Page 1 of 30 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM DATE : 2 November 2010 SUBJECT: Thiamethoxam . Petition to Establish Permanent Tolerance s for Residues of

the Insecticide Resulting from Food/Feed Use as a Seed Treatment on Peanuts and Alfalfa , and from Applications in Food - Handling Establishments . Summary of Analyti cal Chemistry and Residue Data . PC Code: 060109 DP Barcode s : D3 7 6 36 7 , D 380653 Decision N umbers : 4 24517, 4 36785 File Symbol, Registration Numbers : 100 - RGAL, 100 - 9 41 , 100 - 1306 Petition Number s : 9F7657, 0F7707, 0F7734 Regulatory Action: Amended Section 3 Risk Assessment Type: NA Case N umber : NA T XR Number : NA CAS N umber : 153719 - 23 - 4 MRID # N umbers : See MRID Summary Table 40 CFR: § 180 . 5 65 FROM: William T. Drew, Chemist

Ris k A ssessment Branch 2 (RAB2) Health Effects Division (HED), 7509P THRU: Dennis McNeill y , Chemist

Richard A. Loranger , PhD , Sen i or Scienti st RAB2/HED, 7509P TO: Kable Davis and Venus Eagle, RM Team 1

Insecticide/Rodenticide Branch (IRB) Registration Division (RD), 7505P MRID Summary Table. MRID #Number Study Type Comments 45093704 860.1500 Crop Field Trials/Residue Decline New DER; p eanut ( nutmeat, h ay) . 860.1520 Processed Food and Feed New DER; p eanut ( meal, refined o il) . 48020201 860.1500 Crop Field Trials/Residue Decline New DER; a lfalfa (f

orage, h ay). 4 8110202 Food - Handling Establishments New DER; spot, void, or crack and crevice treatment .Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 2 of 30 Executive Summary Thiamethoxam ( 3 - [(2 - chloro - 5 - thiazolyl)methyl ]tetrahydro - 5 - methyl -N - n itro - 4H - 1,3,5 - oxadiazin - 4 - imine) belongs to the pesticide chemical class known as the neonicotinoids (Group 4A) . It is a broad - spectrum, sy stemic insecticide with activity against suckin g and chewing insects on a wide variety of crops. It i s also effective against a wide variety of interior and exterior pests, including termites, ants, beetles, and cockroaches. Sy ngenta Crop Protection submitted a p etition to register a new use of thiamethoxam on peanuts (PP#9F7657) . One end - use product (EP) relevant to this petition is Cruiser PD (EPA File Sy mbol 100 - RGAL ), a wettable powder formulation intended for dry- application seed treatment (WS), containing 70% of the active ingredient (ai), thiamethoxam . The other EP relevant to this petition is Cruiser 5FS (EPA Registration #100 - 941), a flowable concentrate formulation intended for seed treatment (FS), containing 5 pounds of ai per gallon (lb ai/gal). Both are proposed for pre - plant seed treatment of peanuts at 0.20 - 0.29 mg ai/seed , to provide earl y season protection of seedlings against injury from thrips, aphids, wireworms and white grubs, and suppression of three - cornered alfalfa hoppers, and plant bugs. Inconjunction with the proposed use, S yn genta has requested the establishment of permanent tolerance s for residues of thiamethoxam and its metabolite , CGA - 322704 (clothianidin), in or on peanut commoditie s , as listed below.

Peanut ................................ ................................ .......................... 0.0 5 ppm Peanut, hay ................................ ................................ .................. 0.25 ppm In support of the proposed registration and tolerance s , Sy ngenta submitted a magnitude of the residue study on peanut nutmeat and hay ( MRID # 45093704 ). The submitted peanut data are evaluated in this Summary Document. Sy ngenta also submitted a petition to register a new use of thiamethoxam on alfalfa (PP# 0 F7 707 ) . The EP relevant to this petition is Cruiser 5FS (EPA Registration #100 - 941). It is proposed for pre - plant seed treatment of alfalfa at 0.00 1 mg ai/seed , to provide earl y season protection of seedlings against damage caused by aphids and leaf hoppers (first cut crop only) . In conjunction with the proposed use, Sy ngenta has requested the establishment of permanent tolerance s for residues of thiamethoxam and its metabolite, C GA - 322704 (clothianidin), in/on alfalfa commodities , as listed below.

A lfalfa, forage ................................ ................................ ............. 0.0 5 ppm A lfalfa, hay ................................ ................................ .................. 0. 1 2 ppm In support of the proposed registration and tolerances, Sy ngenta submitted a magnitude of the residue study on alfalfa forage and hay ( MRID #48020201). The submitted alfalfa data are evaluated in this Summary Document. Additionally , Sy

ngenta submitted a petition to register a new food use of thiamethoxam in food handling establishment s (PP# 0F7734 ) . The EP relevant to this petition is Optigard Flex Liquid (EPA Registration #100 - 1306) , a suspension concentrate (SC) formulation that contains 2Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 3 of 30 lb ai/gal . It is proposed for indoor spot, void, and crack and crevice applications a s 0.05 and 0.1 % ai solutions , to control a wide variety of insect pests . In conjunction with the proposed use, Sy ngenta has requested the establishment of a permanent tolerance for residues of thiamethoxam and its metabolite, CGA - 322704 (clothianidin), in/on food or feed commo dities, as listed below.

Food commodities/feed commodities (other than those covered b y a higher tolerance as a result of use on growing crops) in food/feed handling establishments ................................ ................................ ............. 0.0 1 ppm In support of the proposed registration and tolerance, Sy ngent a submitted a magnitude of the residue study on various food items following indoor applications in two different food handling establishments (MRID # 48110202 ). The submitted food handling establishment data are evaluated in this Summary Document. Tol erances for residues of thiamethoxam are listed in 40CFR §180.565 , and are expressed in terms of the combined residues of the insecticide thiamethoxam and its metabolite , CGA - 322704. The metabolite CGA - 322704 is identical to the active ingredient , clothianidin (PC Code 044309). The established tolerances in plant commodities, under 40CFR §180.565 [ a ] , range from 0.02 ppm to 4.5 ppm; about half of the tolerances are set at the combined limit of quantitation (L OQ) for thiamethoxam and CGA - 322704 of 0 .02 ppm . Tolerances are also established under 40CFR § 180.565 [ a ] in livestock commodities . The tolerances in milk and meat of cattle, goat, horse and sheep , and in meat and meat b yproducts of hog, are set at 0.02 ppm each. The tolerances in meat by produc ts of cattle, goat, horse and sheep are set at 0.0 4 ppm each. The nature of the residue in plants and animals has been adequatel y delineated , based on metabolism studies with corn, cucumber, lettuce, pear, potato, rice, tobacco, wheat, goats and hens . The studies on corn, potato and wheat reflected seed treatment and/or soil drench applications. The residues of concern (ROCs) , for the purposes of tolerance expression and risk assessment , are the combined residues of thiamethoxam and CGA - 322704. The nature of the residue in rotational crops is adequately understood. HED has determined (RAB2 continues to support the decision) that the major residues from the confined rotational crop studies are the parent , thiamethoxam , and its CGA - 322704 metabolite. Inanimal feedstuffs, CGA - 265307, a metabolite containing the N - nitro group, was found to be a major residue. HED recommended that all three compounds be anal yz ed in field rotational crop studies. Several field rotational crop studies on thiamethoxam are available . These data indicate that at an application rate of 0.179 pounds ai per acre ( lb ai/A), roughl y 1X the maximum seasonal use rate of 0.188 lb ai/A o n rotatable crops, quantifiable levels of thiamethoxam ROCs are not expected from a 120 - day plantback interval (PBI) . The proposed seed treatment use of Cruiser PD and Cruiser 5FS on peanuts would result in a maximum per acre application rateThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 4 of 30 equivalent to 0. 0 8 lb ai/A ( approximately 0. 4 3 X the maximum use rate o n rotatable crops ) , based on 850 seeds/lb, and a seeding (planting) rate of 142 pounds of seeds per acre (lb seeds/A) . The proposed seed treatment use of Cruiser 5FS on alfalfa would result in per acre application rates equivalent to 0. 0037 - 0. 013 0 lb ai/A (approximately 0. 02 - 0 . 07 X the maximum use rate on rotatable crops), depending on the seeding rate , in lb seeds/A. Novartis Anal ytical Method AG - 675, a method utilizing high - performance liquid chromatography ( HPL C ) with ultraviolet (UV ) or mass spectrometric ( MS ) detection, is the original enforcement method , and was submitted in conjunction with previous thiamethoxam petitions. Method AG - 675 determines residues of thiamethoxam and CGA - 322704 in crop and lives tock commodities. The method has undergone a successful independent laboratory validation (ILV), and Agenc y petition method validation (PMV). Following approval of Method AG - 675 as an enforcement method, Sy ngenta submitted a modification of the method to include a microwave extraction step for liver. In its review of the modified Method AG - 675, HED ( D281702; M. Doherty ; 17 April 2007 ) required that the method be completel y rewritten to include the full residue extraction steps for both plant and livest ock commodities. Sy ngenta responded to this data gap by submitting Method GRM.009 .04A ( MRID #47786103) , which supersede s Method AG - 675. Method GRM.009 .04A determines residues of parent thiamethoxam and its metabolites (CGA - 322704 and CGA 265307) individually

using HPLC/UV for f

ruits, vegetables, oils, grains , and animal matrices other than liver . The LOQ for each anal yt e is 0.010 ppm in all substrates except milk and fruit juices (0.0 0 5 ppm). The method includes a step in the calculation to conv ert residues of CGA 322704 to thiamethoxam equivalents. For anal ys is of cotton, tobacco, and the forage, fodder and straw of cereal grains, the method determines thiamethoxam ROCs using HPL C/MS , with an LOQ of 0.010 ppm in each anal yt e except grass (0.05 0 ppm). For anal ys is of liver, final residue determination is made using HPL C with tandem mass spectrometric detection ( HPL C/MS/MS ) ; the L OQ is 0.010 ppm ea ch for thiamethoxam, CGA - 322704 and CGA - 265307. Sy ngenta al s o submitted method validation data for Method GRM.009.04A (MRID #47786102). No ILV data have been submitted , nor will ILV data be required , becau s e the method is a revised version of an existing enf

