[Federal Register Volume 87, Number 192 (Wednesday, October 5, 2022)]
[Proposed Rules]
[Pages 60344-60347]
[FR Doc No: 2022-21572]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1253; Project Identifier MCAI-2022-00698-T]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace LP Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Gulfstream Aerospace LP Model Gulfstream G280 airplanes. This
proposed AD was prompted by a determination that the existing wet
runway performance tables in the airplane flight manual (AFM) may not
provide an acceptable level of safety. This proposed AD would require
revising the existing AFM to incorporate new wet runway performance
tables, as

specified in a Civil Aviation Authority of Israel (CAAI) AD, which is
proposed for incorporation by reference. The FAA is proposing this AD
to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by November
21, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact Civil Aviation Authority of Israel (CAAI), P.O. Box 1101,
Golan Street, Airport City, 70100, Israel; telephone 972-3-9774665; fax
972-3-9774592; email [email protected]. You may find this material on the
CAAI website at caa.gov.il. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at regulations.gov by searching for and locating Docket No. FAA-
2022-1253.

Examining the AD Docket

    You may examine the AD docket at regulations.gov by searching for
and locating Docket No. FAA-2022-1253; or in person at Docket
Operations between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The AD docket contains this NPRM, the mandatory
continuing airworthiness information (MCAI), any comments received, and
other information. The street address for Docket Operations is listed
above.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-1253; Project Identifier
MCAI-2022-00698-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected]. Any commentary that
the FAA receives which is not specifically designated as CBI will be
placed in the public docket for this rulemaking.

Background

    The CAAI, which is the aviation authority for Israel, has issued
CAAI AD ISR-I-97-2022-04-9, dated May 1, 2022 (CAAI AD ISR-I-97-2022-
04-9) (also referred to as the MCAI), to correct an unsafe condition
for all Gulfstream Aerospace LP Model Gulfstream G280 airplanes.
    This proposed AD was prompted by the determination that the
existing wet runway performance tables in the AFM may not provide an
acceptable level of safety, and that the wet runway performance tables
have been updated in the Performance section of the G280 AFM, Revision
10. The FAA is proposing this AD to address the existing wet runway
performance tables that could allow the airplane to experience runway
excursions or overruns during takeoff. See the MCAI for additional
background information.

Related Service Information Under 1 CFR Part 51

    CAAI AD ISR-I-97-2022-04-9 specifies procedures for updating the
Performance section of the G280 AFM to incorporate new wet runway
tables.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with the State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in CAAI AD ISR-I-97-2022-04-9 described previously, except for any
differences identified as exceptions in the regulatory text of this
proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate CAAI AD ISR-I-97-2022-04-9 by reference in
the FAA final rule. This proposed AD would, therefore, require
compliance with CAAI AD ISR-

I-97-2022-04-9 in its entirety through that incorporation, except for
any differences identified as exceptions in the regulatory text of this
proposed AD. Service information required by CAAI AD ISR-I-97-2022-04-9
for compliance will be available at regulations.gov by searching for
and locating Docket No. FAA-2022-1253 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 195 airplanes
of U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85          $16,575
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Gulfstream Aerospace LP: Docket No. FAA-2022-1253; Project
Identifier MCAI-2022-00698-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by November 21, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Gulfstream Aerospace LP Model Gulfstream
G280 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by a determination that the existing wet
runway performance tables in the airplane flight manual (AFM) may
not provide an acceptable level of safety. The FAA is proposing this
AD to address the existing AFM wet runway performance tables that
could allow the airplane to experience runway excursions or overruns
during takeoff.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, Civil Aviation Authority of Israel (CAAI) AD ISR-I-
97-2022-04-9.

(h) Exception to CAAI AD ISR-I-97-2022-04-9

    Where CAAI AD ISR-I-97-2022-04-9 refers to its effective date,
this AD requires using the effective date of this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j)(2) of
this AD. Information may be emailed to: [email protected].
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or CAAI; or CAAI's
authorized Designee. If approved by the CAAI Designee, the approval
must include the Designee's authorized signature.

(j) Related Information

    (1) For CAAI AD ISR-I-97-2022-04-9, contact Civil Aviation
Authority of Israel (CAAI), P.O. Box 1101, Golan Street, Airport
City, 70100, Israel; telephone 972-3-9774665; fax 972-3-9774592;
email [email protected]. You may find this CAAI AD on the CAAI website
at caa.gov.il. You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket at regulations.gov by searching for and locating Docket No.
FAA-2022-1253.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer,

Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

    Issued on September 29, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-21572 Filed 10-4-22; 8:45 am]
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[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Rules and Regulations]
[Pages 47365-47366]
[FR Doc No: 2023-15595]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-0985; Airspace Docket No. 23-ASO-16]
RIN 2120-AA66

Amendment of Class E Airspace; Cross City, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace extending upward from 700
feet above the surface for Cross City Airport, Cross City, FL, as a new
instrument approach procedure has been designed for this airport. This
action also updates this airport's geographic coordinates.

DATES: Effective 0901 UTC, October 5, 2023. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11 and
publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval helps, and guidelines are available on the
website. It is available 24 hours a day, 365 days a year.
    FAA Order JO 7400.11G Airspace Designations and Reporting Points
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it amends Class E airspace in Cross City, FL, to support IFR
operations in the area.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA 2023-0985 in the Federal Register (88 FR 24937; April 25, 2023),
proposing to amend Class E airspace for Cross City Airport, Cross City,
FL. Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. One
comment was received supporting this action yet questioning why the FAA
proposed to remove the existing extension to the south. The extension
is no longer required, as the VOR approach into runway 31 has not been
authorized for several years, and Cross City VORTAC is scheduled for
decommissioning next year.

Incorporation by Reference

    Class E airspace designations are published in Paragraph 6005 of
FAA Order JO 7400.11, Airspace Designations and Reporting Points,
incorporated by reference in 14 CFR 71.1 annually. This document amends
the current version of that order, FAA Order JO 7400.11G, dated August
19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is
publicly available as listed in the ADDRESSES section of this document.
These amendments will be published in the next update to FAA Order JO
7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by amending Class E airspace
extending upward from 700 feet above the surface for Cross City
Airport, Cross City, FL, to accommodate area navigation (RNAV) global
positioning system (GPS) standard instrument approach procedures
(SIAPs) serving this airport. The existing radius is increased to 7
miles (previously 6.8 miles), and the southern extension is removed.
The Cross City VORTAC is removed from the airspace description, as it
will soon be decommissioned. This action also updates the airport's
geographic coordinates to coincide with FAA's database. Controlled
airspace is necessary for the area's safety and management of
instrument flight rules (IFR) operations.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances warrant the preparation of an environmental
assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

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

* * * * *

ASO FL E5 Cross City, FL [Amended]

Cross City Airport, FL
(Lat 29[deg]38'08'' N, long. 83[deg]06'17'' W)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Cross City Airport.
* * * * *

    Issued in College Park, Georgia, on July 18, 2023.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2023-15595 Filed 7-21-23; 8:45 am]
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[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42601-42602]
[FR Doc No: 2015-17611]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2014-44]

Petition for Exemption; Summary of Petition Received; William
Robertson

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 6, 2015.

ADDRESSES: Send comments identified by docket number FAA-2015-2192
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Keira Jones<PHONE_NUMBER>, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on July 14, 2015.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-2192.
    Petitioner: William Robertson.
    Section(s) of 14 CFR Affected: Sec. Sec.  61.153(e), 61.165(f)(1),
and (2).
    Description of Relief Sought: William Robertson holds an airline
transport pilot (ATP) certificate in the airplane category with a
single engine class rating and seeks relief to add a multiengine class
rating to his ATP certificate without complying with the training and
knowledge testing requirements. Based upon previous academic training,
flight training, and professional pilot experience, the petitioner
seeks exemption from Sec.  61.153(e), which requires applicants seeking
an ATP certificate in the airplane category with a multiengine class
rating to complete the training required in Sec.  61.156 before
applying for the knowledge test required by Sec.  61.153(g). In
addition, the petitioner seeks exemption from Sec. Sec.  61.165(f)(1)
and (2), which require an applicant seeking to add a multiengine class
rating to an ATP certificate with a single engine class rating to meet
the eligibility requirements of Sec.  61.153 and pass a knowledge test
on the aeronautical knowledge areas of Sec.  61.155(c) as applicable to
multiengine airplanes.

[FR Doc. 2015-17611 Filed 7-16-15; 8:45 am]
 BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: 4/ 30/ 04 Subject: Amitraz. TRED  Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decisions. Residue Chemistry Considerations. Case No. 0234.

