[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Notices]
[Pages 4651-4653]
[FR Doc No: 2018-02027]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0265; FRL-9972-01]

Dicloran (DCNA); Amendments To Terminate Uses for Certain
Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's final order for the amendments to
terminate uses, voluntarily requested by the registrant and accepted by
the Agency, of products containing dicloran (DCNA), pursuant to section
6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended. This termination order follows a March 16, 2016
Federal Register Notice of Receipt of Request from the registrant
listed in Table 2 of Unit III. to voluntarily amend product
registrations to terminate DCNA use on certain products. The Agency
hereby issues in this notice a termination order granting the requested
amendments to terminate DCNA use on certain products. Any distribution,
sale, or use of the products subject to this termination order is
permitted only in accordance with the terms of this order, including
any existing stocks provisions.

DATES: The amendments are valid February 1, 2018.

FOR FURTHER INFORMATION CONTACT: Patricia Biggio, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; fax number: (703) 308-
7070; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0265. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday

through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

II. Background

    This termination order follows a Federal Register of March 16, 2016
(81 FR 14109) (FRL-9941-37), Notice of Receipt of Request from the
registrant listed in Table 2 of Unit III. to voluntarily amend product
registrations to terminate DCNA use on apricot, chrysanthemum, conifer,
gladiolus, grape, greenhouse cucumber, greenhouse lettuce, greenhouse
rhubarb, greenhouse tomato, nectarine, peach, plum/prune, rose, and
sweet cherry. These are not the last products containing this pesticide
registered for use in the United States (U.S.). In the March 16, 2016
notice, EPA indicated that it would issue an order implementing the
amendments to terminate uses, unless the Agency received substantive
comments within the 180-day comment period that would merit its further
review of these requests, or unless the registrant withdrew their
request. The Agency received seven comments on the notice; none of
which would affect the Agency's action. The Agency hereby issues in
this notice a termination order granting the requested amendments to
terminate these DCNA uses.

III. What action is the Agency taking?

    This notice announces the amendments to delete uses, as requested
by the sole registrant, of products registered under section 3 of
FIFRA. These registrations are listed in sequence by registration
number in Table 1 of this unit.

      Table 1--DCNA Product Registration Amendments To Delete Uses
------------------------------------------------------------------------
  EPA  registration No.        Product name           Uses deleted
------------------------------------------------------------------------
10163-189................  Botran 75-W          apricots,
10163-195................   Fungicide.           chrysanthemums,
10163-226................  Botran Technical...   conifers, gladiolus,
                           Botran 5F Fungicide   grapes, greenhouse
                                                 cucumbers, greenhouse
                                                 lettuce, greenhouse
                                                 rhubarb, greenhouse
                                                 tomato, nectarines,
                                                 peaches, plums/prunes,
                                                 roses, and sweet
                                                 cherries.
10163-329................  Botran P 5F
                            Fungicide.
------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record for
the registrant of the products in Table 1 of this unit, in sequence by
EPA company number. This number corresponds to the first part of the
EPA registration numbers of the products listed above.

                 Table 2--Registrant of Amended Products
------------------------------------------------------------------------
             EPA  company No.                 Company name and address
------------------------------------------------------------------------
10163.....................................  Gowan Company, P.O. Box
                                             5569, Yuma, AZ 85366-5569.
------------------------------------------------------------------------

IV. Summary of Public Comments Received and Agency Response to Comments

    During the public comment period provided, EPA received seven
comments in response to the Federal Register of March 16, 2016 (81 FR
14109), notice announcing the Agency's receipt of the request to
voluntarily amend product registrations to delete DCNA uses for
products listed in Table 1 of Unit III.
    Six of the seven comments were from growers outside of the U.S.
that supported the continued use of DCNA. In addition, the Agency also
received a single comment from the registrant (Gowan) which proposed
the conversion of dicloran crop residue tolerances to import tolerances
based on conclusions from previous DCNA risk assessments and Pesticide
Data Program (PDP) data from 2004 to 2014. The Agency has reviewed
these comments and the Agency's formal response is available at
regulation.gov in the DCNA reregistration docket EPA-HQ-OPP-2005-0265.
    Per the Agency's response, the 2006 dietary risk assessment
concluded that dietary exposure from all currently registered crops
does not exceed the Agency's level of concern. In addition, following a
review of available monitoring data, EPA concluded that the small
number of samples with detectable residues in monitoring data and the
low residue levels found in those samples support Gowan's claim that
imported commodities are not likely to pose risks of concern. The
monitoring data also supports Gowan's assertion that the subject
commodities will not likely be contaminated with residue levels over
tolerance. Therefore, the Agency does not expect that the use of DCNA
on the subject commodities will create a risk of concern. As such, the
Agency supports retaining the DCNA tolerances for import of these
commodities to avoid potential trade barriers with countries that use
Codex Maximum Residue Levels (MRLs) or have DCNA tolerances established
for these commodities, and will convert the existing tolerances to
import tolerances in a separate action.

V. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
amendments to terminate uses of DCNA for registrations identified in
Table 1 of Unit III. Accordingly, the Agency hereby orders that the
product registrations identified in Table 1 of Unit III. are amended to
terminate use on apricots, chrysanthemums, conifers, gladiolus, grapes,
greenhouse cucumbers, greenhouse lettuce, greenhouse rhubarb,
greenhouse tomato, nectarines, peaches, plums/prunes, roses, and sweet
cherries. The effective date of the amendments to terminate affected
uses that are subject of this notice is February 1, 2018. Any
distribution, sale, or use of existing stocks of the products
identified in Table 1 of Unit III. in a manner inconsistent with any of
the provisions for disposition of existing stocks set forth in Unit
VII. will be a violation of FIFRA.

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

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment in the Federal Register of March 16, 2016 (81 FR 14109) (FRL-
9941-37). The comment period closed on September 12, 2016.

VII. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and

which were packaged, labeled, and released for shipment prior to the
effective date of the action. The existing stocks provision for the
products subject to this order is as follows.
    The registrant may continue to sell and distribute existing stocks
of products listed in Table 1 until February 1, 2019, which is 1 year
after publication of this termination order in the Federal Register.
Thereafter, the registrant is prohibited from selling or distributing
products listed in Table 1 of Unit III. that contains directions for
use on the deleted uses, except for export in accordance with FIFRA
section 17 or for proper disposal.
    Persons other than the registrant may sell, distribute, or use
existing stocks of products listed in Table 1 of Unit III until
supplies are exhausted, provided that such sale, distribution, or use
is consistent with the terms of the previously approved labeling on, or
that accompanied, the deleted uses.

