EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [insert name and telephone number with area 

code] 

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: 

[Gowan Company]

[ PPxxxxxx]

 EPA has received a pesticide petition ([PPxxxxxx]) from [Gowan Company], 

[370 South Main Street, Yuma, Arizona 85364] 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)

 1. by establishing a tolerance for residues of 

 2. to establish an exemption from the requirement of a tolerance for

[flutolanil [N-[3-(1-methylethoxy)phenyl]-2-(trifluoromethyl)benzamide]] in or on 

the raw agricultural commodity [beet, sugar and beet, sugar, tops] at [0.5 & 25] 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; 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 metabolic profile of flutolanil is well understood and 

has been elucidated in three dissimilar crops: peanuts, rice and cucumber. The 

metabolic profile is similar in all crops. The major route of degradation is 4'-0-
2

dealkylation to desisopropylflutolanil (M-4), followed by conjugation. Other 

metabolites may occur at very low levels due to hydroxylation and oxidation of the 

side chain, hydroxylation of the aniline ring, and methylation of the hydroxyl 

groups. These minor metabolites were also subject to conjugation. The residues of 

concern are the parent (flutolanil) and M-4 (desisopropyl flutolanil). 

]

 2. Analytical method. [Residues of flutolanil and its M-4 metabolite in sugar 

beet roots, sugar beet tops, and processed commodities were quantitated by HPLC 

employing tandem mass spectrometric (MS/MS) detection. The analytical method 

used was the Xenos Analytical Method: XAM-65, entitled "LC/MS Determination 

of Flutolanil and its Metabolite (M-4) in Cotton Seed and Corn Grain," dated 

December 18, 2000, with modifications dated January 20, 2009. The method was 

verified on control samples of sugar beet tops and sugar beet roots prior to the 

analysis of RAC field samples and control samples of sugar beet molasses and sugar 

beet dried pulp concurrently with the analysis of processed commodity samples in 

this study. The fortification levels were 0.05 (LOQ) and 0.50 ppm. Method 

verification recoveries ranged from 76 to 107% across all matrices. Analytical 

method performance was monitored through concurrent analysis of freshly fortified 

control samples along with field RAC and processed samples. Due to the small 

number of sugar beet processed commodity samples, they were analyzed 

concurrently with corresponding applicable method verification (molasses and dried 

pulp); therefore, the method verification recoveries for molasses and dried pulp 

served as procedural recoveries as well. Fortification levels ranged from 0.05 

(LOQ) to 20.0 ppm. These samples were extracted and analyzed according to the 

same procedure as the study samples. Procedural recoveries ranged from 82 to 

120% across all matrices. The limit of quantitation (LOQ) was 0.05 ppm and the 

limit of detection (LOD) was defined as approximately 1/3 the LOQ or 0.0167 ppm. 

]

 3. Magnitude of residues. [Insert The results from these trials show that after 

an in-furrow at-planting application and a 44 to 46-day PHI foliar broadcast 

application of Moncut® 70-DF Fungicide at 1.54 lb ai/A/application (1.73 kg 

ai/ha/application) (±5%) residues of flutolanil ranged from not detected (ND) (no 

detectable peak) to 0.217 ppm in/on sugar beet root RAC samples from the twelve 

trial sites. Residues of the flutolanil M-4 metabolite were less than the LOD in/on 

sugar beet root RAC samples from the twelve trial sites. Residues of flutolanil 

ranged from 0.0656 to 17.4 ppm in/on sugar beet top RAC samples from the twelve 

trial sites. Residues of the flutolanil M-4 metabolite ranged from ND to 0.109 ppm 

in/on sugar beet top RAC samples from the twelve trial sites. Total combined 

residues (flutolanil + M-4) ranged from ND to 0.222 ppm in/on the sugar beet root 

RAC samples and from 0.0712 to 17.5 ppm in/on the sugar beet top RAC samples. 
3

Mean combined flutolanil and M-4 residues in/on the decline trial sugar beet root 

RAC samples and the sugar beet top RAC samples declined from 0.0790 to 0.0259 

ppm and 4.96 to 1.05 ppm, respectively, across the 30 to 72 DALA sampling 

intervals. These data indicate that residues do not increase over the 42 day 

sampling period. 

The results from the processing study show that after an in-furrow at-planting 5× 

application and a 45-day PHI foliar broadcast 5× application of Moncut® 70-DF 

Fungicide at 7.7 lb ai/A/application (8.63 kg ai/ha/application) mean combined 

residues of flutolanil and M-4 in/on sugar beet roots were 1.19 ppm. Mean 

combined residues of flutolanil and M-4 in sugar beet refined sugar were 0.125 ppm. 

Mean combined residues of flutolanil and M-4 in sugar beet molasses were 0.362 

ppm. Mean combined residues of flutolanil and M-4 in sugar beet dried pulp were 

0.0814 ppm. A comparison of the residues in the RAC with those in each processed 

fraction indicated that residues of flutolanil and M-4 do not concentrate in refined 

sugar, molasses, or dried pulp (concentrations factors <1).] 

B. Toxicological Profile

 1. Acute toxicity. [Acute toxicity data show that technical grade flutolanil has 

relatively low acute toxicity (Category III and IV). Flutolanil is not a dermal 

sensitizer, primary eye irritant, or primary skin irritant.]

 2. Genotoxicty. [The toxicological database for flutolanil is complete. The 

database contains no evidence of genotoxicity attributable to flutolanil.]

