[Federal Register Volume 79, Number 151 (Wednesday, August 6, 2014)]
[Rules and Regulations]
[Pages 45702-45705]
[FR Doc No: 2014-18619]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 228

[EPA-R06-OW-2014-0234; FRL-9914-59-Region 6]

Ocean Dumping: Cancellation and Modification of Final Site
Designations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) today cancels the
final designation of two Ocean Dredged Material Disposal Sites (ODMDSs)
located in the Gulf of Mexico near the Houma Navigational Canal (HNC)
and near the Mississippi River Gulf Outlet (MRGO) Canal, Louisiana.
Both sites are EPA-approved ocean dumping sites for the disposal of
suitable dredged material. This final action is being taken because
there is no clear future need for the sites. Additionally, EPA is
modifying the period of use, use restriction, and name of the Homeport
Project ODMDS located in the Gulf of Mexico offshore of Port Aransas,
Texas.

DATES: This Final Rule is effective on September 5, 2014.

ADDRESSES: The EPA established a docket for this action under Docket
No. EPA-R06-OW-2014-0234. All documents in the docket are listed on the
http://www.regulations.gov Web site. Publicly available docket
materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jessica Franks, Ph.D., Marine and
Coastal Section (6WQ-EC), Environmental Protection Agency, Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733, telephone (214)
665-8335, fax number<PHONE_NUMBER>; email address
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Potentially Affected Persons
II. Background
III. Final Action
IV. Responses to Comments
V. Administrative Review
    1. Executive Order 12886
    2. Paperwork Reduction Act
    3. Regulatory Flexibility Act, as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996
    4. Unfunded Mandates Reform Act
    5. Executive Order 13132: Federalism
    6. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    7. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    8. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use Compliance With Administrative
Procedure Act
    9. National Technology Transfer Advancement Act
    10. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low Income
Populations

I. Potentially Affected Persons

    Persons potentially affected by this action include those who seek
or might seek permits or approval by EPA to dispose of dredged material
into ocean waters pursuant to the Marine Protection Research and
Sanctuaries Act, 33 U.S.C. 1401 et seq. The Final Rule would be
relevant to persons, including organizations and government bodies
seeking to dispose of dredged material in ocean waters offshore of
Terrebonne, Louisiana, the Mississippi River Gulf Outlet Canal,
Louisiana, and Corpus Christi, Texas. Currently, the U.S. Army Corps of
Engineers (Corps) and other persons with permits to use designated
sites offshore Terrebonne, Louisiana, the Mississippi River Gulf Outlet
Canal, Louisiana, and Corpus Christi, Texas would be most impacted by
this final action. Potentially affected categories and persons include:

------------------------------------------------------------------------
                                       Examples of potentially regulated
               Category                             persons
------------------------------------------------------------------------
Federal government...................  USACE Civil Works and O & M
                                        projects; other Federal
                                        agencies, including the
                                        Department of Defense.
Industry and general public..........  Port authorities, marinas and
                                        harbors, shipyards and marine
                                        repair facilities, berth owners.
State, local and tribal governments..  Governments owning and/or
                                        responsible for ports, harbors,
                                        and/or berths, Government
                                        agencies requiring disposal of
                                        dredged material associated with
                                        public works projects.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding persons likely to be affected by this
action. For any questions regarding the applicability of this action to
a particular entity, please refer to the contact person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

II. Background

    Section 102(c) of the Marine Protection, Research, and Sanctuaries
Act (MPRSA) of 1972, as amended, 33 U.S.C. 1401 et seq., gives the
Administrator of EPA the authority to designate sites where ocean
disposal may be permitted. On October 1, 1986, the Administrator
delegated the authority to designate ocean disposal sites to the
Regional Administrator of the Region in which the sites are located.
These cancellations and modification are being made pursuant to that
authority.
    The EPA Ocean Dumping Regulations promulgated under MPRSA (40 CFR
Chapter I, Subchapter H, Sec.  228.11) state that modifications in
disposal site use which involve withdrawal of disposal sites from use
or permanent changes in the total specified quantities or types of
wastes permitted to be discharged to a specific disposal site will be
made by promulgation in this part 228. These site cancellations and
modification of types of wastes permitted to be discharged to a
specific disposal site are being published as final rulemaking in
accordance with Sec.  228.11(a) of the Ocean Dumping Regulations, which
permits the withdrawal of designated disposal sites from use or changes
in the total specified quantities or types of wastes permitted to be
discharged to a specific disposal site based upon changed circumstances
concerning use of the site.

III. Final Action

    The final cancellation of the designations of these sites is needed
as a housekeeping measure. In essence, these ODMDSs either are no
longer a suitable disposal option or have no foreseeable need. The
Houma ODMDS is now partially occupied by the Houma Navigational Canal.
The U. S. Corps of Engineers has re-aligned the Cat Island Pass portion
of the HNC several times since the construction of this federal
navigation channel in order to retain a channel segment that requires
little maintenance dredging due to the natural hydrodynamics in the
vicinity. This particular portion of the HNC Cat Island Pass channel is
characterized by an area of deeper water (erosional zone) that is
moving westwards. Once this deeper water erosional zone has moved far

enough west from the Corps' channel alignment that area of the channel
begins to shoal (becomes a depositional zone). To avoid increased
maintenance dredging costs, the Corps re-aligns this portion of the
channel westwards to ``keep up'' with the deeper water zone as it
continues to migrate westwards. The Houma ODMDS is located on the west
side of this channel, and the deeper water zone has migrated into the
ODMDS boundaries. The Houma ODMDS has not been used for more than
twenty (20) years. Instead, dredged material from the HNC has been used
beneficially under section 404 of the Clean Water Act on the two (2)
single point discharge (SPD) sites located within the ODMDS. It is the
Corps intention to continue this practice. As such, this type of
placement is excluded by definition from regulation by MPRSA. De-
designation of the Houma ODMDS will allow the Corps to expand the
beneficial use of dredged material for the creation of durable islands
for seasonal bird nesting areas regulated under section 404 of the
Clean Water Act.
    The Mississippi River-Gulf Outlet (MRGO) ODMDS is no longer needed.
On June 5, 2008 the Assistant Secretary of the Army for Civil Works
forwarded the Final MRGO Deep-Draft De-authorization Report to Congress
officially de-authorizing the MRGO from the Gulf Intercoastal Water Way
(GIWW) to the Gulf of Mexico as a federal navigation project. The
report also authorized the construction of a rock closure structure
across MRGO which was completed in late July 2009.
    The modification of the period of use and use restriction on the
Homeport Project ODMDS is needed to change the use of the site to
include suitable dredged material from the greater Corpus Christi,
Texas vicinity over an indefinite period of time. The Homeport Project
ODMDS was designated to provide a disposal area for placement of
suitable construction dredge material from the U.S. Navy's Homeport
Project at Corpus Christi/Ingleside, Texas. The Homeport Project never
materialized and therefore, the ODMDS was never used. Use of the ODMDS
was limited to suitable dredged material from the Homeport Project over
a 50 year period. There is a need for placement of construction dredged
material from the Corpus Christi Channel Channel Improvement Project
(CIP) as described in the Final Environmental Impact Statement (FEIS)
for the Corpus Christi Ship Channel Channel Improvements Project Corpus
Christi and Nueces Bays Nueces and San Patricio Counties, Texas
published in April 2003. Based on the FEIS, suitable dredged material
will be placed beneficially in the location of the Homeport Project
ODMDS under section 404 of the Clean Water Act (CWA). CWA section 404
has jurisdiction in the Territorial Sea or coastal waters from the
baseline to three (3) nautical miles seaward. Because the Homeport
Project ODMDS is located beyond the boundary of the Territorial Sea and
in the open ocean, the CWA section 404 does not have jurisdiction. As a
result there is a need to change the use restriction placed on the
Homeport Project ODMDS to include suitable dredged material from the
greater Corpus Christi, Texas vicinity. Since dredged material
placement at this ODMDS is expected to be an on-going process over many
years, the period of use is being changed to continuing use. EPA is
also changing the name of the Homeport Project ODMDS to Corpus Christi
New Work ODMDS. The current name is no longer applicable since it was
the name of the project at the time the ODMDS was designated.

