[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Rules and Regulations]
[Pages 13065-13067]
[FR Doc No: 2017-04568]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0116; Airspace Docket No. 17-AGL-2]
RIN 2120-AA66

Amendment of Air Traffic Service (ATS) Routes Q-917 and Q-923;
Northcentral United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, technical amendment.

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SUMMARY: The FAA is amending two high altitude area navigation (RNAV)
Q-routes that cross the United States (U.S.)/Canada border in the
northcentral U.S. to update the waypoint name for one Canadian waypoint
listed in the Q-route descriptions. Specifically, this action changes
the SASUT waypoint name to DUTEL in RNAV routes Q-917 and Q-923 to
match the waypoint information contained in the FAA and Canadian
aeronautical databases. No air traffic services are affected by this
action.

DATES: Effective date 0901 UTC, June 22, 2017. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://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. The Order is also available for inspection at the National
Archives and Records

Administration (NARA). For information on the availability of FAA Order
7400.11A at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

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. 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
the 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 amend the route structure as required to preserve
the safe and efficient flow of air traffic across the U.S./Canadian
border.

History

    On September 26, 2014, the FAA published in the Federal Register a
final rule (79 FR 57758), Docket No. FAA-2014-0295, that amended,
removed, and established multiple ATS routes in the northcentral U.S.
to reflect and accommodate route changes being made in Canadian
airspace as part of a Canadian airspace redesign project. The FAA
recently identified that the SASUT waypoint name duplicates an existing
waypoint name in Mexico and advised NAV CANADA accordingly. NAV CANADA
has elected to change the SASUT waypoint name to DUTEL to overcome any
potential confusion created by the SASUT waypoint name being used in
Canada and Mexico.
    This rule makes the editorial waypoint name correction to match the
FAA and Canadian aeronautical databases. On January 19, 2017, the FAA
issued a final rule; technical amendment that updated the geographical
coordinates for five Canadian waypoints, including SASUT (82 FR 6212),
Docket No. FAA-2016-9319. That final rule becomes effective on April
27, 2017. The geographic coordinates for DUTEL (SASUT) in the legal
description in this rule reflect the updated coordinates.
    High altitude Canadian RNAV routes (Q-routes) are published in
paragraph 2007 of FAA Order 7400.11A dated August 3, 2016, and
effective September 15, 2016, which is incorporated by reference in 14
CFR 71.1. The high altitude Canadian RNAV routes (Q-routes) listed in
this rule will be subsequently published in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending Title 14, Code of Federal Regulations (14 CFR)
part 71 by modifying RNAV routes Q-917 and Q-923. The route
modifications are editorial in nature and change the SASUT waypoint
name to DUTEL to match the FAA and Canadian aeronautical databases
information. No air traffic services are affected by this action and no
substantive changes to the RNAV routes are being made. Therefore,
notice and public procedures under 5 U.S.C. 553(b) is unnecessary.
    The RNAV route modifications accomplished by this action are
outlined below.
    Q-917: change the SASUT waypoint name from ``SASUT'' to ``DUTEL.''
    Q-923: change the SASUT waypoint name from ``SASUT'' to ``DUTEL.''

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.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (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 only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this airspace action of modifying two
high altitude RNAV Q-routes by updating the waypoint name for one
Canadian waypoint listed in the Q-route descriptions has no potential
to cause any significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment. Therefore, this proposed airspace action qualifies for
categorical exclusion under the National Environmental Policy Act and
its implementing regulations at 40 CFR part 1500-1508, and in
accordance with FAA Order 1050.1F, Environmental Impacts: Policies and
Procedures, Paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points). In accordance with
FAAO 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this
action has been reviewed for factors and circumstances in which a
normally categorically excluded action may have a significant
environmental impact requiring further analysis, and it is determined
that no extraordinary circumstances exist that warrant preparation of
an environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 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 part 71 continues to read as follows:

    Authority: 49 U.S.C. 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 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 2007 Canadian Area Navigation Routes.

* * * * *

Q-917 Sault Ste Marie, MI (SSM) to WOZEE, NY [Amended]

Sault Ste Marie, MI    VOR/DME               (Lat. 46[deg]24'43.60'' N., long. 084[deg]18'53.54'' W.)
 (SSM)
ULUTO, Canada          WP                    (Lat. 46[deg]18'16.00'' N., long. 084[deg]05'41.00'' W.)
VIGLO, Canada          WP                    (Lat. 45[deg]23'48.00'' N., long. 082[deg]25'11.00'' W.)
DUTEL, Canada          WP                    (Lat. 44[deg]39'59.00'' N., long. 081[deg]17'47.00'' W.)
PEPLA, Canada          WP                    (Lat. 43[deg]47'50.98'' N., long. 080[deg]00'53.56'' W.)
HOZIR, NY              WP                     (Lat. 43[deg]06'03.59'' N., long. 079[deg]02'05.27'' W.)
WOZEE, NY              WP                    (Lat. 42[deg]56'01.65'' N., long. 078[deg]44'19.64'' W.)
Excluding the airspace within Canada.

