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### UNITED STA**TES ENVIRONMENTA L PROTECTION A** **GENCY**

WA SHINGTON, D.C. 20460 **OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION** 

### MEMORANDUM **Date** : 26 - MAR- 2013 **Subject** : **Spirotetramat.** Proposed Uses in/on Taro, Leaves; Watercress; Pomegranate;

Banana; Vegetable, Bulb, Group 3 - 07; Low growing Berry Subgroup 13 - 07H, Except Strawberry

and Lowbush Blueberry ; Bushberry Subgroup 13 - 07B; Artichoke, Globe; Vegetable, Fruiting, Group 8 - 10; Fruit, Pome, Group 11 - 10; Fruit, Citrus, Group 10 - 10; Pineapple; and Coffee; and Tolerances without U.S. Registration in/on Corn, Sweet, Kernel Plus Cob with Husks Removed as Part of the U.S. - Canada Regulatory Cooperation Council (RCC) Pilot Proj ect. **Summary of Analytical Chemistry and Residue Data**  . **PC Code:** 392201 **DP Barcode s**  **:** D398856 , D400037 **Decision No s**  **.:** 459092 , 459087 **Registration Nos. :**  264 - 1050, 264 - 1065, 264 - 1051 **Petition No.:** 1E7958 **Regulatory Action:** Sec. 3 Registration **Risk Assessment Type:**  NA **Case No.:** 7452 **T XR No.:**  NA **CAS No.:** 382608 - 10 - 8 **MRID Nos.:** 486976 - 01 thru - 10 , 48770501 **40 CFR:** §180.641 **From** : George F. Kramer, Ph.D., Senior Chemist

Risk Assessment Branch 1 (RAB1) Health Effects Division (HED) (7509P) **Through** : Dana M. Vogel, Acting Branch Chief , RAB1 Associate Division Director, HED (7509P) **To** : Barbara Madden/Laura Nollen, RM 05

Registration Division (RD; 7505P) **Executive Summary** Spirotetramat is a tetramic acid derivative (ketoenole) developed b y Bayer CropScience AG. This foliar insecticide is active against sucking insects in vegetables, citrus, pome fruit, stone fruit, grapes, cotton, and other plants. It is systemic (xylem and phloem mobile) and can control hidden pests and protect new shoot s. The Interregional Research Project Number 4 (IR- 4) has submitted a Section 3 request to register a 2 lb ai/gal suspension - concentrate (SC) formulation (Movento ® 

### ; EPA Reg. No. 264 - 1050), a 1.25 lb ai/gal SC formulation (Ultor® 

### ; EPA Reg. No. 264 - 1065), and a 1.25 lb ai/gal oil dispersion (OD) formulation (BYI 8330 OD; EPA Reg. No. 264 - 1051) for use on taro, watercress, pomegranates, bananas, bulb vegetables, low - growing berries (except strawberries),Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### bushberries , globe artichokes, fruiting vegetables, p ome fruit, citrus fruit, pineapples, and coffee. The end - use products are proposed for 2 to 5 foliar spray applications at 0.05 - 0.25 lb ai/A/application with minimum retreatment intervals (RTI s) of 7 - 30 days, for maximum seasonal rates of 0.16 - 1.25 lb ai/A. Applications may be made using ground or aerial equipment, and use of an adjuvant is required. Preharvest intervals (PHI s) of 1 - 14 days are proposed. The rotational crop plantback intervals (PBIs) are 30 days for all non - labeled crops. Concurrentl y, IR- 4 has submitted a petition for the establishment of permanent tolerances for the residues of the insecticide spirotetramat, including its metabolites and degradates, in or on the commodities summarized below. Compliance with the tolerance levels speci fied below is to be determined b y measuring only the sum of spirotetramat ( cis - 3 - (2,5 - dimethly phenyl) - 8 - methoxy2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl - ethylcarbonate]) and its metabolites cis - 3 - (2,5 - dimethylphenyl ) - 4 - hydroxy- 8 - methoxy- 1 - azaspiro[4.5]dec - 3 - en - 2 - one, cis - 3 - (2,5 - dimethylphenyl ) - 3 - hydroxy- 8 - methoxy- 1 - azaspiro[4.5]decane - 2,4 - dione, cis - 3 - (2,5 - dimethylphenyl ) - 8 - methoxy- 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - ylbeta - D - glucopy ranoside, and ci s - 3 - (2,5 - dimethylphenyl) - 4 - hydrox y- 8 - methoxy- 1 - azaspiro[4.5]decan - 2 - one, calculated as the stoichiometric equivalent of spirotetramat, in or on the following commodities:

Taro, leaves ................................ ................................ .................... 9 ppm Watercress ................................ ................................ ...................... 1.5 ppm Pomegranate ................................ ................................ ................... 0.5 ppm Banana ................................ ................................ ............................ 4 ppm Vegetable, bulb, group 3 - 07 ................................ .......................... 0.6 ppm Low growing berry

subgroup 13 - 07H, except strawberry ............. 0.3 ppm Bushberry

subgroup 13 - 07B ................................ ......................... 3 ppm Artichoke, globe ................................ ................................ ............. 2 ppm Vegetable, fruiting, crop group 8 - 10 ................................ .............. 2.5 ppm Fruit, pome, crop group 11 - 10 ................................ ....................... 0.7 ppm Fruit, citrus, crop group 10 - 10 ................................ ........................ 0.6 ppm Pineapple ................................ ................................ ........................ 0.3 ppm Pineapple, process residue ................................ .............................. 0.36 ppm Coffee, green bean ................................ ................................ .......... 0.2 ppm Coffee, roasted bean ................................ ................................ ....... 0.32 ppm Permanent tolerances are currentl y established for the combined residues of the insecticide spirotetramat, including its m etabolites and degradates. Compliance with the tolerance levels is to be determined b y measuring onl y the sum of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BY I 08330 - enol - Glc, and BYI 08330 - mono - hydroxy , calculated as the stoichiometric equival ent of spirotetramat, in/on bulb onions, citrus, cucurbit vegetables, fruiting vegetables, grapes, hops, leafy Brassica vegetables, leafy non -Brassica vegetables, pome fruit, tuberous and corm vegetables, stone fruit, tree nuts, cotton, legume vegetables including so ybean (crop groups 6 and 7A), and tropical fruit (40 CFR §180.641(a)(1)). Tolerances are also established for residues of the insecticide spirotetramat, including its metabolites and degradates, in or on livestock commodities. Compliance with the tolerance levels is to be determined b y measuring only

the sum of spirotetramat and its metabolite BYI 08330 - enol, calculated as the stoichiometric equivalent of spirotetramat (40 CFR §180.641(a)(2)). No new data were submitted to support the proposed tolerances for residues in/on vegetable, fruiting, crop group 8 - 10, citrus, group 10 - 10; or fruit, pome, group 11 - 10. IR- 4 has requested that existing tolerances be expanded to their respective crop groups or crop subgroups. ResidueSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### data for green and bulb onion, globe artichoke, and sweet corn were reviewed by the Pest Management Regulatory

Agency (PMRA) of Canada as part of a U.S. - Canada RCC pilot project. RD has also requested that HED make a recommendation on establishing a tolerance on sweet corn imported from Canada based on PMRA’s evaluation of the Canadian residue data for this commodity . The nature of the residue in plants, rotational crops, and livestock is adequately understood based on acceptable metabolism studies conducted on apple, lettuc e, cotton, potato, rotational crops, lactating goats, and laying hens. The residues of concern for the tolerance expression and risk assessment for primary

and rotational crops are spirotetramat and its metabolites BYI 08330 - enol, BYI 08330 - ketohydroxy, B YI08330 - enol - Glc, and BYI 08330 - mono - hydroxy ; the residues of concern for the tolerance expression for livestock commodities are spirotetramat and its metabolite BYI 08330 - enol and the residues of concern for the risk assessment for livestock commodities are spirotetramat and its metabolites BYI 08330 - enol and BYI 08330 - enol - GA (Memo, J. Tyler et al. , 16 - APR- 20 08; D333437). Samples were anal yz ed for residues of spirotetramat and its metabolites BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - mono - hydroxy , and BYI 08330 - enol - glucoside using a high performance liquid chromatography method with tandem mass spectroscopy detection (HPLC MS/MS), Method 00857, the current enforcement method for crop commodities. Residues of each metabolite were reported in parent equivalents. The method was adequate for data collection based on acceptable concurrent method recovery data. The submitted magnitude of the residue data for the raw agricultural commodities (RACs) of watercress, pomegranates, bananas, bulb vegetabl es, low - growing berries (except strawberries), bushberries , globe artichokes, pineapples, and coffee will support the proposed use patterns. There are adequate storage stability data to validate the storage conditions and intervals of samples collected from the field trials. As no residue data were submitted for an OD or equivalent formulation, the use directions for the subject crops should be removed from the BYI 8330 OD label. In addition, as all of the banana field trials were performed in HI , the re gistration for use on this crop should be limited to the state of HI. Acceptable coffee and pineapple processing studies are available. The processing studies show that following processing of RAC samples bearing quantifiable residues, total residues o f spirotetramat and its metabolites concentrated in roasted coffee bean ( < 1.9X), instant coffee (< 10X), and pineapple process residue (1.2X). The only feedstuff associated with the proposed new uses is pineapple process residue, a minor feed item. The established tolerances for residues of spirotetramat and its metabolite in livestock commodities are adequate to support the proposed new uses. **Regulatory Recommendations and Residue Chemistry Deficiencies** Pending submission of rev ised Sections B and F (see requirements under Directions for Use and Proposed Tolerances) and anal ytical reference standards (see requirements under Submittal of Analy tical Reference Standards) , there are no residue chemistry issues that would preclude granting an unconditional registration for the use of spirotetramat on the requested crops. The proposed uses and the submitted data support the following permanent tolerances forSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### residues of the insecticide spirotetramat, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined b y measuring only the sum of spirotetramat ( cis - 3 - (2,5 - dimethly phenyl) - 8 - methoxy2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl - ethylcarbonat e]) and its metabolites cis - 3 - (2,5 - dimethylphenyl ) - 4 - hydroxy- 8 - methoxy- 1 - azaspiro[4.5]dec - 3 - en - 2 - one, cis - 3 - (2,5 - dimethylphenyl ) - 3 - hydroxy- 8 - methoxy- 1 - azaspiro[4.5]decane - 2,4 - dione, cis - 3 - (2,5 - dimethylphenyl ) - 8 - methoxy- 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - ylbeta - D - glucopy ranoside, and cis - 3 - (2,5 - dimethylphenyl) - 4 - hydrox y- 8 - methoxy- 1 - azaspiro[4.5]decan - 2 - one, calculated as the stoichiometric equivalent of spirotetramat, in or on the following commodities: Taro, leaves 9.0 ppm Artichoke, globe 1.50 ppm Watercress 2.0 ppm Vegetable, fruiting, crop group 8 - 10 2.50 ppm Bushberry subgroup 13 - 07B 3.0 ppm Fruit, pome, crop group 11 - 10 0.70 ppm Pomegranate 0.50 ppm Fruit, citrus, crop group 10 - 10 0.60 ppm Banana 1 4.0 ppm Pineapple 0.30 ppm Vegetable, bulb, group 3 - 07 0.80 ppm Coffee, green bean 0.15 ppm Lo w growing berry subgroup 13 - 07H, except straw

berry and low bush blueberry 3.0 ppm Coffee, instant 0.50 ppm Corn, sweet, kernel plus cob with husks removed2 1.5 ppm 1 This tolerance should be established under 40 CFR §180.641(c) Tolerances with regional registrations. 2 There are no U.S. registrations as of [date] for use on corn, sweet. **Note to RD:** With the establishment of these tolerances, the following tolerance s for the following commodities should be deleted: onion, bulb, subgroup 3A - 07; vegetable, fruiting group 8; citrus, group 10; fruit, pome, group 11; and okra. HED also notes that the established tolerances for residues in/on feijoa, papaya, and Spanish lime in 40 CFR §180.641 are incorrect and the previously recommended tolerance for residues in/on persimmon is missing. The correct tolerances are: 2.5 ppm for feijoa, 0.35 ppm for papaya, 13 ppm for Spanish lime, and 2.5 ppm for persimmon (Memo, J. Van Alstine et al. , 22 - DEC - 2010; D368785). 40 CFR §180.641 (a)(1) should be updated to reflect the recommended tolerances. 

