Document ID: EPA-HQ-OPP-2015-0791-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2016-03-16T04:00Z

October 15, 2015

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

5F8414

Valent USA Corporation
            
 Summary of Petition
      
EPA has received a pesticide petition (Insert Petition Number) 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 0.10 ppm and potato processed waste to 0.25 ppm, potato flakes at 0.15ppm, and potato chips 0.1ppm 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. 
      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, tolerance-based 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 99.9[th] 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.