                                                  * * * * * * *
Q-923 HOCKE, MI to DUTEL, Canada [Amended]

HOCKE, MI              WP                    (Lat. 43[deg]15'43.38'' N., long. 082[deg]42'38.27'' W.)
KARIT, MI              WP                    (Lat. 43[deg]43'23.00'' N., long. 082[deg]08'40.00'' W.)
DUTEL, Canada          WP                    (Lat. 44[deg]39'59.00'' N., long. 081[deg]17'47.00'' W.)
Excluding the airspace within Canada.

                                                  * * * * * * *

    Issued in Washington, DC, on March 1, 2017.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2017-04568 Filed 3-8-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 30, 2010 (Volume 75, Number 167)]
[Notices]
[Page 52937-52938]
[DOCID:fr30au10-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP10-481-000; PF09-14-000]

Turtle Bayou Gas Storage Company, LLC; Notice of Application

August 20, 2010.
    Take notice that on August 6, 2010, Turtle Bayou Gas Storage
Company, LLC (Turtle Bayou), One Office Park Circle, Suite 300,
Birmingham, Alabama 35223, filed in the above referenced docket an
application pursuant to section 7(c) of the Natural Gas Act (NGA), for
an order granting a certificate of public convenience to construct,
own, operate, and maintain a new salt dome natural gas storage facility
in two caverns and related facilities to be located in Chambers and
Liberty Counties, Texas. Turtle Bayou is requesting blanket
certificates under Part 284, Subpart G and Part 157, Subpart F of the
Commission's regulations. Turtle Bayou also seeks for authorization of
market based rates, approval of the pro forma tariff, and waivers of
some of the Commission's regulations, all as more fully set forth in
the application which is on file with the Commission and open to public
inspection.
    The filing may also be viewed on the Web at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Turtle Bayou's new storage project has been designed to provide
approximately 12 billion cubic feet (Bcf) of working gas capacity with
a maximum injection rate of up to 300 million cubic feet per day (MMcf/
d) and a maximum withdrawal rate of 600 MMcf/d. Additionally, Turtle
Bayou intends to construct a total of 13.1 miles of 24-inch diameter
pipeline to deliver the natural gas to Natural Gas Pipeline Company of
America and Texas Eastern Transmission, LP, as well as three
reciprocating units to produce a total of 16,470 horsepower, leaching
facilities, water supply wells, brine disposal wells, and two meter
stations.
    Any questions concerning this application may be directed to Jim
Lindsay, Turtle Bayou Gas Storage Company, LLC, One Office Park Circle,
Suite 300, Birmingham, Alabama 35223, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>or Amy L. Baird, Jackson Walker L.L.P., 1401
McKinney Street, Suite 1900, Houston, Texas 77010, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and seven copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for

review in the Commission's Public Reference Room in Washington, DC.
There is an ``eSubscription'' link on the Web site that enables
subscribers to receive e-mail notification when a document is added to
a subscribed docket(s). For assistance with any FERC Online service,
please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll
free). For TTY, call<PHONE_NUMBER>.
    Comment Date: September 10, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-21465 Filed 8-27-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Proposed Rules]
[Pages 72621-72624]
[FR Doc No: 2015-29617]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-5809; Directorate Identifier 2015-NM-055-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2006-19-
12, which applies to certain The Boeing Model 777-200 and -300 series
airplanes. AD 2006-19-12 currently requires inspecting the lower web of
the aft fairing of the engine struts for any discoloration and doing
any related investigative and corrective action if necessary;
inspecting the heat shield castings for any damage and doing any
corrective action if necessary; installing gap cover strips; and
replacing insulation blankets with new insulation blankets. Since we
issued AD 2006-19-12, we have received a report that an aft fairing
lower spar web exceeded the allowable conductivity limits. This
proposed AD would also require, depending on airplane configuration,
one-time or repetitive detailed inspections for cracking and
deformation, as applicable, of the aft fairing lower structure, and
one-time or repetitive conductivity inspections of the aft fairing
lower structure and related investigative and corrective actions if
necessary. This proposed AD also adds airplanes to the applicability.
We are proposing this AD to detect and correct degradation of the aft
fairing lower web, which could lead to cracking of the web and could
allow flammable fluids to leak into the heat shield pan castings, and
consequent increased risk of an uncontained fire and subsequent
structural damage.

DATES: We must receive comments on this proposed AD by January 4, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-5809.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
5809; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sue Lucier, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-917-
6438; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-5809;
Directorate Identifier 2015-NM-055-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On September 13, 2006, we issued AD 2006-19-12, Amendment 39-14769
(71 FR 55727, September 25, 2006), for certain Boeing Model 777-200 and
-300 series airplanes. AD 2006-19-12 requires inspecting the lower web
of the aft fairing of engine struts for any discoloration and doing any
related investigative and corrective action if necessary; inspecting
the heat shield castings for any damage and doing any corrective action
if necessary; installing gap cover strips; and replacing insulation
blankets with new insulation blankets. AD 2006-19-12 resulted from a
report that several discolored fairing lower webs and some damaged/
deteriorated insulation blankets were found in the aft fairings of
engine struts. We issued AD 2006-19-12 to prevent cracking of lower
webs of the aft fairings, which could result in flammable hydraulic
fluid leaking onto or near an ignition source, and possibly result in
an uncontrollable fire in the engine strut area.