IV. Responses to Comments

    The proposed rule was published in the Federal Register on April
21, 2014, as docket number EPA-R06-OW-2014-0234. The comment period
closed on June 5, 2014. The EPA received two comments on the proposed
rule from two entities. These comments are responded to here.

1. Request for Geographic Coordinates

    NOAA asked for the geographic coordinates for the two ODMDS being
cancelled. The Houma Navigation Channel ODMDS is bounded by the
following coordinates (North American Datum from 1927):
29[deg]05'22.3'' N., 90[deg]34'43'' W.; 29[deg]02'17.8'' N.,
90[deg]34'28.4'' W.; 29[deg]02'12.6'' N., 90[deg]35'27.8'' W.;
29[deg]05'30.8'' N., 90[deg]35'27.8'' W.
    The Mississippi River Gulf Outlet ODMDS is bounded by the following
coordinates (North American Datum from 1927): 29[deg]32'35'' N.,
89[deg]12'38'' W.; 29[deg]29'21'' N., 89[deg]08'00'' W.; 29[deg]24'51''
N., 88[deg]59'23'' W.; 29[deg]24'28'' N., 88[deg]59'39'' W.;
29[deg]28'59'' N., 89[deg]08'19'' W.; 29[deg]32'15'' N., 89[deg]12'57''
W.

2. Comment Regarding NHPA Section 106 Consultation

    The Choctaw Nation of Oklahoma requested to be a consulting party
under Section 106 of the National Historic Preservation Act for the
portion of the project in Louisiana under Section 106.
    The cancellation of the Houma ODMDS and Mississippi River Gulf
Outlet ODMDS do not have the potential to effect historic resources
listed on or eligible for listing on the National Register. Cancelation
of these sites by this Notice does not authorize any action or ground
disturbance activities which would have the potential to effect
resources. Therefore, Section 106 review is not necessary for this
action.

V. Administrative Review

1. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993) EPA must
determine whether the regulatory action is `significant,'' and
therefore subject to office of Management and Budget (OMB) review and
other requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to lead to a
rule that may:
    (a) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way, the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local or Tribal governments or communities;
    (b) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (c) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs, or the rights and obligations of
recipients thereof: Or
    (d) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    This final rule should have minimal impact on State, local, or
Tribal governments or communities. Consequently, EPA has determined
that this final rule is not a ``significant regulatory action'' under
the terms of Executive Order 12866.

2. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., is intended to
minimize the reporting and recordkeeping burden on the regulated
community, as well as to minimize the cost of Federal information
collection and dissemination. In general, the Act requires that
information requests and record-keeping requirements affecting ten or
more non-Federal respondents be approved by OMB. Since the final rule
would not establish or modify any information or recordkeeping
requirements, but only clarifies existing requirements, it is not
subject to the provisions of the Paperwork Reduction Act.

3. Regulatory Flexibility Act, as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    This final rule will not impose any requirements on small entities.
The modification of the Homeport Project ODMDS broadens the use of the
site providing an additional option for dredged material placement in
the Corpus Christi, Texas vicinity. The removal of the Houma ODMDS will
allow for the beneficial use of dredged material under CWA Section 404
for the creation of bird islands. The closing of the Mississippi River
Gulf Outlet Navigation Channel was mandated by Congress and therefore
the associated ODMDS is no longer needed.
    For these reasons, the Regional Administrator certifies, pursuant
to section 605(b) of the RFA, that the final rule will not have a
significant economic impact on a substantial number of small entities.

4. Unfunded Mandates Reform Act

    This final rule contains no Federal mandates under the provisions
of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) of 1995
(Pub. L. 104-4) for State, local, or tribal governments or the private
sector that may result in estimated costs of $100 million or more in
any year. It imposes no new enforceable duty on any State, local or
tribal governments or the private sector nor does it contain any
regulatory requirements that might significantly or uniquely affect
small government entities. Thus, the requirements of section 203 of the
UMRA do not apply to this final rule.

5. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.
``Policies that have federalism implications'' are defined in the
Executive Order to include regulations that have ``substantial direct
effects 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.''
    This final rule does not have federalism implications. It will not
have substantial direct effects 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,
as specified in Executive Order 13132.

6. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by Tribal officials in the development of regulatory
policies that have Tribal implications.'' This final rule does not have
Tribal implications, as defined in Executive Order 13175.

7. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This Executive Order (62 FR 19885, April 23, 1997) applies to any
rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by EPA. This final rule is not subject
to the Executive Order because it is not economically significant as
defined in Executive Order 12866, and because EPA does not have reason
to believe the environmental health or safety risks addressed by this
action present a disproportionate risk to children.

8. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use Compliance With Administrative Procedure
Act

    This final rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a
significant regulatory action under Executive Order 12866.

9. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. This final rule does not involve technical
standards. Therefore, EPA is not considering the use of any voluntary
consensus standards.

10. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low Income Populations

    Executive Order 12898 (59 FR 7629) directs Federal agencies to
determine whether the Final Rule would have a disproportionate adverse
impact on minority or low-income population groups within the project
area. The Final Rule would not significantly affect any low-income or
minority population.

List of Subjects in 40 CFR Part 228

    Environmental protection, Water pollution control.

    Dated: July 18, 2014.
Samuel Coleman,
Deputy Regional Administrator, Region 6.

    In consideration of the foregoing, EPA amends part 228, chapter I
of title 40 of the Code of Federal Regulations as follows:

PART 228--CRITERIA FOR THE MANAGEMENT OF DISPOSAL SITES FOR OCEAN
DUMPING

0
1. The authority citation for part 228 continues to read as follows:

    Authority:  33 U.S.C. 1412 and 1418.

0
2. Section 228.15 is amended by:
0
a. Removing and reserving paragraphs (j)(1) and (j)(4);
0
b. Revising paragraph (j)(16) introductory text; and
0
c. Revising paragraphs (j)(16)(v) and (j)(16)(vi).
    The revisions read as follows:

Sec.  228.15  Dumping sites designated on a final basis.

* * * * *
    (j) * * *
    (16) Corpus Christi New Work ODMDS, Corpus Christi, Texas.
* * * * *
    (v) Period of Use: Continuing use.
    (vi) Restrictions: Disposal shall be limited to suitable dredged
material

from the greater Corpus Christi, Texas vicinity. Disposal shall comply
with conditions set forth in the most recent approved Site Management
and Monitoring Plan.
* * * * *
[FR Doc. 2014-18619 Filed 8-5-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Rules and Regulations]
[Pages 26836-26838]
[FR Doc No: 2018-12519]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-1163; Product Identifier 2017-CE-041-AD; Amendment
39-19260; AD 2018-09-04]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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

SUMMARY: The FAA is correcting an airworthiness directive (AD) that
published in the Federal Register. The AD applies to certain Gulfstream
Aerospace Corporation Models G-IV and GIV-X airplanes. Paragraphs
(h)(3) through (5) of the AD incorrectly reference Customer Bulletin
238A as Customer Bulletin 283A. This document corrects that error. In
all other respects, the original document remains the

same; however for the sake of clarity, we are publishing the entire
rule in the Federal Register.

DATES: The effective date of AD 2018-09-04 remains June 11, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of June 11, 2018
(83 FR 19922, May 7, 2018).

ADDRESSES: You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1163; or in person at the Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for the Docket Operations (phone: 800-
647-5527) is U.S. Department of Transportation, Docket Operations, M-
30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue
SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: William O. Herderich, Aerospace
Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park,
Georgia 30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION: AD 2018-09-04, Amendment 39-19260 (83 FR
19922, May 7, 2018), requires incorporating new revisions into the
Instructions for Continued Airworthiness of the Limitations section of
the FAA-approved maintenance program (e.g., maintenance manual) that
establish an inspection cycle for the repaired main landing gear side
brace actuator fittings.
    As published, paragraphs (h)(3) through (5) of the AD contain a
typographical error. The published references are Customer Bulletin No.
283A, dated June 15, 2017, and they should be Customer Bulletin No.
238A, dated June 15, 2017.
    Although no other part of the preamble or regulatory information
has been corrected, for the sake of clarity, we are publishing the
entire rule in the Federal Register.
    The effective date of this AD remains June 11, 2018.