### 860.1200 Directions for Use

 A 260 - day

PBI for rotational crops is required to support the proposed use on watercress.  As no residue data were submitted for an OD or equivalent formulation and higher residues result from this formulation ty pe (Memo, G. Kramer, 17 - APR- 2008; D339694) , the use directions for the subject crops should be removed from the BYI 8330 OD label.  As all of the banana field trials were performed in HI, the registration for use on this crop should be limited to the state of HI. 860.1650 Submittal of Analy tical Reference Standards The anal ytical reference standard for BYI 08330 - ketohydroxy h as expired and the standards for the isotopically

labeled internal standards of BYI 08330 - enol and BYI 08330 - ketohydroxy will soon expire (7/11/2013). The registrant should either recertify the lot in the repository

and send an updated certificate of anal ys is (COA), or submit new standards (different lot #) if the previous lots will not be recertified. If new standards are being submitted, then they should be sent to the Analy tical Chemistry

L ab, which is located at Fort Meade, to the attention of either Theresa Cole or Thuy Nygen at the following address: USEPA National Pesticide Standards Repository /Anal ytical Chemistry

Branch/OPP 701 Mapes RoadSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### Fort George G. Meade, MD 20755 - 5350 860.1550 Proposed Tolerances The petitioner is requested to submit a r evised Section F specify ing the following:

 Revised tolerance levels and commodity definitions presented in Table 27 (summarized above). A human - health risk assessment is forthcoming. **Background** Spirotetramat is a tetramic acid derivative (ketoenole) developed b y Bayer CropScience AG. This foliar insecticide is active against sucking insects in vegetables, citrus, pome fruit, stone fruit, grapes, cotton, and other plants. I t is systemic (xy

lem and phloem mobile) and can control hidden pests and prot ect new shoots. Details of the test compound nomenclature for spirotetramat and its metabolites BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - mono - hydroxy, BYI 08330 - enol - GA, and BYI 08330 - enol Glc are presented in Table 1. The phys icochemical proper ties of technical grade spirotetramat are listed in Table 2. **Table 1. Test Compound Nomenclature.** Compound Chemical Structure

Common name Spirotetramat Company experimental name BYI 08330 IUPAC name cis - 4 - (ethoxycarbonyloxy) - 8 - methoxy- 3 - (2,5 - xyl yl) - 1 - azaspiro[4.5]dec - 3 - en - 2 - one CAS name cis - 3 - (2,5 - dimethylphenyl) - 8 - methoxy- 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl ethyl carbonate CAS # 382608 - 10 - 8 End -use product/EP Movento ® , Ultor® , BYI 8330 OD

Compound: BYI 08330 - enol Chemical Structure

Common name BYI 08330 - enol Company experimental name BYI 08330 - enol IUPAC name None provided CAS name cis - 3 - (2,5 - dimethylphenyl) - 4 - hydroxy- 8 - methoxy- 1 - azaspiro[4.5]dec - 3 - en - 2 - oneSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 6 of 43 CAS # None provided Compound: BYI 08830 - ketohydroxy Chemical Structure

Common name BYI 08830 - ketohydroxy Company experimental name BYI 08830 - ketohydroxy IUPAC name None provided CAS name cis - 3 - (2,5 - dimethylphenyl) - 3 - hydroxy- 8 - methoxy- 1 - azaspiro[4.5]decane - 2,4 - dione CAS # None provided Compound: BYI 08330 - enol Glc Chemical Structure

Common name BYI 08330 - enol - Glc Company experimental name BYI 08330 - enol - Glc IUPAC name None provided CAS name cis - 3 - (2,5 - dimethylphenyl) - 8 - methoxy- 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl beta- D glucopyranoside CAS # None provided Compound: BYI 08330 - mono hydroxy Chemical Structure

Common name BYI 08330 - mono - hydroxy Company experimental name BYI 08330 - mono - hydroxy IUPAC name None provided CAS name cis - 3 - (2,5 - dimethylphenyl) - 4 - hydro xy- 8 - methoxy- 1 - azaspiro[4.5]decan - 2 - one CAS # None provided Compound: BYI 08330 - enol GA Chemical Structure

Common name BYI 08330 - enol - GA Company experimental name BYI 08330 - enol - GA IUPAC name None provided CAS name cis - 3 - (2,5 - dimethylphenyl) - 4 - (β - D - glucopyranosyloxy) - 8 - methoxy- 1 - azaspiro[4.5]dec - 3 - en - 2 - one CAS # None providedSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 7 of 43 **TABLE 2. Physicochemical Properties of the Spirotetramat.** Parameter Value Reference Melting point 142 °C EPA Chemical Fact Sheet for Spirotetramat, June 2008 pH 6.3 Density D 4 20 = 1.22 Water solubility (20 oC) pH 4: 33.5 mg/L pH 7: 29.9 mg/L pH 9: 19.1 mg/L Solvent solubility (20 oC) Solvent g/L n - hexane 0.055 Dichloromethane >600 Dimethyl Sulfoxide 200 - 300 Toluene 60 Acetone 100 - 120 Ethyl acetate 67 Ethanol 44 Vapor pressure Extrapolated Values: 5.6 x 10 - 9 Pa (20 oC) 1.5 x 10 - 8 Pa (25 oC) 1.5 x 10 - 6 Pa (50 oC) Dissociation constant, pKa 10.7 Included in MRID 47648203 Octanol/water partition coefficient, Log(KOW) pH 4: 2.51 pH 7: 2.51 pH 9: 2.50 EPA Chemical Fact Sheet for Spirotetramat, June 2008 UV/visible absorption spectrum Peak Maxima Molar Absorptivity (nm) (1000 cm2/ mol) 211 22.0 x 10 3 276 0.8 x 10 3 

### 860.1200 Directions for Use The petitioner has submitted draft labels for the 2 lb ai/gal SC formulation (Movento ® 

### ; EPA Reg. No. 264 - 1050), for the 1.25 lb ai/gal SC formulation (Ultor® 

### ; EPA Reg. No. 264 - 1065), and the 1.25 lb ai/gal OD formulation (BYI 8330 OD; EPA Reg. No. 264 - 1051). Information pertaining to the proposed end-use product is listed in Table 3. A summary of the proposed use patterns on taro, watercress, pomegranates, b ananas, bulb vegetables, low - growing berries (except strawberries), bushberries; globe artichokes, fruiting vegetables, pome fruit, citrus fruit, pineapples, and coffee is detailed in Table 4. **Table 3. Summary of Proposed End -**  **Use Products.** Trade Name Reg.

No. ai (% of formulation) Form

ulation Ty pe Target Crops Target Pests Label Date Movento ® 264 -

1050 22.4 SC taro, watercress, pomegranates, bananas, bulb vegetables, low growing berries (except straw berries), bushberries , globe artichokes, fruiting vegetables, pome fruit, citrus fruit, pineapples, and coffee. sucking insects Draft labels

submitted 7/24/12 Ultor® 264 -

1065 14.5 SC BYI 8330 OD 264 -

1051 15.3 ODSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 8 of 43 **Table 4. Summary of Directions for Use of Spirotetram**  **at.** Trade Names Application

Timing, Type, and Equipment Application

Rate (lb ai/A) Maximum

Number Applications per Season Maximum

Seasonal Application Rate (lb ai/A) PHI

(days) Use Directions and Limitations Banana and Plantain BYI 8330 OD Movento ® Ultor® Gr ound &

aerial 0.16 - 0.25 7 1.25 1 Minimum RTI : 14 days Minimum spray volume: 50 gallons per acre (GPA) ground, 10 GPA aerial Bushberry subgroups 13 - 07B and 13 - 07H BYI 8330 OD Movento ® Ultor® Gr ound &

aerial 0.13 - 0.16 3 0.47 7 Minimum RTI : 7 days Minimum spray volume: 30 GPA ground, 10

GP A aerial Coffee BYI 8330 OD Movento ® Ultor® Gr ound &

aerial 0.13 - 0.16 3 0.47 14 Minimum RTI : 21 days Minimum spray volume: 30 GPA ground, 10

GP A aerial Pineapple BYI 8330 OD Movento ® Ultor® Gr ound &

aerial 0.16 2 0.32 1 Minimum RTI : 14 days Minimum spray volume: 30 GPA ground, 10

GP A aerial Pomegranate BYI 8330 OD Movento ® Ultor® Gr ound &

aerial 0.13 - 0.16 2 0.32 1 Minimum RTI : 14 days Minimum spray volume: 50 gallons per acre (GPA) ground, 10 GPA aerial Bulb vegetables subgroups 3 - 07A and 3 - 07B BYI 8330 OD Movento ® Ultor® Gr ound ,

chemigation, & aerial 0.08 2 0.16 3 (3 - 07A) 7 (3 - 07B) Minimum RTI : 7 days

Minimum spray volume: 15 GPA ground, 5

GP A aerial Globe artichoke BYI 8330 OD Movento ® Ultor® Gr ound,

chemigation, & aerial 0.05 - 0.1 3 6 0.5 3 Minimum RTI : 7 days Minimum spray volume: 15 GPA ground, 5

GP A aerial Watercress BYI 8330 OD Movento ® Ultor® Gr ound,

chemigation, & aerial 0.0 6 - 0.2 6 0.4 3 Minimum RTI : 7 days Minimum spray volume: 15 GPA ground, 5

GP A aerial Additional Restrictions for all Crops: Movento ® and Ultor® must be tank- mixed with a spray adjuvant/additive. BYI 8330 OD may not be tank- mi xed with a spray adjuvant/additive having sticking properties. Use in enclosed structures, such as greenhouses or planthouses, is not permitted. Rotational crop PBIs: 30 days for all non - labeled crops. 

### Conclusions: The submitted use directions for Movento ® 

### and Ultor® 

### are adequate to allow evaluation of the residue data relative to the proposed uses except that a 260 - day PBI is required to support the proposed use on watercress. As all of the banana field trials were performed in HI, the registration for use on this crop should be limited to the state of HI. In addition, as no residue data were submitted for an OD or equivalent formulation and higher residues result from this formulation ty

pe (Memo, G. Kramer, 17 - APR- 2008; D339694) , the use directions for the subject crops should be removed from the BYI 8330 OD label. **Revised labels are required.**Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### 860.1300 Nature of the Residue **- Plants**  Reference List: Memo, G. Kramer, 17 - APR- 2008; D339694 

### The nature of the residue in plants is adequatel y understood based on acceptable metabolism studies conducted on apple, lettuce, cotton, and potato. The major metabolic reaction involved the hydrol ytic cleavage of the carbonate ester parent bond of the parent compound to form BYI 08330 - enol. Further reduction of the double bond in the tetramic acid moiety of BYI 08330 - enol occurred to form the BYI 08330 - mono - hydroxy metabolite. Hydroxyl ation in the tetramic acid moiety resulted in BYI 08330 - ketohydroxy. Demethylation of the methoxy group of the cyclohexyl ring resulted via a proposed intermediate (BYI 08330 - desmethyl - enol) in BYI 08330 - desmethyl - ketohydrox y (after the corresponding hydroxyl ation). Oxidation of the methoxy group resulted in BYI 08330 - ketohydroxy- formiate. Partly , metabolites bearing a hydroxy group were conjugated with glucose. The residues of concern for the tolerance expression and risk assessment for plant commodities are spirotetramat and its metabolites BYI 08330 - enol, BYI 08330 - ketohydrox y, BYI 08330 - enol - Glc, and BYI 08330 - mono - hydroxy (Memo, J. Tyler et al. , 16 - APR- 2008 ; D333437). **860.1300 Nature of the Residue -**  **Livestock** Reference List: Memo, G. Kramer, 17 - APR- 2008; D339694 

### The nature of the residue in livestock is adequately understood based on acceptable metabolism studies conducted on lactating goats and laying hens. In livestock, the biodegradation of spirotetramat in livestock can be characterized as cleavage of the car bonate ester group to the primary metabolite BYI 08330 - enol followed b y conjugation of the enol hydroxy group with glucuronic acid to BYI 08330 - enol - GA. Oxidation of the azaspirodecenylmoiety to BYI 08330 - ketohydroxy

and demethylation of the methoxy grou p to BYI 08330 - desmethyl - enol were minor metabolic reactions in ruminants as well as reduction of the azaspirodecenyl moiety to BY I 08330 - monohydrox y. Based on the currentl y proposed uses, the residues of concern for the tolerance expression for livestock commodities are spirotetramat and its metabolite BYI 08330 - enol and the residues of concern for the risk assessment for livestock commodities are spirotetramat and its metabolites BYI 08330 - enol and BYI 08330 - enol - GA (Memo, J. Tyler et al. , 16 - APR- 2008 ; D 333437). **860.1340 Residue Analytical Methods** Reference List: Memo, G. Kramer, 17 - APR- 2008; D339694 

### Samples were anal yz ed for residues of spirotetramat and its metabolites BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - mono - hydroxy , and BYI 08330 - enol - glucoside using a HPLC MS/MS method, Method 00857, the current enforcement method for crop commodities. Residues of each metabolite were reported in parent equivalents. Anal ytical method 00857 was developed for the determination of residues of spirotetramat, the metabolites BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - mono - hydroxy, and BYI 08330 - enol - Glc in plant matrices by HPLC - MS/MS using isotopically labeled internal standards. Spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - m ono - hydroxy, and BYI 08330 - enol - Glc were extracted from the plant commodity using a blender with acidic acetonitrile/water (4/1, v/v). AfterSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### subsequent clean -up of the extract through a Bond Elut clean polyethylene frit, the corresponding internal standards were added. The solution was made up to volume, diluted , and subjected to HPLC - MS/MS with multiple - reaction monitoring of two transitions for each matrix and analy te for quantitation and confirmation purposes. The limit of quantitation (LOQ) was 0.01 ppm for each anal yt e on all tested plant commodities with the exception of roasted coffee bean (BYI 08830 - glucoside had an LOQ of 0.05 ppm) and freeze - dried coffee (the LOQ was 0.1 ppm for each anal yt e). The method was adequate for data collection based on acceptable concurrent method recovery

data. **860.1360 Multiresidue Methods (MRMs)** DER Reference List: 46904496.der.doc 