Actions Since AD 2006-19-12, Amendment 39-14769 (71 FR 55727, September
25, 2006) Was Issued

    Since we issued AD 2006-19-12, Amendment 39-14769 (71 FR 55727,
September 25, 2006), we have received a report that an aft fairing
lower spar web exceeded the allowable conductivity limits. An
investigation concluded that wear to the pan casting and gap cover
strips allowed increased heat into the aft fairing heat shield cavity,
which exceeded the thermal capability of the insulation blankets.

Related Service Information Under 1 CFR Part 51

    We have reviewed Boeing Service Bulletin 777-54-0026, Revision 2,
dated January 5, 2012. The service information describes procedures for
a detailed inspection of the gap cover strips and heat shield pan
castings for damage, corrective actions, and installation of new gap
cover strip fillers, new velcro strips, and new aft fairing insulation
blankets.
    We reviewed Boeing Special Attention Service Bulletin 777-54-0038,
dated March 6, 2015. The service information describes procedures for
one-time and repetitive detailed inspections for any cracking and
deformation, as applicable, of the aft fairing lower structure;
conductivity

inspections of the aft fairing lower structure; and related
investigative and corrective actions.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section of this
NPRM.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would retain all requirements of AD 2006-19-12,
Amendment 39-14769 (71 FR 55727, September 25, 2006). In addition, this
proposed AD would add airplanes to the applicability of this AD. This
proposed AD would also require accomplishing the actions specified in
the service information described previously.
    The phrase ``related investigative actions'' is used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that (1) are related to the primary action, and (2) further investigate
the nature of any condition found. Related investigative actions in an
AD could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.

Change to AD 2006-19-12, Amendment 39-14769 (71 FR 55727, September 25,
2006)

    Since AD 2006-19-12, Amendment 39-14769 (71 FR 55727, September 25,
2006) was issued, the AD format has been revised, and certain
paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers have been redesignated in this proposed AD, as
listed in the following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                     Corresponding  requirement in this
   Requirement in AD 2006-19-12                  proposed AD
------------------------------------------------------------------------
 paragraph (f)                       paragraph (g)
 paragraph (g)                       paragraph (h)
 paragraph (h)                       paragraph (i)
------------------------------------------------------------------------

Costs of Compliance

    We estimate that this proposed AD affects 99 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection and other actions      Up to 11 work-      Up to $16,179,      Up to $17,114,      Up to $1,694,286,
 [retained actions from AD 2006-   hours x $85 per     depending on        depending on        depending on
 19[dash]12, Amendment 39-14769    hour = $935,        airplane            airplane            airplane
 (71 FR 55727, September 25,       depending on        configuration.      configuration.      configuration
 2006)].                           airplane
                                   configuration.
Inspections [new proposed         Up to 24            $0................  Up to $2,040,       Up to $201,960,
 action].                          work[dash]hours x                       depending on        depending on
                                   $85 per hour =                          airplane            airplane
                                   $2,040, depending                       configuration.      configuration
                                   on airplane
                                   configuration.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary related
investigative and corrective actions that would be required based on
the results of the proposed inspection. We have no way of determining
the number of aircraft that might need these inspections and
replacements:

                                               On-Condition costs
----------------------------------------------------------------------------------------------------------------
                 Action                           Labor cost            Parts cost         Cost per product
----------------------------------------------------------------------------------------------------------------
Related Investigative Actions...........  Up to 36 work[dash]hours x              $0  Up to $3,060, depending on
                                           $85 per hour = $3,060,                      airplane configuration
                                           depending on airplane
                                           configuration.
Corrective Actions......................  Up to 38 work[dash]hours x               0  Up to $3,230, depending on
                                           $85 per hour = $3,230,                      airplane configuration
                                           depending on airplane
                                           configuration.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, all of the costs of this proposed AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2006-19-12, Amendment 39-14769 (71 FR 55727, September 25, 2006), and
adding the following new AD:

The Boeing Company: Docket No. FAA-2015-5809; Directorate Identifier
2015-NM-055-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by January 4,
2016.

(b) Affected ADs

    This AD replaces AD 2006-19-12, Amendment 39-14769 (71 FR 55727,
September 25, 2006).

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, -300ER, and 777F series airplanes, certified in any category,
as identified in Boeing Special Attention Service Bulletin 777-54-
0038, dated March 6, 2015.

(d) Subject

    Air Transport Association (ATA) of America Code 54, Nacelles/
pylons.

(e) Unsafe Condition

    This AD was prompted by a report that an aft fairing lower spar
web exceeded the allowable conductivity limits. An investigation
concluded that wear to the pan casting and gap cover strips allowed
increased heat into the aft fairing heat shield cavity. We are
proposing this AD to detect and correct degradation of the aft
fairing lower web, which could lead to cracking of the web and could
allow flammable fluids to leak into the heat shield pan castings,
and consequent increased risk of an uncontained fire and subsequent
structural damage.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Inspection, Installation, and Replacement Actions With No
Changes

    This paragraph restates the actions required by paragraph (f) of
AD 2006-19-12, Amendment 39-14769 (71 FR 55727, September 25, 2006),
with no changes. For Model 777-200 and -300 series airplanes
identified in Boeing Special Attention Service Bulletin 777-54-0021,
Revision 1, dated March 16, 2006: Except as provided by paragraph
(h) of this AD, within 12 months after October 30, 2006 (the
effective date of AD 2006-19-12), do the actions specified in
paragraphs (g)(1), (g)(2), (g)(3), and (g)(4) of this AD, in
accordance with the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 777-54-0021, Revision 1, dated March 16,
2006.
    (1) Do a general visual inspection of the lower web of the aft
fairing for any discoloration and do any related investigative
action.
    (2) Do a general visual inspection of the heat shield castings
for any damage (crack(s), dent(s), gouge(s), warpage, fretting, or
missing/loose nutplates).
    (3) Install gap cover strips on the heat shield pans.
    (4) Replace insulation blankets on the heat shield pans with new
insulation blankets.