DP Barcode: D300301 PC Code: 106201 40 CFR: § 180.287 From: José J. Morales, Chemist Reregistration Branch 3 Health Effects Division ( 7509C)

Through: Danette Drew, Branch Senior Scientist Reregistration Branch 3 Health Effects Division ( 7509C)

To: John Pates, Chemical Review Manager Reregistration Branch 1 Special Review and Reregistration Division ( 7508C) Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 2 Executive Summary Amitraz [ N'( 2,4 dimethylphenyl) N[[( 2,4 dimethylphenyl) imino] methyl] Nmethylmethanimidamide is an insecticide/ acaricide with registered food/ feed uses in the U. S. on cotton, pears, beef and dairy cattle, and hogs. Amitraz is currently registered for use on cotton to control various insects ( bollworm larvae and eggs, beet armyworm, whitefly, aphids, and spider mites) as well as on pears for the control of pear psylla and grape mealybug. Amitraz can be applied by airblast and concentrate spray ( pears) with up to 3.0 lb a. i./ acre applied during dormancy and throughout the growing season excluding prebloom applications. It can also be applied via ground boom or aircraft ( cotton) with up to 1.0 lb a. i./ acre during the growing season with a maximum of eight applications per year. Current formulations include: wettable powder, emulsifiable concentrate, and soluble concentrate/ liquid. In addition, an import tolerance has been established to support amitraz use on hops to be imported into the U. S. Amitraz products with food/ feed uses are registered in the U. S. to Bayer CropScience ( BCS) LP and Intervet, Inc. under the trade names Ovasyn ® , Mitac ® , and Taktic ® . Currently, the 1.5 lb/ gal soluble concentrate ( SC), 50% wettable powder ( WP), and 12.5% emulsifiable concentrate ( EC) formulations are registered for use on food/ feed sites. The SC formulation is registered for use on cotton, and the WP formulation is registered for use on pears. The EC formulation is registered for use on cattle and swine as dermal treatments.

Amitraz is also used for tick control on dogs as well as mite and lice management on beef cattle, dairy cattle and swine. In the case of tick and flea collars ( Preventic ® and Preventic ® Plus), application should be made every three months in dogs more than 12 weeks of age. Additionally, amitraz can be applied via dip or low pressure hand spray for cattle and swine with up to 0.2 lb a. i./ 50 gallons of water. For the use of Taktic E. C. on beef cattle, dairy cattle and swine, the following application methods are suggested: 1) cattle applied via spraying or by a spray dip machine, 2) swine applied via spraying, and 3) piglets/ weaners applied by dipping. However, Taktic E. C. is not to be applied within three days of slaughter for swine, which are not to be treated more than four times per year. All of the established tolerances for meats, meat byproducts and milk will be maintained to support the animal health uses.

In a recent letter to the Agency, BCS has decided to voluntarily withdraw the registrations of Ovaysn Insecticide/ Miticide ( EPA Reg. No. 264 625) and Mitac W Insecticide ( EPA Reg. No. 264 636). The registrant has also requested to maintain the registration of technical amitraz, to revoke established tolerances for apples, beeswax, honey, and pears as well as maintain import tolerances for hops and cottonseed ( Amitraz Use Closure Memo, 10/ 22/ 03). Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 3 Amitraz is a FIFRA List A pesticide assigned to Case No. 0234 and was the subject of a Reregistration Standard Guidance Document dated 10/ 87. The Residue Chemistry Chapter of the Amitraz Reregistration Standard Update was issued 7/ 6/ 90. The Residue Chemistry Chapter for the Amitraz Reregistration Eligibility Decision document ( RED) was issued 9/ 17/ 93, and the Amitraz RED was signed 03/ 95. The information contained in this document outlines the Residue Chemistry Science Assessments with respect to the reassessment of tolerances for amitraz residues of concern.

The qualitative nature of the residue in plants and animals is adequately understood based on plant metabolism studies with apples, beans, lemons, citrus, cotton, and pears, and animal metabolism studies with cattle and swine ( dermal application) and cattle, goats and hens ( oral dosing).

Tolerances have been established under 40 CFR § 180.287 for the combined residues of amitraz and its two metabolites, N( 2,4 dimethylphenyl) formamide and N( 2,4 dimethylphenyl) Nmethylmethanimidamide both calculated as the parent compound in/ on cotton, undelinted seed, at 1 ppm, honey at 1 ppm, honeycomb at 6 ppm, dried hop cones at 60 ppm, pear at 3 ppm, and in animal commodities at levels ranging from 0.01 to 0.3 ppm.

Adequate tolerance enforcement methods are listed in PAM Volume II for the determination of amitraz residues of concern in plant and animal commodities.

Residue Chemistry Deficiencies Provided that the registered uses on cotton and pears are cancelled, there are no residue chemistry deficiencies pertaining to amitraz reregistration.

The registrant has indicated that they would like to keep the cotton tolerance as an import tolerance. HED notes that there is a Codex MRL for cottonseed. If a Codex MRL has been established, the NAFTA countries may conduct a more limited review of the residue chemistry data under certain conditions. The NAFTA countries are more likely to adopt MRLs similar to Codex MRL levels if MRLs for the pesticide are already established on other commodities with a contemporary robust database. Standard data and review requirements would be applied where exposure and/ or risk to any subpopulation from the pesticide is high. An EPA specific detailed description of how the U. S. may consider Codex MRLs as they relate to data requirements can be found in Unit VIII of the U. S. Import Tolerances Guidance document ( 65 FR 35069). The registrant needs to submit a formal request to the Agency for establishment of the cottonseed tolerance as an import tolerance, and information about the use pattern in foreign countries, and residue data from those countries to support the request. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 4 N N N C H 3 CH 3 C H 3 CH 3 CH 3 Background The PC Code and nomenclature of amitraz are listed below in Table 1. The physicochemical properties of amitraz are listed in Table 2. The chemical names and structures of amitraz residues of concern are presented in Table 3.

Table 1. Amitraz Nomenclature Chemical structure Common name Amitraz Molecular Formula C19H23N3 Molecular Weight 293.42 IUPAC name N methylbis( 2,4 xylyliminomethyl) amine CAS name N'( 2,4 dimethylphenyl) N[[( 2,4 dimethylphenyl) imino] methyl] Nmethylmethanimidamide CAS # 33089 61 1 PC Code 106201 Current Food/ Feed Site Registration Cotton, pear, beef and dairy cattle, hog, goats, horses, sheep Table 2. Physicochemical Properties of Amitraz.

Parameter Value Reference Melting point/ range 86 87

C Amitraz RED, 03/ 95 pH of 1% aqueous suspension N/ A ( low solubility; decomposes in water) Amitraz RED, 03/ 95 Density or specific gravity 1.128 g/ mL at 20

C Amitraz RED, 03/ 95 Water solubility < 1 ppm at 20 25

C Amitraz RED, 03/ 95 Solvent solubility At 20 25

C xylene 66.6 g/ 100 mL acetone 50.0 g/ 100 mL methanol 2.38 g/ 100 mL Amitraz RED, 03/ 95 Vapor pressure 3.4 x 10 4 Pa at 25

C Amitraz RED, 03/ 95 Octanol/ water partition coefficient ( Kow) 3.0 x 105 at 25

C ( pH 5.8) CBRS No. 3975, 7/ 21/ 88, H. Fonouni. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 5 N N N C H 3 CH 3 C H 3 CH 3 CH 3 NH O H C H 3 CH 3 N NH C H 3 CH 3 CH 3 Table 3. Chemical Names and Structures of Amitraz and its Residues of Concern.

Company Name Chemical Name Structure Amitraz N'[ 2,4 dimethylphenyl] N[[( 2,4 dimethylphenyl) imino] methyl]] Nmethyl methanimidamide BTS 27919 N( 2,4 dimethylphenyl) formamide BTS 27271 N( 2,4 dimethylphenyl) Nmethylmethanimidamide RESIDUE CHARACTERIZATION General Discussion on Residue Chemistry of Amitraz 860.1200 Directions for Use Product List A 6/ 9/ 03 product registration query of the Agency's OPPIN database identified three amitraz end use products ( EPs) registered for use on food/ feed sites. These EPs are listed in Table 4 below. There are no SLN registrations associated with amitraz.

At the time of the 9/ 93 RED Chapter, there were six registered EPs with food/ feed uses: the Nor Am Chemical Company 50% WP ( EPA Reg. No. 45639 61), 1.5 lb/ gal EC ( EPA Reg. No. 45639 49), and 1.5 lb/ gal SC ( EPA Reg. No. 45639 146), and the Hoechst Roussel Agri Vet Company 12.5% EC ( EPA Reg. No. 54382 3) and 10% Impr ( EPA Reg. Nos. 54382 4 and 54382 5). The Nor Am 1.5 lb/ gal SC has since been transferred to Bayer CropScience, the Hoechst 12.5% EC is currently registered to Intervet Inc., and the remaining EPs have been canceled. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 6 Table 4. Amitraz End Use Products ( EPs) with Food/ Feed Uses.

EPA Reg. No. Formulation Registrant Product Name 264 625 1.5 lb/ gal SC Bayer CropScience Ovasyn ® Insecticide/ Miticide; An Organophosphate Insecticide for Use on Cotton 264 636 50% WP Bayer CropScience Mitac ® W Insecticide For Pears 54382 3 12.5% EC Intervet Inc. Taktic ® Emulsifiable Concentrate Miticide/ Insecticide Use Patterns A tabular summary of the residue chemistry science assessments for reregistration of amitraz is presented in Table 5. The conclusions listed in Table 5 regarding the reregistration eligibility of amitraz food/ feed uses are based on the use patterns to be supported by the data submitters, Bayer CropScience and Intervet, Inc. When end use product DCIs are developed, RD should require that all end use product labels ( e. g., MAI labels, SLNs, and products subject to the generic data exemption) be amended such that they are consistent with the basic producers' labels.

We note that since the 9/ 93 RED Chapter, the uses in beehives have been cancelled. In addition, Bayer CropScience has stated that they will be requesting cancellation of use of amitraz on cotton and pears.

