Document ID: EPA-HQ-OPP-2008-0271-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-07-14T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		November 28, 2008

Subject:		Indoxacarb.  Section 3 Registration Request to Add New Uses on
the Bushberry Crop Subgroup 13-07B and Beets (Garden).  Summary of
Analytical Chemistry and Residue Data.    

PC Code:  067710	DP Barcode No.:  356925

Decision No.:  390597	Registration No.: 352-597

Petition No.:  8E7324	Regulatory Action: Amended Section 3 Registration

Risk Assessment Type: NA	Case No.: NA

TXR No.:  NA	CAS No.: 173584-44-6

MRID No.:  47341001 & 47341002	40 CFR:  §180.564

		              									Ver.Apr.08

	From:	Peter Savoia, Chemist

		Reregistration Branch 3

		Health Effects Division (7509P)

	Through:	William H. Donovan, Ph.D., Chemist 

		Reregistration Branch 3

		Health Effects Division (7509P)

		

	To:	Daniel Rosenblatt, Risk Manager

		Risk Integration, Minor Use & Emergency Response Branch

		Registration Division (7505P)

This document was originally prepared under contract by Dynamac
Corporation (1910 Sedwick Road, Building 100, Suite B, Durham, NC
27713).  The document has been reviewed by the Health Effects Division
(HED) and revised to reflect current Office of Pesticide Programs (OPP)
policies.

Executive Summary

Indoxacarb, (S)-methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate, is an
insecticide active ingredient (ai) developed by DuPont for the control
of lepidopteran pests on fruit, vegetable, and field crops.  

Permanent tolerances are established under 40 CFR 180.564(a) for the
combined residues of indoxacarb and its inactive R-enantiomer on a
number of plant as well as livestock commodities.  In cooperation with
the registrant DuPont, the Interregional Research Project No. 4 (IR-4)
has submitted Petition No. 8E7324 requesting new crop uses of
indoxacarb.  In this petition, IR-4 is proposing that permanent
tolerances for residues of indoxacarb be established in/on the following
raw agricultural commodities (RACs):   

Beet, garden, roots	0.30 ppm

Beets, garden, tops	6.0 ppm

Bushberry, crop subgroup 13-07B	1.5 ppm

The end-use product relevant for this petition is the Avaunt®
insecticide formulation (EPA Reg. No. 352-597).  It is a
water-dispersible granular (WDG) product which contains 30% of the
indoxacarb ai by weight.  For this petition, its prescribed use will
allow up to four broadcast foliar treatments to be made at the maximum
rate of 0.11 lb ai/A/application using ground or aerial equipment, for a
combined total of 0.44 lb ai/A/season.  A specified minimum retreatment
interval (RTI) of 3 days for garden beets and 7 days for bushberries is
put forward along with a minimum preharvest interval (PHI) of 7 days for
both types of crops.  In situations where it can be difficult to achieve
adequate coverage, the proposed label specifies that an adjuvant may be
used to improve performance.   

Well before this action, the relevant residues of concern for indoxacarb
tolerance enforcement and risk assessment were established by the
Metabolism Assessment Review Committee (MARC).  Based on the available
cotton, lettuce, and tomato metabolism studies, the nature of indoxacarb
residue in plants was concluded to be adequately understood.  It was
determined that indoxacarb along with its R-enantiomer are the residues
of concern to be used in risk assessment and the tolerance expression
for crops (DP No. D263986, S. J. Levy, 07/10/2000).  Adequate studies on
the lactating cow and laying hen are also available which depict the
metabolism of indoxacarb in livestock.  Based on these studies, the MARC
has determined that the tolerance expression for milk and ruminant
commodities will include indoxacarb and its R-enantiomer (DP No.
D263986, S. J. Levy, 07/10/2000).  For risk assessment, the MARC
determined indoxacarb and its R-enantiomer to be the residues of concern
for ruminants, but for milk, this expression will also include the
metabolite IN-MP819.  As for poultry commodities, the MARC has
determined that for risk assessment purposes the residues of concern are
indoxacarb, its R-enantiomer, and the metabolites IN-JT333, IN-JU873,
IN-KB687, IN-KG433, IN-KT319, 5-HO-IN-JT333, and Metabolite F (DP No.
277922, S. J. Levy, 04/10/2001).  Whereas, the tolerance expression for
poultry commodities will include indoxacarb, its R-enantiomer, and only
the metabolites IN-JT333, IN-JU873, IN-KB687, IN-KG433, and IN-KT319 (DP
No. 297936, S. J. Levy, 09/22/2004).    

Two High Performance Liquid Chromatograph/Ultraviolet Detection
(HPLC/UV) methods, DuPont protocols AMR 2712-93 and DuPont-11978, are
available for enforcing tolerances established on crops.  A third Gas
Chromatograph/Mass-Selective Detection (GC/MSD) procedure, DuPont method
AMR 3493-95 Supplement No. 4, is also available for the confirmation of
residues in plants.  The limits of quantitation (LOQs) for the HPLC/UV
methods were determined for a variety of plant RACs to range from
0.01-0.05 ppm with limits of detection (LODs) ranging from 0.0025-0.006
ppm.  For the GC/MSD data collection procedure, the LOQs range from
0.2-1.0 ppm with LODs ranging from 0.0008-0.21 ppm depending upon the
crop matrix being analyzed.  In regard to the enforcement of tolerances
established for livestock commodities, DuPont method AMR 3337-95 is
another HPLC/UV protocol developed by the registrant to perform these
analyses.  This method offers an LOQ of 0.01 ppm with LODs determined to
range from 0.002-0.003ppm.  These protocols are all common moiety
methods which work to provide a total measure of concentration by
determining both indoxacarb and its R-enantiomer as a single component. 

For this petition, the blueberry and garden beet field trial studies
were carried out using different analytical procedures to determine the
combined residues of indoxacarb which were found.  An HPLC/UV procedure
derived from Dupont Report No. AMR 2712-93 was used to quantitate
blueberries.  Alternately, a Gas Chromatogrph/Nitrogen-Phosphorus
Detector (GC/NPD) technique derived from Dupont Report No. AMR 4271-96
was used to quantitate garden beets.  Both methods were adequately
validated in conjunction with the sample analyses which were performed. 
For these data submissions, the validated LOQs for residues of
indoxacarb were determined to be 0.02 ppm in blueberries along with 0.01
ppm for the garden beet roots and tops which were analyzed.

