Page 1 of 28 **UNITED STA**

**TES ENVIRONMENTA L PROTECTION A** **GENCY** WA SHINGTON, D.C. 20460 **OFFICE OF CHEMICAL SAFETY AND**

**POLLUTION PREVENTION MEMORANDUM**  Date: 0 2 - May- 2013 Subject: **Indoxacarb** . Petition for the Establishment of Permanent Tolerances and

Registration for Use on D ry Bean, S nap B ean, Small Fruit Vine Climbing Subgroup (except kiwifruit) 13 - 07F and Low Growing Berry Subgroup (except strawberry) 13 - 07H . Summary of Anal ytical Chemistry and Residue Data. PC Code: 067710 DP Barcode: D 408982 Decision No.: 464583 Registration No. : 352 - 579 and 352 - 638 Petition No.: 2E8029 Regulatory Action: New Tolerance Risk Assessment T ype: NA Case No.: NA T XR No.: NA CAS No.: 173584 - 44 - 6 MRID No.: 48788901 and 48788902 40 CFR : §180.564 From: Id eliz 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 D 408982

Page 2 of 28 **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 Anal ytical 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 Phy sical/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 Anal ytical 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 Analy tical 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 ............... 28Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 3 of 28 **1.0 Executive Summary**  Indoxacarb, (S

) - methyl 7 - chloro - 2,5 - dihydro - 2 - [[(methoxycarbonyl )[4 - (trifluoromethox y)phenyl ] amino]carbonyl]indeno[1,2 - e ][1,3,4]oxadiazine - 4a(3 H ) - carbox yl ate , is an insecticide active ingredient (ai) developed by DuPont for the control of lepidopteran pests on fruit, v egetable, and field crops. IR - 4 has submitted field trial data in support of a petition p roposing 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 , respectivel y . Permanent tolerances are established under 40 CF R 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 indoxac arb. 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 7 day s is proposed for all crops except small fruit vine climbing subgroup 13 - 07F which has a RTI of 21 - day s. The preharvest interval s (PHI s ) are 3 - day s for snap beans, 7 - day s for dry beans and small fruit vine climbing subgroup 13 - 07F, and 30 day s for low growing ber ry 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 anal ytical 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, “Analy tical Enforcement Method (HPL C/Column Switching/UV) for the Determination of Residues of DPX - KN128 (S - enantiomer) and IN KN127 (R - enantiomer) in Crops . ” Both methods were adequately validated in conjunction with the sample anal ys es. 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 .Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 4 of 28 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 PHIspecified for each crop in the corresponding label . Samples were all anal yz ed using adequate anal ytical methods with sample holding intervals supported by

storage stability

data generated concurrentl y with each field trial study. Tolerances were recommended based on OECD calculation procedures and harmonization considerations, see Table 2.2.2. Inaddition, 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, respectivel y. The residue data for grapes and cranberries w ere 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 indoxac arb. 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 e stablished 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. L ev y, D276516, 30 - May- 2002). The current dietary burden estimate for dairy

cattle covers the proposed new uses o f indoxacarb and existing tolerances for ruminant commodities are not underestimated. H owever, dietary burden calculations for beef cattle, dairy cattle and poultry

s hould be revisited during registration review to re - evaluate the existing tolerances . **2.0 R** **egulatory R ecommendations**  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 kiw ifruit, subgroup 13 - 07F ........ 2 ppm Low growing berry , except strawberry , subgroup 13 - 07H..................... 1 ppmIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 5 of 28 A human health risk assess ment 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 d iscrepancies 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 method s 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. Inaddition, m ethod 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, s mall f

ruit v ine c limbing s ubgroup 13 - 07F , and l ow growing b erry s ubgroup 13 - 07H . **2.2.2 Recommended Tolerances**  HED recommends that 40 CFR be amended b y 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:Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 6 of 28 **Table 2.2.2**  **. Tolerance Summary for Indoxacarb**  **. Comm**  **odity Establis**  **hed/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 Cow pea, forage Cow pea, hay NA 100 Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13 - 07F 2.0 2 Lo w growing berry, except straw berry , 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 b y 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 onl y significant feedstuff associated with beans, the correct commodity definition would be cowpea, forage instead of bean, forage. In order to harmonize with the Codex MRLfor cowpea (see discussion below), the tolerance for dry bean obtained b y 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 b y the HED. **2.2.4 International Harmonization**  U.S. tolerances are recommended for dry beans, succulent beans, s mall f ruit v ine c limbing s ubgroup 13 - 07F , and l ow growing b erry s ubgroup 13 - 07H based on residues of indoxacarb and its R- enantiomer. Maximum residue limits (MRL s) have not been established by

