[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Rules and Regulations]
[Page 65567]
[DOCID:fr26oc10-5]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0924]

Drawbridge Operation Regulations; Mystic River, Charlestown, MA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
S99 Alford Street Bridge across the Mystic River, mile 1.4, at
Charlestown, Massachusetts. The deviation allows the bridge to remain
in the closed position three days in November to facilitate scheduled
bridge maintenance.

DATES: This deviation is effective from 8 p.m. on November 12, 2010
through 4 a.m. on November 15, 2010.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-0924 and are available online
at http://www.regulations.gov, inserting USCG-2010-0924 in the
``Keyword'' and then clicking ``Search''. They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. John McDonald, Project Officer, First Coast Guard
District<EMAIL_ADDRESS>or telephone<PHONE_NUMBER>. If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    The S99 Alford Street Bridge, across the Mystic River at mile 1.4,
at Charlestown, Massachusetts, has a vertical clearance in the closed
position of 7 feet at mean high water and 16 feet at mean low water.
The drawbridge operation regulations are listed at 33 CFR 117.609.
    The owner of the bridge, the City of Boston, requested a temporary
deviation from the regulations to facilitate scheduled bridge
maintenance, replacing steel members and steel deck grid at the bridge.
    Under this temporary deviation the S99 Alford Street Bridge may
remain in the closed position from 8 p.m. on November 12, 2010 through
4 a.m. on November 15, 2010.
    Vessels that can pass under the bridge in the closed position may
do so at any time. A work barge will be located in the main navigation
channel during the structural repairs to the bridge. The work barge
will move out of the channel upon request by calling William Schurman,
of SPS New England at<PHONE_NUMBER>.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: October 14, 2010.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2010-26984 Filed 10-25-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Rules and Regulations]
[Pages 44907-44914]
[FR Doc No: 2017-20559]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0813; Product Identifier 2017-NM-109-AD; Amendment
39-19059; AD 2017-20-02]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule; request for comments.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2017-13-05,
which applied to all Airbus Model A330-200, A330-300, A340-200, A340-
300, A340-500, and A340-600 series airplanes. AD 2017-13-05 required an
inspection, corrective actions if necessary, lubrication of the ball-
nut, modification of the trimmable horizontal stabilizer actuator
(THSA), and additional work for previously modified airplanes. For
certain airplanes, AD 2017-13-05 required installation of an electronic
harness, terminating actions, and a ball-screw assembly inspection.
This AD clarifies the formatting of a figure in the published version
of AD 2017-13-05. This AD was prompted by reports indicating that
affected parties misinterpreted the intent of a figure as formatted in
the published version of AD 2017-13-05, which could result in a
negative effect on compliance. We are issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective October 12, 2017.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 28,
2017 (82 FR 34251, July 24, 2017).
    We must receive comments on this AD by November 13, 2017.

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 Airbus service information identified in this final rule,
contact Airbus, Airworthiness Office-EIAS, 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 Standards Branch, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0813.

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-2017-
0813; 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 AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, 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: Vladimir Ulyanov, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 1601 Lind
Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>; fax 425-227-
1149.

SUPPLEMENTARY INFORMATION:

Discussion

    On June 15, 2017, we issued AD 2017-13-05, Amendment 39-18935 (82
FR 34251, July 24, 2017) (``AD 2017-13-05''), which applied to all
Airbus Model A330-200, A330-300, A340-200, A340-300, A340-500, and
A340-600 series airplanes. AD 2017-13-05 was prompted by the need for a
modification that automatically detects failure of the ball-screw
assembly. AD 2017-13-05 required an inspection, corrective actions if
necessary, lubrication of the ball-nut, modification of the trimmable
horizontal stabilizer actuator (THSA), and additional work for
previously modified airplanes. For certain airplanes, AD 2017-13-05
required installation of an electronic harness, terminating actions,
and a ball-screw assembly inspection. We issued AD 2017-13-05 to detect
and correct wear on the THSA, possibly resulting in damage to the ball-
screw and fail-safe nut, which could jam the THSA and result in reduced
control of the airplane.
    Since we issued AD 2017-13-05, we have received reports indicating
that affected parties could misinterpret the identity of applicable
service information to use for the modification, due to the formatting
of figure 2 to paragraphs (h) and (i) in the published version of AD
2017-13-05. Since the published figure could result in a negative
effect on compliance, we have determined that clarification of the
formatting of the published figure is necessary.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2014-0219, dated September 29, 2014 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all Airbus Model A330 and Model A340
series airplanes. (Model A330-223F and A330-243F airplanes were removed
from AD 2017-13-05 to correspond with the MCAI.) The EASA AD is
referenced in AD 2017-13-05. EASA has not revised its AD since the
issuance of AD 2017-13-05.
    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-2017-
0813.

Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information. The service
bulletins having the same document number (but different revision
levels) are distinct because each revision contains unique editorial
changes.
    The following service information describes procedures for doing
repetitive inspections for integrity of the primary and secondary load
paths of the ball-screw assembly of the THSA. These service bulletins
are distinct because they apply to different airplane models.
     Airbus Service Bulletin A330-27-3102, Revision 09, dated
March 29, 2016.
     Airbus Service Bulletin A340-27-4107, Revision 09, dated
March 29, 2016.
    The following service information describes procedures for
installing two electrical detection devices, also called CSPs, on the
lower attachment secondary load path of the THSA, and modifying the
THSA. These service bulletins are distinct because they apply to
different airplane models equipped with THSAs having different part
numbers.
     Airbus Service Bulletin A330-27-3137, including Appendix
01, dated March 20, 2007.
     Airbus Service Bulletin A330-27-3137, Revision 01,
including Appendix 1, dated December 6, 2007.
     Airbus Service Bulletin A330-27-3137, Revision 02, dated
January 18, 2010.
     Airbus Service Bulletin A330-27-3143, Revision 01, dated
July 10, 2012.
     Airbus Service Bulletin A340-27-4136, including Appendix
01, dated March 20, 2007.
     Airbus Service Bulletin A340-27-4136, Revision 01,
including Appendix 1, dated December 6, 2007.
     Airbus Service Bulletin A340-27-4136, Revision 02,
including Appendix 1, dated February 24, 2010.
     Airbus Service Bulletin A340-27-4143, dated February 21,
2012.
     Airbus Service Bulletin A340-27-5030, Revision 01,
including Appendix 1, dated November 20, 2009.
    The following service information describes procedures for
installing electrical wiring harnesses and brackets to connect the
secondary nut detection device to the monitoring systems. These service
bulletins are distinct because they apply to different airplane models.
     Airbus Service Bulletin A330-92-3046, Revision 04, dated
July 16, 2010.
     Airbus Service Bulletin A330-92-3046, Revision 05, dated
November 7, 2011.
     Airbus Service Bulletin A330-92-3046, Revision 07, dated
January 13, 2017.
     Airbus Service Bulletin A340-92-4056, Revision 03, dated
July 16, 2010.
     Airbus Service Bulletin A340-92-4056, Revision 04, dated
December 5, 2013.
     Airbus Service Bulletin A340-92-5008, Revision 07, dated
February 8, 2013.
    The following service information describes system equipment
maintenance requirements (SEMR) that refer to preventative maintenance
requirements found necessary to comply with safety objectives. These
documents are distinct because they apply to different airplane models.
     Airbus A330 Airworthiness Limitations Section (ALS) Part
4--System Equipment Maintenance Requirements (SEMR), Revision 05, dated
October 19, 2015.
     Airbus A340 Airworthiness Limitations Section (ALS) Part
4--System Equipment Maintenance Requirements (SEMR), Revision 04, dated
October 19, 2015.
     Airbus A340 Airworthiness Limitations Section (ALS) Part
3--Certification Maintenance Requirements (CMR), Revision 03, dated
October 19, 2015, describes CMRs that are system-related periodic tasks
established during type certification.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This 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 issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

FAA's Justification and Determination of the Effective Date

    We are superseding AD 2017-13-05 to clarify the formatting of a
figure in the regulatory text of the published AD. No other changes
have been made to AD 2017-13-05. Therefore, we determined that notice
and opportunity for prior public comment are unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2017-0813; Product
Identifier 2017-NM-109-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 33 airplanes of U.S. registry.
This AD adds no new economic burden to AD 2017-13-05.
    We estimate that it takes about 68 work-hours per product to comply
with the basic requirements of this AD. The average labor rate is $85
per work-hour. Required parts would cost about $17,481 per product.
Based on these figures, we estimate the cost of this AD on U.S.
operators to be $764,808, or $23,260 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.
    This AD is issued in accordance with authority delegated by the
Executive

Director, Aircraft Certification Service, as authorized by FAA Order
8000.51C. In accordance with that order, issuance of ADs is normally a
function of the Compliance and Airworthiness Division, but during this
transition period, the Executive Director has delegated the authority
to issue ADs applicable to transport category airplanes to the Director
of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    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.

Adoption of the Amendment

    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  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2017-13-05, Amendment 39-18935 (82 FR 34251, July 24, 2017), and adding
the following new AD:

2017-20-02 Airbus: Amendment 39-19059; Docket No. FAA-2017-0813;
Product Identifier 2017-NM-109-AD.

(a) Effective Date

    This AD is effective October 12, 2017.

(b) Affected ADs

    This AD replaces AD 2017-13-05, Amendment 39-18935 (82 FR 34251,
July 24, 2017) (``AD 2017-13-05'').

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD, certificated in any category.
    (1) Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -
303, -321, -322, -323, -341, -342, and -343 airplanes, all
manufacturer serial numbers.
    (2) Airbus Model A340-211, -212, -213, -311, -312, -313, -541,
and -642 airplanes, all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
Controls.

(e) Reason

    This AD was prompted by the need for a modification that
automatically detects failure of the ball-screw assembly. We are
issuing this AD to detect and correct wear on the trimmable
horizontal stabilizer actuator (THSA), possibly resulting in damage
to the ball-screw and fail-safe nut, which could jam the THSA and
result in reduced control of the airplane.

