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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS 

PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: Kathryn Montague 703-305-1243

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In cases 

where the outline element does not apply, please insert “NA-Remove” and maintain 

the outline. Please do not change the margins, font, or format in your pesticide 

petition. Simply replace the instructions that appear in green, i.e., “[insert company 

name],” with the information specific to your action.

TEMPLATE:

Syngenta Crop Protection, Inc.

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from Syngenta 

Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419 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.

(Options (pick one)

by establishing a tolerance for residues of fluazifop-p-butyl in or on the raw 

agricultural commodity cotton, undelinted seed at 0.9 and cotton, gin by-products

at 0.8 parts per million (ppm). EPA has determined that the petition contains data 

or information regarding the elements set forth in section 408 (d)(2) of FDDCA; 
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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 fluazifop-p-butyl is adequately 

understood for the purpose of the proposed tolerances.]

2. Analytical method. [Syngenta has developed and validated analytical 

methodology for enforcement purposes. This method has been submitted to the 

Agency and is in PAM Vol. II, Method II. An extensive database of method validation 

data using this method on various crop commodities is available.]

3. Magnitude of residues. [Complete residue data to support the requested 

tolerances have been submitted by Syngenta. The data from these studies support the 

requested tolerances. The residue studies were conducted per EPA Test Guidelines 

860.1000 and 860.1500.]

B. Toxicological Profile

[EPA has evaluated the toxicology data and considered its validity, completeness and 

reliability as well as the relationship of the results of the studies to human risk. EPA 

has also considered available information concerning the variability of the sensitivities 

of the major identifiable subgroups of consumers, including infants and children. The 

nature of the toxic effects caused by fluazifop-p-buty, as well as the no observable 

adverse effect levels (NOAEL) and the lowest observed adverse effect levels (LOAEL) 

from the toxicity studies reviewed are discussed in the Federal Register of March 4

2009(Federal Register Volume 74, No. 41, March 4, 2009, pages 9367-9373). Specific 

information on the studies received and the nature of the adverse effects caused by 

fluazifop-p-butyl as well as the no-observed-adverse-effect level (NOAEL) and the 

lowest-observed adverse- effect-level (LOAEL) from the toxicity studies can be found 

at http:// www.regulations.gov in the document Fluazifop-P-Butyl. Amended Human

Health Risk Assessment to Support Use on Dry Beans, Peanuts, and the Post- Bloom 

Application to Soybeans, page 11 in docket ID number EPA–HQ–OPP– 2008–0066.]
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1. Acute toxicity. [NA-Remove]

2. Genotoxicty. [NA-Remove]

3. Reproductive and developmental toxicity. [NA-Remove]

4. Subchronic toxicity. [NA-Remove]

5. Chronic toxicity. [NA-Remove]

6. Animal metabolism. [NA-Remove]

7. Metabolite toxicology. [NA-Remove]

8. Endocrine disruption. [NA-Remove]

C. Aggregate Exposure

1. Dietary exposure. [Acute (Tier III) and chronic (Tier III) dietary exposure 

evaluations were performed for fluazifop-p-butyl using the Dietary Exposure 

Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM, 

version 2.16) from Exponent. All consumption data for these assessments were taken 

from the USDA’s Continuing Survey of Food Intake by individuals (CSFII) with the 1994-

96 consumption database and the Supplemental CSFII children’s survey (1998) 

consumption database. These exposure assessments included all currently registered 

uses for fluazifop-p-butyl including amended cottonseed residue data plus pending 

uses on bananas, citrus fruits, grapes, sugar beets, and imported potatoes. Residue 

data was taken from field trials where fluazifop-p-butyl was applied at the maximum 

intended use rate and samples were harvested at the minimum pre-harvest interval 

(PHI) to obtain maximum residue values. An experimental processing factor of 1.05x 

was used for “refined cottonseed oil” to replace the processing factor for “crude 

cottonseed oil” that had been used in all previous fluazifop-p-butyl assessments, since 

“crude cottonseed oil” is not a relevant processed commodity. Actual and estimated 

percent crop treated (%CT) values based upon economic, pest, and competitive 

pressures were incorporated in these assessments. Anticipated residues in meat and 

milk were calculated by constructing maximum reasonably balanced diets utilizing 

three classes of livestock feedstuffs (carbohydrate concentrate, protein concentrate, 

and roughage) that reflect agricultural feeding practices. Drinking water estimates 

were included directly into the dietary exposure assessment using the higher of the 

estimated drinking water concentrations (EDWCs) for surface and ground water.]
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i. Food. [Acute Risk. The acute assessment was only performed for the females 

