[Federal Register: December 31, 2009 (Volume 74, Number 250)]
[Rules and Regulations]
[Page 69260-69262]
[DOCID:fr31de09-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1211; Directorate Identifier 2009-NM-121-AD;
Amendment 39-16149; AD 2009-26-10]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A380-841, -842, and -861
Airplanes

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

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    As a result of the Movable Flap Track Fairing (MFTF) 6
crack findings (ref. AD 2008-0216), a detailed review has been
launched for all MFTF 2 to 6. This investigation
has revealed some cracking at MFTF 4 pivot support-ring.
    This condition, if not corrected, could lead to in-flight loss
of MFTF 4, potentially resulting in injuries to persons on
the ground.
* * * * *
This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective January 15, 2010.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of January 15,
2010.
    We must receive comments on this AD by February 16, 2010.

ADDRESSES: You may send comments 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 W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
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 Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1175; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2009-0113, dated May 27, 2009 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    As a result of the Movable Flap Track Fairing (MFTF) 6
crack findings (ref. AD 2008-0216), a detailed review has been
launched for all MFTF 2 to 6. This investigation
has revealed some cracking at MFTF 4 pivot support-ring.
    This condition, if not corrected, could lead to in-flight loss
of MFTF 4, potentially resulting in injuries to persons on
the ground.
    To prevent the risk of a MFTF 4 detachment, this AD
requires an inspection programme and/or replacement of the fairings
in order to ensure they are removed from service before any crack
becomes critical.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued Mandatory Service Bulletin A380-57-8016, dated
May 11, 2009. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This 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 the same
type design.
    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Register in the future.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product,
notice and opportunity for public comment before issuing this AD 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-2009-1211; Directorate
Identifier 2009-NM-121-

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.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this 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 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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 adding the following new AD:

2009-26-10 AIRBUS: Amendment 39-16149. Docket No. FAA-2009-1211;
Directorate Identifier 2009-NM-121-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective January
15, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A380-841, -842, and -861
airplanes; certificated in any category; all serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Reason

    (e) The mandatory continued airworthiness information (MCAI)
states:

    As a result of the Movable Flap Track Fairing (MFTF) 6
crack findings (ref. AD 2008-0216), a detailed review has been
launched for all MFTF 2 to 6. This investigation
has revealed some cracking at MFTF 4 pivot support ring.
    This condition, if not corrected, could lead to in-flight loss
of MFTF 4, potentially resulting in injuries to persons on
the ground.
    To prevent the risk of a MFTF 4 detachment, this AD
requires an inspection programme and/or replacement of the fairings
in order to ensure they are removed from service before any crack
becomes critical.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) At the applicable time specified in paragraphs (f)(1)(i) and
(f)(2)(ii) of this AD: Do special detailed (ultrasonic and high
frequency eddy current) inspections on the  4 left-hand and
right-hand movable flap track fairing (MFTF) for cracks of the filet
radii of the pivot bracket support rings and the monolithic carbon
fibre reinforced plastic (CFRP) structure in the pivot support area,
in accordance with the Accomplishment Instructions of Airbus
Mandatory Service Bulletin A380-57-8016, dated May 11, 2009.
    (i) For Airbus Model A380-841 and -842 airplanes, do the actions
before the accumulation of 600 flight cycles on the 4 MFTF
on an airplane, or within 60 flight cycles after the effective date
of this AD, whichever occurs later.
    (ii) For Airbus Model A380-861 airplanes, do the actions before
the accumulation of 300 flight cycles on the 4 MFTF on an
airplane, or within 30 flight cycles after the effective date of
this AD, whichever occurs later.
    (2) If no crack is found during any inspection required by
paragraph (f)(1) of this AD, repeat the inspections at the
applicable time specified in paragraph (f)(2)(i) or (f)(2)(ii) of
this AD; except as provided by paragraph (f)(4) of this AD.
    (i) For Model A380-841 and -842 airplanes: At intervals not to
exceed 60 flight cycles.
    (ii) For Model A380-861 airplanes: At intervals not to exceed 30
flight cycles.
    (3) If any crack is found during any inspection required by
paragraph (f)(1) of this AD, before further flight, replace the
4 MFTF with a new or serviceable 4 MFTF, in
accordance with the Accomplishment Instructions of Airbus Mandatory
Service Bulletin A380-57-8016, dated May 11, 2009. Do the
inspections required by paragraph (f)(1) of this AD at the
applicable time specified in paragraph (f)(1) of this AD.
    (4) Replacing any 4 MFTF extends the interval for the
next inspections to the applicable time specified in paragraph
(f)(1) of this AD.
    (5) After the first 4 MFTF is replaced as required by
this AD, submit a one-time report to Wera Dietz, Senior Retrofit
Manager, AIRBUS Customer Services--SEOT2, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 561 933 333;
Fax +33 561 932 745; e-mail<EMAIL_ADDRESS>at the applicable
times specified in paragraph (f)(5)(i) and (f)(5)(ii) of this AD.
The report must include the serial number of the removed 4
MFTF, the associated airplane manufacturer serial number, and the
number of flight cycles accumulated by the 4 MFTF at the
time of replacement.
    (i) If the replacement was done on or after the effective date
of this AD: Submit the report within 30 days after the inspection.
    (ii) If the replacement was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.

FAA AD Differences

    Note 1:
    This AD differs from the MCAI and/or service information as
follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Todd Thompson, Aerospace Engineer,
International Branch,

ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
227-1149. Before using any approved AMOC on any airplane to which
the AMOC applies, notify your principal maintenance inspector (PMI)
or principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0113, dated May 27, 2009; and Airbus Mandatory
Service Bulletin A380-57-8016, dated May 11, 2009; for related
information.

Material Incorporated by Reference

    (i) You must use Airbus Mandatory Service Bulletin A380-57-8016,
dated May 11, 2009, to do the actions required by this AD, unless
the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus SAS--EANA (Airworthiness Office); 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 562 110 253;
Fax +33 562 110 307; e-mail<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the 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/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington on December 16, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-30700 Filed 12-30-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: October 24, 2006 (Volume 71, Number 205)]
[Proposed Rules]
[Page 62227-62229]
[DOCID:fr24oc06-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 49 and 51

[EPA-HQ-OAR-2003-0076; FRL-8233-3]
RIN 2060-AH37

Review of New Sources and Modifications in Indian Country

AGENCY: Environmental Protection Agency (EPA).

ACTION: Announcement of extension of comment period.

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SUMMARY: The EPA is announcing an extension of the public comment
period on our proposed Review of New Sources and Modification in Indian
Country Federal Implementation Plan (FIP) (August 21, 2006). The
proposed FIP changes would include two basic air quality regulations
for the protection of communities in Indian country. The first rule
would apply to minor stationary sources and minor modifications at
major stationary sources in Indian country (minor New Source Review
(NSR) rule). The second rule would apply to all new major stationary
sources and major modifications located in areas of Indian country that
are designated as not attaining the National Ambient Air Quality
Standards (NAAQS)

(nonattainment major NSR rule). These rules would be implemented by
EPA, or a delegate tribal agency assisting EPA with administration of
the rules, until replaced by an EPA-approved tribal implementation plan
for an area of Indian country. The EPA is extending the public comment
period from November 20, 2006 to January 19, 2007. The EPA is extending
the public comment period by 60 days because of the number of requests
we received in a timely manner.

DATES: Comments. Comments must be received on or before January 19,
2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2003-0076, by one of the following methods:
     http://www.regulations.gov. Follow the online instructions

for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Attention Docket ID No. EPA-HQ-OAR-2003-0076, U.S.
Environmental Protection Agency, EPA West (Air Docket), 1200
Pennsylvania Avenue, Northwest, Mailcode: 6102T, Washington, DC 20460.
Please include a total of 2 copies. In addition, please mail a copy of
your comments on the information collection provisions to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC
20503.
     Hand Delivery: U.S. Environmental Protection Agency, EPA
West (Air Docket), 1301 Constitution Avenue, Northwest, Room B-102,
Washington, DC 20004, Attention Docket ID No. EPA-HQ-OAR-2003-0076.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2003-0076. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional instructions on submitting
comments, go to the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental

Protection Agency, Air Docket, EPA/DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the Air Docket is (202) 566-
1742.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
http://www.epa.gov/epahome/dockets.htm for current information on

docket operations, locations and telephone numbers. The Docket
Center's mailing address for U.S. mail and the procedure for
submitting comments to http://www.regulations.gov are not affected

by the flooding and will remain the same.

FOR FURTHER INFORMATION CONTACT: For technical information, contact
Jessica Montanez, Air Quality Policy Division, U.S. EPA, Office of Air
Quality Planning and Standards (C504-03), Research Triangle Park, North
Carolina 27711, telephone number<PHONE_NUMBER>, facsimile number (919)
541-5509, electronic mail e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI
    Do not submit this information to EPA through http://www.regulations.gov
 or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. Send or deliver information
identified as CBI only to the following address: Roberto Morales, OAQPS
Document Control Officer (C404-02), U.S. EPA, Research Triangle Park,
NC 27711, Attention Docket ID No. EPA-HQ-OAR-2003-0076.
2. Tips for Preparing Your Comments
    When submitting comments, remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.

