[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Rules and Regulations]
[Pages 37702-37733]
[FR Doc No: 2018-15995]

Vol. 83

Wednesday,

No. 148

August 1, 2018

Part III

Environmental Protection Agency

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40 CFR Parts 9 and 721

Significant New Use Rules on Certain Chemical Substances; Final Rule

Federal Register / Vol. 83 , No. 148 / Wednesday, August 1, 2018 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0366; FRL-9970-23]
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 145 chemical substances
which were the subject of premanufacture notices (PMNs). The chemical
substances are subject to consent orders issued by EPA pursuant to
section 5(e) of TSCA. This action requires persons who intend to
manufacture (defined by statute to include import) or process any of
these 145 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.
Persons may not commence manufacture or processing for the significant
new use until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required with that determination.

DATES: This rule is effective on October 1, 2018. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
August 15, 2018.
    Written adverse comments on one or more of these SNURs must be
received on or before August 31, 2018 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on
one or more of these SNURs before August 31, 2018, 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-2017-0366, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

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

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 August 31, 2018
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see Sec.  721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.

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

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

II. Background

A. What action is the Agency taking?

    1. Direct Final Rule. 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 obligates EPA to assess
risks that may be associated with the significant new uses under the
conditions of use and, if appropriate, to regulate the proposed uses
before they occur.
    2. Proposed Rule. In addition to this Direct Final Rule, elsewhere
in this issue of the Federal Register, EPA is issuing a Notice of
Proposed Rulemaking for this rule. If EPA receives no adverse comment,
the Agency will not take further action on the proposed rule and the
direct final rule will become effective as provided in this action. If
EPA receives adverse comment on one or more of SNURs in this action by
August 31, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the

Agency will publish in the Federal Register a timely withdrawal of the
specific SNURs that the adverse comments pertain to, informing the
public that the actions will not take effect. EPA would then address
all adverse public comments in a response to comments document in a
subsequent final rule, based on the proposed rule.

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

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

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec.  [emsp14]721.1(c), persons subject to these SNURs must comply
with the same SNUN requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA 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 authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the
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 145 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.
     Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substance in support of a request by the PMN submitter to modify the
Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR. This information
may include testing required in a TSCA section 5(e) Order to be
conducted by the PMN submitter, as well as testing not required to be
conducted but which would also help characterize the potential health
and/or environmental effects of the PMN substance. Any recommendation
for information identified by EPA was made based on EPA's consideration
of available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models. EPA also recognizes that
whether testing/further information is needed will depend on the
specific exposure and use scenario in the SNUN. EPA encourages all SNUN
submitters to contact EPA to discuss any potential future testing. See
Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of
this rule. The regulatory text section of each rule specifies the
activities designated as significant new uses. Certain new uses,
including exceedance of 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.
These rules include 145 PMN substances that are subject to 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 Orders require protective
measures to limit exposures or otherwise mitigate the potential
unreasonable risk. The SNURs identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to the restrictions imposed by the underlying
Orders, consistent with TSCA section 5(f)(4).
    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) Order usually requires, among other
things, that potentially exposed employees wear specified respirators
unless actual measurements of the workplace air show that air-borne
concentrations of the PMN substance are below a New Chemical Exposure
Limit (NCEL) that is established by EPA to provide adequate protection
to human health. In addition

to the actual NCEL concentration, the comprehensive NCELs provisions in
TSCA section 5(e) 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 that 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)
Order for the same chemical substance.

PMN Numbers: P-14-472 and P-14-496

    Chemical names: Polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with N-(aminoiminomethyl)urea (generic)
(P-14-472) and Polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu
acrylate, N-(hydroxymethyl)propenamide and styrene (generic) (P-14-
496).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) uses of the PMN substances are as a site-controlled
intermediate (P-14-472) and a paper additive (P-14-496). Based on
Structure Activity Relationship (SAR) analysis of test data on
acrylates/methacrylates, and other structurally similar substances,
there is potential for irritation and sensitization for P-14-472. For
P-14-496 there is concern for sensitization based on the presence of
formaldehyde and concern for irritation and lung effects from the
surfactant properties of the substance. Further, based on SAR analysis
of test data on analogous phosphates, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 3 parts per billion
(ppb) of P-14-472 and 4 ppb of P-14-496 in surface waters. The Order
was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based
on a finding that the available information is insufficient to permit a
reasoned evaluation of the human health effects of the PMN substances.
Further, the Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that the substances may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment to prevent dermal exposure.
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the Safety Data Sheet (SDS).
    4. No release of the PMN substances resulting in surface water
concentrations that exceed 3 ppb for P-14-472 and 4 ppb for P-14-496.
    5. No modification of the manufacturing process that results in
inhalation exposure and no use involving application methods that
generate a dust, mist, or aerosol.
    6. Use of the PMN substances only as a site-limited intermediate
(P-14-472) and the confidential use specified in the Order (P-14-496).
    The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the fate and human health toxicity of the PMN
substances may be potentially useful to characterize the effects of the
PMN substances in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing a skin sensitization study and a
biodegradation test on each substance. In addition, EPA has determined
that the results of a pulmonary effects testing of the PMN substance
may be potentially useful in characterizing the health effects of the
PMN substances. Although the Order does not require this additional
testing, 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 information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citations: 40 CFR 721.11024 (P-14-472) and 40 CFR 721.11025 (P-
14-496).

PMN Number: P-14-630

    Chemical name: Bismuth bromide iodide oxide.
    CAS number: 340181-06-8.
    Effective date of TSCA section 5(e) Order: May 10, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a pigment for liquid coatings solvent based
system; a pigment for powder coatings; and a pigment for polymer
materials. Based on test data and physical/chemical properties of the
PMN substance, as well as SAR analysis of analogous respirable, poorly
soluble particulates, EPA identified concerns for lung effects,
including fibrosis. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substance may present an unreasonable risk of injury to human health.
EPA assessed risks based on the specific manufacturing, processing,
use, distribution/transportation, treatment and disposal processes,
process equipment, engineering controls, and handling practices
(including worker activities and cleaning procedures) described in the
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of a National Institute for Occupational Safety and Health
(NIOSH)-certified respirator with an Assigned Protection Factor (APF)
of at least 10 (where there is a potential for inhalation exposures) or
compliance with a New Chemical Exposure Limit (NCEL) of 2.4 milligram/
meter\3\ (mg/m\3\) as an 8-hour time-weighted average.
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. No use of the substance in a consumer product that generates a
dust, mist, or aerosol.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures, and any use to vary or alter, the
manufacturing, processing, use, distribution/transportation, treatment
and disposal processes, process equipment, engineering controls, and
handling practices (including worker activities and cleaning
procedures) described in the PMN in such a way as to change the
magnitude of inhalation exposure.

    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the effects of the PMN substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit without
performing specific target organ toxicity testing. In addition, EPA has
determined that the results of a chronic toxicity/carcinogenicity test
of the PMN substance may be potentially useful in characterizing the
health effects of the PMN substance. Although the Order does not
require this additional testing, 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 information that EPA determines is relevant
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11026.

