                 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.

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

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
                                       