List of Subjects in 14 CFR Part 39

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

Adoption of the Correction

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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  [Corrected]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-09-04 Gulfstream Aerospace Corporation: Amendment 39-19260;
Docket No. FAA-2017-1163; Product Identifier 2017-CE-041-AD.

(a) Effective Date

    This AD is effective June 11, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following Gulfstream Aerospace
Corporation model airplanes that are certificated in any category:
    (1) Model G-IV, serial numbers (S/Ns) 1000 through 1399 having
Aircraft Service Change (ASC) 416A (MSG-3) incorporated; and S/Ns
1400 through 1535; and
    (2) Model GIV-X, S/Ns 4001 through 4355.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 32, Landing Gear.

(e) Unsafe Condition

    This AD was prompted by the potential for fatigue cracks in the
main landing gear (MLG) actuator attachment fitting that had a
certain repair incorporated. We are issuing this AD to prevent
failure of the MLG actuator attachment. The unsafe condition, if not
addressed, could compromise the lateral support of the MLG during
ground maneuvers, possibly leading to collapse of the affected MLG
with consequent loss of control. In addition, this condition could
also cause the MLG side brace to fail, which could result in a
penetration of the wing fuel tank causing an uncontained fire.

(f) Compliance

    At whichever of the following compliance times in paragraphs
(f)(1) and (f)(2) that occurs later, comply with the actions in
paragraphs (g) through (i) of this AD, unless already done.
    (1) Within the next 100 hours time-in-service after June 11,
2018 (the effective date of this AD); or
    (2) Within the next 3 months after June 11, 2018 (the effective
date of this AD).

(g) Inspect Maintenance Records

    Inspect the airplane maintenance records to determine if repair
SE05732102 for the MLG side brace fitting has been incorporated. To
do this inspection, use the Accomplishment Instructions in
Gulfstream G350 Customer Bulletin Number 192A; Gulfstream G450
Customer Bulletin 192A; Gulfstream IV Customer Bulletin Number 238A;
Gulfstream G300 Customer Bulletin Number 238A; and Gulfstream G400
Customer Bulletin Number 238A; all dated June 15, 2017, as
applicable. The service information referenced in this paragraph
specifies sending a service reply card back to Gulfstream Aerospace
Corporation if repair SE05732102 for the MLG side brace fitting has
been not been incorporated. This action is not required in this AD.

(h) Determine Initial and Repetitive Inspection Requirements

    If it is determined during the maintenance records inspection
required in paragraph (g) that repair SE05732102 for the MLG side
brace fitting has been incorporated, determine the initial and
repetitive inspection requirements using the Accomplishment
Instructions of the service information identified in paragrap (g)
along with the following documents, as applicable. Comply with the
inspection requirements as determined.
    (1) Appendix A, Gulfstream Document GIV-SGER-553, Revision A,
Instructions for Continued Airworthiness for Gulfstream Repair
Drawing SE05732102, dated December 14, 2016, to Gulfstream G350
Customer Bulletin No. 192A, dated June 15, 2017;
    (2) Appendix A, Gulfstream Document GIV-SGER-553, Revision A,
Instructions for Continued Airworthiness for Gulfstream Repair
Drawing SE05732102, dated December 14, 2016, to Gulfstream G450
Customer Bulletin No. 192A, dated June 15, 2017;
    (3) Appendix A, Gulfstream Document GIV-SGER-553, Revision A,
Instructions for Continued Airworthiness for Gulfstream Repair
Drawing SE05732102, dated December 14, 2016, to Gulfstream IV
Customer Bulletin No. 238A, dated June 15, 2017;
    (4) Appendix A, Gulfstream Document GIV-SGER-553, Revision A,
Instructions for Continued Airworthiness for Gulfstream Repair
Drawing SE05732102, dated December 14, 2016, to Gulfstream G300
Customer Bulletin No. 238A, dated June 15, 2017; and
    (5) Appendix A, Gulfstream Document GIV-SGER-553, Revision A,
Instructions for Continued Airworthiness for Gulfstream Repair
Drawing SE05732102, dated December 14, 2016, to Gulfstream G400
Customer Bulletin No. 238A, dated June 15, 2017.

(i) Revise Limitations Section

    Insert the documents listed in paragraphs (h)(1) through (5) of
this AD into the Instructions for Continued Airworthiness of the
Limitations section of the FAA-approved maintenance program (e.g.,
maintenance manual), as applicable. The revised limitations sections
establish inspections of the repaired MLG side brace actuator
fittings.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, 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 certification office, send it to the attention of
the person identified in paragraph (k) of this AD.
    (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) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of paragraphs (g)
through (i) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    For more information about this AD, contact William O.
Herderich, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701
Columbia Avenue, College Park, Georgia 30337; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email: [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Gulfstream G350 Customer Bulletin Number 192A, dated June
15, 2017, that incorporates Appendix A, Gulfstream Document GIV-
SGER-553, Revision A, Instructions for Continued Airworthiness for
Gulfstream Repair Drawing SE05732102, dated December 14, 2016.
    (ii) Gulfstream G450 Customer Bulletin 192A, dated June 15,
2017, that incorporates Appendix A, Gulfstream Document GIV-SGER-
553, Revision A, Instructions for Continued Airworthiness for
Gulfstream Repair Drawing SE05732102, dated December 14, 2016.
    (iii) Gulfstream IV Customer Bulletin Number 238A, dated June
15, 2017, that incorporates Appendix A, Gulfstream Document GIV-
SGER-553, Revision A, Instructions for Continued Airworthiness for
Gulfstream Repair Drawing SE05732102, dated December 14, 2016.
    (iv) Gulfstream G300 Customer Bulletin Number 238A, dated June
15, 2017, that incorporates Appendix A, Gulfstream Document GIV-
SGER-553, Revision A, Instructions for Continued Airworthiness for
Gulfstream Repair Drawing SE05732102, dated December 14, 2016.
    (v) Gulfstream G400 Customer Bulletin Number 238A, dated June
15, 2017, that incorporates Appendix A, Gulfstream Document GIV-
SGER-553, Revision A, Instructions for Continued Airworthiness for
Gulfstream Repair Drawing SE05732102, dated December 14, 2016.
    (3) For Gulfstream Aerospace Corporation service information
identified in this AD, contact Gulfstream Aerospace Corporation,
P.O. Box 2206, Savannah, Georgia 31402-2206; telephone: (800) 810-
4853; fax<PHONE_NUMBER>; email: [email protected]; internet: http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm.
    (4) You may view this service information at FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on June 5, 2018.
David R. Showers,
Aircraft Certification Service, Acting Deputy Director, Policy and
Innovation Division, AIR-601.
[FR Doc. 2018-12519 Filed 6-8-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]
[Page 36241]
[DOCID:fr22jy09-93]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0302]

Withdrawal of Approval of New Animal Drug Applications; Ketamine;
S-Methoprene; Nitazoxanide

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of two new animal drug applications (NADAs) and an abbreviated new
animal drug application (ANADA) listed in table 1 of this document. In
a final rule published elsewhere in this issue of the Federal Register,
FDA is amending the animal drug regulations to remove portions
reflecting approval of these NADAs and ANADA.

DATES:  Withdrawal of approval is effective August 3, 2009.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the two NADAs and ANADA listed in table 1 of
this document because the products are no longer manufactured or
marketed:

                                 Table 1.
------------------------------------------------------------------------
                                                   21 CFR Cite Affected
        Sponsor             NADA/ANADA Number      (Sponsor Drug Labeler
                              Product (Drug)               Code)
------------------------------------------------------------------------
Wellmark International,  NADA 141-162             520.1390 (011536)
 1501 East Woodfield     Zodiac Fleatrol Flea
 Rd., suite 200, West     Caps (S-methoprene)
 Schaumburg, IL 60173
------------------------------------------------------------------------
IDEXX Pharmaceuticals,   NADA 141-178             520.1498 (065274)
 Inc., 7009 Albert Pick  NAVIGATOR Paste
 Rd., Greensboro, NC      (nitazoxanide)
 27409
------------------------------------------------------------------------
Abbott Laboratories,     ANADA 200-279            522.1222a (000074)
 North Chicago, IL       KETAFLO Injection
 60064                    (ketamine HCl, USP)
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec.  514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
141-162 and 141-178, and ANADA 200-279, and all supplements and
amendments thereto, are hereby withdrawn, effective August 3, 2009.
    In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending the animal drug regulations to reflect the
withdrawal of approval of these NADAs.

