Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### UNITED STATES ENVIRONMENTA L PROTECTION AGENCY

WA SHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### MEMORANDUM Date : 2 4 - MAR- 20 1 1 Subject : Saflufenacil in/on Vegetable, Legume, Subgroup 6C, pea and bean (except

soy bean) ; Soy

bean ; Rapeseed Subgroup 20A ; Sunflower Subgroup 20B ; and Cottonseed Subgroup 20C . Summary of Analytical Chemistry and Residue Data . PC Code: 118203 DP Barcode s : D 381129 , D 381977 Decision No s .: 4 36 793, 437943 Registration No . : 7 969 - 278 Petition No s . : 0F7744 , 0F7766 Regulatory Action: Sec. 3 Registration Risk A ss essment Type : NA Case No.: NA T XR No. : NA CAS No.: 372137 - 35 - 4 MRID No s . : 480809 - 01 thru - 06 , 48135201 , 48135202 40 CFR: §180. 649 From : George F. Kramer, Ph.D., Senior Chemist

Sarah J. Levy, Chemist Risk Assessment Branch 1 (RAB1) Health Effects Division (HED) (7509P) Through : Dana M. Vogel , Branch Chief

RAB1/HED (7509P) To : Kathry

n Montague/ Susan Stanton , PM Team 23 Registration Division (RD; 7505P) Executive Summary Saflufenacil (BAS 800 H) is a broad - spectrum herbicide developed by BASF. It belongs to the herbicide mode - of

- action Group 14 (cell membrane disruptors). Saflufenacil acts through the inhibition of protoporphyrinogen oxidase (PPO), resulting in cell memb rane damage and subsequent plant death. SharpenTM 

### Powered b y Kixor Herbicide (EPA Reg. No. 7969 - 278 ), a 2.85 lb ai/gal suspension - concentrate (SC) formulation, is currently registered for use on legume vegetables ( Crop Group 06), the foliage of legume vegetables ( Crop Group 07), cereal grains ( Crop Group 15), the forage, fodder , and straw of cereal grains ( Crop Group 16), cotton , and sunflower . BASF has submitted a proposal to amend the established tolerances for saflufenacil on cotton, dry bean, dry pea , and soy

bean (PP# 0F7744 ) . The amended tolerances on these crops are the result of the proposed harvest aid/desiccation use pattern for SharpenTM 

### Powered b y KixorSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### Herbicide (EPA Reg. No. 7969 - 278 ); the currently- registered uses are for preplant application . In addition, BASF has submitted a proposal for a new use of SharpenTM 

### on rapeseed s ubgroup 20A as harvest aid/desiccant (PP#0F7744). SharpenTM 

### is proposed for up to 2 foliar spray application s with a total maximum application rate of 0.045 lb ai/A as a harvest aid. Applications may be made using ground or aerial equipment, and use of an adjuvant is required. Preharvest intervals (PHIs) of 2 - 5 days are proposed. Concurrentl y, BASF has petition ed for the establishment of permanent tolerances for “ saflufenacil, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of saflufenacil, 2 - chloro - 5 - [3,6 - dihydro - 3 - methyl - 2,6 - dioxo - 4 - (trifluoromethyl ) - 1(2H ) -py rimidinyl] - 4 - fluoro -N

- [[methyl(1 - methylethyl)amino]sulfonyl]benzamide, and its metabolites N

- [2 - chloro - 5 - (2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) -py rimidinyl) - 4 - fluorobenzoyl] -N

' - isopropylsulfamide and N - [4 - chloro - 2 - fluoro - 5 - ({[(isopropylamino)sulfonyl]amino}carbonyl )phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil ” in/on the following raw agricultural commodities (RACs) : PP# 0F 7744 Oilseeds, Cottonseed S ubgroup 20C, gin by products 3.5 ppm Oilseeds, Cottonseed Subgroup 20C, undelinted seed 0.2 ppm Oilseeds, Sunflower Subgroup 20B, seed 1.0 ppm Pea, vines 8.0 ppm Soy bean, aspirated grain fractions 4.52 ppm Soy bean, hulls 0.42 ppm Soy bean, seed 0.1 ppm Vegetable, Legume, Subgroup 6C, beans, dry 0.5 ppm Vegetable, Legume, Subgroup 6C, peas, dry 0.1 ppm PP# 0F 7766 Oilseeds, Rapeseed Subgroup 20A, seed 0.8 ppm The nature of the residue in plants, rotational crops, and livestock is adequately understood based on acceptable metabolism studies conducted on corn (preplant application), soy bean (preplant and preharvest application), tomato (preplant application), rotational crops, lactating goats, and laying hens. In plants, the main reactions involved in the metabolic pathway of saflufenacil are N

demethylation at the uracil ring, stepwise degradation ( N - dealkyl ation) of the N

- methyl -N

isopropyl group, hydrol ytic opening of the uracil ring generating a urea side chain, and hydrox yl ation of the phenyl ring. M800H11 was found in all corn and soybean matrices from both 14 

### C - labeled uracil and 14 

### C - labeled phenylsaflufenacil. M800H11 is formed when saflufenacil undergoes demethylation at both nitrogen atoms. M800H35 was detected onl y after 14 

### C - labeled phenylsaflufenacil treatment and was detected at higher levels in soy bean matrices. M800H35 is formed when parent saflufenacil undergoes demethylation at the sulfonylurea side chain and opening of the uracil ring. The HED Residues of Concern K nowledgebase Subcommittee (ROCKS) determined that residues of concern for the tolerance expression andSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### risk assessment consist of saflufenacil, M800H11, and M800H35 (Memo, B. Daiss, 1/6/09; D 359645 ). An additional major metabolite (M800H02 ) that is not in cluded in the tolerance expression was observed in soy bean seed following post - emergence application . As the structure of M800H02 is closely related to the parent compound and it is the precursor of the regulated metabolite M800H11, HED concludes that M80 0H02 is a residue of concern for riskassessment purposes in seed crops following post - emergence treatment. The metabolism of saflufenacil in rotational crops appears to be consistent with the pathway observed in the plant metabolism studies. The residue s of concern for rotational crops are saflufenacil, M800H11, and M800H35 (Memo, B. Daiss, 1/6/09; D 359645 ). Unless the petitioner requests plantback intervals (PBIs) shorter than 4 months, no additional data are required, and tolerances for inadvertent residues in/on rotational crops need not be established in conjunction with the proposed uses. In livestock, saflufenacil was metabolized by several dealkyl ation steps occurring at two different sites in the molecule ( N - isopropyl -N

