EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE 

PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

Interregional Research No. 4, Rutgers, The State University of New Jersey, 500 College Road 

East, Suite 201-W, Princeton, NJ 08540

PP# 6E8464

EPA has received a pesticide petition (PP# 6E8464) from Interregional Research Project Number 

4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, 

Princeton, NJ 08540 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:

1) establishing a tolerance for residues of the fungicide fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide], including its metabolites and degradates, in 

or on the raw agricultural commodities: basil, dried leaves at 200 parts per million (ppm); basil, 

fresh leaves at 30 ppm; bean, succulent at 0.9 ppm; citrus, dried pulp at 0.048 ppm; citrus, oil at 

1.94 ppm; hop, dried cones at 15 ppm; fruit, citrus, group10-10 at 0.02 ppm; fruit, small, vine 

climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; and vegetable, fruiting, group 8-

10 at 1.60 ppm; and

2) removing established tolerances for residues of the fungicide fluopicolide [2,6-dichloro-N-[[3-

chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide], including its metabolites and 

degradates, in or on raw agricultural commodity grape at 2.0 ppm and vegetable, fruiting, group 

8 at 1.60 ppm.

EPA has determined that the petition contains data or information regarding the elements set 

forth in section 408 (d)(2) of FDDCA; 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. 

3. Magnitude of residues. Residue data which adequately support the proposed 

tolerances in the proposed crops have been submitted.

B. Toxicological Profile

The toxicological profile and toxicological endpoints for fluopicolide supporting this petition for 
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tolerances was published in the Federal Register on January 30, 2008 (Volume 73, Number 20),

May 28, 2008 (Volume 73 Number 103) and March 5, 2014 (Volume 79, Number 43) for 

rotational corn. The toxicology database for fluopicolide is complete. The chronic reference 

dose (cRfD) of 0.2 mg/kg/day was calculated from the NOAEL of the rabbit developmental 

toxicity study and an uncertainty factor of 100X. Because fluopicolide is not acutely toxic or 

carcinogenic, no acute or cancer exposure assessment was performed. 

The fluopicolide metabolite 2,6-dichlorobenzamide (BAM) was not assessed as the new use 

pattern does not add significantly to the BAM dietary exposure.

C. Aggregate Exposure

1. Dietary exposure.

i. Food. Chronic dietary exposure (food) assessments were conducted by EPA 

Health Effects Division (HED) 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 crops 

for which there are existing tolerances. Details can be found in “Fluopicolide. Chronic 

Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 

Tolerances on Rotational Corn.”, 4/8/2013. Proposed tolerance-level residues, default 

processing values and 100% percent crop treated were used for the Tier I assessment using 

DEEM-FCID Version 3.16. Residues of food or water from uses in the current petition were not 

included in the analysis as they would have a negligible contribution to the dietary burden. 

ii. Drinking water. Surface (drinking) water concentrations were calculated by 

the Environmental Fate and Effects Division (EFED) using PRZM version 3.21/EXAMS version 

2.98. Details can be found in: “Tier II Drinking Water Exposure Assessment for Fluopicolide 

and its Major Degradate, 2, 6-Dichlorobenzamide (BAM) for Use on Potatoes, Carrots, Sugar 

Beets and Brassica (Cole) Leafy Vegetables” 6/20/2010. The modeled chronic (non-cancer) 

exposure concentration of fluopicolide in surface water was estimated to be 0.02414 ppm. 

2. Non-dietary exposure. There is no potential for non-dietary residential exposure from 

uses in the current petition. However, previously registered uses (turf, gardens and golf courses) 

do present the potential for non-dietary exposures. These scenarios have been assessed by EPA 

previously. Details can be found in “Fluopicolide. Human Health Risk Assessment for the New 

Section 3 Tolerances on Rotational Corn”, 5/8/2013.

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.
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E. Safety Determination

FFDCA section 408 provides that EPA shall apply an additional margin of safety, up to ten-fold, 

for added protection for infants and children in the case of threshold effects, unless EPA 

determines that a different margin of safety will be safe for infants and children. The 

toxicological database for evaluating prenatal and postnatal toxicity for fluopicolide is complete 

with respect to current data requirements, and there are no special prenatal or postnatal toxicity 

concerns for infants and children. EPA has concluded that reliable data support reduction of the 

FQPA Safety Factor for protection of infants and children to 1X. 

1. U.S. population. Based on a highly conservative assessment of currently registered 

uses, the chronic dietary exposure estimates result in estimated exposures to the US population 

of 7.6% of the chronic population adjusted dose (cPAD) Chronic aggregate exposures below 

100% of the cPAD are generally considered to represent a reasonable certainty of no harm to 

exposed populations. 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. Based on currently registered uses, total chronic aggregate 

exposure to fluopicolide is conservatively estimated to be 12% of the cPAD for children aged 1-

2 years (the most highly exposed subpopulation). Chronic aggregate exposure below 100% of 

the cPAD is generally considered to represent a reasonable certainty of no harm to exposed 

populations. When dietary exposures are aggregated with non-dietary exposures from treated 

turf and gardens, the overall MOE’s do not exceed the level of concern. Aggregate MOEs 

greater than 100 indicate a reasonable certainty of no harm to exposed populations. 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

Crop MRL (ppm)

EU Korea Turkey

Basil 9 - 9

Citrus Crop Group - 0.7 -

Hops 0.7 0.1 0.02