     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

B. Where Can I Get a Copy of This Document and Other Related
Information?

    In addition to being available in the docket, an electronic copy of
this proposal will also be available on the http://WWW. Following signature by

the EPA Administrator, a copy of this notice will be posted in the
regulations and standards section of our NSR home page located at
http://www.epa.gov/nsr and on the tribal air home page at http://www
.epa.gov/oar/tribal.

    Dated: October 12, 2006.
Jeffrey S. Clark,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. E6-17809 Filed 10-23-06; 8:45 am]

BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF

	PREVENTION, PESTICIDES, AND

	TOXIC SUBSTANCES

MEMORANDUM

Date:		07/25/2007

Subject:	Bifenthrin (Chemical No. 128825).  PP#6E7125, PP#6E7126,
PP#6E7127, PP#6E7128; Section 3 Registration for Application of
Bifenthrin to Mayhaw, Root Vegetables, (Except Sugar Beets, Crop
Subgroup 1B), Peanut, Pistachio, Soybean, and Fruiting Vegetables (Crop
Group 8).  Summary of Residue Chemistry Data.

Petition Nos.	6E7125, 6E7126, 6E7127, 6E7128	Decision No:	371452,
371451, 371450, 371449

DP Number:	335693, 335688, 335696, 335695	40 CFR:	§180.442

Chemical No.:	128825	Class:	Synthetic Pyrethroid

Trade Name:	Capture 2EC, Capture 1.15G, Brigade WSB	EPA Reg. No.:
279-3069; 279-3244; 279-3108

MRIDs:	46960801, 4691102, 46961103, 46961101, 46960401, 46960402,
46960403, 46960404,

46098701

From:		William D. Wassell, Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED, 7509P)

Through:	George F. Kramer, Ph.D., Senior Chemist

			RAB1/HED (7509P)

To:			Daniel Rosenblatt/Shaja Brothers (RM 05)

Registration Division (7505P)

The Interregional Research Project Number 4 (IR-4) has submitted
requests for Section 3 registrations for the application of bifenthrin
to mayhaw, root vegetables, (except sugar beets, crop subgroup 1b),
peanut, pistachio, soybean, and fruiting vegetables (crop group 8).  In
conjunction with this request, the petitioner has proposed the
establishment of tolerances for bifenthrin
[(2-methyl[1,1′-biphenyl]-3-yl)methyl
(1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-dimethylcyc
lopropanecarboxylate] in/on:

Mayhaw	1.4 ppm

Vegetable, root, except sugar beet and garden beet, subgroup 1B	0.07 ppm

Beet, garden, root	0.45 ppm

Beet, garden, top	15 ppm

Radish, top	4.5 ppm

Soybean	0.2 ppm

Soybean, hulls	0.7 ppm

Soybean, refined oil	0.4 ppm

Vegetable, fruiting, group 8	0.5 ppm

Peanut	0.05 ppm

Pistachio	0.05 ppm

Executive Summary

Background:  Bifenthrin is a broad-spectrum, non-systemic
insecticide/miticide in the class of synthetic pyrethroids.  It is
registered to FMC Corporation for use as foliar applications on a
variety of field, fruit, and vegetable crops.  Additionally, tolerances
are established for residues of bifenthrin per se in or on a variety of
fruits and vegetables (40 CFR §180.442).  Specifically tolerances for
residues of bifenthrin per se are established for the tree nut crop
group (group 14) at 0.05 ppm, bell and non-bell peppers at 0.5 ppm,
tomato at 0.15 ppm, and eggplant at 0.05 ppm. Bifenthrin is formulated
for use on crops as a 2.0 lb/gal emulsifiable concentrate (Capture 2EC;
EPA Reg. No. 279-3069), a 1.15% granule (Capture 1.15G; EPA Reg. No.
279-3244), and a 10% (by weight) wettable-powder formulation in
water-soluble bags (Brigade WSB, EPA Reg. No. 279-3108).

Application Scenarios:  The petitioner has proposed the use of Brigade
WSB, Capture 2EC, and/or Capture 1.15G for use on mayhaw, root
vegetables, (except sugar beets, crop subgroup 1b), peanut, pistachio,
soybean, and fruiting vegetables (crop group 8).  The proposed label
indicates that application through irrigation equipment is prohibited
and does not include rotational crop restrictions.  Table 3 is a summary
of the proposed application scenarios.

The submitted labels adequately describe the proposed application
scenarios.  Based on the current rotational crop data, HED concludes
that a 30-day rotational crop restriction is appropriate for all
non-labeled crops (labeled crops may be planted at anytime; see section
OPPTS 860.1850).  A revised Section B is required.

Nature of the Residue – Plants & Livestock:  Based on the
previously-submitted cotton, corn, apple, potato, hen, and goat
metabolism data, the nature of bifenthrin residues in plants and
livestock is understood.  The residues of concern are bifenthrin per se
in primary, rotated crop commodities and livestock tissues.

Analytical Enforcement Method – Plant & Livestock Commodities:
Several methods are available for enforcement of tolerances for
bifenthrin residues in plant and livestock commodities.  FMC Methods
P-1031, P-2550 M, and RAN-0140 are gas chromatography
(GC)/electron-capture detector (ECD) methods that are available for
determination of residues in milk and tissues, corn commodities, and
cottonseed, respectively.  In addition, GC/ECD methods P-1843M and
RAN-0204M are available for determination of bifenthrin residues in
poultry tissues and eggs, respectively.  The Tolerance Reassessment
Eligibility Decision (TRED) for bifenthrin states that adequate GC/ECD
methods are available for enforcement purposes.

Crop field trial samples were analyzed for residues of bifenthrin using
FMC Methods P-2132 (mayhaw, radish, garden beet), PC-0130 (peanut
commodities) and P-3457 (soybean commodities) which are modifications of
the tolerance enforcement methods.  The reported limit of quantification
(LOQ) for these methods is 0.05 ppm.  In some cases, sample extracts
were analyzed by gas chromatography/mass- selective detector (GC/MSD)
instead of with GC/ECD.  Adequate concurrent method recovery data have
been submitted for these methods.

Magnitude of the Residue - Plants:  The field trials with bifenthrin on
mayhaw, radish, garden beet, carrot, peanut, and soybeans are   SEQ
CHAPTER \h \r 1 adequate.  An adequate number of trials were conducted
reflecting the proposed use patterns in the appropriate geographic
regions, and the appropriate commodities were collected at the proposed
pre-harvest intervals (PHIs).  Samples were analyzed using adequate
analytical methods, and the sample storage intervals are supported by
the available storage stability data.  Tolerance levels for residues
in/on mayhaw, root vegetables (subgroup 1B), radish tops, garden beets
were determined using the NAFTA MRL/Tolerance Harmonization Spreadsheet.

Although tolerances are proposed for bifenthrin per se in/on pistachios
at 0.05 ppm and the fruiting vegetables crop group (group 14) at 0.5
ppm, residue data for these crops were not included in the current
submissions.  A tolerance is established for residues of bifenthrin per
se in/on the tree nut crop group (group 14) at 0.05 ppm.  For
pistachios, HED policy is to translate data and tolerances from almonds
to pistachios (Reviewer’s Guide & Summary of HED ChemSAC Approvals for
Amending Crop Group/Subgroups [40 CFR §180.41] & Commodity Definitions
[40 CFR 180.1(h)], 6/14/2006, B Schneider).  Thus, a tolerance for
residues of bifenthrin per se should be established in/on pistachios at
0.05 ppm.  For fruiting vegetables, tolerances are established for
residues of bifenthrin per se at 0.05 ppm in/on eggplant, at 0.15 ppm
in/on tomato, and at 0.5 ppm in/on bell and non-bell pepper.  HED has
determined that a fruiting vegetables crop group tolerance for residues
bifenthrin per se is not appropriate for the following reasons:  maximum
residues in eggplants are more than a factor of five lower than the
tolerance for tomatoes and the use pattern for tomato and tomatillo are
different from the other members of the crop group in terms of the PHI,
maximum seasonal use rate, number of applications, and interval between
applications.  However, HED could recommend for tolerances for residues
in/on groundcherry and pepino at 0.50 ppm.  A revised Section F would be
required.  As 40 CFR §180.1 indicates that a tolerance for residues
in/on tomato applies to tomatillo, a tolerance for residues in/on
tomatillo is not required.

Mayhaw:  Residues of bifenthrin ranged from 0.24 to 0.78 ppm in/on
mayhaw harvested 28 to 29 days following two broadcast foliar
applications of Capture 2EC for a total rate of approximately 0.2 pounds
active ingredient per acre (lb ai/A).  HED concludes a tolerance for
residues of bifenthrin per se in/on mayhaw at 1.4 ppm is appropriate.

Radish:  Residues of bifenthrin ranged from <0.05 to 0.07 ppm in radish
roots and ranged from 0.56 to 2.26 ppm in radish tops harvested 6 to 8
days following an in-furrow application of Capture 1.15G at planting and
two broadcast foliar applications of Capture 2EC for a total foliar rate
of approximately 0.20 lb ai/A.  Based upon the submitted data, HED
concludes a tolerance for residues of bifenthrin per se in/on radish
tops at 4.5 ppm is appropriate.  For radish roots, see the discussion
below concerning the tolerances for residues in/on subgroup 1B.