    Authority: 7 U.S.C. 136 et. seq.

    Dated: January 10, 2018.
Yu-Ting Guilaran,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2018-02027 Filed 1-31-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 94 (Wednesday, May 15, 2019)]
[Rules and Regulations]
[Pages 21703-21704]
[FR Doc No: 2019-10033]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0362]

Safety Zones; Fireworks Displays in the Fifth Coast Guard
District

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Barnegat Bay, Ocean Township,
NJ, safety zone from 9:00 p.m. through 10:00 p.m. on May 25, 2019. This
action is necessary to ensure safety of life on the navigable waters of
the United States immediately prior to, during, and immediately after
the fireworks displays. Our regulation for safety zones of fireworks
displays in the Fifth Coast Guard District identifies the regulated
area for this event on Barnegat Bay in Ocean Township, NJ. During the
enforcement period, vessels may not enter, remain in, or transit
through the safety zone unless authorized by the Captain of the Port or
designated Coast Guard patrol personnel on scene.

DATES: The regulations in the table to 33 CFR 165.506 at (a)(12) will
be enforced from 9:00 p.m. through 10:00 p.m. on May 25, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, you may call or email Petty Officer Thomas
Welker, U.S. Coast Guard, Sector Delaware Bay, Waterways Management
Division, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
in the Table to 33 CFR 165.506, entry (a)(12) for the Ocean Township
Memorial Day Fireworks display from 9:00 p.m. through 10:00 p.m. on May
25, 2019. This action is necessary to ensure safety of life on the
navigable waters of the United States immediately prior to, during, and
immediately after the fireworks displays. Our regulation for safety
zones of fireworks displays within the Fifth Coast Guard District,
table to Sec.  165.506, entry (a)(12), specifies the location of the
regulated area as all waters of Barnegat Bay in Ocean Township, NJ,
within 500 yards of a fireworks barge launch site at approximate
position latitude 39[deg]47'33'' N, longitude 074[deg]10'46'' W. During
the enforcement period, as reflected in Sec.  165.506(d), vessels may
not enter, remain in, or transit through the safety zone during the
enforcement period unless authorized by the Captain of the Port or
designated Coast Guard patrol personnel on scene.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard will provide notification of this enforcement period
via broadcast notice to mariners.

    Dated: May 10, 2019.
Scott E. Anderson,
Captain, U.S. Coast Guard, Captain of the Port, Delaware Bay.
[FR Doc. 2019-10033 Filed 5-14-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43550-43551]
[FR Doc No: 2021-16937]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0030]

Extension of the Period Before the Food and Drug Administration
Intends To Begin Enforcing the Statutory 5 Percent Limit on Out of
State Distribution of Compounded Human Drug Products

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; extension of the period before FDA intends to begin
enforcing the statutory 5 percent limit on out of state distribution of
compounded human drug products.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the period for States to decide whether to sign the final
standard memorandum of understanding (MOU) entitled ``Memorandum of
Understanding Addressing Certain Distributions of Compounded Human Drug
Products Between the [insert State Board of Pharmacy or Other
Appropriate State Agency] and the U.S. Food and Drug Administration''
(final standard MOU) before FDA intends to begin enforcing the
statutory 5 percent limit on distribution of compounded human drug
products out of the State in which they are compounded in States that
do not sign the final standard MOU. FDA is extending the period, which
was scheduled to end on October 27, 2021, to October 27, 2022. States
may sign the final standard MOU at any time, including after the period
is scheduled to end on October 27, 2022.

DATES: FDA is extending the period before FDA intends to begin
enforcing the statutory 5 percent limit on distribution of compounded
human drug products out of the State in which they are compounded in
States that do not sign the final standard MOU as of August 9, 2021.

FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5169, Silver Spring, MD 20993-0002, 240-
402-4078.

SUPPLEMENTARY INFORMATION: Section 503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that
must be satisfied for drug products compounded by a licensed pharmacist
or licensed physician in a State licensed pharmacy or a Federal
facility, to be exempt from the following sections of the FD&C Act: (1)
Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP) requirements), (2) section 502(f)(1) (21
U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use), and (3) section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug applications or abbreviated new
drug applications).
    One of the conditions to qualify for the exemptions listed in
section 503A of the FD&C Act is that (1) the drug product is compounded
in a State that has entered into an MOU with FDA that addresses the
distribution of inordinate amounts of compounded drug products
interstate and provides for appropriate

investigation by a State agency of complaints relating to compounded
drug products distributed outside such State; or (2) if the drug
product is compounded in a State that has not entered into such an MOU,
the licensed pharmacist, pharmacy, or physician does not distribute, or
cause to be distributed, compounded drug products out of the State in
which they are compounded in quantities that exceed 5 percent of the
total prescription orders dispensed or distributed by such pharmacy or
physician (statutory 5 percent limit) (see section 503A(b)(3)(B)(i) and
(ii) of the FD&C Act).
    In the Federal Register of October 27, 2020 (85 FR 68074), FDA
announced the availability of the final standard MOU describing the
responsibilities of a State Board of Pharmacy or other appropriate
State agency that chooses to sign the final standard MOU in
investigating and responding to complaints related to drug products
compounded in such State and distributed outside such State and in
addressing the interstate distribution of inordinate amounts of
compounded human drug products.
    In the October 27, 2020, Federal Register notice, FDA stated that
it was providing a 365-day period for States to decide whether to sign
the final standard MOU before FDA intended to begin enforcing the
statutory 5 percent limit in States that do not sign the final standard
MOU. Based on comments from stakeholders, it was FDA's understanding
that this timeframe corresponds to a full legislative cycle for most
States and would, therefore, afford sufficient time for States to
modify their laws and regulations, if necessary in order to enter into
the final standard MOU.
    Following publication of October 27, 2020, Federal Register notice,
FDA received requests to extend the period before FDA intends to begin
enforcing the statutory 5 percent limit in States that do not sign. The
requesters asserted that the time period of 365 days was insufficient
to allow State governments to thoroughly evaluate the final standard
MOU and modify their laws and regulations, if necessary in order to
sign, because many State governments were focused on addressing
concerns raised by the Coronavirus Disease 2019 (COVID-19) pandemic.
    FDA has considered the requests and other relevant factors and is
extending the period before FDA intends to begin enforcing the
statutory 5 percent limit in States that do not sign the final standard
MOU until October 27, 2022. FDA believes that an additional 1 year will
allow sufficient time for States to consider the final standard MOU and
modify their laws and regulations, if necessary. FDA's understanding is
that emergency pandemic response activities have now begun to ease,
permitting States more time to take up other issues. Accordingly, we
believe a 1-year extension addresses the need that some States have
expressed for additional time, without adding significant delay to
FDA's implementation of the important public health protections
afforded by section 503A(b)(3)(B) of the FD&C Act.
    States may sign the final standard MOU at any time, including after
the period is scheduled to end on October 27, 2022.