### Spirotetramat and five metabolites BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - mono hydrox y, BY I 08330 - enol - Glc, and BYI 083 30 - enol - GA were screened through multiresidue methods described in the U.S. Food and Drug Administration (FDA) Pesticide Anal ytical Manual, Vol. I (PAM I). Spirotetramat and the metabolites were tested for natural fluorescence using procedures outlined in Protocol A of PAM I. BYI 08330 - mono - hydroxy was the onl y compound found to be naturally fluorescent; no further test with this protocol was performed. Spirotetramat and its metabolites were subjected to Protocol C, modules DG1, DG5, DG13, DG17, and DG18. Due to the poor sensitivity of the test substances to detection by method described in Protocol C, no further anal ys es were performed for Protocols D, E, or F. Since the test substances are not acidic, phenols or substituted ureas, anal ys es were no t performed using Protocols B or G. Conclusions : The MRMs are not suitable for the anal ys is of spirotetramat or its metabolites. **860.1380 Storage Stability** Reference List: Memo, G. Kramer, 17 - APR- 2008; D339694 

### Freezer storage stability

data are av ailable for five diverse crops (i.e., a fruiting vegetable tomato; a root crop -potato, a leafy vegetable - head lettuce; a nut - almond nutmeat; and a legume bean with pod) which demonstrate stability of residues of spirotetramat, BYI 08330 - enol, BYI 08330 - eno l - Glc, BYI 08330 - ketohydroxy, and BYI 08330 - mono - hydroxy for up to 718 days of frozen storage. These data support the storage conditions and intervals of samples collected from the various crop field trials. There are no unresolved storage stability issues, and no corrections need to be applied to the various residue crop studies. **860.1480 Meat, Milk, Poultry, and Eggs** Reference List: Memo, G. Kramer, 17 - APR- 2008; D339694 

### The currently

established livestock tolerances are based on the following rea sonably balanced dietary burdens (RBDBs) for spirotetramat and its metabolites: 2.7 ppm for beef cattle, 10.2 ppm for dairy

cattle, 1.2 ppm for poultry , and 0.75 ppm for swine. The only feedstuff associatedSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### with the proposed new uses is pineapple process residue, a minor feed item. As the calculated maximum residue calculated for pineapple process residue (0.14 ppm, see 860.1520 Processed Food and Feed) is very

low relative to the RBDBs, addition of this feed item to the livestock diets would not have a significant effect on the estimated residue levels in livestock commodities. The currently established tolerances for residues of spirotetramat and its metabolite in livestock commodities are thus adequate to support the proposed new uses. **860.1500 Crop Fi**  **eld Trials** Bushberry

subgroup 13 - 07B DER Reference List: 48697601.der.doc 

### Eleven blueberry

field trials were conducted in the U.S. or Canada encompassing North Atlantic Free Trade Agreement (NAFTA) Growing Zones 1 (NB and ME; 2 trials on lowbush blueberries), 1A (NS; 2 trials on lowbush blueberries), 2 (NC and NJ; 3 trials on highbush blueberries), 5 (ON; 1 trial on highbush blueberries), 5A (MI; 2 trials on highbush blueberries), and 12 (OR; 1 trial on highbush blueberries) during the 2009 growing season. Two trials on highbush blueberries in Zone 5A were conducted b y the same Principal Field Investigator (PFI) and at the same location in Michigan. Based on examination of the field trial records, it is concluded that MItrials AAFC09 - 030R- 136 and AAFC09 - 030R- 137 constitute a single trial with replicate samples for purposes of 860.1500 data requirements. Other than having independentl y prepared tank - mixes, there were no differences between the trials judging by the HED Science Advisory Council for Chemistry

(ChemSAC) criteria for differentiation of field trials. With the classification of these trials as replicates, the number of separate trials for the purposes of 860.1500 data requirement s is adjusted to 10 for lowbush and highbush blueberries combined, with there being six trials, instead of seven, for highbush blueberries, distributed among Zones 2 (3 trials) , 5 (1 trial) , 5A (1 trial) , and 12 (1 trial) . At each trial location, a 2 lb ai/gal SC formulation of spirotetramat was applied to blueberries in three foliar applications during various fruiting (berry- formation) stages, at rates of 0.152 - 0.167 lb ai/A/application, for total seasonal rates of 0.466 - 0.497 lb ai/A (1X) . Applications were made using ground equipment in volumes of 12.3 - 61.3 GPA. RTI s were 5 - 8 days. A non - ionic surfactant (NIS) was added to the spray mixture as an adjuvant for all applications. Each field trial site consisted of one untreated plot and one treated plo t. Blueberries were harvested at PHIs of 6 - 8 days. In one lowbush blueberry trial, samples were harvested at PHIs of 1, 3, 7, and 10 days after treatment to assess residue decline. Following three foliar broadcast applications of the 2 lb ai/gal SC formulation of spirotetramat totaling 0.466 - 0.497 lb ai/A per season , combined residues (and per- trial averages) of spirotetramat and its metabolites in/on blueberries harvested at a 6 - to 8 - day PHIwere 0.369 - 1.235 ( 0.378 - 1.209 ) ppm for lowbush blueberries and 0.400 - 1.560 ( 0.448 - 1.548 ) ppm for highbush blueberries (Table 5). Residue - decline data show that residues of spirotetramat and its metabolites decrease in blueberries with increasing PHI s.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 12 of 43 **Table 5. Summary of Residue Data from Crop Field Trials with S**  **pirotetram at.**  Commodity Total Applic.

Rate (lb ai/A) PHI

(days) Combined Residue Levels (ppm) 1 n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Proposed use = 0.47 lb ai/A total application rate; PHI of 7 days** Lowbush Blueberries 0.466 - 0.469 7 - 8 4 0.369 1.235 0.378 1.209 0.548 0.671 0.378 Highbush Blueberries 0.466 - 0.497 6 - 7 6 3 0.400 4 1.560 0.448 1.548 0.589 0.789 0.435 1 Except for sample min/max, values reflect per- trial means; n = number of field trials. Calculation assumed LOQ residues for residues <LOQ. 2 LAFT = lowest - average field trial; HAFT = highest - average field trial. 3 N is 6 instead of 7 because trial pair AAFC09 - 030R- 136 /AAFC09 - 030R- 137 constitutes a single trial with replicate samples for purposes of 860.1500 data requirements. 4 The sample minimum was from one of four samples collected in the replicate trial pair AAFC09 - 030R- 136 /AAFC09 - 030R137. 

### Conclusio ns : The number and locations of the crop field trials are not in accordance with OPPTS Guideline 860.1500 (Table 6) as a highbush blueberry trial was not performed in Zone 1 . HED will not require additional data as four lowbush blueberry trials were perf

ormed in this zone and residues in highbush lowbush blueberries are comparable. The submitted residue data are thus adequate to fulfill data requirements for highbush blueberries as a representative crop of the bushberry

subgroup 13 - 07B . The available data will support the proposed use pattern. **Table 6. Trial Numbers and Geographical Locations** . NAFTA Gro wing Zones Blueberry Submitted Requested Canada U.S. 1 2 (both lowbush) 1 (highbush) 1A 2 (both lowbush) 2 3 (all highbush) 3 (all highbush) 5 1 (highbush) 3 (all highbush) 5A 1 1 (highbush) 12 1 (highbush) 1 (highbush) Total 10 (4 lowbush and 6 highbush) 8 (all highbush) 1 Trial pair AAFC09 - 030R- 136 /AAFC09 - 030R- 137 constitutes a single trial with replicate samples for purposes of 860.1500 data requirements. 

### The residue data for highbush blueberries were analyzed using the Organization for Economic Co - operation and Development (OECD) tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 3.0 ppm in/on the bushberry subgroup 13 - 07B . Low - growing berry

subgroup 13 - 07H, except strawberry DER Reference List: 48697602.der.doc 

### Six cranberry

field trials were conducted in the U.S. or Canada encompassing NAFTA Growing Zones 1 (MA; 1 trial), 2 (NJ; 1 trial), 5A (WI ; 2 trials), and 12 (BC and OR; 1 trial in each) during the 2009 growing seas on. MRID 48697602 identifies the trial in Chatsworth, NJ, as being in NAFTA Growing Zone 1; however, according to OCSPP 860.1500, that trial would be in Zone 2 because it was located south of Rt. 1, which would place it about 25 miles outside of Zone 1. Two trials on cranberries in Zone 5A were conducted by the same PFI and at the same location in Wisconsin. Based on examination of the field trial records, it is concluded that WItrialsSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 13 of 43 

### AAFC09 - 050R- 145 and AAFC09 - 050R- 146 constitute a single trial with replicate samples for purposes of 860.1500 data requirements as onl y three of the four variables of the HED ChemSAC criteria for differentiation of field trials were met: (1) having independentl y prepared tank- mixes, (2) using different varieties, and (3) using spray volumes that were sufficientl y and consistently

different. With the classification of these trials as replicates, the number of separate trials for the purposes of 860.1500 data requirements is five, with one in Zone 1, one in Zone 2, one in Z one 5A, and two in Zone 12. At each trial location, a 2 lb ai/gal SC formulation of spirotetramat was applied to cranberries in three foliar applications during various fruiting (berry- formation) or mature - fruit stages, at rates of 0.151 - 0.165 lb ai/A/application, for total seasonal rates of 0.462 - 0.489 lb ai/A (1X) . Applications were made using ground equipment in volumes of 25.7 - 59.3 GPA. RTI s were 6 - 8 days. A NIS was added to the spray mixture for all applications. Each field trial site cons isted on one untreated plot and one treated plot. Cranberries were harvested at PHI s of 7 - 8 days. Additional samples of cranberries were harvested from one trial at PHIs of 1, 4, and 11 days after treatment to assess residue decline. Following three fol iar broadcast applications of the 2 lb ai/gal SC formulation of spirotetramat totaling 0.462 - 0.489 lb ai/A per season, combined residues (and per- trial averages) of spirotetramat and its metabolites in/on cranberries harvested at a 7 - to 8 - day PHIwere <0. 05 - 0.153 ( 0.052 - 0.152 ) ppm (Table 7) . Residue - decline data show that residues of spirotetramat and its metabolites decrease in cranberries with increasing PHIs. **Table 7. Summary of Residue Data from Crop Field Trials with Spirotetram**  **at.** Commodity Total Applic.

Rate (lb ai/A) PHI

(days) Combined Residue Levels (ppm) 1 n Sample Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Proposed use = 0.47 lb ai/A total application rate; PHI of 7 days** Cranberries 0.462 - 0.489 7 - 8 5 3 <0.05 0.153 0.052 0.152 0.076 0.085 0.041 1 Except for sample min/max, values reflect per- trial means; n = number of field trials. Calculation assumed LOQ residues for residues <LOQ. 2 LAFT = lowest - average field trial; HAFT = highest - average field trial. 3 N is 5 instead of 6 because trial pair AAFC09 - 050R- 145 /AAFC09 - 050R- 146 constitutes a single trial with replicate samples for purposes of 860.1500 data requirements. 

### Conclusions : The submitted residue data are adequate to fulfill data requirements for cranberries as a representative crop of the low - growing berry subgroup 13 - 07H, except strawberry . The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 8). The available data will support the proposed us e pattern. **Table 8. Trial Numbers and Geographical Locations** . NAFTA Gro wing Zones Cranberry Submitted Requested Canada U.S. 1 1 2 2 1 1 5 2 5A 1 2 12 2 1 Total 5 5 1 MRID 48697602 identifies the trial in Chatsworth, NJ, as being in NAFTA Growing Zone 1; however, according to OCSPP 860.1500, that trial would be in Zone 2 because it was located south of Rt. 1, which would place it about 25 miles outside of Zone 1. 2 Trial pair AAFC09 - 050R- 145 /AAFC09 - 050R- 146 constitutes a single trial with replicate samples for purposes of 860.1500 data requirements.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 14 of 43 

### The residue data for cranberries were anal yz ed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BY I 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 0.30 ppm in/on the low - growing berry subgroup 13 - 07H, except strawberry

and lowbush blueberry . The exclusion of lowbush blueberry is nec essitated b y the residue data that show that a tolerance level of 3.0 ppm is required for this crop (see Appendix II). Since lowbush blueberries are also a member of bushberry subgroup 13 - 07B, a separate tolerance for residues in/on “blueberry , lowbush” i s not required. Watercress DER Reference List: 48697603.der.doc 

### Three field trials were conducted in the U.S. during the 2008 growing season in the NAFTA Growing Zones 1 (MD; 1 trial) and 3 (FL; 2 trials). The FL38 and FL39 trials were conducted in th e same county and under similar soil (sand) and similar growing conditions (re - circulating the water using pumps and man - made drainage s ys tems simulating natural water flow). These trials would not normally

satisfy the HED ChemSAC criteria for differentiation of field trials; however, because the trials were conducted b y different personnel in different ponds and the geographic area suitable for watercress cultivation is limited, HED concludes that these trials may be counted as separate trials for purpose s of 860.1500 data requirements. Each trial consisted of one untreated plot and one or two treated plots. At each trial location, one treated plot received two foliar broadcast applications of Movento ® 

### (2 lb ai/gal SC) at 0.189 - 0.199 lb ai/A/application, for a total seasonal rate of 0.379 - 0.395 lb ai/A (~1X). Applications were made at 7 - to 8 - day

RTI s using ground equipment in spray volumes of 29.94 - 38.16 GPA. At the FL38 trial site, a second plot received two chemigation applications using overhead mini sprinklers at the same treatment rate in spray volumes of 601.76 - 608.98 GPA (RTI= 8 days). A non - ionic surfactant/organosilicone surfactant (NIS/OSS) was added to the spray mixture for each of the applications, with the exception of application 1 at the FL39 trial which did not use an adjuvant. Samples of watercress were harvested from all trials at a 3 - day PHI . Following two foliar broadcast applications of the 2 lb ai/gal SC formulation of spirotetramat at 0.379 - 0.395 lb ai/A (use pattern 1), combined residues (and per- trial averages) of spirotetramat and its metabolites in/on watercress leaves and stems harvested at a 3 - day PHIwere <0.29 - <0.70 (<0.29 - <0.67) ppm; corresponding residues (and per- trial averages) fo llowing two chemigation applications at 0.392 lb ai/A (use pattern 2) were <0.53 - <0.59 (<0.56) ppm (Table 9). Examination of the results indicates that the residues from the chemigation samples fell within the range of residues of samples from both treatm ent ty pes. Thus, there were no significant differences in residues resulting from the conventional spray application and the chemigation application.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 15 of 43 **T able**  **9. Summary of Residue Data from Watercress Field Trials with Spirotetram**  **at (Com bined Broadcast**  **and Chemigation Trials).** Commodity Analyte Total Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Proposed use = 0.4 lb ai/A total application rate; PHI of 3 days** Watercress, leaves and stems Spirotetramat 0.379 - 0.395 3 4 <0.01 0.054 <0.01 0.049 0.013 0.021 0.019

Enol 3 0.16 0.40 0.17 0.37 0.28 0.28 0.083 Enol - glucoside 3 <0.01 <0.01 < 0.01 <0.01 0.01 0.01 N/A Ketohydroxy3 0.090 0.28 0.094 0.27 0.25 0.21 0.081 Monohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined4 <0.29 <0.70 <0.29 <0.67 0.58 0.53 0.17 1 Except for sample min/max, values reflect per- trial averages; n = no. of field trials. N/A= not applicable 2 LAFT = lowest - average field trial; HAFT = highest - average field trial. 3 Data reflect conversion of quantifiable residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydroxy, and BYI 08330 - enol - Glc to parent equivalents. 4 Combined residues include spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 -monohydroxy, and BYI 08330 - enol - Glc, expressed as parent equivalents. 