(h) Retained Repair Instructions

    This paragraph restates the actions required by paragraph (g) of
AD 2006-19-12, Amendment 39-14769 (71 FR 55727, September 25, 2006),
with no changes. If any damage, discoloration, heat damage, or crack
is found during any inspection required by paragraph (g) of this AD:
Before further flight, do all applicable corrective actions in
accordance with a method approved by the Manager, Seattle Aircraft
Certification Office (ACO), FAA, or in accordance with the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 777-54-0021, Revision 1, dated March 16, 2006.

(i) Retained Credit for Previous Actions With Revised Format

    This paragraph restates the credit provided by paragraph (h) of
AD 2006-19-12, Amendment 39-14769 (71 FR 55727, September 25, 2006),
with revised format. This paragraph provides credit for actions
required by paragraph (g) of this AD, if those actions were
performed before October 30, 2006 (the effective date of AD 2006-19-
12, Amendment 39-14769 (71 FR 55727, September 25, 2006)) using
Boeing Special Attention Service Bulletin 777-54-0021, dated June
23, 2005, except where Boeing Special Attention Service Bulletin
777-54-0021, dated June 23, 2005, does not provide an International
Annealed Copper Standard (IACS) value for determining the results of
the inspection for heat damage, the maximum acceptable IACS value is
42 percent. Boeing Special Attention Service Bulletin 777-54-0021,
dated June 23, 2005, is not incorporated by reference in this AD.

(j) New Requirements: Detailed and Conductivity Inspections and Related
Investigative and Corrective Actions (Repetitive Inspections for
Certain Airplanes)

    Within 24 months after the effective date of this AD: Do
detailed and conductivity inspections of the aft fairing lower
structure for cracks and deformation, as applicable, and do all
applicable related investigative and corrective actions, in
accordance with the Accomplishment Instructions of Boeing Special
Attention Service Bulletin 777-54-0038, dated March 6, 2015. Do all
applicable related investigative and corrective actions before
further flight. For Group 1, Configurations 1 and 3 airplanes, and
Group 2, Configuration 1, airplanes, identified in Boeing Special
Attention Service Bulletin 777-54-0038, dated March 6, 2015, repeat
the inspections thereafter at intervals not to exceed 24 months
until the terminating action specified in paragraph (k) of this AD
is done.

(k) Optional Terminating Action

    Accomplishing a detailed inspection of the gap cover strips and
heat shield pan castings for damage and applicable corrective
actions, and installation of new gap cover strip fillers, new velcro
strips, and new aft fairing insulation blankets, in accordance with
the Accomplishment Instructions of Boeing Service Bulletin 777-54-
0026, Revision 2, dated January 5, 2012, concurrently with
accomplishing detailed and conductivity inspections and all
applicable related investigative and corrective actions required by
paragraph (j) of this AD, terminates the repetitive inspections
specified in paragraph (j) of this AD; except where Boeing Service
Bulletin 777-54-0026, Revision 2, dated January 5, 2012, specifies
to contact the manufacturer, repair using a method approved in
accordance with the procedures specified in paragraph (l) of this
AD.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the

attention of the person identified in paragraph (m)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs approved for AD 2006-19-12, Amendment 39-14769 (71 FR
55727, September 25, 2006) are approved as AMOCs for the
corresponding provisions of paragraphs (g), (h), and (i) of this AD.

(m) Related Information

    (1) For more information about this AD, contact Sue Lucier,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle ACO,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-917-
6438; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on November 12, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-29617 Filed 11-19-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28240-28241]
[FR Doc No: 2018-12976]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2016]

Epidermolysis Bullosa: Developing Drugs for Treatment of
Cutaneous Manifestations; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous
Manifestations.'' The purpose of this draft guidance is to assist
sponsors with the development of drugs for treatment or prevention of
the serious cutaneous manifestations of the heterogeneous group of
disorders collectively known as epidermolysis bullosa (EB). There is an
unmet medical need for EB patients due to the paucity of effective
treatment options.

