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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, 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 Project. Summary 

of Analytical Chemistry and Residue Data.

PC Code: 392201 DP Barcodes: D398856, D400037

Decision Nos.: 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

TXR 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 by 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 shoots. 

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 oildispersion (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, pome 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 (RTIs) 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 (PHIs) of 1-14 days are proposed. The rotational 

crop plantback intervals (PBIs) are 30 days for all non-labeled crops.

Concurrently, 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 specified below is to be 

determined by measuring only the sum of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy2-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, 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 currently established for the combined residues of the insecticide 

spirotetramat, including its metabolites and degradates. Compliance with the tolerance levels is 

to be determined by measuring only the sum of spirotetramat, BYI 08330-enol, BYI 08330-

ketohydroxy, BYI 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 soybean 

(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 by 

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. Residue 
Spirotetramat 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, lettuce, 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, BYI 08330-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-2008; D333437).

Samples were analyzed for residues of spirotetramat and its metabolites BYI 08330-enol, BYI 

08330-ketohydroxy, BYI 08330-mono-hydroxy, and BYI 08330-enol-glucoside using a highperformance liquid chromatography method with tandem mass spectroscopy detection (HPLCMS/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 vegetables, 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 

registration 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 of 

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 revised Sections B and F (see requirements under Directions for Use and 

Proposed Tolerances) and analytical reference standards (see requirements under Submittal of 

Analytical 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 for 
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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 by measuring only the sum of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy2-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, 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

Banana14.0 ppm Pineapple 0.30 ppm

Vegetable, bulb, group 3-07 0.80 ppm Coffee, green bean 0.15 ppm

Low growing berry subgroup 13-07H, 

except strawberry and lowbush 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 tolerances 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 type (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 Analytical Reference Standards

The analytical 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 certificate of analysis (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 

Analytical Chemistry Lab, 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/Analytical Chemistry Branch/OPP

701 Mapes Road
Spirotetramat 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 revised Section F specifying 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 by 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 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-enolGlc are presented in Table 1. The physicochemical properties 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-xylyl)-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-one
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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-enolGlc

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-Dglucopyranoside

CAS # None provided

Compound: BYI 08330-monohydroxy

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-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one

CAS # None provided

Compound: BYI 08330-enolGA

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 provided
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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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 D4

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 10-9Pa (20 oC)

1.5 x 10-8Pa (25 oC)

1.5 x 10-6Pa (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 103 

 276 0.8 x 103

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, bananas, 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)

Formulation 

Type

Target Crops Target 

Pests Label Date

Movento® 264-

1050 22.4 SC taro, watercress, pomegranates, bananas, bulb vegetables, lowgrowing berries (except 

strawberries), 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 OD
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Table 4. Summary of Directions for Use of Spirotetramat.

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®

Ground & 

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®

Ground & 

aerial 0.13-0.16 3 0.47 7

Minimum RTI: 7 days

Minimum spray volume: 30 GPA ground, 10 

GPA aerial

Coffee

BYI 8330 

OD 

Movento®

Ultor®

Ground & 

aerial 0.13-0.16 3 0.47 14

Minimum RTI: 21 days

Minimum spray volume: 30 GPA ground, 10 

GPA aerial

Pineapple

BYI 8330 

OD 

Movento®

Ultor®

Ground & 

aerial 0.16 2 0.32 1

Minimum RTI: 14 days

Minimum spray volume: 30 GPA ground, 10 

GPA aerial

Pomegranate

BYI 8330 

OD 

Movento®

Ultor®

Ground & 

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®

Ground, 

chemigation,

& aerial

0.08 2 0.16 3 (3-07A)

7 (3-07B)

Minimum RTI: 7 days

Minimum spray volume: 15 GPA ground, 5 

GPA aerial

Globe artichoke

BYI 8330 

OD 

Movento®

Ultor®

Ground, 

chemigation, 

& aerial

0.05-0.13 6 0.5 3

Minimum RTI: 7 days

Minimum spray volume: 15 GPA ground, 5 

GPA aerial

Watercress

BYI 8330 

OD 

Movento®

Ultor®

Ground, 

chemigation, 

& aerial

0.06-0.2 6 0.4 3

Minimum RTI: 7 days

Minimum spray volume: 15 GPA ground, 5 

GPA 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-mixed 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 type (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.
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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 adequately understood based on acceptable metabolism 