orcement method. HED will forward Method GRM.009 .04A ( MRID # 47786103) to FDA for an update of the thiamethoxam enforcement method in PAM Volume II. Samples of the peanut raw agricultural commodities (RACs) , nutmeat and hay , were anal yz ed for residues of thiamethoxam and its metabolite, CGA - 322704 (clothianidi n), using Method AG - 675 with either ultraviolet (HPLC/UV), or tandem mass spectrometric detection (HPL C/MS/MS ) . This method is adequate for data collection, based on acceptable concurrent method recoveries. The LOQ was 0.01 ppm for each analy te , resultin g in an LOQ for combined residues of 0.02 ppm . Samples of the alfalfa RAC s, forage and hay , were anal yz ed for residues of thiamethoxam and its metabolite, CGA - 322704 (clothianidin), using an HPLC/MS/MS method , Sy ngenta Anal ytical Method GRM009.02A. This method is also known as ADPEN Method M1104, and is adequate for data collection, based on acceptable concurrent method recoveries. The LOQ was 0.01 ppm for each analy te , resulting in an LOQ for combined residues of 0.02 ppm .Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 5 of 30 Samples of the various food commodities utilized in the food handling establishment study were analy

zed for residues of thiamethoxam and its metabolite, CGA - 322704 (clothianidin), via HPL C/MS/MS using Method AG - 675 . This method is adequate for data collection, based on accepta ble concurrent method recoveries. The LOQ was 0.01 ppm for each anal yt e in all matrices , resulting in an LOQ for combined residues of 0.02 ppm . The FDA multiresidue method s (MRMs) of PAM Volume I are not adequate for tolerance enforcement , as thiametho xam ROCs are not adequately recovered by any of the tested MRM protocols . Adequate storage stability data are available for thiamethoxam and CGA - 322704 to support the storage conditions and duration s of samples collected from the magnitude of the residu e and food handling establishment studies. There are no storage stability issues, and no corrections for potential decline during storage are needed for any of the residue studies. The submitted field trial data for thiamethoxam on peanut s are acceptable , and support the proposed use of Cruiser PD and Cruiser 5F S as pre - plant seed treatment s . An adequate number of trials w ere conducted in the appropriate geographic regions at roughl y 1 .5 - 3 X the maximum proposed rate. Based on the maximum combined thiamethoxam ROCs of 0.09 and 0.2 3 ppm in treated nutmeat and hay samples, respectivel y, HED con curs with the proposed tolerance s of 0. 0 5 ppm in peanut nutmeat, and 0. 25 ppm in peanut hay . The submitted field trial data for thiamethoxam on alfalfa are acceptable, and support the proposed use of Cruiser 5F S as a pre - plant seed treatment . An adequate number of trials were conducted in the appropriate geographic regions at 1X the maximum proposed rate. Based on the maximum combined thiamethoxam ROCs of 0.0 4 and 0. 10 ppm in treated forage and hay samples, respectively , HE D concurs with the proposed tolerance s of 0.05 ppm in alfalfa forage , and 0. 1 2 ppm in alfalfa hay . The submitted data for thiamethoxam use in food handling areas are acceptable, and support the proposed use of Optigard Flex Liquid as a spot, void, and crack and crevice treatment in food handling establishments . An adequate variety of food commodities were exposed to thiamethoxam, in two different types of foo d handling establishments, at 1X the maximum proposed rate. M aximum thiamethoxam and CGA - 322704 residue s were each < 0.01 ppm in food commodities exposed to 1X treatment in food handling areas (with the vast majority of samples containing non - detectable re sidues) . Based on the presence of detectable residues of thiamethoxam or CGA - 322704 in various samples, HED recommends a tolerance of 0.0 2 ppm in food /feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) . There are no processed commodities associated with the proposed use on alfalfa. The processed commodities associated with the proposed use on peanut s are peanut meal and refined oil. Tw o peanut field trials were conducted in the US during the 1999 grow ing season in which peanut seeds treated at an exaggerated (roughly 6 - 6.5 X) rate were grown for processing into peanut meal and refined oil . Thiamethoxam residues were not detected in the nutmeat nor processed fractions of peanuts grown from peanut seeds treated at the 6 - 6.5X rate. Residues were not detected in any of the peanut oil samples upon processing. Residues were observed in the nutmeat and meal of peanuts , grown from peanut seeds treated at roughly a 2 X rate , from both field trial s . The theoretical concentration factor for peanut meal ( OPPTS ResidueThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 6 of 30 Chemistry

Test Guideline 860. 1520, Table 3) is 2.2 X . The empirical concentration factors for thiamethoxam in meal (range 2.0 - 3.1 X , average 2.6 X) conform well to the theoretical value . A tolerance is not required in peanut oil. Based on the HAFT combined residues of 0.05 ppm (0.09 ppm at a 2X rate) in peanut nutmeat, and the theoretical concentration factor for peanut meal of 2.2X, HED recommends a tolerance of 0.15 ppm in peanut meal . Analy tical reference standards for thiamethoxam and its metabolite , CGA - 322704 , are currentl y available at the EPA National Pesticide Standards Repository (NPSR) . There are no Codex or Mexican maximum residue limits ( MRL s ) established for residues of thiamethoxam in crops associated with this review. Canada has established an MRL of 0.02 mg/kg for combined residues of thiamethoxam and CGA - 322704 in all food crops. Regulatory Recommendations and Residue Chemistry Deficiencies HED has examined the residue chemistry database for thiamethoxam. There are no residue chemistry

issues that would preclude granting Section 3 registration s , an d establish i n g permanent tolerance s , for the requested use of thiamethoxam (as Cruiser PD or Cruiser 5F S ) on peanut s , for the requested use (as Cruiser 5F S ) on alfalfa, and for the requested use (as Optigard Flex Liquid) in food handling establishments . Provided that the forthcoming human health risk assessment does not identify any issues of co ncern, the submitted data support tolerance s for thiamethoxam , including its metabolites and degradates, in or on peanut nutmeat , hay and meal , alfalfa forage and hay , and food /feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) , at the level s listed below . Comp liance with the tolerance level s specified below is to be determined by measuring only thiamethoxam and CGA 322704 ( calculated as thiamethoxam equivalents) .

Peanut ................................ ................................ .......................... 0.0 5 ppm Peanut, hay ................................ ................................ .................. 0.25 ppm Peanut, meal ................................ ................................ ................ 0. 1 5 ppm Alfalfa, forage ................................ ................................ ............. 0.05 ppm Alfalfa, hay ................................ ................................ .................. 0.12 ppm Food commodities/feed commodities (other than those covered b y a higher tolerance as a result of use on growing crops) in food/feed handling establishments ................................ ................................ ............. 0.02 ppm A revised Section F should be submitted to reflect the additional tolerance in peanut meal, and the higher tolerance arising from the food/feed handling use. BackgroundThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 7 of 30 Thiamethoxam is a broad - spectrum nitroguanidine insecticide which belongs to the pesticidal class of compounds known as the neonicotinoids (Group 4A). It has activity against sucking and chewing insects, such as leafhoppers and potato beetles, as well as other insect pests , on a wide variety

of crops. It also i s effective against a w ide variety of interior and exterior pests, including termites, ants, beetles, and cockroaches. It appears to interfere with the nicotinic acetyl choline receptors of the insect’s nervous s ys tem, but the specific receptor site is unknown at this time. It does not inhibit cholinesterase, nor does it interfere with sodium channels, and thus has a different mode of action than the organophosphate, carbamate and py rethroid insecticides. In support of a petition for use of thiamethoxam on peanuts (PP#9F7657) , Sy ngenta submitted field trial data reflecting the seed treatment use of thiamethoxam ( 70% ai W S , and 5 lb ai/gal FS ) on peanuts . Insupport of a petition for use of thiamethoxam on alfalfa (PP# 0 F7 707 ) , Sy ngenta submitted field trial data reflecting the seed treatment use of thiamethoxam ( 5 lb ai/gal FS ) on alfalfa . In support of a petition for use of thiamethoxam in food handling establishment s (PP# 0F7734 ) , Sy

ngenta submitted data reflecting spot, void, and crack and crevice applications of thiamethoxam ( 2 lb ai/gal SC ) in food handling areas of a restaurant and a delicatessen . The nomenclature of thiamethoxam and its metabolite s , is summarized in Table 1 (below) , and the phy sicochemical properties of the technical grade of thiamethoxam are summarized in Table 2 (below) . TABLE 1 Test Compound Nomenclature. Com pound

Common name Thiamethoxam Com pany experimental name CGA 293343 Molecular formula C 8 H 10 ClN 5 O 3 S Molecular weight 291.71 IUPAC name 3 - (2 - chloro - 1,3 - thiazol - 5 - ylmethyl) - 5 - me thyl - 1,3,5 - oxadiazinan - 4 - ylidene(nitro)amine CAS name 3 - [(2 - chloro - 5 - thiazolyl)methyl]tetrahydro - 5 - methyl - N - nitro - 4H - 1,3,5 - oxadiazin - 4 - imine CAS registry number 153719 - 23 - 4 End - use products (EPs) 70% ai W S formulation (Cruiser PD Insecticide; EPA File Symbol 100 - RGAL ) 5 lb ai/gal FS formulation ( Cruiser 5FS Insecticide; EPA Registration #100 - 9 41 ) 2 lb ai/gal SC formulation (Optigard Flex Liquid; EPA Registration #100 - 1306 ) N O N N C H 3 N S Cl O 2 NThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 8 of 30 TABLE 1 Test Compound Nomenclature. Chemical structure of CGA - 322704 metabolite (clothianidin)

N - [(2 - chloro - 5 - thiazoyl)methyl] - N’ - methyl -N” - nitroguanidine Chemical structure of CGA - 265307 metabolite

N - (2 - chloro - thiazol - 5 - ylmethyl) -N’ - nitroguanidine TABLE 2 Physicochemical Properties of Technical Grade Thiamethoxam. Param eter Value Reference * Melting point/range 139.1  C PMRA Regulatory Note (REG2001 - 03) on Thiamethoxam, 9 February 20 01 pH 4.7 (1% solution in water) Density 1.57 x 10 3 kg/m 3 Water solubility 4.1 g/L (25°C) Solvent solubility Solvent acetone dichloromethane ethyl acetate hexane methanol octanol toluene Solubility (g/L) 48 110 7.0 <1 mg/L 13 0.62 0.68 Vapor pressure 2.7 x 10 - 9 Pa (20  C) 6.6 x 10 - 9 Pa (25  C) Dissociation constant, pKa No dissociation for pH range 2