860.1300 Nature of the Residue  Plants The qualitative nature of the residue in plants is adequately understood. Acceptable plant metabolism studies have been submitted for apples, beans, lemons, citrus, cotton, and pears, and were reviewed either in the 10/ 15/ 84 Residue Chemistry Science Chapter of the Registration Standard or the 7/ 6/ 90 Reregistration Standard Update. The terminal residues of concern are amitraz and its metabolites containing the 2,4 dimethylaniline ( 2,4 DMA) moiety ( BTS 27919 and BTS 27271); these are the residues which are presently included in the tolerance expression. The HED Metabolism Committee, in its 7/ 15/ 92 deliberations concerning the toxicological significance of 2,4 DMA per se, has determined that this metabolite does not require separate regulation and/ or quantitation of residues, concluding that there is no need to require residue data for 2,4 DMA because the current analytical enforcement methods detect all residues containing the 2,4 DMA moiety.

The HED Chem SAC ( 3/ 31/ 04 meeting) has recommended that the current tolerance expression for amitraz needs to be changed by removing the reference to specific metabolites. The tolerance expression should specify that the terminal residues of concern for enforcement purposes are amitraz and its metabolites containing the 2,4 dimethylaniline moiety. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 7 860.1300 Nature of the Residue  Livestock Because the registrant intends to cancel use of amitraz on cotton, data pertaining to the qualitative nature of the residue in poultry and ruminants following oral dosing is not required.

The qualitative nature of the residue in livestock following dermal application is adequately understood. The terminal residues of concern are amitraz and its metabolites containing the 2,4 dimethylaniline ( 2,4 DMA) moiety ( BTS 27919 and BTS 27271); these are the residues which are presently included in the tolerance expression ( HED Metabolism Committee review of 7/ 20/ 92).

The HED Chem SAC ( 3/ 31/ 04 meeting) has recommended that the current tolerance expression for amitraz needs to be changed by removing the reference to specific metabolites. The tolerance expression should specify that the terminal residues of concern for enforcement purposes are amitraz and its metabolites containing the 2,4 dimethylaniline moiety.

860.1340 Residue Analytical Methods Enforcement methods: There are two adequate methods listed in FDA's Pesticide Analytical Manual ( PAM Vol. II) for purposes of data collection and enforcement of tolerances for residues of amitraz and its metabolites containing the 2,4 dimethylaniline moiety. Methods I ( designed for animal tissues and milk) and II ( designed for plant commodities) are both GLC methods with electron capture detection ( ECD), and involve conversion of residues of amitraz and its metabolites containing the 2,4 dimethylaniline moiety to 2,4 DMA using acid and base hydrolysis, respectively. The detection limits of the methods are 0.01 ppm for milk and 0.05 ppm for plant commodities and animal tissues.

The enforcement methods have not been radiovalidated; however, the data collection method for plant commodities ( similar to Method II) was successfully radiovalidated using samples from the pear metabolism study. Because the extraction procedure is extensive ( hydrolysis with acid at reflux), the Agency will not require radiovalidation data for the enforcement method for animal commodities.

Data collection methods: A GC/ ECD method was used for the determination of amitraz residues of concern in hops. A brief description of this method follows.

Samples were hydrolyzed with 2N HCl at reflux for 3 hours to liberate amitraz and its metabolites from conjugates. The hydrolysate was basified with sodium hydroxide, and the mixture was refluxed for 1.5 hours to convert amitraz and metabolites to 2,4 dimethylaniline, which was isolated by steam distillation and then partitioned into hexane. Residues were cleaned up by aqueous/ solvent partition and then derivatized with heptafluorobutyric anhydride for GC/ ECD analysis. The limit of quantitation was 0.05 ppm for dried hops. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 8 This method differs from the enforcement method for plant commodities in that residues are extracted/ hydrolyzed using acid and then basified to convert to 2,4 dimethylaniline; 2,4 dimethylaniline residues are then distilled into hexane. In Method II of PAM Vol. II, base hydrolysis is used to extract residues and convert them to 2,4 dimethylaniline; these residues are then partitioned into isooctane. HED has recommended that this method be forwarded to FDA for publication in PAM Vol. II as Method A.

Amitraz residues of concern in animal commodities were determined using a GC/ ECD method similar to the method used for hops.

860.1360 Multiresidue Methods The FDA PESTDATA database dated 11/ 01 ( PAM Volume I, Appendix I) indicates that amitraz has small recovery (< 50%) using Multiresidue Method Section 302 ( Luke Method; Protocol D) and that metabolite BTS 27919 is completely recovered using Section 302. The database contains no information on the recovery of amitraz or its metabolites using Multiresidue Method Sections 303 ( Mills, Onley, and Gaither Method; Protocol E, nonfatty food) and 304 ( Mills Method; Protocol E, fatty food).

860.1380 Storage Stability Adequate data are available to support the existing crop field trial and feeding studies.

Storage stability studies have been conducted using fortified samples of citrus fruits, cow tissues and milk, and cottonseed. Residues of amitraz are stable in cottonseed for 13.5 months of frozen storage, and residues of BTS 27271 and BTS 27919 are stable in/ on citrus fruits stored frozen ( 20

C) for up to 18 months; these data may be translated to hops. Residues of amitraz, BTS 27271, and BTS 27919 are stable in cow tissues and milk stored frozen ( 20

C) for up to 12 15 months, and in hog muscle and fat stored frozen (   15

C) for at least 12 months. The storage intervals and conditions from the magnitude of the residue studies in plants and animals are adequately supported by storage stability data.

860.1400 Water, Fish, and Irrigated Crops Amitraz is not presently registered for direct use on water and aquatic food and feed crops; therefore, no residue chemistry data are required under these guideline topics.

860.1460 Food Handling Amitraz is not presently registered for use in food handling establishments; therefore, no residue chemistry data are required under this guideline topic. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 9 860.1480 Meat, Milk, Poultry, and Eggs Currently, there are registered direct animal treatments of amitraz to beef and dairy cattle and hogs. The only registered amitraz use with associated livestock feed items is cotton, which the registrants do not intend to support. An HED document dated 4/ 21/ 04 estated the following: At an OECD guidelines harmonization meeting ( March 16 to 18, 2004), the Croplife International representative from Europe stated that cotton gin byproducts or cotton gin trash are not allowed to be fed to livestock in Europe. Therefore, imported meat is not an issue with respect to amitraz secondary residues by feeding cotton gin trash. The imported cottonseed items from Australia are undelinted cottonseed. According to the U. S. Department of Census Bureau, Foreign Trade Statistics approximately 320, 959 MT of cottonseed from Australia was imported in to the U. S. in 2001, and 264, 627 MT in 2002. In comparison the US produces cotton on 5.17 million hectare and produces 18.6 million 480 lb bales, and over 6,000,000 MT of cottonseed, while Australia on 0.19 million hectares and produces 0.34 million 480 lb bales. The imported cottonseed from Australia is used by California dairy industry as part of their diet, and is fed as cottonseed only. Some is planted as seed cotton. The Californian dairy industry is run like a cattle feedlot, unlike other areas of the country where they are allowed to pasture. Only 7 9 lb cottonseed/ cow can be fed each day. Therefore, even in this cottonseed is fed to animals, the contribution to the diet will be insignificant when compared with the contribution from the dermal applications.

Currently, amitraz may be applied twice to beef and dairy cattle as a 0.05% ai spray, with a 7 day retreatment interval and no pre slaughter interval ( PSI). Hogs may be treated four times per year with a solution containing 0.36 lb ai/ 100 gal, or 0.05%. A 3 day PSI has been established. Although an acceptable dairy cattle feeding study has been submitted, the only magnitude of the residue data relevant to the current use pattern are dermal application data.

Data have been submitted reflecting total amitraz residues ( residues of amitraz and its metabolites convertible to 2,4 dimethylaniline) in cattle matrices following dermal treatment. Cattle were treated twice with either a 0.05% or 0.15% ai spray solution with a 7 day retreatment interval and then sacrificed at pre slaughter intervals of 1, 3, 7, and 14 days. The results of this study are presented below. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 10 Pre slaughter Interval ( days) % ai in Spray Maximum Total Amitraz Residues ( ppm) in Cattle Muscle Liver Kidney Fat 1 0.05 ( 2 applications) 0.02 0.09 0.13 0.04 3 0.01 0.08 0.08 0.07 7 < 0.01 0.04 0.02 0.02 14 < 0.01 0.02 0.01 0.01 1 0.15 ( 2 applications) 0.05 0.24 0.31 0.09 3 0.02 0.15 0.21 0.09 7 < 0.01 0.07 0.07 0.04 14 < 0.01 0.03 0.01 0.02 In addition, in a study in which lactating dairy cattle were treated with two sprays containing 0.025% ( 0.5X), 0.05% ( 1X), or 0.10% ( 2X) amitraz, with a 10 day retreatment interval, total amitraz residues in milk were 0.003 0.013 ppm, 0.006 0.025 ppm, and 0.012 0.038 ppm, respectively. Residues were found to concentrate 5x in butterfat.

Data have been submitted reflecting total amitraz residues in hog matrices following dermal treatment. Hogs were sprayed to runoff with a solution containing 0.1% amitraz. Two applications were made seven days apart, and the hogs were slaughtered one day following the second treatment. Maximum combined residues of amitraz and its metabolites containing the 2,4 dimethylaniline moiety were < 0.05 ppm in muscle, 0.06 ppm in fat, 0.05 ppm in liver, and 0.07 ppm in kidney.

