Spirotetramat 1531 SPIROTETRAMAT (234)

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1 Spirotetramat 5 SPIROTETRAMAT (24) The first draft was prepared by Professor Arpad Ambrus, Hungarian Food Chain Safety Office, Budapest Hungary EXPLANATION The compound was evaluated by the JMPR for the first time in 28. The Meeting established an ADI of.5 mg/kg bw per day and an ARfD of mg/kg/bw and defined the residues as follow: Residue for enforcement plant commodities: spirotetramat plus spirotetramat enol, expressed as spirotetramat. Residue for dietary intake plant commodities: spirotetramat plus the metabolites enol, ketohydroxy, enol glucoside, and monohydroxy, expressed as spirotetramat. Residue for enforcement and dietary intake animal commodities: spirotetramat enol, expressed as spirotetramat. The residue is not fat soluble. The Meeting estimated residue levels for a number of commodities. Additional residue data were evaluated by the 2 Meeting. Subsequently, the recommendations, including several animal feed commodities, were adopted as Codex MRLs except those for strawberry, avocado and guava. The manufacturer provided new supervised trial data in avocado, guava and sweet corn and corresponding labels for the evaluation by the 25 JMPR. METHODS OF RESIDUE ANALYSIS Several analytical methods were developed for the residue analysis of spirotetramat in different matrices. The analytical method 85 used to measure residues of spirotetramat () and its metabolites, -enol, -ketohydroxy, -mono-hydroxy and -enol-glc was evaluated by the JMPR in 28. This method was applied with minor modifications for determination of residues in guava, avocado and sweet corn on cob husk removed, sweet corn forage and fodder. The residues were extracted with an acidic acetonitrile/water mixture (4/,v/v) filtered and quantitated by high performance liquid chromatography/triple stage quadrupole mass spectrometry (LC/MS/MS) using stable isotopically labelled internal standards. The individual analyte derived residues were converted to spirotetramat equivalents and summed up to yield the total residue of BYI8 calc.. Additionally the sum of spirotetramat and cis-enol was calculated. The limit of quantitation (LOQ) for each analyte was. mg/kg (expressed as parent equivalents), the LOQ for the total residue was.5 mg/kg and was.2 mg/kg for the sum of spirotetramat and BYI8 enol. The recoveries obtained during the validation of the method and analysis of supervised trial samples are summarized in Tables -6. Table Recoveries for, -enol, -ketohydroxy, -mono-hydroxy and -enol-glc in/on guava fruit RAFNP42 FN5-BA-B FN5-BA-A FN5-BA-A2 FN6-HA-A FN6-HA-A2 2/28, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD. ; 2; ; ; overall 9 2. cis-enol. 2; 4; ; 8; overall cis-ketohydroxy. 4; 9; ; 5;

2 52 Spirotetramat RAFNL58 FN2-DB-A FN2-DB-B FN2-DB-C FN2-DB-D FN-DA-A FN-DA-B FN-DA-C FN-DA-D 2 : spirotetramat, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD 6 overall monohydroxy. 94; 2; ; ; overall enolglucoside. 8; 4; ; 88; overall ; 99; 9; 9; ; ; ; 9; 8; ; 9; 8; 99; overall 2 9. cis-enol. ; 9; 92; 2; ; ; 96; 9; ; ; 9; ; ; overall cis-ketohydroxy. ; ; 95; ; 98; ; 98; ; 9; ; 8; 9; 8; overall monohydroxy. 5; 99; 2; ; ; 4.6 ; 8; 6; 4; ; 89; ; 6; overall enolglucoside. 5; 9; 86; 96; 94; 99; ; 96; 2; ; 86; 85; 84; overall Table 2 Recoveries for, -enol, -ketohydroxy, -mono-hydroxy and -enol-glc in/on avocado fruit Spirotetramat, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD RAFNP42. ;;9;9;9;9;98;;4;9 9. FN-BA-A FN-BA-A ;88 9;9; FN-BA-B 5 overall FN-DA-A cis-enol. 9;8;9;88;6;86; 8;86;86; FN-DA-A2 2. 9; FN2-HA-A.5 ;88; FN2-HA-A2 5 overall FN-BB-A FN-BB-A2 cis-ketohydroxy 2. ; ;8;86;94;88;82; 9;95;84; FN-BB-B FN4-HA-A.5 5;; FN4-HA-A2 5 overall : spirotetramat monohydroxy enolglucoside. ;9;9;96;5;2;69;96;96; ; ;; overall ;94;9;5;92;9; ;;88; ; ;8; overall 9.6

3 Spirotetramat 5 Table Recoveries for, -enol, -ketohydroxy, -mono-hydroxy and -enol-glc in/on sweet corn ear without husk AAFC9-2R AAFC9-2R-6 AAFC9-2R- AAFC9-2R-8 AAFC9-2R-9 AAFC9-2R-2 AAFC9-2R-2 AAFC9-2R-22 AAFC9-2R-2 29 AAFC9-2R AAFC9-2R-6 AAFC9-2R- AAFC9-2R-8 AAFC9-2R-9 AAFC9-2R-2 AAFC9-2R-2 AAFC9-2R-22 AAFC9-2R-2 GLP: yes 29 BCS-22 B-T2 GLP: yes 28 Spirotetramat, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD ; 8.5; 9.2; overall cis-enol 4. 2.; 99.5;.5; overall cis-ketohydroxy monohydroxy enolglucoside ; 9.4; 9.8; overall ; 8.; 94.8; overall ; 95.5; 98.5; overall ; 84.9; 8.; ; overall cis-enol 4. 9.; 9.; 95.5; ; overall cis-ketohydroxy monohydroxy enolglucoside ; 9.; 9.; ; overall ;.;.4; ; overall ; 99.;.5; ; overall ;85; ;95; overall cis-enol.24 94;9; ;96; overall cis-ketohydroxy monohydroxy enolglucoside.24 2;6; ;9; overall ;92; ;9; overall ;89; ;94;