– 12 Octanol/water partition coefficient, Log(KOW) 0.13 ± 0.0017 (25  C) UV/visible absorption spectrum Molar absorbance coefficients for the absorbance maximum: 16,800 L/mol/cm at 255 nm (neutral) 17,000 L/mol/cm at 255 nm (acidic) 15,900 L/mol/cm at 255 nm (basic) (No further adsorption maxim a between 290 and 750 nm were observed. ) MRID # 47287502

* As referenced in D349272 ; M. Doherty ; 12 August 20 08. N H N H N C H 3 N S Cl O 2 N

N H 2 N H N N S Cl N O 2Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 9 of 30 860.1200 Directions for Use Peanuts: The EP s proposed for use on peanuts are Cruiser PD (EPA File Sy mbol 100 - RGAL), a WS formulation of thiamethoxam containing 70% ai , and Cruiser 5FS (EPA Registration #100 - 941), an FS formulation of thiamethoxam containing 5 lb ai/gal . They are proposed for use as pre - plant seed treatment s of peanuts to provide earl y s eason protection of seedlings against injury

from thrips, aphids, wireworms and white grubs, and suppression of three - cornered alfalfa hoppers, and plant bugs . The proposed use directions on peanuts , obtained from draft label s dated 7 December 20 09 for Cruiser PD and Cruiser 5F S, are presented in Table 3 (below) . In response to questions from HED, Sy ngenta clarified that the maximum use rate for peanuts should be 0.0 8 lb ai/A instead of 0.266 lb ai/A (electronic message of 18 October 2010, from Sy ngenta’s Patrick McCain to RD’s Kable Davis) . This rate was calculated using assumptions which HED considers reasonable (850 seeds/lb, and 142 lb seeds/A) . Alfalfa: The EP proposed for use on alfalfa is Cruiser 5FS (EPA Registration #100 - 941) . It is proposed for use as a pre - plant seed treatment of alfalfa to provide early season protection of seedlings against damage caused b y aphids and leafhoppers (first cut crop only) . The proposed use directions on alfalfa, obtained from a draft label dated 3 March 20 1 0 for Cruiser 5FS , are presented in Table 3 (below) . Food handling establishments: The EP proposed for use in food handling establishment s is Optigard Flex Liquid (EPA Registration #100 - 1306) , an SC formulation of thiamethoxam that contains 2 lb ai/gal . It is proposed for use as spot, void, and crack and crevic e applications in food handling and other areas of food handling establishment s . The proposed use directions for food handling establishment s , obtained from a draft label dated 10 June 2010 for Optigard Flex Liquid , are presented in Table 3 (below ) . TABLE 3 Summary of Proposed Use Directions on Peanuts and Alflalfa, and in Food Handling

Establishments . Use Timing; Type; and Equip me nt Product [ File

Symbol or Reg istration Number ] Single

Use Rate Maxim um

Uses per Season Maximum

Seasonal Use Rate PHI

(D ays) Use Directions and

Limitations Peanuts Pre -plant ; s eed treatment . Cruiser PD

[100 - RGAL ] Cruiser 5FS [100 - 94 1 ] 0. 2 0 - 0.2 9

mg ai/ seed 1 (Implied) 0. 08 lb ai/A N S 1 No soil or foliar application of

thiamethoxam to p eanut s grown from seed treated wi th Cruiser PD or Cruiser 5FS . Apply Cruiser PD in dry form , using equipment intended for dry - application seed treatment only (not for use in on - farm applicators; use in commercial seed treatment facilities only) .Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 10 of 30 TABLE 3 Summary of Proposed Use Directions on Peanuts and Alflalfa, and in Food Handling

Establishments . Use Timing; Type; and Equip me nt Product [ File

Symbol or Reg istration Number ] Single

Use Rate Maxim um

Uses per Season Maximum

Seasonal Use Rate PHI

(D ays) Use Directions and

Limitations Alflalfa Pre -plant ; seed treatment . Cruiser 5FS

[100 - 94 1 ] 0.00 1 mg

ai/seed 1 (Implied) NS (0.0130) 2 N S No soil or foliar application of

thiamethoxam to alfalfa grown from seed treated with Cruiser 5FS . Food Handling Establishment s Pest pressure; coarse lowpressure spot spray , void injection , or crack and crevice spray . Optigard Flex

Liquid [100 - 1306] 0.05 -

0.10% spray N S NS NA 3 Prior to application , remove or cover all food items in area s to be treated. Do not apply where food utensils or food surfaces may be come contaminated . Treatments to be made by commercial pesticide applicators only. 1. NS = Not S pecified . 2. The alfalfa field trials utilized single (and seasonal ) use rate s of 0.0037 - 0. 0 1 30 lb ai/A , b ased on the respective seeding rate s ( 8.00 - 27.90 lb seed s /A) , and an average of 210,000 alfalfa seed s/lb . 3. NA = Not Applicable. Conclusion The submitted use directions for treatment of peanuts and alfalfa, and for applications in food handling establishment s , are sufficient to allow for evaluation of the submitted residue data relative to the proposed use pattern s . 860.1300 Nature of the Residue - Plants M etabolismDecision Mem o D258614 ; G.J. Herndon; 31 August 19 99 Residue Chemistry Mem o D252021 ; G.J. Herndon; 30 March 20 00 Residue Chemistry Mem o D265079 ; G.J. Herndon; 8 May 2000 Residue Chemistry Mem o D281702; M. Doherty; 17 April 2007 Plant m etabolism studies with thiamethoxam have been submitted on corn, cucumber, lettuce, pear, potato, rice, tobacco and wheat . The studies on cucumber, lettuce, pear and rice reflected foliar applications, while the studies on corn, potato and wheat reflected seed treatment and/or soil drench applications . The tobacco stu dies included soil and foliar treatment s . HED previously determined (and continues to support the decision) that the ROCs , for purposes of tolerance enforcement and risk assessment , are the combined residues of thiamethoxam and CGA - 3 22704. 860.1300 Nature of the Residue - LivestockThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 11 of 30 Me tabolismDecision Mem o D258614; G.J. Herndon; 31August 1999 Residue Chemistry Mem o D252021; G.J. Herndon; 30 March 2000 Residue Chemistry Mem o D265079; G.J. Herndon; 8 May 2000 The nature of the residue in livestock is adequately understood , based on acceptable goat and hen metabolism studies. F or purposes of tolerance enforcement and risk assessment , the ROCs are the combined res idues of thiamethoxam and CGA - 322704. 860.1340 Residue Analytical Methods Residue Chemistry Mem o D252021; G.J. Herndon; 30 March 2000 Residue Chemistry Mem o D265079; G.J. Herndon; 8 May 2000 Residue Chemistry Mem o D271516 ; M. Doherty; 29 May 2001 Residue Chemistry Mem o D281702; M. Doherty; 17 April 2007 Enforcement M

ethod An HPL C method with UV or MS detection, Method AG - 675, submitted in conjunction with previous thiamethoxam petitions, is adequate for collecting residue data , and enforcing tolerances for residues of thiamethoxam and CGA - 322704 in crop and livestock commodities. The validated LOQ for each analy te is 0.010 ppm in all plant matrices , with the exception of fruit juices (0.005 ppm), grass (0.05 ppm) and cured tobacco (0.1 0 ppm). In livestock, the validated LOQ s for residues of thiamethoxam and CGA - 322704 are 0.010 ppm for each anal yt e in meat, poultry and eggs , and 0.005 ppm each in milk. Briefl y, samples are extracted with acetonitrile (ACN) /water ( 4 : 1 , volume to volume, or v/v), and the extract is subjected to partitioning with toluene and hexane (livestock commodity and oil samples only) , and then cleaned up by solid - phase extraction (SP E) . Residues of thiamethoxam and CGA - 322704 are determined in fruits, vegetables, oils, grains, and livestock commodities using HPLC/UV. HPL C/MS is used to determine residues in cotton commodities, tobacco comm odities, and the forage, fodder and straw of cereal grains and grasses to achieve the desired LOQs. The method includes a step in the calculation to convert residues of CGA 322704 to thiamethoxam equivalents. Adequate method validation data have been submitted, and the method has undergone a suc cessful ILV and PMV . In addition, the method has been adequatel y radiovalidated in crop and livestock commodities. Sy ngenta has submitted a re - written version of Method AG - 675, and renamed it as Method GRM.009.04A (MRID # 47786103 ) , which supersede s Method AG - 675 . The full extraction steps for plant and livestock commodities, including the microwave extraction step for liver, have been incorporated, as previously requested by

HED as a condition of registration. The LOQs of Method GRM.009.04A have be en established at 0.010 ppm each for residues of thiamethoxam, CGA - 322704 and CGA - 265307 . Sy ngenta has submitted method validation data for Method GRM.009.04A (MRID #47786102). No ILV data have been submitted , nor will ILV data be required , becau s e the m ethod is a revised version of an existing enf orcement method. Al though the addition of a microwave extraction step is a significant change to the method, residues of thiamethoxam , CGA - 322704 and CGA - 265307 are likely to be low in livestockThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 12 of 30 commodities (th e dosing levels used in the metabolism studies were 100X f o r goats , and 400 X for poultry) . In addition, the extensive cleanup procedures after the microwave extraction step are very similar to the cleanup procedures used for the Poly tron extract of livest ock commodity samples in Method AG - 675, which has been adequately validated by the Biological and Economic Anal ys is Division’s Analy tical Chemistry