Garden Beet:  Residues of bifenthrin ranged from <0.05 ppm to 0.28 ppm
in garden beet roots and ranged from 4.8 ppm to 12.2 ppm in garden beet
tops harvested 1 day following four broadcast foliar applications of
Capture 2EC for a total rate of approximately 0.40 lb ai/A.  Based upon
the submitted data, HED concludes tolerances for residues of bifenthrin
per se in/on garden beet tops and roots at 15 ppm and 0.45 ppm,
respectively, are appropriate.

Carrot:  Residues of bifenthrin were less than the method LOQ (<0.05
ppm) in/on carrots harvested 7, 14, and 20 to 22 days following a three
broadcast foliar applications of Capture 2EC for a total rate of 0.49 to
0.51 lb ai/A.

Carrot and radish are the representative commodities of the root
vegetables, except sugar beet, crop subgroup (1B).  The petitioner has
proposed tolerances for residues of bifenthrin in/on root vegetables,
except sugar beet, crop subgroup (1B) at 0.07 ppm.  Residues of
bifenthrin ranged from <0.05 to 0.07 ppm in radish roots with 4 of 6
trials showing residues levels less than the LOQ (<0.05 ppm).  Residues
of bifenthrin were less than the LOQ (<0.05 ppm) in/on carrots from all
of the submitted trials (10 trials).  Based upon the submitted data, HED
concludes a tolerance for residues of bifenthrin per se in/on root
vegetables, except sugar beet, crop subgroup (1B) at 0.10 ppm is
appropriate.

Peanut:  For the treated peanut nutmeat samples, residues of bifenthrin
were not detected (less than the limit of detection, <LOD, <0.01 ppm) in
all samples except one which had apparent residue levels estimated at
0.01 ppm.  Apparent residues of bifenthrin were not detected (<LOD,
<0.01 ppm) in/on 9 samples of untreated peanut nutmeats.  HED concludes
a tolerance for residues of bifenthrin per se in/on peanut at 0.05 ppm
is appropriate.

Soybean:  Residues of bifenthrin ranged from <0.05 to 0.18 ppm in
soybean seed harvested 17 to 21 days following the last of three
broadcast foliar applications of Capture 2EC for a total foliar rate of
approximately 0.30 lb ai/A.  In 12 of 15 trials, residues of bifenthrin
were less than the LOQ (<0.05 ppm).  HED concludes a tolerance for
residues of bifenthrin per se in/on soybean at 0.20 ppm is appropriate.

Processed Food and Feed:

Peanut:  The petitioner has submitted processing data for the use of
bifenthrin on peanuts and subsequent processing of the peanuts to peanut
meal and refined oil.  In a field trial conducted during the 1993
growing season in GA, three foliar applications of Capture 2EC were made
at 0.3 lb ai/A to the treated plots.  The total foliar application rate
was 0.9 lb ai/A per season (9.0x exaggerated rate).  The harvested
peanuts were dried, shelled, and processed into meal and refined oil
using simulated commercial practices.

The results show that residues of bifenthrin were below the method LOQs
(<0.05 ppm) but above the LOD (0.01 ppm) in/on peanut nutmeat treated at
a seasonal rate of 0.9 lb ai/A.  Apparent residue levels of bifenthrin
were estimated at 0.02 ppm in/on treated peanut nutmeats.  Following
processing of the treated nutmeat, the residues were not detected (<0.01
ppm) in peanut meal and were below the method LOQs but above the method
LOD in/on all treated peanut refined oil samples except one which had
bifenthrin residues at the LOQ (0.05 ppm).  Apparent residue levels of
bifenthrin in peanut refined oil were estimated at 0.04 ppm.  As
residues decreased when peanut nutmeats are processed to meal, a
processing factor for this process was not calculated and tolerances for
residues in/on peanut meal are not required.  The processing factors for
the processing of peanut nutmeats to refined oil were estimated to be
2.2x.  The highest-average field trial (HAFT) value for residues of
bifenthrin in/on peanut nutmeats is 0.01 ppm (residues were
non-detectable).  The processing factor for nutmeats to oil multiplied
by the HAFT is 0.022ppm (2.2 x 0.01 ppm).  As this value is below the
LOQ (0.05 ppm) and recommended tolerance level for bifenthrin in/on
peanuts, a tolerance for residues in/on peanut oil is not required.

Soybean:  The petitioner has submitted  SEQ CHAPTER \h \r 1  a
processing study with bifenthrin on soybeans.  In one trial conducted in
Iowa during the 2001 growing season, soybean seed was harvested 18 days
following the last of three foliar broadcast applications of Capture 2EC
for a total rate of 0.7 lb ai/A (7.0x).  Soybean seed samples were
processed into meal, hulls, and refined oil.  Additionally, aspirated
grain fractions (AFGs) were generated.

The average total residues of bifenthrin were the LOQ of 0.05 ppm (0.025
ppm) in/on the raw agricultural commodity (RAC) soybean seed treated at
a total rate of 0.7 lb ai/A.  Following processing of the treated RAC,
total residues did not concentrate in meal, but concentrated slightly in
hulls (2.6x) and refined oil (1.6x).  Additionally, residues
significantly concentrated in AFGs (9.51 ppm, 380x).  The observed
processing factors are less than the theoretical concentration factors
for soybean commodities.

The AGF samples were collected and classified via sieve.  After
classification, the fractions were recombined to produce the AGF
samples.  The study report indicates that the AFGs were recombined as
per the specifications of the Study Director; however, the report does
not indicate the final makeup of the AGF samples in terms of percent
composition based upon particle size.  This information should be
submitted prior to granting of a permanent registration for soybeans.
Once these data are submitted, HED will make a determination as to
whether additional data or an altered tolerance level is needed.

The HAFT value for residues of bifenthrin in/on soybean is 0.18 ppm.
The processing factors for soybeans to hulls, meal, refined oil, and AGF
is as follows:

Soybean hulls:  0.18 ppm x 2.6 = 0.47 ppm.

Soybean meal:  no concentration of residues.

Soybean refined oil:  0.18 ppm x 1.6 = 0.29 ppm

Soybean aspirated grain fractions:  0.18 ppm x 380 = 68.4 ppm

HED concludes tolerances for residues of bifenthrin in/on soybean hulls
at 0.50 ppm, soybean refined oil at 0.30 ppm and aspirated grain
fractions at 70 ppm are appropriate.

Magnitude of the Residue - Livestock:

Livestock feed items for ruminants and poultry are associated with
peanut and soybeans.  Tolerances are currently established (40 CFR
§180.442) for residues of bifenthrin per se in cattle, goat, hog,
horse, and sheep meat at 0.5 ppm, meat byproducts at 0.10 ppm, fat at
1.0 ppm, milk fat at 1.0 ppm (reflecting 0.10 ppm in whole milk).
Additionally, tolerances are established for residues of bifenthrin per
se in poultry fat, meat, and meat byproducts at 0.05 ppm.

Several cattle feeding studies are discussed in a previous residue
chemistry review (Memo, 12/24/87, M. Flood PP#7F3546).  Based upon the
previously-submitted studies,  HED concludes that the established
tolerances for residues in milk fat and whole milk are adequate.

For livestock tissues, the calculated residues based on the 3.05 ppm
beef cattle dietary burden and the results from the 50-ppm feeding
levels are as follows:  0.054 ppm in muscle; 0.35 ppm in fat; 0.0055 ppm
in liver; and 0.030 ppm in kidney.  These values indicate that the
established tolerances for residues at 1.0 ppm, 0.5 ppm and 0.1 ppm for
fat, meat, and meat byproducts, respectively, of cattle, goat, hog,
horse and sheep are adequate to cover the new uses.

Residues in Rotational Crops:

Adequate confined and field rotational crop studies are available.
Based on the confined study, HED has concluded that the residue of
concern in rotational crops is the parent compound only.  Based on a
maximum seasonal use rate of 0.5 lb ai/A for annual crops, the confined
study and the available field rotational crop study on wheat also
support a 30-day plant back interval (PBI) for all crops on the labels.
Crops having bifenthrin tolerances may be replanted at any time, and all
other crops may be replanted 30 days following the last application of
bifenthrin.  No rotational crop tolerances are required.

Recommendations

Provided the petitioner submits revised Sections B and F, HED concludes
that the residue chemistry database is sufficient for conditional
registration and establishment of the following tolerances for the
residues of bifenthrin [(2-methyl[1,1′-biphenyl]-3-yl)methyl
(1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-dimethylcyc
lopropanecarboxylate] in or on the following commodities:

Mayhaw	1.4 ppm

Vegetable, root, except sugar beet and garden beet, subgroup 1B	0.10 ppm

Beet, garden, root	0.45 ppm

Beet, garden, top	15 ppm

Radish, top	4.5 ppm

Soybean	0.20 ppm

Soybean, hulls	0.50 ppm

Soybean, refined oil	0.30 ppm

Aspirated grain fractions	70 ppm

Groundcherry	0.50 ppm

Pepino	0.50 ppm

Peanut	0.05 ppm

Pistachio	0.05 ppm

The registration may be made permanent after additional information
concerning the soybean processing study is submitted.