Canada or Mexico. However, Codex ha s established MRL s 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 R enantiomer. The U . S . tolerances for raisins (5.0 ppm) and cranberries (1 ppm) are harmonized with the co rresponding Codex MRL s. 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 fie ld 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 allo w harmonization with Codex. The tolerance for dryIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 7 of 28 bean ( 0.06 ppm) obtained by the OECD calculation procedures will be increased to 0. 2 ppm in order to harmonize with the Codex MRLfor 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 day s.”  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. Itis 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 onl y on the amount of indoxacarb. As an alternative to organophosphate insecticides, indoxacarb works b y blocking the sodium channels in the insect nervous s ys tem through ingestion and contact routes. Applications are to be made at the labeled use rates when insect populations reach locall y 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 fo r 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 by products up to 4.0 ppm in milk fat. IR - 4 has submitted field trial data in support of a petition p roposing 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 currentIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 8 of 28 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.**  Com pound

Common name Indoxacarb Com pany experimental name DPX - KN128 IUPAC name (S) - me thyl 7 - chloro - 2,5 - dihydro - 2 - [[(methoxycarbonyl)[4 - (trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2 - e][1,3,4]oxadiazine 4a(3 H ) - carboxylate CAS name methyl (4aS) - 7 - chloro - 2,5 - dihydro - 2 - [[(methoxycarbonyl)[4 - (trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2 - e][1,3,4]oxadiazine 4a(3H) - carboxylate CAS registry number 173584 - 44 - 6 End - use product (EP) 30% WDG (DuPont Avaunt® Insecticide; EPA Reg. No. 352 - 597) and 16% Em usifiable Concentrate (Steward ® EC Insecticide; EPA Reg. No. 352 - 638) Com pound

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. In doxacarb is soluble in water ( 15.4 μ g/L) and does not dissociate under environmental relevant conditions. O N N

O O CH 3 Cl N O O O

O C F 3 C H 3

O N N

O O C H 3 Cl N O O O C H 3

O C F 3Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 9 of 28 **3.3 Pesticide Use Pattern/** **Directions for Use (860.1200)**  IR - 4 has submitted field trial data in support of a petition p roposing 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) 1 3 - 07H are proposed based on established tolerances f or grapes and cranberry . The proposed new uses are summarized below in Table 3. 3. **T able**  **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 - 8 Pa (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 environm ental significance.Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 10 of 28 **Table 3. 3**  **Summary of Directions for Use of Indoxacarb.** Applic. Timing, Type, and Equip. 1 Form ulation [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, d**  **ry** 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 . **Sm all 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: C rops with labeled uses and alfalfa, cotton, peanuts and soy beans 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, arrow

roo t, Chinese artichoke, edible canna (Queensland arrow root), 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 immediatel y 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 ; h owever, 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 clari fy 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 ta bulated 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 theIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 11 of 28 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. Lev y, 0 1/19/200 0). 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 enf orcement and risk assessment of crops (D263986, S. J. L ev y, 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 Sum**  **mary of Livestock Metabolism (860.1300)** Adequate ruminant and poultry metabolism studies were previously reviewed in conjunction with an earlier indoxacarb petition (D244253, S. J. Lev y, 0 1/19/20 00). 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. Lev y, 0 7/10/20 00). 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 I N - 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, I N JU873, IN - KB687, IN - KG433, IN - KT319, 5 - HO - IN - JT333, and Metabolite F (D2 77922, S. J. L ev y, 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 subm ission of a subsequent feeding study (MRID No. 46114302), adequate data were appropriatel y provided which established the relevant residues of concern needed for tolerance enforcement in poultry . In accordance, the tolerance expression for poultry commodi ties will include indoxacarb, its R - enantiomer, and the metabolites IN - JT333, IN - JU873, I N - KB687, IN - KG433, and IN - KT319 (D297936, S. J. L ev y, 09/22/2004). Conclusions . As previously noted, the onl y significant feedstuff associated with the proposed n ew indoxacarb use s is cowpea, forage which is fed to dairy cattle . The ruminant metabolism study