DATES: Submit either electronic or written comments on the draft
guidance by August 17, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and

identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2016 for ``Epidermolysis Bullosa: Developing Drugs for
Treatment of Cutaneous Manifestations; Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Barbara Gould, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5166, Silver Spring, MD 20993-0002, 301-
796-4224; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Epidermolysis Bullosa: Developing Drugs for Treatment of
Cutaneous Manifestations.'' The purpose of this draft guidance is to
assist sponsors with the development of drugs for treatment or
prevention of the serious cutaneous manifestations of the heterogeneous
group of disorders collectively known as EB. There is an unmet medical
need for EB patients due to the paucity of effective treatment options.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous
Manifestations.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12976 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Susan Lewis;<PHONE_NUMBER>

Inter-Regional Research Project Number 4 (IR-4 Project)

Petition 4E8335

	EPA has received a pesticide petition (4E8335) from Inter-Regional Research Project Number 4 (IR-4 Project), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.567 by establishing tolerances for residues of the sum of zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 parts per million (ppm) and vegetable, tuberous and corm, subgroup 1C at 0.060 ppm. Further amendment to 40 CFR part 180.567 is requested, to establish tolerances for residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxypropyl)-4-methylbenzamide, in or on raw agricultural commodity tomato subgroup 8-10A at 2.0 ppm and fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm.

	IR-4 also proposes, upon the approval of the aforementioned tolerances, to remove established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm.

EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. A plant metabolism study was not conducted on ginseng; a metabolism study performed on potatoes, which analyzed for zoxamide and its metabolites, is referenced due to the nature of the crops. The metabolism of zoxamide and its metabolites was also investigated for grapes and tomatoes.

	2. Analytical method. Adequate enforcement methodology is available to enforce the tolerance expression.  A tolerance enforcement analytical method for the analysis of zoxamide and its metabolites, RH-1452 and RH-1455, in/on ginseng was developed by the Analytical Chemistry Branch (ACB).

	3. Magnitude of residues. No residue data will be provided for ginseng.  The translation of potato granules/flakes tolerance of 0.30 ppm to ginseng will occur based on the following: potato is the representative commodity for crop group 1, similarity of the nature of the crops and use patterns, and low consumption of ginseng.  Furthermore, residues in ginseng are expected to be lower than the residues in potatoes since ginseng has a higher PHI and lower moisture content.

B. Toxicological Profile

      1. Acute toxicity.  Acute studies have been evaluated by the Agency and considered valid and complete.  The acute oral study (MRID No. 44731806) in both rat and mouse produced an LD50 of >5,000 m/kg (males and females combined).  A dermal study (MRID No. 44731807) in rats resulted in a toxicity category III with an LD50 > 2,000 mg/kg (males and females combined) while an inhalation study produced an LC50 > 5.3 mg/L (MRID No. 44731808).  A primary eye irritation study was performed on rabbits and resulted as a moderate irritant (MRID No. 44731809); a primary skin irritation study proved not to be an irritant (MRID No. 44731809).  Two sensitization studies conducted using both maximization and Buehler methods were performed according to guideline 870.2600.  The maximization test proved to be a skin sensitizer (MRID No. 44731811); Buehler method on guinea pigs also produced delayed hypersensitivity at all concentrations tested (MRID No.  44731812).
      Acute dietary risk assessments were not performed as no acute dietary endpoint was identified; no effects were observed in oral toxicity studies that could be attributable to a single dose.

	2. Genotoxicty. Zoxamide is not mutagenic in Ames assays, in Chinese Hamster Ovary (CHO) cells assay at the Hypoxonthine guanine phosphoribosyle transferase (HGPRT) locus, and in the mouse bone marrow micronucleus assay. Zoxamide did not induce structural chromosome aberrations in cultured CHO cells treated up to the limit of toxicity but did induce increased levels of numerical aberrations.

	3. Reproductive and developmental toxicity. A two year generation reproductive toxicity study on rats indicated that continuous exposure of rats to zoxamide technical in the diet had a No Observed Adverse Effect Level (NOAEL) for parental animal toxicity of 5,000 ppm.  The only effect seen at 20,000 ppm  was a decrease in body weight gain and feed consumption.  No adverse reproductive or developmental effects were seen at doses up to and including 20,000 ppm
	Two developmental studies have been performed on rats and rabbits using an oral gavage method.  When zoxamide technical was administered to pregnant rats, the No Observed Effect Level (NOEL) of 1000 mg A.I./kg/day (limit dose) was achieved.  Zoxamide is not maternally toxic, embryo-feto toxic or teratogenic at doses up to and including 1,000 mg A.I./kg/day (limit dose).  When administered orally by gavage to pregnant rabbits, the NOEL for maternal toxicity was observed to be greater than or equal to 1,000 mg AI/kg.  There were no developmental toxicity or teratogenicity observed at any dose level.

	4. Subchronic toxicity. The NOAEL in a 90-day rat subchronic feeding and neurotoxicity study was 1,500 mg/kg/day in males and 1,622 mg/kg/day in females HDT.  Zoxamide did not produce neurotoxic or neuropathologic effects.
    A 90-day feeding study with mice, the NOAEL was 436 mg/kg/day in males and 574 mg/kg/day in females based on a slight decrease in weight gain among the females only at the LOAEL of 1,666 mg/kg/day.
    A 90-day dog feeding study gave a NOAEL of 55 mg/kg in males and 62 mg/kg/day in females based on increased liver weights without a corresponding clinical or histopathologic change in females only at 322 mg/kg/day.
    No signs of systemic toxicity were observed when zoxamide was administered dermally to rats for 28-30 days at a limit dose of 1,000 mg/kg/day).  This occurred despite skin irritation at all doses tested (150, 400, and 1,000 mg/kg/day).  Similarly, in vivo dermal absorption was shown to be low regardless of concentration or formulation type (i.e., 1-6% of the administered dose was systemically absorbed after 24 hrs.)

