Document ID: EPA-HQ-OPP-2012-0941-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-08-23T04:00Z

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).  



	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
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 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

Valent U.S.A. Corporation		

Notice of Filing																															Page   PAGE  1 

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

Tolerance Petition-Aquatic Herbicide		Page  page  41