    Dated: July 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-17408 Filed 7-21-09; 8:45 am]

BILLING CODE 4160-01-S


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

Date:	07-August-2008

SUBJECT:	Flutolanil.  Human Health Assessment Scoping Document in Support of Registration Review.

PC Code:  128975	DP Barcode:  349580

MRID No.:  None	Registration No.: None

Petition No.:  None	Regulatory Action: Registration Review Scoping Document

Assessment Type:  None	Reregistration Case No.:  None

TXR No.:  None

FROM:	Myron S. Ottley, Pharmacologist

		Barry O’Keefe, Senior Biologist

		Amelia Acierto, Chemist

		Registration Action Branch 3

		Health Effects Division (7509P)

		Office of Pesticide Programs

THRU:	Paula Deschamp, Branch Chief

		Registration Action Branch 3

		Health Effects Division (7509P)

		Office of Pesticide Programs

TO:	Tom Myers / Jill Bloom (RM-52

		Reregistration Branch 2

		Special Review and Reregistration Division (7508P)

		Office of Pesticide Programs

Executive Summary

Flutolanil [N-[3-(1-methylethoxy)-phenyl]-2-(trifluoromethyl)-benzamide] is a systemic benzanilide fungicide which has preventative and curative actions against Rhizoctonia solani, which causes limb/pod rot in peanuts, sheath blight in rice, and black scurf in potatoes.  Flutolanil is also effective in controlling Southern stem rot (white mold) Sclerotium rolfsii in peanuts and rust diseases of several crops.

Flutolanil is currently registered for food and non-food uses.  Food uses include application to wheat, soybean, peanut, potato, and rice.  Tolerances are also established for ruminant byproducts and other organ meats.  Non-food uses of flutolanil include turf, greenhouse, and potted ornamentals.

The acute, subchronic and chronic toxicity of flutolanil is generally low, producing low toxicity at moderate to high dose levels.  An acute dietary endpoint was not identified for flutolanil.  A chronic dietary endpoint was identified based on a chronic dog study, with the chronic RfD set at 0.50 mg/kg/day based on an increased incidence of clinical signs (NOAEL = 50 mg/kg/day) at the LOAEL of 250 mg/kg/day.  Uncertainty factors (including FQPA) totaled 100. Endpoints were not identified for incidental oral, dermal or inhalation exposure. Flutolanil is considered to be non-carcinogenic.  The chronic dietary exposure estimates for food and drinking water do not exceed the Agency’s level of concern for the general U.S. population (<1% of the population adjusted dose (PAD) and all population subgroups (< 1% PAD).

The HED Flutolanil Registration Review Team has evaluated the most recent human health assessments and database for the fungicide flutolanil, supporting several Section 3 registered products and Section 24C registrations by Nichino America, Inc. (formerly Nihon Nohyaku), to determine the scope of work necessary to support the Registration Review process. The most recent human health assessment (November 2007), which addressed requests for inadvertent or indirect tolerances for use on soybean, wheat, corn and cotton adequately reflects current registrations and uses of flutolanil, current Food Quality Protection Act (FQPA) policies, and adequately addresses susceptibility of infants and children, and aggregate exposures.  For a complete listing of the registrations, please see the Attachments section.

Introduction

The HED Flutolanil Registration Review Team has evaluated the human health assessments for the fungicide flutolanil to determine the scope of work necessary to support the Registration Review.  A comprehensive listing of the documents considered is presented in the reference section of this document. The purpose of this screen is to determine whether sufficient data are available and whether a new human health risk assessment is needed to support continued registration. The HED Risk Assessment team is Myron Ottley, Barry O’Keefe, and Amelia M. Acierto.

The HED registration review team contacted the Pesticide Management Regulatory Agency (PMRA) of Canada, and the California Department of Pesticide Regulation (CalDPR) to determine if they are actively working on the active ingredient flutolanil, or are planning on doing so in the near future.  The team has learned that flutolanil has never been registered in Canada and therefore not subject to re-evaluation. Flutolanil has been placed in the low priority category for risk assessment by CalDPR, and they do not expect to conduct any risk assessment unless there are some significant changes in the established use patterns.  Additionally, the HED registration review team accessed the OECD monograph document repository.  An OECD Monograph was completed for flutolanil in May 2006.  Flutolanil is authorized for use on various crops in Belgium, Finland, France, Great Britain, Netherlands, and Spain

No new data germane to risk assessment of flutolanil were available from the open literature.  The primary sources for the status update were the risk assessments on the registered uses in peanut, potato and rice (F. Fort, D334156, D335050, 11/26/07). The molecular structure, chemical names, and other identifiers are found in the chemical identity table attached to this document.

Flutolanil is currently registered for food and non-food uses.  Food uses include broadcast foliar applications and/or in-furrow applications to soybean, wheat, peanuts, potatoes, and rice.  Flutolanil is also used as a tree bark dust application – Non-food uses include turf, greenhouse, and potted ornamentals.  The currently registered uses of flutolanil will result in exposures in food and drinking water.  Residential uses of flutolanil can result in dermal, inhalation, and incidental oral exposures.  Occupational uses will result in exposures via the dermal and inhalation routes.

Hazard Identification/Toxicology

Overall, the quality of the toxicology data base for flutolanil is good and confidence in the hazard and dose response assessments is high.  At the time of the last human health risk assessment (11/26/07), the toxicology data base was deemed to be complete, adequate to support existing and proposed registrations, and there were no data gaps.  No new data have been submitted since then; however, acute and subchronic neurotoxicity studies and an immunotoxicity study are now required under the revised 40 CFR §158.340.  For more detailed information about the toxicology of flutolanil, please refer to the Hazard Identification Assessment Review Committee Report (HIARC report dated 11/2/99; TXR No. 013851).

The toxicology studies conducted on flutolanil demonstrate few or no biologically significant toxic effects at relatively low-dose levels in animal studies and only mild or no toxic effects at high doses. Acute toxicity data show that technical grade flutolanil has relatively low acute toxicity (Category III and IV).  Flutolanil is not a dermal sensitizer, primary eye irritant, or primary skin irritant.

Subchronic and chronic toxicity studies showed that the primary effects of flutolanil are increases in liver weight combined with decreases in body weight.  The available data for flutolanil do not show neurotoxic, carcinogenic, nor mutagenic effects.  Flutolanil is not a developmental or reproductive toxicant.  There is no evidence of increased susceptibility of rat or rabbit fetuses to in-utero exposure or rat pups to post-natal exposure to flutolanil.  No toxic effects were observed in studies in which flutolanil was administered by the dermal routes of exposure.

The FQPA Safety Factor for flutolanil was reduced to 1X because there was no increased sensitivity to fetuses as compared to maternal animals in the developmental rat and rabbit studies and no increased sensitivity to pups as compared to adults in a multi-generation reproduction study in rats.

Only a chronic dietary endpoint was identified for flutolanil (Table 4).   HED selected a chronic RfD/PAD of 0.50 mg/kg/day (NOAEL = 50 mg/kg/day; Uncertainty Factor = 100).  This chronic RfD/PAD is based on the chronic oral toxicity study in dogs in which increased incidences of clinical signs (emesis, salivation, and soft stool) occurred at LOAEL = 250 mg/kg/day following 65 weeks of exposure.

Dietary Exposure

 conducted using the Dietary Exposure Evaluation Model, DEEM-FCID™, Version 2.03, which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes from 1994-1996 and 1998. An acute exposure assessment for flutolanil was not performed since an appropriate endpoint attributable to a single oral dose was not established.