(f) Compliance

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

(g) Retained Actions for Electronic Centralized Aircraft Monitor (ECAM)
Fault Messages, With Revised FAA Contact Information

    This paragraph restates the requirements of paragraph (g) of AD
2017-13-05, with revised FAA contact information. For airplanes
other than those identified in figure 1 to paragraphs (g), (h), and
(q) of this AD: If, during any flight, one of the ``PRIM X PITCH
FAULT'' or ``STAB CTL FAULT'' messages is displayed on the ECAM
associated with the ``PITCH TRIM ACTR (1CS)'' maintenance message,
before further flight after each time the message is displayed on
the ECAM, do the actions specified in paragraphs (g)(1) and (g)(2)
of this AD.
    (1) Do the applicable detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path; check
the checkable shear pins (CSP), if installed; and do all applicable
corrective actions; as specified in paragraph (g)(1)(i), (g)(1)(ii),
or (g)(1)(iii) of this AD. Do all applicable corrective actions
before further flight.
    (i) For Model A330 series airplanes: Do the actions in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A330-27-3102, Revision 09, dated March 29, 2016, except as
required by paragraph (n)(1) of this AD.
    (ii) For Model A340-200 and -300 series airplanes: Do the
actions in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A340-27-4107, Revision 09, dated March 29, 2016,
except as required by paragraph (n)(1) of this AD.
    (iii) For Model A340-500 and -600 series airplanes: Do the
actions using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus's EASA Design Organization Approval
(DOA).
    Note 1 to paragraph (g)(1)(iii) of this AD: Guidance for the
inspection of the ball-screw assembly can be found in Task 274000-
B0002-1-C, Inspection of the ball-screw assembly for integrity of
the primary and secondary load paths, of the Airbus A340
Airworthiness Limitations Section (ALS) Part 3--Certification
Maintenance Requirements (CMR), Revision 03, dated October 19, 2015.
    (2) Lubricate the THSA ball-nut in accordance with the
applicable service information specified in paragraph (g)(2)(i),
(g)(2)(ii), or (g)(2)(iii) of this AD.
    (i) Task<PHONE_NUMBER>2-1-E, Lubrication of the THSA ball-nut, of
Airbus A330 ALS Part 4--System Equipment Maintenance Requirements
(SEMR), Revision 05, dated October 19, 2015 (for Model A330 series
airplanes).
    (ii) Task<PHONE_NUMBER>2-1-E, Lubrication of the THSA ball-nut, of
Airbus A340 ALS Part 4--System Equipment Maintenance Requirements
(SEMR), Revision 04, dated October 19, 2015 (for Model A340-200 and
-300 series airplanes).
    (iii) Task 274000-B0003-1-C, Lubrication of THS Actuator ball-
screw nut, of Airbus A340 ALS Part 3--Certification Maintenance
Requirements (CMR), Revision 03, dated October 19, 2015 (for Model
A340-500 and -600 series airplanes).
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[GRAPHIC] [TIFF OMITTED] TR27SE17.010

(h) Retained Installation of CSP and Electrical Harness, With No
Changes

    This paragraph restates the requirements of paragraph (h) of AD
2017-13-05, with no changes. For all airplanes, except Group 2
airplanes specified in figure 1 to paragraphs (g), (h), and (q) of
this AD, and except for airplanes identified in paragraphs (i), (j),
and (n)(2) of this AD: Within 12 months after August 28, 2017 (the
effective date of AD 2017-13-05), modify the airplane by installing
a CSP on the THSA and an additional electrical harness, in
accordance with the Accomplishment Instructions of the Airbus
service information specified in figure 2 to paragraphs (h) and (i)
of this AD, as applicable to the part number of the THSA installed
on the airplane, except as provided by paragraph (n)(2) of this AD.
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[GRAPHIC] [TIFF OMITTED] TR27SE17.011

(i) Retained ``Additional Work'' on Previously Modified Airplanes, With
No Changes

    This paragraph restates the requirements of paragraph (i) of AD
2017-13-05, with no changes. For airplanes that have already been
modified (installation of CSP on the THSA and electrical harness)
before August 28, 2017 (the effective date of AD 2017-13-05), in
accordance with the Accomplishment Instructions of any previous
revision of an Airbus service bulletin specified in figure 2 to
paragraphs (h) and (i) of this AD, as applicable: Within 12 months
after August 28, 2017, do the ``Additional Work'' specified in, and
in accordance with, the Accomplishment Instructions of the
applicable Airbus service information specified in figure 2 to
paragraphs (h) and (i) of this AD.

(j) Retained Installation of Electrical Harness on Airplanes Equipped
with a CSP, With No Changes

    This paragraph restates the requirements of paragraph (j) of AD
2017-13-05, with no changes. For airplanes having one of the THSAs
installed with a part number listed in figure 3 to paragraph (j) of
this AD, and that have been modified by installing a CSP on the THSA
as required by paragraph (h) of this AD: Within 12 months after
August 28, 2017 (the effective date of AD 2017-13-05), inspect to
determine if the electrical harness identified in the applicable
Airbus service information specified in figure 3 to paragraph (j) of
this AD is installed on the airplane, and, if not installed, modify
the airplane by installing an electrical harness, in accordance with
the Accomplishment Instructions of the Airbus service information
specified in figure 3 to paragraph (j) of this AD, as applicable to
the part number of the THSA installed on the airplane. Airplanes
having one of the THSAs installed with a part number listed in
figure 3 to paragraph (j) of this AD already have the CSP installed
on the THSA, and only the electrical harness must be installed on
the airplane.

[GRAPHIC] [TIFF OMITTED] TR27SE17.012

(k) Retained Provisions for Terminating Action for Repetitive
Inspections of Airbus Model A330-200 and -300 Series Airplanes, With No
Changes

    This paragraph restates the provisions of paragraph (k) of AD
2017-13-05, with no changes. Accomplishment of a modification before
August 28, 2017 (the effective date of AD 2017-13-05), using the
Accomplishment Instructions of Airbus Service Bulletin A330-27-3137,
including Appendix 01, dated March 20, 2007; or Revision 01,
including Appendix 1, dated December 6, 2007; and Airbus Service
Bulletin A330-92-3046, Revision 04, dated July 16, 2010; or Revision
05, dated November 7, 2011; or Revision 06, dated November 15, 2013;
terminates the repetitive inspections specified in paragraphs (k)(1)
through (k)(4) of this AD. Modification of an airplane as specified
by this paragraph does not constitute terminating action for the
actions specified in paragraph (g)(2) of this AD or the additional
work specified in paragraph (i) of this AD.
    (1) Task<PHONE_NUMBER>1-1-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
check the gap at the secondary nut trunnion, of Airbus A330 ALS Part
4--System Equipment Maintenance Requirements (SEMR), Revision 05,
dated October 19, 2015.
    (2) Task<PHONE_NUMBER>1-2-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
check the CSPs, of Airbus A330 ALS Part 4--System Equipment
Maintenance Requirements (SEMR), Revision 05, dated October 19,
2015.
    (3) Task<PHONE_NUMBER>1-3-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
check the CSPs, of Airbus A330 ALS Part 4--System Equipment
Maintenance Requirements (SEMR), Revision 05, dated October 19,
2015.
    (4) Task<PHONE_NUMBER>1-4-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
check the CSPs, of Airbus A330 ALS Part 4--System Equipment
Maintenance Requirements (SEMR), Revision 05, dated October 19,
2015.

(l) Retained Provisions for Terminating Action for Repetitive
Inspections of Airbus Model A340-200 and -300 Series Airplanes, With No
Changes

    This paragraph restates the provisions of paragraph (l) of AD
2017-13-05, with no changes. Accomplishment of a modification in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A340-27-4143, dated February 21, 2012; and Airbus Service
Bulletin A340-92-4056, Revision 03, dated July 16, 2010; terminates
the actions required by paragraph (g)(1) of this AD for modified
Airbus Model A340-200 and -300 series airplanes only. Modification
of an airplane as specified in this paragraph does not constitute
terminating action for the actions specified in paragraph (g)(2) of
this AD, or the additional work specified in paragraph (i) of this
AD.

(m) Retained Provisions for Terminating Action for Repetitive
Inspections of Airbus Model A340-200 and -300 Series Airplanes, With No
Changes

    This paragraph restates the provisions of paragraph (m) of AD
2017-13-05, with no changes. Accomplishment of a modification before
August 28, 2017 (the effective date of AD 2017-13-05), using the
Accomplishment Instructions of Airbus Service Bulletin A340-27-4136,
including Appendix 01, dated March 20, 2007; or Revision 01,
including Appendix 1, dated December 6, 2007; and Airbus Service
Bulletin A340-92-4056, Revision 03, dated July 16, 2010; terminates
the repetitive inspections specified in paragraphs (m)(1) through
(m)(4) of this AD. Modification of an airplane as specified in this
paragraph does not constitute terminating action for the actions
specified in paragraph (g)(2) of this AD, or the additional work
specified in paragraph (i) of this AD.
    (1) Task<PHONE_NUMBER>1-1-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
gap check at the secondary nut trunnion, of Airbus A340 ALS Part 4--
System Equipment Maintenance Requirements (SEMR), Revision 04, dated
October 19, 2015.
    (2) Task<PHONE_NUMBER>1-2-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
CSP check, of Airbus A340 ALS Part 4--System Equipment Maintenance
Requirements (SEMR), Revision 04, dated October 19, 2015.
    (3) Task<PHONE_NUMBER>1-3-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
CSP check, of Airbus A340 ALS Part 4--System Equipment Maintenance
Requirements (SEMR), Revision 04, dated October 19, 2015.
    (4) Task<PHONE_NUMBER>1-4-E, Detailed inspection of the ball-screw
assembly for integrity of the primary and secondary load path and
CSP check, of A340 ALS Part 4--System Equipment Maintenance
Requirements (SEMR), Revision 04, dated October 19, 2015.

(n) Retained Exceptions to the Actions in Certain Service Information
and Paragraph (h) of This AD, With No Changes

    This paragraph restates the exceptions of paragraph (n) of AD
2017-13-05, with no changes.
    (1) Where Airbus Service Bulletin A330-27-3102, Revision 09,
dated March 29, 2016 (for Model A330 series airplanes); or Airbus
Service Bulletin A340-27-4107, Revision 09, dated March 29, 2016
(for Model A340 series airplanes); specifies to contact Airbus for a
damage assessment: Before further flight, accomplish the required
actions in accordance with the procedures specified in paragraph
(s)(2) of this AD.
    (2) For airplanes that already had the electrical harness
installed during production using Airbus Modifications 52269 and
56056 for Airbus Model A330-200 and -300 series airplanes and Airbus
Model A340-200 and -300 series airplanes, and using Airbus
Modifications 52191 and 56058 for Model A340-500 and -600 series
airplanes: Only the CSP must be installed on the THSA in

accordance with applicable Airbus service bulletins and within the
compliance time specified in paragraph (h) of this AD.