Provided that label revisions are made, the field trial data submitted
for this petition are adequate to support the proposed use of indoxacarb
on the bushberry crop subgroup 13-07B and garden beets.  A
representative number of tests were conducted on both blueberries and
garden beets in the appropriate geographic regions.  Applications were
made at the proposed maximum labeled seasonal use rate following the
recommended re-treatment interval (RTI) and pre-harvest interval (PHI)
specified for each RAC.  Samples were all analyzed using adequate
analytical methods with sample holding intervals supported by storage
stability data generated concurrently with each field trial study.  As
such, the compiled residue data support the proposed 1.5 ppm tolerance
for bushberry crop subgroup 13-07B along with the garden beet levels of
0.30 ppm for roots and 6.0 ppm for tops.  

In granting this action, the proposed new uses of indoxacarb will have
no impact on the dietary burden of livestock because there are no feed
items associated with bushberries and garden beets.  As a result, all
existing tolerances established for livestock commodities remain
adequate for this petition.  For rotational crops, these data
requirements have already been fulfilled in earlier actions made to
obtain the prior registered crop uses of indoxacarb.  In accordance, the
current plant-back restrictions on the label remain adequate with no
additional studies being needed to support the use of indoxacarb on
busberries and garden beets proposed in this petition.

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

Pending the revision of Sections B and F, there are no residue chemistry
deficiencies that preclude the granting of unconditional registrations
of indoxacarb for use on bushberry crop subgroup 13-07B and beets
(garden).  The proposed use-pattern and supporting data are sufficient
to support permanent tolerances for the combined residues of the
insecticide indoxacarb and its R-enantiomer in/on:       

Beet, garden, roots	0.30 ppm

Beet, garden, tops	6.0 ppm

Bushberry, crop subgroup 13-07B	1.5 ppm

A human health risk assessment for indoxacarb will be prepared as a
separate document.

 

860.1200 Directions for Use

	•	The available blueberry and garden beet field trial data did not
provide results supporting the use of an adjuvant in the spray mix. 
Therefore, the Section B proposed label directions should be amended to
prohibit the use of adjuvants in applications made to bushberries and
garden beets.

	•	The bushberry commodities specified on the proposed label
directions for use did not list lingonberry under the crops available
for treatment.  Following registration of the bushberry crop subgroup
13-07B, if so inclined, the petitioner should feel free to specify
lingonberry on the Section B proposed label directions as being
appropriate for use.

860.1550 Proposed Tolerances

	•	A revised Section F must be submitted which consistently denotes
the bushberry crop subgroup designation as being 13-07B in their
submission proposing tolerance levels. 

Note to RD

The tolerances currently listed under 40 CFR 180.564(a) for indoxacarb
do not include any of the combined residue levels previously determined
to be relevant for poultry commodities (DP No. D297936, S. J. Levy,
09/22/2004).  Accordingly, a separate section of 40 CFR 180.564 must be
prepared specifying the combined residues of indoxacarb, its
R-enantiomer, and the metabolites IN-JT333, IN-JU873, IN-KB687,
IN-KG433, and IN-KT319 as the tolerance expression for poultry stated
as:

Tolerances for the combined residues of (R,S)-Methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]am
ino]-carbonyl]indeno[1,2-e][1,3,4]-oxadiazine-4a(3H)-carboxylate, and
metabolites Methyl
7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)-phenyl]amino]carbonyl]ind
eno-[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate, Methyl
5-chloro-2,3-dihydro-2-hydroxy-1-[[[[4-(trifluoromethoxy)phenyl]amino]-c
arbonyl]hydrazono]-1H-indene-2-carboxylate, Methyl
[4-(trifluoro-methoxy)phenyl]-carbamate, Methyl
5-chloro-2,3-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-trifluoromethoxy
0phenyl]amino]carbonyl]hydrazono]1H-indene-2-carboxylate and (E)-methyl
5-chloro-2,3-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-(trifluoromethox
y)phenyl]amino]-carbonyl]hydrazono]-1H-indene-2carboxylate in and on the
 following poultry commodities:       

Egg	0.20 ppm

Poultry, fat	0.20 ppm

Poultry, meat	0.06 ppm

Poultry, meat byproducts	0.06 ppm

Background

Indoxacarb is an oxadiazine insecticide (Group 22) used for controlling
the larval stages of lepidopteran pests on a variety of fruit,
vegetable, and field crops.  It is a reduced-risk insecticide registered
to Dupont as the WDG Avaunt® (EPA Reg. No. 352-597) and Steward®
suspension concentrate (EPA Reg. No. 352-598) end-use products.  These
formulations contain an isometric mixture of 75% indoxacarb
(insecticidally active S-enantiomer; DPX-KN128) and 25% of the
R-enantiomer (insecticidally inactive; IN-KN127).  In general, the
percentage of active ingredient (ai) listed on the product labels and
the corresponding use rates specified for each crop are based solely on
the amount of indoxacarb.

As an alternative to organophosphate insecticides, indoxacarb works by
blocking the sodium channels in the insect nervous system through
ingestion and contact routes.  Applications are to be made at the
labeled use rates when insect populations reach locally determined
economic thresholds.  Follow-up treatments should be made as needed to
control insect populations for the purposes of forming a comprehensive
integrated pest management program.  Permanent tolerances are
established under 40 CFR 180.564(a) for the combined residues of
indoxacarb and its inactive R-enantiomer (DP Nos. 325479, 326516, 326544
& 333333, S. J. Levy, 03/09/2007).  Plant commodities specified for
tolerance enforcement range at levels from 0.01 ppm in/on peanuts and
potatoes up to 50.0 ppm for alfalfa hay.  Tolerances are also
established for several livestock commodities which range at levels from
0.03 ppm in meat byproducts up to 4.0 ppm in milk fat.  

IR-4 has submitted field trial data in support of a petition proposing
tolerances for the use of Avaunt® on bushberry crop subgroup 13-07B and
garden beets.  IR-4 proposes using Avaunt® on bushberries to control
the cranberry fruitworm, cherry fruitworm, and winter moth as well as on
garden beets to manage beet armyworm infestation.  The nomenclature and
physicochemical properties of indoxacarb are presented below in Tables 1
and 2 for review.

TABLE 1.	Indoxacarb Nomenclature.