available is appropriate to cover residues of concern in dairy cattle.Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 12 of 28 **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. Lev y, 0 1/19/20 00) . The submitted confined rotational crop study

were considered marginall y 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. Lev y, 0 7/10/20 00). 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 interv al for all non - labeled crops ( D256351, S. J. Lev y, 0 9/07/20 00). 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 th**  **e Risk Assessment and**  **Tolerance Expression 1**  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) M etabolite IN - MP819 (for milk only) Indoxacarb and its R enantiomer

Poultry Indoxacarb, its R- enantiomer, and

the metabolites IN - JT333, IN JU873, IN - KB687, IN - KG433, IN - KT319, 5 - HO - IN - JT333, and Metabolite F Indoxacarb, its R- enantiomer, and the metabolites IN - JT333, IN JU873, IN - KB687, IN - KG433, and IN - KT31 9 Drinking Water Indoxacarb , and the degradation products IN - JT333, IN - KG4333, IN - KT413, and IN - ML437 - 0H 1 Adapted from: S. Levy, D 325479, 03/09/2007 ; and D402100, C hristopher M. Koper, 11/06/2012.Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 13 of 28 **5.0 Residue Profile**  **5.1 Residue Analytical Methods (860.1340)**  **5.1 .1**  **Data Collection Methods** The method used for analy sis of snap bean samples (pods/seeds and foliage) was working outline 9.97, versions 1, 2 and 3. S amples of bean (dry) seeds were analyzed using the Cornell Analy

tical Laboratory

Method titled “Residue Anal ys is 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, “Analy tical Enforcement Method (HPL C/Column Switching/UV) for the Determination of Residues of DPX - KN128 (S - enantiomer) and IN - KN127 (R - enantiomer) in Crops . ” M odifications made to the reference method were c onsidered 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 disc arded. 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 ElutR column and purified. The column was further washed with additional acetonitrile and the combined eluent was evaporated to dry ness 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 b y solid phase extraction (SPE) with a combination of silica an d a strong anion exchange (SAX) cartridge. After evaporation of the ACN eluent solvent , the purified sample wa s reconstituted in a mixture of 60% ACN and 40 % 0.03M phosphate buffer, and anal yz ed . Samples were anal yz ed 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 anal ytical method does not distingui sh between the two enantiomers. The instrument L OQ 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 b ean (dry) seed samples , respectively .Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 14 of 28 Method validation with snap bean commodities was performed both prior to and concurrent with sample anal ys is. For method validation, untreated control samples were fortified with indoxacarb/IN - KN127 at 0. 0 1 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 . S ince 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) f or bean (snap) pods/seeds, w ith samples fortifi ed at levels of 0.03 ppm an d 0.1 ppm. Recoveries ranged from 82 % - 95% (90 % ± 4 % , n = 11) for foliage w ith 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 anal ys is. Method validation recoveri es 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 Table s 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 adequatel y bracket ed within the spike levels used in the recovery studies. In all, b oth data collection procedures used for testing were adequately validated prior to and in conjunction with the anal ys is 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 P rotocols C, D, and E found in PAM, Volume 1 . The indoxacarb residues of concern were not evaluated through FDA multiresidue method P rotocol A since neither compound possesses an N - methylcarbamate structure . They were also not tested through Protocol B given that neither compound possesses carbox yl ic 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 b e completely recovered through Protocol D but it was noted that m atrix enhancement effects were observed in certain samples. In accordance, the indoxacarb multiresidue testing results obtained were appropriatel y forwarded to FDA for their review and concurrence D260953, S. J. L ev y, 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 whichIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 15 of 28 work to provide a total measure of concentration by determining both indoxacarb and its R enantiomer as a single component . Plants The primary protocol for the tolerance enforcement of plant commodities is DuPont method AMR 2712 - 93 which is an HPL C/UV procedure. It has been validated by the Agency and forwarded to the FDA for inclusion in PAM Vol. II (D267339, S. J. Lev y, 10/12/20 00). 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 b y column switching HPLC/UV (310 nm) using C 18 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 v alidat ed by the Agency