(o) Retained Provisions for Terminating Action for Repetitive
Inspections for Airplanes on Which Actions Required by Paragraph (h),
(i), or (j) of This AD Are Done, With No Changes

    This paragraph restates the provisions of paragraph (o) of AD
2017-13-05, with no changes. Modification of an airplane as required
by paragraph (h), (i), or (j) of this AD, as applicable, constitutes
terminating action for that airplane for the applicable actions
identified in paragraphs (o)(1) through (o)(4) of this AD.
    (1) For all airplanes: The actions required by paragraph (g) of
this AD.
    (2) For Model A340-500 and -600 series airplanes: Task 274000-
B0002-1-C, Inspection of the ball-screw assembly for integrity of
the primary and secondary load paths, of Airbus A340 ALS Part 3--
Certification Maintenance Requirements (CMR), Revision 03, dated
October 19, 2015.
    (3) For Model A330-200 and -300 series airplanes: The ALS tasks
identified in paragraphs (k)(1) through (k)(4) of this AD.
    (4) For Model A340-200 and -300 series airplanes: The ALS tasks
identified in paragraphs (m)(1) through (m)(4) of this AD.

(p) Retained Ball-screw Assembly Inspection for Certain Airplanes, With
Revised FAA Contact Information

    This paragraph restates the requirements of paragraph (p) of AD
2017-13-05, with revised FAA contact information. For Model A340-500
and -600 airplanes that are in post-Airbus Service Bulletin A340-92-
5008, at Revision 06 or earlier, configuration: Before exceeding the
threshold or interval, as applicable, of Task 274000-B0002-1-C,
Inspection of the ball-screw assembly for integrity of the primary
and secondary load paths, of Airbus A340 ALS Part 3--Certification
Maintenance Requirements (CMR), Revision 03, dated October 19, 2015,
or within 3 months after August 28, 2017 (the effective date of AD
2017-13-05), whichever occurs later, accomplish Task 274000-B0002-1-
C, Inspection of the ball-screw assembly for integrity of the
primary and secondary load paths, of Airbus A340 ALS Part 3--
Certification Maintenance Requirements (CMR), Revision 03, dated
October 19, 2015; and do all applicable corrective actions. Do all
applicable corrective actions before further flight using a method
approved by the Manager, International Section, Transport Standards
Branch, FAA; or EASA; or Airbus's EASA DOA. Repeat Task 274000-
B0002-1-C, Inspection of the ball-screw assembly for integrity of
the primary and secondary load paths, thereafter at the applicable
intervals specified in Airbus A340 ALS Part 3--Certification
Maintenance Requirements (CMR), Revision 03, dated October 19, 2015.

(q) Retained Parts Installation Prohibitions, With No Changes

    This paragraph restates the requirements of paragraph (1) of AD
2017-13-05, with no changes.
    (1) For all airplanes except Group 2 airplanes as identified in
figure 1 to paragraphs (g), (h), and (q) of this AD: After
modification of the airplane as required by paragraph (h), (i), or
(j) of this AD, as applicable, no person may install any THSA having
part number (P/N) 47172-300, P/N 47147-500, P/N 47175-200, or P/N
47175-300.
    (2) For Group 2 airplanes, as identified in figure 1 to
paragraphs (g), (h), and (q) of this AD: As of August 28, 2017 (the
effective date of AD 2017-13-05), no person may install on any Group
2 airplane any THSA having P/N 47172-300, P/N 47147-500, P/N 47175-
200, or P/N 47175-300.

(r) Retained Credit for Previous Actions, With No Changes

    This paragraph restates the provisions of paragraph (r) of AD
2017-13-05, with no changes.
    (1) This paragraph provides credit for actions required by
paragraph (g)(2) of this AD, if those actions were performed before
August 28, 2017 (the effective date of AD 2017-13-05), using the
applicable service information specified in paragraphs (r)(1)(i)
through (r)(1)(iv) of this AD.
    (i) Task<PHONE_NUMBER>2-1-E, Lubrication of the THSA ball-nut, of
Airbus A330 ALS Part 4--Ageing Systems Maintenance, Revision 03,
dated September 9, 2011 (for Model A330 series airplanes).
    (ii) Task<PHONE_NUMBER>2-1-E, Lubrication of the THSA ball-nut, of
Airbus A330 ALS Part 4--Ageing Systems Maintenance, Revision 04,
dated August 27, 2013 (for Model A330 series airplanes).
    (iii) Task<PHONE_NUMBER>2-1-E, Lubrication of the THSA ball-nut,
of Airbus A340 ALS Part 4--Ageing Systems Maintenance, Revision 02,
dated October 12, 2011 (for Model A340-200 and -300 series
airplanes).
    (iv) Task<PHONE_NUMBER>2-1-E, Lubrication of the THSA ball-nut, of
Airbus A340 ALS Part 4--Ageing Systems Maintenance, Revision 03,
dated November 15, 2012 (for Model A340-200 and -300 series
airplanes).
    (2) This paragraph provides credit for the electrical harness
installation required by paragraph (h) of this AD and the inspection
and electrical harness installation required by paragraph (j) of
this AD, if those actions were performed before August 28, 2017 (the
effective date of AD 2017-13-05), using Airbus Service Bulletin
A330-92-3046, Revision 06, dated November 15, 2013.

(s) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the
attention of the person identified in paragraph (t)(2) of this AD.
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.
    (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
Section, Transport Standards Branch, FAA; or EASA; or Airbus's EASA
DOA. If approved by the DOA, the approval must include the DOA-
authorized signature.

(t) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0219, dated September 29,
2014, for related information. You may examine the MCAI on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0813.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (u)(4) and (u)(5) of this AD.

(u) 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 this AD specifies otherwise.
    (3) The following service information was approved for IBR on
August 28, 2017 (82 FR 34251, July 24, 2017).
    (i) Airbus A330 Airworthiness Limitations Section (ALS) Part 4--
System Equipment Maintenance Requirements (SEMR), Revision 05, dated
October 19, 2015.
    (ii) Airbus A340 Airworthiness Limitations Section (ALS) Part
3--Certification Maintenance Requirements (CMR), Revision 03, dated
October 19, 2015.
    (iii) Airbus A340 Airworthiness Limitations Section (ALS) Part
4--System Equipment Maintenance Requirements (SEMR), Revision 04,
dated October 19, 2015.
    (iv) Airbus Service Bulletin A330-27-3102, Revision 09, dated
March 29, 2016.
    (v) Airbus Service Bulletin A330-27-3137, including Appendix 01,
dated March 20, 2007.
    (vi) Airbus Service Bulletin A330-27-3137, Revision 01,
including Appendix 1, dated December 6, 2007.
    (vii) Airbus Service Bulletin A330-27-3137, Revision 02, dated
January 18, 2010.
    (viii) Airbus Service Bulletin A330-27-3143, Revision 01, dated
July 10, 2012.
    (ix) Airbus Service Bulletin A330-92-3046, Revision 04, dated
July 16, 2010.
    (x) Airbus Service Bulletin A330-92-3046, Revision 05, dated
November 7, 2011.
    (xi) Airbus Service Bulletin A330-92-3046, Revision 07, dated
January 13, 2017.

    (xii) Airbus Service Bulletin A340-27-4107, Revision 09, dated
March 29, 2016.
    (xiii) Airbus Service Bulletin A340-27-4136, including Appendix
01, dated March 20, 2007.
    (xiv) Airbus Service Bulletin A340-27-4136, Revision 01,
including Appendix 1, dated December 6, 2007.
    (xv) Airbus Service Bulletin A340-27-4136, Revision 02,
including Appendix 1, dated February 24, 2010.
    (xvi) Airbus Service Bulletin A340-27-4143, dated February 21,
2012.
    (xvii) Airbus Service Bulletin A340-27-5030, Revision 01,
including Appendix 1, dated November 20, 2009.
    (xviii) Airbus Service Bulletin A340-92-4056, Revision 03, dated
July 16, 2010.
    (xix) Airbus Service Bulletin A340-92-4056, Revision 04, dated
December 5, 2013.
    (xx) Airbus Service Bulletin A340-92-5008, Revision 07, dated
February 8, 2013.
    (4) For service information identified in this AD, contact
Airbus, Airworthiness Office- EIAS, 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.
    (5) You may view this service information at the FAA, Transport
Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
    (6) 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 Renton, Washington, on September 14, 2017.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2017-20559 Filed 9-26-17; 8:45 am]
BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  10/22/2009

SUBJECT:	Aminopyralid and Aminopyralid Triisopropanolammonium (TIPA)
Salt.  Request to Add Uses on Field Corn to Milestone® (EPA Reg. No.
62719-519).  Summary of Analytical Chemistry and Residue Data.

PC Codes:  005100 (Aminopyralid) and 005209 (Aminopyralid TIPA Salt)	DP
Barcode:  D360100

Decision No.:  401475	Registration No.:  62719-519

Petition No.:  PP#8F7455	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  150114-71-9 (Aminopyralid) and 566191-89-7
(Aminopyralid TIPA Salt)

MRID No.:  46661301, 46729001, 46729601-03, 47572601, 47572603-04	40
CFR:  180.610

FROM:	Douglas Dotson, Ph.D., Chemist

		Risk Assessment Branch II

Health Effects Division, 7509P  SEQ CHAPTER \h \r 1

THROUGH:	Michael Doherty, Ph.D., Chemist

		Richard Loranger, Ph.D., Senior Scientist

		Risk Assessment Branch II

Health Effects Division, 7509P

TO:		Kathryn Montague/Joanne Miller, RM 23

		Herbicide Branch

		Registration Division, 7505P		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h
\r 1

  SEQ CHAPTER \h \r 1 This document was originally prepared under
contract by Dynamac Corporation (1901 Research Boulevard, Suite 220;
Rockville, MD 20850).  The document has been reviewed by the Health
Effects Division (HED) and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

Aminopyralid is a systemic postemergence herbicide which belongs to the
pyridine carboxylic acid class of herbicides.  It is currently
registered for use on rangeland, permanent grass pastures, and wheat.
In addition, it is registered for use on wildlife habitat and industrial
vegetation management areas, including right-of-way for roads,
railroads, and utility lines.

