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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

Date: 02-May-2013

Subject: Indoxacarb. Petition for the Establishment of Permanent Tolerances and 

Registration for Use on Dry Bean, Snap Bean, Small Fruit Vine Climbing 

Subgroup (except kiwifruit) 13-07F and Low Growing Berry Subgroup (except 

strawberry) 13-07H. Summary of Analytical Chemistry and Residue Data.

PC Code: 067710 DP Barcode: D408982

Decision No.: 464583 Registration No.: 352-579 and 352-638

Petition No.: 2E8029 Regulatory Action: New Tolerance

Risk Assessment Type: NA Case No.: NA

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

MRID No.: 48788901 and 48788902 40 CFR: §180.564

From: Ideliz Negrón-Encarnación, Ph.D., Chemist

 Risk Assessment Branch V

Health Effects Division (HED; 7509P)

Through: Danette Drew, Senior Chemist

 Risk Assessment Branch V

Health Effects Division (HED; 7509P)

To: Laura Nollen, Risk Manager Reviewer

Risk Management Division (7505P)
Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D408982

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Table of Contents

1.0 Executive Summary................................................................................................... 3

2.0 Regulatory Recommendations................................................................................... 4

2.1 Data Deficiencies/Data Needs................................................................................. 5

2.2 Tolerance Considerations........................................................................................ 5

2.2.1 Enforcement Analytical Method...................................................................... 5

2.2.2 Recommended Tolerances............................................................................... 5

2.2.3 Revisions to Petitioned-For Tolerances........................................................... 6

2.2.4 International Harmonization ............................................................................ 6

3.0 Introduction................................................................................................................ 7

3.1 Chemical Identity .................................................................................................... 8

3.2 Physical/Chemical Characteristics.......................................................................... 8

3.3 Pesticide Use Pattern/Directions for Use (860.1200).............................................. 9

4.0 Metabolite/Degradate Residue Profile..................................................................... 11

4.1 Nature of the Residue............................................................................................ 11

4.1.1 Summary of Plant Metabolism (860.1300).................................................... 11

4.1.3 Summary of Confined Rotational Crops (860.l850)...................................... 12

4.3 Residues of Concern Summary and Rationale...................................................... 12

5.0 Residue Profile......................................................................................................... 13

5.1 Residue Analytical Methods (860.1340)............................................................... 13

5.1.1 Data Collection Methods ............................................................................... 13

5.1.2 Multi-Residue Methods (860.1360)............................................................... 14

5.1.3 Tolerance Enforcement Methods................................................................... 14

5.1.4 Submittal of Analytical Reference Standards (860.1650) ............................. 16

5.2 Storage Stability (860.1380) ................................................................................. 16

5.3 Residue Data ......................................................................................................... 17

5.3.1 Crop Field Trials (860.1500) ......................................................................... 17

5.3.2 Field Rotational Crops (860.1900) ................................................................ 20

5.3.3 Processed Food and Feed (860.1520)............................................................ 20

5.3.4 Meat, Milk, Poultry and Eggs (860.1480) ..................................................... 20

5.3.5. Food Handling (860.1460)............................................................................. 21

5.3.6 Water, Fish, and Irrigated Crops (860.1400)................................................. 21

6.0 Tolerance Derivation ............................................................................................... 21

Appendix A. International Residue Limits Table ............................................................... 22

Appendix B. OECD MRL Calculation Procedure Inputs/Outputs..................................... 23

Appendix C. Highest/average residues of indoxacarb in feedstuff commodities............... 28

 
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1.0 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. IR-4 has submitted field trial data in 

support of a petition proposing tolerances for the use of Avaunt® and Steward®EC on dried 

beans, and Avaunt®on snap beans. In addition, registration (Avaunt®) and subgroup 

tolerances for small fruit vine climbing subgroup (except kiwifruit) 13-07F and low 

growing berry subgroup (except strawberry) 13-07H are proposed based on the current 

tolerances for grapes and cranberry, respectively. 

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. The Interregional Research Project No. 4 (IR-4) has submitted Petition No. 

2E8029 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): 

Bean, dry, seed ...................................................................... 0.07 ppm

Bean, succulent .................................................................... 0.64 ppm

Bean, forage ......................................................................... 37 ppm

Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F ........ 2.0 ppm

Low growing berry, except strawberry, subgroup 13-07H..................... 0.9 ppm

Avaunt®Insecticide (EPA Reg. No. 352-597) is a water-dispersible granular (WDG) 

product which contains 30% of the indoxacarb ai by weight. The prescribed use will allow 

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 for dry beans, 

snap beans and low growing berry subgroup 13-07H and 0.22 lb ai/A/season for small fruit 

vine climbing subgroup 13-07F. A specified minimum retreatment interval (RTI) of 7days 

is proposed for all crops except small fruit vine climbing subgroup 13-07F which has a RTI 

of 21-days. The preharvest intervals (PHIs) are 3-days for snap beans, 7-days for dry beans 

and small fruit vine climbing subgroup 13-07F, and 30 days for low growing berry

subgroup 13-07H. In situations where it can be difficult to achieve adequate coverage, the 

proposed label specifies that an adjuvant may be used to improve performance. 

The dry bean and snap bean field trial studies were carried out using different analytical 

procedures to determine the combined residues of indoxacarb and its R-enantiomer. 

However, both methods were adapted from the DuPont method (DuPont Report No. AMR 

2712-93), dated Aug. 08, 1997, titled, “Analytical Enforcement Method (HPLC/Column 

Switching/UV) for the Determination of Residues of DPX-KN128 (S-enantiomer) and INKN127 (R-enantiomer) in Crops.” Both methods were adequately validated in conjunction 

with the sample analyses. The validated LOQs for residues of indoxacarb were 0.01 ppm

for dry bean and snap bean, and 0.03 ppm for snap bean foliage.
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Provided that label revisions are made, the field trial data submitted for this petition are 

adequate to support the proposed use of indoxacarb on dry bean, and snap bean. A 

representative number of tests were conducted in the appropriate geographic regions. 

Applications were made at the proposed maximum seasonal use rate following the 

recommended RTI and PHI specified for each crop in the corresponding label. Samples 

were all analyzed using adequate analytical methods with sample holding intervals 

supported by storage stability data generated concurrently with each field trial study. 