4 54 Spirotetramat Spirotetramat, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD 6 overall Table 4 Recoveries for, -enol, -ketohydroxy, -mono-hydroxy and -enol-glc in/on sweet corn fodder. Spirotetramat, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD BCS ;92; B-T2. 86;9; GLP: yes 6 overall cis-enol.24 99;; ;8; overall BCS-9 C45-T2 C458-T2 C459-T2 29 BCS-22 AUS-BCS-22- C4-A AUS-BCS-22- C42-A AUS-BCS-22- C4-A 2 cis-ketohydroxy monohydroxy enolglucoside.24 86;; ;; overall ;9; ;8; overall ;6; ;88; overall ;; ;8; overall 8 9. cis-enol.24 ;5; ;8; overall cis-ketohydroxy monohydroxy enolglucoside.24 4;4; ;88; overall ;84; ;82; overall ;2; ;8; overall ;85; ;96; overall cis-enol.24 9;8; ;95; overall cis-ketohydroxy monohydroxy enolglucoside ; ;86; overall ; ;99; overall ;9; ;; overall

5 Spirotetramat 55 Spirotetramat, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD BCS-22 AUS-BCS ;8;4 85;88; C4-A 6 overall AUS-BCS-22- cis-enol.24 99;8; C42-A AUS-BCS ;98; C4-A 6 overall : Spirotetramat cis-ketohydroxy monohydroxy enolglucoside.24 92;6; ;8; overall ;8; ;; overall ;99; ;; overall Table 5 Recoveries for, -enol, -ketohydroxy, -mono-hydroxy and -enol-glc in/on sweet corn forage AAFC9-2R AAFC9-2R- 6 AAFC9-2R- AAFC9-2R- 8 AAFC9-2R- 9 AAFC9-2R- 2 AAFC9-2R- 2 AAFC9-2R- 22 AAFC9-2R Spirotetramat, metabolite n Spike level Recovery (%) Individual recoveries Min Max Mean RSD 4. 9.;9.6;8.; overall cis-enol ; 94.; 94.; overall cis-ketohydroxy monohydroxy enolglucoside 4. 9.; 9.; 9.2; overall ; 98.9; 8.; overall ; 95.5; 95.; overall Table 6 Recoveries for, -enol, -ketohydroxy, -mono-hydroxy and -enol-glc in/on sweet corn stover AAFC9-2R AAFC9-2R- 6 AAFC9-2R- Spirotetramat, metabolite n Spike level mg/kg Recovery (%) Individual recoveries Min Max Mean RSD Spirotetramat, ; 84.9; 8.; ; overall cis-enol 4. 9.; 9.; 95.5;

6 56 Spirotetramat AAFC9-2R- 8 AAFC9-2R- 9 AAFC9-2R- 2 AAFC9-2R- 2 AAFC9-2R- 22 AAFC9-2R Spirotetramat, metabolite cis-ketohydroxy monohydroxy enolglucoside n Spike level mg/kg Recovery (%) Individual recoveries Min Max Mean RSD ; overall ; 9.; 9.; ; overall ;.;.4; ; overall ; 99.;.5; ; overall Stability of residues in stored analytical samples Individual data on storage stability of spirotetramat and its metabolites were evaluated by the JMPR in 28. No new information was provided. The 28 Meeting concluded that spirotetramat, when determined as the sum of spirotetramat and its enol, was stable ( 8% remaining) for 2 years in tomato, potato, lettuce, almond nutmeat, climbing French beans and tomato paste on various commodities stored frozen for intervals typical of storage prior to analysis. Considered alone, however, spirotetramat may show significant loss (to spirotetramat enol). Likewise, the metabolites spirotetramat enol, spirotetramat ketohydroxy, spirotetramat monohydroxy, spirotetramat enol Glc (glucoside) are stable. No new information was provided. USE PATTERN The use patterns relevant for the residue data submitted for evaluation by the present meeting are summarized in Table. Spirotetramat 5 OD is an oil dispersible (OD) formulation containing 5 g ai/l; Spirotetramat 24 SC is a suspension concentrate (SC) formulation containing 24 g ai/l. Table Foliar spray application for spirotetramat on avocado, guava and sweet corn Crop and/ country Pests or Group of pests controlled Formu lation Type Application No. Interval min (min) max kg ai/hl min/ max Water L/ha min/ max kg ai/ha min/ max PHI Remarks: USA Mexico Chile Guava USA Aphids thrips Mealybugs Scales Whiteflies Aphids. thrips Mealybugs Scales Whiteflies 24S C 5 OD S C 5 OD/ 24 SC 4 max n.a not given. 4 max Max. dose per season is.44 kg/ha not given max. dose per season is.44 kg/ha