studies conducted on apple, lettuce, cotton, and potato. The major metabolic reaction involved 

the hydrolytic 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. Hydroxylation 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-ketohydroxy (after the corresponding hydroxylation). 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-ketohydroxy, 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 carbonate ester group to the 

primary metabolite BYI 08330-enol followed by conjugation of the enol hydroxy group with 

glucuronic acid to BYI 08330-enol-GA. Oxidation of the azaspirodecenyl moiety to BYI 08330-

ketohydroxy and demethylation of the methoxy group to BYI 08330-desmethyl-enol were minor 

metabolic reactions in ruminants as well as reduction of the azaspirodecenyl moiety to BYI 

08330-monohydroxy. Based on the currently 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; D333437). 

860.1340 Residue Analytical Methods

Reference List: Memo, G. Kramer, 17-APR-2008; D339694

Samples were analyzed for residues of spirotetramat and its metabolites BYI 08330-enol, BYI 

08330-ketohydroxy, BYI 08330-mono-hydroxy, and BYI 08330-enol-glucoside using a HPLCMS/MS method, Method 00857, the current enforcement method for crop commodities. 

Residues of each metabolite were reported in parent equivalents. Analytical 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-mono-hydroxy, and BYI 08330-enol-Glc were extracted 

from the plant commodity using a blender with acidic acetonitrile/water (4/1, v/v). After 
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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 analyte 

for quantitation and confirmation purposes. The limit of quantitation (LOQ) was 0.01 ppm for 

each analyte 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 analyte). 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-monohydroxy, BYI 08330-enol-Glc, and BYI 08330-enol-GA were screened through multiresidue 

methods described in the U.S. Food and Drug Administration (FDA) Pesticide Analytical 

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 only 

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 analyses were performed for Protocols D, E, or F. Since the 

test substances are not acidic, phenols or substituted ureas, analyses were not performed using 

Protocols B or G.

Conclusions: The MRMs are not suitable for the analysis of spirotetramat or its metabolites. 

860.1380 Storage Stability

Reference List: Memo, G. Kramer, 17-APR-2008; D339694

Freezer storage stability data are available for five diverse crops (i.e., a fruiting vegetabletomato; a root crop-potato, a leafy vegetable-head lettuce; a nut-almond nutmeat; and a legumebean with pod) which demonstrate stability of residues of spirotetramat, BYI 08330-enol, BYI 

08330-enol-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 reasonably 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 associated 
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 11 of 43

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 Field 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 by 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 MI trials AAFC09-030R-136 and AAFC09-030R-137 constitute a 

single trial with replicate samples for purposes of 860.1500 data requirements. Other than 

having independently 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 requirements 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. RTIs 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 plot. 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 PHI were 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 PHIs.
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 Spirotetramat.

Commodity

Total Applic. 

Rate (lb ai/A)

PHI 

(days)

Combined Residue Levels (ppm)1

n

Sample

Min.

Sample

Max. LAFT2 HAFT2 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

0.40041.560 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.

Conclusions: 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 performed 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 

Growing 

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 season. 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 WI trials 
Spirotetramat 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 only three of the four variables of the HED 

ChemSAC criteria for differentiation of field trials were met: (1) having independently prepared 

tank-mixes, (2) using different varieties, and (3) using spray volumes that were sufficiently 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 Zone 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. RTIs were 6-8 

days. A NIS was added to the spray mixture for all applications. Each field trial site consisted 

on one untreated plot and one treated plot. Cranberries were harvested at PHIs 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 foliar 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 PHI were <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 Spirotetramat.

Commodity

Total Applic. 

Rate (lb ai/A)

PHI 

(days)

Combined Residue Levels (ppm)1

n

Sample

Min.

Sample

Max. LAFT2 HAFT2 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 use pattern.

Table 8. Trial Numbers and Geographical Locations.

NAFTA 

Growing 

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 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 0.30 ppm in/on the low-growing berry subgroup 13-07H, 

except strawberry and lowbush blueberry. The exclusion of lowbush blueberry is necessitated by 

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” is 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 

the same county and under similar soil (sand) and similar growing conditions (re-circulating the 

water using pumps and man-made drainage systems 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 by 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 purposes 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 RTIs 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 minisprinklers 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 PHI were <0.29-<0.70 

(<0.29-<0.67) ppm; corresponding residues (and per-trial averages) following 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 treatment types. 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

Table 9. Summary of Residue Data from Watercress Field Trials with Spirotetramat (Combined Broadcast 

and Chemigation Trials).