Branch (BEAD/ACB) . HED will forward MRID #47786103 to FDA for an update of the current method in PAM Volume II. Data- collection methods Peanuts: Novartis Analy tical Method AG - 675 was used to determine residues of thiamethoxam and its metabolite, CGA - 322704, in peanut nutmeat, hay , meal and oil , with HPL C/UV , HPLC/MS and HPL C/MS/MS systems successfull y utilized to anal yz e the samples. The limits of detection (LODs), defined as the lowest mass injected that could be reliabl y detected, were 1.25 ng for the HPL C/UV s ys tem , 0.125 ng for the HPL C /MS system , and 4 pg for the HPL C/MS/MS sy stem. The LOQ , defined as the lowest recovery level anal yz ed in peanut samples, was 0.01 ppm for each anal yt e in all matrices , resulting in an LOQ for combined residues of 0.02 ppm . The anal ytical procedures that were used are summarized below. The ma jority of the peanut nutmeat samples were anal yz ed using HPLC/UV. S ample s ( 10 gram s) w ere extracted twice by poly tron homogenization in ACN/water (4:1 v/v). The extraction volume was 200 mL , and a 50 - mLaliquot was anal yz ed. The aliquot was evaporated t o aqueous, and initially

purified using reverse - phase (phenyl ) SPE. After elution from the phenyl SPE column with methanol/water (1:1, v/v), the sample was evaporated to aqueous, and partitioned with ethyl acetate. The ethyl acetate fraction was evaporat ed, and further purified b y normal - phase SPE, using a combination of amino and alumina cartridge column s (the amino column was omitted in a few analy tical sets without affecting the results). The eluted sample was evaporated, and reconstituted in 1 mLof mobile phase (increased volumes were used as needed for larger compound concentrations). Analy sis was performed using a normal - phase Spherisorb Amino HPL C column (250 mm length x 4.6 mm ID), with a mobile phase of hexane/ethyl ace tate/methanol/ isopropanol (11:3:1: 1, v/v) . The anal yt es were detected using a wavelength of 255 nm. Peanut h ay , and a few peanut nutmeat samples , were anal yz ed using HPLC/MS /MS. S ample s ( 10 gram s) w ere extracted twice b y pol ytron homogenization in ACN/water ( 4 : 1 , v/v). The extraction volume was 2 00 mL , and a 50 - mLaliquot was anal yz ed. Samples were first purified using a combination of anion - exchange (SAX) and reverse - phase (phenyl ) SPE. After elution from the phenylSPE column with methanol/water ( 1 : 1 , v/v), the sample was evaporated to aqueous , and partitioned with ethyl acetate ( although some of the nutmeat samples were anal yz ed after elution from the phenyl SPE by evaporating to aqueous , and diluting to final volume as described below). The ethylacetate fraction was evaporated , and further purified by normal phase SPE using an alumina cartridge column. The eluted sample was evaporated , and reconstituted in 30 mLof ACN/water ( 1:9, v/v); increased volumes were used as needed for larger compo und concentrations . Anal ys is was performed using a Phenomenex Luna 311 C 18 HPL C column (250 mm length x 2.0 mm ID ). The mobile phase was a gradient of ACN and water , each mixed with 0.1% acetic acid. Thiamethoxam was detected b y co llision - induced dissoc iation (CID ) of the parent ion (M+ H + ion, m/z of 292), to form the daughter ion with m/z of 211.2. The m/z 211.2 daughter ion was used to detect and quantify thiamethoxam . TheThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 13 of 30 metabolite , CGA - 322704 , was detected b y C ID of the parent ion (M+ H + ion, m/z of 250), to form a daughter ion with m/z of 169. The m/z 169 daughter ion was used to detect and quantify CGA - 322704. Peanut meal samples were anal yz ed b y HP LC /MS . S ample s ( 10 gram s) w ere extracted twice b y polytron homogenization in ACN/water ( 4 : 1 , v/v). The extraction volume was 200 mL , and a 50 mLaliquot was anal yz ed. The aliquot was evaporated to aqueous , and initially purified using reverse - phase (phenyl) SPE. After elution from the phenylSPE column with methanol/water ( 1 : 1 , v/v), the sample was evaporated to aqueous , and partitioned with ethyl acetate. The ethylacetate fraction was evaporated , and further p urified b y normal phase SPE using a combination of amino an d alumina cartridge column s . The eluted sample was evaporated , and reconstituted in 1 mL ACN/water (1:9 , v/v). Anal ys is was perf ormed using a Phenomenex Luna 311 C 18 HPL C column (250 mm length x 2.0 mm ID ). The mobile phase was a gradient of ACN and water, each mixed with 0.1% acetic acid. Thiamethoxam was detected usi ng the parent ion (M+H + ion, m/z of 292). The metabolite, CGA - 322704, was detected using the parent ion (M+H + ion, m/z of 250). Peanut oil samples were anal yz ed by HPL C /UV. S ample s (5 gram s) w ere extracted by shaking in hexane, salt and toluene to f or m a 3 - layer partition (aqueous in the bottom layer, ACN and toluene in the middle layer, and hexane in the top layer). The middle layer was isolated, evaporated, and initially

purified using reverse - phase (phenyl ) SPE. After elution from the phenyl SPE co lumn with methanol/water (1 : 1, v/v), the sample was evaporated to aqueous , and partitioned with ethyl acetate. The ethylacetate fraction was evaporated , and further purified by normal phase SPE , using a combination of amino and alumina cartridge column s . Oil samples were anal yz ed using the HPL C/UV s ys tem described above. The validity

of the method for the analy sis of thiamethoxam and CGA - 322704 in peanuts, peanut hay , peanut meal, and peanut oil was demonstrated by including control (untreated) sample s, and fortified control samples along with each anal ytical sample set . The fortification levels used for the concurrent recoveries were sufficient in magnitude to bracket the measured residue levels. The overall (all matrices, all fortification levels) average concurrent recoveries ( ± standard deviation) were 9 1 ± 13 % for thiamethoxam, and 89 ± 1 3 % for CGA 322704. Adequate sample calculations and example chromatograms were provided. Where detected in control (untreated) samples, total thiamethoxam residues were below the LOQ. Alfalfa: Sy

ngenta Anal ytical Method GRM009.02A was used to determine residues of thiamethoxam and its metabolite, CGA - 3 22704, in alfalfa commodities. For forage anal ys is, approximately 10.0 grams of sample were weighed into a wide mouth bottle. The control samples used for procedural recoveries were fortified at the LOQ and higher to bracket the residues found in the treated samples. ACN/water (4:1 v/v) was added (135 mL) to each sample, and then homogenized (using a Poly tron homogenizer) for two minutes at 8,000 - 12,000 rpm. Subsequently , 20 mL of ACN/water (4:1 v/v) was used to rinse the rotating shaft of the Poly

tron, and then added to the sample bo ttle. The sample was allowed to settle for 3 - 5 minutes. A Whatman #5 filter was placed onto a Buchner funnel, and the funnel was positioned on top of a 250 mLside - arm flask. The solvent and any suspended material were decanted into a funnel, leaving th e precipitate on the bottom of the bottle. A total of 35 mLof ACN/water (4:1 v/v) was used to rinse the sample bottle, Buchner funnel, side - arm flask, andThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 14 of 30 filter paper (20 mL to rinse out the sample bottle, and 15 mL to rinse out the side - arm flask). Th e sample was transferred to a 200 mLvolumetric flask, and diluted to 200 mLwith ACN/water (4:1 v/v). An aliquot of 5 mLwas placed into a 25 mL concentration tube, and concentrated in a nitrogen evaporator (at 35°C) to a volume of less than 2 mL . The s ample was brought to a volume of 5 mLusing ACN/water (1:9 v/v). The necessary dilutions were performed, and the samples were vialed for HPL C /MS/MS analysis. For hay anal ys is, approximately

5.0 grams of sample w ere weighed into a wide - mouth bottle. Co ntrol samples used for procedural recoveries were fortified at the LOQ and higher to bracket the residues found in the treated samples. ACN/water (4:1 v/v) was added (75 mL) to each sample , and then homogenized (using a Pol ytron homogenizer) for two minut es at 8,000 - 1,2000 rpm. Subsequently , 10 mL of ACN/water (4:1 v/v) was used to rinse the rotating shaft of the Poly tron , and then added to the sample bottle. The sample was allowed to settle for 3 - 5 minutes. A Whatman #5 filter was placed onto a Buchner funnel , and the funnel was positioned on top of a 250mLside - arm flask. The solvent and any suspended material were decanted into a funnel , leaving the precipitate on the bottom of the bottle. A total of 15 mL of ACN/water (4:1 v/v) was used to rinse th e sample bottle, Buchner f unnel, side - arm flask , and filter paper (10 mL to rinse out the sample bottle , and 5 mLto rinse out the side - arm flask). The sample was transferred to a 100 mL volumetric flask , and diluted to 100 mLwith ACN/water (4:1 v/v). An aliquot of 5 mLwas placed into a 25 mLconcentration tube , and concentrated in a nitrogen evaporator ( at 35°C ) to a volume of less than 2 mL. The sample was brought to a volume of 5 mLusing ACN/water (1:9 v/v). The necessary dilutions were performed , and the samples were vialed for HPLC/MS/MS anal ys is. Method validation was completed at three fortification levels for thiamethoxam and CGA - 322704 prior to analy sis of the field trial samples. The average recoveries of thiamethoxam from alfalfa forage at the LOQ (0.01 ppm), 2X LOQ and 10X LOQ were 77, 70 and 66%, respectivel y, whereas the average recoveries from alfalfa hay were 84, 117 and 95%, respectivel y. The average recoveries of CGA - 322704 from alfalfa forage at the L OQ (0.01 ppm), 2X LOQ and 10 X LOQ were 79, 70 and 76%, respectively , whereas the average recoveries from alfalfa hay were 93, 96 and 89%, respectivel y. Adequate sample calculations and example chromatograms were provided. In addition, the performance of the method was demonstrate d by fortifying untreated control samples with thiamethoxam and CGA - 322704 prior to extraction. These fortified samples were anal yz ed along with each anal ytical sample set. The overall (all fortification levels) average concurrent thiamethoxam recoveries (± standard deviation) were 9 5 ± 9 % and 9 1 ± 15 % from forage and hay , respectivel y. The overall average concurrent CGA - 322704 recoveries were 8 5 ± 17 % and 85 ± 1 7 % from forage and hay , respectively . Recovery values were corrected for control residues, if any. The fortification levels used for the concurrent recoveries were sufficient in magnitude to bracket the measured residue levels. Food handling establishments: Samples of the various food commodities were anal yz ed using Novartis Anal ytical Method AG - 675 . Method modifications were issued 28 July 2008 to: 1. document apparatus that was removed from analy sis, 2. document modifications to the method,Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 15 of 30 3. describe preparation of the calibratio n standard solutions, 4. identify

the HPLC/MS/MS detector used and provide the instrument conditions employed, and 5. describe the calculations used for residue determination. To summarize the method, 10.0 - gram samples were extracted twice by homogen ization in ACN/water (4:1, v/v). The extracts were combined, and brought to a final volume of 200 mL . A 20.0 - mLaliquot was processed through a saltwater/toluene/hexane/ACN liquid - liquid partition cleanup step, resulting in three layers:

1. a hexane layer (containing fats and oils), which was discarded, 2. an ACN/toluene layer, which was transferred to an evaporation flask, and 3. an aqueous layer, which was back - extracted with 2% toluene in ACN, and transferred to the same evaporation fla sk containing the ACN/toluene layer. The remaining organic layers were combined, and concentrated to an aqueous remainder. Additional water, saturated with NaCl, was added to the concentrate. The anal yt es were then partitioned (two times) into ethyl ac etate. The combined ethyl acetate extracts were evaporated to dry ness, reconstituted in ethyl acetate/hexane (1:4, v/v), and subjected to amino SPE cleanup. The resulting eluate was evaporated to dry ness. The sample was re - dissolved in 1 mLof HPL C grad e ACN, followed by

9 mLof HPLC - grade water, and then subjected to HPL C anal ys is. Final determination was by HPLC/MS/MS. The LOQ was 0.01 ppm for both analy tes. The anal ytical method was validated using control samples of white bread, whole milk, butt er, raw hamburger, and processed chicken prior to the anal ys is of food samples in this study . Triplicate samples were fortified with thiamethoxam and CGA322704 at the LOQ (0.01 0 ppm), and 10X LOQ (0.1 0 ppm). The analy tical method was not validated in lettuce and apples as part of this study

because these were matrices for which the method had been used previousl y. The performance of the method for determination of thiamethoxam and CGA322704 residues was also demonstrated b y fortifying at least one untreated control sample of each matrix with thiamethoxam and CGA322704 prior to extraction. These fortified samples were anal yz ed concurrently

with each analy

tical sample set. All m ethod recoveries , from both the method validation study , and the concurrent anal ys is of fortified samples , were within the generall y recognized acceptable range of 70 - 120% .Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 16 of 30 Conclusions The various data - collection methods , used for analy sis of samples taken from the magnitude of the residue studies discussed in this summary document , are based on either Method AG - 675 or Method GRM009.02A . The method s w ere deemed acceptable for use with all matrices anal yz ed in th e s e studies . HED will forward Method GRM.009.04A ( MRID #47786103) to FDA for an update of the thiamethoxam enforcement method in PAM Volume II. 860.1360 Multiresidue Methods Residue Chemistry Mem o s D259838 and D 259839 ; G.J. Herndon; 28 September 1999 Residue Chemistry Mem o D252021; G.J. Herndon; 30 March 2000 FDA Pestrak Database ; June 20 05 The Agency

has reviewed data concerning the recovery of residues of thiamethoxam using FDA MRM protocols of PAM Volume I. Thiamethoxam was partially recovered (50 - 60%) using MRM Section 302 ( Protocol D ) , but was not recovered using Sections 303 or 30 4 (Protocols E or F). Metabolites CGA - 322704 and CGA - 265307 were tested using Protocol C, but did not yield adequate responses; no further testing was conducted for the metabolites. The results of the multiresidue testing were forwarded to FDA and ACB/BEAD. 860.1380 Storage Stability Residue Chemistry Mem o D285545 ; M. Doherty; 6 November 2002 Residue Chemistry Mem o D281702; M. Doherty; 17 April 2007 Samples in the peanut field trial and processing studies were stored frozen from sampling to extraction for a maximum duration of 5.1 months. Samples in the alfalfa field trial study were stored frozen from sampling to extraction for a maximum duration of 15.9 months. Sample s in th e food handling establishment study were stored frozen from sampling to extraction for a maximum duration of 2.6 months. Concurrent storage stability data were not submitted with the se studies . However, the storage durations and conditions for s amples from the current field trial , processing , and food handling establishment studies are supported by previously conducted storage stability studies on diverse crops, and animal commodities . For plant commodities, a dequate storage stability data are available on five diverse crops . These data indicat e that residues of thiamethoxam and its metabolite , CGA - 322704 , are stable for up to approximately 2 4 months of frozen storage ( - 18 °C) in apple, tomato, potato, rapeseed, and corn grain ( D281702; M. Doherty ; 17 April 2007 ) . In addition, residues of thiamethoxam and CGA - 322704 have been demonstrated to be relatively stable in canola oil, corn meal, leaf lettuce, safflo wer se ed, and tomato puree for up to roughl y 40 - 42 months at - 20°C. These data represent sufficiently diverse crops (a root crop, a leafy vegetable, a grain, an oilseed, a fruit, and a fruiting vegetable) to allow the determination that residues of thiamethoxam and CGA - 322704 are stable in all crops for at least 24 months , and in associated processed commodities for at least 40 months.Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 17 of 30 For animal commodities, HED has reviewed data indicating that residues of thiamethoxam , CGA - 322704 and CGA - 265307 are reasonabl y stable in eggs, milk, beef muscle, and beef liver for 15 - 17 months. In addition, residues of CGA - 322704 have been demonstrated to be stable in beef liver stored frozen for up to 47.7 months. Samples collected from the magnitude of the residue studies were stored frozen prior to residue analy sis. The storage durations and conditions of samples are presented in Table 4 (below) . TABLE 4 Summary of Storage Conditions and Duration s of Samples from the Peanut, Alfalfa , and

Food Handling Establishment Stud ies . Matrix Storage Temperature (°C) Maximum Storage

Duration (M onths) 1 Interval of Dem onstrated Storage Stability (Months) 2 Peanut nutmeat - 2 0 5 .1 24 Peanut h ay Peanut meal 40 Peanut refined oil Alfalfa f orage - 1 0 15 .9 24 Alfalfa h ay Butter < - 1 0 2.6 Whole milk Raw hamburger Apple Head l ettuce Processed chicken 2.6 40 White bread 1. Actual storage duration from harvest to extraction for analysis. 2. Thiamethoxam and CGA - 322704 residues are relatively stable for up to 24 months in frozen RAC samples of apple, tomato, potato, rapeseed, leaf lettuce, and corn grain, and for up to 40 months in frozen processed commodity samples of corn meal, tomato puree, and canola oil (D281702; M. Doherty; 17 April 2007). Conclusions The available storage stability data for thiamethoxam ROCs in plants are adequate to support the storage durations and conditions of samples of peanut and alfalfa commodities from the submitted field trial and processing studies. The submitted food handling establishment study is supported b y the available storage stability data in plant and animal commodities. There are no storage stability

issues, and no corrections for potential decline during storage are needed for any of the residue studies. 860.1400 Water, Fish, and Irrigated Crops There are no proposed uses that are relevant to this guideline topic. 860.1460 Food Handling DER for MRID #48110202 (F ood handling establishment study with various food items)Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 18 of 30 TABLE 8 Summary of (1X) Residue Data fromUncovered Foods Exposed to Thiamethoxam in the

Food Handling Establishment Study. Comm odity Total Use Rate

(%ai, w/v) Sample Event

(Hours) Thiamethoxam Levels (ppm)

n Min. Max. HA 1 Median Me an Std. Dev. Butter 0.1 1 2 ND 2 ND ND ND ND NA 3 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA White bread 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND <0.01 <0.01 <0.01 <0.01 NA Whole milk 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA Raw hamburger 0.1 1 2 ND <0.01 <0.01 <0.01 <0.01 NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA Processed chicken 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA Apple 0.1 1 2 ND ND ND ND ND NA 4 2 ND <0.01 <0.01 <0.01 <0.01 NA 8 2 ND <0.01 <0.01 <0.01 <0.01 NA Head l ettuce 0.1 1 2 ND <0.01 <0.01 <0.01 <0.01 NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA 1. HA = Highest Average. 2. ND = Not Detected. 3. NA = Not Applicable (standard deviation is only applicable for sample sets of n ≥ 3 samples). TABLE 9 Summary of (1X) Residue Data fromUncovered Foods Exposed to Thiamethoxam in the

Food Handling Establishment Study. Comm odity Total Use Rate

(%ai, w/v) Sample Event

(Hours) CGA - 322704 Levels (ppm)

n Min. Max. HA 1 Median Me an Std. Dev. Butter 0.1 1 2 ND 2 ND ND ND ND NA 3 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA White bread 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA Whole milk 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND <0.01 <0.01 <0.01 <0.01 NAThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 19 of 30 TABLE 9 Summary of (1X) Residue Data fromUncovered Foods Exposed to Thiamethoxam in the

Food Handling Establishment Study. Comm odity Total Use Rate

(%ai, w/v) Sample Event

(Hours) CGA - 322704 Levels (ppm)

n Min. Max. HA 1 Median Me an Std. Dev. Raw hamburger 0.1 1 2 ND <0.01 <0.01 <0.01 <0.01 NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA Processed chicken 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA Apple 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA Head l ettuce 0.1 1 2 ND ND ND ND ND NA 4 2 ND ND ND ND ND NA 8 2 ND ND ND ND ND NA 1. HA = Highest Average. 2. ND = Not Detected. 3. NA = Not Applicable (standard deviation is only applicable for sample sets of n ≥ 3 samples). A summary

of the reviewed data from the food handling establishment study is presented in Tables 8 and 9 (above). The study was conducted to determine the amount of thiamethoxam residues in food following indoor spot, and crack and crevice treatments in a food handling establishment, using the 2 lb ai/gal SC formulation at the maximum proposed label rate. The study also provide d information on the residues in food resulting from treatment at an exaggerated rate, in order to gauge the potential for misuse of the product. The study report summarized residue data for thiam ethoxam and its major metabolite, CGA322704 (clothianidin), in samples of foods ty