    Dated: August 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16937 Filed 8-6-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Proposed Rules]
[Pages 45723-45725]
[FR Doc No: 2022-16222]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0711; Airspace Docket No. 21-ANM-64]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Colorado Plains Regional
Airport, CO

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify the Class E airspace designated
as a surface area, modify the Class E airspace extending upward from
700 feet above the surface, and remove the Class E airspace extending
upward from 1,200 feet above the surface at Colorado Plains Regional
Airport, CO. Additionally, this action proposes several administrative
amendments to update the airport's existing Class E airspace legal
descriptions. These actions will ensure the safety and management of
instrument flight rule (IFR) operations at the airport.

DATES: Comments must be received on or before September 12, 2022.

ADDRESSES: Send comments on this proposal to the U.S. DOT, Docket
Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room
W12-140, Washington, DC 20590; telephone:<PHONE_NUMBER>, or (202) 366-
9826. You must identify ``FAA Docket No. FAA-2022-0711; Airspace Docket
No. 21-ANM-64,'' at the beginning of your comments. You may also submit
comments through the internet at www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Nathan A. Chaffman, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code (U.S.C.). Subtitle I,
Section 106 describes the authority of the FAA Administrator. Subtitle
VII, Aviation Programs, describes in more detail the scope of the
agency's authority. This rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority, as it would modify Class E airspace at Colorado Plains
Regional Airport, CO, to support IFR operations at the airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related

aspects of the proposal. Communications should identify both docket
numbers and be submitted in triplicate to the address listed above.
Persons wishing the FAA to acknowledge receipt of their comments on
this notice must submit with those comments a self-addressed, stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2022-0711; Airspace Docket No. 21-ANM-64.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA
98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, dated August
10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is
publicly available as listed in the ADDRESSES section of this document.
FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air
traffic service routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by modifying
the Class E airspace designated as a surface area, modifying the Class
E airspace extending upward from 700 feet above the surface, and
removing the Class E airspace extending upward from 1,200 feet above
the surface at Colorado Plains Regional Airport, CO.
    The Class E airspace designated as a surface area should be
expanded to more appropriately contain circling maneuvers.
    The Class E airspace extending upward from 700 feet above the
surface should be expanded to the southeast to contain aircraft
conducting procedure turns for the VOR RWY 29 approach, as terrain
exists within 1,500 feet of the minimum procedure turn altitude.
    The Class E airspace extending upward from 1,200 feet above the
surface should be removed, as this area is already contained within the
Denver en route domestic airspace area, and duplication is not
necessary.
    Finally, this action proposes several administrative modifications
to airport's legal descriptions. The airport name in the text header is
incorrect in the existing Class E2 and E5 legal descriptions. They
should read: ``Colorado Plains Regional Airport, CO.'' The geographic
coordinates for the airport should be updated to match the FAA's
database. The navigational aid (NAVAID) used in the existing Class E2
legal description should be removed. The NAVAID has been reclassified,
and is not needed to describe the airspace. Its removal will simplify
the airspace description.
    Class E2 and E5 airspace designations are published in paragraphs
6002 and 6005, respectively, of FAA Order JO 7400.11F, dated August 10,
2021, and effective September 15, 2021, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designations listed in
this document will be published subsequently in FAA Order JO 7400.11,
which is published yearly and becomes effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It therefore: (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT regulatory policies and procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, Environmental Impacts: Policies and
Procedures, prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.

* * * * *

ANM CO E2 Akron, CO [Amended]

Colorado Plains Regional Airport, CO

    (Lat. 40[deg]10'32'' N, long. 103[deg]13'19'' W)

    That airspace extending upward from the surface within a 4.6-
mile radius of the airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM CO E5 Akron, CO [Amended]

Colorado Plains Regional Airport, CO
    (Lat. 40[deg]10'32'' N, long. 103[deg]13'19'' W)

    That airspace extending upward from 700 feet above the surface
within 6.6 miles of the Colorado Plains Regional Airport, and that
airspace between 4 miles southwest and 8 miles northeast of the
123[deg] bearing from the airport, extending from the 6.6-mile
radius to 18.3 miles southeast of the airport.

    Issued in Des Moines, Washington, on July 19, 2022.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2022-16222 Filed 7-28-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Rules and Regulations]
[Pages 63839-63840]
[FR Doc No: 2011-26548]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0901]

Drawbridge Operation Regulations; Neuse River, New Bern, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Neuse River Railroad Bridge, at mile 33.7, over the Neuse River, at New
Bern, NC. The deviation restricts the operation of the draw span to
facilitate repairs to the main mechanism of the bridge.

DATES: This deviation is effective from 9 a.m. on October 4, 2011,
until 6 p.m. October 13, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket USCG-2011-0901 and are available online by going to http://www.regulations.gov, inserting USCG-2011-0901 in the ``Keyword'' box,
and then clicking ``Search.'' This material is also available for
inspection or copying the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Bill H. Brazier, Bridge Management Specialist, Fifth
Coast Guard District, telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on reviewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, (202) 366-
9826.

SUPPLEMENTARY INFORMATION: Norfolk and Southern Railroad Corporation,
who owns and operates this swing bascule bridge, has requested a
temporary deviation from the current operating regulations set out in
33 CFR 117.824, to facilitate repairs to the main mechanism of the
drawbridge.
    In the closed position to vessels, the Neuse River Railroad Bridge,
at mile 33.7, at New Bern, NC has no available vertical clearance.
    Under this temporary deviation, the drawbridge will be closed to
vessels requiring an opening of the draw span from 9 a.m. on October 4,
2011 until and including 6 p.m. October 6, 2011 and from 9 a.m. on
October 11, 2011 until and including 6 p.m. on October 13, 2011. The
drawbridge can open in an emergency. There are no alternate routes for
vessels transiting this section of the Neuse River.
    The majority of the vessels that transit through this bridge during
this time of year are generally recreational with intermittent tug and
barge traffic. The Coast Guard has carefully coordinated

the restrictions with commercial and recreational waterway users. The
Coast Guard will inform all users of the waterway through our Local and
Broadcast Notice to Mariners of the closure periods for the bridge so
that vessels can arrange their transits to minimize any impacts caused
by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the draw must return to its
original operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: September 26, 2011.
Waverly W. Gregory, Jr.,
Bridge Program Manager, By direction of the Commander, Fifth Coast
Guard District.
[FR Doc. 2011-26548 Filed 10-13-11; 8:45 am]
BILLING CODE 9110-04-P