A second hog study reflecting dermal application was conducted in which hogs were treated with a solution of 2 oz ( 0.05% amitraz) or 4 oz ( 0.10 % amitraz) of product ( Taktic E. C.) in 3 gal of water. A second application was made seven days after the first, and hogs were slaughtered 1, 3, 7, and 14 days following treatment. Maximum combined residues of amitraz and its metabolites containing the 2,4 dimethylaniline moiety were 0.006 ppm in muscle, 0.017 ppm in fat, 0.038 ppm in liver, and 0.039 ppm in kidney from hogs slaughtered 3 days following treatments at 2 oz product/ 3 gal ( approximately 1x).

A hog skin processing study has also been submitted. The results of this study indicated that residues in hog skin and puffed rind exceeded 0.2 ppm and that a 0.3 ppm tolerance was appropriate for hog meat byproducts. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 11 860.1500 Crop Field Trials The 9/ 93 RED Chapter concluded that the reregistration data requirements for magnitude of the residue in plants were fulfilled for the food/ feed crops registered at that time, cotton and pears. It was also concluded that reregistration data requirements pertaining to magnitude of the residue were fulfilled for honey. Since the 9/ 93 RED Chapter, all uses of amitraz in beehives have been cancelled, and the registrant has stated that they intend to cancel uses of amitraz on cotton and pears. Therefore, no additional data pertaining to the magnitude of the residue are required for cotton, pears, honey, or honey comb.

An import tolerance petition for dried hops was pending at the time of the 9/ 93 RED Chapter. This tolerance has since been established. Reregistration requirements pertaining to magnitude of the residue in plants are fulfilled for dried hops. At the time of the petition request, amitraz was registered for use on hops in the UK at 2 lb ai/ A with a 49 day PHI, and in Germany and Czechoslovakia at 2.14 lb ai/ A with a 21 day PHI. In trials conducted in Germany, Czechoslovakia, and the UK, combined residues of amitraz and its metabolites convertible to 2,4 dimethylaniline were 1.3 45 ppm in dried hops harvested 28 days following the last of two applications of a 20% EC formulation at a total rate of 3.2 3.77 lb ai/ A (  1.5 2x). Combined residues were 12.6 58.6 ppm in/ on dried hops harvested 20 22 days following two applications of a 20% EC formulation at 1.11 1.34 lb ai/ A/ application ( 1 1.3x) in Germany, and were 26 42 ppm in/ on dried hops harvested 28 35 days following two applications at 1.6 and 1.78 lb ai/ A ( total rate of 3.38 lb ai/ A; 1.6x) in Germany.

860.1520 Processed Food and Feed The 9/ 93 RED Chapter concluded that the reregistration data requirements pertaining to magnitude of the residues in processed food/ feed were fulfilled. Adequate cotton processing studies indicate that amitraz residues of concern do not concentrate in the hulls, meal, crude oil, refined oil, and soapstock processed from cottonseed following application at exaggerated rates.

860.1850 and 860.1900 Confined and Field Accumulation in Rotational Crops The 9/ 93 RED Chapter concluded that additional data were required to upgrade the available confined rotational crop study to allow a conclusion to be made regarding the magnitude of residues in rotational crops. These data were considered confirmatory for the purposes of reregistration. The RED Chapter also noted that field rotational crop studies had been reviewed by EFED and deemed acceptable.

Since the 9/ 93 RED Chapter, the available field rotational crop studies, originally reviewed by EFED, have been evaluated by HED. It was concluded that the limited field rotational crop studies were adequate and that additional data were no longer needed to upgrade the confined rotational crop study. The available data support rotational crop restrictions of 44 days for root and leafy vegetables and 60 days for small grains and other crops, which are the established Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 12 rotational crop restrictions for use of amitraz on cotton. Rotational crop tolerances are not needed.

The registrants have stated that they intend to cancel use of amitraz on cotton, the only annual crop with registered uses. Therefore, no data pertaining to confined and field accumulation in rotational crops are required.

860.1650 Submittal of Analytical Reference Standards As of 8/ 22/ 03, an analytical reference standard for amitraz is available at the EPA National Pesticide Standards Repository. No reference standards for the metabolites BTS 27919 and BTS 27271 are available. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 13 Table 5. Residue Chemistry Science Assessment for Reregistration of Amitraz ( PC Code 106201).

GLN Data Requirements Current Tolerances ( ppm) [ § 180.287] Additional Data Needed? MRID Nos. 1 860.1200: Directions for Use N/ A = Not Applicable No See Table 4 and Appendix 1 860.1300: Nature of the Residue  Plants N/ A No 00028664 00028666 00055718 00161022 00161023 405906012 405908013 409995024 41206701 860.1300: Nature of the Residue  Animals N/ A No 408113055 409995034 426670016429693017 432871018 860.1340: Residue Analytical Method  Plant Commodities N/ A No 00046030 00051929 00051930 GS00234013 421613019 43699901 4369990310  Animal Commodities N/ A No 408113105 860.1360: Multiresidue Method N/ A No 40811311 408113125, 11 4129550312 860.1380: Storage Stability Data  Plant Commodities N/ A No 00046029 GS00234014 408113095 409995084  Animal Commodities N/ A No 408113085 426320016 860.1400: Magnitude of the Residue  Water, Fish, and Irrigated Crops N/ A N/ A 860.1460: Magnitude of the Residue  Food Handling N/ A N/ A 860.1480: Magnitude of the Residue  Meat, Milk, Poultry, Eggs  Cattle fat, meat, and meat byproducts 0.05, meat; 0.1, fat; 0.3, mbyp No No MRID No. 13 No MRID No. 14 40811306 408113075  Goat fat, meat, and meat byproducts " 0", fat, meat, and mbyp No  Hog fat, meat, and meat byproducts 0.05, meat; 0.1, fat; 0.2, kidney & liver; 0.3, mbyp No 0016039115 0016207316  Horse fat, meat, and meat byproducts None established17 No  Sheep fat, meat, and meat byproducts " 0", fat, meat, and mbyp No Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 Table 5. Residue Chemistry Science Assessment for Reregistration of Amitraz ( PC Code 106201).

GLN Data Requirements Current Tolerances ( ppm) [ § 180.287] Additional Data Needed? MRID Nos. 1 14  Milk 0.03, milk; 0.3, milk fat No 40811306 408113075  Eggs and the Fat, Meat, and Meat Byproducts of Poultry 0.01, eggs, fat, and meat; 0.05, mbyp No 40999504 409995054 860.1500: Crop Field Trials Pome Fruit Group  Pear 3 No18 00046029 00051717 4337030119 Miscellaneous Commodities  Cotton, seed and gin byproducts 1.0, seed No20 409995064 41444201 4144420321  Honey 1.0, honey; 6.0, honeycomb No22 41295501 4129550223  Hop, dried cones 60.0 No 42044502 420445039 42161302 421613049 421780019 43369901 4336990310 860.1520: Processed Food/ Feed  Cotton None established No20 409995074 4144420221 4147890124 860.1850: Confined Accumulation in Rotational Crops N/ A No25 4267390126 860.1900: Field Accumulation in Rotational Crops N/ A No25 4099950927 4163730227 Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 15 1. Bolded reference( s) were reviewed in the Update of 7/ 6/ 90. Unbolded references were reviewed in the Residue Chemistry Science Chapter of the Registration Standard dated 10/ 84. All other references were reviewed as noted.

2. CB Nos. 3515 and 3735, 5/ 5/ 88, F. Suhre.

3. CB Nos. 3402 and 3403, 5/ 11/ 88, F. Suhre.

4. CB Nos. 5008, 5009, 5020, 5021, 5121, and 5122; 5/ 31/ 89; M. Flood.

5. CB Nos. 4374 and 4375, 1/ 10/ 89, M. Kovacs.

6. D185748, D187485, D188495, and D192950, 7/ 27/ 93, F. Griffith.

7. DP Barcode D196559, 2/ 15/ 94, C. Swartz, and D210892, 1/ 23/ 95, F. Griffith.

8. DP Barcode D205735, 8/ 4/ 94, C. Swartz.

9. DP Barcodes D174990, D181748, and D181628; 8/ 21/ 92; F. Griffith.

10. DP Barcodes D207742, D208224, D208225, D208229, D208232, D208234, D208247, D208356, D208360, D208365, and D208394; 11/ 8/ 94; F. Griffith.

11. Memo from M. Kovacs to L. Sawyer, 1/ 10/ 89.

12. Memo from S. Koepke to L. Sawyer, 4/ 19/ 90.

13. 45639 EUP 9, 2/ 2/ 83, R. Loranger.

14. 83 PR 02, 12/ 3/ 82, E. Zager.

15. PP# 4F3081, 7/ 11/ 84, E. Haeberer.

16. CB No. 1241, 10/ 15/ 86, F. Griffith.

17. Tolerances for horse commodities have been revoked ( 67 FR 49606; 7/ 31/ 2002).

18. The registrant has stated that they intend to cancel use of amitraz on pears.

19. DP Barcode D209191, 11/ 18/ 94, C. Swartz.

20. The registrant has stated that they intend to cancel use of amitraz on cotton.

21. CB No. 6592, 5/ 17/ 90, M. Flood.

22. The previously registered uses of amitraz in beehives have been cancelled.

23. CB No. 6046, 5/ 7/ 90, S. Koepke.

24. CB No. 6665, 6/ 11/ 90, M. Flood. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 16 25. Because the registrant intends to cancel use of amitraz on cotton, the only annual crop with registered uses, rotational crop data are no longer required.