- methylsulfamide side ch ain and at the uracil ring) and via hydrol ytic opening of the uracil ring (goat only) . In the ruminant metabolism study, saflufenacil was a major residue in all matrices. M800H04, a ring opening product, was the onl y significant metabolite found (liver). In the poultry metabolism study , saflufenacil was a major residue in all matrices and no significant metabolites were found . The HED ROCKS determined that saflufenacil per se is the only residue of concern in livestock for the tolerance expression and risk assessment (Memo, B. Daiss, 1/6/09; D 359645 ). The petitioner has submitted two liquid chromatography/mass spectroscopy/mass spectroscopy (L C - MS/MS) anal ytical methods for the determination of residues of the parent and its metabolites in/on plant and livestock commodities. BASF Method D0603/02 was developed for determination of residues of saflufenacil and its metabolites M800H11 and M800H35 in different plant matrices using LC - MS/MS. The limit of quantitation (LOQ) was 0.01 ppm for each anal yt e in food matrices (human consumption) and 0.025 ppm for each anal yt e in feed matrices (livestock consumption). BASF analy tical Method No. L0073/01 was developed for determination of saflufenacil in livestock matrices using LC - MS/MS. The LOQ was 0.01 ppm in all matrices. These methods were used as the data - collection methods in the anal ys is of samples for residues of concern from the various studies associated with the current petition. Each method has been adequately validated by

the petitioner as well as by independent laboratories. Method No. L 0073/01 was also adequatel y radiovalidated using weathered samples obtained from metabolism studies. HED has determined that Methods D0603/02 and L0073/01 are suitable enforcement methods for plant and livestock c ommodities, respectively , as defined in Standard Operating Procedure (SOP) No. ACB - 019 (9/15/08). The submitted magnitude of the residue data for the raw and processed commodities of cotton, dry bean, dry pea, canola, and soy

bean are adequate. There are also adequate storage stability data to validate the storage conditions and intervals of samples collected from the field and processing trials. With the exception of soy bean hulls and aspirated grain fractions (AGF s ) , no concentration of the total saflufenacil residue was found in any processed commodity, separate tolerances for residues in/on processed commodities are not required.Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### An adequate dairy

cow feeding study

has been submitted; this study is acceptable for determining tolerance levels for ruminant commodities. The increased reasonably-balanced dietary burdens (RBDBs) resulting from the proposed uses necessitate that the established tolerances be increased to 2.5 ppm for residues in liver and 0.05 ppm for residues in meat by products except liver of c attle, goats, horses, and sheep . Regulatory Recommendations and Residue Chemistry Deficiencies Pending submission of a revised Section F (see requirements under Proposed Tolerances), and the submission of reference standards for the saflufenacil metabolites (see requirements under Submittal of Analy

tical Reference Standards); there are no residue chemistry issues that would preclude granting an unconditional registration for the use of saflufenacil on the requested crops. The proposed uses and the submitted data support: “Tolerances are established for residues of saflufenacil, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of saflufenacil (2 - chloro - 5 - [3,6 - dihydro - 3 - methyl - 2,6 - dioxo - 4 - (trifluoromethyl ) - 1(2H ) -py rimidinyl] - 4 - fluoro -N

- [[methyl(1 - methylethyl)amino]sulfonyl]benzamide) and its metabolites N

- [2 - chloro - 5 - (2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) -py rimidinyl) - 4 - fluorobenzoyl] -N

' - isopropylsulfamide and N - [4 - chloro - 2 - fluoro - 5 - ({[(isopropylamino)sulfonyl]amino}carbonyl )phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil, in or on the commodities.” Cotton, gin byproducts 0.45 ppm Cottonseed Subgroup 20C 0.20 ppm Sunflower Subgroup 20B 1.0 ppm Pea, hay 17 ppm Grain, aspirated fractions 10 ppm Soy bean, hulls 0.50 ppm Soy bean, seed 0.10 ppm Pea and bean, dried shelled, except soybean, subgroup 6C 0.30 ppm Rapeseed Subgroup 20A 0.45 ppm 

### Note to RD: In conjunction with establishing these tolerances, the existing tolerance for “Vegetable, foliage of legume, group 7 ” should be modified to “Vegetable, foliage of legume, group 7 (except pea hay)”; the existing tolerance for “Vegetable, legume, group 6 ” should be replaced with " Vegetable, legume, edible podded, subgroup 6A " plus " Pea and bean, succulent shelled, subgroup 6B "; and the existing tolerances for “ Sunflower, seed ” and " Cotton, undelinted s eed " should be deleted. The proposed uses and the submitted data also support: “Tolerances are established for residues of saflufenacil, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only saflufenacil, 2 - chloro - 5 - [3,6 - dihydro - 3 - methyl - 2,6 - dioxo - 4 - (trifluoromethyl) - 1(2H ) - py rimidinyl] - 4 - fluoro -N

- [[methyl(1 - methylethyl)amino]sulfonyl]benzamide, in or on the commodities.”

Cattle, li ver 2.5 ppm Cattle, meat by

products , except liver 0.05 ppmSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 5 of 43 Goat, liver 2.5 ppm Goat, meat by

products , except liver 0.05 ppm Sheep, liver 2.5 ppm Sheep, meat by

products , except liver 0.05 ppm Horse, liver 2.5 ppm Horse, meat by

products , except liver 0.05 ppm 

### 860.1650 Submittal of Analy tical Reference Standards

 Analy tical standards of saflufenacil, M800H11, and M800H35 are currently available in the National Pesticide Standards Repository [source: personal communication with T. Cole of Anal ytical Chemistry L aboratory

/Biological and Economics Analysis Division (ACL/BEAD) , 10/28/10]. However, since the standards for M800 H11 and M800H35 expired on 10/ 1 /10, the petitioner is requested to provide an updated Certificate of Analysis (COA) or a new supply to the Repository. 860.1550 Proposed Tolerances

 The petitioner is requested to submit a revised Section F specifying the r evised tolerance levels and commodity

definitions are presented in Table 22 (summarized above). A human - health risk assessment is forthcoming in a separate document (DP# 380636 ) . Background Saflufenacil is a broad - spectrum herbicide developed by BASF. It belongs to the herbicide mode - of - action Group 14 (cell membrane disruptors). Saflufenacil acts through the inhibition of PPO, resulting in cell membrane damage and subsequent plant death. Susceptible weeds develop sy mptoms within hours of application under active growing conditions. Plant death occurs within 3 - 5 days depending upon growing conditions. The chemical structure and nomenclature of saflufenacil and its metabolites M800H11 and M800H35 , and the phys icochemical properties of the technical grade of saflufenacil, are presented in Tables 1 and 2. T able 1. Saflufenacil and Metabolite Nom enclature. Chemical Structure

Common name Saflufenacil Company experimental name BAS 800 H (synonyms : AC 433 379, BASF Reg. No. 4054449) IUPAC name N ' - [2 - C hloro - 4 - fluoro - 5 - (3 - methyl - 2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) - pyrimidinyl)benzoyl] -N