December 9 and 10, 2003 FIFRA SAP MEETING AGENDA December 5, 2003 Page 1 of 5 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING December 9 and 10, 2003 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Proposed Science Policy: PPAR

Agonist Mediated Hepatocarcinogenesis in Rodents and Relevance to Human Health Risk Assessments TUESDAY, DECEMBER 9, 2003 HOLIDAY INN NATIONAL AIRPORT 2650 JEFFERSON DAVIS HIGHWAY ARLINGTON, VIRGINIA 22202 703 684 7200 Please note that all times are approximate.

8: 30 AM Meeting Opening  Stephen M. Roberts, Ph. D. ( Chair of the FIFRA SAP)

8: 35 AM Introduction of Panel Members  Gary E. Isom, Ph. D. ( FIFRA SAP Session Chair)

8: 40 AM Administrative Procedures by Designated Federal Official  Mr. Steven Knott

8: 45 AM Welcome  Mr. Joseph Merenda, Jr. ( Director, Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances, EPA)

8: 50 AM Opening Remarks  Mr. William Jordan ( Office of Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances, EPA)

9: 00 AM Introduction and Background  Margaret Stasikowski, M. P. H. ( Health Effects Division, Office of Pesticide Programs, EPA)

9: 10 AM Presentation on PPAR  Agonist Induced Rodent Tumors: Modes of Action and Human Relevance  Jeff Peters, Ph. D. ( Penn State University)

9: 50 AM Break

10: 05 AM Proposed Science Policy: PPAR

Agonist Mediated Hepatocarcinogenesis in Rodents and Relevance to Human Health Risk Assessments  Elizabeth Mendez, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

10: 45 AM Public Comments

12: 00 PM Lunch

1: 00 PM Public Comments Continued December 9 and 10, 2003 FIFRA SAP MEETING AGENDA December 5, 2003 Page 2 of 5

2: 00 PM Questions to the Panel OVERVIEW:

Developments in the area of research on peroxisome proliferating chemicals have led to a reevaluation of the state of the science to characterize the mode( s) of action ( i. e., PPAR  agonism) and the human relevance of rodent tumors induced by PPAR  agonists. Recently, the ILSI Risk Science Institute ( ILSI RSI) convened a large expert technical group ( ILSI document, 2003) to evaluate new information on the association between PPAR  agonism and the induction of tumors by peroxisome proliferating chemicals. OPPTS considered the 2003 ILSI report as well as the pertinent scientific literature in developing its proposed science policy. Please provide comments and advice on the following questions. In addressing these, questions consider the completeness of the data sets evaluated.

Question 1  Rodent PPAR   Mode of Action for Hepatocarcinogenesis OPPTS has concluded that there is sufficient weight of evidence to establish the mode of action for PPAR  agonist induced rodent hepatocarcinogenesis. It is proposed in the OPPTS document that PPAR  agonists activate PPAR  leading to an increase in cell proliferation and a decrease in apoptosis, and eventually further clonal expansion of preneoplastic cells and formation of liver tumors. The key events in PPAR  agonist induced hepatocarcinogenesis may be classified as either causal ( required for this MOA) or associative ( marker of PPAR  agonism).

Please comment on the weight of evidence and key events for the proposed mode of action for the PPAR  agonist induced rodent hepatocarcinogenesis. Please comment on the adequacy of the data available to identify the key events in the PPAR  MOA. Discuss whether the uncertainties and limitations of these data have been adequately characterized.

3: 00 PM Break

3: 15 PM Question to the Panel Continued Question 2  Relative Sensitivity of Fetal, Neonatal, and Adult Rodent OPPTS has provided a review of the ontogeny of PPAR  expression and peroxisomal assemblage during fetal and postnatal development in rodents as well as an analysis of the available data evaluating effects on peroxisomal proliferation, peroxisomal enzyme activity, and liver weights following exposure to PPAR  agonists during fetal and postnatal development in rats and mice ( see Section V of the OPPTS Document). Based on this analysis, OPPTS concluded that fetal and neonatal rats do not exhibit an increased sensitivity to PPAR  agonistinduced hepatocarcinogenicity relative to the adult rodent. Therefore, any conclusions regarding this mode of action in adult rodents would also apply to young rodents, and similarly any conclusions regarding the relevance of this mode of action for human hepatocarcinogenesis would apply to the young, as well as the adults. December 9 and 10, 2003 FIFRA SAP MEETING AGENDA December 5, 2003 Page 3 of 5 Please comment on the weight of the evidence approach and mechanistic data used to support this conclusion.

5: 30 PM Adjournment WEDNESDAY, DECEMBER 10, 2003 HOLIDAY INN NATIONAL AIRPORT 2650 JEFFERSON DAVIS HIGHWAY ARLINGTON, VIRGINIA 22202 703 684 7200 Please note that all times are approximate.

8: 30 AM Meeting Opening  Stephen M. Roberts, Ph. D. ( Chair of the FIFRA SAP)

8: 35 AM Introduction of Panel Members  Gary E. Isom, Ph. D. ( FIFRA SAP Session Chair)

8: 40 AM Administrative Procedures by Designated Federal Official  Mr. Steven Knott

8: 45 AM Follow up from Previous Day's Discussion  Margaret Stasikowski, M. P. H. and Elizabeth Mendez, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

9: 00 AM Questions to the Panel Continued Question 3  Human Relevance OPPTS has provided an analysis of a variety of in vitro and in vivo studies on the key events pertaining to PPAR  agonist induced hepatocarcinogenesis with hamsters, guinea pigs, non human primates, and humans. Based on the weight of the evidence, OPPTS concludes that although PPAR  agonists can induce liver tumors in rodents and while PPAR  is functional in humans, quantitatively, humans and nonhuman primates are refractory to the hepatic effects of PPAR  agonists.

Therefore, OPPTS is proposing the following scientific policy:

When liver tumors are observed in long term studies in rats and mice, and 1) the data are sufficient to establish that the liver tumors are a result of a PPAR  agonist MOA and 2) other potential MOAs have been evaluated and found not operative, the evidence of liver tumor formation in rodents should not be used to characterize potential human hazard.