pically used in 2 types of food handling establishments, including an oily food (butter), baked cereal product (bread), beverage (milk), raw meat (hamburger), processed meat (chicken), fresh fruit (apple), and fresh vegetable (lettuce). Two ty pes of food handling establishments ( in which the principal business involved the preparation and sale of food directly to the consuming public ) were used in the study . The establishm ents selected, a restaurant and a delicatessen, were typical of the expected product use areas. Each establishment received an initial application of Optigard Flex Liquid at a dilution rate of 0.1% ai, weight to volume (ai, w/v), equal to 16 mL (3.9 g ai) per gallon of finished solution, and a second application at 0.2% ai, w/v, equal to 32 mL (7.8 g ai) per gallon of finished solution. Two day s elapsed between applications at each establishment. Crack and crevice , and spot treatments were made to the ki tchen, storage and eating areas of each facility by a commercial licensed pest control operator. Crack and crevice treatment included the lower portion of the walls, cabinets and areas where pests may hide or enter a building. Spot treatment included bas eboard areas of the floor and walls that did not exceed 2 square feet per spot (sq ft/spot). Foods that were used in the study represented the wide range of food items that are expected to be prepared and served in food service establishments. A single control sample of each of the seven food types was collected at each establishment prior to the 1X rate application.Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 20 of 30 Six replicates of each food ty pe without any packaging (uncovered), and six replicates of each food ty pe that were covered, were placed o n tables in the food preparation and serving areas (three replicates of each food ty pe/coverage type in each area). Duplicate samples of each food ty pe/coverage type (one replicate from each of the two areas) were collected at 1, 4 and 8 hours following e ach application at each establishment. All samples were stored frozen after collection, and shipped frozen to Morse Laboratories in Sacramento, CA. Samples were anal yz ed by Morse Laboratories using Method AG - 675. Final determination was b y HP LC/MS/MS. The L OQ was 0.01 ppm for both analy tes in all matrices , resulting in an LOQ for combined residues of 0.02 ppm . The first stage of sample anal ys is was focused on the uncovered food samples exposed for eight hours following the application of the exaggerated (2X) use rate, which would be considered the worst - case scenario for residues. The results of these anal yses (all residues were either non - detectable or <LOQ) led to the second stage, which was anal ys is of uncovered food samples only

from each of the exposure intervals (1, 4 or 8 hours) following e ach application rate (1X or 2X). These data showed that residues were not present at levels at or above the LOQ from any sampling event following either application rate. Conclusions The submitte d data on thiamethoxam residues in food commodities following indoor spot, and crack and crevice treatments in food handling establishments are adequate. The data reflect the use of the 2 lb ai/gal SC formulation of thiamethoxam at 0.1% ai (w/v) and 0.2% ai (w/v). An acceptable method was used for the quantitation of thiamethoxam residues in the various food commodities, and adequate storage stability data are available to support the sample storage durations and conditions. In addition, there were no th iamethoxam residues detected at quantifiable levels in any of the wide variety of uncovered food types which were exposed for up to 8 hours to an exaggerated use pattern (1X rate, followed by 2X rate within 48 hours). Based on the presence of detectable residues of thiamethoxam or CGA - 322704 in various samples, HED recommends a tolerance of 0.02 ppm in food /feed commodities (other than those covered b y a higher tolerance as a result of use on growing crops) . 860.1480 Meat, Milk, Poultry, and Eggs The livestock feedstuffs associated with the proposed seed treatment use s of thiamethoxam on peanuts and alfalfa are peanut meal and hay, and alfalfa forage, hay , meal and silage . These uses have the potential for exposing livestock to thiamethoxam residue s in their diet. Secondary

transfer of thiamethoxam ROCs to meat, milk, poultry and eggs is therefore possible from the proposed use s on peanuts and alfalfa . Ergo, reasonabl y balanced dietary burdens (RBDBs) were recalculated for the currently requested uses, and are presented in Table 5 (below).Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 21 of 30 TABLE 5 Calculation of Reasonably Balanced Dietary Burdens of Thiamethoxam Residues to

Livestock. Feedstuff Type 1 % Dry Matter 2 % Diet 2 Tolerance (ppm) Dietary Contribution

(ppm) 3 Beef Cattle - R 15%, CC 80%, PC 5% Soy bean hulls R 90 15 2.0 0.34 Potato processed waste CC 20 30 0.25 4 0.38 Barley grain CC 88 50 0.3 0.17 Soy bean meal PC 88 5 0.02 5 0.0012 TO TAL BURDEN 100 0.90 Dairy Cattle - R 45%, CC 45%, PC 10% Almond hulls R 90 10 1.2 0.14 Wheat forage R 25 20 0.5 0.4 Barley hay R 88 15 0.4 0.07 Barley grain CC 88 45 0.3 0.16 Undelinted c ottonseed PC 88 10 0.1 0.012 TO TAL BURDEN 100 0.78 Poultry - CC 75%, PC 25% Barley grain CC 88 75 0.3 0.26 Alfalfa meal PC 89 5 0.12 0.007 Cottonseed meal PC 88 20 0.1 6 0.023 TO TAL BURDEN 100 0.29 Swine - CC 85%, PC 15% Barley grain CC 88 20 0.3 0.068 F ield c orn grain CC 88 65 0.02 0.015 Cottonseed meal PC 88 15 0.1 6 0.017 TO TAL BURDEN 100 0.10 1. R = Roughage, CC = Carbohydrate C oncentrate , PC = Protein C oncentrate. 2. OPPTS 860.1000 Table 1 Feedstuffs (June 2008). 3. Contribution = ([ T olerance / %DM] x % D iet) for beef and dairy cattle . C ontribution = ( T olerance x % D iet) for poultry and swine. 4. Based on the 0.25 ppm potato tolerance . 5. B ased on the 0.02 ppm soybean seed tolerance. 6. B ased on the 0.1 ppm undelinted cottonseed tolerance. Conclusions Because the projected thiamethoxam ROC s in poultry at the 1X feeding level w ould still be <LOQ, HED concludes that residues in eggs and poultry meat, fat , and meat by

products remain a 40CFR § 180.6 [a][ 3 ] situation (there is no expectation of finite residues in these commodities). As a result, tolerances are not required. This conclusion will be reevaluated when new poultry

feed items are proposed in the future. The RBDBs to cattle and swine have not increased significantly from those previousl y calculated. Therefore, the current tolerances in livestock commodities remain appropriate , and do not need to be increased.Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 22 of 30 860.1500 Crop Field Trials DER for MRID # 45093704 ( C rop field trial s with peanuts ) DER for MRID # 48020201 ( C rop field trials with alfalfa ) TABLE 6 Summary of Residue Data fromPeanut Field Trials with Thiamethoxam. Peanut Matrix Use Rate (g

ai/ 100 kg S eed s ) EP Combined Residue Levels ( ppm Thiamethoxam E quivalents) 1 n Min. Max. 2 HAFT 3 Me an Std. Dev. Hay 2 00 5FS 18 <0.02 0.06 0.05 0.026 0.011 70WS 36 <0.02 0.23 0.20 0.032 0.043 Nutmeat 5FS 18 <0.02 0.05 0.05 0.026 0.011 70WS 36 <0.02 0.04 0.03 0.021 0.004 Hay 600 70WS 4 <0.02 0.79 0.64 0.33 0.38 Nutmeat 4 <0.02 0.02 0.02 0.02 0 1. For calculation of the mean, HAFT, and standard deviation, the LOQ was used for residues reported as below the LOQ. 2. The table does not include the residue level in nutmeat used for the processing study. As noted in Section 860.1520, a RAC residue of 0.09 ppm was found in nutmeat following application at 200g ai/100 kg seeds (equivalent to 0.16 lb ai/A). 3. HAFT = Highest Average Field Trial. Peanuts: A summary

of the reviewed data from the peanut field trials is presented in Table 6 (above). Twelve peanut field trials were conducted in the US during the 1999 growing season. Each site consisted of one untreated plot, and at least one treated plot. At all trial sites, one treated plot was planted with peanut seeds that had been treated with an aqueous slurry of the 70% ai WS formulation . At 3 sites, side - by- side trials were conducted, comparing the 70 % ai WS product with the 5 lb ai/gal FS formulation. For both formulations, peanut seeds were treated at the rate of 200 grams ai per 100 kg of seed s . Based on the amounts of seeds planted per acre, the rates were 0.126 - 0.24 lb ai/A (1.5 - 3X the proposed maximum per- acre rate). The peanut crop s w ere allowed to grow to commercial maturity according to good agricultural practices. Samples of nutme at and hay were harvested 101 - 1 5 3 day s after planting (DAP). At 2 of the trial site s (in GA and TX), peanut seeds treated at an exaggerated rate (0.48 - 0.522 lb ai/A) were also grown, for processing into peanut meal and refined oil . A dditionally , at 2 tri al site s (in GA and TX) samples were harvested at 4 time intervals, in order to assess residue decline. Samples of the peanut RACs were anal yz ed for residues of thiamethoxam and its metabolite, CGA - 322704 (clothianidin), using Method AG - 675. This method is adequate for data collection, based on acceptable concurrent method recoveries. The LOQ was 0.01 ppm for each anal yt e matrices , resulting in an LOQ for combined residues of 0.02 ppm . In nutmeat, the highest individual residue was 0.04 ppm for thiamethoxam , and 0.01 ppm for CGA - 322704 , excluding the samples generated for processing. The nutmeat for processing , from an application rate of 0.16 lb ai/A , had total residues of 0.09 ppm . In hay , the highest individual residue was 0.19 ppm for thiamethoxam , and 0.03 ppm for CGA - 322704. A rate response was observed where exaggerated rates were included. R esidues following application of the 70 % ai WS and 5 lb ai/gal FS fo rmulations were similar in the side - by- sid e comparison trial s. The magnitude o f the residue is therefore unaffected by the choice of either fo rmulation. Total residues in hay

were ob served to decline with time at one decline field trial , dropping fromThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 23 of 30 a highest average residue of 0.04 ppm on day 111 (after planting of the treated seed) to 0.02 ppm on day 132. Total nutmeat residues from this field trial increased from day 111 (highest average residue of 0.01 ppm) to day 118 (0.04 ppm), and subsequently declined to 0.01 ppm by

day 132. No decline was detect e d in the other decline field trial due to the low residues observed. Conclusions The submitted peanut field trial data are adequate, and reflect the planting of peanut seeds treat ed with either the 70% ai WS formulation, or the 5 lb ai/gal FS formulation of thiamethoxam at 200 g ai/ 100 kg seed s (0.126 - 0.24 lb ai/A , 1.5 - 3X the maximum proposed use rate) . The study satisfied OPPTS Residue Chemistry Test Guideline 860.1500 (Tables 1 and 5) for number and geographic distribution of the twelve field trial locations to determine the magnitude of the residues of thiamethoxam and its major metabolite, CGA - 322704 (clothianidin), in peanut RACs. An acceptable method was used for the quantit ation of thiamethoxam residues in peanut nutmeat and hay , and adequate storage stability data are available to support sample storage durations and conditions. Because a large percentage of the residue values were below the combined L OQ of 0.02 ppm, the tolerance harmonization spreadsheet was not used to determine an appropriate tolerance. Based on the maximum combined thiamethoxam ROCs of 0.0 9 and 0.23 ppm in 1 .5X - to 3 X - treated nutmeat and hay samples, respectivel y, HED recommends a tolerance of 0.0 5 ppm in peanut nutmeat, and a tolerance of 0.25 ppm in peanut hay . TABLE 7 Summary of Residue Data fromAlfalfa Field Trials with Thiamethoxam. Alfalfa Comm odity Maximum