7 Spirotetramat 5 Crop and/ country Pests or Group of pests controlled Formu lation Type Application No. Interval min (min) max kg ai/hl min/ max Water L/ha min/ max kg ai/ha min/ max PHI Remarks: Sweet corn Australia Corn aphid 24S C -2 min. Min a Sweet corn Canada Aphids 24 SC /5 c / b a : Do not graze or cut for stock food for days after application b : Max. annual rate.264 kg/ha c : PHI is 5 days if the crop is being harvested for silage RESIDUES RESULTING FROM SUPERVISED TRIALS ON CROPS The residue trials were conducted with the two formulations OD 5 (5 g ai/l) and SC 24 (24 g ai/l). Trials were generally well documented with laboratory and field reports. Laboratory reports included method validation with procedural recoveries from spiking at residue levels similar to those occurring in samples from the supervised trials. Dates of analyses or duration of residue sample storage were also provided. Although trials included control plots, no control data are recorded in the tables except where residues in control samples exceeded the LOQ. Unless stated otherwise, residue data are recorded unadjusted for recovery. Residues have generally been rounded to two significant figures or, for residues near the LOQ, to one significant figure. Residue values from the trials conducted according to GAP have been used for the estimation of maximum residue levels. Those results used for estimation of maximum residue levels and dietary intake calculations are underlined and double underlined, respectively. Assorted tropical and sub-tropical fruits edible peel Guava Four supervised field residue trials were conducted with spirotetramat on guava in Mexico in the growing seasons 2/28 (2) (Hoag, P.E. and Harbin, A.M. 29) and 2 (2) (Hoag, R.E., Fain, J. 2). Each trial included several plots, where the application parameters varied (spray volume, SC or OD formulation, application rate). In total plots were treated. Three dilute or concentrated airblast applications of spirotetramat 5 OD were made to guava trees at a target rate of.5 kg ai/ha or.288 kg ai /ha/application. The actual application rates ranged from.4-.5 and.24 to.9 g ai/ha/application. Side-by-side bridging trials conducted in 28 and 2 received three concentrated airblast applications of spirotetramat 24 SC or spirotetramat OD 5 at the same rate to confirm that the formulation type (OD or SC) does not have any effect on residue behaviour. Adjuvant Dyne Amic or Induce was included in all spray mixtures at a rate of.25% or.5%, respectively. Samples of guava fruit were taken and days after last treatment in trials conducted during 28 growing season. From the 2 trials samples of guava fruit were taken on day,,, and 2 (4) days after the last treatment. The two parallel samples of guava fruit were analysed using method 85 with minor modifications. The maximum storage period of deep-frozen samples before analysis was 44 days (5.8 months), which is covered by the storage stability studies. Residues of spirotetramat (), cis-enol, cis-keto-hydroxy, BYI8 monohydroxy, enolglucoside were determined separately and each expressed as the parent compound. The sum of and cis-enol, as well as the sum of residues of and 4 metabolites were calculated and expressed as.

8 58 Spirotetramat The full dataset on guava (including the two trials already described in 2) is presented in Table 8. Assorted tropical and sub-tropical fruits inedible peel A total of 5 residue trials are available which were conducted with spirotetramat in avocado in the USA (2) (Hoag, P.E. and Harbin, A.M. 29.), Chile (2) and Mexico () following three broadcast foliar spray applications (either diluted or concentrated spray) of spirotetramat. The nominal application rate per treatment was.288 kg ai/ha. Actual application rates for all plots ranged from.24 to.9 g ai/ha. Side-by-side bridging plots were included that received three concentrated airblast applications of spirotetramat 24 SC at the rate of.288 to.22 kg ai/ha/application. The concentrated spray applications were made at spray volumes ranging from 64 to 686 L/ha and the dilute spray applications were made at spray volumes ranging from 94 to 289 L/ha. The intervals between applications ranged from 2 to 4 days. For all trials, the first application was made between BBCH 4 and 85. Adjuvant Dyne Amic or Induce was included in all spray mixtures at a rate of.25% or.5% respectively. Samples of avocado fruit were taken and days after the last treatment. In one decline trial additional samples were taken on day, 5 and days after the last application. The samples were analysed for the parent compound spirotetramat () and its metabolites cis-enol, cisketo-hydroxy, cis-enol-glucoside and 8 cis-mono-hydroxy using method 85 with the LOQ of. mg/kg for each analyte. The maximum storage period of deep-frozen samples before analysis was 2 days which is covered by the storage stability studies reported by the previous Meeting. Residue results are presented in Table 9. Fruiting vegetables other than cucurbits Sweet corn Eight trials on sweet corn were conducted in Canada during the 29 growing season at about the maximum dose specified on the Canadian label (.88 kg ai/ha at days PHI and maximum seasonal rate of.264 kg ai/ha) (Lonsbary, S. 2). Actual application rates ranged from 8 to 95 g as/ha/application, with re-treatment intervals of three to eight days and a PHI of ± days. Seven trials on sweet corn were conducted in Australia during the growing season 28 (), 29 () and 2 () according to Australian label (2 up to.2 kg ai/ha at days interval and day PHI) (Radunz, L. 29. Radunz, L. 2.). The actual application rates ranged from.5 to.8 kg ai/ha/application. The spray intervals between applications ranged from 6 to 9 days. A Hasten adjuvant was included in all spray mixtures at a rate of.5. L/ha. Ear without husk and fodder samples were collected 6 to 9 days after the final application. Stover samples were collected to 85 days after the last application, according to the normal harvest of stover. Residues of spirotetramat and its four metabolites -enol, -ketohydroxy, -monohydroxy and -enol-glucoside (Glc) were analysed using method 85, including minor modifications. For all analytes the limit of quantitation (LOQ) was determined to be. mg/kg. The maximum storage period of deep-frozen samples before analysis was 552 days for Canadian trials and 25 days for Australian trials. These storage periods are covered by the previously reported storage stability studies. The results are summarized in Tables and.