26. DP Barcode D189026, 7/ 20/ 93, G. Kramer.

27. DP Barcode D195591, 11/ 29/ 93, G. Kramer. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 17 TOLERANCE REASSESSMENT SUMMARY Tolerance Reassessments for Amitraz Tolerances for residues of amitraz in/ on plant and animal commodities are expressed in terms of the combined residues of " amitraz ( N'[ 2,4 dimethylphenyl] N[[( 2,4 dimethylphenyl) imino] methyl]] N methylmethanimidamide) and its metabolites N( 2,4 dimethylphenyl) N methyl formamide and N( 2,4 dimethylphenyl) N methylmethanimidamide," both calculated as the parent compound [ 40 CFR § 180.287].

There is an error in the name of one of the metabolites in the tolerance expression ( metabolite BTS 27919). Currently the chemical name for the metabolite reads: N( 2,4 dimethylphenyl) N methyl formamide. The correct name for the metabolite is as follows: N( 2,4 dimethylphenyl) formamide.

The HED Chem SAC ( 3/ 31/ 04 meeting) has recommended that the current tolerance expression for amitraz needs to be changed by removing the reference to specific metabolites. The tolerance expression should specify that the terminal residues of concern for enforcement purposes are amitraz and its metabolites containing the 2,4 dimethylaniline moiety.

A summary of the amitraz tolerance reassessments and recommended modifications in commodity definitions is presented in Table 6.

Tolerances Listed Under 40 CFR § 180.287:

Adequate residue data have been submitted to reassess the established tolerances for the following commodities: cattle, fat; cattle, meat byproducts; cattle, meat; hog, fat; hog, kidney; hog, liver; hog, meat byproducts; hog, meat; hop, dried cones; milk; and milk, fat. The available data indicate that the established tolerances for cattle meat byproducts, hog liver and kidney, and milk fat may be reduced. The tolerances for cattle fat, hog fat, hog meat byproducts, hog meat, hop dried cones, and milk are reassessed at the same level. We note that for dried hops, because the percent dry matter was not known for all samples submitted in support of the tolerance petition, HED recommended a tolerance level higher than the maximum observed residues to account for the potential that the samples had dry matter contents different from the expected value of approximately 85%.

Because the tolerance for dried hops under 40 CFR § 180.287 is an import tolerance, the tolerance listing should be amended with a footnote stating " No U. S. registrations as of [ date of FR notice]". The registrant has indicated that they would like to keep the cotton tolerance as an import tolerance. HED notes that there is a Codex MRL for cottonseed. If a Codex MRL has been established, the NAFTA countries may conduct a more limited review of the residue chemistry data under certain conditions. The NAFTA countries are more likely to adopt MRLs similar to Codex MRL levels if MRLs for the pesticide are already established on other commodities with a contemporary robust database. Standard data and review requirements Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 18 would be applied where exposure and/ or risk to any subpopulation from the pesticide is high. An EPA specific detailed description of how the U. S. may consider Codex MRLs as they relate to data requirements can be found in Unit VIII of the U. S. Import Tolerances Guidance document ( 65 FR 35069). The registrant needs to submit a formal request to the Agency for establishment of the cottonseed tolerance as an import tolerance, and information about the use pattern in foreign countries, and residue data from those countries to support the request. Also, the tolerance listing should be amended with a footnote stating " No U. S. registrations as of [ date of FR notice]".

All registered uses of amitraz in beehives have been cancelled, and the registrants intend to cancel use of amitraz on cotton and pears in the U. S. Therefore, the established tolerances for the following commodities should be revoked: cotton, undelinted seed; honey; honeycomb; and pear. In addition, because there will no longer be any dietary exposure of livestock to amitraz, the established tolerances for the following animal commodities should be revoked: egg; goat, fat; goat, meat byproducts; goat, meat; poultry fat/ meat; poultry meat byproducts; sheep, fat; sheep, meat byproducts; and sheep, meat. Tolerances for horse commodities were previously revoked ( 67FR 49606, 7/ 31/ 02).

Proposed Tolerances PP# 9F3772: Tolerances have been proposed for residues of amitraz and its metabolites containing the 2,4 dimethylaniline moiety in the meat, fat, and meat byproducts of goats and sheep, resulting from direct dermal application, at 0.2 ppm in liver and kidney, 0.3 ppm in meat and meat byproducts, and 0.5 ppm in fat. This petition has received a favorable recommendation, toxicological considerations permitting, ( CB No. 6466, 6/ 4/ 90, R. Cook). However, the registrant does not intend to support uses on goats and sheep.

We note that a petition to support an amended registration request to allow use of pour on mineral oil based formulation on swine had been submitted and evaluated by the Agency ( PP# 2F4110). This petition has been withdrawn since the 9/ 93 RED Chapter ( 60 FR 38333, 7/ 26/ 95).

Table 6. Tolerance Reassessment Summary for Amitraz.

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/[ Correct Commodity Definition]

Tolerances Listed Under 40 CFR § 180.287:

Cattle, fat 0.1 0.04 Cattle, meat byproducts 0.3 0.2 Cattle, meat 0.05 0.02 Cotton, undelinted seed 1 1 The registrant intends to cancel use of amitraz on cotton in the US and to retain the tolerance as an import tolerance. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 Table 6. Tolerance Reassessment Summary for Amitraz.

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/[ Correct Commodity Definition]

19 Egg 0.01 Revoke When use of amitraz on cotton is cancelled, there will be no need for tolerances for poultry commodities.

Goat, fat 0 Revoke When use of amitraz on cotton is cancelled, there will be no need for tolerances for goat commodities. Goat, meat byproducts 0 Revoke Goat, meat 0 Revoke Hog, fat 0.1 0.1 Hog, kidney 0.2 0.1 Hog, liver 0.2 0.1 Hog, meat byproducts 0.3 0.3 Hog, meat byproducts, except kidney and liver Hog, meat 0.05 0.05 Honey 1 Revoke There are no longer any registered uses of amitraz in beehives. Honeycomb 6 Revoke Hop, dried cones 60 60 The following footnote should be added to the tolerance listing for dried hop cones: " No U. S. registrations as of [ date of FR notice]."

Milk 0.03 0.03 Milk, fat 0.3 0.2 Pear 3 Revoke The registrant intends to cancel use of amitraz on pears.

Poultry fat/ meat 0.01 Revoke When use of amitraz on cotton is cancelled, there will be no need for tolerances for poultry commodities. Poultry meat byproducts 0.05 Revoke Sheep, fat 0 Revoke When use of amitraz on cotton is cancelled, there will be no need for tolerances for sheep commodities. Sheep, meat byproducts 0 Revoke Sheep, meat 0 Revoke Codex/ International Harmonization Several maximum residue limits ( MRLs) for amitraz have been established by Codex in various commodities. The Codex MRLs are currently expressed as the sum of amitraz and N( 2,4 dimethylphenyl) N' methylformamidine calculated as N( 2,4 dimethylphenyl) N' methylformamidine. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 20 The Codex tolerance expression is somewhat different from the U. S. tolerance expression. The Codex expression is the sum of amitraz plus metabolite BTS 27271, calculated as BTS 27271. The U. S. expression is the sum of amitraz and its metabolites BTS 27271 and BTS 27919, both calculated as the parent compound. The enforcement methods for amitraz tolerances in the U. S. ( Methods I and II of PAM Vol. II) consists of hydrolysis of all metabolites containing the 2,4 DMA moiety to 2,4 DMA and determination using gas chromatography with electron capture detection. The enforcement method under the Codex system involves treatment of the RAC with acidic methanol to convert the parent compound to metabolite BTS 27271, followed by extraction, cleanup, and determination of BTS 27271 using gas liquid chromatography with flame ionization detection. Presently, compatibility between the Codex MRL and U. S. tolerance cannot be achieved due to the differences between the tolerance definitions and analytical enforcement methods.

A summary of the established and proposed Codex MRLs is presented in Table 7. The current U. S. tolerances and Codex MRLs are identical in magnitude for cattle and pig meat. However, the reassessed tolerances in the U. S. are lower than Codex MRLs with the exception of milk which are the same. There are several Codex MRLs for which there are no U. S. tolerances.

There is a Mexican MRL established for amitraz on cottonseed at 1.0 mg/ kg. MRLs have been established in Canada for amitraz and its metabolite N( 2,4 dimethylphenyl) N' methyl formamidine in/ on pears at 1.0 ppm, apples at 0.5 ppm, and liver and kidney of cattle and hogs at 0.2 ppm. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 21 Table 7. Codex MRLs and Applicable U. S. Tolerances for Amitraz. Recommendations are Based on Conclusions Following Reassessment of U. S. Tolerances ( see Table 6).

Codex Reassessed U. S. Tolerance, ppm Recommendation And Comments Commodity, As Defined MRL ( mg/ kg) Step Cattle meat 0.051 CXL 0.02 Cherries 0.5 CXL None established No U. S. registrations for use on cherry.

Cotton seed 0.5 CXL 1 Registrant intends to cancel use on cotton in the U. S. and retain the tolerance as an import tolerance.

Cotton seed oil, Crude 0.05 CXL None established Cucumber 0.5 CXL None established No U. S. registrations for use on cucumber.