- isopropyl -N

- methylsulfamide CAS name 2 - C hloro - 5 - [3,6 - dihydro - 3 - methyl - 2,6 - dioxo - 4 - (trifluoromethyl) - 1(2H ) - pyrimidinyl] - 4 - fluoro -N - [[methyl(1 - methylethyl)amino]sulfonyl]benzamide CAS registry number 372137 - 35 - 4 Cl F N N O

O C H3 F F F O N H S N O O C H

3 C H 3 C H 3Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 6 of 43 T able 1. Saflufenacil and Metabolite Nom enclature. End -use product (EP) SharpenTM Powered by Kixor Herbicide (EPA Reg. No. 7969 - 278 ) ( 2.85 lb ai/gal SC formulation) Chemical Structure

Common name M800H11 Chemical name N - [2 - C hloro - 5 - (2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) -pyrimidinyl) - 4 - fluorobenzoyl] -N

' - isopropylsulfamide Chemical Structure

Common name M800H35 Chemical name N - [4 - C hloro - 2 - fluoro - 5 - ({[(isopropylamino)sulfonyl]amino}carbonyl)phenyl]urea T able 2. Physicochemical Properties of Technical Grade Saflufenacil. Parameter Value Melting point Average = 189.9 ° C, peak max = 193.4 ° C pH 4.43 of 1% solution at 25 ° C Bulk Density (ambient temp.) 0.661 kg/L (free fall), 0.736 kg/L (packed) Water solubility (20°C) in g/100 - mL: 0.0025 in water (pH = 5) ; 0.0014 in pH 4 buffer ; 0.21 in pH 7 buffer ; not determined due to degradation in pH 9 buffer Solvent solubility (20°C) in g/100 - mL: 19.4 acetonitrile ; 24.4 dichloromethane ; 55.4 N,N - dimethylformamide ; 27.5 acetone ; 6.55 ethyl acetate ; 36.2 tetrahydrofuran ; 35.0 butyrolactone ; 2.98 methanol ; 0.25 isopropyl alcohol ; 0.23 toluene ; <0.01 1 - octano l; <0.005 n - heptane V apor pressure at 20/25°C 20 ° C = 4.5 x 10 - 15 Pa 25° C = 2.0 x 10 - 15 Pa Dissociation constant (pKa) 4.41 Octanol/water partition coefficient Mean Log P ow = 2.6 (P ow = 368.3) UV/visible absorption spectrum wavelength maximum: λmax = 271.6 nm extinction coefficient: ε = 9709 L/mol - cm Reference : BA SF Registration Document Number (DocID) 2005/1026464. 

### 860.1200 Directions for Use BASF has submitted draft label s dated 6 /24/ 1 0 for the 2 .85 lb ai/gal SC formulation ( SharpenTM 

### Powered b y Kixor Herbicide (EPA Reg. No. 7969 - 278 ) . Information pertaining to the proposed end - use product is listed in Table 3. A summary of the proposed use patterns on legume vegetables and oilseeds is detailed in Table 4. Cl F N N H O

O F F F O N H S N H O O C H

3 C H 3

Cl F N H O

O N H S N H O O C H

3 C H 3 N H 2Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 7 of 43 T able 3 . Summary of Pro posed End - Use Product s . Trade Name Reg.

No. ai (% of formulation) Form

ulation Ty pe Target Crops Target Pests Label Date SharpenTM Powered by Kixor Herbicide 7969 -

278 29.74 SC legume vegetables, oilseeds Broadleaf

weeds Draft label s

submitted 6/24/10 Table 4. Summary of Directions for Use of Saflufenacil . Applic. Timing, Ty pe, and Equip. Form

ulation [EPA Reg. No.] App. ate

(lb ai/acre ) Max. No.

App. per Season Max. Seasonal

App. Rate (lb ai/acre ) PHI

(days) Use Directions and

Limitations Oilseeds, Rapeseed Subgroup 20A Preharvest Desiccation Broadcast, Ground or aerial SharpenTM

Herbicide 2 . 85 lb/gal S C [ 7969 - 278 ] 0.0225 -

0.045 2 0. 0 45 3 Applications are to be made in ≥ 10 gal/acre ( ground) or ≥ 3 gal/acre ( aerial ) . Oilseeds, Sunflower Subgroup 20B Preharvest Desiccation Broadcast, Ground or aerial SharpenTM

Herbicide 2 . 85 lb/gal S C [ 7969 - 278 ] 0.0225 -

0.045 2 0. 0 90 7 Applications are to be made in ≥ 10 gal/acre ( ground) or ≥ 3 gal/acre ( aerial ) . Oilseeds, Cottonseed Subgroup 20C Preharvest Desiccation Broadcast, Ground or aerial SharpenTM

Herbicide 2 . 85 lb/gal S C [ 7969 - 278 ] 0.0112 -

0.045 2 0. 045 5 Applications are to be made in ≥ 10 gal/acre ( ground) or ≥ 5 gal/acre ( aerial ) . Dry Edible Beans (all Phaseolus, Lupinus and Vigna species, broad bean (fava bean), garbanzo bean (chickpea), guar, lablab bean (hyacinth bean), and lentils) Preharvest Desiccation Broadcast, Ground or aerial SharpenTM

Herbicide 2 . 85 lb/gal S C [ 7969 - 278 ] 0.0225 -

0.045 2 0. 045 2 Applications are to be made in ≥ 10 gal/acre ( ground) or ≥ 3 gal/acre ( aerial ) . Do not graze or feed treated hay or straw to livestock. Dry P ea s (including dry field peas as well as all other Pisum species and pigeon pea) Preharvest Desiccation Broadcast, Ground or aerial SharpenTM

Herbicide 2 . 85 lb/gal S C [ 7969 - 278 ] 0.0225 -

0.045 2 0. 045 3 Applications are to be made in ≥ 10 gal/acre ( ground) or ≥ 3 gal/acre ( aerial ) . Desiccation treated pea vines may be grazed or fed to livestock Soy b eans Preharvest Desiccation Broadcast, Ground or aerial SharpenTM

Herbicide 2 . 85 lb/gal S C [ 7969 - 278 ] 0.0225 -

0.045 2 0. 045 3 Applications are to be made in ≥ 10 gal/acre ( ground) or ≥ 3 gal/acre ( aerial ) . Do not graze or feed treated hay or straw to livestock. Note: Thorough spray coverage and a methylated seed oil (MSO) plus ammonium -based adjuvant system is required for optimum desiccation activity .Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 8 of 43 Table 5. Rotational Crop PBIs for Saflufenacil (fromMaster Label, no changes proposed) . Crop PBI (months) Application rate ( lb ai/acre) 0.0225 0.045 0.067 0. 089 0.112 0.13 4 Corn 0 0 0 0 0 0 Corn, sweet 0 .5 1 2 3 4 4 Sorghum 0 0 0 0 1 1 Small Grains 0 0 0 0 3 3 Chickpea, Field pea, Edible pea 0 0 3 3 6 6 Lentil 1 2 3 4 6 9 Soy bean 1 2 3 4 6 9 Cotton 1 .5 3 4 6 6 9 Other Crops 4 5 6 7 8 9 