Compound	

Common name	Indoxacarb

Company experimental name	DPX-KN128

IUPAC name	  SEQ CHAPTER \h \r 1 (S)-methyl
7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]am
ino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate

CAS name	  SEQ CHAPTER \h \r 1 methyl
(4aS)-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4
a(3H)-carboxylate

CAS registry number	173584-44-6

End-use product (EP)	30% WDG (DuPont Avaunt® Insecticide; EPA Reg. No.
352-597)

Compound	

Common name	IN-KN127 (inactive R-enantiomer)

TABLE 2.	Physicochemical Properties of Indoxacarb

Parameter	Value	Reference

Melting point/range	140-141ºC	DP# D244253, S. Levy, 1/19/2000

pH	5.32 at 25ºC

	Density	1.34 at 20ºC

	Water solubility	15.4 ± 2.3 ppb in pH 5 buffer

	Solvent solubility	1.72 g/L in n-heptane; 14.5 g/L in 1-octanol; 103
g/L in methanol; 117 g/L in o-xylene; 139 g/L in acetonitrile; 160 g/L
in ethyl acetate; and >250 g/kg in methylene chloride, acetone, and
dimethyl-formamide

	Vapor pressure	2.5 x 10-8 Pa

	Dissociation constant, pKa	Does not dissociate at pHs of 2.42-11.36

	Octanol/water partition coefficient, Log(KOW)	4.65 at pH 5

	UV/visible absorption spectrum	Molar absorptivities at 3 maxima were
affected by pH, but not over wavelengths of environmental significance.

	860.1200  Directions for Use

™ Avaunt® Insecticide (EPA Reg. No. 352-597) to include new uses on
the bushberry crop subgroup 13-07B and garden beets.  The petitioner has
provided a summary of the proposed new crop applications along with an
example label from DuPont containing the use directions.  The proposed
new uses are summarized below in Table 3.

Table 3.	Summary of Directions for Use of Indoxacarb.

Applic. Timing, Type, and Equip. 1	Formulation

[EPA Reg. No.]	Applic. Rate 

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

(lb ai/A)	PHI

(days)	Use Directions and 

Limitations 2

Bushberries 3

Broadcast foliar applications when insects reach economic thresholds;
ground or air equipment	30% WDG

[352-597]	0.11	4	0.44	7	A minimum 7-day RTI is specified.

Apply in a minimum of 10 or 20 gal/A for aerial and ground applications,
respectively.

Do not apply dilute applications of more than 200 gal/A.

Garden beet

Broadcast foliar applications when insects reach economic thresholds;
ground or air equipment	30% WDG

[352-597]	0.11	4	0.44	7	A minimum 3-day RTI is specified.

Apply in a minimum of 5 or 10 gal/A for ground and aerial applications,
respectively.

1	Do not apply through any type of irrigation system, expect for
application to cranberry, mint, potato, and sweet corn, and as allowed
on supplemental labels.

2	Applications may include the use of an adjuvant.  Rotational crop
restrictions:  crops with labeled uses and alfalfa, cotton, peanuts and
soybeans may be planted immediately following harvest of a treated crop.
 Do not plant any food or feed crops not registered for use with
indoxacarb for 30 days after last use. 

3	Includes aronia berry, high and low bush blueberries, Chilean guava,
currants (black, buffalo, native and red), European barberry,
elderberry, gooseberry, highbush cranberry, honeysuckle, huckleberry,
jostaberry, juneberry, lingonberry, salal, and sea buckthorn.

Conclusions.  The new label directions are adequate in allowing for an
evaluation of the residue data to be made relative to the proposed new
uses.  The available blueberry and garden beet field trial data are
sufficient to support treatments of the Avaunt® 30% WDG end-use product
of indoxacarb to be made at the proposed application rates.  Although
the proposed label allows for the use of adjuvants, the blueberry and
garden beet field trial data provided did not include any results for
treatments made with these additives in the spray mix.  Therefore, the
label directions should be amended to prohibit the use of adjuvants in
applications to bushberries and garden beets.  The petitioner should
also note that the bushberry commodities specified on the proposed label
directions for use did not list lingonberry under the crops available
for treatment.  Following registration of the bushberry crop subgroup
13-07B, if so inclined, the petitioner should feel free to specify
lingonberry on the Section B proposed label directions as being
appropriate for use.

860.1300 Nature of the Residue – Plants.

  SEQ CHAPTER \h \r 1 Adequate metabolism studies on cotton, lettuce,
and tomatoes were previously reviewed in conjunction with an earlier
indoxacarb petition (DP No. D244253, S. J. Levy, 01/19/2000).  Based
upon these studies, the MARC determined that indoxacarb and its
R-enantiomer were the relevant residues of concern to be established for
the tolerance enforcement and risk assessment of crops (DP No. D263986,
S. J. Levy, 07/10/2000). 

Conclusions.  For the purposes of this petition, the available plant
metabolism data will also support the new uses of indoxacarb proposed
for bushberries and garden beets.  

860.1300 Nature of the Residue – Livestock.

Adequate ruminant and poultry metabolism studies were previously
reviewed in conjunction with an earlier indoxacarb petition (DP No.
D244253, S. J. Levy, 01/19/2000).  Based on these studies, the MARC has
determined that the tolerance expression for milk and ruminant
commodities will include indoxacarb and its R-enantiomer (DP No.
D263986, S. J. Levy, 07/10/2000).  For the purposes of risk assessment,
the MARC at this time determined that indoxacarb and its R-enantiomer
are likewise the residues of concern for ruminants.  In conjunction, the
MARC went on to determine that the residues of concern in milk for risk
assessment will be indoxacarb and its R-enantiomer along with the
metabolite IN-MP819. 

For poultry commodities, the MARC has determined that for risk
assessment purposes the residues of concern are indoxacarb, its
R-enantiomer, and the metabolites IN-JT333, IN-JU873, IN-KB687,
IN-KG433, IN-KT319, 5-HO-IN-JT333, and Metabolite F (DP No. 277922, S.
J. Levy, 04/10/2001).  

However, the MARC concluded at this time that additional data were still
needed to determine if finite indoxacarb residues are incurred in
poultry through feed items so that tolerances could be established.

Through the submission of a subsequent feeding study (MRID No.
46114302), adequate data were appropriately provided which established
the relevant residues of concern needed for tolerance enforcement in
poultry.  In accordance, the tolerance expression for poultry
commodities will include indoxacarb, its R-enantiomer, and the
metabolites IN-JT333, IN-JU873, IN-KB687, IN-KG433, and IN-KT319 (DP No.
297936, S. J. Levy, 09/22/2004).   

Conclusions.  As previously noted, there are no livestock feedstuffs
associated with the proposed new indoxacarb uses on bushberries and
garden beets.  Therefore, data requirements for livestock metabolism are
not relevant to this tolerance petition.

860.1340 Residue Analytical Methods

Enforcement Methods  

A number of adequate methods are available for enforcing indoxacarb
tolerances on both plant and livestock commodities.  These protocols are
all common moiety methods which work to provide a total measure of
concentration by determining both indoxacarb and its R-enantiomer as a
single component. 