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the memorandum: “Flutolanil Tier II Estimated Environmental Concentration for Use in the Human Health Drinking Water Risk Assessment” (D260066, S. Abel, 12/13/99).  The surface water and groundwater, estimated drinking water concentrations (EDWCs) were generated from PRZM/EXAMS and from Tier I SCI-GROW analysis, respectively. The inputs and assumptions used to generate the EDWCs for flutolanil adequately cover the currently registered use patterns. The water residues were incorporated directly in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

The chronic dietary assessments for food and drinking water demonstrated that exposures for the general population and all population subgroups were less than 1% of the population adjusted dose. These assessments are considered conservative as they were conducted assuming tolerance level residues and 100% crop treated.

Residential Exposure

There are non-occupational/residential uses associated with flutolanil.  Registered products include several for use on turf grass and potted ornamentals which, if not specifically prohibited through label directions could be used in a residential/public site.  However, although such potential residential handler and post-application exposures exist, assessments were not conducted because no dermal, oral (incidental), or inhalation toxicological endpoints attributable to short- or intermediate-term exposures have been identified, and the current use patterns do not indicate long-term exposure (6 or more months of continuous exposure) potential.  Therefore, there is currently adequate information to support non-occupational/residential uses of flutolanil.  However, should HED identify new regulatory endpoints for risk assessment purposes for flutolanil in the future, then non-occupational/residential exposures may need to be assessed.

Aggregate Risk Assessment

Aggregate risk assessments for flutolanil were performed for chronic aggregate exposure (food + drinking water) only.  Short- and intermediate-term aggregate risk assessments were not performed because toxicological endpoints from dermal, inhalation, and incidental oral exposures were not identified.  Additionally, the Agency does not expect residential exposure durations that would result in long term exposures.  A cancer aggregate risk assessment was also not performed because flutolanil is not carcinogenic.

The chronic aggregate risk assessment takes into account average exposure estimates from dietary consumption of flutolanil (food and drinking water) The chronic dietary exposure estimates for food and drinking water are below HED’s level of concern (<100% cPAD) for the general U.S. population (1% of the cPAD) and all population subgroups (<1%).  Therefore, the chronic aggregate risk associated with the registered uses of flutolanil does not exceed HED’s level of concern for the general U.S. population or any population subgroups. Should HED identify new regulatory endpoints for risk assessment purposes, revise the current safety factors for flutolanil, or update the dietary assessment, a new aggregate risk assessment may need to be conducted.

Occupational Exposure

Occupational handlers may be exposed to flutolanil during mixing, loading, and application of products containing flutolanil.  Additionally, workers may be exposed to flutolanil residues during postapplication activities.  Based on the proposed application rates and use scenarios, short- and intermediate-term occupational exposures may occur.  However, assessments of exposures and risks were not conducted because no dermal or inhalation toxicological endpoints attributable to short- or intermediate-term exposures have been identified, and the current use patterns do not indicate long-term exposure potential.  Therefore, there is currently adequate information to support occupational uses of flutolanil.  However, should HED identify new regulatory endpoints for risk assessment purposes for flutolanil in the future, then occupational exposures may needed to be assessed.

Public Health and Pesticide Epidemiology Data

A summary report listing incidents reported to EPA for flutolanil will be provided for the docket.  The reported incidents will be screened in more detail during the development of the Final Work Plan for flutolanil.

Tolerance Assessment

Tolerances have been established in 40 CFR§180.484 for residues of flutolanil and its metabolites converted to 2-trifluoromethyl)benzoic acid (calculated as flutolanil) in/on plant and livestock commodities.

International Harmonization

Codex Maximum Residue Limits (MRLs) for flutalonil and transformation products containing the 2-trifluoromethyl-benzoic acid moiety, expressed as flotolanil, are established in rice commodities at 1 to 10 ppm, and in livestock commodities at 0.05 to 0.2 ppm.

The US tolerances for both plant and livestock commodities are expressed as flutolanil, N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethy)benzamide, and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil.  These US tolerance, for rice, peanuts and potatoes, are listed under 40 CFR §180.484(a) at 0.2 – 25.0 ppm, and for soybean and wheat, are listed under 40 CFR §180.484(d) at 0.05 – 8.0 ppm.  US tolerances for livestock commodities are also established under §180.484(a) at levels ranging from 0.05 ppm for egg, milk, meat, and meat byproducts to 2.0 ppm for liver.

The US and Codex residue definitions for livestock commodities both include flutolanil and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil; however, there are quantitative differences in the US tolerance levels and Codex MRLs.  In the case of plant commodities, the US and Codex residue definitions as well as US tolerance levels and Codes MRLs are different.  Future work is needed to achieve harmonization in this area.    For a complete listing of US Tolerances and Codex MRLs, please refer to Table 5 in the Attachments section.

No Canadian or Mexican MRLs have been established.

Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations,"   HYPERLINK "http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pd f"  http://www.epa.gov/compliance/resources/policies/ej/exec_order_12898.pdf .  The Office of Pesticide Programs (OPP) typically considers the highest potential exposures from the legal use of a pesticide when conducting human health risk assessments, including, but not limited to, people who obtain drinking water from sources near agricultural areas, the variability of diets within the U.S., and people who may be exposed when harvesting crops.  Should these highest exposures indicate potential risks of concern, OPP further refines the risk assessments to ensure that the risk estimates are based on the best available information.

Cumulative

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to flutolanil and any other substances and flutolanil 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 flutolanil has a common mechanism of toxicity with other substances.  For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/.

Human Studies

Flutolanil risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical.  These studies have been determined to require a review of their ethical conduct, and have received that review.

Data Requirements

Toxicology

The revised Toxicology Data Requirements for Conventional Pesticides [40 CFR §158.340] now include studies which are better able to detect toxicities that are outside the scope of standard subchronic and chronic assays.  These new studies are:

   Acute neurotoxicity  [OPPTS Guideline 870.6200a]

   Subchronic neurotoxicity  [OPPTS Guideline 870.6200b]

   Immunotoxicity  [OPPTS Guideline 870.7800]

For a more complete rationale on these data requirements, please see Tables 6 and 7.

Chemistry

The availability of the analytical reference standards for flutolanil and its metabolites has been verified and reported in 2007 to be either “not in stock” or “have expired” (D335050, F. Fort, 11/26/2007).  An updated inventory from the National Pesticide Standard Repository (e-mail, Dallas Wright, EPA, Analytical Chemistry Laboratory, 08/14/2008) showed that the analytical standards for flutolanil [with expiration date of 10/27/2011] and flutolanil metabolite, 2-trifluoromethyl benzoic acid metabolites [which expired 8/12/2008] are available.  Standards for metabolites M-2 and M-4 are still not in stock, and standards for metabolites M-3 and M-7 [which expired on 1/1/04 and 4/1/02, respectively] have not been replenished nor recertified (updated Certificate of Analysis).  Therefore, the requirements for standards have not been satisfied.

The Agency previously concluded that the following additional data are required to support the enforcement method AU/95R/04:  (1) additional radio validation data from all previously submitted metabolism studies; and (2) additional recovery data for potato.  In addition, because the method is a common moiety method, a confirmatory method was required that is able to confirm the identity and amount of all residues of concern. These requirements do not appear to have been addressed, and the results of the petition method validation were not available.  In addition, we note that the method must be rewritten to include instructions for analysis of additional crops including potatoes and rotational crops for which tolerances are to be established.

References

Author	Barcode	Date	Title

M. Xue	D261391	12/10/1999	PP# 6F4693 & PP#4F4380. Flutolanil in/on Potatoes and Rice. Memo to the Metabolism Assessment Review Committee (MARC)

W. Wassell	D267571	7/21/2000	PP6F4693/PP6H5749.  Flutolanil in/on Potatoes and Rice. Evaluation of Independent Laboratory Valiation Data.

M. Xue	D265019	7/24/2000	Reevaluation of Chronic Dietary Exposure Analyses for Proposed Tolerances for Flutolanil in/on Rice, Potatoes and Potato Processed Commodities. (PC Code 128975.

M. Xue	D267657	8/2/2000	PP# 6F4693 & PP#6H5749.. Flutolanil in/on Potatoes and Rice.  Review of Storage Stability and Magnitude of Residue Data for Rice.