9 Spirotetramat 59 Animal feed Sweet corn forage, fodder and stover The trial conditions are described under sweet corn. The results are summarized in Tables 2-4. Table 8 Results of residue trials conducted with SC 24 and OD 5 formulations on guava in Mexico Plot No. Crop Variety Appl. DAT Rate b (kg ai/ha) US GAP: max. x.9 at 4 days, PHI of day RAFNP42 FN5-BA- Guava 24SC FN5- BA B 28 Media China c.24- Mexico Municipio Juarez RAFNP42 FN6- HA Mexico Calvillo RAFNL58 FN2- DB Mexico Zitacuaro FN5-BA- A 28 FN5-BA- A2 28 FN6-HA- A 2 FN6-HA- A2 2 FN2-DB- A 2 FN2-DB- B 2 Guava Media China Guava Media China Guava China Guava China Guava Media China Guava Media China.29 5OD c OD d OD c OD d SC c SC c Residues [mg/kg] a cisenol cisketohydroxy enolglucoside monohydroxy Sum of and cisenol residue of

10 54 Spirotetramat Cont. RAFNL58 FN2- DB Plot No. Crop Variety FN2-DB- C 2 FN2-DB- D 2 Guava Media China Guava Media China Appl. DAT Rate b (kg ai/ha) 5OD c OD c Residues [mg/kg] a cisenol cisketohydroxy enolglucoside monohydroxy Sum of and cisenol residue of RAFNL58 FN- DA Mexico Zitacuaro Cont. RAFNL58 FN- DA RAFNL58 Guava FN-DA Calvillo FN-DA- A 2 FN-DA- B 2 24SC c.5-.5 Guava 24SC Calvillo c FN-DA- C 2 Guava 5OD Calvillo c

11 Spirotetramat 54 Plot No. Crop Variety Sum of and cisenol FN-DA- D 2 Guava 5OD Calvillo c Appl. DAT Rate b (kg ai/ha) 2 2 Residues [mg/kg] a cisenol Notes: c: concentrated spray; d: diluted spray; : The residues were measured in guava fruits. b : The applications were made at growth stages between -8. cisketohydroxy enolglucoside monohydroxy residue of Calc : Residues of, cis-enol, cis-keto-hydroxy, BYI8 monohydroxy, enol-glucoside each expressed as. residue of calc. and Sum of and cis-enol expressed as. Table 9 Results of residue trials conducted with spirotetramat on avocado Plot No. GLP Crop Variety Appl. rate (kg ai/ha) DALT Mexico GAO: times.29 kg ai/ha at 4 days intervals and PHI of day RAFNP FN-BA FN-BA- A San Luis Obispo, USA, California Haas 28 (conc.) c RAFNP42 FN-BA FN-BA- A2 San Luis Obispo, USA, California RAFNP42 FN-BA FN-BA- B San Luis Obispo, USA California Haas 28 Haas (diluted) c.288 (conc.) b Residues a cisenol cisketohydroxy enolglucoside.. monohydroxy Sum of and cisenol residue of calc

12 542 Spirotetramat Plot No. GLP RAFNP42 FN-DA FN-DA- A Arroyo Grande, USA California RAFNP42 FN-DA FN-DA- A2 Arroyo Grande, USA California RAFNP42 FN2-HA FN2-HA- A Mexico Nuevo Parangaricutiro RAFNP42 FN2-HA FN2-HA- A2 Mexico Nuevo Parangaricutiro RAFNP42 FN-BB FN-BB- A Chile Llay Llay, Valparaiso RAFNP42 FN-BB FN-BB- A2 Chile Llay Llay, Valparaiso RAFNP42 FN-BB FN-BB- B Chile Llay Llay, Valparaiso RAFNP42 FN4-HA FN4-HA- A Chile Ocoa, Valparaiso Crop Variety Hass 28 Haas 28 Haas 28 Haas 28 Hass 28 Hass 28 Hass 28 Hass 28 Appl. rate (kg ai/ha).288 (conc.) c (diluted) c DALT.288 (conc.) c.288 (diluted) c.288 (conc.) c.288 (diluted) c.288 (conc.) b.288 (conc.) c Residues a cisenol cisketohydroxy enolglucoside monohydroxy Sum of and cisenol residue of calc

13 Spirotetramat 54 Plot No. GLP RAFNP42 FN4-HA FN4-HA- A2 Chile Ocoa, Valparaiso Crop Variety Hass 28 Appl. rate (kg ai/ha).288 (diluted) c DALT Residues a cisenol cisketohydroxy enolglucoside monohydroxy Sum of and cisenol residue of calc a : Residues of, cis-enol, cis-keto-hydroxy, enol-glucoside each expressed as. residue of calc. and Sum of and cis-enol expressed as. The residues were measured in avocado fruits. b 24 EC; c 5 OD; the applications were made at growth stages between BBCH Table Results of residue trials conducted with an SC 24 formulation in/on sweet corn in Canada Plot No. Location Variety Dosage Dosage Kgai/ha DALT Sum of and cisenol Canadian max GAP x.88 kgai/ha at days with PHI of days. AAFC9- Brocade 2R AAFC9-2R-6 Delhi, Residues a [mg/kg] cis- cis-enol keto- hydroxy enolglucoside monohydroxy residue of calc AAFC9-2R AAFC9-2R- Delhi, 29 AAFC9-2R AAFC9-2R-8 Harrow, 29 AAFC9-2R AAFC9-2R-9 Harrow, 29 AAFC9-2R AAFC9-2R-2 L'Arcadie, 29 Luscious Fantastic.8-.9 x Awesome E Fleet