PMN Number: P-15-450

    Chemical name: Aluminum cobalt lithium nickel oxide.
    CAS number: 177997-13-6.
    Effective date of TSCA section 5(e) Order: March 23, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a mixed metal oxide for batteries. Based on
test data on the PMN substance, EPA identified concerns for spleen and
kidney toxicity. Based on physical/chemical properties of the PMN
substance, as well as SAR analysis of analogous respirable, poorly
soluble particulates, EPA identified concerns for lung effects based on
lung overload. Based on the crystalline structure of the PMN substance,
EPA identified concern for lung carcinogenicity. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on
insufficient information to make a reasoned evaluation and a finding
that the substance may present an unreasonable risk of injury to human
health. EPA assessed risks based on the specific manufacturing,
processing, use, distribution/transportation, treatment and disposal
processes, process equipment, engineering controls, and handling
practices (including worker activities and cleaning procedures)
described in the PMN. To protect against these risks, the Order
requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the time limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves
and protective clothing (where there is a potential for dermal
exposures).
    3. Use of a NIOSH-certified respirator with an APF of at least
1,000 (where there is a potential for inhalation exposure) or
compliance with a NCEL of 0.000092 ppm as an 8-hour time-weighted
average.
    4. Use of the chemical transfer processes and air ventilation
processes described in the PMN and the exposure monitoring requirements
described in the Order.
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    6. Disposal of the PMN substance by landfill only. Air releases are
limited by processes described in the PMN, including filtering through
a high-efficiency particulate air filter with an efficiency rate of
99.99%.
    7. No domestic manufacture of the PMN substance.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the effects of the PMN substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. The submitter
has agreed not to exceed the time limit without performing specific
target organ toxicity testing and carcinogenicity testing. In addition,
EPA has determined that the results of medical monitoring of the
workers exposed to the substance during manufacturing, processing, and
use may be potentially useful in characterizing the health effects of
the PMN substance. Although the Order does not require this medical
monitoring, 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 information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citation: 40 CFR 721.11027.

PMN Number: P-15-705

    Chemical name: Alkylarylamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a chemical intermediate and as an additive
and octane booster in aviation fuels.
    Based on test data on the PMN substance, EPA has identified
concerns for dermal irritation, developmental toxicity, and blood
effects. Based on test data on analogous anilines, EPA has identified
concerns for cardiovascular, eye, liver, kidney, and pulmonary effects,
as well as bladder cancer. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment including impervious
gloves, full body chemical protective clothing and chemical goggles or
equivalent eye protection (where there is a potential for dermal
exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least
1,000 (where there is a potential for inhalation exposure) or
compliance with a NCEL of 0.48 mg/m\3\ as an 8-hour time-weighted
average. (EPA's estimates indicate that variations of the parameters
(including batch size, number of processing sites, days per year of
operation) of the uses identified below would not result in inhalation
exposure that would indicate a different respirator.)
    4. No use of the substance in a consumer product.
    5. No use other than as a chemical intermediate or as an additive
and octane booster in aviation fuels.
    6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    7. No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substance may be potentially useful to characterize the effects of the
PMN substance in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a

SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing specific target organ toxicity testing and a
chronic aquatic toxicity test.
    CFR citation: 40 CFR 721.11028.

PMN Numbers: P-15-706 and P-15-707

    Chemical names: Aliphatic N-alkyl urea polymer containing
cyclohexyl groups and trimethoxy silanes (generic) (P-15-706) and
Aliphatic N-alkyl urea polymer containing aspartic ester groups and
trimethoxy silanes (generic) (P-15-707).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
use of the substances will be as ingredients for multipurpose exterior
coatings. Based on SAR analysis on reactive methoxy silane moieties,
EPA has identified concerns for irritation to lungs, eyes, and mucus
membranes. There are also concerns for acute toxicity, neurotoxicity,
and developmental toxicity based on the presence of methanol, and for
sensitization if there are residual isocyanates. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on
insufficient information to make a reasoned evaluation and a finding
that the substances may present an unreasonable risk of injury to human
health. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the production limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 10
(where there is a potential for inhalation exposure) or compliance with
a NCEL of 0.9 mg/m\3\ as an 8-hour time-weighted average. (EPA's
estimates indicate that variations of the parameters (including batch
size, number of processing sites, days per year of operation) of the
uses identified below would not result in inhalation exposure that
would indicate a different respirator.)
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    5. No manufacture beyond an annual production volume of 250,000
kilograms (kg).
    6. Manufacture of the PMN substances to contain no more than 0.1%
residual isocyanate by weight.
    7. No uses of the substances other than allowed in the Order.
    8. No use of the substances in a consumer product.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substances may
be potentially useful to characterize the effects of the PMN substances
in support of a request by the PMN submitter to modify the Order, or if
a manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit without
performing specific target organ toxicity testing for P-15-706.
    CFR citation: 40 CFR 721.11029 (P-15-706) and 40 CFR 721.11030 (P-
15-707).

PMN Numbers: P-16-273 and P-16-274

    Chemical names: Alkyl heteromonocycle, polymer with
heteromonocycle, carboxyalkyl alkyl ethers (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as ingredients in
metalworking fluids. Based on submitted test data for P-16-273 and
structurally similar surfactants, EPA has identified concerns for
dermal sensitization and irritation and lung effects. Based on
submitted toxicity data for P-16-273, EPA estimates toxicity to aquatic
organisms may occur for both PMNs at concentrations that exceed 10 ppb
of the PMN substances in surface waters. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on
insufficient information to make a reasoned evaluation and a finding
that the substances may present an unreasonable risk of injury to human
health and the environment. To protect against these risks, the Order
requires:
    1. No domestic manufacture of the PMN substances.
    2. Use of the PMN substances only: (i) For the confidential uses
specified in the Order, (ii) at a concentration no greater than 3% of
the metalworking fluid, and (iii) used only in closed metalworking
systems as specified in the PMNs with no modifications in the process
that would result in worker inhalation exposure.
    3. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    4. No release of the PMN substances resulting in surface water
concentrations that exceed 10 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the fate and toxicity of the PMN substances may be
potentially useful to characterize the health and environmental effects
of the PMN substances in support of a request by the PMN submitter to
modify the Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of specific target organ
toxicity testing and a biodegradation test of the PMN substances may be
potentially useful in characterizing the health and environmental
effects of the PMN substances. 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 information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citation: 40 CFR 721.11031.

PMN Number: P-16-289

    Chemical name: Benzene dicarboxylic acid, polymer with alkane dioic
acid and aliphatic diamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the substance
will be used as an extrusion compounding molding resin. Based on test
data on analogous high molecular weight polymers, EPA has concerns for
lung effects, which includes lung overload. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on
insufficient information to make a reasoned evaluation and a finding
that the substance may present an unreasonable risk of injury to human
health. To protect against these risks, the Order requires:
    1. Submission of particle size testing on the PMN substance prior
to exceeding the time limit as specified in the Order.