	5. Chronic toxicity. In a combined rat chronic/oncogenicity study, the NOAEL for chronic toxicity was 51 mg/kg/day in males and 65 mg/kg/day in females based on an equivocal increase in relative liver weight at a LOAEL of 328 mg/kg/day in females at the interim sacrifice only.  The NOAEL was considered to be 1,058 mg/kg/day in males and 1331 mg/kg/day in females (HDT, limit dose).  No carcinogenicity was observed.
    An 18-month mouse oncogenicity study (MRID No. 44731819) showed no signs of carcinogenicity or of any other compound-related effect at dosage levels up to 1021 mg/kg/day in males and 1,289 mg/kg/day in females (limit dose).
    The NOAEL in a 1-year feeding study in dogs was 255 mg/kg/day in males and 48 mg/kg/day in females based on minimal effects on body weight and body weight gain and increased liver weights in females only at a LOAEL of 278 mg/kg/day (MRID No. 44731817).

	6. Animal metabolism. In pharmacokinetic and metabolism studies in the rat, zoxamide was extensively absorbed following oral dosing, rapidly and extensively metabolized to a large number of metabolites, and rapidly eliminated from the body.  No evidence of accumulation of the parent compound or its metabolites was observed).

	7. Metabolite toxicology. The tolerances requested for ginseng are for the sum of zoxamide (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the stoichiometric equivalent of zoxamide.
	Neither metabolite RH-141455 nor metabolite RH-141452 (MRID No. 44731835) is mutagenic in a Salmonella gene mutation assay.

	8. Endocrine disruption. Zoxamide is listed in the November 2012 U.S. Environmental Protection Agency Endocrine Disruptor Screening Program Universe of Chemicals.
      Zoxamide is unlikely to exhibit endocrine activity based on structure-activity and mode of action information as well as the lack of developmental and reproductive toxicity,  There was no evidence of a functional or histopathologic change in the male or female reproductive tract, and no indicators of an endocrine effect of any kind below limit doses in mammalian subchronic or chronic studies or in mammalian and avian reproduction studies.  A slight thyroid effect at the limit dose (994-1139 mg/kg/day) in the subchronic and chronic dog studies was secondary to liver hypertrophy and enlargement at that dose.  Collectively, the weight of evidence provides no indication of an endocrine effect of zoxamide.

C. Aggregate Exposure

	1. Dietary exposure. Tolerances are established for residues of the fungicide zoxamide (3, 5-dichloro- N -(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide),  in or on grape (3.0 ppm), grape, raisin (15.0 ppm), tomato (2.0 ppm), and vegetable cucurbit, group 9 (1.0 ppm).  Tolerances are also established for the combined residues of zoxamide and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) in or on potatoes (0.060 ppm), potato granules/flakes (0.30 ppm), and wet peel potatoes (0.10 ppm).
      IR-4 Project seeks to establish a tolerance for the sum of zoxamide and its metabolites (RH-1455 and RH-141455; RH-1452 and 141452) calculated as the stoichiometric equivalent of zoxamide in or on ginseng at 0.30 ppm.  No residue trials were conducted.
      Current mancozeb tolerances published in 40 CFR §180.176 support ginseng uses.

	i. Food. A Tier I DEEM-FCID (Dietary Exposure Evaluation Model  -  Food Commodity Intake Database) Chronic analysis (Version 3.16) for zoxamide was completed for purposes of assessing the potential aggregate exposure from food under existing and proposed tolerances for zoxamide.  The model was performed assuming 100% crop treated.
      A chronic dog NOEL of 48 mg/kg bw/day determined for zoxamide in a 1-year toxicity study in dogs was used for the DEEM.

	ii. Drinking water. PRZM/EXAMS and SCI-GROW models illustrate that the EECs of zoxamide for chronic exposures are estimated to be 21.8 parts per billion (ppb) for surface water and 2.1 ppb for ground water.

	2. Non-dietary exposure. Zoxamide is not registered for residential uses; therefore, residential exposure is not expected.

D. Cumulative Effects

	EPA does not have available data to determine whether zoxamide has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment.  Zoxamide does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, EPA has not assumed that zoxamide has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Chronic dietary exposure to zoxamide from food (including ginseng) utilizes 1.4% of the cPAD (0.48 mg/kg/day) for the total U.S. population. The chronic (non-cancer) exposure to zoxamide is 0.48 mg/kg/day.

	2. Infants and children. Chronic dietary exposure to zoxamide from food (including ginseng) utilizes 10% of the Chronic Population Adjusted Dose (cPAD) for infants and children ages 1-12 years of age.
F. International Tolerances

	Neither Codex Alimentarius, Canada nor Mexico have established Maximum Residue Levels (MRLs) for zoxamide on ginseng.  Therefore, no compatibility issues exist with regard to the proposed U.S. ginseng tolerance.