Detailed Considerations

Background

Bifenthrin is a broad-spectrum, non-systemic insecticide/miticide in the
class of synthetic pyrethroids.  It is registered to FMC Corporation for
use as foliar applications on a variety of field, fruit, and vegetable
crops.  Bifenthrin is formulated for use on crops as a 2.0 lb/gal
emulsifiable concentrate (Capture 2EC; EPA Reg. No. 279-3069), a 1.15%
granule (Capture 1.15G; EPA Reg. No. 279-3244), and a 10% (by weight)
wettable-powder formulation in water-soluble bags (Brigade WSB, EPA Reg.
No. 279-3108).

Table 1.  Nomenclature of Bifenthrin.

Compound

Common name	Bifenthrin

Company experimental names	Capture® Insecticide/Miticide

IUPAC name	2-methylbiphenyl-3-ylmethyl
(1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclop
ropanecarboxylate

or

2-methylbiphenyl-3-ylmethyl
(1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclop
ropanecarboxylate

CAS name	(2-methyl[1,1′-biphenyl]-3-yl)methyl
(1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-dimethylcyc
lopropanecarboxylate

CAS #	82657-04-03

End-use products/EPs	2.0 lb ai/gal emulsifiable concentrate formulation
(Capture 2EC; EPA Reg. No. 279-3069)

1.15% granular formulation (Capture 1.15G; EPA Reg. No. 279-3244)

10% wettable-powder formulation  (Brigade WSB, EPA Reg. No. 279-3108)

Table 2.  Physicochemical Properties of the Technical Grade Bifenthrin.

Parameter	Value	Reference

Melting range	68-70.6°C	Product Chemistry Chapter of the TRED

<0.1 μg/L

	Solvent solubility (g/100 mL)	8.9 in heptane and methanol

125 in acetone, chloroform, ether, methylene chloride, and toluene

	Vapor pressure (Pa) at 25°C	2.41 x 10-5

	Dissociation constant (pKa)	Not applicable

	Octanol/water partition coefficient (Kow)	>1 x 10 6

	UV/visible absorption spectrum	NA

	1 NA = information not available.

860.1200  Directions for Use

The petitioner has proposed the use of Brigade WSB, Capture 2EC, and/or
Capture 1.15G for use on mayhaw, root vegetables, (except sugar beets,
crop subgroup 1B), peanut, pistachio, soybean, and fruiting vegetables
(crop group 8).  Table 3 is a summary of the proposed application
scenario.

The submitted labels adequately describe the proposed application
scenarios.  As the petitioner has not requested the establishment of
tolerances for residues in/on peanut hay, the following restriction must
be added to the label:  Do not feed green immature plants and peanut hay
to livestock.  Based on the current rotational crop data, HED concludes
that a 30-day rotational crop restriction is appropriate for all
non-labeled crops (labeled crops may be plant at anytime; see section
OPPTS 860.1850).  A revised Section B is requested.

Table 3.  Proposed Application Scenarios.

Formulation

Crop

App. Rate

(lb ai/acre)1

PHI2 (days)

Comments3

Brigade WSB

Capture 2EC	Mayhaw	0.08 to 0.10 	30	Apply in at least 28 gallons per
acre.  Apply no more than once every 7 days.  Do not apply more than 0.2
lb ai/A per season.

Brigade WSB

Capture 2EC

Capture 1.15G	Root Crops (edible burdock, carrot, celeriac, chevil,
chicory, ginseng, horseradish, parsley, parsnip, radish, oriental
radish, rutabaga, salsify, black salsify, Spanish salsify, skirret,
turnip)	0.08 to 0.10

(0.006 lb ai per 1000 linear ft)3	21	Apply in at least 25 gallons per
acre.  Apply no more than once every 7 days.  Do not apply more than 0.5
lb ai/A per season (including soil application).  (Make one in-furrow
application of Capture 1.15G at planting.)

Brigade WSB

Capture 2EC

Capture 1.15G	Garden beet	0.08 to 0.10

(0.006 lb ai per 1000 linear ft)	1	Apply in at least 25 gallons per
acre.  Apply no more than once every 7 days.  Do not apply more than 0.4
lb ai/A per season (including soil application).  (Make one in-furrow
application of Capture 1.15G at planting.)

Brigade WSB

Capture 2EC	Peanut	0.033 to 0.10	14	Apply in at least 10 gallons per
acre.  Apply no more than once every 14 days.  Do not apply more than
0.5 lb ai/A per season.

Brigade WSB

Capture 2EC	Pistachio	0.05 to 0.20	21	Apply in at least 50 gallons per
acre by ground and at least 10 gallons per acre by air.  Apply no more
than once every 15 days.  Do not apply more than 0.2 lb ai/A per
application and do not exceed 0.50 lb ai/A per season.

Brigade WSB

Capture 2EC	Soybean	0.033 to 0.10	18	Apply in at least 10 gallons per
acre.  Apply no more than once every 30 days.  Do not apply more than
0.3 lb ai/A per season.

Brigade WSB

Capture 2EC

Capture 1.15G	Eggplant, bell and non-bell pepper, groundcherry, pepino
0.033 to 0.08

(0.04 to 0.10)	7	Apply in at least 2 gallons per acre by air or 10
gallons per acre by ground.  Apply no more than once every 7 days.  Do
not apply more than 0.2 lb ai/A per season. (Make application of Capture
1.15G as soon as pest are present.)

Brigade WSB

Capture 2EC

Capture 1.15G	Tomato, tomatillo	0.033 to 0.08

(0.04 to 0.10)	1	Apply in at least 15 gallons per acre.  Apply no more
than once every 10 days.  A maximum of 4 applications may be applied per
season.  (Make application of Capture 1.15G as soon as pest are
present.)

1  The rates list in parentheses are for Capture 1.156 G.

2  PHI = pre-harvest interval.

3  The comments in parentheses and application rates are specific to
Capture 1.156 G.

860.1300 Nature of the Residue - Plants

Bifenthrin TRED,   SEQ CHAPTER \h \r 1 S. Levy, 21-AUG-2002; DP# 283808

Adequate studies are available depicting the metabolism of
[14C]bifenthrin in apples, corn, and cotton.   The nature of the residue
in plants is adequately understood based on previously-submitted plant
metabolism studies on corn, cotton, apple and potato.  HED has
determined that for purposes of the tolerance expression and risk
assessment, the residue of concern in cotton and apple commodities is
bifenthrin per se.  The HED Metabolism Committee in 1993 re-examined the
cotton and apple metabolism data and examined additional corn metabolism
data; the Committee determined that the residues of concern in plant
commodities for tolerance setting and risk assessment are bifenthrin per
se (Memo, M. Flood, 7/23/93).

OPPTS GLN 860.1300: Nature of the Residue - Livestock

Bifenthrin TRED,   SEQ CHAPTER \h \r 1 S. Levy, 21-AUG-2002; DP# 283808

Adequate studies are available depicting the metabolism of
[14C]bifenthrin in ruminants and poultry. The nature of the residue in
livestock is adequately understood based on goat and hen metabolism
studies.  The HED Metabolism Committee determined that for purposes of
tolerance expression and risk assessment, the residue of concern in
livestock is bifenthrin per se (Memo, M. Flood, 7/23/93).

OPPTS GLN 860.1340: Residue Analytical Method – Plants & Livestock

Bifenthrin TRED,   SEQ CHAPTER \h \r 1 S. Levy, 21-AUG-2002; DP# 283808

Several methods are available for enforcement of tolerances for
bifenthrin residues in plant and livestock commodities.  FMC Methods
P-1031, P-2550 M, and RAN-0140 are GC/ECD methods that are available for
determination of residues in milk and tissues, corn commodities, and
cottonseed, respectively.  In addition, GC/ECD methods P-1843M and
RAN-0204M are available for determination of bifenthrin residues in
poultry tissues and eggs, respectively.  The TRED for bifenthrin states
that adequate GC/ECD methods are available for enforcement purposes.

Crop field trial samples were analyzed for residues of bifenthrin using
FMC Methods P-2132 (mayhaw, radish, garden beet, carrot), PC-0130
(peanut commodities) and P-3457 (soybean commodities) which are
modifications of the tolerance enforcement methods.  The reported LOQ
for these methods is 0.05 ppm.  In some cases, sample extracts were
analyzed by GC/MSD instead of a GC/ECD.  Adequate concurrent method
recovery data have been submitted for these methods.

OPPTS GLN 860.1360: Multiresidue Method (MRM)

Bifenthrin TRED,   SEQ CHAPTER \h \r 1 S. Levy, 21-AUG-2002; DP# 283808

The Food and Drug Administration’s PESTDATA database dated 10/99
(Pesticide Analytical Manual (PAM) Vol. I, Appendix II) indicates that
bifenthrin is completely recovered using MRM Section 303 (Mills, Onley,
and Gaither Method; Protocol E, non-fatty food) and that recoveries
using Section 302 (Luke Method; Protocol D) are variable.  No
information pertaining to the recovery of bifenthrin using Section 304
(Mills Method; Protocol E, fatty food) is available.  Additional MRM
data for bifenthrin are not required.  The MRM methods are adequate for
enforcement of bifenthrin tolerances.