14 544 Spirotetramat Plot No. Location Sum of and cisenol.84.6 AAFC9-2R AAFC9-2R-2, L'Arcadie 29 AAFC9-2R AAFC9-2R-22 Taber, 29 AAFC9-2R AAFC9-2R-2, Agassiz 29 Variety Dosage Hybrid Trinity King Cobb G8K Luscious Dosage Kgai/ha.8-.9 x DALT Residues a [mg/kg] cis- cis-enol keto- hydroxy enolglucoside monohydroxy residue of calc. a Residues of, cis-enol, cis-keto-hydroxy, enol-glucoside each expressed as. residue of calc. and Sum of and cis-enol expressed as Trials 6- are not considered independent. Same location, soil week difference in application with same/similar equipment. Trials 8-9 are not considered independent. Same location, dates of application equipment and soil Trials 2-2 are not considered independent. Same location, dates of application equipment and soil. Table Results of residue trials conducted with an SC 24 formulation in/on sweet corn in Australia Plot No. Location Variety Dosage Dosage kg ai/ha DALT Sum of and cisenol Australian max GAP: 2.2 kg ai/ha at days interval with PHI of days. BCS-22 B B-T2 44 Gatton 28 Golden sweet improved * BCS-9 C45 C45-T2 485 Bowen 29 BCS-9 C458 C458-T2 485 Bowen 29 Golden Sweet 2. * 4 4 Sentinel 2. * 4 4 Residues a [mg/kg] cisenol cisketohydroxy enolglucoside monohydroxy <.44 <.44 <.44 <.44 < <.44 <.44 <.44 < <.44 residue of calc <. <. <. <. <..2.2 <. <. <. <...2 <.

15 Spirotetramat 545 Plot No. Location BCS-9 C459 C459-T2 44 Laidley 29 Variety Dosage BCS-22 Golden C4 Sweet AUS-BCS- 22- C4-A 98 Koo Wee Rup 2 BCS-22 C42 AUS-BCS- 22- C42-A 48, Stanthorpe 2 BCS-22 C4 AUS-BCS- 22- C4-A Wesley Vale, 2 Dosage kg ai/ha H DALT * 4 2. * 4 4 Spaceship Super Sweet * * 4 Residues a [mg/kg] cisenol cisketohydroxy enolglucoside monohydroxy Sum of and cisenol <.44 < residue of calc a : Residues of, cis-enol, cis-keto-hydroxy, enol-glucoside each expressed as. residue of calc. and Sum of and cis-enol expressed as

16 546 Spirotetramat Animal feed Table 2 Results of residue trials conducted with an SC 24 formulation in/on sweet corn forage in Canada Plot No. Location Variety Dosage DALT Canadian max GAP.88 kg ai/ha at days with PHI of days. AAFC9-2R AAFC9-2R-6 Delhi, 29 Brocade AAFC9-2R Luscious.8- AAFC9-2R-.9 Delhi, 29 AAFC9-2R Fantastic.9- AAFC9-2R-8.95 Harrow, 29 AAFC9-2R Awesome.89- AAFC9-2R-9.9 Harrow, 29 AAFC9-2R AAFC9-2R-2 L'Arcadie 29 AAFC9-2R AAFC9-2R-2 L'Arcadie 29 AAFC9-2R AAFC9-2R-22 Taber, 29 AAFC9-2R AAFC9-2R-2 Agassiz, 29 4E Fleet Hybrid Trinity King Cobb G8K Luscious Residues [mg/kg] cis-enol cisketohydroxy enolglucoside monohydroxy Sum of and cis-enol residue of +4 metabolite Table.Results of residue trials conducted with an SC 24 formulation in/on sweet corn stover in Canada Residues [mg/kg] Variety Dosage DALT cisenoketo- cis- Plot No.GLP hydroxy Canadian max GAP x.88 kg ai/ha at days with PHI of days. Sum of and cisenol AAFC9-2R AAFC9-2R-6 Canada, Delhi 29 Brocade enolglucoside monohydroxy residue of calc <.5

17 Spirotetramat 54 Sum of and cisenol.2 Plot No.GLP AAFC9-2R AAFC9-2R- Canada, Delhi 29 AAFC9-2R AAFC9-2R-8 Canada, Harrow 29 AAFC9-2R AAFC9-2R-9 Canada, Harrow 29 AAFC9-2R AAFC9-2R-2 Canada L'Arcadie 29 AAFC9-2R AAFC9-2R-2 Canada L'Arcadie 29 AAFC9-2R AAFC9-2R-22 Canada, Taber 29 AAFC9-2R AAFC9-2R-2 Canada Agassiz 29 Variety Dosage DALT Luscious.8-.9 Fantastic Awesome E Fleet.8-.9 Hybrid Trinity King Cobb G8K Luscious.8-.9 x Residues [mg/kg] cisenol cisketohydroxy enolglucoside monohydroxy residue of calc..8.6 <.5 <.5 <.5 <

18 548 Spirotetramat Table 4 Results of residue trials conducted with an SC 24 formulation in/on sweet corn fodder in Australia Plot No. Variety Dosage DALT Residues [mg/kg] cis-enol cisketohydroxy enolglucoside monohydroxy Sum of and cisenol residue of calc. Australian max GAP: 2.2 kgai/ha at days interval with PHI of 5 days for stover. BCS-22 B B-T2 Australia 44 Gatton 28 BCS-9 C45 C45-T2 Australia 485 Bowen 29 BCS-9 C458 C458-T2 Australia 485 Bowen 29 Golden sweet improved Golden Sweet * 2. * 4 4 Sentinel 2. * BCS-9 C459 C459-T2 Australia 44 Laidley 29 BCS-22 C4 AUS- BCS- 22- C4-A 98 Koo Wee Rup 2 BCS-22 C42 AUS- BCS- 22- C42-A Australia 48 Stanthorpe 2 H Golden Sweet * 4 2. * 4 4 Spaceship *