Edible offal of cattle, pigs & sheep 0.21 CXL 0.1 hog fat, hog kidney & liver; 0.04 for cattle fat; and 0.3 hog mbyp Revoke sheep tolerances When use on cotton is cancelled, there will be no need for tolerances on sheep.

Milks 0.01(*) 1,2 CXL 0.03 Oranges, Sweet, Sour 0.5 CXL None established No U. S. registrations for use on orange.

Peach 0.5 CXL None established No U. S. registrations for use on peach.

Pig meat 0.051 CXL 0.05 Pome fruits 0.5 CXL Revoke Registrant intends to cancel use on pears in the U. S.

Sheep meat 0.11 CXL Revoke When use on cotton is cancelled, there will be no need for tolerances on sheep.

Tomato 0.5 CXL None established No U. S. registrations for use on tomato.

1 The MRL accommodates external animal treatment. 2 (*) = At or about the limit of determination. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 22 BIBLIOGRAPHY Study Citations 00028664 Lewis, D. K. ( 1970) RD 27 419, Plant Biochemistry Report No. 1: FM 70 158. ( Unpublished study received Apr 9, 1980 under 43142 EX 1; submitted by Boots Hercules Agrochemicals Co., Wilmington, Del.; CDL: 099371 A)

00028666 Somerville, L.; Spiers, M. J. ( 19??) BTS 27 419: Metabolism in Apple Leaves: AX 72 002. ( Unpublished study received Apr 9, 1980 under 43142 EX 1; submitted by Boots Hercules Agrochemicals Co., Wilmington, Del.; CDL: 099371 C)

00046029 Joos, J. L.; Sigetko, J.; Lee, B. L.; et al. ( 1980) Baam WP Insecticide for Pears. ( Compilation; unpublished study received Jul 25, 1980 under 1023 61; submitted by Upjohn Co., Kalamazoo, Mich.; CDL: 242996 C)

00046030 Nappier, J. L.; Hornish, R. E.; Lane, R. E. ( 1976) Total Residue Method for U 36,059 1,5 Di( 2,4 dimethylphenyl) 3 methyl 1,3,5 triazapenta 1,4 diene in Oranges: Report No. 315 9760 70. Method dated Mar 24, 1976. ( Unpublished study received Jul 25, 1980 under 1023 61; submitted by Upjohn Co., Kalamazoo, Mich.; CDL: 242996 D)

00051717 Holifield, E. L.; Bowers, R. C.; Lee, B. L.; et al. ( 1975) Residue Data for Baam on Pears. ( Unpublished study received Jun 24, 1976 under 6F1817; submitted by Upjohn Co., Kalamazoo, Mich.; CDL: 096422 E)

00051929 Nappier, J. L.; Hornish, R. E. ( 1975) Total Residue Method for U 36,059... in Apples, Pears and Soils: Report No. 315 9760 32. Method dated Sep 26, 1975. ( Unpublished study received Dec 18, 1975 under 1023 EX 34; submitted by Upjohn Co., Kalamazoo, Mich.; CDL: 094993 D)

00051930 Upjohn Company ( 1975) Comparison of the Analytical Residue Procedures for U 36,059 and U 40,481 ( Used in 1973 and 1974) with the Degradative Procedure ( Used in 1975). ( Unpublished study received Dec 18, 1975 under 1023 EX 34; submitted by Upjohn Co., Kalamazoo, Mich.; CDL: 094993 E)

00055718 Somerville, L.; Nicholson, J. E. ( 1977) BTS 27 419 Metabolism in Apples, Variety Cox's Orange Pippin. ( Unpublished study received Oct 7, 1974 under 5G1558; submitted by Upjohn Co., Kalamazoo, Mich.; CDL: 094250 C)

00160391 Nor Am Chemical Co. ( 1984) Residue Chemistry: Discussion of Amitraz Residue Data in Hogs. Unpublished compilation. 80 p. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 23 00161022 McGibbon, A.; Kelly, I. ( 1984) Metabolism of Carbon 14 Amitraz in Pears: ( An Interim Report): Study No. 44L: Report No. METAB/ 84/ 4. Unpublished study prepared by FBC Ltd., Chesterford Park Research Station. 20 p.

00161023 McGibbon, A.; Kelly, I. ( 1984) The Metabolism of Carbon 14 ¿  Amitraz in Lemons under Glasshouse Conditions: ( An Interim Report): Study No. 52L: Report No. METAB/ 84/ 6. Unpublished study prepared by FBC Ltd., Chesterford Park Research Station. 16 p.

00162073 Nor Am Chemical Co. ( 1986) Amitraz Residues in Hog Skin and Processed Food Made from Hog Skins. Unpublished compilation. 101 p.

40590601 Smith, S.; Campbell, J. ( 1988) M73 Metabolism of Carbon 14 Amitraz in Lemons: Laboratory Project ID ENVIR/ 87/ 44. Unpublished study prepared by Schering Agrochemicals Limited. 64 p. 64 p.

40590801 Fortsch, A. ( 1988) M77 Amitraz: The Fate of Amitraz in Cotton: Late Season Application: Laboratory Project ID UPSR 5/ 88. Unpublished study prepared by Schering AG. 76 p.

40811305 Phillips, M.; Swalwell, L.; Needham, D. ( 1988) M74 Identification of Metabolites of Amitraz in the Milk and Meat of a Cow Dosed for 4 Days with Amitraz: Report No. ENVIR/ 87/ 46. Unpublished study prepared by Schering Agrochemicals Ltd. 31 p.

40811306 Manley, J.; Snowden, P. ( 1988) R274 Amitraz derived Residues Containing the 2,4 Dimethylaniline Moiety in the Tissue and Milk of Cattle Following a 28 Day Feeding Study in the UK, 1987: Laboratory Project ID RESID/ 87/ 117. Unpublished study prepared by Schering Agrochemicals Ltd. 44 p.

40811307 Roberts, N.; Cameron, D.; Redgrave, V. ( 1988) R274A Amitraz Technical Residues in Milk and Tissues of Dairy Cows Animal Phase: Laboratory Project ID SMS/ 81/ 884: Sponsor's Project No. 082/ 05/ 011. Unpublished study prepared by Huntingdon Research Centre. 29 p.

40811308 Manley, J.; Snowdon, P. ( 1988) R 249 Stability of Amitraz, BTS 272 71, and BTS 27919 Residues in Animal Tissues and Milk During Deep Freeze Storage: Laboratory Project ID RESID/ 87/ 122. Unpublished study prepared by Schering Agrochemicals Ltd. 31 p.

40811309 Chambers, J.; Longland, R.; Stalley, F. ( 1988) R222 2nd edn. Stability of the Amitraz Metabolites BTS 27271 and BTS 27919 in Oranges During Deep Freeze Storage: Interim Report to 18 Months: Laboratory Project ID RESID/ 87/ 125. Unpublished study prepared by Schering Agrochemicals Ltd. 38 p.

40811310 Manley, J.; Snowdon, P. ( 1988) R206 2nd edn. Analytical Method for the Determination of Combined Residues of Amitraz and Metabolites Hydrolysing to 2,4 Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 24 Dimethylaniline in Animal Tissues, Milk and Eggs by Gas Chromatography: Laboratory Project ID RESID/ 87/ 108. Unpublished study prepared by Schering Agrochemicals Ltd. 42 p.

40811311 Castro, L. ( 1988) R254 Behaviour of Amitraz, BTS 27271 HCl, and BTS 27919 Through EPA Multiresidue Protocol II: Laboratory Project ID 12013A. Unpublished study prepared by Nor Am Chemical Co. 35 p.

40811312 Bardalaye, P. ( 1988) R259 Amitraz and its Metabolites, BTS 27217 and BTS 27919, Through EPA Multiresidue Protocol III: Laboratory Project ID 12013B. Unpublished study prepared by Nor Am Chemical Co. 30 p.

40999502 Fortsch, A. ( 1988) M79 the Fate of Amitraz in Cotton Seed: Project ID: UPSR 73/ 88. Unpublished study prepared by Schering Ag. 52 p.

40999503 Needham, D.; Hemmings, P. ( 1988) ( M75) the Metabolism and Distribution of Amitraz Residues in the Laying Hen Following the Daily Oral Administration of 24.5 mg carbon 14 Amitraz per Bird for 4 Days: Project ID: Envir/ 88/ 6. Unpublished study prepared by Schering Agrochemicals Ltd. 40 p.

40999504 Manley, J.; Snowdon, P. ( 1988) R266 Amitraz Derived Residues Containing the 2,4 Dimethylaniline Moiety in the Tissue and Eggs of Laying Hens Following a 28 Day Feed Study in the UK, 1987: Project ID: RESID/ 88/ 42. Unpublished study prepared by Schering Agrochemicals Ltd. 38 p.

40999505 Roberts, N.; Hakin, B. ( 1988) R266A Amitraz Technical: Residues in the Eggs and Tissues of the Laying Hen Following Administration by Oral Gavage for 28 Days: Project ID: RESID/ 88/ 42. Unpublished study prepared by Huntingdon Research Centre. 39 p.

40999506 Catro, L. ( 1988) R257: Total Terminal Residues of Amitraz and its Major Metabolites in Ginned Cottonseed Resulting from Application of Mitac EC in Trials Conducted in the USA in 1987: Project ID: 12016. Unpublished study prepared by NOR AM Chemical Co. 70 p.