### Conclusions : The submitted residue data for watercress are adequate to fulfill data requirements. The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 10). The available data will support the proposed use pattern. **Table 10. Trial Numbers and Geographical Locations** . NAFTA Growing Regions Watercress Submitted Requested 1 Canada U.S. 1 1 -- -- 3 2 -- -- Total 3 -- 2 1 As per OPPTS 860.1500, Table 1 for watercress; Table 5 does not include watercress. Two field trials are required in major watercress producing regions. 

### The residue data for watercress were anal yz ed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BY I 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 2.0 ppm. Coffee DER Reference List: 48697604.d er1.doc 

### Five field trials were conducted in the U.S. during the 2009 growing season in the NAFTA Growing Zone 13 (HI). All trials were conducted by the same principal field investigator (PFI) but trials 09 - HI 09 & 09 - HI 11, 09 - HI 10, and 09 - HI 12 & 09 - HI 13 w ere conducted on different Hawaiian Islands; thus, HED concludes that these trials may be counted as separate trials for purposes of 860.1500 data requirements. Trial pairs 09 - HI 09 & 09 - HI 11 and 09 - HI 12 & 09 - HI 13 would not normally satisfy the HED ChemSAC criteria for differentiation of field trials; however, because the geographic area suitable for coffee cultivation is limited, HED concludes that these trials may

be counted as separate trials for purposes of 860.1500 data requirements. Each trial consis ted of one untreated plot and one treated plot. At each trial location, the treatedSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 16 of 43 

### plot received three foliar directed applications of Movento ® 

### (2 lb ai/gal SC) at 0.1584 - 0.1727 lb ai/A/application, for a total seasonal rate of 0.4778 - 0.5052 lb ai/A (1X) . Applications were made at 20 - to 22 - day

RTIs using ground equipment in spray volumes of 25.39 - 49.82 GPA; the interval between the second and third application was shortened to 13 and 7 days, respectively , in trials 09 - HI 11 and 09 - HI 12 because the beans were ripening earlier than expected. A NI S/OSS was added to the spray mixture for each of the applications. Samples of coffee bean “cherries” were harvested from four trials at a 13 - 14 - day PHI; samples were collected at a 7 - day PHIin trial 09 - HI 11. Additional samples were collected at PHIs of 1, 7, and 21 days from one trial (09 - HI 13) to assess residue decline. The coffee bean cherries were processed by field personnel into the green bean coffee RAC. Following three foliar directed applications of the 2 lb ai/gal SC formulation of spirotetramat at 0.4778 - 0.5052 lb ai/A, residues (and per - trial averages) of BYI 08330 - enol, BYI 08330 - glucoside, and combined residues of parent and all metabolites, respectivel y, in/on green bean coffee harvested at a 14 - day PH I were <0.01 - 0.033 (<0.01 - 0.028), <0.01 - 0.016 (<0.01 - 0.014), and <0.05 - <0.079 (<0.05 - <0.072) ppm; residues of spirotetramat, BYI 08330 - ketohydroxy, and BYI 08330 - monohydroxy were <LOQ (0.01 ppm) in/on all samples of green bean coffee (Table 11). The residue - decline data indicate that residues of BYI 08330 - enol and combined residues increased with increasing PHI s. Residues of spirotetramat, BYI 08330 - ketohydroxy, BY I 08330 - monohydrox y, and BYI 08330 - glucoside were near to or <LOQ at each sampling inter val; therefore, residue decline could not be assessed. **Table 11. Summary of Residue Data from Coffee Field Trials with Spirotetram**  **at.** Commodity Analyte Total Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Proposed use = 0.47 lb ai/A total application rate; PHI of 14 days** Coffee, Green bean Spirotetramat 0.4778 - 0.5052 14 4 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Enol 3 <0.01 0.033 <0.01 0.028 0.018 0.019 0.007 Ketohydroxy3 < 0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Monohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Glucoside 3 <0.01 0.016 <0.01 0.014 0.011 0.011 0.002 Combined4 <0.05 <0.079 <0.05 <0.072 0.058 0.060 0.009 1 Except for sample min/max, values reflect per- trial averages; n = no. of field trials. N/A= not applicable 2 LAFT = lowest - average field trial; HAFT = highest - average field trial. 3 Data reflect conversion of quantifiable residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydroxy, and BYI 08330 - Glc to parent equivalents. 4 Combined residues include spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 -monohydroxy, and BYI 08330 - enol - Glc, expressed as parent equivalents. 

### Conclusio ns : The submitted residue data for coffee are adequate to fulfill data requirements. The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 12). The available data will support the proposed use pattern.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 17 of 43 **Table 12. Trial Numbers and Geographical Locations** . NAFTA Growing Regions Coffee Submitted Requested 1 Canada U.S. 13 5 -- 5 Total 5 -- 5 1 As per OPPTS 860.1500, Table 5 for coffee. 

### The residue data for coffee, green bean were analyzed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 0.20 ppm. Banana DER Reference List: 48697605.der.doc 

### Five field trials were conducted in the U. S. during the 2008 - 2009 growing seasons in the NAFTA Growing Zone 13 (HI). All trials were cond ucted b y the same PFI, but trials 08 - HI 05 & 08 - HI 10 and 08 - HI 06 & 08 - HI 09 & 09 - HI 14 were conducted on different Hawaiian Islands and trial pair 08 - HI 05 & 08 - HI 10 were conducted in different growing seasons; thus, HED concludes that these trials may

be counted as separate trials for purposes of 860.1500 data requirements. Trials 08 - HI 06 & 08 - HI 09 & 09 - HI 14 were separated by >20 miles, had a >30 day- off set in application dates, and used a different variety of banana (trial 08 - HI 06 onl y). Trials 08 - HI 09 & 0 9 - HI 14 would not normally satisfy the HED ChemSAC criteria for differentiation of field trials; however, because the geographic area suitable for banana cultivation is limited, HED concludes that these trials may

be counted as separate trials for purposes of 860.1500 data requirements. Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received five foliar directed applications of Movento ® 

### (2 lb ai/gal SC) at 0.245 - 0.267 lb ai/A/application, for a tot al seasonal rate of 1.25 - 1.30 lb ai/A (1X). The test substance was applied to bagged bunches at trial HI05; the bunches were not bagged at the remaining trial sites. Applications were made at 13 - to 15 - day RTIs using ground equipment in spray volumes of 40.99 - 80.16 GPA. A NIS/OSS was added to the spray mixture for each of the applications. Samples of bananas (fruit with peel) were harvested from all trials at a 1 - day PHI ; samples of peeled fruit were also collected from one trial (HI06). Additional sam ples were collected at PHI s of 3, 7, and 14 days from one trial (HI14) to assess residue decline. Following five foliar - directed applications of Movento ® 

### (2 lb ai/gal SC) at 1.25 - 1.30 lb ai/A, residues (and per- trial averages) of combined residues of spirotetramat and its metabolites in/on unbagged banana fruit, bagged banana fruit, and combined bagged and unbagged fruit, respectivel y, harvested at a 1 - day PHI were <0.51 - <2.1 (<0.62 - <1.8), <0.19 - <0.20 (<0.20), and <0.19 - <2.1 (<0.20 - <1.8) ppm (Table 13) . Residues of BYI 08330 - monohydroxy were below the LOQ (<0.01 ppm) in/on all samples of banana; residues of BYI 08330 - glucoside were onl y detected at the HI10 trial site (0.014 - 0.015 ppm). Combined residues of spirotetramat and its metabolites in/on peel ed fruit were <0.19 ppm (0.31X the residue in the corresponding unpeeled sample). Residues were highest in fruit samples that were not bagged. The residue - decline data indicate that average combined residues of spirotetramat and its metabolites were <1.5 ppm at the 1 - day PHI, decreased to <0.49 ppm at the 7 - day PHI, andSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 18 of 43 

### increased to <0.63 ppm at the 14 - day PHI. Individual residues of spirotetramat reflected this same trend, whereas BYI 08330 - enol decreased with increasing PHIs. Residues of BYI 08330 - ketohydroxy

increased with increasing PHIs. At a 1 - day PHI average residues of BYI 08330 - ketohydroxy

were 0.048 ppm and increased to 0.086 ppm by the 14 - day

PHI. Residues of BYI 08330 - monohydrox y and BYI 08330 - glucoside were <LOQ at each sampling interval; therefore, residue decline could not be assessed. **Table 13. Summary of Residue Data from Unbagged**  **Banana Field Trials with Spirotetram at.**  Commodity Analyte Total Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Proposed use = 1.25 lb ai/A total application rate; PHI of 1 days** Banana, Whole Fruit Spirotetramat 1.25 - 1.29 1 4 0.20 1.5 0.29 1.2 0.77 0.76 0.46

Enol 3 0.21 0.61 0.26 0.60 0.38 0.40 0.17 Ketohydroxy3 0.034 0.092 0.048 0.087 0.052 0.060 0.018 Monohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Glucoside 3 <0.01 0.015 <0.01 0.015 0.010 0.011 <0.001 Combined4 <0.51 <2.1 <0.62 <1.8 1.4 1.3 0.50 Banana, Peeled Fruit Spirotetramat 1.26 1 1 0.013 0.017 0.015 0.015 0.015 0.015 N/A

Enol 3 0.12 0.12 0.12 0.12 0.12 0.12 N/A Ketohydroxy3 0.033 0.033 0.033 0.033 0.033 0.033 N/A Monohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Glucoside 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined4 <0.19 <0.19 <0.19 <0.19 0.19 0.19 N/A 1 Except for sample min/max, values reflect per- trial averages; n = no. of field trials. N/A= not applicable. 2 LAFT = lowest average field trial; HAFT = highest average field trial. 3 Data reflect conversion of quantifiable residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydroxy, and BYI 08330 - Glc to parent equivalents. 4 Combined residues include spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 -monohydroxy, and BYI 08330 - enol - Glc, expressed as parent equivalents. 

### Conclusions : The number and locations of the crop field trials are not in accordance with OPPTS Guideline 860.1500 (Table 14) as a banana trial was not performed in Zone 3 . Provided that the registration is limited to HI , the submitted residue data for bananas are adequate to fulfill data requirements for a regional registration. The available data will support the proposed use pattern. **Table 14. Trial Numbers and Geographical Locations** . NAFTA Growing Regions Banana Submitted Requested 1 Canada U.S. 3 -- -- 1 13 5 -- 4 Total 5 -- 5 1 As per OCSPP 860.1500, Table 5 for banana. 

