[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Rules and Regulations]
[Pages 50838-50849]
[FR Doc No: 2018-21871]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0649; FRL-9984-65]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 28 chemical substances
which were the subject of premanufacture notices (PMNs). The chemical
substances are subject to 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 28
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 December 10, 2018. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 24, 2018.
    Written adverse comments on one or more of these SNURs must be
received on or before November 9, 2018 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments,
on one or more of these SNURs before November 9, 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-2018-0649, 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 November 9, 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 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 rule 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
October 25, 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.  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 28
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 28 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) 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 these rules 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 28 PMN substances that are subject to Orders
under TSCA section 5(e)(1)(A). Each Order is based on one or more of
the findings in TSCA section 5(a)(3)(B): there is insufficient
information to permit a reasoned evaluation; in the absence of
sufficient information to permit a reasoned evaluation, the activities
associated with the PMN substances may present unreasonable risk to
human health or the environment; the substance is or will be produced
in substantial quantities, and enters or may reasonably be anticipated
to enter the environment in substantial quantities or there is or may
be significant (substantial) human exposure to the substance. 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 required, 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-15-442, P-15-443, P-15-444, P-15-445, P-15-446, P-
15-447, P-15-525, P-15-526, P-15-527, and P-15-528.
    Chemical names: Rare earth doped zirconium oxide (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: January 25, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as catalysts. EPA
identified concern for lung toxicity and oncogenicity based on analogy
to respirable poorly soluble particulates and the crystalline structure
of the substances. 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 in the
absence of sufficient information to permit a reasoned evaluation, the
substances may present an unreasonable risk of injury to human health
and the environment. 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
substances will be produced in substantial quantities and that the
substances either enter 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 substances. To
protect against these risks, the Order requires:
    1. Submit to EPA certain toxicity testing for both P-15-443 and P-
15-445 within the 18 and 60-month time limits specified on the Order.
    2. Use of a National Institute of Occupational Safety and Health
(NIOSH)-certified respirator with an assigned protection factor (APF)
of at least 1,000 where there is a potential for inhalation exposure or
compliance with a NCEL of 0.07 mg/m\3\ as an 8-hour time-weighted
average to prevent inhalation 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).
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health effects 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 would be designated by this SNUR. The
submitter has agreed not to exceed the time limits in the Order without
performing specific pulmonary toxicity testing and carcinogenicity
testing on PMN substances P-15-443 and P-15-445.
    CFR citation: 40 CFR 721.11173.
    PMN Numbers: P-16-194, P-16-195, P-16-196, P-16-197, P-16-198, P-
16-199, P-16-460, P-16-461, P-16-462, P-16-463, and P-16-464.
    Chemical names: Silane-treated aluminosilicate (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: January 22, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as process aids. Based
on analysis of test data on the PMN substances, EPA identified human
health concerns for cancer and non-cancer chronic toxicity effects
associated with the metal