    2. Manufacture of the PMN substance such that the solid particle
form has a particle size distribution where less than 1% of the
particles are less than 10 microns.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the physical/chemical characteristics of the PMN
substance may be potentially useful to characterize the health effects
of the PMN substance in support of a request by the PMN submitter to
modify the Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that will be designated by
this SNUR. The submitter has agreed not to manufacture beyond a certain
time period without measuring the particle size distribution to
characterize the fraction of the dry particle PMN substance less than
10 microns. In addition, EPA has determined that the results of
specific target organ toxicity testing of the PMN substance may be
potentially useful in characterizing the health effects of the PMN
substance. Although the Order does not require this additional testing,
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
information that EPA determines is relevant and needed to evaluate a
modification request.
    CFR citation: 40 CFR 721.11032.

PMN Number: P-16-322

    Chemical name: Manganese cyclic (tri)amine chloride complex
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a pulp bleaching
catalyst. Based on test data on an analog, EPA has identified concerns
for kidney, blood, and thyroid effects, immunotoxicity, reproductive
and developmental toxicity, and neurotoxicity. Based on test data on
the PMN substance, EPA estimates that toxicity to aquatic organisms may
occur at concentrations that exceed 18 ppb of the PMN substance in
surface waters. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substance may present an unreasonable risk of injury to human health
and the environment. To protect against these risks, the Order
requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment to prevent dermal exposure
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 25
(where there is a potential for inhalation exposure) or compliance with
a NCEL of 1.2 ppm as an 8-hour time-weighted average. (EPA's estimates
indicate that variations of the parameters (including batch size,
number of processing sites, days per year of operation) of the uses
identified below would not result in inhalation exposure that would
indicate a different respirator.)
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    5. No domestic manufacture of the PMN substance.
    6. Process and use of the PMN substance only for the confidential
uses and formulation percentage specified in the Order.
    7. No release of the PMN substance resulting in surface water
concentrations that exceed 18 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substance may be potentially useful to characterize the effects of the
PMN substance in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing specific target organ toxicity testing,
reproductive/developmental toxicity testing; and chronic aquatic
toxicity testing.
    CFR citation: 40 CFR 721.11033.

PMN Numbers: P-16-338, P-16-339, P-16-439, and P-16-440

    Chemical names: Xanthylium, (sulfoaryl)-bis [(substituted aryl)
amino]-, sulfo derivs., inner salts, metal salts (generic) (P-16-338);
Substituted triazinyl metal salt, diazotized, coupled with substituted
pyridobenzimidazolesulfonic acids, substituted
pyridobenzimidazolesulfonic acids, diazotized substituted
alkanesulfonic acid, diazotized substituted aromatic sulfonate,
diazotized substituted aromatic sulfonate, metal salts (generic) (P-16-
339); Carbon black, (organic acidic carbocyclic)-modified, inorganic
salt (generic) (P-16-439); and Carbon black, (organic acidic
carbocyclic)-modified, metal salt (generic) (P-16-440).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) uses of the PMN substances will be as dyestuffs (P-
16-0338 and P-16-0339) and as coloring agents (P-16-0439 and P-16-
0440). Based on physical/chemical properties of the PMN substances and
test data on analogous poorly respirable particles, EPA has identified
concerns for irritation to the eyes, lungs, and mucous membranes, and
lung effects. Further, based on SAR analysis of test data on analogous
dyes, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 200 ppb of the PMN substances in surface
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
    1. No manufacture of the PMN substances beyond the confidential
annual production volume specified in the Order.
    2. No domestic manufacture of the PMN substances.
    3. Import the PMN substances only according to the terms specified
and for the confidential uses specified in the Order.
    4. No release of the PMN substances to surface waters.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the fate, human health toxicity, and aquatic toxicity
of the PMN substances may be potentially useful to characterize the
effects of the PMN substances in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of a
biodegradation test, specific target organ toxicity testing, and acute
and chronic aquatic toxicity testing of the PMN

substances may be potentially useful in characterizing the health and
environmental effects of the PMN substances. 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 information that EPA determines is relevant
and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11034 (P-16-338), 40 CFR 721.11035 (P-16-
339), 40 CFR 721.11036 (P-16-439), and 40 CFR 721.11037 (P-16-440).

PMN Number: P-16-350

    Chemical name: Polyaralkyl aryl ester of methacrylic acid
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a polymer reactant.
Based on test data on methacrylate moieties, EPA has identified
concerns for irritation and sensitization based on analogy to
methacrylates. Based on SAR analysis of test data on structurally
similar respirable surfactants, EPA has identified concerns for lung
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order requires:
    1. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    3. Manufacture of the PMN substance such that it is not less than
the minimum average molecular weight identified in the Order and does
not contain more than the maximum weight percent of low molecular
weight species below 1,000 Daltons.
    4. Use of the PMN substance only for the confidential use specified
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the health effects of the PMN substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. EPA has
determined that the results of specific target organ toxicity testing
and a sensitization test of the PMN substance may be potentially useful
in characterizing the health effects of the PMN 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 information that EPA determines is relevant
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11038.

PMN Number: P-16-352

    Chemical names: Phenol, 2-[[[3-(octyloxy)propyl]imino]methyl]- (P-
16-352, chemical A) and Phenol, 2-[[[3-(decyloxy)propyl]imino]methyl]-
(P-16-352, chemical B).
    CAS numbers: 1858221-49-4 (P-16-352, chemical A) and 1858221-50-7
(P-16-352, chemical B).
    Effective date of TSCA section 5(e) Order: April 21, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the PMN
substances will be used as co-catalysts in the manufacturing of release
coatings for producing papers and films at a concentration of 1% or
less. Based on SAR analysis of test data on analogous phenols, EPA has
identified concerns for respiratory and dermal irritation and
developmental toxicity. In addition, EPA has identified concerns for
liver toxicity and reproductive effects based on the hydrolysis product
o-hydroxybenzaldehyde. Further, based on SAR analysis of test data on
analogous phenols, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of the PMN substances in surface
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. No domestic manufacture of the PMN substances.
    5. No manufacture of the PMN substances beyond an annual production
volume of 250 kg/yr.
    6. No use of the PMN substances in application methods that
generate a dust, mist, or aerosol.
    7. No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substance may be potentially useful to characterize the effects of the
PMN substance in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing specific target organ toxicity, reproductive/
developmental toxicity, and acute aquatic toxicity testing.
    CFR citations: 40 CFR 721.11039 (P-16-352, chemical A) and 40 CFR
721.11040 (P-16-352, chemical B).

PMN Number: P-16-358

    Chemical name: Alkyl phenol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a chemical intermediate. Based on SAR
analysis of test data on analogous phenols, EPA has identified concerns
for developmental toxicity. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).

    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. Use of the PMN substance only as a chemical intermediate.
    5. No manufacture, process, or use of the PMN substance in any
manner or method that generates a dust, mist, or aerosol or in a non-
enclosed process.
    6. No release of the PMN substance to surface waters.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the effects of the PMN substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use will be designated by this SNUR. The submitter has
agreed not to exceed the confidential production limit without
performing specific target organ toxicity and reproductive/
developmental toxicity tests.
    CFR citation: 40 CFR 721.11041.