### Conclusions : The submitted use directions for SharpenTM 

### Herbicide are adequate to allow evaluation of the residue data relative to the proposed use s . 860.1300 Nature of the Residue - Plants DER Reference List : Soy bean ( 48080901 .der.doc) 

### Soybean The metabolism of saflufenacil was investigated in soy bean following a single post - emergent spray of [uracil - 4 - 14 

### C] - saflufenacil to soy bean plants at BBCH growth stage 87 - 89 at an application rate of 0.089 lb/A (2X) . Soy bean matrices (stem, pod, seed, and leaves) were sampled 7 days after application. The soy bean plants were cultivated in containers in climatic chambers (phytotrons) under simulated conditions for a typical U.S. so ybean growing area. The interval of frozen storage of samples for both labels was supported b y the re - extraction and anal ys is of soy

bean seed and leaves samples at the end of the analy tical phase. 14 

### C - Residues in homogenates of so ybean stem, pod, seed, and leaves were extracted sequentiall y three times with methanol (3x) and two times (2x) with water. The unextractable residues after solvent extraction were subjected to solubilization procedures with 1% aqueous ammonia followed b y incubation with macerozyme/cellulase, amylase/amyl oglucosidase, ty rosinase/laccase, and HCl (seed only). The acc ountabilities, calculated as (total extractable + total unextractable)/(calculated total radioactive residue) x 100, were acceptable ranging from 86 - 99%. The radioactivity

in extracts was determined by liquid scintillation counting (L SC). Solid samples were oxidized prior to analysis. The identity of residues in the purified methanol extracts were confirmed by LC - MS and LC - MS/MS analyses. Additional metabolites were identified/characterized by co - chromatography and comparison of retention times with th e respective radiolabeled reference standards; and by comparison of the metabolite profiles. The total radioactive residues (TRR) in soy bean matrices were determined directly by combustion analyses and indirectly by the sum of the extractable and unextractable 14 

### C - residues. The TRR were similar using either method of determination. The TRRs, as determined b y direct combustion analyses, were 19.6 ppm (leaves), 1.74 ppm (pod), 0.412 ppm (stem), and 0.049 ppmSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### (seed). The TRR, determined indirectly by the summation of the extractable and unextractable residues, were 17.9 ppm (leaves), 1.86 ppm (pod), 0.419 ppm (stem), and 0.043 ppm (seed). All calculations throughout the soy bean metabolism study

were based on TRR calculated. The major residues (>10% TRR) identified in soybean leaves were saflufenacil ( 63.8 % of the TRR; 11.4 ppm), M800H02 ( 15.2 % of the TRR; 2.72 ppm), and M800H01 (13.6% of the TRR; 2.44 ppm). In soy

bean seed , the major residues identified were saflufenacil ( 26.1 % of the TRR; 0.011 ppm), M8 00H02 ( 26.3 % of the TRR; 0.011 ppm), and M800H11 ( 10.9 % of the TRR; 0.004 ppm). The only

major residue identified in soy bean pod was saflufenacil (76.4% of the TRR; 1.42 ppm). In soy

bean stem , the major residues identified were saflufenacil (73.2% of the TRR; 0.306 ppm) and M800H02 (18.2% of the TRR; 0.076 ppm). These results are summarized in Table 6. Table 6 . Summary of Characterization and Identification of Radioactive Residues in Soybean Matrices

Following a 2X Post- em ergence Treatment with [Uracil- U 14 C] - Saflufenacil. Compound Stem Pod Seed Leaves TRR = 0.419 ppm TRR = 1.859 ppm TRR = 0.043 ppm TRR = 17.92 ppm ppm % TRR ppm % TRR ppm % TRR ppm % TRR Saflufenacil 0.306 73.2 1.420 76.4 0.011 26.1 11.431 63.8 M800H01 - - 0.048 2.6 - - 2.441 13.6 M800H02 0.076 18.2 0.115 6.2 0.011 26.3 2.716 15.2 M800H03 - - 0.010 0.6 - - 1.589 8.9 M800H11 0.031 7.5 0.054 2.9 0.004 10.9 0.952 5.3 Total identified + characterized 0.420 100.3 1.769 95.1 0.036 84.6 19.493 108.8 Unextractable (PES) 1 0.009 2.0 0.061 3.3 0.002 5.1 0.103 0.6 1 Residues remaining after exhaustive extractions. 

### The proposed metabolic pathway of radiolabeled saflufenacil in soy bean following post emergence treatment is outlined in F igure 1 and can be described as:

 N - demethylation of the 3 - methyl group of the uracil ring to form M800H02 ;  N - demethylation of the N

- isopropyl -N

- methylsulfamide side chain to generate M800H01 and elimination of the respective N - isopropyl group to generate M800H03 ; and  Demethyl ation of the N - isopropyl -N

- methylsulfamide side chain and Ndemethylation of the uracil ring to generate M800H11.Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### FI GURE 1. Metabolic Profile of Saflufenacil in Soybean following Post- emergence

Treatment .

Conclusions : The previously- submitted metabolism data for corn, so ybean, and tomato were adequate to elucidate the nature of the residue in plants resulting from pre -plant/pre - emergence application. The main reactions involve d in the metabolic pathway of saflufenacil were N

demethylation at the uracil ring , s tepwise degradation ( N - dealkyl ation) of the N

- methyl -N

isopropyl group, hydrol ytic cleavage of the uracil ring generating a urea side chain , and hydrox yl ation of the phenyl ring. The HED ROCKS determined that residues of concern for the tolerance expression and risk assessment consist of saflufenacil, M800H11, and M800H35 (Memo, B. Daiss , 1/ 6 /0 9 ; D 359645 ) . The proposed metabolic pathway of radiolabeled saflufenacil in soy

bean following post - emergence treatment follows the same initial pathways, but is not as extensive (comparison of Figure 1 with Figure 2). No new metabolites were observed following post - emergence treatment ; however, an additional major metabolite (M800H02 ) , that is not included in the toleran ce expression , was observed in soy bean seed . As the structure of M800H02 is closely related to the parent compound and it is the precursor of the regulated metabolite M800H11, HED concludes that M800H02 is a residue of concern for risk-Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### assessment purposes in seed crops following post - emergence treatment. FI GURE 2. Metabolic Profile of Saflufenacil in Soybean following Pre - emergence

Treatment .

