percent).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (j) (a significant new use is any 
manufacture at a concentration of greater than 10% of the PMN substance 
in any formulation).
    (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.

0
35. Add Sec.  721.10992 to subpart E to read as follows:

Sec.  721.10992  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).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 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- (PMN P-16-182, 
chemical D; CAS No. 2020407-65-0) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), and (b) (concentration set at 1.0 percent).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (j) (a significant new use is any 
manufacture at a concentration of greater than 10% of the PMN substance 
in any formulation).
    (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.

0
36. Add Sec.  721.10993 to subpart E to read as follows:

Sec.  721.10993  Aryl polyolefin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as aryl 
polyolefin (PMN P-16-190) 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)(3), and (b) (concentration set at 1.0 percent).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
37. Add Sec.  721.10994 to subpart E to read as follows:

Sec.  721.10994  Melamine nitrate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
melamine nitrate (PMN P-16-260) 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=14).
    (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
38. Add Sec.  721.10995 to subpart E to read as follows:

Sec.  721.10995   Lecithins, soya, hydrogenated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lecithins, soya, 
hydrogenated (PMN P-16-272, CAS No. 308068-11-3) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2017-20158 Filed 9-20-17; 8:45 am]
 BILLING CODE 6560-50-P