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.: L 1678-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

Risk 

istina 

Assessment 

Swartz, 

Branch 

Chief 

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 fluensulfone to reflect a change in the proposed application rate of tluensulfone to 

cucurbit vegetables (Crop Group 9) and fruiting vegetables (Crop Group 8). The revised 

recommended tolerance levels are 0.5 ppm for both crop groups. 

Background 

HED recently provided RD with recommended tolerance levels of fluensulfone-related 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, 

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the petitioner for fluensulfone (Makhteshim Agan ofNorth America, Inc.) has reduced the 

proposed application rate for the 480 EC product from 3.5 lb ai/A to 2.5 lb ai/A. The reduction 

represents a decrease of28.6%> which is outside the 25% variance typically allowed without 

conection, for the purpose of setting tolerances; therefore, HED is re-evaluating the residue data 

for purposes of establishing a tolerance that is reflective ofthe revised application rate. The 

residue definition (i.e. residue of concern) for enforcement is the tritluorobutene sulfonic acid 

metabolite (BSA), expressed as fluensulfone equivalents. 

Adjustment Method 

Field trials targeting the originally proposed use pattern (7 days pre-transplant) were conducted 

at rates ranging from 3.25 to 3.68 lhai/A. The residue. of the BSA metabolite from each field 

trial was multiplied by 2.5 lb ai/A and divided by the actual application rate (lb ai/A) used in the 

field trials. The resulting values were then multiplied by 1 .534, which is the stoichiometric 

conversion factor to translate residues of BSA to their fluensulfone-equivalent values. 

Tolerance Recommendation 

The adjusted, fluensulfone-equivalent residue values were put through the OECD tolerance 

calculation procedures (Table l) to obtain the recommended tolerance levels. For each crop 

group, the maximum recommended tolerance from the representative commodities within that 

group is being recommended as the tolerance level for the whole group. For cucurbit 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. 

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Table I. OECD Tolerance Calculation Results for Fluensulfone, Reflecting Adjusted Proposed Application Rate. 

Compound BSA (Parent Equiv) BSA (Parent F.quiv) BSA (Parent F.quiv) 13SA (Parent Equiv) £3SA (Parent Equiv) 

Crop Tomato Bell+Non-l3ell Cucumber Cantaloupe Summer Squash 

Pepper 

Region / Country NAFTA NAFTA NAFTA NAFTA NAFTA 

GAP Broadcast Spmy or Broadcast Spmy or Broadcast Spra) or Broadcast Spray or Broadcast Spray or 

Drip Irrigation. 7 Drip lrrigallon, 7 Drip lmgation. 7 Drip Irrigation. 7 Drip Irrigation. 7 

Days Pre-Transplant .Days Pre-Transplant Days Pre-Transplant Days Pre-Transplant Days Pre-Transplant 

Total number of data (n) 22 13 9 16 10 

Percenlllgc of censored data 18% 0% 44% 44% 20% 

Number of non-censored data 18 13 5 9 8 

Lowest residue 0.010 0.034 0.010 0.010 0.010 

Highest residue 0.293 0.249 0.236 0.218 0.260 

Median residue O.o75 0075 0.068 0.025 O.o75 

Mean 0.094 0.093 0.086 0.046 0.118 

Standard deviation (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 

- Highest residue 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 0.247 0.279 0. 182 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 

Residues (mg/kg) Residues (rnglkg) Residues {mg/kg} Residues (mg/kg.) Residues (mg/kg) 

0.010 • 0.034 0010 .. 0.010 * 0.010 • 

0.010 • 0.040 0.010 .. 0.010 • 0.010 * 

0.010 • 0.043 0.010 * 0.010 * 0.054 

0.0 10 • 0.053 0.010 • 0.010 .. 0.056 

0.021 0.064 0.068 0.0 10 • 0.064 

0.022 0.067 0.078 0.010 • 0.086 · 

0.031 O.o75 0.157 0010 * 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 0.051 

. (),078 0.249 0.065 

0.086 0.069 

0.095 0.142 

0.099 0.218 

0.1 02 

0.182 

0229 

0.240 

0.287 

0.293 

• Res1duc IS < LOQ 

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