OPPTS GLN 860.1380: Storage Stability Data

Bifenthrin TRED,   SEQ CHAPTER \h \r 1 S. Levy, 21-AUG-2002; DP# 283808

The maximum storage interval from harvest to analysis was 13 months for
radish tops, 10 months for radish roots, 21.5 months for mayhaw, 9
months for peanut nutmeat and refined oil, 4 months for peanut meal, 5
months for peanut hay, 18 months for carrots, 30 months for garden beet
tops and roots, 10 months for radish roots, 13 months for radish tops,
and less than 30 days for soybean commodities.

Storage stability data for residues of bifenthrin in/on a variety of
commodities are available.  In the Bifenthrin TRED  SEQ CHAPTER \h \r 1
 SEQ CHAPTER \h \r 1 , HED has concluded that residues of bifenthrin are
stable during frozen storage for up to:  12 months in corn flour, meal,
oil, and starch; 18 months in/on oranges (whole) and orange dried pulp,
juice, and oil; 24 months in/on cottonseed; 34 months in/on corn grain;
36 months in/on lettuce, pecans, and potatoes; and 49 months in/on
apple, corn silage, and corn stover.  Storage stability studies
conducted concurrently with crop field trial studies indicate that
residues of bifenthrin are stable during frozen storage for up to:  147
days in/on artichoke; 196 days in/on lima beans (shelled); 142 days
in/on snap beans; 294 days in/on head and stem Brassica vegetables; 136
days in/on canola; 369 days in/on cantaloupe; 361 days in/on cucumbers;
136 days in/on eggplant; 176 days in/on grapes; 127 days in/on green and
dried hops; 300 days in/on head lettuce; 192 days in/on shelled peas;
166 days in/on bell peppers; 200 days in/on non-bell peppers; 188 days
in/on raspberries; 359 days in/on squash.  In conjunction with the
subject petitions, data were submitted to show that residues of
bifenthrin are stable during frozen storage for 21 months in mayhaw (see
DER for MRID 46960801), 36 months in/on carrots (See DER for MRID
46961101); 30 months in/on garden beet tops and roots (See DER for MRID
46961101).  These data support the frozen storage conditions and
intervals in the subject field trials.  Additional storage stability
data are not required.

OPPTS GLN 860.1480: Meat/Milk/Poultry/Eggs

Bifenthrin TRED,   SEQ CHAPTER \h \r 1 S. Levy, 21-AUG-2002; DP# 283808

Memo, 7/13/2006,   SEQ CHAPTER \h \r 1 G.F. Kramer, DP# 328891

Of the proposed uses, livestock feed items for ruminants and poultry are
associated with peanut and soybeans.  Tolerances are currently
established (40 CFR §180.442) for residues of bifenthrin per se in
cattle, goat, hog, horse, and sheep meat at 0.5 ppm, meat byproducts at
0.10 ppm, fat at 1.0 ppm, milk fat at 1.0 ppm (reflecting 0.10 ppm in
whole milk).  Additionally, tolerances are established for residues of
bifenthrin per se in poultry fat, meat, and meat byproducts at 0.05 ppm.

Using the HED-recommended tolerances for residues of bifenthrin in/on
soybean commodities, the maximum theoretical dietary burdens (MTDB) were
recalculated for cattle, hogs and poultry (Table 4).  The inclusion of
AGFs with tolerance level residues did significantly increased the MTDB
for beef cattle (from 2.7 ppm to 6.84 ppm) and only slightly for dairy
cattle (from 3.3 ppm to 3.41 ppm), hogs (from 0.12 to 0.18 ppm) and
poultry (from 0.14 ppm to 0.17 ppm).  HED considers the MTDB calculated
for beef cattle to be an extreme over-estimate for the following
reasons:

AGFs are normally a composite of more than one grain (corn (46%), wheat
(30%), sorghum, (6%) and soybeans (16%)).

Bifenthrin is not registered for use on wheat and sorghum.

Bifenthrin is registered for use on field corn; however, the requirement
for data concerning AGFs from corn has been waived as grain samples
resulting from the registered use pattern exhibited non-detectable
residues of bifenthrin (<0.01 ppm).

Thus, HED will use a value that is 16% of the proposed tolerance for
determining the adequacy of the established livestock tolerances.

Table 4.	Calculation of MTDB of Livestock to Bifenthrin Residues.

Feed Commodity	% Dry Matter1	% Diet1	Current or Recommended Tolerance
(ppm)	Dietary Contribution (ppm)2

Beef  Cattle

Corn, sweet, forage	48	40	3.0	2.5

Potato, culls	20	30	0.05	0.08

Cotton, seed	88	25	0.5	0.14

Aspirated grain fractions	85	5	70 (11.2)3	4.12 (0.33)

TOTAL BURDEN

100

6.84 (3.05)

Dairy Cattle

Corn, sweet, forage	48	50	3.0	3.13

Potato, culls	20	10	0.05	0.06

Cotton, seed	88	25	0.5	0.14

Soybean hulls	90	15	0.5	0.08

TOTAL BURDEN

100

3.41

Poultry

Field corn, grain	NA	60	0.05	0.030

Soybean, seed	NA	20	0.2	0.040

Cottonseed, meal	NA	20	0.5	0.10

TOTAL BURDEN

100

0.17

Hog

Field corn, grain	--	45	0.05	0.023

Cottonseed, meal	--	15	0.5	0.075

Soybean meal	--	25	0.2	0.05

Soybean, seed	--	15	0.2	0.03

TOTAL BURDEN

100	--	0.178

1	Table 1 (August 1996).

2	Contribution = [tolerance ( %DM (if cattle)] (  % diet.

3	The value in parenthesis represents 16% of the tolerance level for
AGFs (see discussion above).

Several cattle feeding studies are discussed in a previous residue
chemistry review (Memo, 12/24/87, M. Flood PP#7F3546).  In the first
study cattle were fed bifenthrin at a rate of 5, 15 and 50 ppm (1.6x,
4.9x, and 16.4x, respectively, the MTDB to beef cattle and 1.5x, 4.4x,
and 14.7x, respectively, the MTDB to dairy cattle) in the diet for 28
days.  The level of bifenthrin in whole milk plateaued at 0.16, 0.24 and
1.0 ppm, respectively, for the 5-, 15-, and 50-ppm feeding levels.  From
the 50-ppm dose the residue levels in tissues were 0.88, 5.71, 0.09 and
0.49 ppm, for muscle, fat, liver, and kidney, respectively.  In a later
study, residues of bifenthrin were measured in milk fat.  Following
feeding at 5 and 50 ppm, the maximum residues in milk fat were 1.6 and
10.6 ppm, respectively.  Comparing the whole milk values above, it can
be seen that the milk fat residues are about 10x higher than the whole
milk values; this ratio is consistent with the established tolerance of
1.0 ppm in milk fat reflecting 0.1 ppm in whole milk.

Comparing the dairy cattle dietary burden to the first cattle feeding
study yields projected residues (calculated dietary burden x feeding
study residue/feeding level) of 0.109, 0.055 and 0.0682 ppm for whole
milk using the results of the 5-, 15-, and 50-ppm feeding levels.  Using
the later study for milk fat, the projected residues in that commodity
are 1.09 and 0.72 ppm based on the results from the 5- and 50-ppm
feeding levels.  Although the results from the 5-ppm feeding level
predict residues slightly higher than the established tolerance of 1.0
ppm; the calculations based on the higher dosages do not.  Furthermore,
chances of cattle ingesting both sweet corn forage and cottonseed having
tolerance level residues of bifenthrin are low.  Therefore, HED
concludes that the established tolerances for milk fat and whole milk
are adequate.

For livestock tissues, the calculated residues based on the 3.05 ppm
beef cattle dietary burden and the results detailed above from the
50-ppm feeding levels are as follows:  0.054 ppm in muscle; 0.35 ppm in
fat; 0.0055 ppm in liver; and 0.030 ppm in kidney.  These values
indicate that the established tolerances of 1.0 ppm, 0.5 ppm and 0.1 ppm
for fat, meat, and meat byproducts, respectively, of cattle, goat, hog,
horse and sheep are appropriate.

In the poultry feeding study, laying hens were orally dosed with
bifenthrin at levels of 2.5, 25, and 250 ppb in the diet for 28 days.
The maximum expected dietary intake of bifenthrin residues by poultry
was calculated to be 0.17 ppm; therefore, the 2.5-, 25-, and 250-ppb
feeding rates correspond to 0.015x, 0.15x, and 1.5x the MTDB.

Trace residues of bifenthrin (0.002-0.004 ppm) were observed in eggs
from the highest dosing group from four of the sampling days; residues
were non-detectable in eggs from the other sampling days, and in all egg
samples from the other two dosing groups.  Residues of bifenthrin were
non-detectable (<0.005 ppm for muscle and <0.01 ppm for liver) in muscle
and liver samples from the highest dosing group.  Residues of bifenthrin
were non-detectable (<0.01 ppm for fat) from the highest dosing group.
These data indicate that the established tolerances for poultry
commodities, at the method LOQ, are appropriate.