Tolerances were recommended based on OECD calculation procedures and harmonization 

considerations, see Table 2.2.2. In addition, the existing grape and cranberry residue data 

are adequate to support tolerances for the small fruit vine climbing subgroup 13-07F and 

low growing berry subgroup 13-07H, respectively. The residue data for grapes and 

cranberries were used to recommend new tolerances following OECD calculation 

procedures and harmonization considerations. 

Data requirements for rotational crops 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.

The residue data for bean, snap, forage can be used to establish a tolerance for cowpea, 

forage which is a dairy cattle feedstuff. HED is recommending a tolerance be established 

for residues of indoxacarb on cowpea hay; a tolerance for cowpea hay was not proposed. 

Dietary burden calculations previously performed for dairy cattle made use of tolerance 

level residues and dietary contribution from feedstuff commodities that lead to conservative 

dietary burden estimates (S. Levy, D276516, 30-May-2002). The current dietary burden 

estimate for dairy cattle covers the proposed new uses of indoxacarb and existing 

tolerances for ruminant commodities are not underestimated. However, dietary burden 

calculations for beef cattle, dairy cattle and poultry should be revisited during registration 

review to re-evaluate the existing tolerances. 

2.0 Regulatory Recommendations

Pending the revision of Sections B and F, there are no residue chemistry deficiencies that 

preclude granting an unconditional registration of indoxacarb for use on dry bean, snap 

bean, small fruit vine climbing subgroup 13-07F and low growing berry subgroup 13-07H. 

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: 

Bean, dry.............................................................................. 0.2 ppm

Bean, succulent.................................................................... 0.9 ppm

Cowpea, forage ..................................................................... 50 ppm

Cowpea, hay ....................................................................... 100 ppm

Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F ........ 2 ppm

Low growing berry, except strawberry, subgroup 13-07H..................... 1 ppm
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A human health risk assessment for indoxacarb will be prepared as a separate document.

860.1200 Directions for Use

The new label directions are adequate for an evaluation of the residue data to be made 

relative to the proposed new uses. However, recommendations to clarify discrepancies or 

add specificity should be considered, see section 2.3.

860.1550 Proposed Tolerances

A revised Section F must be submitted according to Table 2.2.2. 

2.1 Data Deficiencies/Data Needs

No data deficiencies/needs associated with the current petition would preclude granting 

registration. However, residue data for cowpea, hay is not available at this time. This data 

is required to determine if a tolerance and dietary burden re-evaluation is needed.

860.1500 Crop Field Trials

Residue data depicting residues in/on cowpea, hay.

2.2 Tolerance Considerations

2.2.1 Enforcement Analytical Method

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. The methods limits of quantitation (LOQs) are within 0.01 to 0.05 

ppm for a variety of plant commodities. 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. Adequate validation and concurrent 

recovery data was submitted for indoxacarb in/on dry beans and snap beans using a method 

similar to AMR 2712-93. In addition, method AMR 3493-95 was used for determining 

residues in cranberries and grapes. Based on this, the enforcement methods available are 

adequate for enforcing tolerances for indoxacarb in/on snap bean, dry bean, small fruit vine 

climbing subgroup 13-07F, and low growing berry subgroup 13-07H. 

2.2.2 Recommended Tolerances

HED recommends that 40 CFR be amended by establishing tolerances for the plant 

commodities listed in the Table 2.2.2. Tolerances for livestock commodities and rotational 

crops are not needed to support the proposed uses of indoxacarb. The tolerances for plant 

commodities should be defined as follows:
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Table 2.2.2. Tolerance Summary for Indoxacarb.

Commodity Established/Proposed 

Tolerance (ppm)

HED-Recommended 

Tolerance (ppm)

Comments (correct 

commodity definition)

Bean, dry, seed 0.07 0.2

Pea, southern, seed 0.1 Remove

Bean, succulent 0.64 0.9

Bean, forage 37 50 Cowpea, forage

Cowpea, hay NA 100

Small fruit vine climbing, 

except fuzzy kiwifruit, 

subgroup 13-07F

2.0 2

Low growing berry, except 

strawberry, subgroup 13-07H

0.9 1

Cranberry 0.90 Remove

Grape 2.0 Remove

2.2.3 Revisions to Petitioned-For Tolerances

The proposed tolerances are different from those recommended by the HED. The 

tolerances recommended by the HED were established by using the Organization for the 

Economical Cooperation and Development (OECD) calculation procedures while the 

registrant used the North America Free Trade Agreement (NAFTA) calculation procedures. 

In addition, the tolerance for dry beans covers the southern pea variety (cowpea) which 

already has a tolerance established in the CFR. Since the forage of cowpea are the only 

significant feedstuff associated with beans, the correct commodity definition would be 

cowpea, forage instead of bean, forage. In order to harmonize with the Codex MRL for 

cowpea (see discussion below), the tolerance for dry bean obtained by the OECD 

calculation procedures (0.06 ppm) will be increased to 0.2 ppm. The registrant should 

submit a revised Section F in which the proposed tolerances are the same as those 

recommended by the HED.

2.2.4 International Harmonization

U.S. tolerances are recommended for dry beans, succulent beans, small fruit vine climbing 

subgroup 13-07F, and low growing berry subgroup 13-07H based on residues of 

indoxacarb and its R-enantiomer. Maximum residue limits (MRLs) have not been 

established by Canada or Mexico. However, Codex has established MRLs for grapes (2 

ppm), dry grapes (5.0 ppm), cranberries (1ppm), dry chick-pea (0.2 ppm), dry mung bean 

(0.2 ppm), and dry cowpea (0.1 ppm) based on measurement of indoxacarb and its Renantiomer. The U.S. tolerances for raisins (5.0 ppm) and cranberries (1 ppm) are 

harmonized with the corresponding Codex MRLs. The U.S. tolerance for grapes (subgroup 

13-07F) obtained with the OECD calculator (3 ppm) is higher than the Codex MRL for 

grapes (2 ppm). Since the U.S. crop field trial data for grapes show that the highest residue 

is 1.74 ppm and the registrant proposed tolerance is 2.0 ppm (based on the NAFTA 

calculator procedures), HED understand that establishing a tolerance of 2 ppm is 

appropriate for this case and will allow harmonization with Codex. The tolerance for dry
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bean (0.06 ppm) obtained by the OECD calculation procedures will be increased to 0.2

ppm in order to harmonize with the Codex MRL for dry check pea and dry mung bean and 

cover the MRL for dry cowpea. 