19 Spirotetramat 549 Plot No. Variety Dosage DALT Residues [mg/kg] cis-enol cisketohydroxy enolglucoside monohydroxy Sum of and cisenol residue of calc. BCS-22 C4 AUS- BCS- 22- C4-A Australia Wesley Vale 2 Super Sweet * FATE OF RESIDUES IN STORAGE AND PROCESSING In storage No data are available from the storage under warehouse conditions. In processing The effect of processing on spirotetramat residues have already been evaluated by JMPR in 28. The meeting concluded that spirotetramat-enol was resistant to hydrolysis under all test conditions. Processing factors have been established for cooked bean (.46), canned tomato (.58) and canned cherries (.4). In all these commodities the reduction of residues was observed. Similarly, it is expected that the residues will not concentrate in sweet corn. RESIDUES IN ANIMAL COMMODITIES Farm animal feeding studies Based on a dairy cattle feeding study and poultry metabolism study the 28 JMR estimated residue levels in animal commodities. No new information was provided. APPRAISAL The compound was evaluated by the JMPR for the first time in 28. The Meeting established an ADI of.5 mg/kg bw per day and an ARfD of mg/kg/bw and defined the residues as follow: Residue for enforcement plant commodities: spirotetramat plus spirotetramat enol, expressed as spirotetramat. Residue for dietary intake plant commodities: spirotetramat plus the metabolites enol, ketohydroxy, enol glucoside, and monohydroxy, expressed as spirotetramat. Residue for enforcement and dietary intake animal commodities: spirotetramat enol, expressed as spirotetramat. The residue is not fat soluble. Additional residue data were evaluated by the 2 JMPR.

20 55 Spirotetramat Spirotetramat was listed by the Forty-sixth Session of CCPR (24) for the evaluation by the 25 JMPR for additional MRLs. Supervised trials data were submitted for evaluation on avocado, guava and sweet corn for the evaluation by the 25 JMPR. Analytical methods Analytical methods were evaluated by the 28 and 2 Meetings. Recovery data obtained from the analysis of avocado, guava and sweet corn and sweet corn fodder. The limit of quantification was. mg/kg for individual residues. The residues of individual analyte were expressed as spirotetramat equivalents and summed up to yield the total residue of spirotetramat plus enol (LOQ.2 mg/kg) and spirotetramat plus 4 metabolites (LOQ.5 mg/kg). The recoveries for individual residue components in the matrices tested. and. mg/kg or. and mg/kg spike level and their relative standard deviations were within acceptable range. Stability of analytes Individual data on storage stability of spirotetramat and its metabolites were evaluated by the JMPR in 28. The Meeting concluded that spirotetramat including its enol metabolite was stable ( 8% remaining) for about 2 years in tomato, potato, lettuce, almond nutmeat, climbing French beans and tomato paste. No new information was provided. Residues resulting from supervised trials in crops Results of new trials and some of the previously submitted ones on guava, avocado and sweet corn were evaluated by the present meeting. The sum of respective residues was expressed in spirotetramat equivalent. Assorted tropical and sub-tropical fruits edible peel Guava In 28 and 2, four residue trials in guava were conducted (including plots) in Mexico. The trials were performed either with the OD 5 or the SC 24 formulation. The trials were conducted at two different application rates:.288 kg ai/ha or 5 kg ai/ha at spray intervals of 4 days. The US GAP permits applications at.9 kg ai/ha rate at 4 days intervals with a PHI of day. The results of supervised trials conducted in Mexico are evaluated against the US GAP. The results indicate that the type of formulation and concentration of the spray solution did not affect the residue level. Therefore, the highest residues were selected from each set of trials. The sum of residues of spirotetramat and its enol metabolite deriving from the times.288 kg ai/ha nominal application rates at - days after last application were:.429,.66,.96 and. mg/kg. Taking into account the nominal application rate of 288 g ai/ha and the USA GAP rate of 9 g ai/ha, the scaling factor is 9/228=.625. The residues scaled to match US GAP are in rank order:.2,.4,.56, and.8 mg/kg. The sum of residues of spirotetramat and 4 metabolites are:.44,.9,.965 and. mg/kg. The residues scaled to US GAP are:.29,.49,.6, and.85 mg/kg. The Meeting estimated maximum residue level of 2 mg/kg, an HR of.85 mg/kg and an R residue of.55 mg/kg.

21 Spirotetramat 55 Assorted tropical and sub-tropical fruits inedible peel The uses on avocado and the corresponding residue trials were previously submitted in 2, but no recommendation could be made at that time. Subsequently, the GAPs of Chile and Mexico have been changed. The use of spirotetramat in/on avocado is registered in the USA ( applications of maximum.9 kg ai/ha at 4 days interval with a maximum seasonal rate of.44 kg ai/ha and PHI of day), Chile (2 applications with a maximum seasonal rate of.8 kg ai/ha and PHI of days) and Mexico ( applications at maximum rate of.68 kg ai/ha and PHI of day. Five trials were conducted in USA, Chile and Mexico with nominal application rates of.288 kg ai/ha. The critical GAP is from USA. The results of trials were evaluated based on the US GAP. The highest sum of spirotetramat and enol from each replicate plots corresponding to this GAP are:.45,.,.,.2,.29 mg/kg. Taking into account the targeted application rates of.288 and the maximum authorised rate of.9, the scaling factor is.9/.288=.625. The scaled residues in avocado fruits were in rank order:.28,.6,.6,.25, and.8 mg/kg. For dietary intake assessment the sum of residues of spirotetramat and 4 metabolites was considered. They are in rank order:.55,.,.2,.24, and. mg/kg. The scaled residues in rank order are:.4,.8,.26,.4, and.9 mg/kg. The highest residue observed in any single sample was.2 mg/kg. The Meeting estimated a maximum residue level an R and HR of.4 mg/kg,.26 mg/kg and.2 mg/kg, respectively. Sweet corn Seven trials were conducted in Australia between 28 and 2 with applications close to Australian maximum GAP (2 times.2 kg ai/ha at day intervals with a PHI of days). One sample was taken from each plot. In Australian trials the sum of spirotetramat and enol in ear without husk were:.56,.56,.,.2,.2,.24 and.4 mg/kg. For dietary intake assessment the sum of residues of spirotetramat and 4 metabolites was considered. They were in rank order:.2,.2,.8,.8,.8,. and.62. Eight trials were conducted in Canada approximating maximum GAP which permits treatments with.88 kg ai/ha at days intervals and a PHI of days. Duplicate samples were taken in each trial. Some Canadian trials were carried out at the same location, timing, dosage and equipment. The highest sum of spirotetramat and enol in ear without husk from the independent trials were:.4,.6,.25,.48 and.545 mg/kg. For dietary intake assessment the sum of residues of spirotetramat and 4 metabolites was considered. They were in rank order:.,.25,.,.6 and.695 mg/kg. The maximum residue in a single sample was.5 mg/kg. Based on the Canadian trials reflecting maximum GAP, the Meeting estimated a maximum residue level of.5 mg/kg, and for dietary risk assessment an R residue of. mg/kg and an HR of.5 mg/kg.