A. Lowit,

J. Arthur

M. Bonner

M. Xue	D268880	9/11/2000	Residential uses of flutolanil include turf, greenhouse, and potted ornamentals

M. Xue 	D226667, D226670,D247229	12/1/2000	PP# 6F4693 & PP#6H5749.. Flutolanil in/on Potatoes, Potato Processed Commodities, Rice Grain and Rice Straw.  Evaluation of Analytical Methods and Residue Data.

M. Xue	D278457	11/28/2001	ID#071711-00008, Flutolanil: Label Amendment for Rotational Crop Plantback Intervals for Corn, Soybeans, Cotton and Sorghum.

F. Fort	D346322	11/1/2007	Flutolanil Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action.

F. Fort	D335050	11/26/2007	Flutolanil.   Petitions for Establishment of Tolerances for Indirect or Inadvertent Residues in/on Corn, Cotton, Soybean, and Wheat Commodities.  Summary of Analytical Chemistry and Residue Data.  PRIA R17.  PP#0F6159 (Soybean and Wheat) and PP6F7070 (Corn and Cotton).

W.Wassell	D277210	11/7/2001	WA010016; Special Local Needs Registration (24c) for the use of Flutolanil on Potatoes.  Review of residue Data for Potatoes.

ATTACHMENTS

2-trifluoromethylbenzoic acid (2-TFBA)

Table 2.	Physicochemical Properties of Flutolanil.

Parameter	Value	Reference

Melting range	100.4-103.8 °C	DP#s 190584 and 190586, 3/24/94, J. Garbus; MRID 42606601

pH	5.69

	Density	1.325 @ 20-25

	Water solubility	6.53 mg/L at 20 °C

	Solvent solubility			at 20 °C

Methanol	232 g/L

n-Hexane	  0.9 g/L

	Vapor pressure	4.87 x 10-8 mm Hg at 25 °C

	Dissociation constant, pKa	Not applicable

	Octanol/water partition coefficient, Log(KOW)	log POW = 3.74

	UV/visible absorption spectrum	Not available

Table  3.	Chemical Names and Structures of Flutolanil and Metabolites.

Common name;

Table 4	Summary of Toxicological Doses and Endpoints for Flutolanil for Use in Dietary and Non-Occupational Human Risk Assessments

Exposure

Scenario

Point of Departure

Uncer-tainty/

FQPA Factors

RfD, PAD, Level of Concern for Risk Assess-ment

Study and Toxicological Effects

 Acute Dietary

(All populations)	No appropriate toxicological endpoint attributable to a single exposure (dose) was identified from the oral toxicity studies including developmental toxicity studies in rats and rabbits.  This risk assessment is not required.

Chronic Dietary

(All populations)

NOAEL= 50 mg/kg/day

 	UFA=10X

UFH=10X

FQPA SF = 1X

	cRfD =

0.5 mg/kg/day

cPAD =

0.5 mg/kg/day	2-year Chronic study in dogs.

MRID no. 40342922

LOAEL = 250 mg/kg/day based on increased incidence  of clinical toxic signs (emesis, salivation, and soft stool)

Incidental Oral Short- and intermediate-Terms 	No appropriate endpoint was identified in the database for these durations of exposure.

Dermal

 (all durations)	No appropriate endpoint was identified in the database for this route of exposure.

Inhalation

 Short- and Intermediate-Terms	No appropriate endpoint was identified in the database for these durations of exposure.

Long-term inhalation 	The current use pattern does not indicate long-term inhalation exposure potential.

Cancer (oral, dermal, inhalation)

Classification:  “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  RfD = reference dose.  MOE = margin of exposure.  LOC = level of concern.  PAD = Population adjusted dose

Table 5.  Summary of US and International Tolerances and Maximum Residue Limits

US	Canada	Mexico	Codex

Residue Definition:

40CFR180.484 (a)

 flutolanil, N -(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil .	None	None	For plant commodities, flutolanil.

For animal commodities, flutolanil and transformation products containing the 2-trifluoromethyl-benzoic acid moiety, expressed as flutolanil.

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)

Commodity	US	Canada	Mexico	Codex

Cattle, fat	0.10	None	None

	Cattle, kidney	1.00

	0.1

Cattle, liver	2.00

	0.2

Cattle, meat byproducts	0.05

	Cattle, meat	0.05

	0.05 (*)

Egg	0.05

	0.05 (*)

Goat, fat	0.10

	Goat, kidney	1.00

	0.1

Goat, liver	2.00

	0.2

Goat, meat byproducts	0.05

	Goat, meat	0.05

	0.05 (*)

Hog, fat	0.10

	Hog, kidney	1.00

	0.1

Hog, liver	2.00

	0.2

Hog, meat byproducts	0.05

	Hog, meat	0.05

	0.05 (*)

Horse, fat	0.10

	Horse, kidney	1.00

	Horse, liver	2.00

	Horse, meat byproducts	0.05

	Horse, meat	0.05

	0.05 (*)

Milk	0.05

	0.05 (*)

Peanut	0.5

	Peanut, hay	15.0

	Peanut, meal	1.0

	Potato	0.20

	Potato, wet peel	0.30

	Poultry, fat	0.05

	Poultry, meat	0.05

	0.05 (*)

Poultry, meat byproducts	0.05

	0.05 (*)

Rice, bran	10.0

	10 (unprocessed)

Rice, grain	7.0

	2 husked

1 polished

Rice, hulls	25.0

	Rice, straw	10.0

	10

Sheep, fat	0.10

	Sheep, kidney	1.00

	0.1

Sheep, liver	2.00

	0.2

Sheep, meat	0.05

	0.05 (*)

Sheep, meat byproducts	0.05

	Residue Definition:

40CFR180.484 (d)

indirect or inadvertent residues of the fungicide flutolanil, N -(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil

None	None	None

Soybean, forage	8.0

	Soybean, hay	2.5

	Soybean, seed	0.20

	Wheat, bran	0.20

	Wheat, forage	2.5

	Wheat, grain	0.05

	Wheat, hay	1.2

	Wheat, straw	0.20

* = absent at the limit of quantitation.

				Data Call-In Tables

Table 6.

Guideline Number: 870.7800

Study Title:  Immunotoxicity

Rationale for Requiring the Data

This is a new data requirement under 40 CFR Part 158 as a part of the data requirements for registration of a pesticide (food and non-food uses).

The Immunotoxicity Test Guideline (OPPTS 870.7800) prescribes functional immunotoxicity testing and is designed to evaluate the potential of a repeated chemical exposure to produce adverse effects (i.e., suppression) on the immune system. Immunosuppression is a deficit in the ability of the immune system to respond to a challenge of bacterial or viral infections such as tuberculosis (TB), Severe Acquired Respiratory Syndrome (SARS), or neoplasia.  Because the immune system is highly complex, studies not specifically conducted to assess immunotoxic endpoints are inadequate to characterize a pesticide’s potential immunotoxicity.  While data from hematology, lymphoid organ weights, and histopathology in routine chronic or subchronic toxicity studies may offer useful information on potential immunotoxic effects, these endpoints alone are insufficient to predict immunotoxicity.

Practical Utility of the Data

How will the data be used?

Immunotoxicity studies provide critical scientific information needed to characterize potential hazard to the human population on the immune system from pesticide exposure. Since epidemiologic data on the effects of chemical exposures on immune parameters are limited and are inadequate to characterize a pesticide’s potential immunotoxicity in humans, animal studies are used as the most sensitive endpoint for risk assessment.  These animal studies can be used to select endpoints and doses for use in risk assessment of all exposure scenarios and are considered a primary data source for reliable reference dose calculation. For example, animal studies have demonstrated that immunotoxicity in rodents is one of the more sensitive manifestations of TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) among developmental, reproductive, and endocrinologic toxicities.  Additionally, the EPA has established an oral reference dose (RfD) for tributyltin oxide (TBTO) based on observed immunotoxicity in animal studies (IRIS, 1997).

How could the data impact the Agency's future decision-making?