2.3 Label Recommendations

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 following are recommendations to clarify

discrepancies or add specificity. 

 Under the application instructions (page 3 of Avaunt®label) include dry bean in the 

sentence: “For bushberry, cranberry, dry bean, pome and stone fruit the minimum 

interval between treatments is 7 days.” 

 Under the tabulated instructions (page 6 of Avaunt®label and page 5 of Steward®

EC label) for dry bean and/or succulent bean edit the sentence “Make a uniform 

application in approximately 20-100 gallons of water per acre” to specify the 

volume for ground and/or aerial applications.

3.0 Introduction

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 Avaunt®(EPA Reg. No. 352-597, WDG 

formulation) and Steward® EC (EPA Reg. No. 352-638, emulsifiable concentrate 

formulation) end-use products. These end-use formulations contain an isometric mixture 

of indoxacarb (insecticidally active S-enantiomer; DPX-KN128) + its R-enantiomer 

(insecticidally inactive; IN-KN127); however, the percentage of ai listed on the labels and 

the labeled use rates for each crop are based only 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. 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® and Steward®EC on dried beans and Avaunt®on snap beans. In addition, 

subgroup tolerances for small fruit vine climbing subgroup (except kiwifruit) 13-07F and 

low growing berry subgroup (except strawberry) 13-07H are proposed based on the current 
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tolerances for grapes and cranberry. The nomenclature and physicochemical properties of 

indoxacarb are presented below in Tables 3.1 and 3.2 for review.

3.1 Chemical Identity

Table 3.1 Indoxacarb Nomenclature.

Compound

Common name Indoxacarb

Company experimental name DPX-KN128

IUPAC name (S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine4a(3H)-carboxylate

CAS name methyl (4aS)-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine4a(3H)-carboxylate

CAS registry number 173584-44-6

End-use product (EP) 30% WDG (DuPont Avaunt®Insecticide; EPA Reg. No. 352-597) and 16% 

Emusifiable Concentrate (Steward® EC Insecticide; EPA Reg. No. 352-638)

Compound

Common name IN-KN127 (inactive R-enantiomer)

3.2 Physical/Chemical Characteristics

Indoxacarb has a very low vapor pressure of 1.9x10-10 mmHg at 25 oC; therefore, is not a 

volatile pesticide. The octanol water partition coefficient (Kow = 44000) suggests that it is 

lipophilic. Indoxacarb is soluble in water (15.4 μg/L) and does not dissociate under 

environmental relevant conditions. 

O

N

N

O O

CH3

Cl N

O

O

O

O

CF3

CH3

O

N

N

O O

CH3

Cl N

O

O

O

CH3

O

CF3
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3.3 Pesticide Use Pattern/Directions for Use (860.1200)

IR-4 has submitted field trial data in support of a petition proposing tolerances for the use 

of Avaunt® and Steward®EC on dried beans and Avaunt®on succulent beans. In addition, 

crop subgroup tolerances and registration of Avaunt® WDG for use on small fruit vine 

climbing subgroup (except kiwifruit) 13-07F, and low growing berry subgroup (except 

strawberry) 13-07H are proposed based on established tolerances for grapes and cranberry. 

The proposed new uses are summarized below in Table 3.3.

Table 3.2 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 10-8Pa (1.9x10-10 mmHg)

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 three maxima 

were affected by pH, but not over 

wavelengths of environmental 

significance.
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Table 3.3 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

Bean, succulent

Broadcast foliar 

applications when 

insects reach economic 

thresholds; ground or 

air equipment

30% WDG

[352-597] 0.11 NS 0.44 3

A minimum 7-day RTI is 

specified. Make a uniform 

application of approximately

20-100 gal/A.

Bean, dry

Broadcast foliar 

applications when 

insects reach economic 

thresholds; ground or 

air equipment

30% WDG

[352-597]

and 

16% EC

[352-638]

0.11 NS 0.44 7

A minimum 7-day RTI is 

specified. Make a uniform 

application of approximately

20-100 gal/A.

Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F

Broadcast foliar 

applications when 

insects reach economic 

thresholds; ground or 

air equipment

30% WDG

[352-597] 0.11 NS 0.22 7

A minimum 21-day RTI is 

specified. Apply in a 

minimum of 10 gal/A and 50

gal/A for aerial and ground 

applications, respectively.

Low growing berry, except strawberry, subgroup 13-07H

Broadcast foliar 

applications when 

insects reach economic 

thresholds; ground or 

air equipment

30% WDG

[352-597] 0.11 NS 0.44 30

A minimum 7-day RTI is 

specified. Apply in a 

minimum of 5 gal/A and 10

gal/A for aerial and ground 

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: (1) 30%WDG: 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. (2) 16% EC: Crops that are on this label and all brassica leafy vegetables, cucurbit vegetables, 

fruiting vegetables, leafy green vegetables, leafy petiole vegetables, pome fruit and stone fruit, plus sweet 

corn, cranberry, grape, mint, southern pea and the tuberous and corm vegetables found in crop subgroup 1C 

(arracacha, arrowroot, Chinese artichoke, edible canna (Queensland arrowroot), bitter and sweet cassava, 

chayote(root), chufa, dasheen (taro), ginger, leren, potato, sweet potato, tanier (cocoyam), tumeric, yam 

bean (jicama, manoic pea) and true yam) may be planted immediately following harvest. Do not plant for 

food or feed any other crops not registered for use with indoxacarb for 30 days after last use.

Conclusions. The proposed use pattern is supported by the crop field trials in all 

commodities. For the low growing berry subgroup 13-07H, the residue data may support 

either a 14 or 30-day PHI; however, in accordance with the proposed use pattern the 

tolerance was calculated with the residue data obtained for a 30-day PHI. The following 

are label recommendations to clarify discrepancies or add specificity. Under the 

application instructions (page 3 of Avaunt®label) include dry bean in the sentence: “For 

bushberry, cranberry, dry bean, pome and stone fruit the minimum interval between 

treatments is 7 days.” Under the tabulated instructions (page 6 of Avaunt®label and page 5 

of Steward®EC label) for dry bean and/or succulent bean edit the sentence “Make a 

uniform application in approximately 20-100 gallons of water per acre” to specify the 
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volume for ground and/or aerial applications.