impurities found in the PMN substances. Environmental effects were
identified for the metal constituents in the PMN substances. 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 in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
    1. Submit to EPA metals content analysis of the material used to
manufacture the PMN substances.
    2. Provide personal protective equipment to its workers to prevent
dermal exposure where there is 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 exposures.
    4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    5. Not manufacture or process the PMN substances other than at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
    6. Not use the PMN substances other than as described in the PMN.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health effects 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 would be designated by this SNUR. The
submitter has agreed not to exceed the time limits in the Order without
sampling and analyzing the immediate precursor used to manufacture the
PMN substances via EPA Method 6010B for the following elements:
arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, lead,
manganese, mercury, nickel, selenium, silver, vanadium, and zinc.
    CFR citations: 40 CFR 721.11174.
    PMN Number: P-16-307
    Chemical Name: Heteropolycycliccarboxylic acid, 1,3-dihydro-
disubstituted-, polymer with 1,1'-methylenebis, reaction products with
silica (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: January 5, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be an open, non-dispersive
use. Based on physical/chemical properties of the PMN substance and
structure activity relationship (SAR) analysis of test data on
analogous poorly, soluble respirable particles and isocyanates, EPA
identified concerns for lung effects and dermal and respiratory
sensitization. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risks, the Order requires:
    1. Manufacture of the PMN substance to contain no more than 0.1%
residual of free isocyanate by weight;
    2. Use of personal protective equipment where there is a potential
for dermal exposure;
    3. No manufacturing, processing, or use of the PMN substance in any
manner that generates a vapor, dust, mist, or aerosol;
    4. Refraining from manufacture, processing or use for consumer use
or in commercial use where there is use in a consumer setting;
    5. Manufacture, process, or use the PMN substance only in liquid
formulation; and
    6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about health effects 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 would be designated by this SNUR. EPA has also
determined that the results of acute toxicity testing and specific
target organ toxicity testing would help characterize the potential
human effects of the PMN substance. Although the Order does not require
these tests, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or relevant
information.
    CFR citation: 40 CFR 721.11175.
    PMN Number: P-17-176
    Chemical name: Carbonic acid, alkyl carbomonocyclic ester
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: February 21, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substance will be as a battery
ingredient. Based on toxicology data from an analogue, EPA has
identified possible human health concerns for developmental toxicity
and effects on the ovaries, adrenals and liver. 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 in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health. To protect against these risk, the Order
requires:
    1. Submit to EPA certain toxicity testing within 3 years of the
notice of commencement of manufacturing (including import) of the PMN
substance;
    2. Use of personal protective equipment to its workers to prevent
dermal exposure 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. Refraining from domestic manufacture in the United States (i.e.,
import only); and
    5. No release of the PMN substance into waters of the United States
exceeding 45 parts per billion.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the environmental and health effects 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 would be designated by this SNUR.
The submitter has agreed not to manufacture the PMN substance without
performing specific reproductive/developmental toxicity testing 3 years
from the notice of commencement. EPA has also determined that the
results of specific chronic aquatic toxicity testing would help
characterize the potential environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11176.
    PMN Number: P-17-183.

    Chemical name: 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with 2-(chloromethyl)oxirane, reaction products with polyethylene-
polypropylene glycol 2-aminopropyl Me ether.
    CAS number: 1627528-04-4.
    Effective date of TSCA section 5(e) Order: February 28, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substance will be as a pigment wetting
and dispersing additive. Based on the surfactant potential of the PMN
compound, EPA has identified concerns for lung effects to workers if
respirable particulates or droplets are inhaled. 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 substance. To protect
against these risks, the Order requires:
    1. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
    2. Refraining from domestic manufacture in the United States (i.e.,
import only);
    3. No manufacturing, processing, or using the PMN substance in any
manner that results in inhalation exposure to vapors, mists, aerosols
or dusts;
    4. No use of the PMN substance other than the confidential uses
allowed by the Order; and
    5. No use of the PMN substance in consumer products.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health effects 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 would be designated by this SNUR. EPA has
determined that the results of specific physical-chemical properties
and acute and chronic pulmonary toxicity testing would help
characterize the potential health effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11177.
    PMN Number: P-17-232.
    Chemical name: Copolyamide of an aromatic dicarboxylic acid and a
mixture of diamines (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 5, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance is as an engineering
thermoplastic. Based on SAR analysis on structurally similar poorly
soluble particles, EPA identified concerns for lung effects to workers
if respirable particles are present. The Order was issued under TSCA
section 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health. To protect against these risk, the Order requires:
    Manufacture the PMN substance with a particle size of greater than
10 microns.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health effects 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 would be designated by this SNUR. EPA has also
determined that the results of pulmonary toxicity testing would help
characterize the potential human effects of the PMN substance. Although
the Order does not require this testing, the Order's restrictions
remain in effect until the Order is modified or revoked by EPA based on
submission of this or relevant information.
    CFR citation: 40 CFR 721.11178.
    PMN Number: P-17-257.
    Chemical name: Single-walled carbon nanotubes.
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: January 17, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an additive in
composite materials for mechanical, thermal, and conductivity
improvements. Based on analysis of analogous carbon nanotubes, EPA
identified concerns for pulmonary toxicity. Based on analogous carbon
nanotubes, EPA also identified potential toxicity to aquatic organisms
if the PMN substance is released to water. The order was issued under
TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the PMN substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
    1. Submit to EPA certain toxicity testing before manufacturing
(including import) by the times specified in the Order.
    2. Provide personal protective equipment to its workers to prevent
dermal exposure where there is a potential for dermal exposure.
    3. Provide NIOSH certified respirators with an APF of at least 50
to its workers to prevent inhalation exposure.
    4. No use of the PMN substance in application methods that generate
a dust, vapor, mist or aerosol.
    5. Use the PMN substance for industrial uses only.
    6. Use the PMN substance only for the confidential uses allowed in
the Order.
    7. No release of the PMN substance to water.
    8. Disposal of the PMN substance only via landfill or incineration.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the environmental and health effects 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 would be designated by this SNUR.
The submitter has agreed not to manufacture the PMN substance without
performing specific physical property and pulmonary toxicity testing.
EPA has also determined that the results of specific chronic aquatic
toxicity testing would help characterize the potential environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or relevant
information.
    CFR citation: 40 CFR 721.11179.
    PMN Number: P-17-283.
    Chemical name: Arenesulfonic acid, alkyl derivatives, metal salts
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: February 6, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a lubricating oil
additive for automotive engine oils. Based on