### The residue data for unbagged bananas were analyzed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 0.50 ppm.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 19 of 43 

### Pomegranate DER Reference List: 48697606.der.doc 

### Four field trials were conducted in the U.S. during the 2009 growing season in NAFTA Growing Zone 10 (CA). Trial pairs 09 - CA71 & 09 - CA72 and 09 - CA69 & 09 - CA70 were each conducted at the same location and used the same variety of pomegranate. Examination of the field trial records indicates that the only differences between trials 09 - CA69 & 09 - CA70, in addition to different tank mixes, were: a >30 - day off - set in application dates and the spray volume varied by >25%; there were no differences (other than separate tank mixes) for the 09 - CA71 & 09 - CA72 trials. These trials would not normally satisfy the HED ChemSAC criteria for differentiation of field trials; however, because areas suitable for pomegranate production are l imited, HED concludes that these trials may be counted as separate trials for purposes of 860.1500 data requirements. Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received two foliar directed a pplications of Movento ® 

### (2 lb ai/gal SC) at 0.154 - 0.162 lb ai/A/application, for a total seasonal rate of 0.311 - 0.318 lb ai/A (1X). Applications were made at a 14 - day RTI using ground equipment in spray volumes of 58.71 - 113.69 GPA. A NI S was added to the spray

mixture for each of the applications at the Reedley , CA trial sites and a crop oil concentrate (COC) was added to the spray mixture at the Gridley , CA trial sites. Samples of pomegranate were harvested from all trials at a 1 - day PHI . Additional samples were collected at PHI s of 3, 7, and 14 days from one trial (CA69) to assess residue decline. Following two foliar directed applications of the 2 lb ai/gal SC formulation of spirotetramat at 0.311 - 0.318 lb ai/A, residues (and per- trial averages) of spirotetramat, BYI 08330 - enol, BYI 08330 - glucoside, and combined residues, respectively , in/on pomegranates harvested at a 1 - day PHIwere 0.025 - 0.13 (0.029 - 0.11), 0.015 - 0.085 (0.017 - 0.073), <0.01 - 0.024 (<0.01 - 0.022), and <0.070 - <0.199 (<0.076 - <0.174) ppm; residues of BYI 08330 - ketohydroxy and BY I 08330 - monohydrox y were <LOQ (0.01 ppm) in/on all samples of pomegranate (Table 15). The residue - decline data indicate that residues of spirotetramat, BYI 08330 - enol, and combined residues decreased with increasing PHIs. Residues of BYI 08330 - ketohydroxy, BYI 08330 - monohydrox y, and BY I 08330 - glucoside were near to or <LOQ at each sampling interval; therefore, residue decline could not be assessed. **Table 15. Summary of Residue Data from Pomegranate Field Trials with Spirotetramat.**  Commodity Analyte Total Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Proposed use = 0.32 lb ai/A total application rate; PHI of 1 day** Pomegranate, Fruit Spirotetramat 0.311 - 0.318 1 4 0.025 0.13 0.029 0.11 0.054 0.062 0.035

Enol 3 0.015 0.085 0.017 0.073 0.052 0.048 0.028 Ketohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Monohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Glucoside 3 <0.01 0.024 <0.01 0.022 0.015 0.016 0.006 Combined4 <0.070 <0.199 <0.076 <0.174 0.165 0.145 0.047 1 Except for sample min/max, values reflect per- trial averages; n = no. of field trials. N/A= not applicable. 2 LAFT = lowest average field trial; HAFT = highest average field trial. 3 Data reflect conversion of quantifiable residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydroxy, and BYI 08330 - Glc to parent equivalents by the petitioner.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 20 of 43 4 Combined residues include spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 -monohydroxy, and BYI 08330 - enol - Glc, expressed as parent equivalents. 

### Conclusions : The submitted residue data for pomegranate are adequate to fulfill data requirements. The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 16). The available data will support the proposed use pattern. **Table 16. Trial Numbers and Geographical Locations** . NAFTA Growing Regions Pomegranate Submitted Requested 1 Canada U.S. 10 4 -- -- Total 4 -- 3 or 2 2 1 As per OCSPP 860.1500, Table 1 for pomegranate; Table 5 does not include pomegranate. The field trials are required in major pomegranate producing regions. According to OCSPP 860.1500, Table 6, 99% of pomegranate production is in Zone 10. 2 As per OCSP P 860.1500, Table 1, the petitioner has the option of doing three trials with two treated samples (1X rate) per- trial or two trials with four treated samples (two at 1X rate, two at 2X rate) per- trial. 

### The residue data for pomegranate were anal yz ed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 0. 50 ppm. Artichoke, globe DER Reference List: 48697607.der.doc (prepared by PMRA) 

### Agriculture and Agri - Food has submitted field trial data for spirotetramat on globe artichoke. A total of five globe artichoke field trials were conducted in Canada and the U.S. during the 2009 - 2010 growing seasons encompassing NAFTA Growing Zones 5B (1 trial in QC), 10 (3 trials in CA), and 12 (1 trial in BC). At each trial site, Movento ® 

### (2 lb ai/gal SC) was applied to globe artichoke plants as four foliar applications at rates of 0.12 - 0.13 lb ai/A, with RTI s of 5 - 9 days, for a total application rate of 0.49 - 0.50 lb ai/A/season (1X). A NI S was included in each of the spray mixtures at a rate of 0.25 - 0.26%, v/v. Globe artichoke flower heads (buds) were harvested 2 - 3 DA LA. At Trial ID# 125 in L ’Acadie, Quebec, additional samples were harvested at 1, 3, and 10 DALA to assess residue decline behavior. Total residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydrox y, and BYI 08330 - mono - hydrox y ( all expressed as parent equivalents) in/on globe artichokes treated with a suspension concentrate formulation, as four foliar applications at total rates of 0.49 - 0.50 lb ai/A/season and harvested at PHIs of 2 - 3 days ranged from <0.22 - <0.75 ppm (Table 17). The residue decline data indicate that total residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydroxy, and BYI 08330 - mono - hydroxy (all expressed as parent equivalents) in/on globe artichoke decreased with increasing PHIs.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 21 of 43 **Table 17. Summary of Residue Data from Globe Artichoke Crop Field Trials with Spirotetram**  **at.** Analyte Total Applic. Rate (lb ai/A) PHI

(days) Residue Levels (ppm)

n Min. Max. LAFT * HAFT * Median Mean Std. Dev. **Proposed use = 0.5 lb ai/A total application rate; PHI of 3 days**  Spirotetramat 0.49 - 0.50 2 - 3 5 0.012 0.38 0.016 0.32 0.06 0.14 0.14 BYI 08330 - enol 1 5 0.11 0.23 0.11 0.21 0.16 0.17 0.042 BYI 08330 - enol - Glc 1 5 0.02 0.051 0.026 0.036 0.033 0.031 0.004 BYI 08330 - ketohydroxy 1 5 0.066 0.19 0.07 0.17 0.095 0.10 0.037 BYI 08330 - mono - hydroxy 1 5 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Total 2 5 <0.22 <0.75 <0.23 <0.70 0.41 0.46 0.19 * LAFT = lowest average field trial; HAFT = highest average field trial. 1 Residues of the metabolites BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - Keto - OH, and BYI 08330 - Mono - OH were reported in the study as parent equivalents. 2 Total Residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydroxy, and BYI 08330 - mono hydroxy, all expressed as parent equivalents 

### Conclusions : The submitted residue data for globe artichoke are adequate to fulfill data requirements. The number and locations of the crop field trials are in accordance with OPPTS Guideline 860 .1500 (Table 18). The available data will support the proposed use pattern. **TABLE 18. Trial Numbers and Geographical Locations** . NAFTA Growing Regions Globe Artichoke Submitted Requested 1 Canada U.S. 5B 1 10 3 12 1 Total 5 2 3 1 As per OCSPP 860.1500, Table 5 does not include globe artichoke. The field trials are required in major globe artichoke producing regions. According to OCSPP 860.1500, Table 6, 100% of globe artichoke production is in Zone 5. 

### The residue data for glob e artichoke were analyzed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expres sed as parent equivalents, is 1.5 ppm. Vegetable, bulb, group 3 - 07 DER Reference List: Green Onion, 48697609.der.doc (prepared by PMRA)

Bulb Onion, 48697608.der.doc (prepared by PMRA) 

### Agriculture and Agri - Food Canada has submitted field trial data for spirotetramat on **green onions**  . A total of two green onion field trials were conducted in Canada during the 2009 growing season encompassing NAFTA Growing Zones 5 (1 trial in ON) and 5B (1 trial in QC). At each trial site, Movento ® 

### (2 lb ai/gal SC) was applied to green onion as two foliar applications at rates of 0.081 - 0.082 lb ai/A, with RTI s of 6 - 7 days, for a total application rate of 0.16 lb ai/A/season (1X). A NIS was included in each of the spray mixtures at a rate of 0.25%, v/v. Green onion plants were harvested 6 - 7 DALA. At the Ontario trial, additional samples were harvested at 1, 4, and 11 DALA to assess residue - decline behavior. Total residues of spirotetramat, BYI 08330 - eno l, BYI 08330 - enol - Glc, BYI 08330 - ketohydrox y, and BYI 08330 - mono - hydrox y (all expressed as parent equivalents) in/on green onions treated with Movento ® 

### , as two foliar applications at total rates of 0.16 lb ai/A/season and harvested at PHI s of 6 - 7 days rang ed from <0.15 - <0.34 ppm (Table 19). The residue decline data indicateSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 22 of 43 

### that total residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydroxy , and BYI 08330 - mono - hydroxy (all expressed as parent equivalents) in/on green onions decreased with increasing PHIs. At a meeting held on 9/14/2011, the HED ChemSAC concluded that these data could be used to support a conditional registration and a tolerance for the bulb vegetable crop group. The registration should be made conditional pending submission of data from one additional green onion residue trial (conducted in NAFTA Growing Zone 10, four samples at proposed PHI). A preliminary

report of the residue data from this trial has been received by HED (Personal Communication from Barbara Madden, 1/31/2013 ). These data are included in Table 19 and in the OECD tolerance - calculation procedures (see Appendix II). **Table 19. Summary of Residue Data from Green Onion Crop Field Trials with Spirotetram**  **at.** Analyte Total Applic. Rate (lb ai/A) PHI

(days) Residue Levels (ppm)

n Min. Max. LAFT * HAFT * Median Mean Std. Dev. **Proposed use = 0.16 lb ai/A total application rate; PHI of 7 days** Spirotetramat 0.16 6 - 7 3 <0.01 0.10 <0.01 0.10 0.040 0.049 0.045 BYI 08330 - enol 1 3 <0.01 0.16 <0.01 0.14 0.054 0.068 0.066 BYI 08330 - enol - Glc 1 3 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 BYI 08330 - ketohydroxy 1 3 <0.01 0.075 <0.01 0.065 0.050 0.042 0.028 BYI 08330 - mono - hydroxy 1 3 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Total 2 3 <0.051 <0.34 < 0.050 <0.32 0.17 0.18 0.135 * LAFT = lowest - average field trial; HAFT = highest - average field trial. 1 Residues of the metabolites BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - Keto - OH, and BYI 08330 - Mono - OH were reported in the study as parent equivalent s. 2 Total Residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydroxy, and BYI 08330 - mono hydroxy, all expressed as parent equivalents. 

### Agriculture and Agri - Food Canada has submitted field trial data for spirotetramat on **dry bulb onions**  . A total of 12 dry bulb onion field trials were conducted in Canada and the U.S. during the 2008 - 2009 growing seasons encompassing NAFTA Growing Zones 1 (1 trial in NY), 5 (2 trials in ON), 5A (1 trial in WI), 5B (2 trials in QC), 6 (1 trial in TX), 8 (1 trial in CO), 10 (2 trials in CA), 11 (1 trial in ID), and 12 (1 trial in OR). At each trial site, Movento ® 

### (2 lb ai/gal SC) was applied to dry

bulb onions as two broadcast foliar applications at rates of 0.074 - 0.083 lb ai/A, with RTI s of 6 - 8 days , for a total application rate of 0.15 - 0.17 lb ai/A/season (1X). A NIS was included in each of the spray mixtures at a rate of 0.25%, v/v. Dry bulb onions were harvested at PHI s of 2 - 4 days. At two of the trial sites, additional samples were harvested at 1, 6 or 7, and 9 or 10 DALA to assess residue - decline behavior. Total residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydrox y, and BYI 08330 - mono - hydrox y (all expressed as parent equivalents) in/on dry bulb onion samples treated with Movento ® 

### , as two broadcast foliar applications at total rates of 0.15 - 0.17 lb ai/A/season and harvested at PHI s of 2 - 4 days ranged from <0.054 - <0.34 ppm (Table 20). The residue - decline data indicate that total residues of spirotetramat, BYI 083 30 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydrox y, and BYI 08330 - mono - hydroxy (all expressed as parent equivalents) in/on dry

bulb onion remained fairl y stable between PHIs of 1 - 10 days.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 23 of 43 **Table 20. Summary of Residue Data from Dry Bulb Onion Crop Field T**  **rials with Spirotetram at.**  Analyte Total Applic. Rate (lb ai/A) PHI

(days) Residue Levels (ppm)

n Min. Max. LAFT * HAFT * Median Mean Std. Dev. **Proposed use = 0.16 lb ai/A total application rate; PHI of 7 days** Spirotetramat 0.15 - 0.17 2 - 4 12 <0.01 0.012 <0.01 <0.011 0.010 0.010 0.00 BYI 08330 - enol 1 12 <0.012 0.297 <0.012 0.266 0.042 0.071 0.083 BYI 08330 - enol - Glc 1 12 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 0.00 BYI 08330 - ketohydroxy 1 12 <0.012 0.016 <0.012 0.015 0.012 0.012 0.001 BYI 08330 - mono - hydroxy 1 12 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 0.00 Total 2 12 <0.054 <0.34 <0.054 <0.31 0.085 0.11 0.084 * LAFT = lowest - average field trial; HAFT = highest - average field trial. 1 Residues of the metabolites BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - Keto - OH, and BYI 08330 - Mono - OH were converted to parent equivalents . 2 Total Residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydroxy, and BYI 08330 - mono hydroxy, all expressed as parent equivalents 

### Conclusions : The number and locations of the onion crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 21) for green and bulb onions as a representative crop of the bulb vegetable group 3 - 07, except for an additional green onion trial (see footnote 2). The available data will support the proposed use pattern. **Table 21. Trial Numbers and Geographical Locations** . NAFTA Growing Zones Dry Bulb Onion Green Onion Submitted Requested Submitted Requested

Canada U.S. 1 Canada U.S. 1 1 1 1 1 5 2 2 1 1 5A 1 1 5B 2 2 1 1 6 1 1 1 8 1 1 1 10 2 2 2 1 11 1 1 1 12 1 1 Total 12 12 6 3 2 3 2 1 The requested number of trials required for the crop as a representative commodity used to obtain a crop group tolerance. 2 Specific zones are not recommended for crops requiring ≤3 trials; however, 54% and 18% of green onions are grown in Zones 10 and 6, respectively. 