4.0 Metabolite/Degradate Residue Profile

4.1 Nature of the Residue

4.1.1 Summary of Plant Metabolism (860.1300)

Adequate metabolism studies on cotton, lettuce, and tomatoes were previously reviewed in 

conjunction with an earlier indoxacarb petition (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 (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 dry beans and snap beans. 

4.1.2 Summary of Livestock Metabolism (860.1300)

Adequate ruminant and poultry metabolism studies were previously reviewed in 

conjunction with an earlier indoxacarb petition (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 (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, INJU873, IN-KB687, IN-KG433, IN-KT319, 5-HO-IN-JT333, and Metabolite F (D277922, 

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 (D297936, S. J. Levy, 09/22/2004). 

Conclusions. As previously noted, the only significant feedstuff associated with the 

proposed new indoxacarb uses is cowpea, forage which is fed to dairy cattle. The ruminant 

metabolism study available is appropriate to cover residues of concern in dairy cattle.
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4.1.3 Summary of Confined Rotational Crops (860.l850)

An adequate confined rotational crop study was reviewed in conjunction with an earlier 

indoxacarb petition (D244253, S. J. Levy, 01/19/2000). The submitted confined rotational 

crop study were considered marginally adequate because the test substance was applied at 

0.268 lb ai/A of the active isomer S-indoxacarb which was 0.6x the maximum seasonal rate 

for cotton. However, a confined rotational study was not required because the nature of the 

residue was adequately delineated. 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 (D263986, S. J. Levy, 07/10/2000). Although some 

commodities showed total radioactive residues (TRR) above 0.01 ppm 36 days after the 

last application, the parent compound was not detected (LOD of 0.002 ppm) in any

rotational crop commodity at any plantback intervals. The LOQs of the enforcement 

methods are within 0.01 to 0.05 ppm for a variety of plant commodities. Therefore, field 

rotational studies were not requested. Subsequently, it was determined that the available 

data are adequate in supporting a 30-day plant-back interval for all non-labeled crops 

(D256351, S. J. Levy, 09/07/2000). 

Conclusions. The application rate of the confined rotational crop study corresponds to 0.6x 

the maximum seasonal rate proposed for dry beans and succulent beans as well. However, 

based on the rationale discussed above no additional rotational crop data are required to 

support the current petition.

4.3 Residues of Concern Summary and Rationale

Table 4.3 Summary of Metabolites and Degradates to be included in the Risk 

Assessment and Tolerance Expression1

Matrix Residues included in Risk 

Assessment

Residues included in Tolerance 

Expression

Plants

Primary Crop Indoxacarb and its R enantiomer Indoxacarb and its R enantiomer

Rotational Crop Indoxacarb and its R enantiomer Indoxacarb and its R enantiomer

Livestock

Ruminant

Indoxacarb and its R enantiomer

(for all)

Metabolite IN-MP819 (for milk 

only)

Indoxacarb and its R enantiomer

Poultry

Indoxacarb, its R-enantiomer, and 

the metabolites IN-JT333, INJU873, IN-KB687, IN-KG433, 

IN-KT319, 5-HO-IN-JT333, and 

Metabolite F

Indoxacarb, its R-enantiomer, and 

the metabolites IN-JT333, INJU873, IN-KB687, IN-KG433, and 

IN-KT319

Drinking Water

Indoxacarb, and the degradation 

products IN-JT333, IN-KG4333, 

IN- KT413, and IN-ML437-0H

1 Adapted from: S. Levy, D325479, 03/09/2007; and D402100, Christopher M. Koper, 11/06/2012.
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5.0 Residue Profile

5.1 Residue Analytical Methods (860.1340)

5.1.1 Data Collection Methods

The method used for analysis of snap bean samples (pods/seeds and foliage) was working 

outline 9.97, versions 1, 2 and 3. Samples of bean (dry) seeds were analyzed using the 

Cornell Analytical Laboratory Method titled “Residue Analysis of Indoxacarb on Bean

(dry) by HPLC/UV Detection, Version #2”. Both methods were adapted from the DuPont 

method (DuPont Report No. AMR 2712-93), dated Aug. 08, 1997, titled, “Analytical 

Enforcement Method (HPLC/Column Switching/UV) for the Determination of Residues of 

DPX-KN128 (S-enantiomer) and IN-KN127 (R-enantiomer) in Crops.” Modifications 

made to the reference method were considered minor and did not adversely affect the 

study. 

For snap bean, the sample was extracted using hexane-saturated acetonitrile and 

acetonitrile-saturated hexane via homogenization of the mixture in tissuemizer. The 

mixture was filtered under vacuum over a Whatman GF/A filter paper and the filtrate was 

collected. The filtrate was transferred to a separatory funnel and phases were allowed to 

separate. The bottom layer containing product was charged to a TurboVap flask. The top 

hexane layer was discarded. The filter cake was re-extracted 2-5 times, as described above 

and the combined acetonitrile layers were concentrated using a TurboVap flask. The 

extract diluted with acetonitrile in three portions was transferred to a preconditioned 

disposable 5g/20 cc Silica Mega Bond ElutRcolumn and purified. The column was further 

washed with additional acetonitrile and the combined eluent was evaporated to dryness 

resulting in a residue. The residue was dissolved in acetonitrile and buffer (0.03M, pH 2.6, 

5:50 v/v) analyzed. 

For dry bean, indoxacarb was extracted from bean (dry) seeds (10 grams) with

hexane/acetonitrile (ACN). The ACN fraction was then concentrated under vacuum and 

cleaned up by solid phase extraction (SPE) with a combination of silica and a strong anion 

exchange (SAX) cartridge. After evaporation of the ACN eluent solvent, the purified 

sample was reconstituted in a mixture of 60% ACN and 40% 0.03M phosphate buffer, and

analyzed. 