40999507 Castro, L. ( 1988) ( R258) Effects of Processing on Total Residues of Amitraz, BTS 27271, AND bts 27919 in Ginned Cottonseed from Trials Conducted in the USA in 1987: Project ID: 12017. Unpublished study prepared by NOR AM Chemical Co. 51 p.

40999508 Kelly, I. ( 1988) ( R262) Frozen Storage Stability of Amitraz in Cottonseed: Project ID: 12004. Unpublished study prepared by NOR AM Chemical Co. 22 p.

40999509 Castro, L. ( 1988) R272 = W104: Residues of Amitraz and its Major Metabolites in Soil and Rotational Crops Following Application of Mitac EC to Cotton: Project ID: 12010. Unpublished study prepared by NOR AM Chemical Co. 95 p. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 25 41206701 Smith, S. ( 1989) M80 The Metabolism of Amitraz in Pears: Proj. ID ENVIR/ 89/ 21. Unpublished study prepared by Schering Agrochemicals Ltd. 47 p.

41295501 Brady, S. ( 1989) R294: Amitraz: Residues of Amitraz in Honey and Beeswax from Hives Treated with 10.0% Amitraz Strips in North Carolina, 1989: Lab Project Number: R122/ 12/ 89. Unpublished study prepared by Nor Am Chemical Co. 46 p.

41295502 Brady, S. ( 1989) R295: Amitraz: Residues of Amitraz in Honey and Beeswax from Hives Treated with 10.0% Amitraz Strips for 104 Days, Florida, 1989: Lab Project Number: R122/ 06/ 89. Unpublished study prepared by Nor am Chemical Co. 46 p.

41295503 Bardalaye, P. ( 1989) R259 Amitraz and Its Metabolites, BTS 27271 and BTS 17919, Through EPA Multiresidue Protocol III: Lab Project Number: 12013B. Unpublished study prepared by Nor Am Chemical Co. 30 p.

41444201 Brady, S.; Castro, L. ( 1990) ( R296) Total Residues of Amitraz and Major Metabolites at Harvest in Cottonseed Treated with Ovasyn, USA 1988: Lab Project Number: R122.01.88. Unpublished study prepared by NOR AM Chemical Co. 291 p.

41444202 Brady, S. ( 1989) ( R258) Amendment 1: Effects of Processing on Total Residues of Amitraz, BTS 27271, and BTS 27929 in Ginned Cottonseed from Trials Conducted in the USA in 1987: Lab Project Number: 12017. Unpublished study prepared by NOR AM Chemical Co. 18 p.

41444203 Snowdon, P. ( 1988) ( R266 Addendum) Amitraz Derived Residues Contain ing 2,4 Dimethylaniline Moiety in the Tissues and Eggs of Laying Hens Following a 28 day Feeding Study in the UK, 1987: Lab Project Number: RESID/ 88/ 42. Unpublished study prepared by Schering Agrochemicals Ltd. 27 p.

41478901 Brady, S. ( 1989) Total Amitraz derived Residues in Ginned Cottonseed and Hulls following Applications of Ovasyn to Cotton prior to Boll Opening, USA 1989: Study Number: R122.15.89. Unpublished study prepared by Nor am Chemical Co. 62 p.

41637302 Castro, L. ( 1990) Residues of Amitraz in Rotational Crops following Treatment of Cotton with Ovasyn, USA 1988/ 1989: Lab Project Number: R122.08.88. Unpublished study prepared by Analytical BioChemistry Laboratories, Inc. 494 p.

42044502 Cron, J. ( 1982) R146 Amitraz: Analysis of Residues in Hops From Trials with Amitraz in the UK, 1980: Lab Project Number: RESID/ 82/ 85. Unpublished study prepared by Schering Agrochemicals Limited. 16 p.

42044503 Chambers, J.; Snowdon, P. ( 1991) R305 Amitraz Derived Residues Containing the 2,4 Dimethylaniline Moiety in Hops, Spent Hops and Beer Following Application of a 20EC Formulation in the Federal Republic of Germany 1988: Lab Project Number: RESID/ 90/ 115. Unpublished study prepared by Schering Agrochemical Ltd. 28 p. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 26 42161301 Longland, R. ( 1987) R64 2nd Edn: Amitraz: Method of Analysis for Residues of Amitraz and All Metabolites Hydrolysing to 2,4 dimethylaniline in Miscellaneous Crops: Lab Project Number: RESID/ 86/ 91. Unpublished study prepared by Schering Agrochemicals Ltd. 91 p.

42632001 Castro, L. ( 1993) Frozen Storage Stability of Amitraz and Its Major Metabolites BTS 27271 and BTS 27919 in Hog Fat and Muscle: Lab Project Number: 12001. Unpublished study prepared by Nor Am Chemical Co. 47 p.

42667001 Vukich, J. ( 1993) Discussion of the Metabolism Database Available for Amitraz. Unpublished study prepared by Nor Am Chemical Company. 15 p.

42673901 Fordham, L.; Campbell, J. ( 1993) M83 ( AMITRAZ): The Uptake of Amitraz and its Soil Metabolites by Rotational Crops ( Wheat, Lettuce, Radish) and Emergency Plantings under Glasshouse Conditions: Lab Project Number: ENVIR/ 93/ 001: 107L. Unpublished study prepared by Schering Agrochemicals Ltd. 112 p.

42812801 Lauber, J.; Kanter, S. ( 1993) Survey of Swine Experts Concerning the Pre Slaughter Interval ( Time between Treatment and Slaughter) with the Use of Taktic Emulsifiable Concentrate Miticide/ Insecticide and/ or Taktic Linebacker Pour On Insecticide. Unpublished study prepared by Hoechst Roussel Agri Vet Co. 44 p.

42969301 Hawkins, D.; Elsom, L.; Winwick, T. et al. ( 1993) An Investigation of the Nature of the Tissue Metabolites in Pigs Following Dermal Administration of ( carbon 14) Amitraz: Lab Project Number: HST/ 392. Unpublished study prepared by Huntingdon Research Centre Ltd. 153 p.

43287101 Hawkins, D.; Elsom, L.; Curtis, R. et al. ( 1994) Response to EPA Memorandum dated February 15, 1994: Amitraz: Reregistration List A Case No. 0234/ Chemical ID No. 106201. Nature of the Residue in Pigs Following Dermal Application of ( carbon 14) Amitraz. MRID No. 42969301. CBRS No. 12801. DB Barcode No. D196559: Lab Project Number. Unpublished study prepared by Huntingdon Research Center Ltd., Hoechst Veterinar Gmbh. 24 p.

43369901 Snowdon, P. ( 1993) Amitraz 20 EC ( CR 19055: Mitac HF), Green and Dried Hops: Combined AI and Metabolite Residues; Germany 1992: Lab Project Number: RESID/ 93/ 36: R346: 082/ 03/ 117. Unpublished study prepared by Schering Agrochemicals Ltd. 24 p.

43369902 Snowdon, P. ( 1993) Amitraz 20 EC ( CR 19055: Mitac HF), Green and Dried Hops: Combined AI and Metabolite Residues; Czechoslovakia 1992: Lab Project Number: RESID/ 93/ 38: R348: 082/ 03/ 119. Unpublished study prepared by Schering Agrochemicals Ltd. 24 p. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 27 43369903 Snowdon, P. ( 1993) Amitraz 20 EC ( CR 19055: Mitac HF), Green and Dried Hops: Combined AI and Metabolite Residues; UK 1992: Lab Project Number: RESID/ 93/ 89: R352: 082/ 03/ 120. Unpublished study prepared by Schering Agrochemicals Ltd. 24 p.

43370301 Brady, S. ( 1994) At harvest Residues of Amitraz In or On Pears Resulting from Two Applications of Mitac EC or Mitac WP Using Both a 14 Day and a 30 Day Interval Between Applications, USA and Canada, 1991: Lab Project Number: L 91R 01: JES 01: 108 065. Unpublished study prepared by Nor Am Chemical Co. 173 p. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 28 Agency Memoranda Citations Table 8. Agency Memoranda Citations.

Date DP Barcode CB No. From To MRID Nos. Subject 12/ 3/ 82   E. Zager C. Trichilo and Toxicology Branch None 83 PR 02. Proposed Section 18 exemption for the use of amitraz on cattle, goats, and sheep in Puerto Rico.

2/ 2/ 83   R. Loranger J. Ellenberger and Toxicology Branch None 45639 EUP 9. Request for use of amitraz in ear tags on beef cattle and hogs.

7/ 11/ 84   E. Haeberer J. Ellenberger and Toxicology Branch 00143111 00160391 PP# 4F3081. Amitraz in the Meat, Fat, and Meat By

Products of Hogs. Evaluation of Analytical Methods and Residue Data.

10/ 15/ 86  1241 F. Griffith D. Edwards and Toxicology Branch 00162073 PP# 4F3081. Amitraz in the Meat, Fat, and Meat Byproducts of Hogs. Evaluation of the July 9, 1986 Amendment.

5/ 5/ 88  3515 and 3735 F. Suhre D. Edwards 40590601 PP# 2F2705/ FAP# 2H5353; 45639 EUP; Amitraz for Use on Citrus.

5/ 11/ 88  3402 and 3403 F. Suhre D. Edwards 40590801 PP# 7G3547; 45639 EUP 27; Amitraz for Use on Cotton;

Revised Section G.

1/ 10/ 89  4374 and 4375 M. Kovacs D. Edwards and Toxicology Branch II 40811300 40811312 PP# 2F2705/ FAP# 2H5353  Amitraz on Citrus Fruits

Amendment of August 26, 1988.