OPPTS GLN 860.1500: Crop Field Trials

46960801.der.doc (mayhaw)

46961102.der.doc (radish)

46961103.der.doc (garden beet)

46961101.der.doc (carrot)

46960401.der.doc (peanut)

46098701.der.doc (soybeans)

The field trials with bifenthrin on mayhaw, radish, garden beet, carrot,
peanut, and soybeans are   SEQ CHAPTER \h \r 1 adequate.  An adequate
number of trials were conducted reflecting the proposed use patterns in
the appropriate geographic regions, and the appropriate commodities were
collected at the proposed PHIs.  Samples were analyzed using adequate
analytical methods, and the sample storage intervals are supported by
the available storage stability data.  Tolerance levels for residues
in/on mayhaw, radish tops, and garden beet tops were determined using
the Guidance for Setting Pesticide Tolerances Based on Field Trial Data.

Although tolerances are proposed for bifenthrin per se in/on pistachios
at 0.05 ppm and the fruiting vegetables crop group (group 14) at 0.5
ppm, residue data for these crops were not included in the current
submissions.  For pistachios, HED policy is to translate data and
tolerances from almonds to pistachios (Reviewer’s Guide & Summary of
HED ChemSAC Approvals for Amending Crop Group/Subgroups [40 CFR
§180.41] & Commodity Definitions [40 CFR 180.1(h)], 6/14/2006, B
Schneider).  Thus, a tolerance for residues of bifenthrin per se should
be established in/on pistachios at 0.05 ppm.  For fruiting vegetables,
tolerances are established for residues of bifenthrin per se at 0.05 ppm
in/on eggplant, at 0.15 ppm in/on tomato, and at 0.5 ppm in/on bell and
non-bell pepper.  HED has determined that a fruiting vegetables crop
group tolerance for residues bifenthrin per se is not appropriate for
the following reasons:  maximum residues in eggplants are more than a
factor of 5 lower than the tolerance for tomatoes and the use pattern
for tomato and tomatillo versus the other crops of the group are
different in terms of the PHI, maximum seasonal use rate, number of
applications, and interval between applications.  However, HED could
translate data and tolerances from bell and non-bell pepper to
groundcherry and pepino.  Thus, the petitioner should submit a revised
Section F that proposes tolerances for bifenthrin in/on groundcherry and
pepino at 0.50 ppm.  As 40 CFR §180.1 indicates that a tolerance for
residues in/on tomato applies to tomatillo, a tolerance for residues
in/on tomatillo is not required.

The following paragraphs and Tables 5 through 10 are summaries of the
data submitted in support of the current petitions.

Mayhaw:  The petitioner has submitted field trial data for the use of
bifenthrin on mayhaw.  A total of three mayhaw field trials were
conducted during the 2002 growing season in Region 4 (LA, 3 trials).
Each field trial site consisted of one untreated control plot and one
treated plot.  For the treated plots, two foliar applications of Capture
2EC were made 7 days apart.  The applications were targeted to a rate of
0.1 lb ai/A; the actual rates were 0.100 to 0.102 lb ai/A.  The total
application rates ranged from 0.200 to 0.203 lb ai/A per season.
Samples were harvested 28 to 29 days after the last application.
Residue decline samples were not collected.  The number (locations not
specified) of field trials are in accordance with OPPTS Guideline
860.1500 for mayhaw.

Residues of bifenthrin ranged from 0.24 to 0.78 ppm in/on mayhaw
harvested 28 to 29 days following two broadcast foliar applications of
Capture 2EC for a total rate of approximately 0.2 lb ai/A.  Apparent
residues of bifenthrin were below the method LOQ (<0.05 ppm) in/on 6
samples of untreated mayhaw.

Table 5.  Summary of Residue Data from Mayhaw Field Trials with
Bifenthrin.

Commodity	Formulation	Total Applic. Rate

(lb ai/A)	PHI (days)	Bifenthrin

Residue Levels (ppm)

N	Min.	Max.	HAFT1	Mean	Std. Dev.

Mayhaw	Capture 2EC	0.200-0.203	28-29	6	0.24	0.78	0.75	0.47	0.23

1  HAFT = Highest-Average Field Trial.

Conclusions concerning mayhaw:  HED concludes a tolerance for residues
of bifenthrin in/on mayhaw at 1.4 ppm is appropriate (See Attachment 1).

Radish:  The petitioner has submitted field trial data for the use of
bifenthrin on radishes.  A total of 6 radish field trials were conducted
during the 2003 growing season.  The submitted field trials were
conducted in Regions 1 (NY, 1 trial), 3 (FL, 2 trials), 5 (OH, 1 trial),
and 10 (CA, 2 trials).  Each field trial site consisted of one untreated
control plot and one treated plot.  For the treated plots, an in-furrow
application of Capture 1.15G was made at planting.  The in-furrow
application rate was approximately 0.006 pounds ai/1000 linear feet.
Additionally, a foliar application of Capture 2EC was made 14 to 32 days
following the in-furrow application.  A second foliar application was
made 6 to 8 days following the first foliar application.  The foliar
applications were targeted to a rate of 0.1 lb ai/A.  The actual rates
were 0.097 to 0.105 lb ai/A.  The actual total foliar application rates
were 0.198 to 0.215 lb ai/A per season.  Samples were harvested 6 to 8
days following the last application.  Residue decline samples were not
collected in any of the studies.  The number and locations of field
trials are in accordance with OPPTS Guideline 860.1500 for uses on
radish.

Residues of bifenthrin ranged from <0.05 to 0.07 ppm in radish roots and
ranged from 0.56 to 2.26 ppm in radish tops harvested 6 to 8 days
following an in-furrow application of Capture 1.15G at planting and two
broadcast foliar applications of Capture 2EC for a total foliar rate of
approximately 0.20 lb ai/A.  Apparent residues of bifenthrin were below
the method LOQ (<0.05 ppm) in/on 6 samples of untreated radish tops and
roots.

Table 6.  Summary of Residue Data from Radish Field Trials with
Bifenthrin.

Commodity	Formulation	Total Applic. Rate1

(lb ai/A)	PHI (days)	Bifenthrin2

Residue Levels (ppm)

N	Min.	Max.	HAFT3	Mean	Std. Dev.

Radish Roots	1.15G & 2EC	0.197-0.215

(~0.006)	6 to 8	12	<0.05	0.07	0.06	<0.05	NA4

Radish Tops

12	0.56	2.258	2.25	1.51	0.58

1 The value in parentheses is for the in-furrow application and is
expressed in lb ai/1000 linear feet.

2  For the determination of mean and standard deviation, residue levels
noted as <0.05 ppm (Table C3) were assumed to be equal to ½LOQ (0.025
ppm).

3  HAFT = highest-average field trial.

4  As the mean was determined to be <0.05 ppm, no standard deviation was
calculated.

Conclusions concerning radishes:  Based upon the submitted data, HED
concludes a tolerance for residues of bifenthrin in/on radish tops at
4.5 ppm is appropriate (see Attachment 1).  For radish roots, see the
discussion below concerning the tolerances for residues in/on subgroup
1B.

Garden Beet:  The petitioner has submitted field trial data for the use
of bifenthrin on garden beets. A total of 6 garden beet field trials
were conducted during the 2002 growing season.  The submitted field
trials were conducted in Regions 1 (NY, 1 trial), 3 (FL, 1 trial), 5
(OH, 2 trials), 6 (TX, 1 trial), and 12 (OR, 1 trial).  Each field trial
site consisted of one untreated control plot and one treated plot.  For
the treated plots, four foliar applications of Capture 2EC were made 6
to 9 days apart.  The applications were targeted to a rate of 0.1 lb
ai/A; the actual rates were 0.099 to 0.105 lb ai/A.  The total
application rates were approximately 0.40 lb ai/A per season.  Samples
were harvested one day following the last application.  Residue decline
samples were not collected in any of the studies.  The number and
locations of field trials are in accordance with OPPTS Guideline
860.1500 for uses on garden beets.

Residues of bifenthrin ranged from <0.05 ppm to 0.28 ppm in garden beet
roots and ranged from 4.8 ppm to 12.2 ppm in garden beet tops harvested
1 day following four broadcast foliar applications of Capture 2EC for a
total rate of approximately 0.40 lb ai/A.  Apparent residues of
bifenthrin were below the method LOQ (<0.05 ppm) in/on 6 samples of
untreated garden beet tops and roots.

Table 7.  Summary of Residue Data from Garden Beet Field Trials with
Bifenthrin.

Commodity	Formulation	Total Applic. Rate

(lb ai/A)	PHI (days)	Bifenthrin2

Residue Levels (ppm)

N	Min.	Max.	HAFT	Mean	Std. Dev.