F C l N N O O F F F O N S N O O H H M 8 00H03 F C l N N O O F F F O N S N O O H BAS 800 H

F C l N N O O F F F O N S N O O H H M 8 00H 0 1 F C l N N O O F F F O N S N O O

H H

M 8 00H02

F C l N N O O F F F O N S N O O

H H H

M 8 00H 1 1 F C l N N O O F F F O N S N O O

H H

O H

M 8 00H 3 6

F N C l

O N S N H 2 N O

O F F F H O O M 8 00H05 F C l N N O O F F F O N S N H O O

H H

M 8 00H10 O O H F F F M 8 00H 2 9

F C l N N H 2 O O N S N O O H H H M 8 00H35 F C l N O O N S N O O H H N H M 8 00H 37



### soil metabolitesSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### 860.1300 Nature of the Residue - Livestock Conclusions : No new livestock metabolism data were submitted with these petitions. The previously- submitted goat and poultry metabolism data are adequate to satisfy data requirements. Saflufenacil was metabolized by several dealkylation steps occurring at two different sites in the molecule (

N - isopropyl -N

- methylsulfamide side chain and at the uracil ring) and via hydrol ytic opening of the uracil ring (goat only) . In the ruminant metabolism study , s aflufenacil was a major residue in all matrices. Onl y M800H04 , a ring opening product, exceeded 10% of the TRR and 0.05 ppm (liver; 14.2% of the TRR, 0.543 ppm). Inthe poultry metabolism study , s aflufenacil was a major residue in all matrices and no metabolites exceeded 10% of the TRR and 0.05 ppm. The HED ROCKS determined that saflufenacil per se is the only residue of concern for the tolerance expression and risk assessment ( Memo , B. Daiss , 1/6/09; D 359645 ) . Th e decision to exclude the plant metabolites M800H11 and M800H35 as residues of concern in livestock w as based on the low potential for exposure associated with the previously proposed uses and should be reevaluated if additional proposed uses result in a significant increase in the livestock dietary

burden. The post - emergence uses proposed w ith action do result in a significant increase in the livestock dietary burden ; however, metabolites M800H11 and M800H35 are not major residues in soy beans following a desiccation application. M800H02 does not need to be included as a residue of concern a s its concentration in soy bean leaves is 4 - 5X lower than the parent compound. HED thus concludes that saflufenacil per se is still the only residue of concern for the tolerance expression and risk assessment in livestock . 860.1340 Residue Analytical Methods BASF Method D0603/02 is the current enforcement method for determination of residues of saflufenacil and its metabolites M800H11 and M800H35 in different plant matrices. Residues of saflufenacil and its metabolites M800H11 and M800H35 were extracted from non - oily crop matrices with methanol:water (70:30; v:v). The methanol extract, or in some matrices the concentrated methanol extract, was partitioned with a mixture of ethyl acetate - cyclohexane (70:30; v:v) and 0.1% trifluoroacetic acid (TFA) . An aliquot of the organic phase was evaporated and reconstituted in methanol:water (50:50; v:v) for LC - MS/MS analysis. Oil y crops were extracted with methanol:water (70:30; v:v) and pre -partitioned with isooctane. An aliquot of the aqueous methanol phase or the concentrated methanol phase was partitioned with a mixture of ethylacetate - cyclohexane (70:30; v:v) and 0.1% TFA. An aliquot of the organic phase was evaporated and reconstituted in methanol:water (50:50; v:v) for LC - MS/MS quantitation. For the r esidues in oil matrices (corn oil), samples were extracted with acetonitrile. Following partitioning of the acetonitrile extract with isooctane (3 times), an aliquot of the acetonitrile layer was diluted with methanol - water (50:50; v:v) for LC - MS/MS deter mination. Two transitions per anal yte were monitored for the quantitation and confirmation of saflufenacil, M800H11 and M800H35. The residues of each analy te were expressed as parent equivalents using a molecular weight conversion factor (1.0 for saflufenacil, 1.06 for M800H11 , and 1.42 for M800H35). The LOQ was 0.01 ppm for each analy te in food matrices (human consumption) and 0.025 ppm for each analy te in feed matrices (livestock consumption). The limit of detection (LOD) was not tested, but set at 20 % of LOQ. Recovery samples, prepared at levels of LOQ and 10 X LOQ in each matrix, were generally within the acceptable range of 70 - 120%. The method detector response was determined to be linear in the range of 0.05 - 0.5 ng/mL (r ≥0.98).Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### 860.1360 Multir esidue Methods (MRM) Saflufenacil and its metabolites M800H11 and M800H35 were screened through the MRM described in the United States Food and Drug Administration (FDA) Pesticide Anal ytical Manual, Vol. I (PAM I). Saflufenacil and the metabolites were t ested using procedures outlined in Protocols B, C, D, E , and F of the MRM. All Protocols B, C, D, E , and F were found to be unsuitable for determination of residues of saflufenacil and its metabolites M800H11 and M800H35. Since the analy tes are not N

- methyl - carbamates, naturally fluorescent or substituted urea derivatives, the tests using Protocol A and G were not performed. 860.1380 Storage Stability Plant commodities DER Reference List 47523801 .der.doc 

### Samples of corn (forage, grain , and stover), garbanzo bean (chickpea), orange (fruit, juice, oil , and pulp), radish roots, grape (raisin) , and so yb ean (forage, hay , and seed) were fortified separately with saflufenacil, M800H11 , and M800H35 at a level of 1.0 ppm each and were stored at < - 5oC for a duration of 0, 44, 130, 214, 410 - 422 , and 548 - 553 days (approximately 0, 1.5, 4.3 , and 7.1, 13.7 - 14.1 , and 18.3 - 18.4 months). The samples were analysed for residues of saflufenacil and the metab olites M800H11 and M800H35 by LC - MS/MS using BASF Analy tical Method Number D0603/02. The freezer storage stability results were corrected for mean concurrent recovery

values obtained from freshl y fortified samples. Under these conditions , residues of saflufenacil and its metabolites M800H11 and M800H35 are stable in/on corn (grain, forage, stover); soy bean (seed, forage, hay); orange (fruit, pulp, juice , oil); radish (root); grape (raisin); and garbanzo bean (seed) commodities during frozen storage for up to 548 days. Sample storage conditions and intervals The storage intervals and conditions of samples from the residue field trials, rotational crop field trials , and processing studies which were submitted to support this petition are presented in Table 7 . Table 7 . Summary of Stor age Conditions and Intervals of Samples fromCr op Field Trial, Processing, and

Field Rotational Crop Studies. Matrix Storage Tem perature (°C) Actual Storage Duration for Most Samples Interval of Demonstrated Storage Stability Dry Bean (M RID 48080902 ) Bean, D ried S eed < - 5 69 - 163 days 548 days Dry Pea (M RID 48080903 ) Pea, dried seed (dried shelled peas) < - 5 122 - 189 days 548 days Pea, vines 151 - 269 daysSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 14 of 43 Table 7 . Summary of Stor age Conditions and Intervals of Samples fromCr op Field Trial, Processing, and