Use Rate 1 (lb ai/A) EP 2 Residue Levels (ppm) Minimum Maximum HAFT 3 Thiamethoxam Forage 1st cutting 0.0130 Cruiser 5FS <0.01 0.03 0.03 Forage 2nd cutting <0.01 <0.01 <0.01 Forage 3rd cutting <0.01 <0.01 <0.01 Hay 1st cutting <0.01 0.09 0.08 Hay 2nd cutting <0.01 0.01 0.01 Hay 3rd cutting <0.01 <0.01 < 0.01 CGA - 322704 Forage 1st cutting 0.0130 Cruiser 5FS <0.01 <0.01 <0.01 Forage 2nd cutting <0.01 <0.01 <0.01 Forage 3rd cutting <0.01 <0.01 <0.01 Hay 1st cutting <0.01 <0.01 <0.01 Hay 2nd cutting <0.01 <0.01 <0.01 Hay 3rd cutting < 0.01 <0.01 <0.01 1. The alfalfa field trials utilized single (and seasonal) use rates of 0.0037 - 0.0130 lb ai/A, based on the respective seeding rates (8.00 - 27.90 lb seeds/A), and an average of 210,000 alfalfa seeds/lb. 2. EP = End - use Product. 3. HAFT = Highest Average Field Trial (average of duplicate measurements). Alfalfa: A summary

of the reviewed data from the alfalfa field trials is presented in Table 7 (above). Twelve alfalfa field trials were conducted in the US during the 2008 an d 2009Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 24 of 30 growing seasons. Each site consisted of one untreated plot, and one treated plot. The treated plots were planted with alfalfa seeds that had been treated with an aqueous slurry of the 5 lb ai/gal FS formulation, at the rate of 0.001 milligrams of ai per seed (mg ai/seed). Based on seeding rates of 8. 0 to 27.9 lb seeds/A, the application rate is equivalent to 0.0037 to 0.0130 lb ai/A. The alfalfa crop was allowed to grow to commercial maturity according to good agricultural practices. Samples of forage and hay were harvested at roughly 45 DAP ( first cutting), 45 day s after first cutting (second cutting), and 45 day s after second cutting (third cutting) at all trial sites except one (in IA), where the third cutting was not harvested. At one trial site (in CA), additional samples were harvested at 24, 31, 38, and 52 DAP, in order to assess residue decline. Samples of the RAC s, alfalfa forage and hay , were anal yz ed for residues of thiamethoxam and its metabolite, CGA - 322704 (clothianidin), using M ethod GRM009.02A. This method is also known as ADPEN Method M1104, and is adequate for data collection, based on acceptable concurrent method recoveries. The LOQ was 0.01 ppm for each analyte , resulting in an L OQ for combined residues of 0.02 ppm . The maximum residues of thiamethoxam and CGA - 322704 were, respectively , 0.03 and <0.01 ppm in alfalfa forage grown from treated seed. The maximum residues of thiamethoxam and CGA - 322704 were, respectivel y, 0.09 and <0.01 ppm in alfalfa hay grown from treated seed. The maximum combined residues of thiamethoxam and CGA - 322704 were 0.04 and 0.10 ppm in alfalfa forage and hay , respectively . In addition, residue decline data indicated that thiamethoxam residues in alfalfa forage decreased from 0.16 ppm at 24 DAP to below the method L OQ (<0.01 ppm) at 52 DAP. The CGA - 322704 residues in alfalfa forage were <LOQ at all time points. Residue decline data indicated that thiamethoxam residues in alfalfa hay decreased from 0.44 ppm at 24 DAP to below the method L OQ (<0.01 ppm) at 90 DAP (second cutting). The CGA - 322704 residues in alfalfa hay were 0.02 ppm at 24 DAP, and <LOQ at all time points thereafter. Conclusions The submitted alfalfa field trial data are adequate, and reflect the planting of alfalfa seeds treated with the 5 lb ai/gal FS formulation of thiamethoxam at 0.001 mg ai/seed , with harvest occurring at 45 DAP . The study satisfied OPPTS Residue Chemistry Test Guideline 860.1500 (Tables 1 and 5) for number and geographic distribution of the twelve fi eld trial locations to determine the magnitude of the residues of thiamethoxam and its major metabolite, CGA - 322704 (clothianidin), in alfalfa RACs. An acceptable method was used for the quantitation of thiamethoxam residues in alfalfa forage and hay , and adequate storage stability data are available to support sample storage durations and conditions. Because a large percentage of the residue values were below the combined L OQ of 0.02 ppm, the tolerance harmonization spreadsheet was not used to determin e an appropriate tolerance. Based on the maximum combined thiamethoxam ROCs of 0.04 and 0.10 ppm in 1X treated forage and hay

samples, respectivel y, HED recommends a tolerance of 0.05 ppm in alfalfa forage, and a tolerance of 0.12 ppm in alfalfa hay . 86 0.1520 Processed Food and Feed DER for MRID #45093704 (Processed food/feed fr om peanuts)Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 25 of 30 There are no proc essed commodities associated with the proposed use on alfalfa . Tw o peanut field trials were conducted in the US during the 1999 growing season in which peanut seeds treated at exaggerated rate s were grown for processing into peanut meal and refined oil . Samples of the peanut RACs and processed fractions were anal yz ed for residues of thiamethoxam and its metabolite, CGA - 322704 (clothianidin), using Method AG - 675 via HPL C/UV , HPLC/MS or HPL C/MS/MS. This method is adequate for data collection, based on acceptable concurrent method recoveries. The LOQ was 0.01 ppm for each anal yt e in all matrices, resulting in an LOQ for combined residues of 0.0 2 ppm. Thiamethoxam residues were not detected in the nutmeat nor processed fractions of peanuts grown from peanut seeds treated at 0.48 - 0.522 lb ai/A (roughly 6 - 6.5 X the proposed maximum use rate ) . Residues were not detected in any of the peanut oil s amples upon processing. Reduction of thiamethoxam residues in peanut oil after processing was at least 0.22 - 0.40 X . Residues were observed in the nutmeat and meal of peanuts , grown from peanut seeds treated at 0.16 - 0.174 lb ai/A (roughl y 2 X the proposed rate ) , from both field trial s . The theoretical concentration factor for peanut meal , presented in OPPTS Residue Chemistry Test Guideline 860. 1 520, Table 3 (Theoretical Concentration Factors Based u p o n Separation i nto Components) , is 2.2 X . The empirical concentration factors for thiamethoxam in meal (range 2.0 - 3.1 X , average 2.6 X) conform well to the theoretical value . A summary

of the data from the peanut processing study is presented in Table 10 (below). TABLE 10 Residue Data from Peanut Processing Study with Thiamethoxam . RAC Trial ID (Number

County/State) Processed

Comm odity Total Rate

(lb ai/A) PHI

(Days) Residues

(ppm) Processing

Factor Peanut Nutmeat 0S - SR- 837 - 99

Turner/GA RAC 0.170 - 0.174 126 0.05 NA 1

Meal 0.10 2.0 Refined Oil < 0.02 0.40 2 RAC 0.510 - 0.522 <0.02 NA Meal <0.02 NC 3 Refined Oil <0.02 NC 0S - SR- 309 - 99 Lavaca/TX RAC 0.160 132 0.09 NA

Meal 0.28 3.1 Refined Oil <0.02 0.22 2 RAC 0.480 <0.02 NA Meal <0.02 NC Refined Oil <0.02 NC 1. NA = Not Applicable. 2. Residues in oil were undetected; 0.02 ppm was used as the oil residue to calculate the processing factor. 3. NC = Not Calculable. Residues were undetected in RAC and processed fraction samples. Conclusions A tolerance is not required in peanut oil. With HAFT combined residues of 0 .05 ppm inThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 2 6 of 30 peanut nutmeat (based on residue s of 0.09 ppm at a 2X rate) , and the theoretical concentration factor for peanut meal of 2.2X, HED recommends a tolerance of 0.15 ppm in peanut meal . 860.1650 Submittal of Analytical Reference Standards Analy tical reference standards for thiamethoxam (expiration date 30 August 2012 ) and its metabolite , CGA - 322704 (expiration date 31 August 2010 , new standard on order) are currently available at the EPA ’s NPS R , via personal communication with Dallas Wright , of ACB , on 2 3 August 2010 . Analy

tical reference standards should be replenished as requested by the Repository . The reference standards should be sent to the AC B , which is located at Fort Meade, to the attention of Theresa Cole at the following address: USEPA National Pesticide Standards Repository/Analytical Chemistry Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755 - 5350 ( Please n ote that the mail will be returned if the extended zip code is not used.) 860.1850 Confined Accumulation in Rotational Crops Me tabolismDecision Mem o D258614; G.J. Herndon; 31August 1999 Residue Chemistry Mem o D252021; G.J. Herndon; 30 March 2000 (PP#9F5046) Residue Chemistry Mem o D281702; M. Doherty; 17 April 2007 Confined rotational crop studies were previously reviewed in conjunction with the petition for thiamethoxam use on canola (PP#9F5046). These studies indicated that limited field rotational crop studies are necessary to support the proposed 120 - day PBI for rotational crops, and that the metabolism of [ 14 C] - thiamethoxam in rotational crops is similar to the metabolism observed in primary