PMN Number: P-16-364

    Chemical name: Nitrile-butadiene-acrylate terpolymers (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a chemical
intermediate. Based on SAR analysis of test data on structurally
similar respirable particles, EPA has identified concerns for lung
effects, including lung overload. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
    1. Use of the PMN substance only as a site-limited chemical
intermediate.
    2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    3. No manufacture, process, or use of the PMN substance if it
contains more than 5% of the particle size distribution less than 10
microns.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the effects of the PMN substance in support of a
request by the PMN submitter to modify the Order, or if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of specific target organ toxicity testing of the PMN substance
may be potentially useful in characterizing the health effects of the
PMN substance. Although the Order does not require this test, 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
information that EPA determines is relevant and needed to evaluate a
modification request.
    CFR citation: 40 CFR 721.11042.

PMN Number: P-16-399

    Chemical name: Starch, polymer with 2-propenoic acid, potassium
salt, oxidized.
    CAS number: 1638117-09-5.
    Effective date of TSCA section 5(e) Order: April 6, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as an agricultural soil amendment for field
crops, agricultural soil amendment for turf applications and direct
soil injection with fertilizers, and a compound to be used in
preparation of advanced seed coatings. Based on SAR analysis of test
data on structurally similar respirable particles, EPA has identified
concerns for lung effects, including lung overload. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on insufficient information to make a reasoned evaluation and a
finding that the substance may present an unreasonable risk of injury
to human health. The Order was also issued under TSCA sections
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the
substance that the substance is or will be produced in substantial
quantities and that the substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substance. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the time limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. Manufacture of the substance with a particulate size greater
than 30 microns.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the health and environmental effects of the PMN
substance in support of a request by the PMN submitter to modify the
Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to manufacture beyond a certain time limit
without performing an acute aquatic toxicity test. In addition, EPA has
determined that the results of specific target organ toxicity testing
of the PMN substance may be potentially useful in characterizing the
health effects of the PMN substance. Although the Order does not
require this additional testing, 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 information that EPA determines is relevant
and needed to evaluate a modification request.
    CFR citation: 40 CFR 721.11043.

PMN Number: P-16-430

    Chemical name: Pentanedioic acid, 2-methyl-.
    CAS number: 617-62-9.
    Effective date of TSCA section 5(e) Order: May 17, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a filler. Based on test
data on the PMN substance, EPA has identified concerns for systemic and
reproductive toxicity. Based on structural analysis on the acid groups
and test data, EPA has identified concerns for dermal and respiratory
irritation. Further, based on test data on the PMN substance and test
data on analogous neutral organics, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 14 ppb of the PMN
substance in surface waters. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the

substance may present an unreasonable risk of injury to human health
and the environment. EPA assessed risks based on the specific
processing, use, distribution/transportation, treatment and disposal
processes, process equipment, engineering controls, and handling
practices (including worker activities and cleaning procedures)
described in the PMN. To protect against these risks, the Order
requires:
    1. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    2. Use of a NIOSH-certified respirator with an APF of at least 10
(where there is a potential for inhalation exposure). (EPA's estimates
indicate that variations of the parameters (including batch size,
number of processing sites, days per year of operation) of the uses
identified below would not result in inhalation exposure that would
indicate a different respirator.)
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. No domestic manufacture of the PMN substance.
    5. Import of the PMN substance at or below the maximum
concentration specified in the Order.
    6. No release of the PMN substance resulting in surface water
concentrations that exceed 14 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures, and use of the chemical substance to vary or
alter the processing, use, distribution, engineering controls, and
handling practices described in the Order in such a way as to change
the magnitude of inhalation exposure.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the effects of the substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. EPA has
determined that the results of specific target organ toxicity testing
of the PMN substance may be potentially useful in characterizing the
health effects of the PMN substance. Although the Order does not
require this test, 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 information.
    CFR citation: 40 CFR 721.11044.

PMN Number: P-16-495

    Chemical name: 2-Pentanol, 4-methyl-, reaction products with
phosphorus oxide (P2O5), compounds with alkylamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
use (non-confidential) of the substance will be as a lubricant
additive. Based on test data on the substance, EPA has identified
concerns for systemic effects, sensitization and irritation to the eyes
and skin. Based on physical/chemical properties, EPA has concerns for
lung effects, including lung surfactancy. Further, based on test data
on analogous aliphatic amines for the cation and neutral organics for
the anion as well as test data on the PMN substance, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed
200 ppb of the PMN substance in surface waters. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on
insufficient information to make a reasoned evaluation and a finding
that the substance may present an unreasonable risk of injury to human
health and the environment. To protect against these risks, the Order
requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment (where there is a potential
for dermal exposure).
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. No manufacture in any manner or method that results in
inhalation exposure.
    5. No use of the PMN substance in an application method that
generates a vapor, mist, or aerosol.
    6. No release of the PMN substance resulting in surface water
concentrations that exceed 200 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substance may be potentially useful to characterize the effects of the
PMN substance effects of the PMN substance in support of a request by
the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. The submitter has agreed not to
exceed the confidential production limit without performing chronic
aquatic toxicity tests. In addition, EPA has determined that the
results of specific target organ toxicity testing of the PMN substance
may be potentially useful in characterizing the health effects of the
PMN substance. Although the Order does not require this additional
testing, 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 information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citation: 40 CFR 721.11045.

PMN Number: P-16-513

    Chemical name: Hydroxy alkylbiphenyl (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 2, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a chemical intermediate. Based on test data
on an analog, EPA has identified concerns for developmental toxicity,
systemic toxicity, blood effects, and corrosion of the skin, eyes, and
mucous membranes. Further, based on SAR analysis of test data on
analogous amides, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 17 ppb of the PMN substances in surface
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment (where there is a potential
for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50
(where there is a potential for inhalation exposure). (EPA's estimates
indicate that variations of the parameters (including batch size,
number of processing sites, days per year of operation) of the uses
identified below would not result in inhalation exposure that would
indicate a different respirator.)
    4. Use of the PMN substance only as a chemical intermediate.

    5. No release of the PMN substance resulting in surface water
concentrations that exceed 17 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substance may be potentially useful to characterize the effects of the
PMN substance in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing specific target organ toxicity and
reproductive/developmental toxicity testing. In addition, EPA has
determined that the results of acute aquatic toxicity tests may be
potentially useful in characterizing the environmental effects of the
PMN substance. Although the Order does not require these additional
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 information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citation: 40 CFR 721.11046.