The primary protocol for the tolerance enforcement of plant commodities
is DuPont method AMR 2712-93 which is an HPLC/UV procedure.  It has been
validated by the Agency and forwarded to the FDA for inclusion in PAM
Vol. II (DP No. D267339, S. J. Levy, 10/12/2000).  For this method,
residues are extracted with acetonitrile (ACN):hexane and centrifuged. 
Residues in the ACN phase are purified by solid-phase extraction (SPE)
using silica gel and strong anion exchange (SAX) cartridges.  Residues
are then determined by column switching HPLC/UV (310 nm) using C18 and
cyano columns, with an external standard.  The method LOQs are 0.01-0.05
ppm for a variety of plant commodities, and the LOD is 0.0025 ppm.

For the confirmation of residues in plant commodities, DuPont method AMR
3493-95 Supplement No. 4 is a GC/MSD procedure which is also available
for use.  This method has also been validated by the Agency and
forwarded to the FDA accordingly (DP No. D282821, S. J. Levy,
05/09/2002).  For this method, residues are extracted with ethyl
acetate:water and filtered, and residues in the ethyl acetate fraction
are concentrated and purified using silica gel and carbon SPE
cartridges.  Residues are then determined by GC/MSD using an external
standard.  Residues are quantified using the m/z 527 ion, and
confirmatory analyses utilize the 218, 321 and 527 ions.  The method LOQ
ranges from 0.2 to 1.0 ppm depending on the matrix, and the LODs are
0.0008-0.21 ppm.

    

Another HPLC/UV procedure developed by the registrant, DuPont-11978, is
also available for use to perform tolerance enforcement analyses on
crops (DP No. D313518, S. J. Levy, 02/18/2005).  This protocol works by
uniquely combining the extraction procedure of method AMR-3493-95 with
the cleanup and determination techniques developed in method AMR
2712-93.  For this procedure, residues are extracted with ethyl
acetate:water, and residues in the ethyl acetate fraction are purified
by SAX SPE and determined by column switching HPLC/UV (310 nm) using
cyano and C18 columns, with an external standard.  For grape matrices,
the method LOQ is 0.01 ppm and the LOD is 0.006 ppm.

       

To enforce the current tolerances established for livestock commodities,
DuPont method AMR 3337-95 is another HPLC/UV developed by the registrant
which is available for use.  It is capable of determining residues of
the parent compound as well as the metabolite IN-JT333 in livestock
commodities.  This method has also been validated by the Agency and
forwarded to the FDA for inclusion in PAM Vol. II (DP No. 267339, S. J.
Levy, 10/12/2000).  Depending on the matrix, residues extracted with
either ACN, ACN:hexane or ethyl acetate.  Residues are then purified by
solvent partitioning between ACN and hexane, followed by cleanup by SPE
using either C18 or silica gel cartridges.  Residues are determined by
column switching HPLC/UV (310 nm) using cyano and C18 columns, with an
external standard.  The method LOQ is 0.01 ppm and the LOD is
0.002-0.003 ppm.  Residues can be confirmed by GC/MSD using the m/z 527
and 469 ions.

For poultry commodity analyses, DuPont method AMR 12739 is a Liquid
Chromatograph/Mass Spectrometer/Mass Spectrometer (LC/MS/MS) procedure
developed by the registrant for use.  This method has been successfully
validated using hen muscle, liver, skin, and fat as well as, whole egg,
egg yolk, and egg white samples proving it to be adequate for data
collection (MRID No. 46116302).   

Subsequently, an amended version of this protocol, DuPont method AMR
12739 Revision No. 1, has been submitted to the Agency (MRID No.
46308004).  It incorporates the minor findings of the independent
laboratory validation which was undertaken to determine the proficiency
of the DuPont LC/MS/MS procedure (MRID No. 46308003).  The revised
DuPont method appears suitable for the enforcement of poultry tolerances
and will be forwarded to ACL/BEAD for petition method validation.

Data Collection Methods  

In the crop field trial studies submitted in support of this petition,
residues of indoxacarb were all determined using procedures derived from
the proven analytical methods developed by the registrant.  Each data
collection method used was adequately validated concurrently with the
sample analyses that were performed.  This was done using control
samples fortified at concentrations to bracket the expected residue
levels of total indoxacarb that were anticipated.  Acceptable recoveries
were obtained for all of the commodities tested to demonstrate that each
analytical protocol performed adequately.

The measurement data compiled for the blueberry study provided by the
petitioner were generated by the IR-4 satellite laboratory in Fargo, ND,
using a GC/NPD procedure.  The IR-4 protocol is derived from the
“Testing of DFG Method S19 for the determination of Residues of KN128
Along with KN127 in Crops Which Might Be Treated with DPX-MP062”,
DuPont Study No. AMR 4271-96.   The DuPont procedure is a data
collection method developed for plants which provides a total measure of
concentration by determining indoxacarb and its R-enantiomer as a single
component.  The primary modifications made to the DuPont method included
both enhancements made to the sample preparation sequence as well as the
actual instrumental analyses.

In general, the blueberries are homogenized frozen in the presence of
dry ice using an acetone/water solvent mixture.  The homogenate is then
salinized with sodium chloride and ethyl acetate/cyclohexane (1:1) is
added to the mixture followed by continued homogenization to effectuate
sample extraction.  The mixture is then allowed to settle and 200 mL of
the supernatant liquid is decanted from the blender jar.  The organic
solvent is removed from the extract and the remaining residue is
dissolved in a small amount of ethyl acetate.  Water is then removed
from the extract and cyclohexane added to result in a 1:1 ethyl
acetate/cyclohexane extract solution.  The extract is cleaned using
Biobead XAD-8 size exclusion and silica gel absorption columns.  The
final extract is then dissolved in toluene and determined by GC/NPD
analysis.  For this procedure, the LLMV was determined to be 0.02 ppm in
blueberries.  The LOQ was statistically calculated to be 0.026 ppm and
the LOD 0.009 ppm, respectively.

The measurement data compiled for the garden beet study provided by the
petitioner were generated by the IR-4 North Central Region Research
Center in Lansing, MI, using an HPLC/UV procedure.  The IR-4 protocol is
derived from the “Analytical enforcement method (HPLC/Column
Switching/UV) for the determination of residues of DPX-KN128 and
IN-KN127 in Crops”, DuPont Report No. AMR 2712-93.  The DuPont
procedure is the principle tolerance enforcement method for plants which
provides a total measure of concentration by determining indoxacarb and
it’s R-enantiomer as a single component.  The primary modification to
the DuPont enforcement method was that column switching is not used in
the HPLC analyses made by IR-4 with their protocol.  