crops. Ina meeting held on 28 July 19 99, HED determined that the major residues from the confined rotational crop studie s were the parent thiamethoxam , and its CGA 322704 metabolite. In some animal feedstuffs, CGA - 265307, a metabolite containing the N nitro group, was found to be a major residue. HED recommended that all three compounds be anal yz ed in field rotational crop studies.Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 27 of 30 860.1900 Field Accumulation in Rotational Crops Residue Chemistry Mem o D252021; G.J. Herndon; 30 March 2000 (PP#9F5046) Residue Chemistry Mem o D281702; M. Doherty; 17 April 2007 Several field rotational crop studies on thiamethoxam have been submitted and reviewed. The se data indicate that at an application rate of 0.179 lb ai/A (roughly 1X the maximum seasonal use rate of 0.188 lb ai/A o n rotatable crops), quantifiable residues of thiamethoxam ROCs are not expected fr om a 120 - day PBI . The proposed maximum use rate of 0.08 lb ai/A in the petitions under review is well below the rate used in these studies. 860.1550 Proposed Tolerances The submitted field trial data for thiamethoxam on peanuts are acceptable, and support the proposed use of Cruiser PD and Cruiser 5F S as pre - plant seed treatments . An adequate number of trials were conducted in the appropriate geographic regions at roughl y 1 .5 - 3 X the maximum proposed rate. Based on the maximum co mbined thiamethoxam ROCs of 0.09 and 0.23 ppm in treated nutmeat and hay samples, respectivel y, HED recommends a tolerance of 0.0 5 ppm in peanut nutmeat, and a tolerance of 0.25 ppm in peanut hay . The submitted field trial data for thiamethoxam on alfalfa are acceptable, and support the proposed use of Cruiser 5F S as a pre - plant seed treatment . An adequate number of trials were conducted in the appropriate geographic regions at 1X the maximum proposed rate. Based on the maximum combined thiamethoxam ROCs of 0.04 and 0.10 ppm in 1X - treated forage and hay samples, respectively , HED recommends a tolerance of 0.05 ppm in alfalfa forage, and a tolerance of 0.12 ppm in alfalfa hay . The submitted data for thiamethoxam use in food handli ng areas are acceptable, and support the proposed use of Optigard Flex Liquid as a spot, void, and crack and crevice treatment in food handling establishments . An adequate variety of food commodities were exposed to thiamethoxam, in two different types of food handling establishments, at 1X the maximum proposed rate. Based on the presence of detectable residues of thiamethoxam or CGA - 322704 in various samples, HED recommends a tolerance of 0.02 ppm in food /feed commodities (other than those covered b y a h igher tolerance as a result of use on growing crops) . There are no processed commodities associated with the proposed use on alfalfa. The processed commodities associated with the proposed use on peanut s are peanut meal and refined oil. Tw o peanut fie ld trials were conducted in the US during the 1999 growing season in which peanut seeds treated at exaggerated (roughl y 6 - 6.5 X) rate s were grown for processing into peanut meal and refined oil . Thiamethoxam residues were not detected in the nutmeat nor processed fractions of peanuts grown from peanut seeds treated at 6 - 6.5X rate s . Residues were not detected in any of the peanut oil samples upon processing. Residues were observed in the nutmeat and meal of peanuts , grown from peanut seeds treated at the 2 X rate , from both field trial s . The theoretical concentration factor for peanut meal ( OPPTS Residue Chemistry Test Guideline 860. 1520, Table 3) is 2.2 X . The empirical concentration factors for thiamethoxam in meal (range 2.0 - 3.1 X , average 2.6 X) conform w ell to the theoretical value . A tolerance is notThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 28 of 30 required in peanut oil. Based on the HAFT combined residues of 0.05 ppm in peanut nutmeat (based on residues of 0.09 ppm at a 2X rate) , and the theoretical concentration factor for peanut meal of 2.2X, HED recommends a tolerance of 0.15 ppm in peanut meal . There are no Codex or Mexican MRL s established for residues of thiamethoxam in crops associated with this review. Canada has established an MRL of 0.02 mg/kg for residues of thiamethoxam and CGA - 32270 4 in all food crops, and is transitioning to specific commodity MRL s ( all at 0.02 mg/kg) on a variety of crops including various cereal grains, peas and beans, soy bean s , sweet corn, and sunflower. TABLE 11 Tolerance Summary for Thiam ethoxam . Comm odity Proposed/Established Tolerance (ppm) Recommended

Tolerance (ppm) Comments ; C orrect Commodity D efinition Peanut 0.05 0.0 5 Peanut, hay 0.25 0.25 Peanut, meal None 0.15 Alfalfa , forage 0.05 0.05 Alfalfa , hay 0.12 0.12 Food/feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) 0.01 0.0 2

References Thiamethoxam. Results of the HED Metabolism Assessment Review Committee Meeting Held on 7/28/99. ; D 258614 ; G.J. Herndon ; 31 August 1999. Multi -Residue Method Testing of Thiamethoxam (CGA - 293343) and Its Metabolite ; D259838 ; G.J. Herndon ; 28 September 19 99 . Multiresidue Test information for the updating of PAM I ; D 259839 ; G.J. Herndon ; 28 September 19 99 . PP#9F5046. Thiamethoxam on Canola. Section 3 Registration and Permanent Tolerance Request for Use of Thiamethoxam (Helix Formulation) for Use as a Seed Treatment on Canola Seed Prior to Planting. First Food Use. Residue Chemistry Review: Evaluation of Analytical Method and Residue Data. ; D252021 ; G.J. Herndon ; 30 March 2000. PP#9F5051. Thiamethoxam on Various Crops. Section 3 Registration and Permanent Tolerance Request for Use of Thiamethoxam as a Seed Treatment, Soil Treatment, or Foliar Use on Barley, Brassica (Cole) Leafy Vegetables, Cotton, Cucurbit Vegetables, Fruiting (except Cucurbit) Vegetables, Leafy (except Brassica) Vegetables, Pome Fruit, Tuberous and Corm Vegetables, Sorghum, and W heat. Section 3 Registration for Tobacco. Residue C hemistryThiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 29 of 30 Review: Evaluation of Analytical Method and Residue Data. ; D265079 ; G.J. Herndon ; 8 May 2000. PP#95046/95051. Thiamethoxam on Canola, Barley, Sorghum, Wheat, Cotton, Tuberous and Corm Vegetables, Leafy Vegetables, Brassica Vegetables, Fruiting Vegetables, Cucurbit Vegetables, Pome Fruits, and Tobacco. Results of Petition Method Validation. ; D271516 ; M. Doherty ; 29 May

20 01 . PP#0F06142. Thiamethoxam. Section 3 Registration for Use as a Corn Seed Treatment. Summary of Analytical Chemistry and Residue Data. ; D 285545 ; M. Doherty ; 6 November 20 02 . PP#3E6524, 2E6505, 1E6349, 2E6508. Thiamethoxam. Section 3 Registration for Use on Stone Fruit, Coffee, Pecan, and as a Seed Treatment on Sunflower and Succulent Beans. Summary of Anal ytical Chemistry

and Residue Data.; D286726 ; Y. Donovan ; 23 December 20 03 . Thiamethoxam. Summary of Analytical Chemistry and Residue Data. PP#0F6142. Request for Amended Use Patterns for Actara ® Insecticide ( EPA Reg. No. 100- 938), Centric® 40WG Insecticide (EPA Reg. No. 100- 1147), and Platinum® Insecticide (EPA Reg. No. 100- 939) and to Register Actara®

240 SC Insecticide (File Symbol No. 100-RELN). PP#6E7060. IR - 4 Request to Add Uses on Artichoke, Barley, and Caneberry to Actara ® Insecticide ( EPA Reg. No. 100- 939) and Uses on Hops to Platinum® Insecticide (EPA Reg. No. 100 - 939). PP#s3E6805, 9F5051, 3E6806, 3E6781, 2E6363, 3E6800, 3E6807, 4E6819, and 04CA0015. Section 3 Registration for Seed Treatment Uses on Legume Vegetables, Potato Seed Pieces, Oilseed Crops; and Foliar Uses on Cranberry, Mint, Strawberry, Bushberry, and Root Vegetables (E xcept Sugarbeet); and the Section 18 Emergency Exemption on Artichoke. ; D281702, D 325447 , D 335847 , D 292865, D 296610, D 297966, D 298143, D 298157 & D 300775 ; M. Doherty ; 1 7 April 20 07 . PP# 0F6142. Thiamethoxam. Request to Add Foliar Treatment of Soybeans to the Label for Centric ® WG Insecticide. Summary of Analytical Chemistry and Residue Data. ; D346216 ; M. Doherty ; 13 November 20 07 . Thiamethoxam. Application for Amended Section 3 Registration to Add Uses on Citrus Fruit Group 10 and Tree Nut Group 14. Summary of Analytical Chemistry and Residue Data. ; D 349272 ; M. Doherty ; 8 /1 2 August 20 0 8 . Attachment: International Residue Limit Status sheet .Thiamethoxam Summary of Analytical Chemistry and Residue Data D376367, D3 80 6 5 3

Page 30 of 30 

## INTERNATIONAL RESIDUE LIMIT STATUS CAS Name: 3 - [(2 - chloro - 5 - thiazolyl) methyl]tetrahydro - 5 - methyl -N - nitro - 4H - 1,3,5 - oxadiazin 4 - imine . Comm on Name: Thiamethoxam . X Recommende d tolerance

⁮ Reevaluated tolerance ⁮ Other Date: 2 August 20 1 0 Codex Status (Maximum Residue Limits) U S Tolerances X No Codex proposal step 6 or above □ No Codex proposal step 6 or above for the crops requested Petition Number s : 9F7657, 0F7707, 0F7734 DP Barcodes: D376367, D380653 Other Identifier: PC Code 060109 Residue definition (step 8/CXL): Not applicable. Revie wer/Branch: William T. Drew /RAB2 Residue definition: C om bined residues of the insecticide thiamethoxam [3 - [(2 - chloro - 5 - thiazolyl) methyl]tetrahydro - 5 - methyl -N - nitro - 4H - 1,3,5 - oxadiazin - 4 - imine] and its metabolite [N - (2 - chloro thiazol - 5 - ylmethyl) -N’ - methyl -N’ - nitro - guanidine] . Crop(s) MRL (m g/kg) Crop Tolerance (ppm) Peanut 0. 1 0 Peanut, hay 0.25 Peanut, meal 0.15 Alfalfa , forage 0.05 Alfalfa , hay 0.12 Food/feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) 0.01 Limits for Canada 1 Limits for Mexico 2 ⁮ No Limits ⁮ No Limits for the crops requested ⁮ No Limits X No Limits for the crops requested Residue definition: 3 - [(2 - chloro - 5 - thiazolyl) methyl]tetrahydro - 5 - methyl -N - nitro - 4H - 1,3,5 - oxadiazin - 4 - imine,including the metabolite (E) -N - [(2 - chloro - 5 - thiazolyl)methyl] -N' - methyl -N"- nitro - guanidine . Residue definition: T hiamethoxam .

Crop(s) MRL (m g/kg) Crop(s) MRL (m g/kg) Alfalfa 0.02 Peanut 0.02 Notes and/or special instructions: 1. Includes only commodities of interest for this action. 2. Mexico adopts US tolerances and/or Codex MRLs for its export purposes. ( Steve Funk/Meheret Negussie)