PMN Numbers: P-16-534, P-16-535, and P-16-536

    Chemical names: Alkyl alkenoic acid, polymer with
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl
alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol
alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether
and alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-534);
Alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with
substituted alkanoic acid hydroxyl alkyl substituted alkenyl
substituted alkyl ester, alkanediol diheteromonocyclic ether,
polyalkylene glycol alkyl ether alkyl alkenoate and
alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-535); and
Alkyl alkenoic acid, polymer with bis heteromonocyclic substituted
alkyl carbomonocycle, alkenylcarbomonocycle telomer with substituted
alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl
ester, polyalkylene glycol alkyl ether alkyl alkenoate and
alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-536).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 4, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substances will be a component of ink.
Based on test data on structurally similar respirable particles, EPA
has identified concerns for lung effects if inhaled, based on lung
overload. In addition, EPA has identified ecotoxicity concerns for the
substances if made with an acid component exceeding 20% of the
molecular weight due potential for increased absorption and solubility.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
    1. Manufacture of the PMN substances such that the minimum average
molecular weight is 1,800 daltons and the carboxylic acid content does
not exceed 20%.
    2. No domestic manufacture of the PMN substances.
    3. Process or use of the PMN substances only for the use specified
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substances may be potentially useful to characterize the effects of the
substances in support of a request by the PMN submitter to modify the
Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use that will be designated by this SNUR.
EPA has determined that the results of specific target organ toxicity
testing and an acute aquatic toxicity test of the PMN substances may be
potentially useful in characterizing the health and environmental
effects of the PMN substances. 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 information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citations: 40 CFR 721.11047 (P-16-534), 40 CFR 721.11048 (P-16-
535), and 40 CFR 721.11049 (P-16-536).

PMN Numbers: P-16-549, P-16-550, P-16-551, P-16-553, P-16-555, P-16-
556, P-16-557, P-16-558, P-16-560, P-16-561, P-16-562, P-16-563, P-16-
564, P-16-565, and P-16-567

    Chemical names: Alkaline functionalized methacrylate-substituted
polymer (generic) (P-16-549, P-16-550, and P-16-551); Quatenary
alkylamine functionalized methacrylate-substituted polymer (generic)
(P-16-553); Neutral alcohol functionalized methacrylate-substituted
polymer (generic) (P-16-555 and P-16-556); Neutral alkyl salt
functionalized methacrylate-substituted polymer (generic) (P-16-557, P-
16-558, and P-16-560); Acid functionalized methacrylate-substituted
polymer (generic) (P-16-561, P-16-562, P-16-563, P-16-564, and P-16-
565); and Alkylamine functionalized methacrylate-substituted polymer
(generic) (P-16-567).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: May 2, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the substances
will be use as crosslinked resins for chromatographic separation of
biomolecules and biocatalysts. Based on test data on structurally
similar respirable particles, EPA has identified concerns for lung
effects, including lung overload. EPA has also identified irritation
concerns for skin and eyes. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substances may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
    1. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    2. Manufacture of the PMN substances only in the physical form of
spherical beads and with less than 0.1% below a particle size of 10
microns.
    3. No domestic manufacture of the PMN substances.
    4. Process or use of the PMN substances only for the uses specified
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substances may
be potentially useful to characterize the effects of the substances in
support of a request by the PMN submitter to modify the Order, or

if a manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. EPA has
determined that the results of specific target organ toxicity testing
of the PMN substances may be potentially useful in characterizing the
health effects of the PMN substances. Although the Order does not
require this testing, 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 information that EPA determines is relevant
and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11050.

PMN Number: P-16-579

    Chemical name: Waste plastics, poly(ethylene terephthalate),
depolymd. with polypropylene glycol ether with glycerol (3:1), polymers
with alkenoic and alkanoic acids (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as an ultraviolet curable coating resin. Based
on test data on similar structural moieties, EPA has identified
concerns for dermal and respiratory sensitization and irritation of
mucous membranes. In addition, EPA has identified human health and
environmental concerns for the substance if made with lower molecular
weight due potential for increased absorption and solubility. The Order
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on insufficient information to make a reasoned evaluation and a
finding that the substances may present an unreasonable risk of injury
to human health and the environment. To protect against these risks,
the Order requires:
    1. Use of personal protective equipment including gloves and
protective clothing (where there is a potential for dermal exposure).
    2. Use of a NIOSH-certified full face respirator with an APF of at
least 50 (where there is a potential for inhalation exposure). (EPA's
estimates indicate that variations of the parameters (including batch
size, number of processing sites, days per year of operation) of the
uses identified below would not result in inhalation exposure that
would indicate a different respirator.)
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. No manufacture of the PMN substance with an average molecular
weight less than 1,100 Daltons.
    5. Use of the PMN substance only as an ultraviolet curable coating
resin.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the physical-chemical properties and human health and
aquatic toxicity of the PMN substance may be potentially useful to
characterize the effects of the substance in support of a request by
the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that
measurement of certain physical-chemical properties, the results of
specific target organ toxicity, reproductive/developmental toxicity,
sensitization, and acute and chronic aquatic toxicity testing may be
potentially useful in characterizing the health and environmental
effects of the PMN substances. 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 information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citation: 40 CFR 721.11051.

PMN Number: P-17-32

    Chemical name: 1,3,5-Naphthalenetrisulfonic acid.
    CAS number: 6654-64-4.
    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance is for monitoring of oil/gas
well performance. Based on test data on an analog and physical/chemical
properties of the PMN substance, EPA has identified concerns for dermal
and respiratory irritation, developmental toxicity, and blood effects.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order requires:
    1. Submission of certain toxicity testing on the PMN substance
prior to exceeding the confidential production volume limit as
specified in the Order.
    2. Use of personal protective equipment including NIOSH-approved
respirator (APF 50) and impervious gloves (where there is a potential
for inhalation or dermal exposure). (EPA's estimates indicate that
variations of the parameters (including batch size, number of
processing sites, days per year of operation) of the uses identified
below would not result in inhalation exposure that would indicate a
different respirator.)
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. No manufacture or processing of the PMN substance beyond a
confidential annual production volume specified in the Order.
    5. No manufacture, processing, or use using application methods
that intentionally generate a vapor, mist or aerosol.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the effects of the PMN substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit without
performing specific target organ toxicity and developmental toxicity
testing.
    CFR citation: 40 CFR 721.11052.

PMN Numbers: P-17-33, P-17-34, P-17-36, P-17-38, P-17-39, P-17-41, P-
17-42, P-17-43, P-17-45, P-17-47, P-17-50, P-17-52, P-17-55, P-17-57,
P-17-59, P-17-61, P-17-62, P-17-63, P-17-64, P-17-66, P-17-67, P-17-69,
P-17-71, P-17-72, P-17-73, P-17-75, P-17-76, P-17-79, P-17-80, P-17-83,
P-17-85, P-17-87, P-17-90, P-17-91, P-17-93