### The residue data for green onions were anal yz ed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 0.80 ppm in/on the vegetable, bulb, group 3 - 07 . Pine apple DER Reference List: 48697610.der1.doc 

### Five field trials were conducted in the U.S. during the 2011 growing season in NAFTA Growing Zone 13 (HI). All trials were conducted b y the same PFI, but trials HI01, HI02, & HI05 and HI 03 & HI04 were conduct ed on different Hawaiian I slands; thus, HED concludes that these trials may be counted as separate trials for purposes of 860.1500 data requirements. CarefulSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 24 of 43 

### examination of the field trial records indicates that the only differences between trial groups H I01, HI02, & HI05 and HI03 & HI04, in addition to different tank mixes, were: a >30 - day offset in application dates and the spray volume varied by

>25% (HI01, HI02, & HI05 trials only). These trials would not normally satisfy the HED ChemSAC criteria fo r differentiation of field trials; however, because areas suitable for pineapple production are limited, HED concludes that these trials may

be counted as separate trials for purposes of 860.1500 data requirements. Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received two foliar broadcast applications of Movento ® 

### (2 lb ai/gal SC) at 0.154 - 0.161 lb ai/A/application, for a total seasonal rate of 0.313 - 0.320 lb ai/A (1X). Applications were made at 13 - to 14 - day

RTIs using ground equipment in spray volumes of 89 - 204 GPA. A NI S was added to the spray

mixture for each of the applications. Samples of pineapple were harvested from all trials at a 1 - day

PHI. Additional samples were collected at PHIs of 0, 3, 7, and 14 days from one trial to assess residue decline. Following two foliar broadcast applications of the 2 lb ai/gal SC formulation of spirotetramat at 0.313 - 0.320 lb ai/A, residues (and per- trial averages) of spirotetramat, BYI 08330 - enol, and combined residues of spirotetramat and all metabolites, respectivel y, in/on pineapple harvested at a 1 - day PHI were 0.013 - 0.065 (0.014 - 0.060), <0.01 - 0.016 (<0.01 - 0.016), and <0.053 - <0.111 (<0.054 - <0.106) ppm; residues of BYI 08330 - ketohydroxy, BY I 083 30 - monohydroxy, and BYI 08330 - glucoside were <LOQ (0.01 ppm) in/on all samples of pineapple (Table 22). The residue - decline data indicate that residues of spirotetramat and combined residues decreased with increasing PHIs. Residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydrox y, and BY I 08330 - glucoside were <LOQ at each sampling interval; therefore, residue decline could not be assessed. **Table 22. Summary of Residue Data from Pineapple Field Trials with Spirotetram**  **at.** Commodity Analyte Total Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1 n Sample Min. Sample Max. LAFT 2 HAFT 2 Median Mean Std. Dev. **Proposed use = 0.32 lb ai/A total application rate; PHI of 1 days** Pineapple, Fruit Spirotetramat 0.313 - 0.320 1 5 0.013 0.065 0.014 0.060 0.030 0.033 0.018

Enol 3 <0.01 0.016 <0.01 0.016 0.010 0.011 0.003 Ketohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Monohydroxy3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Glucoside 3 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A Combined4 <0.053 <0.111 <0.054 <0.106 0.070 0.074 0.020 1 Except for sample min/max, values reflect per- trial averages; n = no. of field trials. N/A= not applicable. 2 LAFT = lowest average field trial; HAFT = highest average field trial. 3 Data reflect conversion of quantifiable residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydroxy, and BYI 08330 - glucoside to parent equivalents by the petitioner. 4 Combined residues include spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 -monohydroxy, and BYI 08330 - glucoside, expressed as parent equivalents. 

### Conclusions : The submitted residue data for pineapple are adequate to fulfill data requirements. The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 23). The available data will support the proposed use pattern.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 25 of 43 **Table 23. Trial Numbers and Geographical Locations** . NAFTA Growing Regions Pineapple Submitted Requested 1 Canada U.S. 13 5 -- 8/6 Total 5 -- 8/6 2 1 As per OCSPP 860.1500, Table 5 for pineapple. The second number reflects a 25% reduction in the number of trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifi able residues. 2 At a meeting held on 11/3/2010, the HED ChemSAC agreed that five trials are sufficient for new residue studies in support of a pesticide tolerance on pineapple. This number is in the draft revisions for crop field trials, but the revisio ns have not yet been published. 

### The residue data for pineapple were analyzed using the OECD tolerance - calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BY I 08330 - mono - hydroxy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 0.30 ppm. Corn, Sweet DER Reference List: 48770501 .DER .DOC (prepared by PMRA) 

### Agriculture and Agri - Food has submitted field trial data for spirotetramat on sweet corn. A total of eight sweet corn field trials were conducted in Canada during the 2009 growing season encompassing NAFTA Growing Zones 5 (4 trials in ON), 5B (2 trials in QC), 7A (1 trial in AB), and 12 (1 trial in BC). At each trial site, Movento ® 

### (2 lb ai/ gal SC) was applied to sweet corn as three foliar applications at rates of 0.069 - 0.085 lb ai/A, with RTI s of 3 - 8 days, for a total application rate of 0.22 - 0.25 lb ai/A/season. A NIS (Agral 90 or AgSurf) was included in each of the spray

mixtures at a rate of 0.25%, v/v. Sweet corn kernels plus cob with husks removed (K+CWHR) and forage samples were harvested 6 - 8 DALA. Stover samples were harvested at PHI s of 33 - 85 days. At Trial ID# 116 in Delhi, Ontario additional K+CWHR and forage samples were harves ted at 1, 3, and 9 DALA and additional stover samples were harvested at PHI s of 50, 64, and 69 days to assess residue - decline behavior. Total residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydrox y, and BYI 08330 - mono - hydrox y (all expressed as parent equivalents) in/on sweet corn samples treated with Movento ® 

### , as three foliar applications at total rates of 0.22 - 0.25 lb ai/A/season and harvested at PHI s of 6 - 8 days (K+CWHR and forage) and 33 - 85 days (stover), ranged from <0.061 - <0.75 ppm in K+CWHR, <0.05 - <2.1 ppm in forage, and <0.05 - <1.23 ppm in stover (Table 24). The residue decline data indicate that total residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydroxy, and BYI 08330 - mono - hydroxy (all expressed as parent equivalents) in/on K+CWHR increased slightl y from a PHIof 1 - 7 days and then decreased b y a PHI of 9 days. Total residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydrox y, and BYI 08330 - mono - hydroxy (all expres sed as parent equivalents) in/on forage decreased with increasing PHIs, while in/on stover they remained relativel y constant at PHIs ranging from 50 - 69 days.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 26 of 43 **Table 24. Summary of Residue Data from Sweet Corn Crop Field Trials with Spirotetram**  **at.** Analyte Total Applic. Rate (lb ai/A) PHI

(days) Residue Levels (ppm)

n Min. Max. LAFT * HAFT * Median Mean Std. Dev. **Sw eet Corn K+CWHR**  Spirotetramat 0.22 - 0.25 6 - 8 8 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 BYI 08330 - enol 1 8 0.021 0.61 0.028 0.54 0.16 0.23 0.21 BYI 08330 - enol - Glc 1 8 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 BYI 08330 - ketohydroxy 1 8 <0.01 0.16 <0.01 0.14 0.058 0.068 0.049 BYI 08330 - mono - hydroxy 1 8 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Total 2 8 <0.061 <0.75 <0.068 <0.70 0.24 0.33 0.26 **Sw eet Corn Forage**  Spirotetramat 0.22 - 0.25 6 - 8 8 <0.01 1.7 <0.01 1.5 0.032 0.23 0.52 BYI 08330 - enol 1 8 0.011 0.29 0.012 0.29 0.093 0.11 0.089 BYI 08330 - enol - Glc 1 8 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 BYI 08330 - ketohydroxy 1 8 0.011 0.15 0.012 0.14 0.098 0.086 0.049 BYI 08330 - mono - hydroxy 1 8 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Total 2 8 <0.05 <2.1 <0.05 <1.9 0.30 0.44 0.60 **Sw eet Corn Stover (Corrected for % Dry Matter)**  Spirotetramat 0.22 - 0.25 33 - 85 8 <0.01 0.78 <0.01 0.71 0.022 0.12 0.24 BYI 08330 - enol 1 8 <0.01 0.12 <0.01 0.11 0.029 0.034 0.031 BYI 08330 - enol - Glc 1 8 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 BYI 08330 - ketohydroxy 1 8 <0.01 0.31 <0.01 0.29 0.099 0.11 0.088 BYI 08330 - mono - hydroxy 1 8 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Total 2 8 <0.05 <1.23 <0.05 <1.12 0.18 0.28 0.35 * LAFT = lowest - average field trial; HAFT = highest - average field trial. 1 Residues of the metabolites BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - Keto - OH, and BYI 08330 - Mono - OH were reported in the study as parent equivalents. 2 Total Residues of spirotetramat, BYI 08330 - enol, BYI 08330 - enol - Glc, BYI 08330 - ketohydroxy, and BYI 08330 - mono hydroxy, all expressed as parent equivalents. 

### Conclusions : The submitted residue data for sweet corn are adequate to establish a tolerance for residues in/on imported corn, sweet, kernel plus cob with husks removed. The residue data for cor n, sweet, kernel plus cob with husks removed were anal yz ed using the OECD tolerance calculation procedures (see Appendix II). The recommended tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - mono - hydro xy and BYI 08330 - enol - Glc , expressed as parent equivalents, is 1.5 ppm. Vegetable, fruiting, group 8 - 10 No fruiting vegetable field trial data were submitted. A tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc in/on the vegetable, fruiting, group 8 has been established at 2.5 ppm [40 CFR §180.641]. IR- 4 has proposed to convert this tolerance to a vegetable, fruiting, group 8 - 10 tolerance at the same level. As th e proposed use on vegetable, fruiting, group 8 - 10 is identical to the existing use on vegetable, fruiting, group 8 on the product labels for Movento ® 

### (EPA Reg. No. 264 - 1050), Ultor® 

### (EPA Reg. No. 264 - 1065), and BYI 8330 OD (EPA Reg. No. 264 - 1051), the exis ting vegetable, fruiting, group 8 tolerance can be translated to vegetable, fruiting, group 8 - 10. Fruit, citrus, group 10 - 10 No citrus fruit field trial data were submitted. A tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYISpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 27 of 43 

### 08330 - enol - Glc in/on the fruit, citrus, group 10 has been established at 0.60 pp m [40 CFR §180.641]. IR- 4 has proposed to convert this tolerance to a fruit, citrus, group 10 - 10 tolerance at the same level. As the proposed use on fruit, citrus, group 10 - 10 is identical to the existing use on fruit, citrus, group 10 on the product l abels for Movento ® 

### (EPA Reg. No. 264 - 1050), Ultor® 

### (EPA Reg. No. 264 - 1065), and BYI 8330 OD (EPA Reg. No. 264 - 1051), the existing fruit, citrus, group 10 tolerance can be translated to fruit, citrus, group 10 - 10. Fruit, pome, group 11 - 10 No pome fruit field trial data were submitted. A tolerance for the combined residues of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydroxy and BYI 08330 - enol - Glc in/on the fruit, pome, group 11 has been established at 0.70 ppm [4 0 CFR §180.641]. IR- 4 has proposed to convert this tolerance to a fruit, pome, group 11 - 10 tolerance at the same level. As the proposed use on fruit, pome, group 11 - 10 is identical to the existing use on fruit, pome, group 11 on the product labels for Movento ® 

### (EPA Reg. No. 264 - 1050), Ultor® 

### (EPA Reg. No. 264 - 1065), and BYI 8330 OD (EPA Reg. No. 264 - 1051), the existing pome, group 11 tolerance can be translated to pome, group 11 - 10. Taro, leaves From Minutes of the 05/12/2010 ChemSAC Meeting **"Data tr anslation proposal for taro leaves (G. Kramer for K. Dorschner, IR** **- 4):**  IR- 4 has received a request for the registration of spirotetramat (Movento ® 

### insecticide from Bayer CropScience, EPA Reg. No. 264 - 1050) on taro leaves. Spirotetramat is already registe red on taro corms but not on taro leaves. As an alternative to conducting an MOR study for this ultra minor crop, IR- 4 proposes that the registrant's leafy vegetable data be used to establish a taro leaf tolerance and registration. The spirotetramat tolerance for leafy vegetables, except Brassica , crop group 4 is 9.0 ppm (40 CFR Part 180.641). Use directions will be identical to leafy vegetables on the Movento ® 