For the analysis of garden beets, residues are extracted using an
ACN:hexane (2:1, v/v) solvent mixture added to 10 grams of sample.  The
solvent mixture obtained is then cleaned up by vacuum filtration
followed by partition.  Residues are further cleaned up in the ACN
solvent phase through purification by SPE using silica gel and SAX
cartridges.  The resulting final extracts are then concentrated to an
appropriate volume for analysis.  Final determination is then made using
an HPLC/UV instrumental technique configured with a single 5-micron
cyano column and quantitated through the use of an external standard. 
For this procedure, the LLMV was determined to be 0.01 ppm in garden
beets for both the roots and tops.  The LOQ was statistically calculated
to be 0.005 ppm for roots and 0.02 ppm for tops.  In conjunction, the
LOD was likewise calculated to be 0.002 ppm for roots and 0.006 ppm for
tops.

Conclusions.  Adequate methods are available for enforcing the
indoxacarb tolerance levels which are being proposed for bushberries and
garden beets.  Field trial studies were appropriately made to support
the new uses determining residue levels in these crops with GC/NPD and
HPLC/UV data collection methods.  In all, both data collection
procedures used for testing were adequately validated prior to and in
conjunction with the analysis of field samples.

860.1360 Multiresidue Methods

 ≥30%.  However, indoxacarb and its R-enantiomer were found to be
completely recovered through Protocol D but it was noted that matrix
enhancement effects were observed in certain samples.  In accordance,
the indoxacarb multiresidue testing results obtained were appropriately
forwarded to FDA for their review and concurrence (DP No. D260953, S. J.
Levy, 11/03/1999).

860.1380 Storage Stability

Storage stability data have been reviewed for a number of commodities in
  SEQ CHAPTER \h \r 1 conjunction with earlier indoxacarb petitions (DP
No, D244253, S. J. Levy, 01/19/2000; DP No. D256351, S. J. Levy,
09/07/2000 & DP No. 290172, S. J. Levy, 04/14/2004).  These results
indicate that indoxacarb residues are relatively stable in frozen
storage on a wide variety of plant commodities such as apple juice for a
period of 6 months.  It was even found to be stable frozen for 12 months
in broccoli, wet apple pomace, wet grape pomace, wine, tomatoes, and
peppers, as well as in cotton hulls, meal and refined oil.  Most
notably, for durations as long as 13-15 months in pears, cabbage,
lettuce, cottonseed, and cotton gin byproducts, 18 months in apples and
grapes, and even up to 19-23 months in corn forage, stover and ears. 

In furthering the above mentioned data, concurrent storage stability
studies were carried out along with the blueberry and garden beet field
trials that were undertaken to support this petition.  To corroborate
the storage intervals incurred for these studies, replicate control
samples were fortified with indoxacarb at 0.1-1.0 ppm and placed in
frozen storage along with the field trial samples.  Although no 0-day
analysis was conducted for the stored samples, average corrected
recoveries of 98% for blueberries along with 104% and 98% for the garden
beet roots and tops were obtained.  Reflecting the maximum storage
interval for the treated crops, blueberry samples stored at ≤-8ºC
were found to be stable for up to 513 days (16.9 months).  Similarly,
garden beet root and top samples stored at ≤-15ºC were observed to be
stable for up to 530 days (17.4 months).  As such, the storage durations
and conditions of fortified control samples from the crop field trials
submitted to support this petition are presented below in Table 4 for
review.  

≤-8	476	513

Garden beet roots	≤-15	515	530

Garden beet tops

519

	Conclusions.  The concurrent storage stability studies are inadequate
due to a lack of 0-day data for the fortified samples stored for
testing.  However, given the fact that corrected recoveries were
determined which averaged 98-104%, the data obtained will support the
storage intervals incurred in the field trials for purposes of this
petition.  

860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the current petition as no
aquatic uses are being proposed. 

860.1460 Food Handling

This guideline requirement is not relevant to the current petition as no
food handling uses are being proposed. 

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed use on
bushberries or garden beets.  Therefore, data requirements pertaining to
meat, milk, poultry, and eggs are not relevant to this current petition.

860.1500 Crop Field Trials

DER References: 	47341001.der (blueberry)

			47341002.der (garden beet)

In cooperation with the registrant DuPont, IR-4 has submitted field
trial data on blueberries and garden beets for the insecticide
indoxacarb.  These data are provided to support Petition No. 8E7324
requesting that permanent indoxacarb tolerances be established for use
on bushberry crop subgroup 13-07B and garden beets.  A summary of this
residue data is presented below in Table 5 for review.

Table 5.	Summary of Residue Data from Crop Field Trials with Indoxacarb.

Crop matrix	Total Applic. Rate (lb ai/A)	PHI (days)	Residue Levels (ppm)
1

	n	Min.	Max.	HAFT 2	Median	Mean	Std. Dev.

Blueberry (proposed use = 0.44 lb ai/A total application rate, 7-day
PHI)

Blueberry	0.431-0.459	6-8	26	0.20	1.04	1.04	0.56	0.57	0.23

Garden Beet (proposed use = 0.44 lb ai/A total application rate, 7-day
PHI)

Garden beet roots	0.434-0.451	7	10	0.11	0.22	0.22	0.18	0.16	0.04

Garden beet tops

	10	1.31	3.96	3.83	2.19	2.47	0.96

1	Residues of indoxacarb and its inactive R-enantiomer are detected as a
single component.  The LLMV is 0.01 ppm for beet roots and tops and 0.02
ppm for blueberries.  The calculated LOQs are 0.005 ppm for beet roots,
0.02 ppm for beet tops, and 0.026 ppm for blueberries.

2	HAFT = Highest average field trial result.

Blueberry (Bushberry Crop Subgroup 13-07B)

To determine the magnitude of indoxacarb residue in/on blueberries,
thirteen (13) field trials were conducted in the United States and
Canada during the 2003 growing season.  Trials were carried out in NAFTA
growing zones 1 (ME: 1trial), 1A (Nova Scotia: 3 trials), 2 (NJ, GA &
NC: 3 trials), 5 (MI: 3 trials), 5B (Quebec: 1 trial), and 12 (OR & WA:
2 trials).  Nine (9) highbush and four (4) lowbush varieties of
blueberry were cultivated for this study.  For the trials undertaken in
the United States, nine (9) sites were used to cultivate both varieties
of blueberry.  In keeping with the requirements of the OPPTS 860.1500
Residue Chemistry Test Guidelines, eight (8) designated domestic field
trials of the highbush variety with a residue decline study included are
suggested.   