If the immunotoxicity study shows that flutolanil poses either a greater or a diminished risk than that given in the interim decision’s conclusion, the risk assessments for flutolanil may need to be revised to reflect the magnitude of potential risk derived from the new data.

If the Agency does not have this data, a 10X database uncertainty factor may be applied for conducting a risk assessment from the available studies.

Table 7.

Guideline Number:  870.6200

Study Title:  Neurotoxicity Screening Battery

Rationale for Requiring the Data

Acute and subchronic neurotoxicity studies with flutolanil were not conducted, flutolanil showed no indication of neurotoxicity in the provided studies and there was no evidence of neurotoxicity in open literature searches, however, the submitted studies did not examine neurotoxicity endpoints.  These data are now required under the revised CFR 158.340.

Practical Utility of the Data

How did the Agency make its re-registration decision without this data?

For many chemicals, the amount of toxicity data that is available for flutolanil would be considered to be a complete toxicity database.  In fact, the Agency was able to select doses and endpoints for conducting a risk assessment from the available studies. However,the existing toxicity database for flutolanil does not include any neurotoxicity studies.  None of the submitted studies measured neurotoxicity endpoints.  In the absence of any such data, there is uncertainty about the neurotoxicity potential of flutolanil.

How will the data be used?

After the review and evaluation of the acute and subchronic neurotoxicity studies, it is possible that the Agency could choose a dose and endpoint from either the acute or subchronic neurotoxicity study that is appropriate for the deriving the acute RfD.

How could the data impact the Agency’s future decision-making?

If a dose can be selected for the acute RfD from the new data, then a flutolanil acute dietary risk assessment would need to be conducted. At present there were no effects observed in oral toxicity studies including developmental toxicity studies in rats or rabbits that could be attributable to a single dose (exposure).  The risk would then be identified for the acute RfD.

Existing Registrationsfor Flutolanil

Section 3 :

	EPA Reg Nos.:

Bayer Environmental Science

432-1222	Prostar 50WP.  Contains 50.3% flutolanil.  Labeled for the control of brown patch, fairy ring, red thread/pink patch, yellow/patch/Southern blight, gray snow mold, and large brown patch on turf.

432-1223	Prostar 70 WP. Contains70% flutolanil.  Labeled for control of brown patch, fairy ring, red thread/pink patch, yellow/patch/Southern blight, gray snow mold, and large brown patch on turf, various fungal diseases of greenhouse, container, and nursery grown ornamentals.

432-1403	Prostar 1.5G.  Contains 1.5% flutolanil, with fertilizer.  Labeled for control of brown patch on turf.

432-1440	Sysstar WDG.  Contains 51.42% flutolanil and 28.6% thiophanate-methyl.  Labeled for control of multiple fungal diseases of turf and ornamentals.

432-1477	Prostar 70 WDG Fungicide.  Contains 70% flutolanil.  Labeled for control of multiple fungal diseases of turf and ornamentals.

Gowan Company

10163-247	Flutolanil Technical.  Contains 98.3% flutolanil.  For formulation only.

Nichino America, Inc.

71711-1	Moncut® 70 WP (70% ai) registered for control of Southern stem rot (white mold) caused by Sclerotium rolfsii and limb/pod rot complex caused by Rhizoctonia solani in peanuts, and for control of sheath blight caused by Rhizoctonia solani in rice.  The existing label for rotational crops states that corn, soybean, or cotton may be planted 240 days or more following the last application of Moncut 70WP to peanuts; soybean or grain sorghum may be planted 240 days or more following last application to rice.

	71711-2	Moncut CL Flowable fungicide.  Contains 38.6% chlorothalonil and 10.3% flutolanil.   Designed for use on peanuts, under conditions which favor the development of diseases caused by fungi which attack both the crop canopy and structures beneath the soil surface (roots, pegs, and pods).

71711-3	Moncut® 50WP (50% ai) registered for use on peanuts and rice.  The same use as EPA Reg. No. 71711-1.  For control of Southern stem rot (white mold) caused by Sclerotium rolfsii and limb/pod rot complex caused by Rhizoctonia solani in peanuts; for control of sheath blight caused by Rhizoctonia solani in rice; and for control of clack scurf caused by Rhizoctonia solani in peanuts.

71711-5	Flutolanil Technical.  Contains 98.3% flutolanil.  For formulation only.

	71711-8	Moncoat® MZ—a coformulation containing 1.5% flutolanil and 6% mancozeb in a tree bark based formulation.  MonCoat MZ is to be used as an integral part of a potato disease management strategy for the suppression of Black scurf and Rhizoctonia stem canker (Rhizoctonia solani), Fusarium dry rot (Fusarium sambucinum, F. coeruleum), and Silver scarf (Helminthosporium solani) on potato seed pieces.  Use for potato seed treatment @ 0.75 – 1.0 lb product/100 lb seed. (<0.25 lb ai/A).

71711-14	Moncut®70-DF (70% DF formulation) used for on peanut, rice and potato ( Not for use on peanuts and rice in California). as broadcast foliar 2 lb ai/A in forrow application.  For control of Southern stem rot (white mold) caused by Sclerotium rolfsii and limb/pod rot complex caused by Rhizoctonia solani in peanuts; for control of sheath blight caused by Rhizoctonia solani in rice; and for control of clack scurf caused by Rhizoctonia solani in potatoes.

Ð/

P

Q

V

b

s

t

Ž

ã

ä

ö

÷

R

d

“

•

Ý

Þ

ö

 hž

hA

2

Q

R

t

Ž

Ã

â

ã

ä

ö

÷

”

•

hA

hA

hA

hA

hA

hA

hA

hA

hA

h

B*

hA

hA

h

옍)

옍)

옍)

옍)

옍)

옍)

옍)

옍)

옍)

옍)

옍)

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

@

¶

摧烴

摧烴

摧烴

@

B*

hA

 hA

”ÿ•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

…

•

…

•

…

•

…

•

…

•

…

•

…

•

…

옍

ༀ㢄ᄄ삄㟴$␸䠀$葞и葠摧②A

h,k

@

萑֠葠֠摧欬

h,k

ᄀꂄ㜅$␸䠀$葠֠摧ו»

萏ୀ萑褐葞ୀ葠褐摧⮋xᄀ71711-17	Artisan™ Fungicide, 32%, containing 3 lb flutolanil and 0.6 lb propiconazole per gallon.  For use on peanuts.

71711-24	NAI-301, 4SE fungicide (Alternate name fro Artisan Trifecrs) containing 17.2% flutolanil, 1.8% propiconazole and 21.65% chlorothalonil. Used for the control of early and late leaf spot disease as well as control of whit mold (Southern blight) caused by Sclerotium rolfsii and limb rot caused by Rizoctonia solani.

71711-28	Flutolanil 40SC Fungicide.  Contains 40% flutolanil.  Registered 5/2/08; labeled for control of fungal diseases of peanut and potato (in-furrow and seed-piece treatments).

Section 24(c)

		ID040008

ID080003

NV020006

		WA010016

		WA040032

Page   PAGE  1  of   NUMPAGES  18


[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Proposed Rules]
[Pages 69377-69379]
[FR Doc No: 2014-27631]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 225 / Friday, November 21, 2014 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0775; Directorate Identifier 2014-NM-046-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, Model
A300 C4-605R Variant F airplanes (collectively called Model A300-600
series airplanes), and Model A310 series airplanes. This proposed AD
was prompted by reports of insufficient clearance for the electrical
wiring bundles in the leading and trailing edges of the left and right
wings. This proposed AD would require installation of new bracket
assemblies to ensure adequate clearance between the wiring and the
structure, and installation of protective split sleeves as mechanical
protection to the electrical harnesses. We are proposing this AD to
detect and correct insufficient clearance of electrical wiring bundles
located in the leading and trailing edges of the left and right wings,
which could lead to chafing damage and arcing, possibly resulting in an
on-board fire.

DATES: We must receive comments on this proposed AD by January 5, 2015.

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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.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
425-227-1221.