22 552 Spirotetramat Animal feed Residue data on sweet corn forage and stover derived from supervised trials conducted in Australia and Canada were made available for evaluation. The trial conditions, reflecting maximum GAP are described under sweet corn. The independent Canadian trials resulted in the following highest average residues: Sum of spirotetramat and enol: Sweet corn forage days after last application:.2,.8,.8,.25 and.8 mg/kg. Sum of residues of spirotetramat and 4 metabolites: Sweet corn forage days after last application:.6,.29,.2,.5 and.9 mg/kg. The meeting estimated.2 mg/kg median and.9 mg/kg high residue for animal burden calculation. In the independent Canadian trials 4 85 days after last application the residues in sweet corn stover were: Sum of spirotetramat and enol:,.2,.46,. and.4 mg/kg Sum of residues of spirotetramat and 4 metabolites: <.5,.8,.,., and.58 mg/kg. In Australian trials days after last application the sum of residues in/on sweet corn fodder was: Spirotetramat and enol:.8,.2,.,.28,.,.5,.58 mg/kg. Spirotetramat and 4 metabolites:.9,.4,.54,.5,.6,., and.6 mg/kg, The Australian trials resulted in higher residues in sweet corn stover and fodder. Based on the Australian trials the Meeting estimated highest and median residues of.6 mg/kg and.5 mg/kg for sweet corn stover and fodder. Farm animal feeding studies Based on a dairy cattle feeding study and poultry metabolism study the 28 JMPR estimated residue levels in animal commodities. No new information was provided. Residues in animal commodities The residues in sweet corn forage and stover do not increase the maximum animal burden that would affect the maximum, HR and median residue values estimated by the 28 Meeting. RECOMMENDATIONS On the basis of the data from supervised trials the Meeting concluded that the residue levels listed below are suitable for establishing maximum residue limits and for dietary intake assessment. CCN Commodity Recommended Maximum residue level New Previous R or R-P mg/kg FI FI 6 Guava GC 44 Sweet corn.5..5 HR or HR-P mg/kg

23 Spirotetramat 55 DIETARY RISK ASSESSMENT Long-term intake The ADI is.5 mg/kgbw. The long-term intake calculated for the commodities considered by the present meeting is % of maximum ADI and did not affect the previously made long-term dietary estimates. Hence, a new risk assessment was not necessary. Short-term intake The ARfD is mg/kgbw. The estimated short-term intakes of avocado, guava and sweet corn are up to % 2% of ARfD for the general population and children. The Meeting concluded that the short-term intake of residues of spirotetramat from the uses REFERENCES Author(s) Title, Source, Company name, Report No., Date, GLP status published or not Anon. 29 Movento 5 OD - Mexico, Bayer CropScience, Bayer CropScience, Report No.: M , Edition Number: M-695--, Date: , GLP/GEP: n.a., unpublished Anon. 2 Movento, Bayer CropScience LP, RTP, NC, USA, Bayer CropScience, Report No.: M , Edition Number: M , Date: 2-5-2, GLP/GEP: n.a., unpublished Anon. 24 Movento 5 OD - Mexico, Bayer de México, S.A. de C.V., Ecatepec de Morelos, México., Bayer CropScience, Report No.: M-55--, Edition Number: M-55- -, Date: 24--, GLP/GEP: n.a., unpublished Anon. 24 Movento 24 SC insecticide - Australia, Bayer CropScience Pty. Ltd., East Hawthorn, Australia, Bayer CropScience, Report No.: M , Edition Number: M , Date: 24--6, GLP/GEP: n.a., unpublished Anon. 24 Movento SC 24 - Canada - For control of certain insects on listed fruit, vegetable and field crops and in field grown balsam fir and fraser fir, including christmas trees, Bayer CropScience Inc., Calgary, Canada, Bayer CropScience, Report No.: M-42--, Edition Number: M-42--, Date: , GLP/GEP: n.a., unpublished Anon. 24 Spirotetramat (24) - JMPR evaluation - Appendix : Residue data summaries from supervised trials,bayer CropScience, Report No.: M-566--, Edition Number: M , Date: 24--, GLP/GEP: n.a., unpublished Brookey, F. M. 26 Independent laboratory validation of the residue analytical method: "Analytical Method 85 for the determination of residues of BYI8 (parent compound and total residue of BYI8), BYI8-enol, BYI8-ketohydroxy,...Morse Laboratories, Inc., Sacramento, CA, USA, Bayer CropScience, Report No.: RAFNP8, Edition Number: M-25--, EPA MRID No.: , Date: , GLP/GEP: yes, unpublished Freitag, T.; Wolters, A. 26 Analytical method 969 for the determination of residues of BYI8-enol in/on matrices of animal origin by HPLC-MS/MS Bayer CropScience, Report No.: 969, Edition Number: M Method Report No.: MR-6/5, Date: 26--8, GLP/GEP: yes, unpublished Hoag, R. E.; Fain, J. 2 Spirotetramat (BYI8): Magnitude of the residue in/on lychee and guava for U.S. import tolerance, Bayer CropScience LP, Environmental Safety, RTP, NC, USA, Bayer CropScience, Report No.: 494, Edition Number: M , EPA MRID No.: 494, Date: 2-4-, GLP/GEP: yes, unpublished Hoag, R. E.; Harbin, A. M. Hoag, R. E.; Harbin, A. M. 29 Spirotetramat 5 OD and 24 SC - Magnitude of the residue in/on tropical fruit (except grapefruit) - US import tolerance, Bayer CropScience LP, Stilwell, KS, USA, Bayer CropScience, Report No.: RAFNP42, Edition Number: M , EPA MRID No.: , Date: , GLP/GEP: yes, unpublished 29 Spirotetramat 5 OD and 24 SC - Magnitude of the residue in/on tropical fruit (except grapefruit) - US import tolerance, Bayer CropScience LP, Stilwell, KS, USA, Bayer CropScience, Report No.: RAFNP42, Edition Number: M , EPA MRID No.: , Date: , GLP/GEP: yes, unpublished