(13-49 years old) subpopulation as this subpopulation was the only one for which an 

acute endpoint was determined. The acute dietary risk assessment was performed 

with an acute reference dose (aRfD) of 0.5 mg/kg-bw/day based on an acute no 

observed adverse effect level (NOAEL) of 50 mg/kg/day developmental toxicity study 

in rats and an uncertainty factor of 100X to account for intra- and interspecies 

variations. No additional FQPA safety factor was applied. For the purpose of 

aggregate risk assessment, the exposure value was expressed in terms of margin of 

exposure (MOE), which was calculated by dividing the NOAEL by the exposure for the 

females (13-49 years old) subgroup. In addition, exposure was expressed as a percent 

of the acute reference dose (% aRfD). The EPA generally has no concern for MOEs 

above the benchmark MOE, in this case 100, or for exposures that are less than 100% 

of the aRFD. Acute food exposure from all current and pending uses of fluaifop-pbutyl to the females (13-49 years old) subpopulation resulted in a MOE of 27,799 and 

corresponded to 0.4% of the aRfD (0.5 mg/kg-bw/day).

Chronic Risk. The chronic assessment was run using DEEM-FCIDTM software 

using average field trial residue values and %CT values. The chronic dietary risk 

assessment was performed for all population subgroups with a chronic reference dose 

(cRfD) of 0.0074 mg/kg-bw/day based on a two-generation reproduction study in rats 

with a NOAEL of 0.74 mg/kg/day and an uncertainly factor of 100X to account for 

intra- and interspecies variations. No additional FQPA safety factor was applied. For 

the purpose of the aggregate risk assessment, the exposure values were expressed in 

terms of MOE, which was calculated by dividing the NOAEL by the exposure for each 

population subgroup. In addition, exposure was expressed as a percent of the chronic 

reference dose (% cRfD). The EPA generally has no concern for MOEs above the 

benchmark MOE, in this case 100, or for exposures that are less than 100% of the 

cRFD. Chronic food exposure from all current and pending uses of fluaifop-p-butyl to 

the U.S. population resulted in a MOE of 9,773 (1.0% of the cRfD of 0.0074 mg/kgbw/day). Chronic food exposure to children 1-2 years old, the most exposed 

population subgroup, resulted in a MOE of 4,032 (2.5% of the cRfD of 0.0074 mg/kgbw/day). 

Cancer. Fluazifop-p-butyl has been classified as “not likely carcinogen to 

humans”. Therefore no dietary cancer assessment was performed.]

ii. Drinking water. [The Estimated Drinking Water Concentrations (EDWCs) of 

fluazifop-p-butyl (evaluated as fluazifop-p-acid) were determined using Tier l SCIGROW which estimates pesticide concentration in ground water and Tier II 

PRZM/EXAMS which estimates pesticide concentration in surface water. EDWCs of 

fluazifop-p-acid from the currently registered uses plus the pending uses on bananas, 
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citrus, grapes, and sugar beets were determined. Based on the SCI-GROW modeling, 

the groundwater EDWC for fluazifop-p-acid is 0.255 ppb (acute and chronic) based on 

the currently registered uses on tree fruits (apricots, cherries, nectarines, peaches, 

plums, prunes) and pecans and pending uses on bananas, citrus, and grapes. Based 

on Tier II PRZM/EXAMS modeling for surface water, the pending citrus use provided 

an acute EDWC of 38.807 ppb and a chronic EDWC of 5.566 ppb (adjusted for a 0.87 

Percent Cropped Area, PCA). Since the surface water EDWCs exceed the ground water 

EDWC, the surface water values were used for risk assessment purposes and will be 

considered protective for any ground water concentration concerns.

Acute Exposure from Drinking Water. The acute surface water EDWC of 38.807 

ppb was input into the DEEM-FCIDTM software as “water, direct and indirect, all 

sources” to model the acute drinking water exposures; exposure contributions at the 

99.9%-ile of exposures were determined by taking the difference between the 

aggregate (food + drinking water) exposures and the food (alone) exposures for each 

population subgroup. The EPA generally has no concern for MOEs above the 

benchmark MOE, in this case 100, or for exposures that are less than 100% of the 

aRFD. Acute drinking water exposure to females (13-49 years old), the only 

population subgroup of concern, resulted in a MOE of 13,376 (0.7% of the aRfD of 0.5 

mg/kg-bw/day). 