The blueberry field trial results in this data submission demonstrate
the application of indoxacarb pesticides made at the 1x maximum directed
labeled use rate.  It illustrates the allowed use of four broadcast
foliar sprays of the 30% WDG Avaunt® indoxacarb formulation.  All
applications were made during fruit development following re-treatment
intervals (RTIs) of 6-9 days at the nominal rate of 0.11-0.12 lb
ai/A/application.  The number and location of field trials comprising
this study were sufficient with respect to geographic representation of
residue data for this RAC.  The OPPTS 860.1500 Residue Chemistry Test
Guidelines recommend use of the highbush variety of blueberry for eight
(8) designated domestic field trials.  However, HED notes that the
highest residue values in the submitted trials were obtained from the
lowbush varieties of blueberry.  

For the determination of total indoxacarb residues in/on blueberries, an
acceptable method was used with adequate storage stability data being
generated concurrently to support this study.  Total indoxacarb residues
were found to range from 0.20-1.04 ppm in/on blueberries harvested at
6-8 DALA.  Average indoxacarb residues at 6-8 DALA were 0.57 ppm, and
the HAFT residue was 1.04 ppm, respectively.  No residue decline study
was included in any of the field trials made herein to support the use
of indoxacarb on the bushberry crop subgroup 13-07B.  In all, these data
adequately represent the proposed use pattern of indoxacarb made to
blueberries (4 applications at 0.11 lb ai/A/application with a minimum
PHI of 7 days and an RTI of 7).  

Beets (Garden)  

For determining the magnitude of indoxacarb residue found in/on garden
beets and its rate of decline, five (5) field trials were conducted
during the 2004 growing season.  The trials for this study were carried
out in NAFTA growing zones 1 (NY; 1 trial), 5 (OH and WI; 2 trials), 6
(TX; 1 trial), and 12 (OR; 1 trial).  The number and location of field
trials comprising this study were sufficient with respect to geographic
representation of residue data for this RAC.  At each test location,
four broadcast foliar treatments of indoxacarb (30% WDG) made at RTIs of
2-4 days were applied to garden beets during root development.  Each
treatment was made at the nominal rate of 0.106-0.115 lb
ai/A/application for a combined total seasonal rate of 0.434-0.451 lb
ai/A.  No adjuvant was added to the spray mixture used for any of the
applications which were made. 

The garden beet field trial results in this data submission demonstrate
the application of indoxacarb pesticides made at the 1x maximum directed
labeled use rate.  It was appropriately carried out in line with the
requirements set forth in the OPPTS 860.1500 Residue Chemistry Test
Guidelines.  For the determination of total indoxacarb residues in/on
garden beets, an acceptable method was used with adequate storage
stability data being generated concurrently to support this study. 
Total indoxacarb residues were found to range from 0.11-0.22 ppm in/on
roots and 1.31-3.96 ppm in/on tops at 7 DALA.  Average indoxacarb
residues at 7 DALA were 0.16 ppm for roots and 2.47 ppm for tops, and
the HAFT residues were 0.22 ppm for roots and 3.83 ppm for tops,
respectively.  For the residue decline study carried out in part with
this crop field trial, total indoxacarb concentrations were found to
decrease in both garden beet roots and tops with later sampling
intervals.  In all, these data adequately represent the proposed
seasonal use pattern of indoxacarb made to garden beets with a minimum
PHI of 7 days and an RTI of 3 days put forward in this study.

Conclusions.  The blueberry and garden beet field trials are adequate,
provided that the label is amended to preclude the addition of adjuvants
to the spray mix.  A sufficient number of trials were conducted on each
crop at 1x the maximum proposed rate in the appropriate geographic
regions with the proper representative RACs being collected for
analysis.  Samples were analyzed using adequate analytical methods, and
the sample storage intervals are supported by the available storage
stability data.

Although no decline trials were conducted on blueberries, none are
required for purposes of this petition.  Adequate residue decline data
are available on mustard greens, spinach, celery, cantaloupe, grapes and
cranberries indicating that indoxacarb residues decline at longer
post-treatment intervals (DP No. D290126, S. J. Levy, 02/18/2005 & DP
No. D325479, S. J. Levy, 03/09/2007).  In all, the residue data provided
are adequate in supporting the proposed tolerances of 1.5 ppm on the
bushberry crop subgroup 13-07B along with 0.30 ppm and 6.0 ppm for the
garden beet roots and tops. 

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with bushberries or garden beets.  Therefore, data
requirements for processed food and feed are not relevant to this
current petition.

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

An analytical standard for the insecticide indoxacarb is currently
available in the EPA National Pesticide Standards Repository.  The
indoxacarb standard has an expiration date of 4/2013 with analytical
reference standards being replenished as requested by the Repository. 
The reference standards should be sent to the Analytical Chemistry
Laboratory located in Fort Meade to the attention of either Theresa Cole
or Thuy Nguyen at the following address:

	U.S. EPA

	National Pesticide Standards Repository/ Analytical Chemistry
Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD 20755-5350

Please note that mail will be returned if the entire extended zip code
is not used when addressing correspondence to the Repository. 

860.1850/860.1900 Confined and Field Accumulation in Rotational Crops

An adequate confined rotational crop study was reviewed in conjunction
with an earlier indoxacarb petition (DP No. D244253, S. J. Levy,
01/19/2000).  From this data the MARC has concluded that the residues of
concern in rotated crops should include only the parent expression of
indoxacarb and its R-enantiomer (DP No. D263986, S. J. Levy,
07/10/2000).  In addition, it was determined that these available data
are adequate in supporting a 30-day plant-back interval for all
non-labeled crops (DP No. D256351, S. J. Levy, 09/07/2000).  As a
result, no additional rotational crop data are required for the current
petition.

 

860.1550 Proposed Tolerances

There are sufficient metabolism study data available for the MARC to
determine that the tolerance expression for plants should only be the
parent compound which includes indoxacarb and its R-enantiomer. 
Permanent tolerances are established under 40 CFR 180.564(a) for the
combined residues of indoxacarb and its inactive R-enantiomer on a
number of plant as well as livestock commodities.  Plant commodities
specified for tolerance enforcement range at levels from 0.01 ppm in/on
peanuts and potatoes up to 50.0 ppm for alfalfa hay.  Tolerances are
also established for several livestock commodities which range at levels
from 0.03 ppm in meat byproducts up to 4.0 ppm in milk fat.

To further develop the use of indoxacarb, IR-4 has submitted field trial
data in part with a petition proposing tolerances for the use of
Avaunt® on bushberry crop subgroup 13-07B and garden beets.