Under PP#8F7455, Dow AgroSciences is proposing the establishment of
permanent tolerances for aminopyralid (2-pyridine carboxylic acid,
4-amino-3,6-dichloro-), expressed as total parent, free and conjugated,
in or on the following raw agricultural commodities:

Corn, forage	0.30 ppm

Corn, grain	0.20 ppm

Corn, stover	0.20 ppm

In conjunction with the submitted petition, Dow AgroSciences is
requesting an amended Section 3 registration to add uses on field corn
to Milestone® (EPA Reg. No. 62719-519), a liquid soluble concentrate
(SL) formulation in which aminopyralid is formulated as the
triisopropanolammonium (TIPA) salt.  The product contains 40.6%
aminopyralid TIPA salt at an acid equivalent (ae) of 21.1% or 2 lb
ae/gal.  The product is proposed for postemergence foliar broadcast or
spot applications to field corn up to the V6 growth stage at a maximum
seasonal rate of 0.027 lb ae/A.  Preharvest intervals (PHIs) of 0 days
for grain and 8 days for forage or silage are proposed.

Tolerances for aminopyralid are currently established under 40 CFR
§180.610.  Tolerances for residues in/on crop commodities are
established under 180.610(a)(1) and are expressed in terms of free and
conjugated residues of aminopyralid, calculated as aminopyralid.
Tolerances have been established for aspirated grain fractions, grass
forage and hay, and wheat bran, forage, grain, hay, and straw.
Tolerances for residues in livestock commodities are established under
180.610(a)(2) and are expressed in terms of aminopyralid.  Tolerances
have been established for milk and the fat, kidney, meat, and meat
byproducts of cattle, goat, horse, and sheep.

The qualitative nature of aminopyralid residues in field corn is
adequately understood for the purposes of this petition based on
previously submitted metabolism studies with grass and wheat.  In
metabolism studies reflecting foliar applications to grass and wheat,
aminopyralid was found to be metabolized to a multi-component mixture of
water-soluble complexes that consist mostly of isomeric mixtures of
acid- and base-labile N-glucosides and glucose ester conjugates of
aminopyralid.  HED concluded that the residues of concern in grass and
cereal grain commodities are free and conjugated aminopyralid.

Previously submitted metabolism studies with lactating goats and laying
hens show that most of the administered dose is rapidly excreted (~80%
for hens and ~95% for goat).  Residues in all poultry commodities,
including eggs, were too low to allow identification of residues
(residues were less than 0.004 ppm aminopyralid-equivalents across all
commodities).  In the goat, residues were less than 0.008 ppm
aminopyralid-equivalents in all commodities except kidney.  In kidney,
80% of the residues (0.07 ppm) were identified as parent aminopyralid.
Although residues in other tissues were too low to permit
identification, the weight of the evidence is that the limited amount of
aminopyralid that is not excreted remains as the parent compound.
Therefore, the residue of concern in livestock is aminopyralid.

Adequate high performance liquid chromatography (LC) methods with tandem
mass spectroscopy detection (MS/MS) have been submitted for tolerance
enforcement for crop and livestock commodities.  The validated limit of
quantitation (LOQ) is 0.01 ppm in each matrix.  Samples from the
submitted field corn crop field trial and processing studies were
analyzed using the crop commodity tolerance enforcement method.  Samples
of grass and wheat commodities from the submitted storage stability
study were analyzed using a previous version of the crop commodity
enforcement method.

The submitted storage stability data are adequate to support the crop
field trial study and the field corn processing study.

Acceptable field corn crop field trial studies have been submitted.  The
proposed use on field corn must be amended to remove the proposed PHIs
of 0 and 8 days for grain and forage, as the submitted data do not
support these low PHIs.  The data support application to field corn up
to the V6 growth stage, with harvest of forage occurring at the dent
growth stage or later.  The data support the proposed tolerances of 0.30
ppm for field corn forage and 0.20 ppm for field corn grain and stover.

The submitted field corn processing study is adequate and indicates that
tolerances are not needed for field corn processed commodities, and that
no change in the existing tolerance for aspirated grain fractions is
needed as a result of the proposed uses on field corn.

The nature of the residue in rotational crops is adequately understood
based on a previously submitted study with lettuce, turnip, and sorghum.
 No field rotational crop data have been submitted for aminopyralid.
Although the proposed uses reflect an increased maximum seasonal rate, a
limited field rotational crop study with aminopyralid does not need to
be submitted.  The only crops which are likely to have quantifiable
residues at the requested plantback intervals (PBIs) are wheat, grasses,
and corn, all of which will be treated as primary crops and have
tolerances to cover the resulting residues.  HED considers the rotation
intervals listed on the supplemental label for field corn to be
adequate.

No changes to the existing tolerances for livestock commodities are
needed as a result of the proposed uses on field corn.

Codex and Canadian MRLs have been established for residues of
aminopyralid; however, no MRLs have been established for the requested
crop commodities.  No Mexican MRLs have been established for
aminopyralid.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

HED has examined the residue chemistry database for aminopyralid.
Pending submission of a revised Section B (see requirements under
Directions for Use) and a revised Section F (see requirements under
Proposed Tolerances), there are no residue chemistry issues that would
preclude granting Section 3 registration for the requested uses of
aminopyralid, or establishment of tolerances for residues of
aminopyralid, as follows:

Corn, field, forage	0.30 ppm

Corn, field, grain	0.20 ppm

Corn, field, stover	0.20 ppm

HED recommends that 40CFR §180.610(a)(1) be amended by replacing the
tolerance expression with the following:  “Tolerances are established
for residues of aminopyalid (4-amino-3,6-dichloro-2-pyridinecarboxylic
acid), including its metabolites and degradates, in or on the
commodities in the table below.  Compliance with the tolerance levels
specified below is to be determined by measuring only free and
conjugated aminopyralid.”  HED further recommends that 40CFR
§180.610(a)(2) be amended by replacing the tolerance expression with
the following:  “Tolerances are established for residues of
aminopyralid, including its metabolites and degradates, in or on the
commodities in the table below.  Compliance with the tolerance levels
specified below is to be determined by measuring only aminopyralid.”

With the review of the interference study and the final report of the
grass and wheat storage stability study in this document, all the data
requirements that were identified as conditions of registration in the
previous aminopyralid petition (PP#4F6827; D305665, M. Doherty, 7/12/05)
have now been satisfied.

860.1200 Directions for Use

The proposed label must be modified to specify that spray or spot
applications may not be made after the V6 growth stage (BBCH 16) and
that forage may not be harvested prior to the dent stage of growth.  If
the petitioner wishes to support a shorter PHI for field corn forage (or
harvest of forage at an earlier growth stage), then adequate crop field
trial data reflecting the shorter PHI and/or earlier forage harvest must
be submitted.

860.1550 Proposed Tolerances

The proposed tolerances should be revised to reflect the correct
commodity definitions as specified above and in Table 8.

Background

Aminopyralid is a systemic postemergence herbicide that belongs to the
pyridine carboxylic acid class of herbicides.  The chemical structure
and nomenclature of aminopyralid and aminopyralid TIPA salt are
presented in Table 1.  The physiochemical properties of the technical
grade of aminopyralid are presented in Table 2.

2′RS,2″RS)-1,1′,1″-nitrilotripropan-2-ol (1:1)

CAS name	4-amino-3,6-dichloropyridine-2-carboxylic acid compound with
1,1′,1″-nitrilotris[2-propanol] (1:1)

CAS registry number	566191-89-7

End-use product (EP)	Milestone® (2 lb ae/gal SL; EPA Reg. No.
62719-519)

TABLE 2.	Physicochemical Properties of the Technical Grade of
Aminopyralid.

Parameter	Value	Reference

Melting point/range	  SEQ CHAPTER \h \r 1 163.5ºC	  SEQ CHAPTER \h \r 1
MRID 46235703

pH	  SEQ CHAPTER \h \r 1 2.31 at 23.4ºC (1% solution in water)	MRID
46235703

Density	  SEQ CHAPTER \h \r 1 1.72 at 20ºC	MRID 46235703

Water solubility	  SEQ CHAPTER \h \r 1 2.48 g/L unbuffered water at
18ºC

212 g/L pH 5 buffer at 20ºC

205 g/L pH 7 buffer at 20ºC

203 g/L pH 9 buffer at 20ºC	MRID 46235703

Solvent solubility at 20°C	  SEQ CHAPTER \h \r 1 methanol	52.2 g/L

acetone	29.2 g/L

n-octanol	3.9 g/L

ethyl acetate	3.9 g/L

1,2-dichloroethane	0.2 g/L

xylene	0.04 g/L

heptane	<10 µg/mL	MRID 46235703

Vapor pressure	  SEQ CHAPTER \h \r 1 2.59 x 10-8 Pa at 25ºC; 9.52 x
10-9 Pa at 20ºC	MRID 46235703

Dissociation constant, pKa	  SEQ CHAPTER \h \r 1 2.56	MRID 46235703

Octanol/water partition coefficient, Log(KOW)	  SEQ CHAPTER \h \r 1
0.201 unbuffered water at 19ºC

-1.76 at pH 5

-2.87 at pH 7

-2.96 at pH 9	MRID 46235703

UV/visible absorption spectrum	  SEQ CHAPTER \h \r 1 Solution

Wavelength

λ max, nm

Extinction coefficient

L/(mol*cm)

Neutral

217

29100

Basic (pH 12.6)

220

26100

Basic (pH 12.6)

245

10150

Acidic (pH 1.4)

217

22800

Acidic (pH 1.4)

270

9140

	MRID 46235703

860.1200 Directions for Use

The petitioner submitted a proposed supplemental label (pin punched with
date 10/15/08) for the 2 lb ae/gal SL product (Milestone®; EPA Reg. No.
62719-519) for use on field corn.  The proposed use directions are
presented in Table 3.  The supplemental label states that use is subject
to all use precautions and limitations imposed by the label on the
parent product.

Table 3.	Summary of Directions for Use of Aminopyralid.

Applic. Timing, Type, and Equip.	Formulation

(EPA Reg. No.)	Applic. Rate

(lb ae/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations

Field Corn and Field Corn grown for Ensilage

Postemergence,

Broadcast,

Ground	2 lb ae/gal SL (62719-519)	0.0089-0.027	Not specified	0.027	0
(grain);

8 (forage or silage)	Application is to be made to actively growing corn
before it reaches 20 inches in height or V6 growth stage.  Spot
treatments are to be made at rates equivalent to broadcast application,
in a minimum spray volume of 0.5 gal/1,000 ft2.