Field Rotational Crop Studies. Matrix Storage Tem perature (°C) Actual Storage Duration for Most Samples Interval of Demonstrated Storage Stability So yb e an (M RID 48080904 & 48080905 ) Soybean , s eed (dried) < - 5 93 - 181 days 548 days Flour, Hulls , Meal , Refined Oil , Soy milk , Tofu , AGFs 15 - 30 days Canola (M RID 48135201 & 48135202 ) Canola , s eed (dried) < - 5 Maximum, 299 days 548 days Meal , Refined oil 98 - 217 days Cotton (M RID 48080906 ) Undelinted s eed and gin byproducts < - 5 214 days 548 days Hulls , Meal , Crude oil , Refined oil 112 days 

### Conclusions : Adequate storage stability data have been submitted. Residues of saflufenacil, M800H11 , and M800H35 

### were stable (<30% degradation) in all plant matrices during freezer storage for up to 54 8 days. These data support the storage conditions and intervals of samples collected from the various crop field trials. There are no unresolved s torage stability issues , and no corrections need to be applied to the various magnitude of the residue studies . 860.1480 Meat, Milk, Poultry, and Eggs Livestock dietary

burdens The potential for secondary transfer of saflufenacil residues of concern in meat, milk, and eggs exists because there are livestock feedstuffs associated with the existing and proposed uses. The livestock dietary

burdens of saflufenacil and its metabolite s are presented in Table s 8a - 8d and reflect the most recent guidance from HED ( June , 2008 ) concerning revisions of feedstuff percentages in Table 1 and constructing RBD B s. The calculated total dietary burdens of saflufenacil and its metabolites (based on tolerance - level residues) are 0.1 3 ppm for beef cattle, 0.77 ppm for dairy

cattle, 0.27 ppm for poultry , and 0.18 ppm for swine . Table 8 a. Beef Cattle Dietary Burden Contribution for Saflufenacil . Feedstuff Ty pe 1 Tolerance (ppm) % Dry

Matter % Diet2 Dietary Contribution (ppm) 3 Target % Diet Roughage 15 Corn, field, forage R 0.10 40 1 0 0.0 25 Cotton, gin byproducts R 0.45 90 5 0.025 Target % Diet Carbohydrate Concentrate 80 Corn, field, grain CC 0.03 88 80 0.027 Target % Diet Protein Concentrate 5 Sunflower meal PC 1.0 92 5 0.054 TOTALS 100 0.1 3Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 15 of 43 Table 8 b. Dairy Cattle Dietary Burden Contribution for Saflufenacil. Feedstuff Ty pe 1 Tolerance (ppm) % Dry

Matter % Diet2 Dietary Contribution (ppm) 3 Target % Diet Roughage 45 Field pea, hay R 4.88 4 8 8 10 0 . 55 Corn, field, forage R 0.10 40 3 5 0.0 9 Target % Diet Carbohydrate Concentrate 45 Corn, field, grain CC 0.03 88 45 0.015 Target % Diet Protein Concentrate 10 Sunflower meal PC 1.0 92 10 0.11 TOTALS 100 0 . 77 Table 8 c. Poultry Dietary Burden Contribution for Saflufenacil. Feedstuff Ty pe 1 Tolerance (ppm) % Dry

Matter % Diet2 Dietary Contribution (ppm) 3 Target % Diet Carbohydrate Concentrate 75 Corn, field, grain CC 0.03 -- 75 0.022 Target % Diet Protein Concentrate 25 Sunflower meal PC 1.0 -- 25 0.25 TOTALS 100 0.27 Table 8 d. Swine Dietary Burden Contribution for Saflufenacil . Feedstuff Ty pe 1 Tolerance (ppm) % Dry

Matter % Diet2 Dietary Contribution (ppm) 3 Target % Diet Carbohydrate Concentrate 85 Corn, field, grain CC 0.03 -- 85 0.026 Target % Diet Protein Concentrate 15 Sunflower meal PC 1.0 -- 15 0.15 TOTALS 100 0.18 1 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate. 2 OPPTS 860.1000 Table 1 Feedstuffs ( June 200 8 ). 3 D ietary c ontribution = tolerance ÷ % dry matter x % diet ( for poultry and swine % dry matter is not considered) . 4 The maximum residue for pea hay ( 4.88 ppm) was used in these calculations due to the large difference as compared to the recommended tolerance (17 ppm). This process will allow harmonization with Canadian MRLs. 

### Dairy cattle feeding study Saflufenacil was administered orally in treated feed to 14 Friesian dairy cows for 28 - 29 consecutive days (Table 9) . The target doses were 0.1 ( 0. 13 X), 0.3 ( 0. 39 X ), and 1.0 ppm ( 1 . 3 X) . In whole milk samples, residues of saflufenacil were <0.01 ppm (< LOQ ) over the entire 28 - to 29 - day dosing period. Residues of saflufenacil did not concentrate in samples of skim milk (<0.01 ppm) or cream (<0.01 ppm). In tissues, residues of saflufenacil were not quantifiable in fat (<0.01 ppm) or muscle (<0.01 ppm). There was a linear relationship between the feeding level and residues of saflufenacil in kidney and liver. Residues of saflufenacil in kidney were <0.01 ppm at the 0.1 -ppm dose level, 0.02 ppm at the 0.3 -ppm dose level and ranged from 0.03 ppm to 0.04 ppm at the 1.0 -ppm dose level. In liver, residues of saflufenacil ranged from 0.17 ppm to 0.26 ppm at the 0.1 -ppm dose level, 0.67 ppm to 0.88 ppm at the 0.3 -ppm dose level , and from 2.09 ppm to 3.49 ppm at the 1.0 -ppm dose level.Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### Following withdrawal of the dose, residues of saflufen acil were <0.01 ppm (<LOQ) in samples of whole milk, muscle , and fat on day 30 and day

35 of the study . In kidney , residues of saflufenacil decreased from 0.03 ppm at day 30 to <0.01 ppm at day

