Significant New Use Rules on Certain Chemical Substances, 44079-44099 [2017-20158]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://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 https://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-
ethylhexano