Postemergence,

Spot treatment,

Ground

0.00021-0.00063 lb ae/1,000 ft2

The label specifies that aerial applications are not to be made unless
permitted by EPA-approved supplemental labeling.  Under the mixing
instructions, the master label specifies that a non-ionic surfactant at
0.25-0.5% v/v (1-2 quarts per 100 gallons spray) is recommended to
enhance herbicide activity under adverse environmental conditions.

The following rotational crop restrictions are specified:  0-month
plantback interval for wheat; 4-month plantback interval for grasses and
field corn; 12-month plantback interval for barley, canola (rapeseed),
flax, grain sorghum, mustard, oats, sweet corn, and popcorn; and a
24-month plantback interval for crops not listed.  The label also
specifies that a field bioassay should be conducted prior to planting
any broadleaf crops not listed within 18 months of application.

Conclusions.  The submitted label is adequate to allow evaluation of the
residue data relative to the proposed use.  The submitted crop field
trial data represent application at the proposed maximum seasonal rate
(with a nonionic surfactant) and at the proposed growth stage.  The
proposed PHIs of 0 days for grain and 8 days for forage or silage are
not supported by the submitted data.  The proposed label should be
modified to specify that spray or spot applications may not be made
after the V6 growth stage (BBCH 16) and that forage may not be harvested
prior to the dent stage of growth.  If the petitioner wishes to support
a shorter PHI for field corn forage (or harvest of forage at an earlier
growth stage), then adequate crop field trial data reflecting the
shorter PHI and/or earlier forage harvest must be submitted.

860.1300 Nature of the Residue - Plants

Residue Chemistry Memo DP# 305665, 7/12/05, M. Doherty (PP#4F6827)

The nature of the residue in field corn is adequately understood for the
purposes of this petition based on previously submitted metabolism
studies with grass and wheat.  The major residue identified in these
studies was the parent aminopyralid (free and conjugated).  In the grass
metabolism study, there did not appear to be any significant metabolic
alterations to the basic structure of the parent compound, with the
exception of a minor conjugated metabolite formed by addition of a
hydroxyl group to the parent molecule and found to be present at <1%
total radioactive residues (TRR).  Aminopyralid was rapidly conjugated
to yield a multi-component mixture of water-soluble complexes which
consisted mostly of isomeric mixtures of acid- and base-labile
N-glucosides and glucose ester conjugates of aminopyralid.  In the wheat
metabolism study, the petitioner concluded that the major metabolic
pathway of aminopyralid in wheat proceeded via conjugation of
aminopyralid and hydroxylated aminopyralid with glucose.  The petitioner
further concluded that any metabolites present in wheat which were not
identified were believed to be conjugates of glucose or similar
endogenous compounds, based on the fact that most of the radioactivity
in the wheat samples that was not initially detected as the parent could
be hydrolyzed to aminopyralid.

Based on these studies, HED concluded that the residues of concern in
grass and cereal grain commodities are free and conjugated aminopyralid.
 Additional metabolism data will be required to support uses on
non-grass or non-grain commodities.

860.1300 Nature of the Residue - Livestock

Residue Chemistry Memo DP# 305665, 7/12/05, M. Doherty (PP#4F6827)

The nature of the residue in livestock is adequately understood based on
previously submitted studies with goat and hen.  Although the residues
in the goat and hen studies were too low to allow adequate
characterization/identification of residues, HED concluded that new
studies would not be needed.  The available metabolism data from the
goat, hen, and rat indicate that the majority of the administered
aminopyralid is excreted as unchanged parent in all three species, and
the small amount which is absorbed remains unchanged.  Therefore, the
residue of concern in livestock is aminopyralid.  This finding is
supported by the residues of concern for the related compounds picloram
and clopyralid which, in each case, show parent compound to be the major
residue.

860.1340 Residue Analytical Methods

Crop commodities

DER References:	46729001.der.doc

		47572602.de1.doc

MRID 46729601 (no DER; reviewed herein)

MRID 46729603 (no DER; reviewed herein)

Residue Chemistry Memo DP# 305665, 7/12/05, M. Doherty (PP#4F6827)

Analytical Chemistry Branch Memo DP# 312724, 11/3/05, D. Wright

Enforcement method:  Dow AgroSciences had previously proposed an
LC/MS/MS method, Method GRM 02.31, for the enforcement of tolerances for
aminopyralid residues in grass and wheat commodities.  The method was
adequately validated in barley grain, forage, and straw; grass forage
and hay; sorghum grain, forage, and stover; and wheat grain, forage, and
straw.  Adequate ILV data were submitted for the method using grass
forage and wheat grain, and adequate radiovalidation data were submitted
for the extraction procedures using samples of grass and wheat
commodities bearing incurred residues from the metabolism studies.

Method GRM 02.31 was sent to ACB for review.  It was concluded that the
method was adequate for enforcement purposes and that no laboratory
validation at ACB was needed.  ACB concluded that the method needed
confirmatory procedures.  The single ion transition monitored in the
method is not considered sufficient for positive confirmation of analyte
information.  ACB additionally noted two errors in the analyte peak
response area and quantitation ratio data reported in one of the
representative chromatograms in the independent laboratory validation
study (MRID 46235712).

In review of Method GRM 02.31, HED expressed concern that the proposed
enforcement method might not be able to differentiate between
aminopyralid, picloram, and clopyralid, and requested that the
petitioner complete an interference study using these three compounds.

In response, the petitioner submitted a revised version of Method GRM
02.31 in MRID 46729601.  The revised method includes instructions for
monitoring two additional MS/MS transitions for confirmation of residue
identity.  In addition, the petitioner submitted MRID 46726903, a
revised version of the ILV study, in which the two errors noted by ACB
in the representative chromatogram were corrected.

In addition, Dow AgroSciences submitted the requested interference study
for the derivatization and LC/MS/MS analysis procedures of Method GRM
02.31.  To investigate the potential inference of picloram and
clopyralid in the determination of aminopyralid, the petitioner prepared
analytical standards of picloram and clopyralid, as well as
aminopyralid, and derivatized the standards to form the 1-butyl esters
of the compounds using the procedures of Method GRM 02.31.  The
derivatized compounds were then analyzed by LC/MS/MS.

The analysis of the 1-butyl esters of aminopyralid, clopyralid, and
picloram demonstrated that the three compounds have different retention
times and that there was no interference in the ion transitions.
Therefore, clopyralid and picloram do not interfere in the determination
of aminopyralid residues using Method GRM 02.31.

The petitioner noted that, since the original aminopyralid methods were
developed, minor changes in the LC conditions and MS/MS parameters have
been made to improve the sensitivity and selectivity of the method,
including the addition of two ion transitions to monitor for the
confirmation of aminopyralid residues.  Representative chromatograms
from the analysis of a grass forage sample were provided for the
quantitation ion transition and the two confirmation ion transitions.
The changes in the LC and MS/MS conditions are reflected in the revised
methods that were submitted with this tolerance petition:  Method GRM
07.07 for crop commodities and Method GRM 07.08 for livestock
commodities (see below).

With PP#8F7455, Dow AgroSciences has proposed an LC/MS/MS method, Method
GRM 07.07, for the determination of residues of aminopyralid in crop
commodities (wet, dry, acidic, and oily crops).  The method description
indicates that Method GRM 07.07 supersedes Method 02.31.  The major
differences between the two methods are that Method GRM 02.31 uses a
different internal standard (13C215N-aminopyralid) and only includes
instructions for the determination of residues in barley, sorghum,
wheat, and grass commodities.

Briefly, residues are extracted from homogenized agricultural
commodities using 0.1 N NaOH, which hydrolyzes bound residues and
base-labile conjugates to yield free aminopyralid.  The hydrolysate is
acidified with 2 N HCl.  Oil samples are extracted with acetone and the
extract is evaporated to dryness, redissolved in hexane, and partitioned
into water.  The aqueous phase is mixed with 0.2 N NaOH to hydrolyze
bound residues and base-labile conjugates to yield free aminopyralid,
and then acidified with 3 N HCl.  For both crop samples and oil samples,
the acidified extract is heated at 80°C for 90 minutes, which
hydrolyzes acid-labile conjugates to yield free aminopyralid and further
solubilizes bound residues.  The extract is then purified by
anion-exchange solid phase extraction (SPE), using ethyl
acetate:trifluoroacetic acid (99:1, v:v) to elute residues.  An internal
standard (13C22H15N-aminopyralid) is added to the eluate, which is
evaporated to dryness, reconstituted in acetonitrile:pyridine:1-butanol
(22:2:1, v:v:v; derivatization coupling reagent) and derivatized with
butyl chloroformate to form the 1-butyl esters of the analyte and the
internal standard.  The mixture is diluted with a solution of
methanol:water (40:60, v:v) containing 0.05% formic acid and 5 mM
ammonium formate for LC/MS/MS analysis.  The LOQ and limit of detection
(LOD) are 0.01 and 0.003 ppm, respectively, for aminopyralid in each
tested matrix.

Method GRM 07.07 was adequately validated using samples of untreated wet
crops (broccoli and tomato), dry crops (wheat forage, grain, and straw,
corn forage and grain, and grass forage and straw), acidic crops (lemon
whole fruit and orange peel, pulp, and whole fruit), and oily crops
(palm oil and sunflower seed) fortified with aminopyralid at 0.01 and 2
ppm for all crops other than grass forage and straw, and at 0.01 and 50
ppm for grass forage and straw.  The recovery ranges for these matrices
were 75-102% for wet crops (average ± standard deviation: 86% ± 6.6%),
70-102% for dry crops (86% ± 8.3%), 72-105% for acidic crops (88% ±
7.4%), and 82-106% for oily crops (93% ± 6.5%).

The fortification levels and samples used in method validation are
adequate to bracket expected residue levels.  Although field corn
stover, aspirated grain fractions, and processed commodities were not
included in the validation study, adequate concurrent method recovery
data for these commodities were included with the field corn field trial
and processing studies submitted with this petition.

The method includes instructions for monitoring up to three ion
transitions for aminopyralid; therefore, confirmatory analysis
procedures are not needed.

The method is very similar to the current enforcement method, LC/MS/MS
Method GRM 02.31, for which adequate radiovalidation and independent
laboratory validation data have been submitted.  Because Method GRM
07.07 is considered to be an improvement to Method GRM 02.31, no
independent laboratory validation or validation by ACB is needed.

