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-

pyridylmethyl]-benzamide, as an indicator of combined residues of fluopicolide and its 

metabolite, 2,6-dichlorobenzamide (BAM), in or on the raw agricultural commodity corn, 

field, forage at 0.09 ppm; corn, field, grain, at 0.01 ppm; and corn, field, stover at 0.3 

ppm; resulting from the proposed use as a fungicide. Additional data included in the 

petition, to assess 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 reported 

previously and is adequately understood for the purpose of granting the proposed 

tolerances. 

2. Analytical method. Practical analytical methods for detecting and measuring levels 

of fluopicolide and its metabolites have been developed and validated in/on all 

appropriate plant and animal matrices. An analytical 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 analytical 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 analytical method for detecting P1x and PCA in corn grain (for assessing 

dietary exposure) has been submitted with this petition. The LOQ 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 in field corn have been submitted which adequately 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 of 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 Brassica), 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 analysis 

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 System (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 tolerancelevel 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 risks. 

2. Non-dietary exposure. There is a potential residential exposure to adults and 

children entering residential turf areas treated with fluopicolide. The following postapplication exposure scenarios were evaluated: adults and toddler (children 1-2) 

incidental dermal exposure, and toddler exposure from hand-to-mouth transfer or objectto-mouth transfer from pesticide-treated residential areas. A dermal absorption value of 

37% was used in the assessment. The amount of material considered available 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 toxicology 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 99.9th percentile exposure pathway, children ages 1-2 were 

the highest exposed group with 11.8 % cPAD and a MOE of 848. For drinking water, the 

99.9th 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) requires 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, EPA 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 (or 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 MRLs