Please comment on the data and weight of evidence regarding the hepatic effects of December 9 and 10, 2003 FIFRA SAP MEETING AGENDA December 5, 2003 Page 4 of 5 PPAR  agonists in humans, and please comment on the proposed OPPTS's science policy regarding human relevance.

10: 30 AM Break

10: 45 AM Question to the Panel Continued Question 4  Data Requirements OPPTS has proposed a data set that would be sufficient to demonstrate that PPAR  agonism is the mode of action for the induction of rodent liver tumors. The data set includes evidence of PPAR  agonism ( i. e. from an in vitro reporter gene assay), in vivo evidence of an increase in number and size of peroxisomes, increases in the activity of acyl CoA oxidase, and hepatic cell proliferation. The in vivo evidence should be collected from studies designed to provide the data needed to show dose response and temporal concordance between precursor events and liver tumor formation.

Please comment in general on the proposed data set and particularly on its adequacy to demonstrate that a PPAR  agonist mediated MOA is operating in rodent hepatocarcinogenesis.

12: 00 PM Lunch

1: 00 PM Questions to the Panel Continued Question 5  Other Tumors Induced by PPAR  Agonists Some PPAR  agonists may also induce pancreatic acinar cell and Leydig cell tumors in rats and modes of action involving agonism of PPAR  have been proposed. An in depth analysis of these tumors is provided in the 2003 ILSI technical panel report. Based on this analysis, OPPTS agrees that the data available to date are insufficient to support the proposed MOAs.

Thus, OPPTS is proposing the following science policy:

Given the limited evidence available to support that a chemical may induce pancreatic and Leydig cell tumors through a PPAR  agonist mode of action, the evidence is inadequate at this time to support a linkage between PPAR  agonism and formation of these tumor types. Thus, it is presumed that chemicals that induce pancreatic or Leydig cell tumors may pose a carcinogenic hazard for humans.

Please comment on OPPTS's conclusion that there is limited evidence that a chemical may induce pancreatic and Leydig cell tumors through a PPAR  agonist mode of action, and OPPTS's proposed science policy regarding other tumors induced by PPAR  agonists. December 9 and 10, 2003 FIFRA SAP MEETING AGENDA December 5, 2003 Page 5 of 5

3: 00 PM Adjournment As noted above, please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Mr. Steven Knott, via telephone: ( 202) 564 8450; fax: ( 202) 564 8382; or email: knott. steven@ epa. gov.


[Federal Register Volume 80, Number 100 (Tuesday, May 26, 2015)]
[Notices]
[Pages 30071-30072]
[FR Doc No: 2015-12608]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6756-008]

Sweetwater Hydroelectric, Inc.; Lower Valley, LLC; Notice of
Transfer of Exemption

    1. By letter filed April 24, 2015,\1\ William B. Conway, Jr.,
Counsel for Enel Green Power North America, Inc. (EGPNA),\2\ informed
the Commission that the exemption from licensing for the Lower Valley
Project, FERC No. 6756, originally issued November 9, 1982,\3\ has been
transferred to Lower Valley, LLC, an affiliate of Enel Green Power. The
project is located on the Sugar River in Sullivan County, New
Hampshire. The transfer of an exemption does not require Commission
approval.
---------------------------------------------------------------------------

    \1\ Seventeen other exempted projects which are to be
transferred were included in the April 24, 2015 letter. These
exemptions will be handled under separate proceedings.
    \2\ Enel Green Power North America, Inc. is a wholly owned
subsidiary of Enel Green Power. Enel Green Power is a well-
capitalized publicly traded company.
    \3\ 21 FERC ] 62,216, Notice of Exemption from Licensing (1982).
---------------------------------------------------------------------------

    2. Lower Valley, LLC is now the exemptee of the Lower Valley
Project, FERC No. 6756. All correspondence should be forwarded to:
Lower Valley, LLC, c/o Enel Green Power North America, Inc., Attn:
General Counsel, 1 Tech Drive, Suite 220, Andover, MA 01810.

    Dated: May 19, 2015.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-12608 Filed 5-22-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 95 (Thursday, May 16, 2019)]
[Proposed Rules]
[Pages 22084-22087]
[FR Doc No: 2019-10184]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0759; FRL-9993-72-Region 4]

Air Plan Approval; Kentucky; Interstate Transport (Prongs 1 and
2) for the 2010 1-Hour NO2 Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
Commonwealth of Kentucky, through the Kentucky Energy and Environment
Cabinet by a letter dated November 16, 2018, for the purpose of
addressing the Clean Air Act (CAA or Act) ``good neighbor'' interstate
transport (prongs 1 and 2) infrastructure SIP requirements for the 2010
1-hour Nitrogen Dioxide (NO2) National Ambient Air Quality
Standard (NAAQS). The CAA requires that each state adopt and submit a
SIP for the implementation, maintenance, and enforcement of each NAAQS
promulgated by EPA, commonly referred to as an ``infrastructure SIP.''
Specifically, EPA is proposing to approve Kentucky's November 16, 2018,
SIP revision addressing prongs 1 and 2 to ensure that air emissions in
Kentucky do not significantly contribute to nonattainment or interfere
with maintenance of the 2010 1-hour NO2 NAAQS in any other
state.

DATES: Comments must be received on or before June 17, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2018-0759 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Evan Adams of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Adams can be
reached by phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On January 22, 2010, EPA established a new 1-hour primary NAAQS for
NO2 at a level of 100 parts per billion (ppb), based on a 3-
year average of the 98th percentile of the yearly distribution of 1-
hour daily maximum concentrations.\1\ See 75 FR 6474

(February 9, 2010). This NAAQS is designed to protect against exposure
to the entire group of nitrogen oxides (NOX). NO2
is the component of greatest concern and is used as the indicator for
the larger group of NOX. Emissions that lead to the
formation of NO2 generally also lead to the formation of
other NOX. Therefore, control measures that reduce
NO2 can generally be expected to reduce population exposures
to all gaseous NOX which results in a reduction in the
formation of ozone and fine particles both of which pose significant
public health threats. For comprehensive information on the 2010 1-hour
NO2 NAAQS, please refer to the February 9, 2010 Federal
Register document. See 75 FR 6474.
---------------------------------------------------------------------------