 3. Reproductive and developmental toxicity. [The Agency has set the FQPA 

Safety Factor for flutolanil at 1X because there was no increased sensitivity to 

fetuses as compared to maternal animals in the developmental rat and rabbit studies 

and no increased sensitivity to pups as compared to adults in a multi-generation 

reproduction study in rats.]

 4. Subchronic toxicity. [Subchronic and chronic toxicity studies showed that 

the primary effects of flutolanil are increases in liver weight combined with 

decreases in body weight. The available data for flutolanil do not show neurotoxic, 

carcinogenic, nor mutagenic effects. Flutolanil is not a developmental or 

reproductive toxicant. There is no evidence of increased susceptibility of rat or 

rabbit fetuses to in-utero exposure or rat pups to post-natal exposure to flutolanil. 

No toxic effects were observed in studies in which flutolanil was administered by the 

dermal routes of exposure.] 

 5. Chronic toxicity. [Only a chronic dietary endpoint was identified for 

flutolanil. The Agency has selected a chronic RfD/PAD of 0.50 mg/kg/day (NOAEL 

= 50 mg/kg/day; Uncertainty Factor = 100). This chronic RfD/PAD is based on the 

chronic oral toxicity study in dogs in which increased incidences of clinical signs 

(emesis, salivation, and soft stool) occurred at LOAEL = 250 mg/kg/day following 65 

weeks of exposure.]
4

 6. Animal metabolism. [The metabolism of flutolanil has been extensively 

studied in various species of mammals. Studies in rats, ruminants, and poultry 

suggest that flutolanil is not well absorbed following oral administration. Once 

absorbed, however, it is rapidly metabolized, primarily to desisopropylflutolanil and 

it conjugates, and rapidly excreted via urine and feces.]

 7. Metabolite toxicology. [Flutolanil does not metabolize to a significantly toxic 

metabolite nor does it share a toxic metabolite with any other pesticide registered in 

the U.S.]

 8. Endocrine disruption. [No evidence of endocrine effects has been observed 

in the subchronic, chronic or reproductive studies. The potential for flutolanil to 

cause endocrine effects is not considered relevant.]

C. Aggregate Exposure

 1. Dietary exposure. [ 1. Dietary exposure. Sufficient residue data for flutolanil 

are available to assess tolerances and conduct a dietary risk assessment. No acute 

dietary risk assessment is necessary as no toxic effects from a single oral dose have 

been observed in toxicology studies. A Tier I chronic riskassessment was conducted 

based on the Agency’s cPAD of 0.5 mg/kg bw/day using DEEM-FCID v. 2.16. The 

maximum dietary risk for any dietary subpopulation was a maximum of 2% of the 

cPAD (non-Hispanic, non-white, non-black).]

 i. Food. [A Tier I risk analysis (tolerance level residues assumed with 100% 

crop treated) was run including all proposed tolerances. The addition of ginseng 

(dry) and Brassica leafy vegetables at presumed tolerance levels had a negligible 

effect on chronic dietary risk.]

 ii. Drinking water. [Worst-case drinking water values were included in the 

chronic dietary risk assessment described above. The drinking water residues used 

in the dietary risk assessment were provided by the Ageny in a memorandum (S. 

Abel: “Flutolanil Tier II Estimated Environmental Concentration for Use in the 

Human Health Drinking WaterRisk Assessment, D260066, 12/13/99) The maximum 

drinking water residue of 0.00375 ppm was incorporated in the DEEM-FCID into 

the food categories“water, direct, all sources” and “water, indirect, all sources.”]

 2. Non-dietary exposure. Flutolanil is currently registered for use on the 

following residential non-dietary sites: Turf grass. The risk assessment was 

conducted using the following residential exposure assumptions: There are nonoccupational uses associated with flutolanil. Non-occupational handlers may mix, 

load, and apply flutolanil products on turf grass. These exposures were assessed for 

inhalation risk. Post-application inhalation exposure following turfgrass treatment 

is considered negligible and was not assessed. Because certain flutolanil products 

are registered for use on residential lawns, postapplication exposure to infants may 
5

result in their hand-to-mouth activities on treated turf. The MOE’s for these 

scenarios ranged from 6.7 x 102 to 1.4 x 103. These modeled exposures do not trigger 

the Agency’s Level of Concern.

D. Cumulative Effects

Flutolanil has demonstrated only minimal toxicity in animal studies and the 

mechanism of this toxicity is not known. Flutolanil does not share a mechanism of 

toxicity with another registered pesticide nor does it share a common toxic 

metabolite with any other registered pesticide. There are no available data to 

indicate that flutolanil has a common mechanism of toxicity with other substances.]

E. Safety Determination

 1. U.S. population. [An acute dietary endpoint has not been set for flutolanil 

by the Agency due to a lack of observable toxic effects from a single dose at any level 

tested. A chronic dietary risk assessment has been conducted using the Agency’s 

cPAD of 0.5 mg/kg bw/day. The calculated chronic daily exposure for the general 

US population is 0. 0.002666 mg/kg/bw/day which represents 0.5% of the cPAD.]

 2. Infants and children. The Agency has set the FQPA factor for flutolanil at 

1X based on lack of neurotoxic and teratogenic effects in chronic tests on rabbits 

and rats. The highest chronic risk calculated for any pre-teen dietary subgroup was 

1.4% of the cPAD (non-nursing infants).]

F. International Tolerances

 [There are no national or transnational MRLs for flutolanil on sugar beets: 

root, tops, dried pulp, molasses, refined sugar.]