The tolerances being proposed by the petitioner are listed below in
Table 6 along with the Agency’s recommended tolerance levels.  There
are no changes required in the current animal tolerances because the
proposed new uses do not include any crops which provide livestock feed
items.  The recommended tolerances on bushberry crop subgroup 13-07B,
along with those for garden beet roots and tops, were determined using
the Agency’s Guidance for Setting Pesticide Tolerances Based on Field
Trial Data.  Tolerance calculations made with the provided residue data
along with the resulting spreadsheet outputs were all generated
following the Agency’s guidance and are presented in Appendix II for
review. 

For these purposes, the available residue data on blueberries will
support the establishment of a tolerance level for the bushberry crop
subgroup 13-07B.  Likewise, the residue data available are adequate to
establish tolerance levels on garden beet roots and tops.  There are no
established or proposed Canadian maximum residue limits (MRLs) for
residues of indoxacarb, but MRLs for residues of indoxacarb have been
established on a variety of crops by both Codex and Mexico. 
Nonetheless, international harmonization is not an issue for this
petition because there are no proposed and/or established Codex or
Mexican MRLs for indoxacarb on any bushberries or beets. 

Table 6. 	Tolerance Summary for Indoxacarb.

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

Beet, garden, roots	0.30	0.30	Adequate data are available

Beet, garden, tops	6.0	6.0	Adequate data are available

Bushberry, subgroup 13-07B	1.5	1.5	Adequate data are available

References

DP#:	D263986

Subject:	Results of HED Metabolism Assessment Review Committee (MARC)
Meeting of 06/12/2000.  Indoxacarb (DPX-MP062).  PP#8F04948.

From:	S. J. Levy/M. Copley

To:	G. F. Kramer

Dated:	07/10/2000

MRID#:	None

DP#:	D277922

Subject:	Indoxacarb:  Results of Health Effects Division (HED)
Metabolism Assessment Review Committee (MARC) Meeting of 09/18/2001.
PP#: 000352-00594.

From:	S. J. Levy/J. Kidwell

To:	Y. Donovan

Dated:	10/04/2001

MRID#:	None

  SEQ CHAPTER \h \r 1 DP#s:	297936

Subject:	Indoxacarb.  Review of Amendment Submitted in Response to
HED’s Memorandum of 19-JAN-2000.

From:	S. J. Levy

To:	R. Kumar/D. Kenny

Dated:	09/22/2004

MRID#:	46114302  SEQ CHAPTER \h \r 1 

DP#s:	325479, 326516, 326544, and 333333

Subject:	PP#s:  5E6911, 5E6926 and 5E6991.  Indoxacarb.  Petitions for
Tolerances on Vegetable, Leafy, Except Brassica (Group 4), Pome Fruits
(Group 11, except pear), Tuberous and Corm Vegetables (Subgroup 1C),
Cucurbit Vegetables (Group 9), Stone Fruits (Group 12), Cranberry, Mint,
Okra, and Southern Pea.  Summary of Analytical Chemistry and Residue
Data.  

From:	S. J. Levy

To:	G. F. Kramer

Dated:	03/09/2007

MRID#:	46520901, 46520902, 46487001, 46487002, 46651501-46651507

DP#s:	D244253, D244460, D245424, D248057

Subject:	PP#8F04948. New Chemical - Indoxacarb (DPX-MP062) in/on
Brassica, Sweet Corn, Cotton, Fruiting Vegetables, Lettuce (Head and
Leaf) and Pome Fruits. Evaluation of Residue Data and Analytical
Methods.

From:	S. J. Levy/S. Chun

To:	D.Peacock/A. Layne

Dated:	01/19/2000

MRID#s:	44477101-44477112, 44477317, 44477318, 44477321-44477344,
44477401-44477417, 44583301, 44815204 44815801-44815803,
44815805-44815808, 44491704.

MRID#:	46114302 McLean, C., Swain, R.  (2003) Magnitude of Residues of
Indoxacarb (As DPX-MP602) in Laying Hen Tissue and Eggs: A Feeding Study
Conducted to EPA Guidelines, Lab Project Number: DuPont-8305; Inveresk
#200491.  Unpublished study prepared by Inveresk Research, PTRL Europe
GmbH, and DuPont.  844 pages.

DP#:	D267339

Subject:	Memo to Mark Wirtz of FDA regarding Enforcement Methods for
Plant and Animal Commodities.

From:	S. J. Levy

To:	M. Wirtz

Dated:	10/12/2000

MRID#s:	44477330-4477332, 44491704, 44477327, and 44477338

DP#:	D282821

Subject:	Memo to Mark Wirtz of FDA regarding Enforcement Method for
Indoxacarb.

From:	S. J. Levy

To:	M. Wirtz

Dated:	05/09/2002

MRID#:	45384306

DP#:	313518

Subject:	Memo to Mark Wirtz of FDA regarding Enforcement Methods for
Plant Commodities.

From:	S. J. Levy

To:	M. Wirtz

Dated:	02/18/2005

MRID#:	45900303

MRID#: 	46308004 Stry, J.  (2004) Analytical Method for the
Determination of DPX-MP062 and Metabolites IN-KB687, IN-KG433, IN-KT319,
IN-JU873, and IN-JT833 in Poultry Skin, Liver, Muscle, and Eggs.  Lab
Project Number: DuPont-12739.  Unpublished study prepared by Dr. Specht
& Partner and DuPont.  158 pages.

MRID#:	46308003 Connelly, P.  (2004) Independent Laboratory Validation
of the Analytical Method, DuPont-12739, “Analytical Method for the
Determination of DPX-MP062 and Metabolites IN-KB687, IN-KG433, In-KT319,
IN-JU873, and IN-JT333 in Poultry Skin, Liver Muscle, and Eggs.  Exygen
Project Number: P0000493.  Unpublished study prepared by Exygen
Research.  53 pages.

 

DP#:	D260953

Subject:	PP# 8F04948.  Multiresidue Method Testing of DPX-JW062.

From:	S. J. Levy

To:	F. Griffith

Dated:	11/03/1999

MRID#:	44477340

  SEQ CHAPTER \h \r 1 DP#s:	D256351 and D256354

Subject:	ID# 000352-LOU.  Indoxacarb (DPX-MP062).  Additional Data to
Amend HED’s Residue Data and Analytical Methods in/on Brassica, Sweet
Corn, Cotton, Fruiting Vegetables, Lettuce (Head and Leaf) and Pome
Fruits Memorandum (D267325, S. Levy 1-Jan-2000) and Response to
Petitioner’s Proposal to Lower Plant-back Intervals for Non-Labled
Crops.  

