Document ID: EPA-HQ-OPP-2006-0481-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-02-04T05:00Z

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 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.

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

Valent U.S.A. Corporation	***TO BE UPDATED -- Valent Project VP-30933

Tolerance Petition-Aquatic Herbicide		Page  page  41