1/ 10/ 89     M. Kovacs L. Sawyer 40811311 40811312 Submission of Multiresidue Test Information for Amitraz to FDA.

5/ 31/ 89  5008, 5009,

5020, 5021,

5121, and 5122 M. Flood D. Edwards and Toxicology Branch 40999501 40999508 PP# 9F3742: 45639 EUP 39. OVASYN Insecticide/ Miticide ( Amitraz) in/ on Cotton.

PP# 9F3730: 45639 RUA: OVASYN ( Amitraz) in/ on Cotton.

4/ 19/ 90   S. Koepke L. Sawyer 41295503 Submission of Multiresidue Test Information for Amitraz to FDA. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 Table 8. Agency Memoranda Citations.

Date DP Barcode CB No. From To MRID Nos. Subject 29 5/ 7/ 90  6046 S. Koepke D. Edwards/ P.

Johnson and Toxicology Branch I 41295500 41295503 PP# 0F3825 Amitraz on/ in honey and beeswax.

Evaluation of Analytical Methods and Residue Data.

5/ 17/ 90  6592 M. Flood D. Edwards 41444200 41444203 PP# 9F3730: OVASYN Insecticide/ Miticide ( Amitraz)

in/ on Cotton.

6/ 4/ 90  6446 R. Cook D. Edwards None PP# 9F3772 Amitraz in Meat, Fat, and Meat Byproducts of Goats and Sheep. Amended Section F and B.

Submission dated 2/ 19/ 90.

6/ 11/ 90  6665 M. Flood D. Edwards and Toxicology Branch 41478901 PP# 9F3730. OVASYN ® Insecticide/ Miticide ( Amitraz)

in/ on Cotton. Submission dated 5/ 8/ 90.

12/ 31/ 91 D162246 7747 C. Swartz D. Edwards 41798705 41798706 Amitraz. Request for registration of a new pour on mineral oil based formulation of Taktic ® to control lice and mange mites on hogs. EPA ID. No. 45639 RUO.

4/ 6/ 92 D173972 9371 C. Swartz M. Fiol 42133501 Amitraz. ID No. 106201. List A Reregistration Case No. 0234.

7/ 20/ 92 None None C. Swartz The Metabolism Committee None Amitraz. List A Reregistration Case No. 0234.

Outcome of the 7/ 15/ 92 Meeting of the HED Metabolism Committee.

8/ 21/ 92 D174990,

D181748,

and D181628 9299, 10401, and 10412 F. Griffith D. Edwards and Toxicology Branch 42161301 42161305 42178001 42044501

42044503 FAP # 2H5618  Amitraz ( Mitac ® ) on Dried Hops.

Evaluation of Analytical Method and Residue Data, and the August 12 and 17, 1992 Amendments.

9/ 25/ 92 D176531,

D181751,

and D182145 9682, 10400, and 10511 F. Griffith D. Edwards and Toxicology Branch 41798705 42247501 PP# 2F4110  Amitraz ( Taktic ® ) on Hogs. Review of Residue Data and Analytical Methods and Amendments of August 17 and 21, 1992. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 Table 8. Agency Memoranda Citations.

Date DP Barcode CB No. From To MRID Nos. Subject 30 9/ 29/ 92 D179596 10058 F. Griffith D. Edwards and J. Kariya None PP# 6F1872 Amitraz on Pears, PP# 4F3081 and 2F4110 Amitraz on Hogs, PP# 0F3825 Amitraz on Honey and Beeswax, PP# 9F3730 Amitraz on Cottonseed, Poultry,

and Eggs, PP# 9F3772 Amitraz in Sheep and Goats,

FAP# 2H5618 Amitraz on Dried Hops. Anticipated Dietary Exposure Estimates.

12/ 29/ 92 D185142 10964 L. Cheng M. Fiol None Amitraz. Swine Dermal Metabolism Protocol.

7/ 20/ 93 D189026 11538 G. Kramer D. Edwards 42673901 ID# 045639 RUA Ovasyn. Review of confined rotational study of amitraz ( N'[ 2,4 Dimethylphenyl] N

[[( 2,4 dimethylphenyl) imino] methyl]

Nmethylmethanimidamide

7/ 27/ 93 D185748,

D187485, D188495,

and D192950 11052, 11310, 11431, and 12228 F. Griffith D. Edwards 42496001 41068401

41068404 40650707 42632001 42667001 PP# 2F4110  Amitraz ( Taktic ® ) on Hogs. Review of the December 16, 1992; January 19, February 12, and July 12, 1993, Amendments.

8/ 4/ 93 D189989 11698 F. Griffith D. Edwards and A. Kocialski None PP# 6F1872  Amitraz on Pears, PP# 4F3081 and PP#

2F4110  Amitraz on Hogs, PP# 0F3825  Amitraz on Honey and Beeswax, PP# 9F3730  Amitraz on Cottonseed, Poultry, and Eggs, PP# 9F3772  Amitraz in Sheep and Goats, FAP# 2H5618  Amitraz on Dried Hops. Anticipated Dietary Exposure Estimates,

Addendum.

8/ 20/ 93 D186339 and D192447 11122 and 12073 F. Griffith R. Quick 42812801 PP# 2F4110  Amitraz ( Taktic ® ) on Hogs. Review of the Petitioner's Minutes from the December 14, 1992 Meeting with EPA, and Use Data for a Longer PSI.

9/ 17/ 93 D192357 12032 C. Swartz N. Thoa None Amitraz. List A Case No. 0234/ Chemical ID No.

106201. Reregistration Eligibility Document: Product and Residue Chemistry Chapters.

11/ 29/ 93 D195591 12643 G. Kramer D. Edwards 41637302 40999509 ID# 045639 00146 Amitraz. Review of limited field rotational crop studies. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 Table 8. Agency Memoranda Citations.

Date DP Barcode CB No. From To MRID Nos. Subject 31 2/ 15/ 94 D196559 12801 C. Swartz L. Propst and D.

Edwards 42969301 Amitraz. Reregistration List A Case No. 0234/ Chemical ID No. 106201. Nature of the Residue in Pigs Following Dermal Application of 14C Amitraz.

7/ 27/ 94 D205793 14068 C. Swartz D. Edwards None Amitraz. List A Reregistration Case No. 0234/ Chemical ID No. 106201. Anticipated Residues in Pears.

8/ 4/ 94 D205735 14088 C. Swartz E. Saito and D.

Edwards None Amitraz. Reregistration List A Case No. 0234/ Chemical ID No. 106201. Hoechst Roussel Submission to Upgrade a Swine Dermal Metabolism Study.

8/ 18/ 94 D206605 14188 C. Swartz D. Edwards None Amitraz. List A Reregistration Case No. 0234/ Chemical ID No. 106201. Anticipated Residues in Pears.

9/ 8/ 94 D207131 14291 C. Swartz D. Edwards None Amitraz. List A Reregistration Case No. 0234/ Chemical ID No. 106201. Revised Anticipated Residues in Pears.

9/ 20/ 94 D197514 and D205238 12939 and 14056 F. Griffith D. Edwards None PP# 2F4110  Amitraz ( Taktic ® ) on hogs. Review of the December 7, 1993, Amendment and RD Concerns on the Dermal Metabolism Study.

11/ 8/ 94 D207742,

D208224, D208225, D208229, D208232, D208234, D208247, D208356, D208360, D208365,

and D208394 14418, 14516

14520, 14522, 14539, 14540, 14542, and 14543 F. Griffith D. Edwards and A. Kocialski 43369901 43369903 PP# 4E4349  Amitraz ( Mitac ® ) on Hops. Evaluation of residue data and analytical method and the October 12 and 17,1994 amendments.

11/ 18/ 94 D209191 14673 C. Swartz D. Edwards 43370301 Amitraz. List A Reregistration Case No. 0234/ Chemical ID No. 106201. Inclusion of Residue Data Generated to Support Registration of Amitraz for Use on Pears in Canada in the Anticipated Residue Assessment for Pears. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 Table 8. Agency Memoranda Citations.

Date DP Barcode CB No. From To MRID Nos. Subject 32 12/ 2/ 94 D209867 14743 C. Swartz D. Edwards 43396802 Amitraz. List A Reregistration Case No. 0234/ Chemical ID No. 106201. Consideration of Pear Processing Data.

12/ 8/ 94 None None N. Thoa and J.

Redden E. Saito None The Revised HED Chapter of the Reregistration Eligibility Decision Document ( RED) for Amitraz, Case # 0234 ( Pesticide Chemical Code 106201; Reg. Group A)

1/ 12/ 95 D210571 14886 F. Griffith D. Edwards and A. Kocialski None PP# 4E4349  Amitraz ( Mitac ® ) on Hops. Evaluation of the November 28, 1994, amendment.

1/ 23/ 95 D210892 14963 F. Griffith D. Edwards 43287101 PP# 2F4110  Amitraz ( Taktic ® ) on hogs. Review of the submission to Upgrade the Porcine Dermal Metabolism Study.

2/ 16/ 95 D211688 15073 F. Griffith D. Edwards and J. Smith None PP# 2F4110  Amitraz ( Taktic ® ) on Hogs. Review of the February 1, 1995, Amendment. Amitraz Residue Chemistry Considerations  TRED Barcode: D300301 33 APPENDIX 1 Food/ Food Use Pattern Table for Amitraz Generated by BEAD/ OPP