Garden Beet Tops	Capture 2EC	0.40-0.41	1	12	4.8	12.2	11.9	7.3	2.6

Garden Beet Roots	Capture 2EC	0.40-0.41	1	12	<0.050	0.28	0.28	0.095
0.095

1  HAFT = Highest Average Field Trial.

2  For the determination of mean and standard deviation, residue levels
noted as <0.050 ppm (Table C3) were assumed to be equal to ½LOQ (0.025
ppm).

Conclusions concerning garden beets:  Based upon the submitted data, HED
concludes tolerances for residues of bifenthrin in/on garden beet tops
and garden beet roots at 15 ppm and 0.45 ppm, respectively, are
appropriate (see Attachment 1).  Tolerances for residues in garden beet
roots were not determined as per the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data since a significant number of the
values in the dataset were less than the LOQ.

Carrot:  The petitioner has submitted field trial data for the use of
bifenthrin on carrots.  A total of 10 carrot field trials were conducted
during the 2002-2003 growing seasons.  The submitted field trials were
conducted in Regions 3 (FL, 1 trial), 5 (IN and OH, 1 trial each), 6
(TX, 2 trials), 10 (CA, 4 trials), and 11 (WA, 1 trial).

Each field trial site consisted of one untreated control plot and one
treated plot.  For the treated plots, three foliar applications of
Capture 2EC were made 6 to 8 days apart with the exception of one trial
(CA*68).  In the CA*68 trial, the second application was not made until
21 days after the first application.  The first application was targeted
at a rate of 0.3 lb ai/A; the actual rates varied from 0.293 to 0.307 lb
ai/A.  The two subsequent applications were targeted to a rate of 0.1 lb
ai/A; the actual rates varied from 0.097 to 0.105 lb ai/A.  The total
application rates ranged from 0.491 to 0.513 lb ai/A per season.
Samples were harvested 21 to 22 days after the last application.  In two
of the trials, residue decline samples were collected at PHIs of 7, 14,
and 21 days.  The number and locations of field trials are in accordance
with OPPTS Guideline 860.1500 for carrots.

Residues of bifenthrin were less than the method LOQ (<0.05 ppm) in/on
carrots harvested 7, 14, and 20 to 22 days following a three broadcast
foliar applications of Capture 2EC for a total rate of 0.49 to 0.51 lb
ai/A.  Apparent residues of bifenthrin were below the method LOQ (<0.05
ppm) in/on 15 samples of untreated carrots.

Table 8.  Summary of Residue Data from Carrot Field Trials with
Bifenthrin.

Commodity	Formulation	Total Applic. Rate

(lb ai/A)	PHI (days)	Bifenthrin

Residue Levels (ppm)

N	Min.	Max.	HAFT1	Mean	Std. Dev.

Carrot	Capture 2EC	0.491-0.513	21-22	20	<0.05	<0.05	<0.05	<0.05	NA

0.496-0.497	14	4	<0.05	<0.05	<0.05	<0.05	NA

0.496-0.497	7	4	<0.05	<0.05	<0.05	<0.05	NA

1  HAFT = Highest-Average Field Trial.

Conclusions concerning root vegetables, except sugar beet and garden
beet, crop subgroup (1B):  Based upon the submitted data, HED concludes
a tolerance for residues of bifenthrin in/on root vegetables, except
sugar beet and garden beets, crop subgroup (1B) at 0.10 ppm is
appropriate. Tolerances for residues in root vegetables, except sugar
beet and garden beet, crop subgroup (1B) were not determined as per the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data
since a significant number of the values in the datasets were less than
the LOQ.

Peanut:  The petitioner has submitted field trial data for the use of
bifenthrin on peanuts.  A total of 9 peanut field trials were conducted
during the 1992 (4 trials), 1995 (1 trial), and 2003 (4 trials) growing
season.  The submitted field trials were conducted in Regions 2 (NC, AL,
VA [2 trials], GA [2 trials]), 3 (FL, 1 trial), and 6 (TX & OK).  Each
field trial site generally consisted of one untreated control plot and
one treated plot.

For the 1992 and 1995 trials, three (1995 trial) or four (1992 trials)
foliar applications of Capture 2EC were made at 0.1 lb ai/A to the
treated plots.  The applications were made with retreatment intervals
(RTIs) of 9 to 56 days.  The total foliar application rate was either
0.3 (1995 trial) or 0.5 lb ai/A per season.  With the exception of the
Emporia, VA and Suffolk, VA trials, peanut samples (nutmeat with hulls)
were harvested on the day of the last application and 7 days following
the last application.  For the Emporia, VA trial, peanut samples
(nutmeat with hulls) were harvested 1 and 8 days following the final
application and for the 1995 trial (Suffolk, VA), peanut samples
(nutmeat with hulls) were harvested 14 days following the final
application.  Additionally, peanut hay samples were collect at all of
the 1992 trial sites with PHIs of 7, 14, and 21 days, except the Emporia
VA trial where samples were collected with PHIs of 8, 15, and 22 days.

For the 2003 trials, a banded application of Capture 1.15G was made at
0.25 lb ai/A and a foliar application of Capture 2EC was made 7 days
after the first application at the rate of 0.25 lb ai/A.  The total
application rate was 0.5 lb ai/A per season.  Samples were harvested 14
days following the final application in all of the 2003 trials except
the Sparks, GA trial where samples were collected at PHIs of 3, 7, 15,
and 17 days to demonstrate residue decline.  However, residues of
bifenthrin were non-detectable (<0.01 ppm) in all residue decline
samples.

For the treated peanut nutmeat samples, residues of bifenthrin were not
detected (<LOD, <0.01 ppm) in all samples except one which had apparent
residue levels estimated at 0.01 ppm.  For the treated hay samples (1992
trials only), overall residues ranged from 2.34 to 13.0 ppm with the
maximum residues at 9.27, 13.0, and 5.28 ppm for samples collected at
PHIs of 7 (or 8), 14 (or 15), and 21 (or 22) days, respectively.
Apparent residues of bifenthrin were not detected (<LOD, <0.01 ppm)
in/on 9 samples of untreated peanut nutmeats and 4 samples of untreated
peanut hay.

Table 9.  Summary of Residue Data from Peanut Field Trials with
Bifenthrin.

Commodity	Formulation	Total Applic. Rate

(lb ai/A)	PHI (days)	Bifenthrin1

Residue Levels (ppm)

N	Min.	Max.	HAFT2	Mean	Std. Dev.

Peanut nutmeat	1.15G & 2EC	0.3 to 0.5	0 to 17	32	ND	ND	ND (0.01)	--	--

Peanut hay	1.15G & 2EC	0.5	7 or 8	8	3.41	9.27	8.65	6.51	2.11

	14 or 15	8	2.34	13.0	11.3	7.36	3.49

	21 or 22	8	3.43	5.28	5.05	4.44	0.64

1  The mean and standard deviation were not determined as all samples,
except one, had residues that were not detected (<LOD, <0.01 ppm).

2  HAFT = highest-average field trial.

Conclusions concerning peanuts:  HED concludes a tolerance for residues
of bifenthrin in/on peanut at 0.05 ppm is appropriate.  The petitioner
has not requested a tolerance for residues in/on peanut hay.

Soybean:  The petitioner has submitted field trial data for the use of
bifenthrin on soybeans.  A total of 15 soybean field trials were
conducted during the 2001 growing season.  The submitted field trials
were conducted in Regions 2 (VA and GA, 2 trials), 4 (AR and MS, 2
trials), and 5 (IL, KS, WI, MO, MN, OH, SD, ND, NE, and IA, 11 trials).
Each field trial site consisted of one untreated control plot and one
treated plot.  For the treated plots, three foliar applications of
Capture 2EC were made on RTIs of 30 to 88 days.  The applications were
targeted to a rate of 0.1 lb ai/A.  The total application rate was 0.3
lb ai/A per season.  Samples were harvested 17 to 21 days following the
last application.  Residue decline samples were collected in two trials
(GA and IL) at PHIs of 13, 17, 22, 26 days and at PHIs of 3, 10, 18, and
26 days, respectively.

Residues of bifenthrin ranged from <0.05 to 0.18 ppm in soybean seed
harvested 17 to 21 days following the last of three broadcast foliar
applications of Capture 2EC for a total foliar rate of approximately
0.30 lb ai/A.  Apparent residues of bifenthrin were below the method LOD
(<0.010 ppm) in/on 15 samples of untreated soybean seed.  In the IL
residue decline study, all samples exhibited residues of bifenthrin that
were below the method LOQ.  In the GA residue decline study, residue
levels decreased as the PHI increased.

Table 10.  Summary of Residue Data from Soybean Trials with Bifenthrin.

Commodity	Formulation	Total Applic. Rate

(lb ai/A)	PHI (days)	Bifenthrin1

Residue Levels (ppm)

N	Min.	Max.	HAFT2	Mean	Std. Dev.

Soybean Seed	Capture 2EC	0.3	17 to 21	30	<0.05	0.18	<0.05	<0.05	NA3

1  For the determination of mean and standard deviation, residue levels
noted as <0.05 ppm (Table C3) were assumed to be equal to ½LOQ or 0.025
ppm.

2  HAFT = highest-average field trial.

3  As the mean was determined to be <0.05 ppm, no standard deviation was
calculated.

Conclusions concerning soybeans:  HED concludes a tolerance for residues
of bifenthrin in/on soybean at 0.20 ppm is appropriate.

