FILE NAME: XXXXX September 16, 2009

EPA Registration Division contact: Janet Whitehurst (703) 305-6129

[9F7617]

Valent USA Corporation

EPA has received a pesticide petition (9F7617) 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 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 vegetable Brassica (cole), leafy, subgroup 5B, at 20 ppm

resulting from the proposed use as a fungicide. 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 mustard 

greens has been submitted with this petition. The LOQ of fluopicolide and the metabolite in the 

analytical method for mustard greens is 10 ppb (0.01 ppm), which will allow monitoring for 

residues at the levels proposed for the tolerances. 

3. Magnitude of residues. Residue data for the use of fluopicolide on mustard greens has 

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). 

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. 

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 proposed new crops 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.

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 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 pesticidetreated 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.

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 

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 

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)

European 

Union

Leafy Brassicas (Chinese cabbage, pak choi, 

Chinese flat cabbage, peking cabbage, cow 

cabbage, kale, Borecole (curly kale) collards)

0.1*

* temporary EU MRLs