Samples were analyzed by HPLC equipped with an ultraviolet (UV) detector operating at 

310 nm. The residue results are expressed as the sum of the residues of the two 

enantiomers, KN128 (indoxacarb) and KN127, as the analytical method does not 

distinguish between the two enantiomers. The instrument LOQ was set at the LLMV for 

indoxacarb in/on bean (snap) pods/seeds samples at 0.01 ppm and for bean (snap) and bean 

(dry), and at 0.03 ppm for foliage. Based on recoveries at the LLMV, the calculated LOD 

(std. dev. x one-tailed t-statistic) and LOQ (LOD x 3) for indoxacarb residues were 0.002 

and 0.006 ppm in/on pods/seeds, 0.007 and 0.02 ppm in/on foliage, and 0.003 and 0.01 

ppm in/on bean (dry) seed samples, respectively. 
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Method validation with snap bean commodities was performed both prior to and concurrent 

with sample analysis. For method validation, untreated control samples were fortified with 

indoxacarb/IN-KN127 at 0.01 ppm, 0.03 ppm, 0.10 ppm, and 1.0 ppm for pods/seeds and at 

0.03 ppm, 0.5 ppm, 10.0 ppm, and 32.0 ppm for foliage. Since residues in some treated 

trials were found to be greater than the highest method validation levels, additional sets of 

method validation were performed with pods/seeds fortified at 1 ppm and foliage fortified 

at 32 ppm to bracket the residue ranges. Method validation recoveries ranged from 69%-

111% (93% ± 11%, n = 15) for pods with seeds and 70%-108% (91% ± 12%, n = 15) for 

plants. A single recovery for bean (snap) pods with seeds fell below 70%. Concurrent 

recovery samples were analyzed for combined residues of indoxacarb and IN-KN127 

together with field treated samples. Recoveries ranged from 91%-109% (101% ± 6%, n = 

11) for bean (snap) pods/seeds, with samples fortified at levels of 0.03 ppm and 0.1 ppm. 

Recoveries ranged from 82%-95% (90% ± 4%, n = 11) for foliage with samples fortified at

levels of 0.52 ppm and 10.5 ppm. 

Method validation with dry beans was performed prior to and concurrent with sample 

analysis. Method validation recoveries at 0.01, 0.30 and 3.0 ppm ranged from 87%-103% 

(95% ± 5%, n = 9). Concurrent recoveries of indoxacarb on bean (dry) seed control 

samples fortified at 0.01, 0.30 and 1.0 ppm ranged from 69%-120% (92% ± 13%, n = 23).

The results are presented in Tables C.1.

Conclusions. Adequate methods were used to determine residue levels in the crop field 

trials for snap bean and dry bean commodities. In general, the residue levels are adequately 

bracketed within the spike levels used in the recovery studies. In all, both data collection 

procedures used for testing were adequately validated prior to and in conjunction with the 

analysis of field samples.

5.1.2 Multi-Residue Methods (860.1360)

Acceptable data are available depicting the recovery of indoxacarb and its R-enantiomer 

using FDA multiresidue method Protocols C, D, and E found in PAM, Volume 1. The 

indoxacarb residues of concern were not evaluated through FDA multiresidue method 

Protocol A since neither compound possesses an N-methylcarbamate structure. They were 

also not tested through Protocol B given that neither compound possesses carboxylic acid 

or phenolic moiety, and Protocol F because they are not recoverable from Florisil at a level 

≥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 D260953, S. J. Levy, 

11/03/1999).

5.1.3 Tolerance 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
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work to provide a total measure of concentration by determining both indoxacarb and its Renantiomer as a single component.

Plants

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 (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 (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 (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.

Livestock

To enforce the current tolerances established for livestock commodities, DuPont method 

AMR 3337-95 is a 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). 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 
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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, was forwarded to ACL/BEAD 

for petition method validation (P. Savoia, D356925, 28-Nov-2008).

Conclusions. In the field trials submitted with the current petition, combined indoxacarb 

residues were determined using a modification of an enforcement method. The data 

collection method was adequately validated in conjunction with the samples analyses, 

using control samples fortified at an appropriate range of concentrations. Acceptable 

recoveries were obtained for all commodities. The recommended tolerance level for 

succulent bean foliage (50 ppm) is above the highest spike level tested; however, good 

recoveries were consistently observed at all spike levels (0.03 to 32 ppm) being within 82-

103% at spike levels of 10 and 32 ppm. Based on this the enforcement methods are 

adequate to support the tolerances recommended for the proposed new uses. In addition, 

appropriate enforcement methods for residues in livestock are available.

5.1.4 Submittal of Analytical Reference Standards (860.1650)

An analytical standard for the insecticide indoxacarb is currently available in the EPA 

National Pesticide Standards Repository. However, the indoxacarb standard has an 

expiration date of 4/2013. A reference standard 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:

USEPA

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. 

5.2 Storage Stability (860.1380)

Storage stability data have been reviewed for a number of commodities in conjunction with 

earlier indoxacarb petitions. Indoxacarb residues are relatively stable in frozen storage on a 

wide variety of plant commodities such as broccoli, wet apple pomace, wet grape pomace, 

wine, tomatoes, peppers, cotton (hulls, meal and refined oil) for 12 months; apple juice for 

6 months; pears, cabbage, lettuce, cottonseed, and cotton gin byproducts for 13-15 months; 

apples and grapes for 18 months; and corn forage, stover and ears for 19-23 months. In 

furthering the above mentioned data, concurrent storage stability studies were carried out 

along with the snap bean and dry bean crop field trials. 

Maximum storage intervals for field-treated samples were 203 days for snap beans (pods 

with seeds), and 205 days for plant/foliage samples. Storage stability samples (both 
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matrices) fortified with a racemic mixture of KN128 and KN127 (50:50) at 0.03 ppm and

held in frozen storage under similar conditions to the field generated samples had 

recoveries of 90%-101% for snap bean (pods with seeds) and 90%-106% for plant/foliage 

after 209 days. The data indicated that indoxacarb was stable under the conditions that the 

samples were stored between harvest and analysis.

Treated dry bean seed samples in this study were stored frozen for 190-225 days. Storage 

stability samples fortified with a racemic mixture of KN128 and KN127 (50:50) at 0.3 ppm 

and held in frozen storage under similar conditions to the field generated samples had 

recoveries of 103% (3 samples) after 210 days. The data indicated that indoxacarb was 

stable under the conditions that the samples were stored between harvest and analysis.

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 recoveries 

averaged 90-106%, the data obtained will support the storage intervals incurred in the field 

trials for purposes of this petition. 

5.3 Residue Data

5.3.1 Crop Field Trials (860.1500)

Crop field trials were conducted for dry beans and snap beans following application of 

Avaunt® 30 WG Insecticide. In addition, three side-by-side crop field trials with the 

Steward®EC Insecticide were conducted to support the use of on dry beans. No additional 

crop field trials were conducted to support tolerances on the proposed new subgroups, 

small fruit vine climbing subgroup (except kiwifruit) 13-07F and low growing berry

subgroup (except strawberry) 13-07H, since the proposal is based on the established 

tolerances for grapes and cranberries, respectively.