Commodity Analyte

Total

Rate

(lb ai/A)

PHI 

(days)

Residue Levels (ppm)1

n

Sample 

Min.

Sample 

Max. LAFT2 HAFT2 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

Enol30.16 0.40 0.17 0.37 0.28 0.28 0.083

Enol-glucoside3<0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

Ketohydroxy30.090 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

Requested1

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 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 2.0 ppm. 

Coffee

DER Reference List: 48697604.der1.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-HI09 & 09-HI11, 09-HI10, and 09-HI12 & 09-HI13 were 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-HI09 & 09-HI11 and 09-HI12 & 09-

HI13 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 consisted of one untreated plot and one treated plot. At each trial location, the treated 
Spirotetramat 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-HI11 and 09-HI12 because the beans were ripening earlier than expected. A 

NIS/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

PHI in trial 09-HI11. Additional samples were collected at PHIs of 1, 7, and 21 days from one 

trial (09-HI13) 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, respectively, in/on green bean 

coffee harvested at a 14-day PHI 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 PHIs. Residues of spirotetramat, BYI 08330-ketohydroxy, BYI 

08330-monohydroxy, and BYI 08330-glucoside were near to or <LOQ at each sampling interval; 

therefore, residue decline could not be assessed.

Table 11. Summary of Residue Data from Coffee Field Trials with Spirotetramat.

Commodity Analyte

Total Rate

(lb ai/A)

PHI 

(days)

Residue Levels (ppm)1

n

Sample 

Min.

Sample 

Max. LAFT2 HAFT2 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

Enol3<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

Glucoside3<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.

Conclusions: 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

Requested1

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 conducted by the same PFI, but trials 08-HI05 & 

08-HI10 and 08-HI06 & 08-HI09 & 09-HI14 were conducted on different Hawaiian Islands and 

trial pair 08-HI05 & 08-HI10 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-HI06 & 08-HI09 & 09-HI14 were separated by >20 miles, had a >30 day-off set in 

application dates, and used a different variety of banana (trial 08-HI06 only). Trials 08-HI09 & 

09-HI14 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 total 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 samples were collected at PHIs 

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, 

respectively, 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 only 

detected at the HI10 trial site (0.014-0.015 ppm). Combined residues of spirotetramat and its 

metabolites in/on peeled 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, and 
Spirotetramat 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-monohydroxy 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 Spirotetramat.

Commodity Analyte

Total Rate

(lb ai/A)

PHI 

(days)

Residue Levels (ppm)1

n

Sample 

Min.

Sample 

Max. LAFT2 HAFT2 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

Enol30.21 0.61 0.26 0.60 0.38 0.40 0.17

Ketohydroxy30.034 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

Glucoside3<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

Enol30.12 0.12 0.12 0.12 0.12 0.12 N/A

Ketohydroxy30.033 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

Glucoside3<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

Requested1

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

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 directed applications 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 NIS was 

added to the spray mixture for each of the applications at the Reedley, CA trial sites and a cropoil 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 

PHIs 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

PHI were 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 BYI 08330-

monohydroxy 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-

monohydroxy, and BYI 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. LAFT2 HAFT2 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

Enol30.015 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

Glucoside3<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

Requested1

Canada U.S.

10 4 -- --

Total 4 -- 3 or 22

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 OCSPP 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 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. 

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 RTIs of 5-9 days, 

for a total application rate of 0.49-0.50 lb ai/A/season (1X). A NIS 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 DALA. 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-ketohydroxy, 

and BYI 08330-mono-hydroxy (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 Spirotetramat.

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-enol15 0.11 0.23 0.11 0.21 0.16 0.17 0.042

BYI 08330-enol-Glc15 0.02 0.051 0.026 0.036 0.033 0.031 0.004

BYI 08330-ketohydroxy15 0.066 0.19 0.07 0.17 0.095 0.10 0.037

BYI 08330-mono-hydroxy15 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

Total25 <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-monohydroxy, 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

Requested1

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 globe 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, expressed 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 RTIs 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-enol, BYI 08330-enol-Glc, BYI 08330-ketohydroxy, 

and BYI 08330-mono-hydroxy (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 

PHIs of 6-7 days ranged from <0.15-<0.34 ppm (Table 19). The residue decline data indicate 
Spirotetramat 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 Spirotetramat.

