### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

. WASHINGTON; 

## D.G. ·_20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: 4 September 2014

. 

### . SUBJECT: Fluensulfone

- Revised Tolerance**R~commendations** 

### for Cucurbit Vegetables and

FROM:

THROUGH: Fruiting**Vegetable~** 

### bue to a Reduced**~pplication** 

### Rate PC Code: 0504 I 0 . Decision No.: 464527 Petition No.: 2F8019 Risk Assessment Type: NA TX;RNo.: NA · DP Barcode : 0421659 Registration Nos.: L1678-TG, 66222-EUG Regulatory Action: Section 3 · Case No . : None CAS No . . : 

### 3 18290:98-1 MRID No.: None 40 CFR: New Active Ingredient 

### Michael A. 

### Doheity ; Ph.O ,

# SeniorC~emist ·

# ~**~/** .dRisk Assessment Branch II ·

# ~ Health EffectsDivisi?n

### ~7509P) / , ·. . . . 

# A. _.. Chr i stina Swartz , Chief

# ~~ Risk Assessment Branch II Health Effects Division (7509P) TO: Jennifer Gairtes / Rube:n Baris (Team 7) Insecticide/Rodenticide Branch Registration Division (7505P) This memorandum summarizes HED's revised tolerance recommendations for the new active ingredient fluensulfo ne to reflect a change in the proposed application rate of tluen sulfone to cucurbit vegetables (Crop Group 9) and fruiting vegetables (Crop Group 8). The revised recommended tolerance le vels are 0.5 ppm for both crop groups. 

### Background HED recently provided RD with recommended tolerance levels of fluensulfone-relat ed residues in cucurbit vegetables (Crop Group 9) at 0 . 80 ppm and fruiting vegetables (Crop Group 8) a:t 0 .70 ppm basedon a proposed application rate of 3 . 5 lb ai/A (D403767, M. Doherty et 

### al. , 

### 18 Jw1e 20 14). 

### In order to mitigate estimated worker risks associated with chemigation operations, Page I of3the petitioner for fluensulfone (Makhteshim Agan ofNorth America , Inc. ) has reduced the proposed application rat e for the 480 EC product from 3.5 lb ai/A to 2 .5 lb ai / A. The reduction represents a decrea se of28.6% > which is outside the 25% variance typicall y allowed without conection, for the purpose of setting tolerances; therefore, HED is re-evaluating the residue data for purposes of establishing a tolerance that i s reflective ofthe revised appl i cation rate . The residue definition (i.e. residue of concern) for enforcement is the tritluorobutene sulfonic acid metabolite ( BS A), expressed as fluensulfone equ i valents. Adjustment Method Field trials targetin g the originally proposed u se pattern (7 days pre-tran s plant) were conducted at rates rang i ng from 3.25 to 3.68 lhai / A. The re sid ue . of the BSA metabolite from each field

t rial was multiplied by 2 .5 lb ai/A and divid ed by the actual application rat e (lb ai / A) used in the field trials. The resulting values were then multiplied by 1 .534 , which is the stoichiometric convers ion factor to translate residues of BSA to their fluensulfone-equivalent values. Tolerance Recommendation The adjusted, fluensulfone-equivalent r es idu e values were put through the OECD tolerance calcu l ation procedure s (Table l) to obtain the recommended tolerance l evels. For each crop

gro up, the maximum r ecommen ded tolerance from the representative commodities within that gro up i s being r ecommended as the toleranc e l eve l for the whole group. For cucu rbit vegetables , the maximum recommended tolerance is 0.5 ppm , coming from cucumber and summer squash. For fruiting vegetables , the maximum recommended tolerance is also 0.5 ppm , coming from tomato. P age 2 of3Table I . OECD Tolerance Ca l culation Results for Fl uensulfone, Refl ecting Adjusted Proposed App lication Rate. Compound BSA (Pare nt E quiv) BSA (Parent F. quiv) BSA (Par ent F.quiv) 13SA (Parent E quiv) £3SA (Parent E quiv ) Crop Tomato Bell +Non-l3e ll Cucumber Ca ntaloupe Summer Squash Pepper Regi on / Country NAFTA N AFTA NAFTA NA FTA NAFTA GAP Br oad cas t Spmy or Br oadcast Spmy or Br o adcas t Spra) or Broadcas t Spray or Broadcast Spray or Drip Irrigation . 7 Drip lrri gallon , 7 Drip l mgati on . 7 Drip Irrigation . 7 Drip Irrigation. 7 Days Pre-Transp lan t . Days Pre-Transp lant Days Pre - Tran splant Days Pre-Tran splant Days Pre -Transp lant Total numbe r ofdata (n) 22 13 9 16 10 Percenlllgc of ce nsor ed data 1 8% 0% 44% 44% 20% Number of n on-cen sored data 1 8 13 5 9 8 Lowest res idu e 0 .0 1 0 0 .034 0.010 0.010 0 .0 1 0 Highest resi due 0.293 0.249 0.236 0 . 218 0.260 Median res idue O.o75 0075 0.068 0.0 25 O.o7 5 Mean 0 .094 0.093 0.086 0.046 0.118 Standard deviati on (SO) 0 . 092 0.065 0 . 089 0 .058 0 .096 Correction factor for 0 . 879 1.000 0.704 0.708 0867 censoring (CF) Proposed MRL estimate

- Highes t resi due 0.293 0249 0.236 0.218 0. 260 -Mean + 4 SO 0.462 0.354 0.442 0 .277 0 . 501.

- CF x3 Mean 0.2 47 0.279 0. 1 82 0.097 0.306 Unrounded MRL 0.462 0.354 0.442 0.277 0.501 Rounded MRI. 0 . 5 0 .4 0 . 5 03 05 Residue s (mg/kg) Residues (rnglkg) Residues {mg/kg} Residues (mg/kg.) Residues (mg/k g) 0 . 0 1 0 

## • 0.034 0010 

# .. 0 .0 1 0 

### * 0 .010 

## • 0 . 0 1 0 

## • 0 .040 0.010 

# .. 0.010 

## • 0.010 * 0 . 010 

## • 0.043 0.010 

### * 0 .0 10 

### * 0 .054 0.0 1 0 

## • 0.053 0.010 

## • 0.010 

# .. 0 .056 0 . 021 0 .064 0.068 0.0 10 

### • 0.0 64 0 . 022 0.067 0 .078 0.010 

## • 0 .086 · 0 . 031 O.o75 0.157 00 1 0 * 0203 0 . 032 0075 0.196 0.022 0.2 11 0.032 O.Q78 0 .236 0 . 027 0224 0 .044 0 .084 0.033 0.260 0.075 0. 148 0.033 0,075 0 . 198 0.0 51

. (),078 0.249 0 . 065

0.086 0 .069 0.095 0 . 142 0.099 0 .218 0 .1 02 0 . 182 0229 0.2 4 0 0.287 0.293 • Res1duc IS < LOQ

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