From:	S. Levy

To:	D. Peacock/T. Levine

Dated:	09/07/2000

MRID#s:	44815801-44815808  SEQ CHAPTER \h \r 1 

  SEQ CHAPTER \h \r 1 DP#s:	D290172

Subject:	Indoxacarb.  Review of Amendment Submitted in Response to
HED’s Memorandums of 19-JAN-2000 and 07-SEP-2000.

From:	S. J. Levy

To:	R. Kumar/D. Kenny

Dated:	04/14/2004

MRID#s:	45795818 and 45795819  SEQ CHAPTER \h \r 1 

  SEQ CHAPTER \h \r 1 DP#s:	290126 and 293792

Subject:	Indoxacarb in/on Grapes, Brassica Leafy Vegetables, and Turnip
Greens.  Summary of Analytical Chemistry and Residue Data.  Petition#s:
3F6576 and 2E6482.

From:	S. J. Levy

To:	A. Hanger

Dated:	02/18/2005

MRID#s:	45718701, 45718702, 45900301, and 45900303

  SEQ CHAPTER \h \r 1 Attachments:  

Appendix I - International Residue Limit Status sheet

Appendix II - Tolerance Assessment Calculations

Template Version September 2005

Appendix I.  International Residue Limit Status Sheet

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoro
methoxy)phenyl]amino]carbonyl]
indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate	Common Name:
Indoxacarb

	X Proposed tolerances

( Reevaluated tolerance

( Other	Date:  07/02/08

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

( No Codex proposal step 6 or above

X No Codex proposal step 6 or above for the crops requested	Petition
Number:  8E7324

DP Barcode:  351087

Other Identifier:  DPX-MP062; DPX-JW062; DPX-KN128

Residue definition (step 8/CXL): Indoxacarb	Reviewer/Branch:  D. Drew,
RRB3

	Residue definition:  

Combined residues of indoxacarb + its R-enantiomer

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

Beet, garden, roots	0.30

Beet, garden, tops	6.0

Bushberry, subgroup 13-07B	1.5

Limits for Canada	Limits for Mexico

X No Limits

( No Limits for the crops requested	( No Limits

X No Limits for the crops requested

Residue definition:  N/A	Residue definition: Indoxacarb

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

	Notes/Special Instructions:

Appendix II.  Tolerance Assessment Calculations.

The dataset used to establish tolerances for indoxacarb residues on
bushberries and garden beet roots and garden beet tops consisted of
field trial data representing application rates of ~0.44 lb ai/A (4
applications at 0.11 lb ai/A/application) with a 7-day PHI.  As
specified by the Agency’s Guidance for Setting Pesticide Tolerances
Based on Field Trial Data, the field trial application rates are within
25% of the maximum label application rate.  The values for indoxacarb
residues in/on blueberries are provided in Table II-1 and the values for
indoxacarb residues in/on garden beet roots and tops are provided in
Table II-2.

The indoxacarb residue data on blueberries, garden beet roots and garden
beet tops were entered into the tolerance spreadsheet.  Visual
inspection of the lognormal probability plots (Figures II-1, II-3 and
II-5) provided in the spreadsheets indicates that the datasets are
reasonably lognormal.  The results from the approximate Shapiro-Francia
test statistic (Figures II-2, II-4 and II-6) confirmed the assumption of
lognormality for residues of indoxacarb on blueberries, garden beet
roots and garden beet tops.

As the field trial data for indoxacarb on blueberries represent a large
dataset (i.e. greater than 15 samples) and are reasonably lognormal, the
minimum of the 95% upper confidence limit (UCL) on the 95th percentile
and the point estimate of the 99th percentile was selected as the
tolerance value.  Because this value was the minimum, 1.5 ppm is the
recommended tolerance level for indoxacarb in/on blueberries, which is
the representative crop for the bushberry subgroup 13-07B.  Therefore
the recommended tolerance level for indoxacarb in/on the bushberry
subgroup 13-07B crop group is 1.5 ppm.  

Because the field trial data for indoxacarb on garden beet roots and
tops represent a small dataset (i.e. less than 15 samples), the upper
bound estimate of the 95th percentile based on the median residue value
was compared to the minimum of the 95% upper confidence limit (UCL) on
the 95th percentile and the point estimate of the 99th percentile, and
the minimum value was selected as the tolerance value.  Using the
rounding procedure as outlined in the Guidance for Setting Pesticide
Tolerances Based on Field Trial Data SOP, the 99% UCL on the 99th
percentile rounds to the value 0.30 ppm for roots and 6.0 for tops
(Figures II-4 and II-6).  Because these values were the minimum values,
0.30 ppm is the recommended tolerance level for indoxacarb residues
in/on garden beet roots and 6.0 ppm is the recommended tolerance level
for indoxacarb residues in/on garden beet tops.



Table II-1.	Indoxacarb Residues in/on Blueberry.

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Blueberry

PHI:	6-8 days

App. Rate:	0.43-0.46 lb ai/A/season

Submitter:	IR-4

MRID Citation:	MRID 47340101

	Residues

	0.20

	0.27

	0.28

	0.30

	0.32

	0.35

	0.38

	0.38

	0.42

	0.51

	0.52

	0.53

	0.55

	0.56

	0.58

	0.58

	0.59

	0.63

	0.73

	0.80

	0.81

	0.81

	0.84

	0.84

	1.03

	1.04

	



 

 

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.	Lognormal Probability Plot of Indoxacarb Residues in/on Blueberry.

Figure II-2.	Data Summary Table for Indoxacarb Residues in/on Blueberry.



Table II-2.	Indoxacarb Residues in/on Garden Beet Roots and Tops.  

Regulator:	EPA

Chemical:	Indoxacarb

Crop:	Beet, garden, root	Beet, garden, tops

PHI:	7 days

App. Rate:	0.44 lb ai/A/season

Submitter:	IR-4

MRID Citation:	MRID 47340102

	Residues	Residues

	0.11	1.31

	0.12	1.31

	0.12	1.86

	0.13	1.88

	0.18	2.15

	0.18	2.23

	0.18	3.01

	0.19	3.28

	0.21	3.70

	0.22	3.96



Figure II- 3.	Lognormal Probability Plot of Indoxacarb Residues in/on
Garden Beet Roots.

Figure II- 4.	Data Summary Table for Indoxacarb Residues in/on Garden
Beet Roots.

Figure II-5.	Lognormal Probability Plot of Indoxacarb Residues in/on
Garden Beet Tops.

Figure II-6.	Data Summary Table for Indoxacarb Residues in/on Garden
Beet Tops.

Indoxacarb	Summary of Analytical Chemistry and Residue Data	DP No.: 
356925

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