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-enol13 <0.01 0.16 <0.01 0.14 0.054 0.068 0.066

BYI 08330-enol-Glc13 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

BYI 08330-ketohydroxy13 <0.01 0.075 <0.01 0.065 0.050 0.042 0.028

BYI 08330-mono-hydroxy13 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

Total23 <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 equivalents.

2 Total Residues of spirotetramat, BYI 08330-enol, BYI 08330-enol-Glc, BYI 08330-ketohydroxy, and BYI 08330-monohydroxy, 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 RTIs 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 PHIs 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-ketohydroxy, 

and BYI 08330-mono-hydroxy (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 PHIs of 2-4 days ranged from <0.054-<0.34 ppm (Table 20). 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 dry bulb onion remained fairly 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 Trials with Spirotetramat.

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-enol112 <0.012 0.297 <0.012 0.266 0.042 0.071 0.083

BYI 08330-enol-Glc112 <0.008 <0.008 <0.008 <0.008 <0.008 <0.008 0.00

BYI 08330-ketohydroxy112 <0.012 0.016 <0.012 0.015 0.012 0.012 0.001

BYI 08330-mono-hydroxy112 <0.012 <0.012 <0.012 <0.012 <0.012 <0.012 0.00

Total212 <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-monohydroxy, 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 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 0.80 ppm in/on the vegetable, bulb, group 3-

07. 

Pineapple

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 by the same PFI, but trials HI01, HI02, & HI05 and 

HI03 & HI04 were conducted on different Hawaiian Islands; thus, HED concludes that these 

trials may be counted as separate trials for purposes of 860.1500 data requirements. Careful 
Spirotetramat 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 

HI01, 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 for 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 NIS 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, respectively, 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, BYI 08330-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-

monohydroxy, and BYI 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 Spirotetramat.

Commodity Analyte

Total Rate

(lb ai/A)

PHI 

(days)

Residue Levels (ppm)1

n

Sample 

Min.

Sample 

Max. LAFT2 HAFT2 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

Enol3<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

Glucoside3<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

Requested1

Canada U.S.

13 5 -- 8/6

Total 5 -- 8/62

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 

quantifiable 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 revisions 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, BYI 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 RTIs 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 

PHIs of 33-85 days. At Trial ID# 116 in Delhi, Ontario additional K+CWHR and forage 

samples were harvested at 1, 3, and 9 DALA and additional stover samples were harvested at 

PHIs of 50, 64, and 69 days to assess residue-decline behavior. 

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 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 PHIs 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 slightly from a PHI of 1-7 days and 

then decreased by a PHI of 9 days. 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 forage decreased with increasing PHIs, while in/on stover they remained 

relatively 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 Spirotetramat.

Analyte

Total 

Applic. Rate

(lb ai/A)

PHI 

(days)

Residue Levels (ppm)

n Min. Max. LAFT* HAFT* Median Mean

Std. 

Dev.

Sweet 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-enol18 0.021 0.61 0.028 0.54 0.16 0.23 0.21

BYI 08330-enol-Glc18 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

BYI 08330-ketohydroxy18 <0.01 0.16 <0.01 0.14 0.058 0.068 0.049

BYI 08330-mono-hydroxy18 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

Total28 <0.061 <0.75 <0.068 <0.70 0.24 0.33 0.26

Sweet 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-enol18 0.011 0.29 0.012 0.29 0.093 0.11 0.089

BYI 08330-enol-Glc18 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

BYI 08330-ketohydroxy18 0.011 0.15 0.012 0.14 0.098 0.086 0.049

BYI 08330-mono-hydroxy18 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

Total28 <0.05 <2.1 <0.05 <1.9 0.30 0.44 0.60

Sweet 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-enol18 <0.01 0.12 <0.01 0.11 0.029 0.034 0.031

BYI 08330-enol-Glc18 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

BYI 08330-ketohydroxy18 <0.01 0.31 <0.01 0.29 0.099 0.11 0.088

BYI 08330-mono-hydroxy18 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.00

Total28 <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-monohydroxy, 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 

corn, sweet, kernel plus cob with husks removed were analyzed using the OECD tolerancecalculation 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 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 the 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 existing 

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 BYI 
Spirotetramat 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 ppm [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 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 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 [40 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 translation 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 registered on 

taro corms but not on taro leaves. As an alternative to conducting an MOR study for this ultraminor 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 Symposium recommended that this crop group be 

redefined to include animal feed items only. 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 

currently members of Crop Group 2 not be moved to Crop Group 4. However, this data 

translation for taro leaves is still appropriate because leafy 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 is very low compared to leafy vegetables.
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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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 of 

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 bean and freeze-dried coffee using 

simulated commercial procedures. Processing was conducted by 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, BYI 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 <0.011 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, respectively) 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 Spirotetramat.