Snap Bean (48788901.der.doc)

The Interregional Research Project No. 4 (IR-4) has submitted field trial data for 

indoxacarb on bean (snap). Nine field trials were conducted in the United States during the 

2005 growing season, one each in NJ and NC (EPA Region 2), two in FL (EPA Region 3), 

one each in MI, WI and OH (EPA Region 5), one in CA (EPA Region 10) and one in ID

(EPA Region 11). The number and geographical distribution of the supervised field trials 

on bean (snap) are adequate. Each field trial site comprised one untreated control plot and 

one treated plot. At all the trials, Avaunt® 30 WG was applied as four foliar applications 6-

8 days apart with a pre-harvest interval (PHI) of 2-3 days. The application rates ranged 

TABLE 5.2 Summary of Storage Conditions For Indoxacarb on Bean (Snap)

Matrix 

(RAC or extract)

Storage Temperature

(°C)

Storage Stability 

Recoveries (%)

Actual Storage 

Duration (days)

Interval of Demonstrated 

Storage Stability

(days)

Bean (snap) pods with seeds -29 to -16 101, 91, 90 68-203 209

Bean (snap) plants 93, 99, 106 70-205 209

Bean (dry) seed -21 ± 7 103, 103, 103 190-225 210
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from 0.108-0.119 lb ai/A per application for a total of 0.438-0.457 (0.542 at OH12) lb ai/A 

per season. No adjuvants were used at any of the trials.

Snap bean (pods with seeds) and foliage (snap bean plants) samples were harvested. At the 

CA trial, additional samples were taken at 0, 7, and 13 days after the last application. No 

residues of indoxacarb were found in control samples above the LLMV (0.01 ppm) during 

the field trials. For pods with seeds samples at 2-3 days PHI, residues in treated field 

samples were found between 0.04 ppm (OH12) and 0.59 ppm (CA107). For plant/foliage 

samples at 2-3 days PHI, residues in treated field samples were found between 1.3 ppm 

(OH12) and 32.1 ppm (MI21). Representative chromatograms for control samples were 

free from interference.

At the CA107 decline trial, in pods with seeds and plant/foliage samples, residues at 13-day

PHI declined to approximately 63% and 86%, respectively, of the residues in the 2-day PHI

samples. In pods with seeds and plant/foliage samples, residues at 13-day PHI declined to 

46% and 56%, respectively, of the residues in the 0-day PHI samples. There was a slight 

increase in residues in the foliage/plant samples from the 2-day PHI samples (15.4 ppm) to 

the 7-day PHI samples (17.39 ppm), which were within normal variability.

TABLE 5.3.1.1. Summary of Residue Data from Bean (Snap) Field Trials with Indoxacarb

Commodity Total Applic. 

Rate

(lb ai/A)

PHI 

(days)

Residue Levels

(ppm)

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

Bean (Snap) 

Pods with 

seed

0.438-0.542 2-3 18 0.04 0.59 0.585 0.15 0.18 0.15

Bean (Snap) 

Plant/Foliage

0.438-0.542 2-3 18 1.3 32.1 31.7 10.2 12.6 8.2

1HAFT = Highest Average Field Trial

Dry Beans (48788902.der.doc)

The Interregional Research Project No. 4 (IR-4) has submitted field trial data for 

indoxacarb on a variety of dry beans (Phaseolusspp). Thirteen field trials were conducted 

in the United States in EPA region 2: NJ (1 trial); region 5: MI (2 trials), ND, OH, WI (1 

trial each); region 7: ND (2 trials); region 8: CO (1 trial); region 9: CO (1 trial); region 10: 

CA (1 trial); region 11: ID and WA (1 trial each) during the 2006 growing season. The 

number and geographical distribution of the supervised field trials on bean (dry) are 

adequate. Each crop field trial consisted of one untreated control plot and one treated plot 

with the exception of three field trials where an additional treated plot was included. At all 

the trials, four foliar applications (5 at CA86) of Steward® EC were performed with a preharvest interval (PHI) of 6-8 days. Avaunt®

30 WG was used for a second treated plot at 

tree field trials.

Dry bean seed samples were either hand or mechanically harvested. At the CA and ND 

trials, additional samples were taken at 0, 13, and 20-22 days after the last application. No 

residues of Indoxacarb were found in control samples above the LLMV (0.01 ppm) during 

the field trials. For the samples harvested 6-8 days after the last application, the total 
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combined residues of indoxacarb (DPX – KN128) and IN – KN127 in/on bean (dry ) seeds 

treated with Steward®ranged from <0.01 ppm to 0.093 ppm. Residues in/on bean (dry) 

seeds treated with Avaunt®ranged from <0.01 ppm to 0.032 ppm. The side-by-side trials 

for dry beans with the Avaunt®and Steward®EC formulations show similar/slightly higher 

residues with the former.

At the CA86 decline trial, samples had residues of 0.038 ppm and 0.048 ppm in/on bean 

(dry) seeds samples at 0-day PHI. In the ND06 trial, the 0-day PHI samples had residues of 

<0.01 and 0.01 ppm. No detectable residues (>0.01 ppm) were observed in the samples 

from the other sampling intervals. The decline data indicated that residues of indoxacarb 

decayed fairly rapidly after the application.

TABLE 5.3.1.2. Summary of Residue Data from Bean (dry) Field Trials with Indoxacarb

Commodity Total Applic. 

Rate

(lb ai/A)

PHI1

(days)

Residue Levels

(ppm)

2

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

Bean (dry) Steward® EC

0.438-0.551 6-8 26 <0.01 0.093 0.0695 0.005 0.01 0.02

Avaunt®30 WG

0.439-0.454 6-7 6 <0.01 0.032 0.03 0.02 0.02 0.01

1HAFT = Highest Average Field Trial

2

For samples with no detectable residues (<0.01 ppm), a value of 1⁄2 LLMV (0.005 ppm) was used in calculating the median, mean and 

standard deviation

Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F

Adequate crop field trials (13) were conducted during the year 2002 to support registration 

and tolerances for indoxacarb (Avaunt®30% WDG) on grapes (S. Levy, D290126, 18-Feb2005). The crop field trials consisted of four broadcast foliar applications at 0.109-0.158 lb 

ai/A, and an interval of 5-days between applications for a total of 0.438-0.507 lb 

ai/A/season. All applications were made using ground equipment. Samples of grapes were 

collected at 7 days after the last application. A tolerance of 0.9 ppm was recommended 

based on NAFTA calculation procedures.