and forwarded to the FDA accordingl y (D282821, S. J. Lev y, 0 5/ 0 9/20 02). For this method, residues are extracted with ethylacetate:water and filtered, and residues in the ethylacetate fraction are concentrated and purified using silica g el 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 anal ys es utilize the 218, 321 and 527 ions. The method L OQ ranges from 0.2 to 1.0 ppm depending on the matrix, and the LODs are 0.0008 - 0.21 ppm. Another HPL C/UV procedure developed by the registrant, DuPont - 11978, is also available for use to perform tolerance enforcement anal ys es on crops (D313518, S. J. L ev y, 02/18/2005). This protocol wo rks by uniquel y combining the extraction procedure of method AMR - 3493 - 95 with the cleanup and determination techniques developed in m ethod AMR 2712 - 93. For this procedure, residues are extracted with ethyl acetate:water, and residues in the ethylacetate fraction are purified by SAX SPE and determined by column switching HPLC/UV (310 nm) using cyano and C 18 columns, with an external standard. For grape matrices, the method L OQ 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 b y 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 L OQ is 0.01 ppm and the LOD is 0.002 - 0.003 ppm. Residues can b e confirmed b y GC/MSD using the m/z 527 and 469 ions. For poultry

commodity

analy ses, DuPont method AMR 12739 is a Liquid Chromatograph/Mass Spectrometer/Mass Spectrometer (LC/MS/MS) procedure developedIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 16 of 28 by the registrant for use. This method has been successfull y validated using hen muscle, liver, skin , and fat a s well as, whole egg, egg yolk, and egg white samples proving it to be adequate for data collection ( MRID No. 46116302 ). Subsequently , an amen ded version of this protocol, DuPont method AMR 12739 Revision No. 1, was forwarded to ACL/BEAD for petition method validation (P. Savoia, D 356925 , 28 -Nov - 2008 ). Conclusions. Inthe field trials subm itted with the current petition , combined indoxacarb re sidues were determined using a modifi cation of an enforcement method. The data collection method was adequatel y 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. Inaddition, appropriate enforcement methods for residues in livestock are available. **5.1.4 Submittal of**  **Analytical Reference Standards (860. 1650)**  An anal ytical stan dard for the insecticide indoxacarb is currentl y 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 Anal ytical Chemistry Laboratory

l ocated in Fort Meade to the attention of either Theresa Cole or Thuy Nguye n at the following address: USEPA National Pesticide Standards Repository /Anal ytical 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 relativel y 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 refine d oil ) for 12 months; apple juice for 6 months; pears, cabbage, lettuce, cottonseed, and cotton gin b yproducts 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, con current storage stability studies were carried out along with the snap bean and dry bean crop field trials . Maximum storage interval s for field - treated samples w ere 203 day s for snap beans (pods with seeds ) , and 205 days for plant/foliage samples. S torage stability samples (bothIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 17 of 28 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 anal ys is. Treated dry

bean seed samples in this study w ere stored frozen for 190 - 225 day s . S torage 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 day s. The data indicated that indoxacarb was stable under the conditions that the samples were stored between harvest and anal ys is.