    \1\ Subsequently, after careful consideration of the scientific
evidence and information available, on April 18, 2018, EPA published
a final action to retain the current NO2 standard at the
2010 level of 100 ppb. This action was taken after review of the
full body of available scientific evidence and information, giving
particular weight to the assessment of the evidence in the 2016
NOX Integrated Science Assessment; analyses and
considerations in the Policy Assessment; the advice and
recommendations of the Clean Air Scientific Advisory Committee; and
public comments. See 83 FR 17226 (April 18, 2018).
---------------------------------------------------------------------------

    Whenever EPA promulgates a new or revised NAAQS, CAA section
110(a)(1) requires states to make SIP submissions to provide for the
implementation, maintenance, and enforcement of the NAAQS.\2\ This
particular type of SIP submission is commonly referred to as an
``infrastructure SIP.'' These submissions must meet the various
requirements of CAA section 110(a)(2), as applicable. Due to ambiguity
in some of the language of CAA section 110(a)(2), EPA believes that it
is appropriate to interpret these provisions in the specific context of
acting on infrastructure SIP submissions. EPA has previously provided
comprehensive guidance on the application of these provisions through a
guidance document for infrastructure SIP submissions and through
regional actions on infrastructure submissions.\3\ Unless otherwise
noted below, EPA is following that existing approach in acting on this
submission. In addition, in the context of acting on such
infrastructure submissions, EPA evaluates the submitting state's SIP
for compliance with statutory and regulatory requirements, not for the
state's implementation of its SIP.\4\ EPA has other authority to
address any issues concerning a state's implementation of the
regulations that comprise its SIP.
---------------------------------------------------------------------------

    \2\ States were required to submit infrastructure SIPs for the
2010 1-hour NO2 NAAQS to EPA no later than January 22,
2013.
    \3\ EPA explains and elaborates on these ambiguities and its
approach to address them in its September 13, 2013 Infrastructure
SIP Guidance, available at https://www3.epa.gov/airquality/urbanair/sipstatus/docs/Guidance_on_Infrastructure_SIP_Elements_Multipollutant_FINAL_Sept_2013.pdf, as well as in numerous agency actions, including EPA's prior
action on Kentucky's infrastructure SIP to address other 110(a)(2)
elements for the PM2.5 NAAQS entitled ``Air Plan
Approval; Kentucky; Infrastructure Requirements for the 2012
PM2.5 National Ambient Air Quality Standard;'' in the
section ``What is EPA's approach to the review of infrastructure SIP
submissions?'' See 82 FR 21751 at 21752-21755 (May 10, 2017).
    \4\ See Montana Environmental Information Center v.Thomas, 902
F.3d 971 (9th Cir. 2018).
---------------------------------------------------------------------------

    Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and
110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct
components, commonly referred to as ``prongs,'' that must be addressed
in infrastructure SIPs. The first two prongs, which are codified in
section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or
other type of emissions activity in one state from contributing
significantly to nonattainment of the NAAQS in another state (prong 1)
and from interfering with maintenance of the NAAQS in another state
(prong 2). EPA sometimes refers to the prong 1 and prong 2 conjointly
as the ``good neighbor'' provision of the CAA. The third and fourth
prongs, which are codified in section 110(a)(2)(D)(i)(II), are
provisions that prohibit emissions activity in one state from
interfering with measures required to prevent significant deterioration
of air quality in another state (prong 3) and from interfering with
measures to protect visibility in another state (prong 4). Section
110(a)(2)(D)(ii) requires SIPs to include provisions ensuring
compliance with sections 115 and 126 of the Act, relating to interstate
and international pollution abatement.
    EPA's most recent infrastructure SIP guidance, the September 13,
2013, ``Guidance on Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),'' did
not explicitly include criteria for how the Agency would evaluate
infrastructure SIP submissions intended to address section
110(a)(2)(D)(i)(I).\5\ With respect to certain pollutants, such as
ozone and particulate matter (PM), EPA has addressed interstate
transport in eastern states in the context of regional rulemaking
actions that quantify state emission reduction obligations.\6\ For
NO2, EPA has considered available information such as
current air quality, emissions data and trends, and regulatory
provisions that control source emissions to determine whether emissions
from one state interfere with the attainment or maintenance of the
NAAQS in another state. EPA's review and proposed action on Kentucky's
CAA section 110(a)(2)(D)(i)(I) interstate transport SIP revisions for
the 2010 NO2 NAAQS is informed by these considerations.
---------------------------------------------------------------------------

    \5\ At the time the September 13, 2013, guidance was issued, EPA
was litigating challenges raised with respect to its Cross-State Air
Pollution Rule (CSAPR), 76 FR 48208 (August 8, 2011), designed to
address the CAA section 110(a)(2)(D)(i)(I) interstate transport
requirements with respect to the 1997 ozone and the 1997 and 2006
PM2.5 NAAQS. CSAPR was vacated and remanded by the United
States Court of Appeals for the District of Columbia Circuit (D.C.
Circuit) in 2012 pursuant to EME Homer City Generation, L.P. v. EPA,
696 F.3d 7. EPA subsequently sought review of the D.C. Circuit's
decision by the Supreme Court, which was granted in June 2013. As
EPA was in the process of litigating the interpretation of section
110(a)(2)(D)(i)(I) at the time the infrastructure SIP guidance was
issued, EPA did not issue guidance specific to that provision. The
Supreme Court subsequently vacated the D.C. Circuit's decision and
remanded the case to that court for further review. 134 S. Ct. 1584
(2014). On July 28, 2015, the D.C. Circuit issued a decision
upholding CSAPR, but remanding certain elements for reconsideration.
795 F.3d 118.
    \6\ Nitrogen Oxides (NOX) SIP Call, 63 FR 57356
(October 27, 1998); Clean Air Interstate Rule (CAIR), 70 FR 25162
(May 12, 2005); CSAPR, 76 FR 48208 (August 8, 2011).
---------------------------------------------------------------------------

    Through this proposed action, EPA is proposing to approve
Kentucky's November 16, 2018, SIP revision addressing prong 1 and prong
2 requirements for the 2010 1-hour NO2 NAAQS. The
Commonwealth addressed CAA section 110(a)(2)(D)(i)(I) by providing
information supporting its conclusion that emissions from Kentucky do
not significantly contribute to nonattainment or interfere with
maintenance of the 2010 1-hour NO2 NAAQS in downwind states.
All other applicable infrastructure SIP requirements for Kentucky for
the 2010 1-hour NO2 NAAQS have been addressed in separate
rulemakings. See 80 FR 14019 (March 18, 2015), 81 FR 83152 (November
21, 2016), and 84 FR 11652 (March 28, 2019).