                     Chemical Names and CAS Numbers
------------------------------------------------------------------------
                     Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2-fluoro-, sodium salt (1:1) (P-17-33)..         6654-64-4
Benzoic acid, 4-fluoro-, sodium salt (1:1) (P-17-34)..          499-90-1
Benzoic acid, 2,3,4,5-tetrafluoro-, sodium salt (1:1)         67852-79-3
 (P-17-36)............................................
Benzoic acid, 2-(trifluoromethyl)-, sodium salt (1:1)          2966-44-1
 (P-17-38)............................................
Benzoic acid, 4-(trifluoromethyl)-, sodium salt (1:1)         25832-58-0
 (P-17-39)............................................
Benzoic acid, 2,5-difluoro-, sodium salt (1:1) (P-17-        522651-42-9
 41)..................................................
Benzoic acid, 3-fluoro-, sodium salt (1:1) (P-17-42)..          499-57-0
Benzoic acid, 2,6-difluoro-, sodium salt (1:1) (P-17-          6185-28-0
 43)..................................................
Benzoic acid, 3,5-difluoro-, sodium salt (1:1) (P-17-        530141-39-0
 45)..................................................
Benzoic acid, 2,4-difluoro-, sodium salt (1:1) (P-17-          1765-08-8
 47)..................................................
Benzoic acid, 3,4-difluoro-, sodium salt (1:1) (P-17-        522651-44-1
 50)..................................................
Benzoic acid, 3,4,5-trifluoro-, sodium salt (1:1) (P-       1180493-12-2
 17-52)...............................................
Benzoic acid, 2,3,4-trifluoro-, sodium salt (1:1) (P-        402955-41-3
 17-55)...............................................
Benzoic acid, 2,4,5-trifluoro-, sodium salt (1:1) (P-        522651-48-5
 17-57)...............................................
Benzoic acid, 2,3-difluoro-, sodium salt (1:1) (P-17-       1604819-08-0
 59)..................................................
Benzoic acid, 3-(trifluoromethyl)-, sodium salt (1:1)         69226-41-1
 (P-17-61)............................................
Benzoic acid, 2-chloro-, sodium salt (1:1) (P-17-62)..        17264-74-3
Benzoic acid, 4-chloro-, sodium salt (1:1) (P-17-63)..         3686-66-6
Benzoic acid, 3-chloro-, sodium salt (1:1) (P-17-64)..        17264-88-9
Benzoic acid, 2,3-dichloro-, sodium salt (1:1) (P-17-        118537-84-1
 66)..................................................
Benzoic acid, 2,5-dichloro-, sodium salt (1:1) (P-17-         63891-98-5
 67)..................................................
Benzoic acid, 3,5-dichloro-, sodium salt (1:1) (P-17-        154862-40-5
 69)..................................................
Benzoic acid, 2,6-dichloro-, sodium salt (1:1) (P-17-         10007-84-8
 71)..................................................
Benzoic acid, 3,4-dichloro-, sodium salt (1:1) (P-17-         17274-10-1
 72)..................................................
Benzoic acid, 2,4-dichloro-, sodium salt (1:1) (P-17-         38402-11-8
 73)..................................................
Benzoic acid, 2-chloro-4-fluoro-, sodium salt (P-17-         855471-43-1
 75)..................................................
Benzoic acid, 3-chloro-4-fluoro-, sodium salt (P-17-        1421761-18-3
 76)..................................................
Benzoic acid, 5-chloro-2-fluoro-, sodium salt (P-17-        1382106-78-6
 79)..................................................
Benzoic acid, 4-chloro-3-fluoro-, sodium salt (P-17-        1421029-88-0
 80)..................................................
Benzoic acid, 4-chloro-2-fluoro-, sodium salt (P-17-        1382106-64-0
 83)..................................................
Benzoic acid, 5-bromo-2-chloro-, sodium salt (P-17-85)      1938142-12-1
Benzoic acid, 3-bromo-4-fluoro-, sodium salt (P-17-87)       938142-13-2
Benzoic acid, 2-bromo-5-fluoro-, sodium salt (P-17-90)      1938142-14-3
Benzoic acid, 4-bromo-2-fluoro-, sodium salt (P-17-91)      1938142-15-4
Benzoic acid, 4-bromo-3-fluoro-, sodium salt (P-17-93)      1535169-81-3
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances are for monitoring of oil/gas
well performance. Based on test data on an analog, EPA has identified
concerns for reproductive, developmental and neuro-toxicity, as well as
lung toxicity and dermal irritation. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substances may present an unreasonable risk of injury to human health.
EPA assessed risks based on the specific manufacturing, processing,
use, process equipment, engineering controls, and handling practices
(including worker activities and cleaning procedures) described in the
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances
prior to exceeding the production volume limit as specified in the
Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50
(where there is a potential for inhalation exposure) or compliance with
a NCEL of 0.0184 ppm as an 8-hour time-weighted average.
    4. Use of processes, process equipment, engineering controls, and
handling practices specified in the Order for manufacturing and
processing.
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    6. No manufacture or process of the PMN substances beyond a
confidential annual production volume specified in the Order.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substances may
be potentially useful to characterize the effects of the PMN substances
in support of a request by the PMN submitter to modify the Order, or if
a manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit without
performing specific target organ toxicity testing on P-17-0091.
    CFR citations: 40 CFR 721.11053.

PMN Numbers: P-17-35, P-17-37, P-17-40, P-17-44, P-17-46, P-17-48, P-
17-51, P-17-53, P-17-54, P-17-56, P-17-58, P-17-60, P-17-65, P-17-68,
P-17-70, P-17-74, P-17-77, P-17-78, P-17-81, P-17-82, P-17-84, P-17-88,
P-17-89, P-17-92, P-17-97

                     Chemical Names and CAS Numbers
------------------------------------------------------------------------
                     Chemical Name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2,3,4,5-tetrafluoro- (P-17-35)..........         1201-31-6
Benzoic acid, 2-(trifluoromethyl)- (P-17-37)..........          433-97-6
Benzoic acid, 2,5-difluoro- (P-17-40).................         2991-28-8
Benzoic acid, 2,6-difluoro- (P-17-44).................          385-00-2
Benzoic acid, 3,5-difluoro- (P-17-46).................          455-40-3
Benzoic acid, 2,4-difluoro- (P-17-48).................         1583-58-0
Benzoic acid, 3,4-difluoro- (P-17-51).................          455-86-7
Benzoic acid, 3,4,5-trifluoro- (P-17-53)..............       121602-93-5
Benzoic acid, 2,3,4-trifluoro- (P-17-54)..............        61079-72-9
Benzoic acid, 2,4,5-trifluoro- (P-17-56)..............          446-17-3
Benzoic acid, 2,3-difluoro- (P-17-58).................         4519-39-5
Benzoic acid, 3-(trifluoromethyl)- (P-17-60)..........          454-92-2
Benzoic acid, 2,3-dichloro- (P-17-65).................           50-45-3
Benzoic acid, 3,5-dichloro- (P-17-68).................           51-36-5
Benzoic acid, 2,6-dichloro- (P-17-70).................           50-30-6
Benzoic acid, 2-chloro-4-fluoro- (P-17-74)............         2252-51-9
Benzoic acid, 5-chloro-2-fluoro- (P-17-77)............          394-30-9
Benzoic acid, 3-chloro-4-fluoro- (P-17-78)............          403-16-7
Benzoic acid, 4-chloro-3-fluoro- (P-17-81)............          403-17-8
Benzoic acid, 4-chloro-2-fluoro- (P-17-82)............          446-30-0
Benzoic acid, 5-bromo-2-chloro- (P-17-84).............        21739-92-4
Benzoic acid, 3-bromo-4-fluoro- (P-17-88).............        11007-16-5
Benzoic acid, 2-bromo-5-fluoro- (P-17-89).............          394-28-5
Benzoic acid, 4-bromo-3-fluoro- (P-17-92).............       153556-42-4
Benzoic acid, 4-bromo-2-fluoro- (P-17-97).............       112704-79-7
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances are for monitoring of oil/gas
well performance. Based on test data on an analog, EPA has identified
concerns for reproductive, developmental and neuro-toxicity, as well as
lung toxicity and dermal irritation. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substances may present an unreasonable risk of injury to human health.
EPA assessed risks based on the specific manufacturing, processing,
use, process equipment, engineering controls, and handling practices
(including worker activities and cleaning procedures) described in the
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances
prior to exceeding the production volume limit as specified in the
Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50
(where there is a potential for inhalation exposure) or compliance with
a NCEL of 0.0184 ppm as an 8-hour time-weighted average to prevent
inhalation exposure.
    4. Use of processes, process equipment, engineering controls, and
handling practices specified in the Order for manufacturing and
processing.
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    6. No manufacture or process of the PMN substances beyond a
confidential annual production volume specified in the Order.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substances may
be potentially useful to characterize the effects of the PMN substances
in support of a request by the PMN submitter to modify the Order, or if
a manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit without
performing specific target organ toxicity and reproductive/
developmental toxicity testing on both P-17-35 and P-17-37.
    CFR citations: 40 CFR 721.11054.