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 average d 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 f ield 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 a pplication s 6 - 8 day s apart with a pre - harvest interval (PHI) of 2 - 3 day s . 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) p ods with seeds - 29 to - 16 101, 91, 90 68 - 203 209 Bean (snap) p lants 93, 99, 106 70 - 205 209 Bean (dry) seed - 21 ± 7 103, 103, 103 190 - 225 210Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 18 of 28 from 0.108 - 0.119 lb ai/A per application for a total of 0. 438 - 0.457 (0.542 at OH 12 ) lb ai/A per season. No adjuvants were used at any of the trials. S nap 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 l ast 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 day s PHI, residues in treated field samples were found between 0.04 ppm (OH12) and 0.59 ppm (CA 107). For plant/foliage samples at 2 - 3 day s 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. HAFT 1 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) Pla nt/Foliage 0.438 - 0.542 2 - 3 18 1.3 32.1 31.7 10.2 12.6 8.2 1 HAFT = 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 trial s ); region 8: CO (1 trial); region 9: CO (1 trial); regi on 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 pre harvest interval (PHI) of 6 - 8 day s. Avaunt ® 30 WG was used for a second treated plot at tree field trials. D ry bean seed samples were either hand or mechanically harvested. At the CA and ND trial s , additional samples were taken at 0, 13, and 20 - 22 day s 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 totalIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 19 of 28 combined residues of indoxacarb (DPX

– KN128) and IN

– KN127 in/on b ean ( dry ) seeds treated with Steward® ranged from <0.01 ppm to 0.093 ppm . Residues in/on b ean ( 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 residue s 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 f rom the other sampling intervals. The decline data indicate d that residues of indoxacarb decayed fairl y 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) PHI 1

(days) Residue Levels (ppm) 2 n Min. Max. HAFT 1 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 1 HAFT = 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 a nd standard deviation Small fruit vine climbing, except fuzzy kiwifruit, subgroup 13 - 07F Adequate crop field trials (13) were conducted during the ye ar 2002 to support registration and tolerances for indoxacarb (Avaunt® 30% WDG) on grapes (S. Levy, D290126, 18 - Feb 2005) . The crop field trials consisted of four broadcast foliar applications at 0.109 - 0.158 lb ai/A, and an interval of 5 - day s between applications for a total of 0.438 - 0.507 lb ai/A/season. All applications were made using ground equipment. Samples of grape s were collected at 7 day s 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 interval s (RTIs) of 6 - 8 day s, for a total application rate of 0.4 36 - 0.4 51 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 day s 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.Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 20 of 28 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 anal ys is . Samples were anal yz ed using adequate anal ytical 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 day s after treatment. The residue data is adequate to recommend regi stration 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 b ean 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 evaluate d 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 - day s instead of 21 - day s) than what is proposed for the small fruit vine climb ing 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 (860.1**  **520)** 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 newIndoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 21 of 28 guidelines that make use of the highest or average residue level in the f eedstuff, and a livestock dietary

burden calculator developed b y 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. D ietary burd en calculations for beef cattle, dairy cattle and poultry

sh ould be revisited during regi stration review in order to re - ev aluate 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**  **cation 1**  **Highest/ Averag e** 

**Residue 2**  **% In Diet**  **Dietary Burden**  Apples, wet pomace 40 C C 1.9 10 0.48 C C 0 35 0.00 Cotton, undelinted seed 88 P C 1.3 10 0.15 Cow pea, 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 wer e 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 MRLcalculation 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 .Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 22 of 28 **Appendix A**  **. International Residue Limits Table**



### Indoxacarb (PC Code 067710 ) Summary of US and International Tolerances and Maximum Res idue Limits Residue Definition : US Canada Mexico 2 Codex 3 40 CFR 180. 564 : Plants: indoxacarb, (S) -me thyl 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 en antiomer. The residue is fat soluble. Commodity 1 Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 2 Codex 3 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 measure d on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 23 of 28 **A ppendix**  **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** Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 24 of 28 **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** Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 25 of 28 **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** Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 26 of 28 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** Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 27 of 28 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]Indoxacarb Summary of Analytical Chemistry and Residue Data Barcode D 408982

Page 28 of 28 **Appendix C. Highest/average residues of indoxacarb in feedstuff commodities**  **6** 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 by

products (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. Soy bean seed (PC) 3 Average f ield trial = **0.088 ppm** 10. Soy bean hulls (R) 3,4 Processing Factor4 = 8.2x; Average field trial of soy bean seed 3 = 0.088 ppm Average residue in so yb ean 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 - JA

N - 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.