II. What is EPA's analysis of how Kentucky addressed prongs 1 and 2?

    Kentucky concluded that the SIP adequately addresses prongs 1 and 2
with respect to the 2010 1-hour NO2 NAAQS in its November
16, 2018, SIP revision. Kentucky provides the following reasons for its
determination: (1) Monitored 1-hour NO2 design values in
Kentucky and neighboring states (Illinois, Indiana, Missouri, Ohio,
Tennessee, and Virginia) are below the 2010 standard; (2) total
emissions of NOX in Kentucky have trended downward from 1987
to 2017; and (3) the SIP contains state regulations that directly or
indirectly control NOX emissions. EPA preliminarily agrees
with the Commonwealth's conclusion based on the rationale discussed
below.
    First, EPA notes that there are no designated nonattainment areas
for the 2010 1-hour NO2 NAAQS in Kentucky or the neighboring
states. On February 17, 2012 (77 FR 9532), EPA designated

the entire country as ``unclassifiable/attainment'' for the 2010 1-hour
NO2 NAAQS, stating that ``available information does not
indicate that the air quality in these areas exceeds the 2010 [1-hour]
NO2 NAAQS.''
    Second, the 2015-2017 NO2 design values in Kentucky and
neighboring states are well below the 2010 1-hour NO2 NAAQS
standard of 100 ppb.\7\ The valid, monitored 2015-2017 valid design
values for Kentucky were 27, 30, 31, 34, 40, and 49 ppb. The highest
monitored 2015-2017 valid design values for the neighboring states of
Illinois, Indiana, Missouri, Ohio, Tennessee, and Virginia are 56, 44,
49, 55, 53, and 45 ppb, respectively.\8\ The design values in Kentucky,
and neighboring states, during this time period were 44 to 73 percent
below the NAAQS.
---------------------------------------------------------------------------

    \7\ See Figure 1 in Kentucky's submittal, which is based on the
NO2 design value data extracted from the EPA website at
https://www.epa.gov/air-trends/air-quality-design-values#report.
    \8\ Monitoring sites must meet the data completeness
requirements listed in Appendix S to 40 CFR part 50 in order to have
a valid design value. Table 1 in Kentucky's submittal did not
include the valid design value of 49 ppb recorded at AQS ID: 21-111-
0075 in Louisville/Jefferson County or the invalid design value of
41 recorded at monitor number 21-111-0067 in Louisville/Jefferson
County. Table 2 in Kentucky's submittal includes all highest, valid
design values for the neighboring states of Illinois, Indiana,
Missouri, Ohio, Tennessee, and Virginia. These values can be found
on EPA's air quality design value website at https://www.epa.gov/air-trends/air-quality-design-values.
---------------------------------------------------------------------------

    Third, NOX emissions data shows that NOX
emissions have continuously trended downward from the years 1987 to
2017.\9\ For example, the point source emissions data provided by the
Commonwealth indicates that NOX emissions for point sources
from 2008 to 2016 has declined by approximately 57 percent.\10\ EPA
data also confirms that NOX emissions from point sources
from Kentucky have declined from 2008 to 2017,\11\ and NOx emissions
from all sectors declined between 2002 and 2014.\12\
---------------------------------------------------------------------------

    \9\ See Figure 1 in Kentucky's November 16, 2018 submittal.
    \10\ See Table 4 in Kentucky's submittal. The data is presented
in the submittal from 2008-2016 to display the decline in emissions
from the start of CAIR in 2008, and then transitioning to CSAPR in
2011.
    \11\ See Emissions Inventory System data for Kentucky, available
in the docket to this action.
    \12\ See 2014 National Emissions Inventory (NEI) Report,
available at https://edap.epa.gov/public/extensions/nei_report_2014/dashboard.html#trend-db. The 2014 NEI Report is the latest available
report.
---------------------------------------------------------------------------

    Finally, Kentucky identifies the following SIP-approved regulations
that directly or indirectly control NOX emissions: 401 KAR
50:055--General compliance requirements; 401 KAR 50:060--Enforcement;
401 KAR 51:001--Definitions for 401 KAR Chapter 51; 401 KAR 51:005--
Purpose and general provisions; 401 KAR 51:010--Attainment status
designations; 401 KAR 51:017--Prevention of significant deterioration
of air quality; 401 KAR 51:052--Review of new sources in or impacting
upon attainment areas; 401 KAR 51:150--NOX requirements for stationary
internal combustion engines; 401 KAR 51:170--NOX requirements for
cement kilns; 401 KAR 52:030--Federally-enforceable permits for non-
major sources; 401 KAR 52:100--Public, affected state, and US EPA
review; 401 KAR 53:005--General provisions; 401 KAR 53:010--Ambient air
quality standards; 401 KAR 59:001--Definitions for abbreviations of
terms used in the Title 401, Chapter 59; 401 KAR 59:005--General
provisions; 401 KAR 59:015--New indirect heat exchangers; 401 KAR
61:001--Definitions for abbreviations of terms used in the Title 401,
Chapter 61; 401 KAR 61:005--General provisions; 401 KAR 61:015--
Existing indirect heat exchangers; and 401 KAR 61:065--Existing nitric
acid plants.
    Kentucky also identified state-only provisions as additional
regulations that the Commonwealth is implementing that provide for the
control of NOX emissions: 401 KAR 52:060--Acid rain permits;
401 KAR 51:240--Cross-State Air Pollution Rule (CSAPR) \13\ NOX annual
trading program; 401 KAR 51:250--Cross-State Air Pollution Rule (CSAPR
Update) \14\ NOX ozone season group 2 trading program.\15\ EPA notes
that the CSAPR and Update rule were established to address transport
for the ozone (1997 and 2008) and fine particulate matter (1997 and
2006) standards, however, the trading programs may yield residual
NOX emissions reduction benefits.\16\ Further, Kentucky
identifies the following provisions where limited portions have been
approved into the SIP: 401 KAR 52:020--Title V permits; 401 KAR
52:040--State-origin permits; and 401 KAR 52:070--Registration of
designated sources.
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    \13\ See 76 FR 48208.
    \14\ See 81 FR 74504.
    \15\ The EPA notes that Kentucky submitted a SIP revision for
401 KAR 51.240, 401 KAR 51.250, and 401 KAR 51.260 on September 17,
2018 to the EPA to adopt the CSAPR and Update trading programs into
their SIP.
    \16\ Kentucky further included existing national rules that are
designed to reduce emissions from on-road and off-road vehicles
through the year 2025 and beyond. This information can be found in
Kentucky's submittal.
---------------------------------------------------------------------------

    For the reasons discussed above, EPA has preliminarily determined
that Kentucky does not contribute significantly to nonattainment or
interfere with maintenance of the 2010 1-hour NO2 NAAQS in
any other state, and that Kentucky's SIP includes adequate provisions
to prevent emissions sources within the Commonwealth from significantly
contributing to nonattainment or interfering with maintenance of this
standard in any other state.