860.1520 Processed Food and Feed

46960403.der.doc (peanut)

46098701.de2.doc (soybean)

Peanut:  The petitioner has submitted processing data for the use of
bifenthrin on peanuts and subsequent processing of the peanuts to peanut
meal and refined oil.  In a field trial conducted during the 1993
growing season in GA, three foliar applications of Capture 2EC were made
at 0.3 lb ai/A to the treated plots.  The applications were made with
RTIs of 11 and 49 days.  The total foliar application rate was 0.9 lb
ai/A per season (9x exaggerated rate).  Single bulk samples of untreated
and treated peanuts were harvested at commercial maturity, 13 days after
the last treatment.  The harvested peanuts were dried, shelled, and
processed into meal and refined oil using simulated commercial
practices.

The results show that residues of bifenthrin were below the method LOQs
(<0.05 ppm) but above the method LOD (0.01 ppm) in/on peanut nutmeat
treated at a seasonal rate of 0.9 lb ai/A.  Apparent residue levels of
bifenthrin were estimated at 0.02 ppm in/on treated peanut nutmeats.
Following processing of the treated nutmeat, the residues were not
detected (<0.01 ppm) in peanut meal and were below the method LOQs but
above the method LOD in/on all treated peanut refined oil samples except
one which had bifenthrin residues at the LOQ (0.05 ppm).  Apparent
residue levels of bifenthrin in the other treated samples were estimated
at 0.04 ppm in/on peanut refined oil. As residues decreased when peanut
nutmeats are processed to meal, a processing factor for this process was
not calculated.  The processing factor for the processing of peanut
nutmeats to refined oil was estimated to be 2.2x.

Table 11.  Residue Data from Peanut Processing Study with Bifenthrin.

RAC	Processed Commodity	Total Rate

(lb ai/A)	PHI

(days)	Residues Levels (ppm)	Processing Factor

Peanut	Nutmeat (RAC)	0.9	13	<0.05, <0.05, <0.05

(0.02, 0.02, 0.02)	--

	Meal

	ND, ND, ND	--

	Refined Oil

	<0.05, <0.05, 0.05

(0.04, 0.04)	2.2x

1 ND = Not detected (<0.01 ppm).  Values in parentheses are estimates of
apparent residue levels that are greater than the LOD (0.01 ppm) and
less than the LOQ (0.05 ppm).

Conclusions:  Based upon the submitted field trial data for peanuts, the
HAFT value for residues of bifenthrin in/on peanut nutmeats is 0.01 ppm
(residues were non-detectable).  The processing factor for nutmeats to
oil multiplied by the HAFT is 0.022ppm (2.2 x 0.01 ppm).  As this value
is below the LOQ (0.05 ppm) and recommended tolerance level for
bifenthrin in/on peanuts, a tolerance for residues in/on peanut oil is
not required.

Soybean:  The petitioner has submitted  SEQ CHAPTER \h \r 1  a
processing study with bifenthrin on soybeans.  In one trial conducted in
Iowa during the 2001 growing season, soybean seed was harvested 18 days
following the last of three foliar broadcast applications of Capture 2EC
for a total rate of 0.7 lb ai/A (7x exaggerated rate).  Soybean seed
samples were processed into meal, hulls, and refined oil.  Additionally,
AFGs were generated.

The average total residues of bifenthrin were estimated at 0.025 ppm
in/on the RAC soybean seed treated at a total rate of 0.7 lb ai/A.
Following processing of the treated RAC, total residues did not
concentrate in meal, but concentrated slightly in hulls (0.065 ppm; 2.6x
processing factor) and refined oil (0.04 ppm; 1.6x).  Additionally,
residues significantly concentrated in AFGs (9.51 ppm, 380x).  The
observed processing factors are less than the theoretical concentration
factors for soybean commodities.

The AGF samples were collected and classified via sieve.  After
classification, the fractions were recombined to produce the AGF
samples.  The study report indicates that the AFGs were recombined as
per the specifications of the Study Director; however, the report does
not indicate the final makeup of the AGF samples in terms of percent
composition based upon particle size.  This information should be
submitted prior to granting of a permanent registration for soybeans.
Once these data are submitted, HED will make a determination as to
whether additional data or an altered tolerance level is needed.

Conclusions:  Based upon the submitted field trials, the HAFT value for
residues of bifenthrin in/on soybean is 0.18 ppm.  The processing
factors multiplied by the HAFT value for soybeans to hulls, meal,
refined oil, and AGF are as follows:

Soybean hulls:  0.18 ppm x 2.6 = 0.47 ppm.

Soybean meal:  no concentration of residues.

Soybean refined oil:  0.18 ppm x 1.6 = 0.29 ppm

Soybean aspirated grain fractions:  0.18 ppm x 380 = 68.4 ppm

HED concludes tolerances for residues of bifenthrin per se in/on soybean
hulls at 0.50 ppm, soybean refined oil at 0.30 ppm and aspirated grain
fractions at 70.0 ppm are appropriate.  A revised Section F and
additional information concerning the study (see above) is required.

OPPTS GLN 860.1850: Confined Accumulation in Rotational Crops

Bifenthrin TRED,   SEQ CHAPTER \h \r 1 S. Levy, 21-AUG-2002; DP# 283808

Adequate confined and field rotational crop studies are available.
Based on the confined study, HED has concluded that the residue of
concern in rotational crops is the parent compound only.  Based on a
maximum seasonal use rate of 0.5 lb ai/A for annual crops, the confined
study and the available field rotational crop study on wheat also
support the current rotational crop restrictions on the labels.  Crops
having bifenthrin tolerances may be replanted at any time, and all other
crops may be replanted 30 days following the last application of
bifenthrin.  No rotational crop tolerances are required.

860.1550 Proposed Tolerances

The tolerances proposed by the petitioner in the subject petitions are
listed below in Table 6, along with HED’s recommended tolerance
levels.   SEQ CHAPTER \h \r 1  The appropriate tolerance levels were
calculated using the methodology formulated by the NAFTA MRL/Tolerance
Harmonization Workgroup for calculating statistically-based pesticide
tolerances for plant commodities based on field trial residue data
(Attachment 1).  A revised Section F is requested.

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Aspirated Grain Fractions 	70

RDI: RAB1 Chemists: 05/14/2007

Registration Numbers:  279-3069, 279-3244, 279-3108

DP Numbers:  335688, 335693, 335695, 335696

PC Code:  128825

W.D. Wassell:S10316:Potomac Yard:703-305-6135:7509P:RAB1

Attachment 1:

EPA

Bifenthrin

Mayhaw

30

0.08 to 0.10

IR-4

Residues

0.43

0.28

0.72

0.35

0.24

0.78

EPA

Bifenthrin

Radish Tops

21

0.08 to 0.10

Residues

2.04

1.77

1.6

1.69

2.25

2.24

1.48

1.83

0.84

1.15

0.69

0.56

EPA

Bifenthrin

Garden Beet Tops

1

0.08 to 0.10

Residues

7.5

7.6

6.5

9.6

4.8

5.2

5.3

4.9

6.2

6.1

11.6

12.2

Bifenthrin (128825)	Residue Chemistry Summary	DP #s 335688, 335693,
335695, 335696

page   PAGE  1  of   NUMPAGES  27


[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Notices]
[Pages 27841-27842]
[FR Doc No: 2012-11458]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2012-0042]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 19 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions will enable these individuals to operate CMVs in
interstate commerce.

DATES: The exemptions are effective May 11, 2012. The exemptions expire
on May 12, 2014.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Background

    On March 23, 2012, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 19 individuals and requested
comments from the public (77 FR 17111). The public comment period
closed on April 23, 2012, and no comments were received.
    FMCSA has evaluated the eligibility of the 19 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 19 applicants have had ITDM over a range of 1 to 36 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the March 23, 2012, Federal Register
notice and they will not be repeated in this notice.

Discussion of Comments

    FMCSA did not receive any comments in this proceeding.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual

provide a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (4)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file, or
keep a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

Conclusion

    Based upon its evaluation of the 19 exemption applications, FMCSA
exempts, Joseph A. Bailey (VA), Patrick J. Beasley (MN), Tounce H.
Gaskin (CT), Joel Gonzalez (CA), John G. Hager, Jr. (NJ), Brian R.
Hallisey (MA), Charles C. Karver (MN), Benjamin Kimbrough, Jr. (KS),
Kevin T. Kruchan (OH), Jeffrey J. Lawrie (OH), Raymond Pittman, Jr.
(IL), Christopher M. Rieman (MN), Daniel J. Russell (OH), Donald L.
Russell, Jr. (MD), Robert J. Smith (PA), Robert J. Socha (NE), Brian A.
Tatum (MS), Thomas C. Torbett, (MO) and Terry R. Wilker (MN) from the
ITDM requirement in 49 CFR 391.41(b)(3), subject to the conditions
listed under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if the following occurs: (1) The person fails to comply
with the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: April 30, 2012.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2012-11458 Filed 5-10-12; 8:45 am]
BILLING CODE 4910-EX-P