Data collection method:  Method GRM 07.07 was used for data collection
in samples of corn forage, grain, stover, aspirated grain fractions, and
processed commodities from the crop field trial and processing studies
submitted with this petition.  Overall concurrent method recoveries
ranged 69-90% from forage, 75-97% from grain, 72-94% from stover, and
75-98% from corn processed commodities.  Samples of grass and wheat
commodities from the storage stability study were analyzed using Method
GRM 02.31; overall concurrent method recoveries ranged 71-106%.

Conclusions.  The submitted crop analytical method data are adequate to
satisfy data requirements.  Method GRM 07.07 satisfies all requirements
for an enforcement method for crop commodities.  The method will be
forwarded to the FDA for publication in PAM Vol. II.

The submitted interference study satisfies the data requirements for
this study identified in PP#4F6827 (Memo, D305665, M. Doherty, 7/12/05).

Livestock commodities

DER References:	47572602.de2.doc

MRID 46729602 (no DER; reviewed herein)

Residue Chemistry Memo:  D305665, M. Doherty, 7/12/05 (PP#4F6827)

Analytical Chemistry Branch Memo:  D312724, D. Wright, 11/3/05

Enforcement method:  Dow AgroSciences had previously proposed an
LC/MS/MS method, Method GRM 03.18, for the enforcement of tolerances for
aminopyralid residues in ruminant milk and tissues.  The method was
adequately validated in bovine whole milk, cream, skimmed milk, fat,
kidney, liver, and muscle, and adequate ILV data were submitted for the
method using bovine milk and kidney.  RAB2 concluded that
radiovalidation data were not needed for the method because the
extraction procedures are very similar to those used in the goat
metabolism study.  The method was sent to ACB for review.  It was
concluded that the method was adequate for enforcement purposes and that
no laboratory validation at ACB was needed.  ACB concluded that the
method needed confirmatory procedures.  ACB additionally noted that step
9.3.17 of Method GRM 03.18 referred to Section 7.5.1 of the method,
which does not exist.

In response, the petitioner submitted a revised version of Method GRM
03.18 in MRID 46729602.  The revised method includes instructions for
monitoring two additional MS/MS transitions for confirmation of residue
identity.  In addition, the erroneous reference to Section 7.5.1 was
removed.

In review of Method GRM 03.18, HED expressed concern that the proposed
enforcement method might not be able to differentiate between
aminopyralid, picloram, and clopyralid, and requested that the
petitioner complete an interference study using these three compounds.
The requested inference study for Method GRM 02.31 has been submitted
(see above).  Because the derivatization and LC/MS/MS analysis
procedures of Method GRM 02.31 are the same as those of Method GRM
03.18, the interference study is sufficient to demonstrate that
clopyralid and picloram will not interfere in aminopyralid determination
using Method GRM 03.18.

With PP#8F7455, Dow AgroSciences has proposed LC/MS/MS Method GRM 07.08
for the determination of residues of aminopyralid in cattle and poultry
tissues, milk, and eggs.  The method description indicates that Method
GRM 07.08 supersedes Method GRM 03.18.  The major differences between
the two methods are that Method GRM 03.18 uses a different internal
standard (13C215N-aminopyralid) and only includes instructions for the
determination of residues in bovine commodities (muscle, fat, liver,
kidney, and milk).

Briefly, sodium bicarbonate is added to homogenized livestock
commodities and the mixture is extracted using methanol.  The extract is
purified by anion-exchange SPE, using ethyl acetate:trifluoroacetic acid
(99:1, v:v) to elute residues.  An internal standard
(13C22H15N-aminopyralid) is added to the eluate, which is evaporated to
dryness, reconstituted in acetonitrile:pyridine:1-butanol (22:2:1,
v:v:v; derivatization coupling reagent) and derivatized with butyl
chloroformate to form the 1-butyl esters of the analyte and the internal
standard.  The mixture is diluted with a solution of methanol:water
(40:60, v:v) containing 0.05% formic acid and 5 mM ammonium formate for
LC/MS/MS analysis.  The LOQ and LOD are 0.01 and 0.003 ppm,
respectively, for aminopyralid in each tested matrix.

The method was adequately validated using samples of untreated cattle
milk, kidney, and fat and poultry egg, liver, and muscle fortified with
aminopyralid at 0.01 and 2 ppm.  The recovery ranges for these matrices
were 90-119% for bovine matrices (average of 98% with a standard
deviation of 5.7%) and 82-111% for poultry matrices (average of 95% with
a standard deviation of 5.9%).  The fortification levels and samples
used in method validation are adequate to bracket expected residue
levels.  Radiovalidation data are not needed for Method GRM 07.08 as the
extraction procedures are very similar to those of Method GRM 03.18.

The method includes instructions for monitoring up to three ion
transitions for aminopyralid; therefore, confirmatory analysis
procedures are not needed.

The method is very similar to the current enforcement method, LC/MS/MS
Method GRM 03.18.  Because Method GRM 07.08 is considered to be an
improvement to Method GRM 03.18, no independent laboratory validation or
validation by ACB is needed.

Conclusions.  The submitted livestock analytical method data are
adequate to satisfy data requirements.  Method GRM 07.08 satisfies all
requirements for an enforcement method for livestock commodities.  The
method will be forwarded to FDA for publication in PAM Vol. II.

860.1360 Multiresidue Methods

Residue Chemistry Memo D305665, M. Doherty , 7/12/05

Adequate multiresidue method testing data have been submitted previously
for aminopyralid.  The results of the study indicate that the FDA
multiresidue methods in PAM Vol. I are not suitable for the
determination of aminopyralid.

860.1380 Storage Stability

DER Reference:	46661301.der.doc

Residue Chemistry Memo D305665, M. Doherty , 7/12/05

Dow AgroSciences has submitted the final report of a storage stability
study with aminopyralid on grass forage and hay, and wheat grain and
straw.  An interim report for this study, reflecting storage intervals
of up to ~6 months, was previously reviewed under PP#4F6827.  Samples of
untreated grass forage, grass hay, wheat grain, and wheat straw were
fortified with aminopyralid at 0.1 ppm and stored frozen (~-20ºC).
Storage intervals tested were 0, 28, 130, 187, and 488 days (grass
forage and hay) or 0, 113, 168/175, 273, and 469 days (wheat grain and
straw).

Samples of grass hay and forage, and wheat grain and straw were analyzed
for residues of aminopyralid using LC/MS/MS Method GRM 02.31.  The
method was adequate for data collection based on acceptable concurrent
method recoveries; the reported LOQ was 0.01 ppm for each commodity.

The study results indicate that residues of aminopyralid are stable
during frozen storage for up to ~16 months in/on grass forage and hay,
and for up to ~15 months in/on wheat grain and straw.

The storage durations and conditions of samples from the crop field
trial and processing studies submitted to support this petition are
presented in Table 4.

Table 4.	Summary of Storage Conditions and Durations of Samples from
Field Corn Crop Field Trial and Processing Studies.

Matrix 	Storage Temperature

 (°C)	Actual Storage Duration1	Interval of Demonstrated Storage
Stability

Field corn forage	~-20	435-518 days (14.3-17.0 months)	Residues of
aminopyralid are stable during frozen storage for up to ~16 months in/on
grass forage and hay, and for up to ~15 months in/on wheat grain and
straw.

Field corn grain

375-448 days (12.3-14.7 months)

	Field corn stover

377-448 days (12.4-14.7 months)

	Field corn AGF

350 days (11.5 months)	No storage stability data are available for field
corn processed commodities.

Flour

355 days (11.7 months)

	Grits

384 days (12.6 months)

	Meal

355 days (11.7 months)

	Starch

341 days (11.2 months)

	Refined oil (wet milled)

387 days (12.7 months)

	Refined oil (dry milled)

350 days (11.5 months)

	1  From harvest/collection to extraction for analysis.

Conclusions.  The submitted storage stability study is adequate to
fulfill data requirements for samples of field corn forage, grain, and
stover from the submitted field trial and processing studies.  The data
indicate that no correction for residue decline during storage will be
needed for these commodities.

The data are also adequate to support the storage conditions and
durations of field corn processed commodities from the processing study
submitted to support this petition.  Although a storage stability study
with aminopyralid residues in field corn processed commodities was not
submitted, the available storage stability data for the wheat and grass
commodities will be considered to be adequate to support the field corn
processing study.  The OECD guideline “Stability of Pesticide Residues
in Stored Commodities” (adopted 10/16/2007) states that storage
stability data for processed foods are not needed if residue decline is
not observed across the range of five commodity categories.  In this
case, HED considers the data for grain and grass commodities to be
adequate in light of the minimal metabolism of aminopyralid in living
plants.  Conjugation is the only significant metabolic pathway, and the
resulting conjugates are determined by the analytical method.

The dates of analysis were not provided for the subject field trial and
processing studies.  For future submissions, the petitioner should note
that dates of extraction and analysis should be provided for all
samples.

Submission of the final report of the grass and wheat storage stability
study satisfies the data requirements for storage stability identified
in PP#4F6827 (Memo, D305665, M. Doherty, 7/12/05).  No correction for
residue decline is needed for any of the grass or wheat commodity
samples submitted under PP#4F6827.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

Residue Chemistry Memo:  D305665, M. Doherty, 7/12/05

There are several livestock feedstuffs associated with the registered
and proposed uses of aminopyralid, including AGF (and milled
byproducts); grass forage, grass hay, field corn grain, field corn
forage, field corn stover, wheat grain, wheat forage, wheat hay, and
wheat straw.  The dietary burdens of aminopyralid to livestock, based on
reasonably balanced diets, are presented in Table 5.  The estimated
dietary burdens are 8.7 ppm for beef cattle, 45 ppm for dairy cattle,
0.15 ppm for poultry, and 0.17 ppm for swine.

Table 5.	Calculation of Dietary Burdens of Aminopyralid Residues to
Livestock.

