# i

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 re place 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 flu azifop

- p - butyl in or on the raw agricultural commodity cotton , u ndelin ted 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;2

however, EPA has not fully evaluated the sufficiency of the submitted d a ta at this time or whether the data supports granting of the petition. Additional data may be needed befo re 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 commodi ties 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 sensit ivities 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 4 200 9 (Federal Register Volume 74, No. 41 , March 4, 2009 , pages 9367

- 9 3 73 ). 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 Healt h 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. ]3

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 asses sments 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 pr ocessing 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, pe st, 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, protei n 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 w ater. ]4

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 uncertain t y factor of 100X to account for intra

- and interspecies variations. No additional FQPA safet y 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

- p butyl 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 ag gregate 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 MO E of 9,773 (1.0% of the cRfD of 0.0074 mg/kg

bw/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/kg

bw/day).

Cancer. Fluazifop

- p - butyl has been class ified 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 SCI

GROW which estimates pesticide concentration in ground water and Tier II PRZM/EXAMS which estimates pesticide concentr ation in surface water. EDWCs of fluazifop

- p - acid from the currently registered uses plus the pending uses on bananas,5

citrus, grapes, and sugar beets were determined. Based on the SCI

- GROW modeling, the groundwater EDWC for fluazifop

- p - acid is 0.255 pp b (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 p ending 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 purp oses 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 d ifference 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 o f 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 t hat 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/kg

bw/day). Chronic drinking water exposure to the most exposed sub

- population (infants, <1 year old) res ulted in a MOE of 1,924 (5.2% of the cRfD of 0.0074 mg/kg

bw/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 bot h liquid concentrates and ready

- to

- use (RTU) liquids. Homeowners can apply the liquid formulations using a low

- pressure hand

- wand (LPHW) or a hose

end 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 sprinkler6

attachment or a trigger

- pump sprayer. The homeowner handler and residential post

application 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 po st

- 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 devel opmental 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 (post

application risk); both are above the Benchmark MO E 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 no t 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). A dditionally , 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. ]7

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

- p butyl 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 Swe den. ]