[Federal Register Volume 86, Number 87 (Friday, May 7, 2021)]
[Rules and Regulations]
[Pages 24507-24510]
[FR Doc No: 2021-09415]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0488; FRL-10022-88-Region 3]

Air Plan Approval; Pennsylvania; 1997 8-Hour Ozone National
Ambient Air Quality Standard Second Maintenance Plan for the
Clearfield/Indiana Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the Commonwealth of
Pennsylvania. The revision pertains to the Commonwealth's plan,
submitted by the Pennsylvania Department of Environmental Protection
(PADEP), for maintaining the 1997 8-hour ozone national ambient air
quality standard (NAAQS) (referred to as the ``1997 ozone NAAQS'') in
the Clearfield/Indiana, Pennsylvania area (``Clearfield/Indiana
Area''). EPA is approving these revisions to the Pennsylvania SIP in
accordance with the requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on June 7, 2021.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2020-0488. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available through
https://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Serena Nichols, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2053. Ms. Nichols can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On February 9, 2021 (86 FR 8729), EPA published a notice of
proposed rulemaking (NPRM). In the NPRM, EPA proposed approval of
Pennsylvania's plan for maintaining the 1997 ozone NAAQS in the
Clearfield/Indiana Area through April 20, 2029, in accordance with CAA
section 175A. The formal SIP revision was submitted by PADEP on
February 27, 2020.

II. Summary of SIP Revision and EPA Analysis

    On March 19, 2009 (74 FR 11674, effective April 20, 2009), EPA
approved a redesignation request (and maintenance plan) from PADEP for
the Clearfield/Indiana Area. In accordance with CAA section 175A(b), at
the end of the eighth year after the effective date of the
redesignation, the State must also submit a second maintenance plan to
ensure ongoing maintenance of the standard for an additional 10 years,
and in South Coast Air Quality Management District v. EPA,\1\ the D.C.
Circuit held that this requirement cannot be waived for areas, like the
Clearfield/Indiana Area, that had been redesignated to attainment for
the 1997 8-hour ozone NAAQS prior to revocation and that were
designated attainment for the 2008 ozone NAAQS. CAA section 175A sets
forth the criteria for adequate maintenance plans. In addition, EPA has
published longstanding guidance that provides further insight on the
content of an approvable maintenance plan, explaining that a
maintenance plan should address five elements: (1) An attainment
emissions inventory; (2) a maintenance demonstration; (3) a commitment
for continued air quality monitoring; (4) a process for verification of
continued attainment; and (5) a contingency plan.\2\ PADEP's February
27, 2020 submittal fulfills Pennsylvania's obligation to submit a
second maintenance plan and addresses each of the five necessary
elements.
---------------------------------------------------------------------------

    \1\ 882 F.3d 1138 (D.C. Cir. 2018).
    \2\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (Calcagni Memo).
---------------------------------------------------------------------------

    As discussed in the February 9, 2021 NPRM, EPA allows the submittal
of a limited maintenance plan (LMP) to meet the statutory requirement
that the area will maintain for the statutory period. Qualifying areas
may meet the maintenance demonstration by showing that the area's
design value \3\ is well below the NAAQS and that the historical
stability of the area's air quality levels indicates that the area is
unlikely to violate the NAAQS in the future. EPA evaluated PADEP's
February 27, 2020 submittal for consistency with all applicable EPA
guidance and CAA requirements. EPA found that the submittal met CAA
section 175A and all CAA requirements, and proposed approval of the LMP
for the Clearfield/Indiana Area as a revision to the Pennsylvania SIP.
Other specific requirements of PADEP's February 27, 2020 submittal and
the rationale for EPA's proposed action are explained in the NPRM and
will not be restated here.
---------------------------------------------------------------------------

    \3\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ozone concentrations. The design value for an ozone nonattainment
area is the highest design value of any monitoring site in the area.
---------------------------------------------------------------------------