Feedstuff	Type1	% Dry Matter2	% Diet2	Established/

Recommended Tolerance (ppm)	Dietary Contribution (ppm)3

Beef Cattle

Grass hay	R	88	15	50	8.5

Corn, field, grain	CC	88	80	0.20	0.18

PC without registered uses	PC	--	5	--	--

TOTAL BURDEN	--	--	100	--	8.7

Dairy Cattle

Grass, forage	R	25	45	25	45

Corn, field, grain	CC	88	45	0.20	0.10

PC without registered uses	PC	--	10	--	--

TOTAL BURDEN	--	--	100	--	45

Poultry

Corn, field, grain	CC	88	75	0.20	0.15

PC without registered uses	PC	--	25	--	--

TOTAL BURDEN	--	--	100	--	0.15

Swine

Corn, field, grain	CC	88	85	0.20	0.17

PC without registered uses	PC	--	15	--	--

TOTAL BURDEN	--	--	100	--	0.17

1  R:  Roughage; CC:  Carbohydrate concentrate; PC:  Protein
concentrate.

2  OPPTS 860.1000 Table 1 Feedstuffs (June 2008).

3  Contribution = ([tolerance/% DM] X % diet) for beef and dairy cattle;
contribution = ([tolerance] X % diet) for poultry and swine.

Ruminants:  The dietary burdens of aminopyralid to livestock were
previously calculated to be 60 ppm for beef and dairy cattle and 0.075
ppm for swine.  Based on an adequate dairy cattle feeding study,
reflecting dosing of dairy cattle with aminopyralid at levels of 32.8,
64.5, 181.5, or 644.7 ppm in the diet, RAB2 concluded that tolerances
were needed for livestock commodities at 0.03 ppm for milk; 0.02 ppm for
the meat and meat byproducts, excluding kidney, of cattle, goats,
horses, and sheep; 0.02 ppm for the fat of cattle, goats, horses, and
sheep; and 0.30 ppm for the kidney of cattle, goats, horses, and sheep.
It was also concluded that no tolerances were needed for swine
commodities.  Because the re-calculated dietary burdens for beef and
dairy cattle are lower than the previously calculated values, no changes
to the existing tolerances for cattle, goat, horse, and sheep
commodities are needed to support the proposed uses.

The lowest dosing level in the cattle feeding study represents 190x the
maximum theoretical dietary burden to swine.  Aminopyralid residues in
milk and tissues from the lowest dosing level in the cattle feeding
study were ≤0.01 ppm in all commodities except kidney and were 0.10
ppm in kidney.  HED concludes that tolerances for hog commodities are
not needed to support the proposed and registered uses of aminopyralid.

Poultry:  No poultry feeding study with aminopyralid has been submitted.
 RAB2 previously concluded that tolerances for poultry commodities were
not needed based on the results of the poultry metabolism study and the
previously calculated dietary burden of 0.075 ppm.

The poultry metabolism study represented a dosing level of 12 ppm and
TRR were <0.01 ppm in eggs and all poultry tissues at this dosing level.
 The dosing level corresponds to 80x the current dietary burden
aminopyralid to poultry.  Therefore, HED concludes that the proposed and
registered uses of aminopyralid result in a 40 CFR §180.6(a)(3)
situation for poultry commodities; i.e., there is no reasonable
expectation of finite residues in poultry commodities.  No poultry
feeding study is needed to support the subject petition.  If additional
uses of aminopyralid with significant poultry feed items are proposed in
the future, then a poultry feeding study might be required.

860.1500 Crop Field Trials

DER Reference:	47572601.de1.doc (includes review of MRID 47572603)

Dow AgroSciences submitted field trial data for aminopyralid on field
corn.  Twenty field corn trials were conducted in the United States
during the 2006 growing season.  One trial each was performed in Zones 1
(PA), 2 (GA), and 6 (TX).  Seventeen trials were performed in Zone 5 (IA
(3), IL (3), IN (1), MI (1), MN (2), MO (1), ND (2), NE (2), OH (1), and
WI (1)).

Each treated plot received a single foliar application of an SL
formulation containing the TIPA salt of aminopyralid at 2 lb ae/gal.
Applications were made at the 4- to 6-leaf growth stage (BBCH 14-16 or
V4-V6).  There were two treated plots at each location.  One treated
plot received an application at ~0.031 lb ae/A (~1x the proposed maximum
seasonal rate) and the other plot received an application at ~0.062 lb
ae/A (~2x).  Applications were made in ~15-24 gal/A spray volumes, using
ground equipment.  A non-ionic surfactant was added to the spray mixture
at ~0.25% (v/v).  Field corn commodities were harvested at normal
harvest times.  Forage was harvested at the dent stage, at a 60- to
87-day preharvest interval (PHI), and grain and stover were harvested at
maturity, at a 105- to 138-day PHI.  In addition, to evaluate residue
decline, forage samples were harvested at the Wisconsin trial and at one
of the Illinois trials at 0-, 7-, 13- to 14-, 21-, and 28-day PHIs.

Samples of field corn forage, grain, and stover were analyzed for
residues of aminopyralid using LC/MS/MS Method GRM 07.07.  The validated
LOQ was 0.01 ppm for each matrix.  The method was adequate for data
collection based on acceptable concurrent method recovery data.

Sample storage conditions and durations are reported in Table 4.
Adequate storage stability data are available to support the storage
conditions and durations of samples from the submitted field corn study.

A summary of the study results is presented in Table 6.  Following
foliar application of the 2 lb ae/gal SL formulation at approximately a
1x application rate (0.030-0.034 lb ae/A), maximum residues of
aminopyralid were 0.262 ppm in/on forage (60- to 87-day PHI), 0.164 ppm
in/on grain (105- to 138-day PHI), and 0.176 ppm in/on stover (105- to
138-day PHI).  Following foliar application at approximately a 2x
application rate (0.060-0.069 lb ae/A), maximum residues of aminopyralid
were 0.293 ppm in/on forage, 0.212 ppm in/on grain, and 0.387 ppm in/on
stover.

In the four forage residue decline trials, average residues of
aminopyralid decreased from the 0-day to either the 14-day PHI or 21-day
PHI and then generally did not decrease further (from the 14- or 21-day
PHI to harvest at 66 or 72 days posttreatment).

Table 6.	Summary of Residue Data from Crop Field Trials with
Aminopyralid.

Crop matrix	PHI (days)	Total Applic. Rate

 (lb ai/A)	Residue Levels (ppm)

	n	Min.	Max.	HAFT1	Median	Mean	Std. Dev.

FIELD CORN

(proposed use = 0.027 lb ai/A total application rate, 0-day PHI for
grain and 8-day for forage and silage)

Field corn forage	60-87	0.030-0.034	40	<0.01	0.262	0.226	0.041	0.059
0.053

0.060-0.069	39	0.018	0.293	0.240	0.083	0.105	0.069

Field corn grain	105-138	0.030-0.034	40	<0.01	0.164	0.155	0.090	0.036
0.032

0.060-0.069	40	<0.01	0.212	0.209	0.049	0.060	0.048

Field corn stover	105-138	0.030-0.034	40	<0.01	0.176	0.153	0.032	0.048
0.041

0.060-0.069	40	0.020	0.387	0.360	0.059	0.084	0.077

1  HAFT = Highest average field trial result.

Conclusions.  The submitted field corn crop field trial data are
adequate to fulfill data requirements provided the proposed use is
amended as requested under 860.1200.  The number and locations of the
corn field trials are in accordance with those specified in OPPTS
Guideline 860.1500 for use on field corn.  Field trials were conducted
at ~1x the proposed maximum seasonal rate, and application was made at
the growth stage specified on the proposed label.  However, it should be
noted that the proposed PHIs of 0 days for grain and 8 days for forage
and silage are not supported.

The available data support the proposed tolerances of 0.30 ppm for field
corn forage, 0.20 ppm for field corn grain, and 0.20 ppm for field corn
stover.  Refer to Appendix I for the tolerance calculation.

Residue data for field corn aspirated grain fractions were submitted and
are discussed below with the field corn processing data.

860.1520 Processed Food and Feed

DER Reference:	47572601.de2.doc (includes review of MRID 47572604)

Dow AgroSciences submitted a processing study for aminopyralid on field
corn.  During the 2006 growing season, a single field corn trial was
conducted in the United States in Zone 5 (Illinois).  A single foliar
broadcast application of an SL formulation containing the TIPA salt of
aminopyralid at 2 lb ae/gal was made to field corn at the BBCH 14-15
growth stage at 0.060 lb ae/A (~2x the proposed maximum seasonal rate).
The application was made using ground equipment in a 17.4 gal/A spray
volume and a non-ionic surfactant was added to the spray mixture.  A
single bulk sample of field corn grain was harvested at a 138-day PHI,
and processed using simulated commercial procedures into aspirated grain
fractions (AGF), as well as flour, grits, meal, and refined oil (dry
milling), and starch and refined oil (wet milling).

Samples of field corn grain raw agricultural commodity (RAC) and
processed fractions were analyzed for residues of aminopyralid using
LC/MS/MS Method GRM 07.07.  The validated LOQ was 0.01 ppm for each
matrix.  The method was adequate for data collection based on acceptable
concurrent method recovery data.

Sample storage conditions and durations are reported in Table 4.
Adequate storage stability data are available to support the storage
conditions and durations of samples of field corn grain and processed
commodities from the processing study.

Residues of aminopyralid were 0.0787 ppm in field corn grain (RAC)
harvested 138 days after a single foliar application of aminopyralid at
0.060 lb ae/A.  Residues of aminopyralid were 0.0270 ppm in AGF, 0.0747
ppm in flour, 0.0886 ppm in grits, 0.1019 ppm in meal, and <0.01 ppm in
starch and wet and dry milled refined oil.  The processing factors for
field corn processed commodities are presented in Table 7.  Residues of
aminopyralid did not concentrate in corn AGF (0.3x), flour (0.9x),
starch (<0.1x), or refined oil (<0.04x for both wet and dry milled), but
concentrated slightly in corn grits (1.1x) and meal (1.3x).

The observed processing factors are below the maximum theoretical
concentration factor of 25x for corn (OPPTS 860.1520, Table 1).

  SEQ CHAPTER \h \r 1 Table 7.	Summary of Processing Factors for
Aminopyralid.

RAC	Processed Commodity	Processing Factor

Field corn, grain	Aspirated grain fractions	0.3x

	Flour	0.9x

	Grits	1.1x

	Meal	1.3x

	Refined oil (dry milling)	<0.04x

	Refined oil (wet milling)	<0.04x

	Starch	<0.1x

Conclusions.  The submitted processing data are adequate to satisfy data
requirements.

The processing data indicate that no tolerances are needed for field
corn flour, starch, or refined oil, and that no change in the existing
tolerance for aspirated grain fractions, at 0.20 ppm, is needed as a
result of the proposed uses on field corn.

