Valent U.S.A. Corporation

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**Section 1 Informative Summary**  **FILE NAME: XXXXX**  May 30, 2011 **EPA Registration Division contact: Dominic Schuler 703**  **- 347**  **- 0260**  **PP# 2F8099 Valent USA Corporation**  Summary of Petition EPA has received a pesticide petition **PP# 2F8099** from Valent U.S .A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.627, by establishing a tolerance for inadvertent residues of the fungicide chemical fluopicolide, 2,6 - dichloro -N - [3 - chloro - 5 - (trifluoromethyl) - 2 - py ridyl methyl] - benzamide , as an indicator of combined residues of fluopicolide and its metabolite, 2,6 - dichlorobenzamide (BAM), in or on the raw agricultural c ommodity corn, field, forage at 0.09 ppm; corn, field, grain, at 0.0 1 ppm; and corn, field, stover at 0. 3 ppm; resulting from the proposed use as a fungicide. Additional data included in the petition, to a ss ess potential dietary exposure from P1x and PCA, shows no inadvertent residues of P1x or PCA in the corn grain. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism . The metabolism of fluopicolide in crop plants has been repo rted previously

and is adequately

understood for the purpose of granting the proposed tolerances. 2. Analytical method. Practical analy tical methods for detecting and measuring levels of fluopicolide and its metabolites have been developed and validat ed in/on all appropriate plant and animal matrices. An anal yt ical method for detecting fluopicolide and BAM in field corn matrices has been submitted with this petition. The LOQ for both fluopicolide and BAM in the anal yt ical method for field corn is 10 ppb (0.01 ppm), which will allow monitoring for residues at the levels proposed for the tolerances. In addition, an anal yt ical method for detecting P1x and PCA in corn grain (for a ss essing dietary exposure) has been submitted with this petition. The L OQ for both P1x and PCA in corn grain is 20 ppb (0.02 ppm).Valent U.S.A. Corporation

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3. Magnitude of residues . Residue data supporting for the indirect residues of fluopicolide i n field corn have been submitted which adequatel y support the proposed tolerances. B. Toxicological Profile The toxicological profile and toxicological endpoints for fluopicolide and BAM supporting this petition for tolerances was published in the Federal Register on January 30, 2008 (Volume 73, Number 20) and May 28, 2008 (Volume 73 Number 103). A new immunotoxicity

study is available and is being submitted along with the current petition. C. Aggregate Exposure An assessment was conducted to evaluate potential risks due to chronic dietary (food and water) and non - dietary

(residential turf) exposure o f the U.S. population subgroups to residues of fluopicolide for all current and pending indoor and outdoor uses of fluopicolide including Crop Group 1 (Root and Tuber Vegetables), Crop Group 3 (Bulb vegetables), Crop Group 4 (Leafy Vegetables, Except Brass ica ), Crop Group 5 ( Brassica (Cole) leafy

vegetables), Crop Group 8 (Fruiting Vegetables), Crop Group 9 (Cucurbit Vegetables), Grape, Turf, and Ornamentals. Inadvertent residues in rotated corn or processed fractions as described in the current petition, were not included in the anal ys is because the measured residues were very low or not detectible and would therefore have a negligible contribution to the dietary burden. The Cumulative and Aggregate Risk Evaluation Sy stem (CARES) Version 3.0b was used to conduct the fluopicolide dietary and non - dietary

exposure assessments using highly conservative, tolerance - based assumptions. Because fluopicolide is not acutely toxic and not carcinogenic, no acute or cancer exposure assessment was performed. 1. Dietary exposure. i. Food. Dietary

exposure (food) assessments were conducted to evaluate the potential risk due to chronic dietary exposure of the U.S. population and various subgroups to tolerance level residues of fluopicolide in/on the pending new crops (except rotated corn) as well as crops for which there are existing tolerances. Proposed tolerance level residues, default processing values and 100% percent crop treated were used for the assessment.Valent U.S.A. Corporation

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ii. Drinking water. Surface (drinking) water concentrations were calculated by the Environmental Fate and Effects Division (EFED) and can be found in: “Drinking Water Exposure and Assessment for Fluopicolide Uses on Grapes, Vegetables, Potatoes and Turf”. The most conservative value, the 1 - in - 10 year annual mean (non - cancer chronic) derived from modeling fluopicolide used on California lettuce with aerial applications, was used in this dietary

assessment. This value was imported into the CARES Water Module in order to calculate drinking water ri sks. 2. Non
- dietary exposure . There is a potential residential exposure to adults and children entering residential turf areas treated with fluopicolide . The following post application exposure scenarios were evaluated: adults and toddler (children 1 - 2) incidental dermal exposure, and toddler exposure from hand - to - mouth transfer or object to - mouth transfer from pesticide - treated residential areas. A dermal absorption value of 37% was used in the assessment. The amount of material considered availabl e for transfer was 10% with a daily decay rate of 10%. 3. Aggregate Exposure Assessment. The aggregate risk assessment includes food, water and residential turf exposures. An acute risk assessment was not conducted because there was no acute toxicolo gy endpoint identified. For the chronic risk assessment scenarios, the endpoint utilized was 20 mg/kg/day based on the rabbit developmental toxicity

study . No additional FQPA factor was used (1X). For the dietary

(food) chronic 99.9 th percentile expos ure pathway , children ages 1 - 2 were the highest exposed group with 11.8 % cPAD and a MOE of 848. For drinking water, the 99.9 th percentile exposure was highest in infants, yet the %cPAD in all cases was <1% (MOE >26,945). In the case of residential turf exposures, MOEs were greater than 400 for all subpopulations. Based on these risk assessments, the exposure for all routes and all population subgroups do not exceed EPA’s level of concern (<100%cPAD). D. Cumulative Effects Section 408(b)(2)(D)(v) requi res that, when considering whether to establish, modify , or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide’s residues and “other substances that have a common mechanism of toxicity” . EPA does not have, at this time, available data to determine whether fluopicolide has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this tolerance action, EP A has not assumed that fluopicolide has a common mechanism of toxicity

with other substances.Valent U.S.A. Corporation

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E. Safety Determination 1. U.S. population . Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (or any sub - populations) by

including the incremental additional exposure resulting from the proposed uses of fluopicolide. 2. Infants and children . Valent USA concludes that there is a reasonable certainty that no harm will result to the U.S. population (o r any sub - populations) by including the incremental additional exposure resulting from the proposed uses of fluopicolide. F. International Tolerances
. Below is a chart of established fluopicolide tolerances/MRL’s in major countries. **Country Commodity**  **MRL (mg/kg)**  EU Corn/ Maize 0.01* * default MRL s