Chronic Exposure from Drinking Water. The chronic surface water EDWC of 

5.566 ppb was input directly into the DEEM-FCIDTM software as “water, direct and 

indirect, all sources” to model the chronic drinking water exposures. The EPA 

generally has no concern for MOEs above the benchmark MOE, in this case 100, or for 

exposures that are less than 100% of the cRFD. Chronic drinking water exposure to 

the U.S. population resulted in a MOE of 6,308 (1.6% of the cRfD of 0.0074 mg/kgbw/day). Chronic drinking water exposure to the most exposed sub-population 

(infants, <1 year old) resulted in a MOE of 1,924 (5.2% of the cRfD of 0.0074 mg/kgbw/day). ]

2. Non-dietary exposure. [Fluazifop-p-butyl is a selective herbicide used in the 

post-emergent control of grasses in agricultural, ornamental, residential and 

recreational (golf course) settings. A residential exposure and risk assessment was 

performed for fluazifop-p-butyl uses on turf and ornamentals using the endpoints and 

uncertainty factors established by the EPA. The fluazifop-p-butyl end-use products are 

formulated as both liquid concentrates and ready-to-use (RTU) liquids. Homeowners 

can apply the liquid formulations using a low-pressure hand-wand (LPHW) or a hoseend sprayer with either a dial type spray attachment (DTS) or a sprinkler attachment. 

Homeowners can apply the RTU liquids using a hose-end sprayer with a sprinkler 
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attachment or a trigger-pump sprayer. The homeowner handler and residential postapplication exposure and risks were determined based on the highest use rates for all 

lawn and garden products that contain fluazifop-p-butyl. Based on the labels for the 

various products containing fluazifop-p-butyl, there is a potential for residential 

handler exposure from consumers making applications to home lawns and 

ornamentals. There is also a potential for post-application residential exposure to 

adults and children re-entering treated lawns and to adults and youths playing golf on 

treated turf. A short-term incidental oral NOAEL of 100 mg/kg/day and a short-term 

dermal NOAEL of 2 mg/kg/day (both from a developmental toxicity study in rats) were 

used in these residential risk assessments. Combined short-term MOEs were 243 for 

adult handlers (hose-end dial type sprayer) and 250 for children 1-6 years old (postapplication risk); both are above the Benchmark MOE of 100 and do not exceed the 

EPAs level of concern (LOC) of 100.]

D. Cumulative Effects

[Cumulative Exposure to Substances with a Common Mechanism of Toxicity. 

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”. The EPA does not have, at this time, available data 

to determine whether fluazifop-p-butyl 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, the EPA has not assumed that fluazifop-p-butyl

has a common mechanism of toxicity with other substances.]

E. Safety Determination

1. U.S. population. [Using the conservative assumptions described above, and 

based on the completeness and reliability of the toxicity data, current and pending 

uses of fluazifop-p-butyl resulted in acute, short-term and chronic MOEs that do not 

exceed the EPA’s LOC. Generally, the EPA does not have concern for MOEs above the 

benchmark MOE, in this case 100, or for exposures that are less than 100% of the 

acute or chronic RFD. For the current and pending uses, the acute aggregate MOE 

was determined to be 9,030 (1.1% of the aRfD of 0.5 mg/kg-bw/day) for females 13-49 

years old (the only population subgroup of concern). Additionally, a short-term 

aggregate MOE of 243 (LOC = 100) and a chronic aggregate MOE of 3,834 (2.6% of the 

cRfD of 0.0074 mg/kg-bw/day) were determined for the U.S. population. ]
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2. Infants and children. [Acute aggregate exposure calculations were not 

performed for infants and children, since a relevant acute endpoint has not been 

identified for these subgroups. Using the conservative assumptions described above, 

and based on the completeness and reliability of the toxicity data, a short-term 

aggregate MOE of 250 (LOC = 100) was determined for children 1-6 years old, and a 

chronic aggregate MOE of 1,605 (6.2% of the cRfD of 0.0074 mg/kg-bw/day) was 

determined for all infants <1 year old. The MOEs for infants and children therefore do 

not exceed the EPAs LOC (MOE = 100 or cRFD > 100%) for fluazifop-p-butyl. ]

F. International Tolerances

[There are currently no Maximum Residue Limits (MRLs) set for fluazifop-pbutyl for crops by the Codex Alimentarius Commission. International MRLs for the 

herbicide fluazifop-p-butyl have been established for various agricultural commodities 

in a number of countries including Czech Republic, Denmark, Luxembourg, 

Netherlands, and Sweden.]