### label. Although taro leaves (leaves of root and tuber vegetables), the IR- 4/USDA International Crop Grouping Sy mposium recommended that this crop group be redefined to include animal feed items onl y. Bernie Schneider confirmed that human food items like taro leaves will be moved to Crop Group 4 (leafy vegetables). Thus, ChemSAC recommends for approval of this proposal." Note: Subsequent to this decision, ChemSAC recommended that human food items that are currentl y members of Crop Group 2 not be moved to Crop Group 4. However, this data translation for taro leaves is still appropriate because l eaf y vegetables like leaf lettuce have a leaf - surface shape and texture that would be a worst case for residue levels in/on taro leaves, which are smooth and waxy (Personal Communication, Bernie Schneider, 11/16/2012). In addition, taro leaf consumption i s very low compared to leafy

vegetables.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 28 of 43 

### 860.1520 Processed Food and Feed Coffee DER Reference List: 48697604.der2.doc 

### In one crop field trial conducted in HI, coffee received three foliar directed applications of Movento ® 

### (2 lb ai/gal SC) at a rate of 0.1584 - 0.1604 lb ai/A/application for a total seasonal rate of 0.4778 lb ai/A (1X). Applications were made at a 21 - day RTI between applications 1 and 2 and at a 7 - day

RTI between applications 2 and 3 using ground equipment in spray volumes o f 25.39 - 25.70 GPA. A NIS/OSS was added to the spray mixture for each of the applications. Coffee cherries were harvested from the plots at a 14 - day PHI, processed into green bean coffee at the field site, and then further processed into roasted coffee be an and freeze - dried coffee using simulated commercial procedures. Processing was conducted b y University of Hawaii at Manoa (Honolulu, HI). Adequate descriptions were provided of the processing procedures, including material balance summaries. Following application of spirotetramat at 0.4778 lb ai/A, residues of spirotetramat, BYI 08330 - ketohydroxy , BY I 08330 - monohydroxy, and BYI 08330 - glucoside were each below the LOQ (<0.01, <0.05, or <0.1 ppm) in/on all samples of green bean seed (RAC), roasted coffee bean, and freeze - dried coffee; therefore, the apparent processing factors may be a result of the higher LOQs in the processed commodities. Average residues of BYI 08330 - enol and combined residues of spirotetramat and metabolites, respectively , were <0.01 1 and <0.051 ppm in/on green bean coffee, 0.018 and <0.058 ppm in roasted coffee bean, and below the LOQ (<0.1 ppm) and combined LOQs (<0.5 ppm) in freeze - dried coffee. The processing data indicate that residues of BYI 08330 - enol and combined residues of spirotetramat and metabolites may concentrate in roasted coffee bean (processing factors of <1.6X and <1.9X, respectivel y) and in freeze - dried coffee (processing factor of <10X). The processing factors calculated in this study were greater than the maximum theoretical concentration factor for coffee of 1.2X for roasted bean and of 4.4X for instant coffee (based on separation into components; OPPTS 860.1520, Table 3). **Table 25. Residue Data from Coffee Processing Study with Spirotetram at.**  RAC Processed

Commodity Total Rate

(lb ai/A) PHI

(days) Combined Residues 1 [Average] Processing Factor2 Coffee Green Bean

Coffee (RAC) 0.4778 14 <0.052, <0.05 [<0.051] -- Roasted Coffee Bean <0.098 <1.9X Freeze - Dried Coffee <0.5 <10X 1 All values are the average of replicate analyses. The LOQ was 0.01 ppm for all analytes in green bean coffee RAC and roasted coffee bean, with the exception of BYI 08330 - Glc which had an LOQ of 0.05 ppm in roasted coffee bean. The LOQ was 0.1 ppm for al l analytes in freeze - dried coffee. Per- trial averages were calculated using the LOQ for all residues reported as <LOQ. Quantifiable residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydroxy, and BYI 08330 - enol - Glc, were converted to parent equivalents. 2 Processing Factor = [Measured residue for analyte in the processed fraction] / [Measured residue for analyte in the green bean RAC]. 

### Conclusions : The submitted coffee processing data are adequate to fulfill data requirements. The total spirotetramat residues were found to concentrate in roasted bean (<1.9X). A tolerance value of 0.14 ppm (i.e., 0.072 ppm (HAFT) x 1.9 = 0.14 ppm) is calculated for roasted beans.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 29 of 43 

### However, as this value is the less than as the recommended tolerance for co ffee, green bean, a separate tolerance for coffee, roasted bean will not be required. The processing residue data for freeze - dried coffee are classified as scientifically unacceptable as the LOQ of the enforcement method was 10X higher in freeze - dried c offee than in the RAC. Thus, an actual processing factor for freeze - dried coffee could not be determined. Based on the maximum theoretical concentration factor, the maximum residue for freeze - dried coffee is 0.32 ppm (i.e., 0.072 ppm (HAFT) x 4.4 = 0.32 ppm). As this value is less than the LOQ of the anal ytical enforcement method, a more sensitive method would be required to determine the actual processing factor for freeze - dried coffee. As freeze - dried coffee is a very minor commodity , HED will not request that the coffee processing study be repeated with a more sensitive method. Instead, a LOQ - level tolerance of 0.50 ppm is re commende d for coffee, instant. Pineapple DER Reference List: 48697610.der2.doc 

### In one crop field trial conducted in HI, pineapple received two foliar broadcast applications of Movento ® 

### (2 lb ai/gal SC) at a field rate of 0.154 - 0.161 lb ai/A/application for a total seasonal rate of 0.315 lb ai/A (1X). Applications were made at a 14 - day RTI using ground equipment in spray vo lumes of 89 - 93 GPA. A NI S was added to the spray mixture for each of the applications. Pineapple was harvested from the plots at a 1 - day PHI, and processed into juice and process residue using simulated commercial procedures at the University of Hawaii at Manoa (Honolulu, HI). Adequate descriptions were provided of the processing procedures, including material balance summaries. Following two foliar broadcast applications at 0.154 - 0.161 lb ai/A/application (RTI= 14 days), residues of BYI 08330 - ketohydrox y, BY I 08330 - monohydroxy, and BY I 08330 - glucoside were each below the LOQ (<0.01 ppm) in/on all samples of pineapple (RAC), juice, and process residue; therefore, processing factors were not calculated. Average residues of spirotetramat, B YI08330 - enol, and combined residues of spirotetramat and metabolites, respectivel y, were 0.042, <0.01, and <0.082 ppm in/on pineapple, 0.019, <0.01, and <0.059 ppm in juice, and 0.050, 0.015, and <0.095 ppm in process residue. The processing data indicate that residues of spirotetramat, BYI 08330 - enol, and combined residues of spirotetramat and metabolites may concentrate in process residue (processing factors of 1.2X, >1.5X, and 1.2X, respectively), but do not concentrate in juice (processing factors of 0.46X, not calculated, and 0.72X, respectively). The processing factors calculated in this study were less than the maximum theoretical concentration factor for pineapple of 3.8X for process residue (based on separation into components; OCSPP 860.1520, Ta ble 3). **Table 26. Residue Data from Pineapple Processing Study with Spirotetram at.**  RAC Processed

Commodity Total Rate

(lb ai/A) PHI

(days) Combined Residues 1, 4 [Average] Processing Factor2, 3 Pineapple Fruit (RAC) 0.315 1 <0.078, <0.085 [<0.082] --

Juice <0.059 0.72X Process Residue <0.095 1.2X 1 All values are the average of replicate analyses. 2 Processing Factor = [Measured residue for analyte in the processed fraction] / [Measured residue for analyte in the pineappleSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 30 of 43 RAC]. 3 NC = not calculated; residues were below the LOQ in both RAC and processed fraction. 4 Quantifiable residues of BYI 08330 - enol, BYI 08330 - ketohydroxy, BYI 08330 - monohydroxy, and BYI 08330 - glucoside, respectively, were converted to parent equivalents. Res idues of the metabolites reported below the LOQ were not converted to parent equivalents. 

### Conclusions . The submitted pineapple processing data are adequate to fulfill data requirements. Total spirotetramat residues were found to concentrate in pineapple process residue (1.2X). No concentration (<1X) of the total spirotetramat residue was found juice. A tolerance value of 0.13 ppm (i.e., 0.106 ppm (HAFT) x 1.2 = 0.13 ppm) is calculated for process residue. However, as this value is the less than as the recommended tolerance for pineapple, a separate tolerance for pineapple process residue will not be required. **860.1650 Submittal of Analytical Reference Standards** Analy tical standards for spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BYI 08330 - mono - hydrox y, and BYI 08330 - enol - Glc , including their corresponding isotopically labeled internal standards, are currentl y available in the National Pesticide Standards Repository [Source: personal communication with Theresa Cole of ACL/B EAD, 02 - JAN - 2013]:

Chemical Name Expiration Date Spirotetramat 5/24/2016 Spirotetramat 13 C3 (K1767) (internal standard) 5/12/2018

Enol 4/3/2018 Enol 13 C3 (1778) (internal standard) 7/11/2013

Ketohydroxy **1/31/2013** Ketohydroxy13 C3 (K1777) (internal standard) 7/11/2013

Monohydroxy 6/3/2020 Monohydroxy13 C3 (K1768) (internal standard) 5/12/2018

Glucoside 6/20/2022 Glucoside 13 C3 (K1766) (internal standard) 4/28/2018 

### The anal ytical reference standard for BYI 08330 - ketohydroxy has expired and the standards for the isotopically

labeled internal standards of BYI 08330 - enol and BYI 08330 - ketohydroxy will soon expire (7 /11/2013). The registrant should either recertify the lot in the repository

and send an updated COA, or submit new standards (different lot #) if the previous lots will not be recertified. If new standards are being submitted, then they should be sent to the Analy tical Chemistry

L ab, which is located at Fort Meade, to the attention of either Theresa Cole or Thuy Nygen at the following address: USEPA National Pesticide Standards Repository /Anal ytical Chemistry

Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755 - 5350Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### 860.1850/860.1900 Confined/Field Accumulation in Rotational Crops Reference List: Memo, G. Kramer, 17 - APR- 2008; D339694 

### The metabolism of spirotetramat in rotational crops appears to be consistent with the pathway observed in the plant metabolism studies. The residues of concern for rotational crops are spirotetramat and BYI 08330 - ketohydroxy and free and conjugated BYI 08 330 - desmethyl ketohydroxy , BY I 08330 - desmethyl - di - hydroxy, and BYI 08330 - ketohydroxy- alcohol (Memo, J. Tyler et al. , 16 - APR- 2008 ; D333437). The available field accumulation data indicate that residues of the parent and its metabolites (BYI 08330 - ketohydro xy , BYI 08330 - desmethyl ketohydroxy , BY I 08330 - desmethyl - di - hydroxy and BYI 08330 - ketohydroxy- alcohol) were each <0.020 ppm in/on all rotational crop matrices at a 30 - day PBI. Unless the petitioner requests PBIs shorter than 30 days or use rates in excess of 0.16 lb ai/A for annual crops, no additional data are required, and tolerances for inadvertent residues in/on rotational crops need not be established in conjunction with the currentl y proposed uses. However, the proposed use rate for watercress is 0. 4 lb ai/A. Based on the results of the confined rotational crop study (conducted at an application rate of 0.36 lbs. ai/A), a 260 - day PBI is required to support the proposed use on watercress. **860.1550 Proposed Tolerances** Permanent tolerances are currentl y established for the combined residues of the insecticide spirotetramat, including its metabolites and degradates. Compliance with the tolerance levels is to be determined b y measuring onl y the sum of spirotetramat, BYI 08330 - enol, BYI 08330 - ketohydroxy , BY I 08330 - enol - Glc, and BYI 08330 - mono - hydroxy , calculated as the stoichiometric equivalent of spirotetramat, in/on bulb onions, citrus, cucurbit vegetables, fruiting vegetables, grapes, hops, leafy Brassica vegetables, leafy non -Brassica vegetables, pome fruit, tuberous and corm vegetables, stone fruit, tree nuts, cotton, legume vegetables including so ybean (crop groups 6 and 7a), and tropical fruit (40 CFR §180.641(a)(1)). Tolerances are also established for residues of the insecticide spirotetramat , including its metabolites and degradates, in or on livestock commodities. Compliance with the tolerance levels is to be determined b y measuring only

the sum of spirotetramat and its metabolite BYI 08330 - enol, calculated as the stoichiometric equivalent of spirotetramat (40 CFR §180.641(a)(2)). The Codex tolerances/maximum residue limits (MRL s) for residues of spirotetramat in/on bulb onions, fruiting vegetables, and citrus and pome fruits cannot be harmonized as the U.S./Canadian residue definition includes metabolites not included in the Codex residue definition (Appendix I). The U.S. and Canadian tolerance/MRLlevels for the subject crops are being harmonized as part of this RCC pilot project. A summary

of the recommended tolerances for the current p etition are listed in Table 27. The petitioner should submit a revised section F reflecting the recommended tolerances and commodity

definitions presented in Table 27. The OECD tolerance - calculation procedures were utilized for determining appropriate to lerance levels; see Appendix II for tolerance calculations.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 32 of 43 **Table 27. Tolerance Summary for Spirotetram at.**  Commodity Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition Taro, leaves 9 9.0 Watercress 1.5 2.0 Pomegranate 0.5 0.50 Banana 1 4 4.0 Vegetable, bulb, group 3 - 07 0.6 0.80 Lo w growing berry subgroup 13 - 07H, except straw

berry 0.3 0.30 Lo w growing berry subgroup 13 - 07H, except straw

berry and low bush blueberry Bushberry subgroup 13 - 07B 3 3.0 Artichoke, globe 2 1.5 Vegetable, fruiting, crop group 8 - 10 2.5 2.5 Vegetable, fruiting, group 8 - 10 Fruit, pome, crop group 11 - 10 0.7 0.70 Fruit, pome, group 11 - 10 Fruit, citrus, crop group 10 - 10 0.6 0.60 Fruit, citrus, group 10 - 10 Pineapple 0.3 0.30 Pineapple, process residue 0.36 - Coffee, green bean 0.2 0.20 Coffee, instant - 0.50 Coffee, roasted bean 0.32 - Corn, sweet, kernel plus cob with husks removed2 - 1.5 1 This tolerance should be established under 40 CFR §180.641(c) Tolerances with regional registrations. 2 There are no U.S. registrations as of [date] for use on corn, sweet.