III. EPA's Response to Comments Received

    EPA received one comment on the February 9, 2021 NPRM. This comment
is in the docket for this rulemaking action. A summary of the comment
and EPA's response are provided herein.
    Comment: The commenter asserts that the LMP should not be approved
because ``Pennsylvania identifies no actual contingency measures.''
According to the commenter, a ``contingency measure is supposed to be a
known measure that can be quickly implemented by a state in order to
prevent the violation of the NAAQS.'' The comment asserts that current
contingency measures are defective because they allegedly will not be
evaluated and determined until after an exceedance of the NAAQS has
occurred. The comment claims that EPA is aware Pennsylvania has a
history of not meeting its CAA requirements on time, and that it can
take Pennsylvania more than two years to implement a regulation, which
would be too long to prevent a violation of the NAAQS.
    Response: The commenter asserts that Pennsylvania identifies no
actual contingency measures because the measures are not yet
``evaluated'' and ``determined'' and cannot be implemented before a
violation of the NAAQS occurs. Because Pennsylvania identifies two
regulatory and six non-regulatory contingency measures in general
terms, EPA understands the comment's use of the term ``evaluated'' and
``determined'' must mean something like the specific measures
identified by PADEP have not been fully promulgated and are not in
effect at this time. If EPA's understanding is correct, EPA agrees with
this fact, but does not agree that this has any bearing on the
approvability of the particular contingency measures or of the overall
LMP.
    PADEP identifies six non-regulatory measures and two regulatory
measures. The two regulatory measures are ``additional controls'' on
consumer products and portable fuel containers. The six non-regulatory
measures are: Voluntary diesel engine ``chip reflash;'' diesel retrofit
for public or private local onroad or offroad fleets; idling reduction
technology for Class 2 yard locomotives; idling technologies or
strategies for truck stops, warehouses, and other freight-handling
facilities; accelerated turnover of lawn and garden equipment;
additional promotion of alternative fuel for home heating and
agriculture use. As stated in the Calcagni memo, EPA's long-standing
interpretation is that contingency measures for maintenance of the
NAAQS are not required to be fully adopted in order to be approved. The
commenter refers to a recent court case vacating, among other things,
the contingency measure provisions in EPA's rule for implementing the
2015 ozone NAAQS, Sierra Club v. EPA, No. 15-1465 (D.C. Cir. January
29, 2021). It is possible that the commenter has conflated the
contingency measure provisions at issue in that case, which pertained
to attainment plans, and those at issue in this LMP, which pertain to
maintenance plans. The contingency measure provisions for maintenance
and attainment are found in two different sections of the CAA, with
substantially different wording and requirements. The attainment plan
contingency measures provisions in CAA section 172(c)(9) require that
the attainment plan have ``specific measures'' that can ``take effect
in any such case without further action by the State or the
Administrator'' if the area fails to make reasonable further progress
or attain the NAAQS. 42 U.S.C. 7502(c)(9). Section 175A of the CAA sets
forth the contingency measure requirements for maintenance areas.
Section 175A(d) requires that the maintenance plan contain ``such
contingency provisions as the Administrator deems necessary to assure
that the State will promptly correct any violation of the standard
which occurs after the redesignation of the area as an attainment
area''. 42 U.S.C. 7505a(d). Unlike section 172(c)(9) there is no
requirement under section 175A that the contingency measures be set
forth with specificity or that they be able to take effect without
further action by EPA or the State.
    With this statutory background in mind, EPA does not agree that the
plan should be disapproved due to PADEP's alleged inability to
promulgate a

contingency measure in sufficient time to avert a violation of the
NAAQS. As noted previously, CAA section 175A(d) mandates that a
maintenance plan must contain ``such contingency provisions as the
Administrator deems necessary to assure that the State will promptly
correct any violation of the standard which occurs after the
redesignation of the area as an attainment area'' (emphasis added). The
statute therefore does not include any requirement that a maintenance
plan's contingency measures prevent a violation of the NAAQS, but
rather only that those selected measures be available to address a
violation of the NAAQS after it already occurs. Pennsylvania also
elected to adopt a ``warning level response,'' which states that PADEP
will consider adopting contingency measures if, for two consecutive
years, the fourth highest eight-hour ozone concentrations at any
monitor in the area are above 84 parts per billion (ppb). But this
warning level response is not required under the CAA, and therefore we
do not agree with the commenter that the plan should be disapproved
based on the commenter's concern over the timeliness of the warning
level response implementation.
    Moreover, as a general matter, we do not agree that the schedules
for implementation of contingency provisions in the LMP are
insufficient. As noted, the CAA provides some degree of flexibility in
assessing a maintenance plan's contingency measures--requiring that the
plan contain such contingency provisions ``as the Administrator deems
necessary'' to assure that any violations of the NAAQS will be
``promptly'' corrected. EPA's longstanding guidance for redesignations,
the Calcagni Memo, also does not provide precise parameters for what
strictly constitutes ``prompt'' implementation of contingency measures,
noting that, for purposes of CAA section 175A, ``a state is not
required to have fully adopted contingency measures that will take
effect without further action by the state in order for the maintenance
plan to be approved.'' Calcagni memo at 12. However, the guidance does
state that the plan should ensure that the measures are adopted
``expediently'' once they are triggered, and should provide ``a
schedule and procedure for adoption and implementation, and a specific
time limit for action by the state.'' Id. We think Pennsylvania's plan,
which provides specific lists of regulatory and non-regulatory measures
that Pennsylvania would consider after evaluating and assessing what it
believed to be the cause of increased ozone concentrations, and the
specific timeframes it would use to expediently implement the various
measures, meets the requirements of CAA section 175A.

IV. Final Action

    EPA is approving PADEP's second maintenance plan for the
Clearfield/Indiana Area for the 1997 ozone NAAQS as a revision to the
Pennsylvania SIP.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 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. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this 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);
     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).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 6, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    This action, approving PADEP's second maintenance plan for the
Clearfield/Indiana Area for the 1997 ozone NAAQS, may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2).)

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, Volatile organic compounds.

    Dated: April 26, 2021.
Diana Esher,
Acting Regional Administrator, Region III.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
the entry ``Second Maintenance Plan for the Clearfield/Indiana 1997 8-
Hour Ozone Nonattainment Area'' at the end of the table to read as
follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

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   Name of non-regulatory SIP        Applicable           State
            revision               geographic area   submittal date   EPA approval date   Additional explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Second Maintenance Plan for the  Clearfield/Indiana         2/27/20  5/7/21, [insert     The Clearfield/Indiana
 Clearfield/Indiana 1997 8-Hour   Area.                               Federal Register    area consists of
 Ozone Nonattainment Area.                                            citation].          Clearfield and Indiana
                                                                                Counties.
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-09415 Filed 5-6-21; 8:45 am]
BILLING CODE 6560-50-P