analysis of test data on the PMN substance, EPA identified concern for
corrosion to skin, eyes, mucous membranes, and lungs. There is also
concern for surfactant effects on the lung based on surfactant
properties of the compounds. There is also concern for acute toxicity,
mutagenicity, irritation, and sensitization based on submitted analogue
test data. 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 in the absence of
sufficient information to permit a reasoned evaluation, the substance
may present an unreasonable risk of injury to human health and the
environment. 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 is or will be produced in substantial quantities and that the
substance wither 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. Submit to EPA certain toxicity testing within six months of
filing a notice of commencement (NOC) to EPA;
    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; and
    4. Refrain from manufacturing, processing, or using the PMN
substance in any manner that produces vapor, mist, spray or aerosol.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health effects 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 would be designated by this SNUR. The
submitter has agreed not to manufacture the PMN substance without
performing sensitization testing. EPA has also determined that the
results of specific physical-chemical properties and acute and chronic
pulmonary toxicity testing would help characterize the potential health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or relevant
information.
    CFR citation: 40 CFR 721.11180.
    PMN Number: P-17-353.
    Chemical name: Heteromonocycle, 2-[(bicarbomonocycle-2-
substituted)alkyl]- (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: February 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an additive in resin
manufacture. Based on information on analogous substances, EPA has
identified concerns for irritation to the eye, lung, and mucous
membranes, skin and lung sensitization, oncogenicity, developmental
toxicity, male reproductive toxicity, liver toxicity, and kidney
toxicity. Ecotoxicity hazard concerns were high based on EcoSAR
analysis of analogous chemical. 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 in the absence of sufficient information to permit a reasoned
evaluation, the PMN substance may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e.,
import only);
    2. Use of the PMN substance only for the confidential use allowed
in the Order;
    3. No processing and use of the PMN substance using methods that
may generate a spray, mist or aerosol.
    4. Use of personal protective equipment where there is a potential
for dermal exposure.
    5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
    6. No release of the PMN substance into the waters of the United
States.
    The SNUR designates as a ``significant new use'' the absence of
these protective measures.
    Potentially useful information: EPA has determined that certain
information about the environmental and health effects 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 would be designated by this SNUR.
EPA has also determined that the results of specific acute and chronic
aquatic toxicity testing, skin sensitization testing, carcinogenicity
testing, and specific target organ testing would help characterize the
potential human effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or relevant information.
    CFR citation: 40 CFR 721.11181.