35. In liver, residues of saflufenacil decreased from 1.66 ppm at day 30 to 0.34 ppm at day

35. Half lives of 2.5 and 4.0 days were calculated for saflufenacil residues in liver and kidney , respectively . Table 9 . Summary of Residue Data fromRuminant F eeding Study with Saflufenacil. 1 Matrix Target Feeding Level (ppm) Residue Levels (ppm)

n Min. Max. Median Mean Std. Dev. Whole milk/day 1 - 28/29 Skim milk/day 22 Cream/day 22 0 3 <0.01 <0.01 <0.01 <0.01 0 0.1 ( 0. 13X ) 3 <0.01 <0.01 <0.01 <0.01 0 0.3 ( 0. 39X ) 3 <0.01 <0.01 <0.01 <0.01 0 1.0 ( 1.3X ) 5 <0.01 < 0.01 <0.01 <0.01 0 Fat 0 3 <0.01 <0.01 <0.01 <0.01 0 0.1 ( 0. 13X ) 3 <0.01 <0.01 <0.01 <0.01 0 0.3 ( 0. 39X ) 3 <0.01 <0.01 <0.01 <0.01 0 1.0 ( 1.3X ) 3 <0.01 <0.01 <0.01 <0.01 0 Muscle 0 3 <0.01 <0.01 <0.01 <0.01 0 0.1 ( 0. 13X ) 3 <0.01 <0.01 <0.01 <0.01 0 0.3 ( 0. 39X ) 3 <0.01 <0.01 <0.01 <0.01 0 1.0 ( 1.3X ) 3 <0.01 <0.01 <0.01 <0.01 0 Liver 0 3 <0.01 <0.01 <0.01 <0.01 0 0.1 ( 0. 13X ) 3 0.17 0.26 0.19 0.21 0.047 0.3 ( 0. 39X ) 3 0.67 0.88 0.76 0.77 0.105 1.0 ( 1.3X ) 3 2.09 3.49 2.25 2.61 0.77 Kidney 0 3 <0.01 <0.01 <0.01 <0.01 0 0.1 ( 0. 13X ) 3 <0.01 <0.01 <0.01 <0.01 0 0.3 ( 0. 39X ) 3 0.02 0.02 0.02 0.02 0 1.0 ( 1.3X ) 3 0.03 0.04 0.04 0.037 0.006 1 The LOQ for saflufenacil in all matrices analyzed was reported as 0.01 ppm. 

### Expected s econdary res idues in m eat and milk To determine the need for tolerances for saflufenacil residues in milk and tissues, the anticipated secondary residues in cattle matrices were estimated using transfer coefficient factors calculated from the maximum residues of saflufenacil observed in the ruminant feeding study . The transfer coefficients (calculated as residue - level - to - feed ratios) are presented in Table 10 . The transfer coefficient for each matrix was then used to calculate the expected secondary residues by multiplying the transfer coefficient by the calculated dietary

burden (Table 8 b ) . Table 10 . Residue - Level- to - Feed Ratios (Transfer Coefficients) in Dairy Cattle Milk and Tissues . 1 Matrix Maximum Residue

(ppm) Feeding Level, ppm Transfer Coefficient Milk/Cream <0.01 1.0 <0.01 Fat <0.01 <0.01 Muscle <0.01 <0.01 Kidney 0.02 0.3 0.067 Ave. = 0.054 0.04 1.0 0.04 Liver 0.26 0.1 2.6 Ave. = 3.0

0.88 0.3 2.9 3.49 1.0 3.49 1 Calculated from the maximum residues divided by the do s e level.Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 17 of 43 Table 11 . Expected Secondary Residues in Meat and Milk. Matrix Dietary burden

(ppm) Secondary Residues

(ppm) 1 Establish ed Tolerance (ppm) Recommended

Tolerance (ppm) Milk 0.77 <0.0 077 0.01 0.01 Fat <0.0 077 0.01 0.01 Kidney 0. 042 0.02 2 0. 0 5 2 Muscle <0.0 077 0.01 0.01 Liver 2.3 0.80 2. 5 1 Calculated from dietary burden x average transfer coefficient from Table 10 . 2 M eat byproducts, except liver . 

### Conclusions : The feeding study data indicate that the established tolerances should be increased to 2. 5 ppm for residues in liver and 0. 0 5 ppm for residues in meat b yproducts except liver ; and do not need to be increased in fat and meat of cattle, goats, horses, and sheep, and in milk . The tolerances for hog commodities do not nee d to be increased as the hog RBDB did not increase. P oultry feeding study waiver request HED previousl y agreed to waive the data requirement for a poultry feeding study . As the poultry RBDB is unchanged by

the proposed new used, this waiver is still a ppropriate . 860.1500 Crop Field Trials Dry Bean DER Reference List 48080902 .der.doc 

### BASF Corporation has submitted field trial data for saflufenacil on dried shelled beans ( Phaseolus spp.). Ten bean field trials were conducted in North American Free Trade Agreement (NAFTA) Growing Zones 5 (MO, ND, IA, and WI ; one trial each), 7 (ND, one trial), 7A (AB, one trial), 8 (KS, one trial), 9 (UT, one trial), 10 (CA, one trial), and 11 (ID, one trial). Each trial location consisted of one untreated and one treated plot. Each treated plot received a single harvest aid/desiccant broadcast application of the 70% WG formulation of saflufenacil (BAS 800 00 H) at 0.044 - 0.046 lb ai/A ( 1X) . The app lications were made using ground equipment with 16 - 30 gal/A spray volumes. An adjuvant (methylated seed oil, Merge TM 

### ) was included in the spray

mixture, together with ammonium sulfate fertilizer. Samples of mature dried seed were harvested at a 2 - day PHI. At one trial in ID , additional treated samples were collected at 0, 1, 7, and 10 days after the last application to evaluate residue decline. The results from these trials on bean show that after a single harvest aid/desiccant broadcast application of saflufenacil applied as a harvest aid/desiccant targeting 0.045 lb ai/A, maximum saflufenacil residues were 0.23 ppm in/on bean dried seed samples harvested at a 2 - day PHI; M800H11 and M800H35 residues were below the LOQ (<0.01 ppm each) in/on all samples (Table 12). Maximum combined residues of saflufenacil in/on dried seed were <0.25 ppm at the 2 - day PHI. In the residue - decline experiment, after an initial increase during the period immediatelySaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### following application, saflufenacil residues decrea sed at longer post - treatment intervals. Mean saflufenacil residues in/on bean , dried seed , were 0.01 ppm on the day of the application, were 0.03 ppm at 1 DAT, were a maximum of 0.10 ppm at 2 DAT, and declined to 0.03 ppm at 7 and 10 DAT; M800H11 and M800 H35 were <0.01 ppm each in all samples at all sampling intervals. Table 12 . Summary of Residue Data fromCrop Field Trials with Saflufenacil. Commodity Total Applic.

Rate (lb ai/A) [kg ai/ha] PHI

(days) Analyte Residue Levels (ppm) 1

n Min. Max. HAFT 2 Median Mean Std. Dev. Bean, Dried , S eed 0. 044 - 0.0 46

[0.0 4 9 - 0.0 5 2] 2 Saflufenacil 20 <0.01 0.23 0.16 <0.01 0.05 0.07 M800H11 20 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 M800H35 20 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Combined 3 20 <0.03 <0.25 < 0.18 <0.03 <0.07 0.07 1 For calcu lation of the HAFT, median, mean, and standard deviation, seed residue values of <0.01 ppm ( <LOQ) were considered to be 0.01 ppm (LOQ) . 2 HAFT = highest - average field trial. 3 Combined residues of saflufenacil (parent + M800H11 + M800H35). 