Low growing berry, except strawberry, subgroup 13-07H

Adequate crop field trials (6) were conducted during 2002-2003 to support registration and 

tolerances for indoxacarb (Avaunt®30% WDG) on cranberries (S. Levy, D325479, 09-

Mar-2007). The field trials consisted of four broadcast foliar applications during fruit 

development at 0.108-0.115 lb ai/A, at retreatment intervals (RTIs) of 6-8 days, for a total 

application rate of 0.436-0.451 lb ai/A. All applications were made using ground 

equipment at 28-46 gallons per acre (GPA), without the use of any adjuvants. Samples of 

cranberries were harvested twice from each trial, at 13-15 and 28-30 days after the last 

treatment (DALA). The residue data may support either a 14 or 30-day PHI; however, in 

accordance with the proposed use pattern the tolerance was calculated with the residue data 

obtained for a 30-day PHI. A tolerance of 2.0 ppm was recommended based on NAFTA 

calculation procedures.
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Conclusions. The dry bean and snap bean field trials are adequate to support the proposed 

new uses on bean, dry and bean, succulent crops. 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. Adequate residue decline data was generated with 

snap beans and dry beans indicating that residues of indoxacarb decline at longer days after 

treatment. The residue data is adequate to recommend registration of the proposed new use 

and tolerances for the corresponding commodities. It is noted that although the tolerance 

for cowpea forage was recommended based on data from snap bean forage, data for hay

was not submitted. However, HED is recommending establishment of a tolerance for 

indoxacarb on cowpea hay of 100 ppm based on the product of the highest forage residue 

(32 ppm) and ratio of percent dry matter for hay and forage (86/30). 

Residue data for cranberries and grapes was previously evaluated and considered 

acceptable. The data for cranberries is adequate to support the tolerance for low growing 

berry subgroup 13-07H. The use pattern of the grape field trial correspond to the same 

single application rate and PHI of the proposed use pattern for small fruit vine climbing 

subgroup 13-07F but the grape field trials used a higher maximum seasonal application rate 

(0.44 lb ai/A instead of 0.22 lb ai/A) and shorter RTI (5-days instead of 21-days) than what 

is proposed for the small fruit vine climbing subgroup. Since the single application rate 

and PHI are similar, and higher residues than the proposed tolerance would not be expected 

it is recommended to use available residue data without applying a scaling factor to adjust 

the residue level. The residue data will be considered adequate to recommend tolerances 

for the corresponding crop subgroups.

5.3.2 Field Rotational Crops (860.1900)

No additional rotational crop data are required for the current petition.

5.3.3 Processed Food and Feed (860.1520)

HED does not require residue data for any processed commodities associated with dry

beans, snap beans or cranberries. Moreover, a grape processing study was previously

submitted in support of the petition for tolerances on grapes. A tolerance for grape raisins 

at 5.0 ppm is established. Processing food/feed studies are not needed to support the

current petition.

5.3.4 Meat, Milk, Poultry and Eggs (860.1480)

The residue data for bean, snap, forage can be used to establish a tolerance for cowpea, 

forage which is a dairy cattle feedstuff. Dietary burden calculations previously performed 

for dairy cattle made use of tolerance level residues and dietary contribution from feedstuff 

commodities that lead to conservative dietary burden estimates (S. Levy, D276516, 30-

May-2002). The revised version of Table 1 (OPPTS Guideline 860.1000), the new 
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guidelines that make use of the highest or average residue level in the feedstuff, and a 

livestock dietary burden calculator developed by HED were used to estimate the dietary

burden for dairy cattle, see Table 5.3.4. The new dietary burden (33.0 ppm) is lower than 

that used (46.1 ppm for dairy cattle and 50.0 ppm for beef cattle) to establish the current 

tolerances (D276516; 30-May-2002). As a result, existing tolerances established for 

ruminant commodities are conservative. Dietary burden calculations for beef cattle, dairy

cattle and poultry should be revisited during registration review in order to re-evaluate the 

existing tolerances for meat, milk, poultry and eggs commodities. 

Table 5.3.4. Dietary Burden for Dairy Cattle Based on Indoxacarb Proposed Uses. 

Feedstuff %DM Classifi

cation1

Highest/ Average

Residue2

% In Diet Dietary 

Burden

Apples, wet pomace 40 CC 1.9 10 0.48

CC 0 35 0.00

Cotton, undelinted seed 88 PC 1.3 10 0.15

Cowpea, forage 30 R 32.1 20 21.40

Alfalfa, hay 89 R 39 25 10.96

Total 100 33.0

1 CC = carbohydrate concentrate; PC = protein concentrate; R = roughage

2 The highest/average residue values were obtained from D244253, S. Levy, 01/19/2000 and D408982; I. Negron-Encarnacion. Values 

used for all feedstuff commodities are in Appendix C.

5.3.5. Food Handling (860.1460)

This guideline requirement is not relevant to the current petition as no food handling uses 

are being proposed. 

5.3.6 Water, Fish, and Irrigated Crops (860.1400)

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

being proposed. 

6.0 Tolerance Derivation

The OECD MRL calculation procedures were used to determine the tolerances for all 

commodities. The procedures generate tolerances based on mean field trial values. The 

spreadsheets for the various commodities can be found in Appendix B.
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Appendix A. International Residue Limits Table

Indoxacarb (PC Code 067710)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

40 CFR 180.564: 

Plants: indoxacarb, (S)-methyl 7-chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2- e

][1,3,4][oxadiazine-4a(3 H )-carboxylate, and its Renantiomer, (R)-methyl 7-chloro-2,5-dihydro-2-

[[(methoxycarbonyl)[4-

(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2- e

][1,3,4][oxadiazine-4a(3 H )-carboxylate.

None Plant/Livestock 

commodities: sum 

of indoxacarb and its 

R enantiomer. 

The residue is fatsoluble.