PMN Numbers: P-17-94, P-17-95, P-17-96, P-17-98, P-17-99, P-17-100, P-
17-101, P-17-102, P-17-103, P-17-104, P-17-105, P-17-114, P-17-122, P-
17-123, P-17-124, P-17-125, P-17-126, P-17-127, P-17-128, P-17-129, P-
17-130, P-17-131, P-17-132, P-17-133, P-17-134, P-17-135, P-17-136, P-
17-137, P-17-138, P-17-139, and P-17-140

                     Chemical Names and CAS Numbers
------------------------------------------------------------------------
                     Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2,3,4,5-tetrafluoro-, ethyl ester (P-17-       122894-73-9
 94)..................................................
Benzoic acid, 4-(trifluoromethyl)-, ethyl ester (P-17-          583-02-8
 95)..................................................
Benzoic acid, 2-(trifluoromethyl)-, ethyl ester (P-17-          577-62-8
 96)..................................................
Benzoic acid, 2,6-difluoro-, ethyl ester (P-17-98)....        19064-14-3
Benzoic acid, 2,5-difluoro-, ethyl ester (P-17-99)....          708-25-8
Benzoic acid, 2,3,4-trifluoro-, ethyl ester (P-17-100)       351354-50-2
Benzoic acid, 2-bromo-5-fluoro-, ethyl ester (P-17-          351354-50-2
 101).................................................
Benzoic acid, 3,5-difluoro-, ethyl ester (P-17-102)...          350-19-6

Benzoic acid, 5-bromo-2-chloro-, ethyl ester (P-17-           76008-73-6
 103).................................................
Benzoic acid, 3-chloro-, ethyl ester (P-17-104........         1128-76-3
Benzoic acid, 2-chloro-, ethyl ester (P-17-105).......         7335-25-3
Benzoic acid, 3-chloro-4-fluoro-, ethyl ester (P-17-         137521-81-4
 114).................................................
Benzoic acid, 4-bromo-2-fluoro-, ethyl ester (P-17-          474709-71-2
 122).................................................
Benzoic acid, 2-bromo-4,5-difluoro-, ethyl ester (P-17-      144267-97-0
 123).................................................
Benzoic acid, 4-bromo-3-fluoro-, ethyl ester (P-17-         1130165-74-0
 124).................................................
Benzoic acid, 3-bromo-4-fluoro-, ethyl ester (P-17-           23233-33-2
 125).................................................
Benzoic acid, 4-chloro-2-fluoro-, ethyl ester (P-17-           4793-20-8
 126).................................................
Benzoic acid, 2,5-dichloro-, ethyl ester (P-17-127)...        35112-27-7
Benzoic acid, 4-chloro-3-fluoro-, ethyl ester (P-17-         203573-08-4
 128).................................................
Benzoic acid, 2-chloro-4-fluoro-, ethyl ester (P-17-         167758-87-4
 129).................................................
Benzoic acid, 5-chloro-2-fluoro-, ethyl ester (P-17-         773139-56-3
 130).................................................
Benzoic acid, 2,4-difluoro-, ethyl ester (P-17-131)...       108928-00-3
Benzoic acid, 3,4-difluoro-, ethyl ester (P-17-132)...       144267-96-9
Benzoic acid, 3,4,5-trifluoro-, ethyl ester (P-17-133)       495405-09-9
Benzoic acid, 2,4,5-trifluoro-, ethyl ester (P-17-134)       351354-41-1
Benzoic acid, 3-(trifluoromethyl)-, ethyl ester (P-17-        76783-59-0
 135).................................................
Benzoic acid, 2,3-difluoro-, ethyl ester (P-17-136)...       773134-65-9
Benzoic acid, 2,6-dichloro-, ethyl ester (P-17-137)...        81055-73-4
Benzoic acid, 3,5-dichloro-, ethyl ester (P-17-138)...        91085-56-2
Benzoic acid, 2,4-dichloro-, ethyl ester (P-17-139)...        56882-52-1
Benzoic acid, 3,4-dichloro-, ethyl ester (P-17-140)...        28394-58-3
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the
substances are for monitoring oil/gas well performance. Based on test
data on an analog, EPA has identified concerns for reproductive,
developmental and neuro-toxicity, as well as lung toxicity and dermal
irritation. Further, based on SAR analysis of test data on analogous
neutral organics, EPA predicts toxicity to aquatic organisms may occur
at concentrations that exceed 15 ppb of the PMN substances in surface
waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substances may present an
unreasonable risk of injury to human health and the environment. EPA
assessed risks based on the specific manufacturing, processing, use,
process equipment, engineering controls, and handling practices
(including worker activities and cleaning procedures) described in the
PMNs. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances
prior to exceeding the production volume limit as specified in the
Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least
1,000 (where there is a potential for inhalation exposure) or
compliance with a NCEL of 0.0184 ppm as an 8-hour time-weighted
average.
    4. Use of processes, process equipment, engineering controls, and
handling practices specified in the Order for manufacturing and
processing.
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    6. No manufacture or process of the PMN substances beyond a
confidential annual production volume specified in the Order.
    7. No release of the PMN substances resulting in surface water
concentrations that exceed 15 ppb.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substances may be potentially useful to characterize the effects of the
PMN substances in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing specific target organ toxicity and
reproductive/developmental toxicity testing on P-17-127; specific
target organ toxicity testing on P-17-101; and acute aquatic toxicity
testing on both P-17-101 and P-17-127.
    CFR citations: 40 CFR 721.11055.