The processing data indicate that aminopyralid residues might
concentrate in field corn grits and meal.  Based on the HAFT residues
for aminopyralid in/on field corn grain (0.155 ppm), and the processing
factors, expected residues of aminopyralid in corn grits and meal
following treatment at 1x would be 0.17 and 0.20 ppm, respectively.
Because these values are not greater than the proposed tolerance of 0.20
ppm for field corn grain, no tolerances are needed for grits and meal.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

An analytical standard for aminopyralid is currently available in the
EPA National Pesticide Standards Repository, with an expiration date of
8/28/2010 (electronic communication, Dallas Wright (ACB) to D. Dotson,
9/15/2009).

860.1850 Confined and Field Accumulation in Rotational Crops

Residue Chemistry Memo:  D305665, M. Doherty, 7/12/05 (PP#4F6827)

umulated at ≥0.01 ppm in 90- and 120-day PBI early sorghum forage
(0.027 ppm and 0.017 ppm, respectively), 90-day PBI sorghum stover
(0.027 ppm), and 120-day PBI mature turnip tops (0.010 ppm); residues in
all other rotational crop commodities ranged <0.001-0.007 ppm.  TRR were
generally found to decrease from the 90-day PBI to the 120-day PBI.
Total identified residues ranged from 17 to 44% TRR in sorghum early
forage and stover as well as in turnip tops, and consisted entirely of
free aminopyralid.  Residue profiles were similar between the matrices.
Aminopyralid was found at 0.012 ppm in 90-day PBI sorghum early forage,
0.005 ppm in 120-day PBI sorghum early forage, 0.005 ppm in 90-day PBI
sorghum stover, and 0.002 ppm in 120-day PBI turnip tops.  In PP#4F6827,
HED concluded that the residues of concern in rotational crop
commodities are the same as for primary crop commodities, free and
conjugated aminopyralid.  HED further concluded that there is potential
for quantifiable residues of aminopyralid in rotated cereal grain forage
at a 3-month PBI.  No field rotational crop study was submitted.  It was
concluded that the available rotational crop data support a 0-day
plantback interval for wheat and a 4-month plant-back interval for
barley, canola, flax, grasses, field corn, grain sorghum, oats, mustard,
popcorn, and sweet corn (the requested rotated crops in PP#4F6827).

With the proposed use on field corn, the maximum seasonal rate to annual
crops has increased from 0.009 lb ai/A to 0.027 lb ai/A.  The available
rotational crop data reflect application at a rate of 0.3x the proposed
maximum seasonal rate.  Because the identified residues in the confined
rotational crop study consisted solely of free and conjugated
aminopyralid, a new confined rotational crop study (conducted at 0.027
lb ai/A) will not be required to support the proposed use.  Although the
available confined data indicate that quantifiable residues of
aminopyralid could occur in grasses and cereal grain foliage with a PBI
of 4 months, the only crops with requested PBIs of less than one year
(i.e., wheat, grasses, and field corn) will be treated as primary crops
and will have tolerances.  Therefore, the petitioner does not need to
submit a limited field rotational crop study for aminopyralid reflecting
a PBI of 4 months.  HED considers the rotation intervals listed on the
supplemental label for field corn to be adequate.  The supplemental
label specifies that wheat may be planted at any time after harvest.
Grasses and field corn may be planted at a 4-month plantback interval.
Barley, canola (rapeseed), flax, grain sorghum, mustard, oats, sweet
corn, and popcorn may be planted at a 12-month plantback interval.  The
crop rotational interval for all other crops not listed on the label is
24 months.

860.1550 Proposed Tolerances

DowAgroSciences has proposed tolerances for residues of aminopyralid
(2-pyridine carboxylic acid, 4-amino-3,6-dichloro-), expressed as total
parent, free and conjugated, in/on field corn commodities.  The proposed
tolerances are listed in Table 8.

HED recommends that 40CFR §180.610(a)(1) be amended by replacing the
tolerance expression with the following:  “Tolerances are established
for residues of aminopyalid (4-amino-3,6-dichloro-2-pyridinecarboxylic
acid), including its metabolites and degradates, in or on the
commodities in the table below.  Compliance with the tolerance levels
specified below is to be determined by measuring only free and
conjugated aminopyralid.”  HED further recommends that 40CFR
§180.610(a)(2) be amended by replacing the tolerance expression with
the following:  “Tolerances are established for residues of
aminopyralid, including its metabolites and degradates, in or on the
commodities in the table below.  Compliance with the tolerance levels
specified below is to be determined by measuring only aminopyralid.”

Codex and Canadian MRLs have been established for residues of
aminopyralid; however, no MRLs have been established for the requested
crop commodities.  No Mexican MRLs have been established for
aminopyralid.

Adequate field trial data have been submitted for field corn.  The
Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data was used for determining appropriate tolerance levels for
field corn raw agricultural crop commodities.  See Appendix I for
tolerance calculations.  The available data will support the proposed
tolerances of 0.30 ppm for field corn forage, 0.20 ppm for field corn
grain, and 0.20 ppm for field corn stover.

The field corn processing study is adequate.  It indicates that no
tolerances are required for field corn flour, grits, meal, refined oil,
or starch, and that no change in the existing tolerance for aspirated
grain fractions, at 0.20 ppm, is needed as a result of the proposed uses
on field corn.

No changes to the existing tolerances for livestock commodities are
needed as a result of the proposed uses.

The proposed tolerances should be revised to reflect the correct
commodity definitions as specified in Table 8.

Table 8. 	Tolerance Summary for Aminopyralid.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;
Correct Commodity Definition

Corn, forage	0.30	0.30	Corn, field, forage

Corn, grain	0.20	0.20	Corn, field, grain

Corn, stover	0.20	0.20	Corn, field, stover

References

D305665, Aminopyralid.  Petition for the Establishment of Permanent
Tolerances for Use of Aminopyralid on Grasses and Wheat.  Summary of
Analytical Chemistry and Residue Data.  PP#4F6827, M. Doherty, 7/12/05,
MRIDs:  46235708-46235712, 46235714, 46235716-46235719,
46235721-46235725

D312724, PP# 4F6827.  Review of Method for the Establishment of
Permanent Tolerances in Aminopyralid in/on Plant and Livestock
Commodities.  ACL Project #:B05-12, D. Wright, 11/3/05, MRIDs:
46235712, 46235714, 46235716, 46235717

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:  4-amino-3,6-dichloro-2-pyridinecarboxylic acid	Common
Name:

Aminopyralid	X Proposed tolerance

( Reevaluated tolerance

( Other	Date:  5/8/09

Codex Status (Maximum Residue Limits)	U. S. Tolerances

( No Codex proposal step 6 or above

X No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#8F7455

DP#: 360100

Other Identifier:  Decision # 401475

Residue definition (step 8/CXL): aminopyralid and its conjugates that
can be hydrolysed, expressed as aminopyralid	Reviewer/Branch:  D.
Dotson/C.Swartz/RAB1

	Residue definition:  Aminopyralid, free and conjugated residues

Crop (s)	MRL (mg/kg)	Crop(s) 	Tolerance (ppm)

Corn, forage	0.30

Corn, grain	0.20

Corn, stover	0.20

Limits for Canada	Limits for Mexico

(No Limits

X No Limits for the crops requested	X No Limits

( No Limits for the crops requested

Residue definition:  4-amino-3,6-dichloro-2-pyridinecarboxylic acid
(free and conjugated)	Residue definition:  N/A

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	Notes/Special Instructions:  S.Funk, 05/13/2009.

Appendix I.  Tolerance Assessment Calculations.

For the field corn commodities listed below, the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data (SOP), along with the
tolerance spreadsheet (January 2008 version), was used for calculating
recommended tolerances.  As specified in the SOP, the minimum of the 95%
upper confidence limit (UCL) on the 95th percentile and the point
estimate of the 99th percentile was selected as the tolerance value
because the datasets were large (40 samples each) and reasonably
lognormal.  The rounding procedures specified in the SOP were also used.

The datasets used to establish tolerances for aminopyralid on field corn
forage, grain, and stover consisted of field trial data representing
application rates of 0.03-0.034 lb ae/A (single application) with a 60-
to 87-day PHI for forage and a 105- to 138-day PHI for grain and stover.
 The field trial application rates are within 25% of the maximum label
application rate; however, the PHIs are much greater than the proposed
PHIs of 0 days for grain and 8 days for forage and silage.  No residue
data were submitted for field corn commodities reflecting the proposed
PHIs.  The residue values that were entered into the tolerance
spreadsheet are provided in Table I-1.

For forage and stover, 39 out of 40 field trial sample results for
aminopyralid were above the LOQ (LOQ = 0.01 ppm), and for field corn
grain, 35 out of 40 field trial results were above the LOQ.  Visual
inspection of the lognormal probability plot (Figures I-1, I-3, and I-5)
and the results from the approximate Shapiro-Francia test statistic
(Figures I-2, I-4, and I-6) indicated that the datasets were reasonably
lognormal.

Using the tolerance spreadsheet, the recommended tolerances are 0.25 ppm
for field corn forage, 0.15 ppm for field corn grain, and 0.20 ppm for
field corn stover.  However, for both forage and grain, the recommended
tolerances are slightly less than the highest residue value observed in
the field trials, of 0.262 ppm and 0.164 ppm, respectively.  Therefore,
HED recommends in favor of tolerances of 0.30 ppm for field corn forage
and 0.20 ppm for field corn grain.

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0.056	0.021	0.060

	0.016	0.031	0.011

	0.012	<0.01	0.011

	0.045	0.035	0.046

	0.042	0.020	0.046

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Figure I-1.  Lognormal probability plot of aminopyralid field trial data
for field corn forage.

Figure I-2.  Tolerance spreadsheet summary of aminopyralid field trial
data for field corn forage.

Figure I-3.  Lognormal probability plot of aminopyralid field trial
data for field corn grain.

Figure I-4.  Tolerance spreadsheet summary of aminopyralid field trial
data for field corn grain.

Figure I-5.  Lognormal probability plot of aminopyralid field trial data
for field corn stover.

Figure I-6.  Tolerance spreadsheet summary of aminopyralid field trial
data for field corn stover.

Page   PAGE  1  of   NUMPAGES  28

Aminopyralid	Summary of Analytical Chemistry and Residue Data	DP#:
360100