Commodity1 Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico2 Codex3

Bean, dry, seed 0.2 0.2 chick-pea (dry), 

0.2 mung bean (dry)

0.1 cowpea (dry)

Bean, succulent 0.9

Cowpea, forage 50

Cowpea, hay 100

Small fruit vine climbing, except fuzzy 

kiwifruit, subgroup 13-07F

2 2 (Grape)

Grape, raisin 5.0 5 Dried grapes 

(=currants, raisins 

and sultanas)

Low growing berry, except strawberry, 

subgroup 13-07H

1 1 (Cranberry)

Completed: M. Negussie; 01/02/2013

1

Includes only commodities of interest for this action. Tolerance values in bold are based on HED 

recommendations, not those proposed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = 

processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured 

on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the 

CAC.
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Appendix B. OECD MRL Calculation Procedure Inputs/Outputs

Bean (Snap)

Residues(mg/kg)

Pods with Seeds Plant without pods

0.590 16.200

0.120 6.800

0.200 10.100

0.170 31.700

0.110 9.000

0.170 12.300

0.130 10.200

0.150 16.500

0.050 1.300

Indoxacarb

Beans (Snap); Pods with Seeds

USA

0.45 lb ai/A, 3-day PHI

Total number of data (n) 9

Percentage of censored data 0%

Number of non-censored data 9

Lowest residue 0.050

Highest residue 0.590

Median residue 0.150

Mean 0.188

Standard deviation (SD) 0.157

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.590

- Mean + 4 SD 0.815

- CF x 3 Mean 0.563

Unrounded MRL 0.815

Rounded MRL 0.9
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Indoxacarb

Beans (Snap); Plant without pods

USA

0.45 lb ai/A, 3-day PHI

Total number of data (n) 9

Percentage of censored data 0%

Number of non-censored data 9

Lowest residue 1.300

Highest residue 31.700

Median residue 10.200

Mean 12.678

Standard deviation (SD) 8.510

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 31.700

- Mean + 4 SD 46.716

- CF x 3 Mean 38.033

Unrounded MRL 46.716

Rounded MRL 50
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Bean (Dry)

Note: The tolerance for dry bean (0.06 ppm) obtained by the OECD calculation procedures 

will be increased to 1 ppm in order to harmonize with the Codex MRL for cowpea. 

Residues(mg/kg)

0.010

0.010

0.010

0.052

0.010

0.010

0.010

0.010

0.010

0.010

0.010

0.010

0.014

0.011

0.022

0.030

Indoxacarb

Beans (Dry); seed

USA

0.45 lb ai/A, 7-day PHI

Total number of data (n) 16

Percentage of censored data 0%

Number of non-censored data 16

Lowest residue 0.010

Highest residue 0.052

Median residue 0.010

Mean 0.015

Standard deviation (SD) 0.011

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.052

- Mean + 4 SD 0.060

- CF x 3 Mean 0.045

Unrounded MRL 0.060

Rounded MRL 0.06
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Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13-07F 

Residues(mg/kg)

0.242

0.180

1.520

0.166

0.086

0.798

0.317

0.436

0.190

0.418

1.330

0.388

0.270

Indoxacarb

Grapes

USA

0.45 lb ai/A, 7-day PHI

Total number of data (n) 13

Percentage of censored data 0%

Number of non-censored data 13

Lowest residue 0.086

Highest residue 1.520

Median residue 0.317

Mean 0.488

Standard deviation (SD) 0.454

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 1.520

- Mean + 4 SD 2.304

- CF x 3 Mean 1.463

Unrounded MRL 2.304

Rounded MRL 3
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Low growing berry, except strawberry, subgroup 13-07H

Residues(mg/kg)

0.116

0.150

0.105

0.180

0.120

0.630

Indoxacarb

Cranberries

USA

0.45 lb ai/A, 30-day PHI

Total number of data (n) 6

Percentage of censored data 0%

Number of non-censored data 6

Lowest residue 0.105

Highest residue 0.630

Median residue 0.135

Mean 0.217

Standard deviation (SD) 0.204

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.630

- Mean + 4 SD 1.034

- CF x 3 Mean 0.651

Unrounded MRL 1.034

Rounded MRL 1

High uncertainty of MRL estimate.

[Small dataset]
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Appendix C. Highest/average residues of indoxacarb in feedstuff commodities6

1. Wet apple pomace (CC)1

Processing factor = 2.6x; Highest field trial residue adjusted for application rate = 0.74 ppm

Average residue in wet apple pomace = 1.9 ppm

2. Cotton undelinted seed (PC)1

Highest field trial residue adjusted for application rate = 1.3 ppm

3. Cotton gin byproducts (R)1

Highest field trial residue adjusted for application rate = 6.7 ppm

* a bridging study showed higher residues than these but were not considered because the 

plants were not allowed to dry before ginning; therefore, they had more leaves than 

normally and resulted in higher residues.

4. Sweet Corn stover (R)1

Highest field trial residue adjusted for application rate = 13.4 ppm

5. Sweet Corn forage (R)1

Highest field trial residue adjusted for application rate = 8.7 ppm

6. Peanut Hay (R)2

Highest / Average field trial residue = 18 ppm / 7.8 ppm

7. Alfalfa forage (R)3

Highest / Average field trial residue = 9.0 ppm / 4.8 ppm

8. Alfalfa hay (R)3

Highest / Average field trial residue = 39 ppm / 15 ppm

9. Soybean seed (PC)3

Average field trial = 0.088 ppm 

10. Soybean hulls (R)3,4

Processing Factor4= 8.2x; Average field trial of soybean seed3= 0.088 ppm

Average residue in soybean hulls = 0.72 ppm

11. Cowpea, foliage (R)5

Highest / Average field trial residue = 32.1 ppm / 12.6 ppm

________________________________________________________

1

 Sarah J. Levy; 19-JAN-2000; DP Barcodes: D244253. 

2

Sarah J. Levy; 7-JAN -2005; DP Barcode 301655.

3

Sarah J. Levy; 30-MAY-2002; DP Barcode: D276516. 

4 MRID 45384305; Devine, T.; 2000.

5

Ideliz Negron-Encarnacion; DP Barcode: D408982.

6 Residue values in bold were used to determine the dietary burden for dairy cattle. These may be highest or 

average values, depending on the level of blending of the feedstuff commodity. Average values, when 

available, were used for dietary burden calculations to support the chronic dietary assessment.