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

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

**POLLUTION PREVENTION** 

### MEMORANDUM Date: 26 September 2012 SUBJECT: Clothianidin

– Proposed Label Amendments: Reduction in PHIfor Crop

Subgroup 8 - 10B (Peppers and Eggplant) and Change in Tolerance . PC Code: 044309 DP Barcode: D399953 Decision No.: 459388 Registration No s . : 59639 - 150, 59639 - 152 Petition No s .: 2F8008 Regulatory Action: Amended Section 3 Risk Assessment T ype: N/A Case No.: 7620 T XR No.: N/A CAS No.: 210880 - 92 - 5 MRID No.: 48708203, 48708204 40 CFR: 180.586 

### FROM: Michael A. Doherty, Ph.D., Chemist Risk Assessment Branch II Health Effects Division (7509P) THROUGH: Dennis McNeill y, Chemist

Risk Assessment Branch II Health Effects Division (7509P) TO: Marianne Lewis/Venus Eagle (RM 01) Insecticide - Rodenticide Branch Registration Division (7505P) **Introduction** Valent U.S.A. Corporation has petitioned the Agency to reduce the pre - harvest interval (PHI) from 7 days to 1 day following application of clothianidin products V - 10170 2.013 SC or Arena 50 WDG to the fruiting vegetable crop subgroup 8 - 10B (pepper and eggplant) . Concomitant with that registration amendment, the registrant has requested changes in the tolerance for residues in/on fruiting vegetables (which currently is 0.2 ppm) as follows: 8 - 10 Fruiting Vegetable Group except 8 - 10B Pepper/Eggplant subgroup ........ 0.2 ppm 8 - 10B Pepper Eggplant subgroup ................................ ................................ ...... 0.7 ppm Valent U.S.A. Corporation has submitted data depicting residues of clothianidin in/on bell and non - bell peppers reflecting a 1 - day PHI.Page 2 of 2



### Conclusion The submitted data are adequate to support the reduction in the PHI and to revise the tolerances for the fruiting vegetable crop group. The Health Effects Division recommends the following revision to 40 CFR 180.586: 1. Delete the existing tolerance entry for Ve getable, fruiting, group 8 at 0.20 ppm. 2. Establish a tolerance entry for Vegetable, fruiting, tomato sub group 8 - 10 A at 0.20 ppm 3. Establish a tolerance entry for Vegetable, fruiting, pepper/eggplant subgroup 8 - 10B at 0.8 0 ppm. Note that the recommended tolerance (0.80 ppm) for the pepper/eggplant crop subgroup is different than the requested tolerance (0.7 ppm). HED used the OECD MRLHarmonization procedures to obtain the recommended tolerance level, which may account for the different values. Also note that the commodity listing in the recommended tolerance expression is different than that petitioned for b y the registrant. The revised listing should be for Subgroup 8 - 10A, not 8 - 10 except the pepper/eggplant subgroup. **Detailed Considerations Field Trial**  **Data** Valent U.S.A Corporation submitted field trials depicting residues of clothianidin in/on bell peppers (six trials, MRID 48708204) and non - bell pepper (three trials, MRID 48708203). For all trials, clothianidin (as V - 10170 2.13 SC; EPA Reg. No. 59639 - 150) was applied, foliarly , two times, at a nominal application rate of 45.4 g a.i./A/application (0.1 lb a.i./A/application) and a retreatment interval of 7 days. Peppers were harvested one day after the second application. Residues of clothianidin were determined using Method RM - 39C - 1, which uses aqueous extraction, sorbent cleanup, and L C/MS - MS separation and detection. Adequate performance has been demonstrated for this method and the studies are supported b y adequate storage stability data. The cl othianidin residue data from the studies are summarized in the table below. The number of field trials are in keeping with the guideline recommendations; however, the locations of the field trials are not as recommended b y OCSPP Guideline 860.1500. Never theless, they

are considered to be adequate for purposes of this petition. Summary of Residue Data for Clothianidin in/on Bell and Non - Bell Peppers Following a 1 - Day PHI. Pepper Type Variety Trial Location Application Rate s , g a.i./A Clothianidin Residues,

ppm Average Residue ± Std. Dev., ppm Bell Hunter Tift, GA 44.54 + 45.16 0.085, 0.123 0.104 ± 0.027

Heritage Barnwell, SC 45.42 + 45.30 0.068, 0.049 0.059 ± 0.013 Green Bell Seminole, FL 45.05 + 44.75 0.094, 0.083 0.089 ± 0.008 Revolution Martin County, FL 46.34 + 46.49 0.048, 0.034 0.041 ± 0.010 McCabi Yuma, AZ 46.38 + 45.89 0.122, 0.127 0.125 ± 0.004 Cal Wonder Tulare County, CA 45.21 + 46.30 0.198, 0.225 0.212 ± 0.019 Non - Bell Mesilla Seminole, FL 44.4 + 45.2 0.312, 0.282, 0.311 0.302 ± 0.017

Dulce Yuma, AZ 46.9 + 47.3 0.069, 0.082, 0.114 0.088 ± 0.023 Conch Tift, GA 45.4 + 45.1 0.019, 0.015, 0.021 0.018 ± 0.003Page 3 of 3



### Tolerance Determination The tolerance recommended by HED is 0.80 ppm based on the non - bell -pepper residue data, and was derived using the OECD Calculation Procedures. Data for bell and non - bell peppers were assessed separatel y (see below). The recommended tolerances are 0.4 ppm based on bell peppers and 0.8 ppm based on non - bell peppers. HED is recommending the higher value for all of Crop Subgroup 8 - 10B (Peppers and Eggplant). S ummary of Tolerance Derivation Calculations Using the OECD Calculation Procedures. Com pound Clothianidin Clothianidin Crop Non - Bell Peppers Bell Peppers Region / Country USA USA GAP Total number of data (n) 3 6 Percentage of censored data 0% 0% Number of non - censored data 3 6 Lo west residue 0.018 0.041 Highest residue 0.302 0.212 Median residue 0.088 0.097 Mean 0.136 0.105 Standard deviation (SD) 0.148 0.061 Correction factor for censoring (CF) 1.000 1.000 Proposed MRL estimate

- Highest residue 0.302 0.212

- Mean + 4 SD 0.728 0.347

- CF x 3 Mean 0.408 0.315 Unrounded MRL 0.728 0.347 Rounded MRL 0.8 0.4 High uncertainty of MRL estimate due to small dataset. High uncertainty of MRL estimate due to small dataset. Residues (mg/kg) Residues (mg/kg) 0.018 0.104 0.302 0.059 0.088 0.089 0.041 0.125 0.212