24 554 Spirotetramat Author(s) Title, Source, Company name, Report No., Date, GLP status published or not Lonsbary, S. 2 Spirotetramat: Magnitude of the residue on corn, sweet, Agriculture and Agri-Food Canada, Ottawa, Canada, -public data-, Report No.: AAFC9-2R, Report includes Trial Nos.: AAFC9-2R-6, AAFC9-2R-, AAFC9-2R-8, AAFC9-2R-9, AAFC9-2R-2, AAFC9-2R-2, AAFC9-2R-22, AAFC9-2R-2, Edition Number: M , Date: 2-2-2, GLP/GEP: yes, unpublished Meyer, M. 28 Determination of residue of spirotetramat () and its metabolites BYI8-enol; BYI8-ketohydroxy, BYI8-mono-hydroxy and BYI8-enol-glucoside in plant material by LC-MS/MS - Independent laboratory validation of the..., SGS Institut Fresenius GmbH, Taunusstein, Germany, Bayer CropScience, Report No.: IF- 8/8966, Edition Number: M-25--, Date: , GLP/GEP: yes, unpublished Radunz, L. 29 Determination of residues of BYI-8 (spirotetramat) in sweet corn cobs and fodder following two applications of BYI-8 24 SC at 2 or 96 g ai/ha at weekly intervals, Bayer CropScience, Eight Mile Plains, QLD, Australia, Bayer CropScience, Report No.: BCS-22, Report includes Trial Nos.: B, Edition Number: M , Date: 29-9-, GLP/GEP: no, unpublished Radunz, L. 29 Determination of residues of BYI-8 (spirotetramat) in sweet corn following two foliar applications of Movento 24 SC at rates of 2 or 96 g ai/ha, Bayer CropScience, Eight Mile Plains, QLD, Australia, Bayer CropScience, Report No.: BCS-9, Report includes Trial Nos.: C45, C458, C459, Edition Number: M , Date: , GLP/GEP: yes, unpublished Radunz, L. 2 Determination of residues of BYI-8 (spirotetramat) in sweet corn cobs and fodder following two foliar applications of Movento 24 SC at rates of 2 or 96 g ai/ha, Bayer CropScience, Eight Mile Plains, QLD, Australia, Bayer CropScience, Report No.: BCS- 22, Edition Number: M-289--, Date: 2-6-, GLP/GEP: yes, unpublished Rauen, H. W. 2 Document E - Listing of MRLs established for the active substance spirotetramat (), Bayer CropScience, Report No.: M , Edition Number: M , Date: 2-2-9, GLP/GEP: n.a., unpublished Rauen, H. W. 24 Document D - Details of uses for avocado, guava and sweet corn - supported by the applicant and for which data have been provided and conditions of use (GAPs) have been established, presented, using the appropriate form, Bayer CropScience, Report No.: M-56--, Edition Number: M-56--, Date: 24--2, GLP/GEP: n.a., unpublished Rauen, H. W. 24 Document E - Listing of MRLs established for the active substance spirotetramat () on avocados, guava and sweet corn, Bayer CropScience, Report No.: M-5--, Edition Number: M-5--, Date: 24--2, GLP/GEP: n.a., unpublished Schoening, R.; Stuke, S.; Billian, P. Schoening, R.; Willmes, J. 25 Analytical method 85 for the determination of residues of BY8(parent compound and total residue of BYI8), BYI8-enol, BYI8-ketohydroxy, BYI8-mono-hydroxy and BYI8-enol-Glc metabolite in/on plant material by HPLC-MS, Bayer AG, Leverkusen, Germany, Bayer CropScience, Report No.: 85, Edition Number: M , Method Report No.: MR-99/4, EPA MRID No.: 428, Date: 25-6-, GLP/GEP: yes, unpublished 28 Analytical method 84 for the determination of residues of spirotetramat (), BYI8-enol, BYI8-ketohydroxy, BYI8-mono-hydroxy and BYI8- enol-glucoside metabolites in/on plant material by HPLC-MS/MS, Bayer CropScience, Report No.: 84, Edition Number: M , Method report NO. 84, EPA MRID No.: 465, Date: ,.Amended: 28-4-, GLP/GEP: yes, unpublished