PMN Number: P-17-198

    Chemical name: Neodymium aluminium alkyl polymer complexes
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 27, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a catalyst in a closed
process. Based on physical/chemical properties of the substance and
test data on the PMN substance, EPA has identified concerns for dermal
and respiratory irritation, corrosion, developmental toxicity, and lung
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substance may present an unreasonable
risk of injury to human health. To protect against these risks, the
Order requires:
    1. Submission of glove permeation testing on the PMN substance
prior to exceeding the production volume limit as specified in the
Order.
    2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    4. No domestic manufacture of the PMN substance.
    5. No use in any manner or method where there is potential for
inhalation exposure.

    6. Use of the PMN substance in a closed system as specified in the
PMN.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measure.
    Potentially useful information: EPA has determined that the results
of glove permeability testing will help characterize the effectiveness
of protective measures to mitigate human health risk of the PMN
substance in support of a request by the PMN submitter to modify the
Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use that will be designated by this SNUR.
The submitter has agreed not to manufacture beyond a certain time
period without performing glove permeability testing.
    CFR citation: 40 CFR 721.11056.

PMN Numbers: P-17-272, P-17-273, P-17-274, P-17-275, P-17-276 and P-17-
277

    Chemical name: Fatty acid amide alkyl amine salts (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: August 4, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as a component in
asphalt emulsion. Based on SAR analysis of test data on analogous
substances, EPA has identified concerns for dermal and respiratory
irritation, corrosion, developmental toxicity, systemic effect,
sensitization and lung effects. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient
information to make a reasoned evaluation and a finding that the
substances may present an unreasonable risk of injury to human health
and environment. To protect against these risks, the Order requires:
    1. Use of the PMN substances only for the use specified in the
Order.
    2. Use of personal protective equipment for workers exposed
dermally to the PMN substances (including impervious gloves, chemical
goggles or equivalent eye protection and clothing which covers any
other exposed areas of the arms and torso).
    3. No modification of the manufacture, process or use of the PMN
substances if it results in inhalation exposure to vapor, dust, mist or
aerosol.
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    5. No release of the PMN substances into the waters of the United
States.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substances may be potentially useful to characterize the effects of the
PMN substances in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that will be designated by this SNUR.
EPA has determined that the results of specific target organ toxicity
testing of the PMN substances, and acute and chronic aquatic toxicity
testing of the PMN substances may be potentially useful in
characterizing the health and environmental effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions on manufacture, processing and distribution in
commerce, will remain in effect until the Order is modified or revoked
by EPA based on submission of this or other information that EPA
determines is relevant and needed to evaluate a modification request.
    CFR citations: 40 CFR 721.11057.

PMN Numbers: P-17-278, P-17-279 and P-17-280

    Chemical name: Fatty acid amide alkyl amine salts (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: August 4, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as a component in
asphalt emulsion. Based on SAR analysis of test data on analogous
substances, EPA has identified concerns for irritation, corrosion,
developmental toxicity, systemic effect, sensitization and lung
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned
evaluation and a finding that the substances may present an
unreasonable risk of injury to human health and environment. To protect
against these risks, the Order requires:
    1. Use of the PMN substances only for the use specified in the
Order.
    2. Use of personal protective equipment for workers exposed
dermally to the PMN substances (including impervious gloves, chemical
goggles or equivalent eye protection and clothing which covers any
other exposed areas of the arms and torso).
    3. No modification of the manufacture, process or use of the PMN
substances if it results in inhalation exposure to vapor, dust, mist or
aerosol.
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    5. No release of the PMN substances into the waters of the United
States.
    The SNUR will designate as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity of the PMN
substances may be potentially useful to characterize the effects of the
PMN substances in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that will be designated by this SNUR.
EPA has determined that the results of specific target organ toxicity
testing and acute and chronic aquatic toxicity testing of the PMN
substances may be potentially useful in characterizing the health and
environmental effects of the PMN substances. Although the Order does
not require these tests, the Order's restrictions on manufacture,
processing and distribution in commerce will remain in effect until the
Order is modified or revoked by EPA based on submission of this or
other information that EPA determines is relevant and needed to
evaluate a modification request.
    CFR citations: 40 CFR 721.11058.

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 all 145
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 SNURs identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying Orders,
consistent with TSCA section 5(f)(4).

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 identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to the restrictions imposed by the underlying
Orders, consistent with TSCA section 5(f)(4).
    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. The effective
date of this rule is October 1, 2018 without further notice, unless EPA
receives written adverse comments before August 31, 2018.
    If EPA receives written adverse comments on one or more of these
SNURs before August 31, 2018, EPA will withdraw the relevant sections
of this direct final rule before its effective date.
    This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse 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 all of the chemical substances, and the PMN submitters
are prohibited by the TSCA section 5(e) consent orders from undertaking
activities which will be designated as significant new uses. The
identities of 38 of the 145 chemical substances subject to this rule
have been claimed as confidential and EPA has received one post-PMN
bona fide submission (per Sec. Sec.  720.25 and 721.11) for a chemical
substance covered by this action. 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 August 1, 2018 (the date of public
release of this rule) as the cutoff date for determining whether the
new use is ongoing. 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 on occasion
posting rules on its website a week or more in advance of Federal
Register publication, this objective could be thwarted even before that
publication.
    Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified as of that
date will have to cease any such activity upon the effective date of
the final rule. To resume their activities, these persons will have to
first comply with all applicable SNUR notification requirements and
wait until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required with that determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: Development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (see 40 CFR 720.50). However, upon
review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. Unit IV. lists potentially useful information for
all of the listed SNURs. Descriptions of this information is provided
for informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. Furthermore, pursuant to TSCA section 4(h), which
pertains to reduction of testing in vertebrate animals, EPA encourages
consultation with the Agency on the use of alternative test methods and
strategies (also called New Approach Methodologies, or NAMs), if
available, to generate the recommended test data. EPA encourages dialog
with Agency representatives to help determine how best the submitter
can meet both the data needs and the objective of TSCA section 4(h). 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 certain of the TSCA section 5(e) consent orders for 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
specified 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. 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.
    Any request by EPA for the triggered and pended testing described
in the Consent Orders was made based on EPA's consideration of
available screening-level data, if any, as well as other available
information on appropriate testing for the PMN substances. Further, any
such testing request on the part of EPA that includes testing on
vertebrates was made after consideration of available toxicity
information, computational toxicology and bioinformatics, and high-
throughput screening methods and their prediction models.
    The potentially useful information identified 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 or other
information 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 generate useful information.
    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.
     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.
[emsp14]721.1725(b)(1) with that under Sec.  [emsp14]721.11 into a
single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.

X. SNUN Submissions

    According to Sec.  [emsp14]721.1(c), persons submitting a SNUN must
comply with the same notification requirements and EPA regulatory
procedures as persons submitting a PMN, including submission of test
data on health and environmental effects as described in 40 CFR 720.50.
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and Sec.  721.25. E-PMN software is
available electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2017-0366.

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 and TSCA section 5(e) consent orders. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
    The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate

includes the time needed to review instructions, search existing data
sources, gather and maintain the data needed, and complete, review, and
submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

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

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

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

H. Executive Order 13211

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

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

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: July 19, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.

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

PART 9--[AMENDED]

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

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

0
 2. In Sec.  [emsp14]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.

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                                                           OMB  control
                     40 CFR citation                            No.
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