### Attachments: Appendix I - International Residue Limits Appendix II - Tolerance - Assessment Calculations

cc: G. Kramer (RAB1) RDI: RAB1 Chemists (11/7/12) G.F. Kramer:S10957:PY - S:(703)305 - 5079:7509P:RAB1Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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### Appendix I - 

## International Residue Limits

**Spirotetramat** ( 392201 ; Date of Request: 10/15/2012) Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 

### Codex 3 40 CFR §180.641 (a)(1): sum of spirotetramat (cis - 3 - (2,5 - dimethlyphenyl) - 8 - methoxy - 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl ethyl carbonate) and its metabolites cis - 3 - (2,5 - dimethylphenyl) - 4 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]dec - 3 - en - 2 - one, cis - 3 - (2,5 - dimethylphenyl) - 3 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]decane - 2,4 - dione, cis - 3 - (2,5 - dimethylphenyl) - 8 - methoxy - 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl beta - D - glucopyranoside, and cis - 3 - (2,5 - dimethylphenyl) - 4 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]decan - 2 - one, calculated as the stoichiometric equivalent of spirotetramat Plants: BYI 08330: cis - 3 - (2,5 - dimethylphenyl) - 8 - methoxy - 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl ethyl carbonate, including the metabolites:enol: cis - 3 - (2,5 - dimethylphenyl) - 4 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]dec - 3 - en - 2 - one, ketohydroxy: cis - 3 - (2,5 - dimethylphenyl) - 3 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]decane - 2,4 - dione, enol Glc: cis - 3 - (2,5 - dimethylphe nyl) - 8 - methoxy - 2 - oxo - 1 - azaspiro[4.5]dec - 3 - en - 4 - yl β - D - glucopyranoside, and mo nohydroxy: cis - 3 - (2,5 - dimethylphenyl) - 4 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]decan - 2 - one calculated as parent equivalent Livestock: cis - 3 - (2,5 - dimethylphenyl) - 8 - methoxy - 2 - oxo - 1 - azaspiro[4.5]dec 3 - en - 4 - yl ethyl carbonate, including the metabolite enol: cis - 3 - (2,5 - dimethylphenyl) - 4 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]dec - 3 - en - 2 - one calculated as parent equivalent Spirotetramat and its enol metabolite, 3 - (2,5 - dimethylphenyl) - 4 - hydroxy - 8 - me thoxy - 1 - azaspiro[4.5]dec 3 - en - 2 - one, expressed as spirotetramat. Animal Commodities: Spirotetramat enol metabolite, 3 - (2,5 - dimethylphenyl) - 4 - hydroxy - 8 - methoxy - 1 - azaspiro[4.5]dec 3 - en - 2 - one, expressed as spirotetramat. The residue is not fat - soluble.

Commodity 1 Tolerance (ppm)/Maximum Residue Limit (mg/kg) US Canada Mexico 2 Codex 3 Taro, leaves 9.0 Watercress 2.0 Pomegranate 0.50 Banana 4.0 Vegetable, bulb, group 3 - 07 0.80 0.3 dry bulb onions 0.4 onion, bulb (proposed) Lo w growing berry subgroup 13 - 07H, except straw

berry and low bush blueberry 0.30 Bushberry subgroup 13 - 07B 3.0 Artichoke, globe 1.5 Vegetable, fruiting, crop group 8 - 10 2.5 2.5 bell peppers, eggplants, ground cherries, non -bell peppers, pepinos, pepper hybrids, tomatillos, tomatoes 1 Fruiting vegetables, other than cucurbits (except chili pepper) 2 peppers chili 15 peppers chili, driedSpirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 34 of 43 Fruit, pome, crop group 11 - 10 0.70 0.7 apples, crabapples, loquats, mayhaws, pears, quinces 0.7 pome fruits

Fruit, citrus, crop group 10 - 10 0.60 0.6 calamondin, citrus citron, citrus hybrids, grapefruits, kumquats, lemons, limes, oranges, pummelos, Satsuma mandarins, tangerines 6.0 citrus oil 0.5 citrus fruits

Pineapple 0.30 Coffee, green bean 0.20 Coffee, instant 0.50 Corn, sweet, kernel plus cob with husks removed 1.5 

### Completed: M. Negussie; 10/17/2012 1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant. 2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 35 of 43 

### Appendix I. Tolerance **- Assessment Calculations.** 

**Spirotetramat & Metabolites (expressed as parent equivalents)**  **Sweet Corn (K+CWHR) Canada**  **0.22 -**  **0.25 lb ai**  **/A; PHI = 6 -**  **8 days Total number of data (n)**  8 **Percentage of censored data** 0% **Number of non -**  **censored data** 8 **Lowest residue** 0.068 **Highest residue** 0.700 **Median residue** 0.245 **Mean** 0.329 **Standard deviation (SD)** 0.258 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.700

**- Mean + 4 SD**  1.361

**- CF x 3 Mean**  0.986 **Unrounded MRL** 1.361 **Rounded MRL 1.5**  **Residues (mg/kg) n**  0.068 1 0.071 1 0.13 1 0.18 1 0.31 1 0.57 1 0.6 1 0.7 1 **Spirotetramat & Metabolites (expressed as parent equivalents)**  **Globe Artichoke Canada/USA**  **0.49 -**  **0.50 lb ai**  **/A; PHI = 2 -**  **3 days Total number of data (n)**  5 **Percentage of censored data** 0% **Number of non -**  **censored data** 5 **Lowest residue** 0.230 **Highest residue** 0.700 **Median residue** 0.410 **Mean** 0.458Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 36 of 43 **Standard deviation (SD)** 0.194 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.700

**- Mean + 4 SD**  1.232

**- CF x 3 Mean**  1.374 **Unrounded MRL** 1.374 **Rounded MRL 1.5**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.23 1 0.34 1 0.41 1 0.61 1 0.7 1 **Spirotetramat & Metabolites (expressed as parent equivalents)**  **Coffee, Green bean**

**USA 0.48**  **- 0.51 lb a.i./A; PHI = 14 days**  **Total number of data (n)**  4 **Percentage of censored data** 0% **Number of non -**  **censored data** 4 **Lowest residue** 0.051 **Highest residue** 0.072 **Median residue** 0.058 **Mean** 0.060 **Standard deviation (SD)** 0.009 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate** 

**- Highest residue**  0.072

**- Mean + 4 SD**  0.096

**- CF x 3 Mean**  0.179 **Unrounded MRL** 0.179 **Rounded MRL 0.2**  High uncertainty of MRL estimate. [Small dataset]Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 37 of 43 **Residues (mg/kg) n**  0.051 1 0.055 1 0.061 1 0.072 1 **Spirotetramat & Metabolites (expressed as parent equivalents) Watercress**  **USA 0.379**  **- 0.395 lb**  **ai /A; PHI = 3 days**  **Total number of data (n)** 4 **Percentage of censored data** 0% **Number of non -**  **censored data** 4 **Lowest residue** 0.290 **Highest residue** 0.670 **Median residue** 0.575 **Mean** 0.528 **Standard deviation (SD)** 0.165 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.670

**- Mean + 4 SD**  1.188

**- CF x 3 Mean**  1.583 **Unrounded MRL** 1.583 **Rounded MRL 2**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.29 1 0.56 1 0.59 1 0.67 1 **Spirotetramat & Metabolites (expressed as parent equivalents)**  **Banana, Whole Fruit**

**USA 1.25**  **- 1.29 lb**  **ai /A; PHI = 1 day; Unbagged**  **Total number of data (n)**  4 **Percentage of censored data** 0% **Number of non -**  **censored data** 4Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 38 of 43 **Lowest residue** 0.620 **Highest residue** 1.800 **Median residue** 1.350 **Mean** 1.280 **Standard deviation (SD)** 0.504 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate** 

**- Highest residue**  1.800

**- Mean + 4 SD**  3.294

**- CF x 3 Mean**  3.840 **Unrounded MRL** 3.840 **Rounded MRL 4**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.62 1 1.2 1 1.5 1 1.8 1 **Spirotetramat & Metabolites (expressed as parent**  **equivalents) Pomegranate**  **USA 0.311**  **- 0.318 lb**  **ai /A; PHI = 1 day; Unbagged**  **Total number of data (n)** 4 **Percentage of censored data** 0% **Number of non -**  **censored data** 4 **Lowest residue** 0.076 **Highest residue** 0.174 **Median residue**  0.165 **Mean** 0.145 **Standard deviation (SD)** 0.047 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.174

**- Mean + 4 SD**  0.331

**- CF x 3 Mean**  0.434 **Unrounded MRL** 0.434 **Rounded MRL 0.5** Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 39 of 43 High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.076 1 0.156 1 0.173 1 0.174 1 **Spirotetramat & Metabolites (expressed as parent equivalents)**  **Pineapple USA**  **0.313 -**  **0.320 lb ai**  **/A; PHI = 1 day; Unbagged Total number of**  **data (n)** 5 **Percentage of censored data** 0% **Number of non -**  **censored data** 5 **Lowest residue** 0.054 **Highest residue** 0.106 **Median residue** 0.070 **Mean** 0.074 **Standard deviation (SD)** 0.021 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.106

**- Mean + 4 SD**  0.157

**- CF x 3 Mean**  0.223 **Unrounded MRL** 0.223 **Rounded MRL 0.3**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.054 1 0.06 1 0.07 1 0.082 1 0.106 1 **Spirotetramat & Metabolites (expressed as parent**  **equivalents) Cranberries**  **USA 0.462**  **- 0.489 lb**  **ai /A; PHI = 7**  **- 8 day** Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 40 of 43 **Total number of data (n)** 4 **Percentage of censored data** 0% **Number of non -**  **censored data** 4 **Lowest residue** 0.052 **Highest residue** 0.152 **Median residue**  0.082 **Mean** 0.092 **Standard deviation (SD)** 0.043 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.152

**- Mean + 4 SD**  0.263

**- CF x 3 Mean**  0.276 **Unrounded MRL** 0.276 **Rounded MRL 0.3**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.052 1 0.076 1 0.088 1 0.152 1 **Spirotetramat & Metabolites (expressed as parent equivalents)**  **Green Onion Canada/USA**  **0.16 lb a.i./A; PHI = 6 -**  **7 day Total number of**  **data (n)** 3 **Percentage of censored data** 0% **Number of non -**  **censored data** 3 **Lowest residue** 0.051 **Highest residue** 0.320 **Median residue** 0.170 **Mean** 0.180 **Standard deviation (SD)** 0.135 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.320

**- Mean + 4 SD**  0.720

**- CF x 3 Mean**  0.541Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 41 of 43 **Unrounded MRL** 0.720 **Rounded MRL 0.8**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.051 1 0.17 1 0.32 1 **Spirotetramat & Metabolites (expressed as parent**  **equivalents) Bulb Onion**  **Canada 0.15**  **- 0.17 lb**  **ai /A; PHI = 2**  **- 4 day**  **Total number of data (n)** 12 **Percentage of censored data** 0% **Number of non -**  **censored data** 12 **Lowest residue** 0.054 **Highest residue** 0.310 **Median residue** 0.085 **Mean** 0.114 **Standard deviation (SD)** 0.084 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest residue**  0.310

**- Mean + 4 SD**  0.450

**- CF x 3 Mean**  0.342 **Unrounded MRL** 0.450 **Rounded MRL 0.5**  **Residues (mg/kg) n**  0.054 3 0.059 1 0.078 1 0.084 1 0.085 1 0.09 1 0.11 1 0.13 1 0.26 1 0.31 1Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 42 of 43 **Spirotetramat & Metabolites (expressed as parent equivalents)**  **Lowbush Blueberries**

**USA 0.466**  **- 0.469 lb**  **ai /A; PHI = 7**  **- 8 day**  **Total number of data (n)** 4 **Percentage of censored data**  0% **Number of non -**  **censored data** 4 **Lowest residue** 0.378 **Highest residue** 1.209 **Median residue** 0.549 **Mean** 0.671 **Standard deviation (SD)** 0.378 **Correction factor for censoring (CF)** 1.000 **Proposed MRL estimate**

**- Highest**  **residue** 1.209

**- Mean + 4 SD**  2.183

**- CF x 3 Mean**  2.013 **Unrounded MRL** 2.183 **Rounded MRL 3**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.378 1 0.441 1 0.656 1 1.209 1 **Spirotetramat & Metabolites (expressed as parent**  **equivalents) Highbush Blueberries** 

**USA 0.466**  **- 0.497 lb**  **ai /A; PHI = 6**  **- 7 day**  **Total number of data (n)** 7 **Percentage of censored data** 0% **Number of non -**  **censored data** 7 **Lowest residue** 0.448 **Highest residue** 1.548 **Median residue** 0.602 **Mean** 0.758 **Standard deviation (SD)** 0.410 **Correction factor for censoring (CF)** 1.000Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 43 of 43 **Proposed MRL estimate**

**- Highest residue**  1.548

**- Mean + 4 SD**  2.398

**- CF x 3 Mean**  2.275 **Unrounded MRL** 2.398 **Rounded MRL 3**  High uncertainty of MRL estimate. [Small dataset] **Residues (mg/kg) n**  0.448 1 0.466 1 0.486 1 0.602 1 0.686 1 1.073 1 1.548 1