III. Proposed Action

    As described above, EPA is proposing to approve Kentucky's November
16, 2018, SIP revision addressing prongs 1 and 2 of CAA section
110(a)(2)(D)(i) for the 2010 1-hour NO2 NAAQS.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);

     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: May 6, 2019.
Mary S. Walker,
Acting Regional Administrator, Region 4.
[FR Doc. 2019-10184 Filed 5-15-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Notices]
[Page 46093]
[FR Doc No: 2020-16577]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0350; FRL-10013-13-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; The Consolidated Air Rule (CAR) for the
Synthetic Organic Chemical Manufacturing Industry (SOCMI) (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), The Consolidated Air Rule (CAR)
for the Synthetic Organic Chemical Manufacturing Industry (SOCMI) (EPA
ICR Number 1854.11, OMB Control Number 2060-0443), to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through September 30, 2020. Public comments
were previously requested via the Federal Register on May 6, 2019
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may neither conduct nor sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.

DATES: Additional comments may be submitted on or before August 31,
2020.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OECA-2013-0350, online using www.regulations.gov (our preferred
method<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460. EPA's policy is that all comments
received will be included in the public docket without change including
any personal information provided, unless the comment includes
profanity, threats, information claimed to be Confidential Business
Information (CBI), or other information whose disclosure is restricted
by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The synthetic organic chemical manufacturing industry
(SOCMI) is regulated by both New Source Performance Standards (NSPS)
and National Emission Standards for Hazardous Air Pollutants (NESHAP)
standards. The affected entities are subject to the General Provisions
of the NSPS (40 CFR part 60, subpart A), and any changes or additions
to the Provisions specified at 40 CFR part 60, subparts Ka, Kb, VV,
VVa, DDD, III, NNN and RRR. The affected entities are also subject to
the General Provisions of the NESHAP at 40 CFR part 63, subpart A, and
any changes, or additions to the Provisions specified at 40 CFR part
63, subparts BB, Y, V, F, G, H and I. As an alternative, SOCMI sources
may choose to comply with the above standards under the consolidated
air rule (CAR) at 40 CFR part 65 as promulgated December 14, 2000.
Synthetic organic chemical manufacturing facilities subject to NSPS
requirements must notify EPA of construction, modification, startups,
shutdowns, date and results of initial performance test and excess
emissions. Semiannual reports are also required. Synthetic organic
chemical manufacturing facilities subject to NESHAP requirements must
submit one-time only reports of any physical or operational changes and
the results of initial performance tests. Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. Periodic reports are also required semiannually at a
minimum. These reports are used by EPA to determine compliance with
these standards.
    Form Numbers: None.
    Respondents/affected entities: Synthetic organic chemical
manufacturing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 65).
    Estimated number of respondents: 1,356 (total).
    Frequency of response: Initially, occasionally, semiannually and
annually.
    Total estimated burden: 1,100,000 hours (per year). Burden is
defined at 5 CFR 1320.3(b).
    Total estimated cost: $192,000,000 (per year), which includes
$64,000,000 in annualized capital/startup and/or operation &
maintenance costs.
    Changes in the Estimates: There is a decrease of 1,109,999 hours in
the total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is not due to any program changes. The
decrease is due to a reduction in the numbers of new and existing
respondents for many of the Subparts. These estimates reflect a
significant decrease in the number of respondents for the referencing
subparts and the CAR from the prior ICR, which listed approximately
5,198 respondents. These estimates are based on the EPA's recent
reevaluation of the source category inventories for the referencing
subparts 40 CFR part 60, subparts Ka, Kb, VV, VVa, DDD, III, NNN, and
RRR, and 40 CFR part 63, subparts F, G, H, and I.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-16577 Filed 7-30-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Rules and Regulations]
[Pages 27523-27524]
[FR Doc No: 2021-10737]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0321]

Safety Zone; Southern California Annual Firework Events for the
San Diego Captain of the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zones for the Big Bay
Boom Fourth of July Fireworks on the waters of San Diego Bay, CA on
Sunday, July 4, 2021. The safety zones are necessary to provide for the
safety of the participants, spectators, official vessels of the event,
and general users of the waterway. Our regulation for the Southern
California Annual Firework Events for the San Diego Captain of the Port
Zone identifies the regulated areas for this event. During the
enforcement period, no spectators shall anchor, block, loiter in, or
impede the transit of official patrol vessels in the regulated areas
without the approval of the Captain of the Port, or his designated
representative.

DATES: The regulations in 33 CFR 165.1123 will be enforced for the Big
Bay Boom Fourth of July Fireworks regulated areas listed in item 5 in
the table to Sec.  165.1123 from 8 p.m. until 10 p.m. on July 4, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Lieutenant John Santorum,
Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone
619-278-7656, email<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
regulations in 33 CFR 165.1123 for the Big Bay Boom Fourth of July
Fireworks regulated area from 8 p.m. until 10 p.m. on July 4, 2021.
This action is being taken to provide for the safety of life on
navigable waterways during the fireworks event. Our regulation for
Southern California Annual Firework Events for the San Diego Captain of
the Port Zone, Sec.  165.1123, identifies the regulated areas for the
Big Bay Boom Fourth of July Fireworks event which encompasses multiple
portions of San Diego Bay. Under the provisions of Sec.  165.1123, a
vessel may not enter the regulated area, unless it receives permission
from the Captain of the Port, or his designated representative.
Spectator vessels may safely transit outside the regulated area but may
not anchor, block, loiter, or impede the transit of participants or
official patrol vessels. The Coast Guard may be assisted by other
Federal, State, or Local law enforcement agencies in enforcing this
regulation.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard plans to provide notification of this enforcement
period via the Local Notice to Mariners, marine information broadcasts,
and local advertising by the event sponsor.
    If the Captain of the Port or his designated representative
determines that the regulated area need not be enforced for the full
duration stated on this document, he or she may use a Broadcast Notice
to Mariners or other communications coordinated with the event sponsor
to grant general permission to enter the regulated area.

    Dated: May 14, 2021.
T.J. Barelli,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2021-10737 Filed 5-20-21; 8:45 am]
BILLING CODE 9110-04-P