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-2014-
0775; 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
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

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-2014-0775;
Directorate Identifier 2014-NM-046-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 based on 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

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2014-0034, dated February 5, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Following publication of FAA SFAR 88 (Special Federal Aviation
Regulation 88) (http://rgl.faa.gov/Regulatory_and_Guidance_Library%5CrgFAR.nsf/0/EEFB3F94451DC06286256C93004F5E07?OpenDocument), EASA issued AD 2006-
0076 (http://ad.easa.europa.eu/ad/2006-0076) requiring inspection
and corrective action to improve the explosion risk protection
system for the left hand (LH) and right hand (RH) wings on A300,
A300-600, A300-600ST and A310 aeroplanes.
    For A300-600, A300-600ST and A310 aeroplanes, the required
detailed visual inspections of electrical bundles located in the
leading and trailing edges of the RH and LH wings and a review of
the wing electrical installation on the final assembly line have
shown that the wing electrical installation does not comply with the
minimum distance inspection criteria to the surrounding structure in
a few wing locations.
    This condition, if not detected and corrected, could lead to
damage on the electrical harnesses and on the surrounding structure.
    To address this unsafe condition, Airbus developed an
improvement of the wing electrical installation to prevent possible
chafing and subsequent damage to the electrical harnesses and
surrounding structure.
    For the reasons described above, this [EASA] AD requires
installation of new bracket assemblies to ensure the clearance
between the wiring and the structure, and installation of protective
split sleeves as mechanical protection to the electrical harnesses.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for

and locating Docket No. FAA-2014-0775.

Relevant Service Information

    Airbus has issued Service Bulletin A300-24-6103, Revision 02,
including Appendix 01, dated February 7, 2013; and Service Bulletin
A310-24-2105, Revision 01, including Appendix 01, dated December 11,
2013. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 199 airplanes of U.S.
registry.
    We also estimate that it would take about 37 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost up to
$18,000 per product. Based on these figures, we estimate the cost of
this proposed AD on U.S. operators to be $4,207,855, or $21,145 per
product.

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 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 this 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. Amend Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus: Docket No. FAA-2014-0775; Directorate Identifier 2014-NM-
046-AD.

(a) Comments Due Date

    We must receive comments by January 5, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD, certificated in any category.
    (1) All Airbus Model A300 B4-601, B4-603, B4-620, and B4-622
airplanes; Model A300 B4-605R and B4-622R airplanes; Model A300 F4-
605R and F4-622R airplanes; and Model A300 C4-605R Variant F
airplanes.
    (2) All Airbus Model A310-203, -204, -221, -222, -304, -322, -
324, and -325 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
Power.

(e) Reason

    This AD was prompted by reports of insufficient clearance for
the electrical wiring bundles in the leading and trailing edges of
the left and right wings. We are issuing this AD to detect and
correct insufficient clearance of electrical wiring bundles located
in the leading and trailing edges of the left and right wings, which
could lead to chafing damage and arcing, possibly resulting in an
on-board fire.

(f) Compliance

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

(g) Modification

    Within 30 months after the effective date of this AD: Modify the
electrical routing installation at the right-hand and left-hand
wing, in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A300-24-6103, Revision 2, including Appendix 01,
February 7, 2013; or Airbus Service Bulletin A310-24-2105, Revision
1, including Appendix 01, dated December 11, 2013.

(h) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (g) of this AD for Model A310 series airplanes, if those
actions were performed before the effective date of this AD using
Airbus Service Bulletin A310-24-2105, dated March 20, 2013.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may
be emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency

(EASA); or Airbus's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency Airworthiness Directive 2014-
0034, dated February 05, 2014, for related information. This MCAI
may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2014-0775.
    (2) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this 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 13, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-27631 Filed 11-20-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 10, 2007 (Volume 72, Number 236)]
[Proposed Rules]
[Page 69640-69641]
[DOCID:fr10de07-33]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2207-29055; Airspace Docket 07-ASO-19]

Proposed Amendment of Class D and E Airspace; Jacksonville Cecil
Field, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: This notice proposes to amend the Class D airspace and
establish E4 airspace at Jacksonville Cecil Field, FL. As a result of
an evaluation, it has been determined the Class D airspace should be
reduced and Class E4 airspace should be established for Jacksonville
Cecil Field F Airport. Additional controlled airspace is necessary for
the safety and management of Instrument Flight rules (IFR) operations
at Jacksonville Cecil Field Airport.

DATES: Comments must be received on or before January 24, 2008.

ADDRESSES: Send comments on this proposal to the Docket Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
1200 New Jersey Ave., SE., West Building, Ground Floor, Room W12-140,
Washington, DC 20590; telephone 1-800-647-5527. You must identify the
docket number FAA-2007-29055/Airspace Docket No. 07-ASO-19, at the
beginning of your comments. You may also submit comments on the
Internet at http://www.regulations.gov. You may review the public

docket containing the proposal, any comments received, and any final
disposition in person in the Dockets Office (see Addresses section for
address and phone number) between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comment 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. Commenter 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-2007-29055/
Airspace Docket No. 07-ASO-19.'' The postcard will be date/time stamped
and returned to the commenters. 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 http://www.regulations.gov Recently published rulemaking documents can also be accessed through the FAA's Web page at http://.

www.faa.gov or the Federal Register's Web page at http://www.gpoaccess.gov/fr/index.html.
 Persons interested in being placed on

a mailing list for future NPRM's should contact the FAA's Office of
Rulemaking,<PHONE_NUMBER>, to request a copy of Advisory Circular No.
11-2A, Notice of Proposed Rulemaking Distribution System, which
describes the application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class D and establish Class E
airspace at Jacksonville Cecil Field, FL. The current Class D airspace
supporting IFR

operations can be reduced and E4 airspace established to contain
operations at Jacksonville Cecil Field Airport. This proposed action
would provide the additional controlled airspace, extending upward from
the surface to support the VHF Omnidirectional Range (VOR) Runway (RWY)
9 Standard Instrument Approach Procedure (SIAP) at Jacksonville Cecil
Field. Class D and E4 airspace designations for airspace areas
extending upward from the surface of the earth are published in
Paragraphs 5000 and 6000 of FAA Order 7400.9R, dated August 15, 2007,
and effective September 15, 2007, which is incorporated by reference in
14 CFR 71.1. The Class D and E4 airspace designations listed in this
document would be published subsequently in the Order.
    The FAA has determined that this proposed 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 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, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    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
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 establishes Class E4 airspace at Cecil Field in Jacksonville, FL.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, 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

    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]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9R, Airspace Designations and
Reporting Points, dated August 15, 2007, and effective September 15,
2007, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Jacksonville Cecil Field, FL [Revised]

Cecil Field, FL
    (Lat. 30[deg]13'07'' N, long. 81[deg]52'36'' W)
Herlong Airport
    (Lat. 30[deg]16'40'' N, long. 81[deg]48'21'' W)

    That airspace extending upward from the surface, to and
including 2,600 feet MSL, within a 4.3-mile radius of Cecil Field;
excluding that airspace within the Jacksonville NAS Class D airspace
area and that airspace within the Jacksonville Whitehouse Class D
airspace area and that airspace within a 1.8-mile radius of Herlong
Airport. This Class D airspace area is effective during the specific
days and times established in advance by a Notice to Airmen. The
effective days and times will thereafter be continuously published
in the Airport/Facility Directory.

* * * * *

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D Surface Area.

* * * * *

ASO FL E4 Jacksonville Cecil Field, FL [NEW]

Cecil Field, FL
    (Lat. 30[deg]13'07'' N, long. 81[deg]52'36'' W)
Cecil VOR
    (Lat. 30[deg]12'47'' N, long. 81[deg]53'27'' W)

    That airspace extending upward from the surface, to and
including 1,900 feet MSL, within 2.4 miles each side of the Cecil
VOR 286[deg] radial extending from the 4.3-mile radius to 7 miles
west of the VOR. This Class E airspace area is effective during the
specific days and times established in advance by a Notice to
Airmen. The effective days and times will thereafter be continuously
published in the Airport/Facility Directory.

* * * * *

    Issued in College Park, Georgia, on November 9, 2007.
Barry A. Knight,
Acting Manager, System Support Group, Eastern Service Center.
[FR Doc. 07-5984 Filed 12-7-07; 8:45 am]

BILLING CODE 4910-13-M