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 28 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) 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, use, 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 December 10, 2018without further notice, unless
EPA receives written adverse comments before November 9, 2018.
    If EPA receives written adverse comments on one or more of these
SNURs before November 9, 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 an
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) Orders have been issued
for all of the chemical substances, and the PMN submitters are
prohibited by the TSCA section 5(e) Orders from undertaking activities
which will be designated as significant new uses. The identities of 26
of the 28 chemical substances subject to this rule have been claimed as
confidential and EPA has received no post-PMN bona fide submissions
(per Sec. Sec.  720.25 and 721.11) 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 October 10, 2018 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.
    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 the information are 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).
    In certain of the TSCA section 5(e) Orders for the chemical
substances regulated under this rule, EPA has established production
volume or time limits in view of the lack of data on the potential
health and environmental risks that may be posed by the significant new
uses or increased exposure to the chemical substances. These limits
cannot be exceeded unless the PMN submitter first submits the results
of toxicity tests that would permit a reasoned evaluation of the
potential risks posed by these chemical substances. Listings of the
information required in the TSCA section 5(e) Orders are included in
Unit IV. The SNURs contain the same production volume limits as the
TSCA section 5(e) 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 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.
    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 may
increase the likelihood that EPA will take action under TSCA section
5(e), particularly if satisfactory test results have not been obtained
from a prior PMN or SNUN submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     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.
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.

X. SNUN Submissions

    According to Sec.  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 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-2018-0649.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances
that were the subject of PMNs, or TSCA section 5(e) 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: October 1, 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.  9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:

Sec.  9.1   OMB approvals under the Paperwork Reduction Act.

* * * * *

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

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

                                * * * * *
721.11173...............................................       2070-0012
721.11174...............................................       2070-0012
721.11175...............................................       2070-0012
721.11176...............................................       2070-0012
721.11177...............................................       2070-0012
721.11178...............................................       2070-0012
721.11179...............................................       2070-0012
721.11180...............................................       2070-0012
721.11181...............................................       2070-0012

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

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  721.11173 to subpart E to read as follows:

Sec.  721.11173   Rare earth doped zirconium oxide (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as rare
earth doped zirconium oxide (P-15-442, P-15-443, P-15-444, P-15-445, P-
15-446, P-15-447, P-15-525, P-15-526, P-15-527, and P-15-528) are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (when determining which persons are reasonably likely to
be exposed as required for Sec.  721.63(a)(4), engineering control
measures (e.g., enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible), (a)(5) (respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor of at least 1000), (a)(6) (particulate), (b)
(concentration set at 1.0%), and (c).

    (A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 0.07 mg/m\3\ as
an 8-hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec.  721.63 respirator requirements may request to do
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii),
(g)(2)(ii), (iii), (iv)(use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.07 mg/m\3\), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(p) (18 months).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d) and (f) through (i) are applicable to
manufacturers and processors of the substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.11174 to subpart E to read as follows:

Sec.  721.11174  Silane-treated aluminosilicate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
silane-treated aluminosilicate (PMNs P-16-194, P-16-195, P-16-196, P-
16-197, P-16-198, P-16-199, P-16-460, P-16-461, P-16-462, P-16-463, and
P-16-464) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substances after they have been completely incorporated into a polymer
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (when determining which persons are reasonably likely to
be exposed as required for Sec.  721.63(a)(4), engineering control
measures (e.g. enclosure or confinement of operation, general and local
ventilation) or administrative control measures (e.g. workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible), (a)(5) (respirators must provide a National
Institute for Occupational Safety and Health assigned protection factor
of at least 50), (a)(6) (particulate), (b) (concentration set at 0.1%),
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(ii),
(iii), (iv), (v), (vi), (vii), (viii), (ix), (g)(2)(i), (ii), (iii),
(iv), (v), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture the substances without sampling and analyzing the immediate
precursor used to manufacture the substances according to the terms
specified in the 5(e) Order for the following elements: Arsenic,
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese,
mercury, nickel, selenium, silver, vanadium, and zinc. It is a
significant new use to manufacture the substances at facilities other
than those equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency. It is a
significant new use to process the substances other than in an enclosed
system that does not allow for the release of particulates or at
facilities equipped with pollution controls, such as a bag house, that
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), (f), (g), (h), and (i) are applicable to
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
6. Add Sec.  721.11175 to subpart E to read as follows:

Sec.  721.11175  Heteropolycycliccarboxylic acid, 1,3-dihydro-
disubstituted-, polymer with 1,1'-methylenebis, reaction products with
silica (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
heteropolycycliccarboxylic acid, 1,3-dihydro-disubstituted-, polymer
with 1,1'-methylenebis, reaction products with silica (P-16-307) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(6) (particulate),
(when determining which persons are reasonably likely to be exposed as
required for Sec.  721.63(a)(1), engineering control measures (e.g.
enclosure or confinement of the operation, general and local
ventilation) or administrative control measures (e.g. workplace
policies and procedures) shall be considered and implemented to prevent
exposures, where feasible), (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substance for consumer use or for
commercial uses that could introduce the substance into a consumer
setting. It is a significant new use to manufacture, process, or use
the substance other than in a liquid formulation. It is a significant
new use to manufacture the PMN substance to contain more than 0.1%
residual isocyanate by weight. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in generation of a vapor, dust, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.

    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  721.11176 to subpart E to read as follows:

Sec.  721.11176   Carbonic acid, alkyl carbomonocyclic ester (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbonic acid, alkyl carbomonocyclic ester (PMN P-17-176) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2), (a)(2)(i), (iv), (a)(3), (a)(6) (particulate),
(a)(6)(v), (vi), (when determining which persons are reasonable likely
to be exposed as required for Sec.  721.63(a)(1), engineering control
measures (e.g. enclosure or confinement of the operation, general and
local ventilation) or administrative control measures (e.g. workplace
policies and procedures) shall be considered and implemented to prevent
exposures, where feasible), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(iv), (v),
(vi), (ix), (g)(2)(i), (v), (g)(3)(i), (ii), (g)(4) (do not release to
water above 45 parts per billion), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f) and (p)(3 years).
    (iv) Release to water. Release to water requirements as specified
in Sec.  721.90(a)(4), (b)(4), and (c)(4) where N = 45 ppb.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), (k).
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.11177 to subpart E to read as follows:

Sec.  721.11177   1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer
with 2-(chloromethyl)oxirane, reaction products with polyethylene-
polypropylene glycol 2-aminopropyl Me ether.

    (a) Chemical substance and significant new used subject to
reporting. (1) The chemical substance identified as 1,3-propanediol, 2-
ethyl-2-(hydroxymethyl)-, polymer with 2-(chloromethyl)oxirane,
reaction products with polyethylene-polypropylene glycol 2-aminopropyl
Me ether (PMN P-17-183, CAS No 1627528-04-4) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii),
(g)(2)(ii), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k), (o). It is a significant new use
to process or use the substance in any manner way that results in
generation of a vapor, dust, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f) through (i) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  721.11178 to subpart E to read as follows:

Sec.  721.11178  Copolyamide of an aromatic dicarboxylic acid and a
mixture of diamines (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
copolyamide of an aromatic dicarboxylic acid and a mixture of diamines
(PMN P-17-232) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture the substance with a particle size less than 10 microns.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i).
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.11179 to subpart E to read as follows:

Sec.  721.11179  Single-walled carbon nanotubes.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as single-walled
carbon nanotubes (PMN P-17-257) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substances that have been:
    (i) Embedded or incorporated into a polymer matrix that itself has
been reacted (cured);
    (ii) Embedded in a permanent solid polymer form that is not
intended to undergo further processing, except mechanical processing;
or
    (iii) Incorporated into an article as defined at 40 CFR 720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (when determining which
persons are reasonable likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measure (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible), (a)(5)(respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 50), (a)(6) (particulate), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(f), (k), (p) (6 months), (y)(1), and
(y)(2). (It is a significant new use to process or use the substance
for non-industrial use except for the confidential non-industrial use
described in the 5(e) Order).