RAC

Processed 

Commodity

Total Rate

(lb ai/A)

PHI

(days) Combined Residues1 [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 all 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 coffee, 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 coffee 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 

analytical 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 recommended 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 volumes of 89-93 GPA. A NIS 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-ketohydroxy, BYI 08330-monohydroxy, and BYI 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, 

BYI 08330-enol, and combined residues of spirotetramat and metabolites, respectively, 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, Table 3).

Table 26. Residue Data from Pineapple Processing Study with Spirotetramat.

RAC

Processed 

Commodity

Total Rate

(lb ai/A)

PHI

(days) Combined Residues1, 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 pineapple
Spirotetramat 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. Residues 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

Analytical standards for spirotetramat, BYI 08330-enol, BYI 08330-ketohydroxy, BYI 08330-

mono-hydroxy, and BYI 08330-enol-Glc, including their corresponding isotopically labeled 

internal standards, are currently available in the National Pesticide Standards Repository

[Source: personal communication with Theresa Cole of ACL/BEAD, 02-JAN-2013]:

Chemical Name Expiration Date

Spirotetramat 5/24/2016

Spirotetramat13C3 (K1767) (internal standard) 5/12/2018

Enol 4/3/2018

Enol13C3 (1778) (internal standard) 7/11/2013

Ketohydroxy 1/31/2013

Ketohydroxy13C3 (K1777) (internal standard) 7/11/2013

Monohydroxy 6/3/2020

Monohydroxy13C3 (K1768) (internal standard) 5/12/2018

Glucoside 6/20/2022

Glucoside13C3 (K1766) (internal standard) 4/28/2018

The analytical 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 Analytical 

Chemistry Lab, 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/Analytical Chemistry Branch/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 31 of 43

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 08330-desmethylketohydroxy, BYI 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-ketohydroxy, BYI 08330-desmethylketohydroxy, BYI 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 currently 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 currently established for the combined residues of the insecticide 

spirotetramat, including its metabolites and degradates. Compliance with the tolerance levels is 

to be determined by measuring only the sum of spirotetramat, BYI 08330-enol, BYI 08330-

ketohydroxy, BYI 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 soybean 

(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 by 

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 (MRLs) 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/MRL levels for the subject crops are 

being harmonized as part of this RCC pilot project.

A summary of the recommended tolerances for the current petition 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 tolerance 

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 Spirotetramat.

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

Banana14 4.0

Vegetable, bulb, group 3-07 0.6 0.80

Low growing berry subgroup 

13-07H, except strawberry 0.3 0.30

Low growing berry subgroup 13-

07H, except strawberry and 

lowbush 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:RAB1
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

Page 33 of 43

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 Mexico2 Codex3

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-ylethyl 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, enolGlc:

cis-3-(2,5-dimethylphenyl)-8-

methoxy-2-oxo-1-azaspiro[4.5]dec-3-

en-4-yl β-D-glucopyranoside, and 

monohydroxy:

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]dec3-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-

methoxy-1-

azaspiro[4.5]dec3-en-2-one, 

expressed as 

spirotetramat.

Animal 

Commodities: 

Spirotetramat enol 

metabolite, 3-(2,5-

dimethylphenyl)-

4-hydroxy-8-

methoxy-1-

azaspiro[4.5]dec3-en-2-one, 

expressed as 

spirotetramat.

The residue is not 

fat-soluble.

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

US Canada Mexico2 Codex3

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)

Low growing berry subgroup 

13-07H, except strawberry and 

lowbush 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, 

dried
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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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

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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 0.458
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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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

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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 4
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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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
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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

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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 0.541
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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 1
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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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) 1.000
Spirotetramat Summary of Analytical Chemistry and Residue Data DP# 398856

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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