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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

Date: 26 September 2012

SUBJECT: Clothianidin – Proposed Label Amendments: Reduction in PHI for Crop 

Subgroup 8-10B (Peppers and Eggplant) and Change in Tolerance.

PC Code: 044309 DP Barcode: D399953

Decision No.: 459388 Registration Nos.: 59639-150, 59639-152

Petition Nos.: 2F8008 Regulatory Action: Amended Section 3

Risk Assessment Type: N/A Case No.: 7620

TXR 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 McNeilly, 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.
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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 Vegetable, fruiting, group 8 at 0.20 ppm.

2. Establish a tolerance entry for Vegetable, fruiting, tomato subgroup 8-10A at 0.20 ppm

3. Establish a tolerance entry for Vegetable, fruiting, pepper/eggplant subgroup 8-10B at 

0.80 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 MRL Harmonization 

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 by 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 LC/MS-MS separation and detection. Adequate performance 

has been demonstrated for this method and the studies are supported by adequate storage stability 

data. The clothianidin 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 by OCSPP Guideline 860.1500. Nevertheless, 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 

Rates, 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 ± 0.003
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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 separately (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).

Summary of Tolerance Derivation Calculations Using the OECD Calculation Procedures.

Compound 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

Lowest 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