    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), (c)(2).
    (iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (j), and (k) are applicable to manufacturers
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.

0
11. Add Sec.  721.11180 to subpart E to read as follows:

Sec.  721.11180  Arenesulfonic acid, alkyl derivatives, metal salts
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
arenesulfonic acid, alkyl derivatives, metal salts (PMN P-17-283) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii), (a)(3), (when determining which persons
are reasonably likely to be exposed as required for Sec.  721.63(a)(1),
engineering control measures (e.g. enclosure or confinement of
operation, general and local ventilation) or administrative control
measures (e.g. workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(skin
sensitization), (eye irritation), (lung effects), (skin corrosion),
(g)(2)(i), (iii), (v), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(p) (6 months). It is a significant new use
to manufacture, process or use the substance in any manner way that
results in generation of a vapor, mist, spray, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i).
    (2) Limitations or revocation of certain notification requirements.
The provision of Sec.  721.185 apply to this section.

0
12. Add Sec.  721.11181 to subpart E to read as follows:

Sec.  721.11181  Heteromonocycle, 2-[(bicarbomonocycle-2-
substituted)alkyl]- (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocycle, 2-[(bicarbomonocycle-2-substituted)alkyl]- (PMN P-17-
353) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substance after they
have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), (iv), (a)(3), (when determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g. enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g. workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible), (b) (concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1),
(g)(1)(iv), (vi), (vii), (ix), (mutagenicity), (eye, skin, lung, and
mucous membrane irritation), (skin and lung sensitization), (g)(2)(i),
(ii), (iii), (v), (avoid workplace airborne concentrations), (g)(3)(i),
(ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities: Requirements
as specified in Sec.  721.80(f) and (k). It is a significant new use to
process or use the substance in any manner that generates a vapor,
spray, mist, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.
721.90(b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[FR Doc. 2018-21871 Filed 10-9-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Rules and Regulations]
[Pages 44061-44063]
[FR Doc No: 2017-19750]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2017-0754]
RIN 1625-AA08

Special Local Regulation; Frogtown Regatta, Maumee River, Toledo,
OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary special local
regulation for all navigable waters of the Maumee River, Toledo, OH
from the Martin Luther King Jr. Memorial Bridge at Maumee river mile
4.30 to the Michael DiSalle Bridge at River mile 6.73. This regulated
area is necessary to protect spectators and vessels from potential
hazards associated with the Frogtown Regatta. Entry of vessels or
persons into this regulated area is prohibited unless specifically
authorized by the Captain of the Port Detroit, or a designated
representative.

DATES: This temporary final rule is effective from 5 a.m. through 6
p.m. on September 23, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-0754 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Ryan Erpelding, Prevention Department,
MSU Toledo, Coast Guard; telephone<PHONE_NUMBER>, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
Coast Guard did not receive the final details of this regatta until
there was insufficient time remaining before the event to publish an
NPRM. We must establish this area by September 23, 2017 and lack
sufficient time to provide a reasonable comment period and then
consider those comments before issuing the rule.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), for the
reasons stated above, the Coast Guard finds that good cause exists for
making this temporary

rule effective less than 30 days after publication in the Federal
Register.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1233. The Captain of the Port Detroit (COTP) has determined that
potential hazard associated with regatta from 5 a.m. through 6 p.m. on
September 23, 2017 will be a safety concern to anyone within waters of
the Maumee River, Toledo, OH from the Martin Luther King Jr. Memorial
Bridge at river mile 4.30 to the Michael DiSalle Bridge at river mile
6.73. This rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone while the
regatta occurs.

