FILE NAME: XXXXX July 10, 2013

EPA Registration Division contact: Tony Kish (703) 308-9443

[3F8191]

Valent USA Corporation

Summary of Petition

EPA has received a pesticide petition (3F8191) 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 revising 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 vegetables, tuberous and corm (subgroup 1C) to 0.30 ppm and 

potato processed waste to 0.3 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, validated, and submitted for all appropriate 

plant and animal matrices -- Valent method RM-43C-1 by liquid chromatography/tandem mass 

spectrometry (LC/MS/MS)

3. Magnitude of residues. Sufficient technical information which adequately supports the 

proposed tolerances in crop group1 C have been submitted to the Agency.
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) and April 20, 2011 

(Volume 76, Number 76). An immunotoxicity study has been submitted to the Agency and is 

currently in review. . The toxicology database for fluopicolide is complete.

C. Aggregate Exposure

Valent USA Corporation has conducted an evaluation to estimate the potential chronic dietary 

exposure of the U.S. population and various subgroups to the revised residues of fluopicolide in 

potatoes. Because fluopicolide is not acutely toxic and not carcinogenic, no acute or cancer 

exposure assessment was performed. 

Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-FCID) version 

2.16 was used to conduct a fluopicolide dietary assessment using highly conservative, tolerancebased assumptions at 1.0 ppm. 

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 and/or its metabolites from currently registered crops and from the 

incremental increase from the proposed revised potato tolerance. Default processing factors and 

100% crop treated were assumed. 

ii. Drinking water. Since fluopicolide application rates do not change from the previous 

assessment conducted by the Agency (U.S. Environmental Protection Agency (EPA). 2010. 

“Fluopicolide and its Metabolite, 2,6-Dichlorobenzamide (BAM). Amended Human Health Risk 

Assessment to Support New Section 3 Uses on Brassica Leafy Greens Subgroup 5B, Potatoes, 

Sugar Beets, Carrots and to Allow Rotation to Wheat. PC Codes 027412 (fluopicolide), 027402 

(BAM), 027401 (dichlobenil). DP Barcode 384431. D.Davis (HED). Office of Pesticide 

Programs, Washington, DC. November 30), no new assessment was conducted.

2. Non-dietary exposure. The proposed revised tolerance will not result in any additional 

non-dietary exposure. 

3. Aggregate Exposure Assessment. The risk assessment includes residues from 

previously approved crop tolerances and the revised potato tolerances at 1.0 ppm. 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 at 1.0 ppm fluopicolide 

equivalents, children ages 1-2 were the highest exposed group with an estimated exposure of 14 
% of the cPAD. 

Drinking water would remain unchanged. Based on this incremental risk assessment, 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 

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.