IV. Discussion of the Rule

    This rule establishes a safety zone from 5 a.m. through 6 p.m. on
September 23, 2017. The safety zone will encompass all U.S. navigable
waters of the Maumee River, Toledo, OH from the Martin Luther King Jr.
Memorial Bridge at river mile 4.30 to the Michael DiSalle Bridge at
river mile 6.73. No vessel or person will be permitted to enter the
safety zone without obtaining permission from the COTP or a designated
representative.
    The Coast Guard will patrol the regatta area under the direction of
the Captain of the Port Detroit (COTP), or a designated representative.
A designated representative may be a Coast Guard Patrol Commander.
Vessels desiring to transit the regulated area may do so only with
prior approval of the COTP or a designated representative and when so
directed by that officer. Vessels will be operated at a no wake speed
to reduce the wake to a minimum, in a manner which will not endanger
participants in the event or any other craft and remain vigilant for
event participants and safety craft. Additionally, vessels must yield
right-of-way for event participants and event safety craft and must
follow directions given by the COTP or a designated representative. The
rules contained in the above two sentences do not apply to participants
in the event or vessels of the patrol operating in the performance of
their assigned duties. Commercial vessels will have right-of-way over
event participants and event safety craft. The races will stop for
oncoming freighter or commercial traffic and will resume after the
vessel has completed its passage through the regulated area. COTP or a
designated representative may direct the anchoring, mooring, or
movement of any boat or vessel within the regatta area. A succession of
sharp, short signals by whistle or horn from vessels patrolling the
area under the direction of the U.S. COTP or a designated
representative shall serve as a signal to stop. Vessels so signaled
must stop and comply with the orders of the COTP or a designated
representative. Failure to do so may result in expulsion from the area,
citation for failure to comply, or both. The COTP or a designated
representative may establish vessel size and speed limitations and
operating conditions and may restrict vessel operation within the
regatta area to vessels having particular operating characteristics.
The COTP or a designated representative may terminate the marine event
or the operation of any vessel at any time it is deemed necessary for
the protection of life and property.
    Patrol Commander means a Coast Guard commissioned, warrant, or
petty officer who has been designated by the COTP to monitor a regatta
area, permit entry into the regatta area, give legally enforceable
orders to persons or vessels within the regatta area, and take other
actions authorized by the COTP. The Patrol Commander will be aboard
either a Coast Guard or Coast Guard Auxiliary vessel. The Patrol
Commander may be contacted on Channel 16 (156.8 MHZ) by the call sign
``Coast Guard Patrol Commander.''

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771. This regulatory action
determination is based on the size, location, duration, and time-of-
year of the regulated area. Vessel traffic will be able to safely
transit around this regulated area, which will impact a small
designated area of the Maumee River from 5 a.m. through 6 p.m. on
September 23, 2017. Moreover, the Coast Guard will issue Broadcast
Notice to Mariners via VHF-FM marine channel 16 about the regulated
area and the rule allows vessels to seek permission to enter the
regulated area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a special local regulation interval lasting from 5a.m.
through 6 p.m., that will prohibit entry within waters of the Maumee
River, Toledo, OH from the Martin Luther King Jr. Memorial Bridge at
river mile 4.30 to the Michael DiSalle Bridge at river mile 6.73. It is
categorically excluded under section 2.B.2, figure 2-1, paragraph 34(h)
of the Commandant Instruction. A Record of Environmental Consideration
(REC) supporting this determination is available in the docket where
indicated in the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 100

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. In Sec.  100.928, effective from 5 a.m. through 6 p.m. on September
23, 2017, suspend paragraph (b) and add paragraph (d) to read as
follows:

Sec.  100.928  Special Local Regulation; Frogtown Regatta, Maumee
River, Toledo, OH.

* * * * *
    (d) Enforcement period. The regulated area described in paragraph
(a) of this section will be enforced from 5 a.m. through 6 p.m. on
September 23, 2017.

    Dated: September 11, 2017.
Jeffrey W. Novak,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2017-19750 Filed 9-20-17; 8:45 am]
 BILLING CODE 9110-04-P