### Conclusions : The submitted residue data are adequate to fulfill data requirements for dried shelled beans as a representative crop of Crop Subgroup 6C , Dried shelled pea and bean (except soy bean) subgroup . The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 13 ) . The available data will support the proposed use pattern. Table 13. Trial Numbers and Geographical Locations . NAFTA Growing Zones Bean (dried shelled beans) Submitted Requested 1 Canada U.S. 1 1 /0 5 4 4 5 /4 7 1 2 /1 7A 1 1 8 1 1 /1 9 1 1 /1 10 1 1 /1 11 1 1 /1 Total 10 5 12 /9 1 As required under US EPA OPPTS 860.1500 for dried bean, and PMRA Directive 98 - 2. 2 The second number is used when the representative commodity is used to obtain a crop group tolerance . 

### The residue data for dried shelled beans were entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data ; see Appendix II . The recommended tolerance for the combined residues of saflufenacil and its metabolites M800H11 and M800H35 , expressed as parent equivalents, is 0.3 0 ppm for Crop Subgroup 6C , Dried shelled pea and bean (except soy bean) subgroup. Dry Peas DER Reference List 48080903 .der.doc 

### BASF Corporation has submitted field trial data for saflufenacil on dried shelled pea s ( PisumSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 19 of 43 

### spp.). Nine pea field trials were conducted in NAFTA Growing Zones 5 (ND and WI ; one trial each), 11 (ID, two trials; OR, one trial), and 14 (AB and MB, one trial each; SK, two trials). Each trial location consisted of one untreated and one treated plot. Each treated plot received a harvest aid/desiccant broadcast application of the 70% WG formulation o f saflufenacil (BAS 800 00 H) applied at 0.044 - 0.046 lb ai/A ( 1X). The applications were made using ground equipment with 19 - 33 gal/A spray

volumes. An adjuvant (methylated seed oil, Merge TM 

### ) was included in the spray mixture, together with ammonium sulfate fertilizer. Samples of mature pea seed and vines were harvested at a 2 - to 4 - day PHI. At one trial in ID , additional treated samples were collected at 0, 1, 7 , and 10 days after the last application, to evaluate residue decline. The results from thes e pea trials show that after a single harvest aid/desiccant broadcast application of saflufenacil (70% WG, BAS 800 00 H) targeting 0.045 lb ai/A, maximum saflufenacil residues were 0.05 ppm in/on pea dried seed samples harvested at a 2 - 4 day PHI; M800H11 and M800H35 residues were below the LOQ (<0.01 ppm each) in/on all samples (Table 14) . Maximum combined residues of saflufenacil in/on dried seed were <0.07 ppm at the 2 - to 4 - day

PHI. Maximum residues of saflufenacil, M800H11, and M800H35 were 4.83, 0.13 , and <0.025 ppm, respectively , in/on pea vines harvested at a 2 - to 4 - day PHI after a single broadcast foliar application of saflufenacil (70% WG, BAS 800 00 H) targeting 0.045 lb ai/A. Maximum combines residues of saflufenacil in pea vines were <4.88 pp m. In the residue - decline experiment, average parent saflufenacil residues in/on seed decreased overall with increasing sampling intervals, from 0.05 ppm at the 0 - day PHI to <0.01 ppm at the 10 - day PHI. Average parent saflufenacil residues in/on pea vine s also decreased with increasing sampling intervals, from 3.45 ppm at the 0 - day PHI to 0.69 ppm at the 10 - day PHI . Residues of the metabolites M800H11 and M800H35 were below the respective LOQs in/on all seed and vines samples (<0.01 or <0.025 ppm) collec ted from the residue decline experiment. The residue decline data indicate that residues of saflufenacil in pea seed and vines decrease at longer PHIs. Table 1 4. Summary of Residue Data fromCrop Field Trials with Saflufenacil. Commodity Total Applic.

Rate (lb ai/A) [kg ai/ha] PHI

(days) Analyte Residue Levels (ppm) 1 n Min. Max. HAFT 2 Median Mean Std. Dev. Pea, dried seed (dried shelled seed) 0.044 - 0.046

[0.049 - 0.051] 2 - 4 Saflufenacil 18 <0.01 0.05 0.04 <0.01 0.02 0.01 M800H11 <0.01 <0.01 < 0.01 <0.01 <0.01 0.00 M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Combined 3 <0.0 3 <0.07 <0.06 <0.03 <0.04 0.01 Pea, vines 0.044 - 0.046

[0.049 - 0.051] 2 - 4 Saflufenacil 18 0.09 4.83 4.56 1.72 2.12 1.58 M800H11 <0.025 0.13 0.13 0.04 0.05 0.04 M800H35 <0.025 <0.025 <0.025 <0.025 <0.025 0.00 Combined 3 <0.2 3 <4.88 <4.61 1. 95 2. 31 1. 6 1 1 For calculation of the HAFT, median, mean, and standard deviation, seed residue values of <0.01 ppm (<LOQ) were considered to be 0.01 ppm (LOQ), and vine residue values of <0.025 ppm (<LOQ) were considered to be 0.025 ppm. 2 HAFT = highest - average field trial. 3 Combined residues of saflufenacil (parent + M800H11 + M800H35). 

### Conclusions : The submitted residue data are adequate to fulfill data requirements for dried shelled peas as a representative crop of Crop Subgroup 6C , Dried shelled pea and bean (except soy bean) subgroup. The number and locations of the trials are in accordance with OPPTS Guideline 860. 1500 (Table 1 5 ) . The available data will suppo rt the proposed use pattern.Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 20 of 43 Table 15 . Trial Numbers and Geographical Locations . NAFTA Growing Zones Peas (dried cultivars of shelled pea, Pisum spp.) Submitted Requested 1 Canada U.S. 5 2 2 11 3 14 4 6 Total 9 8 5 1 As required under US EPA OPPTS 860.1500 for pea, and PMRA Directive 98 - 2. The guidelines do not specifically state the geographical distribution needed for a national registration on dried shelled peas; however, the trials were located in the areas of h ighest crop production for dried shelled peas. 

### The residue data for dried shelled peas were not entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP as the residues significantl y were less than those in dried shelled beans. The results from the dried shelled bean trials will thus be used to set the p ea and bean, dried shelled, except soy bean, subgroup 6C subgroup tolerance . The residue data for dried pea vines were entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data . HED notes that, as defined in OPPTS 860.1000 Table 1 , the commodity

identified b y the petitioner as “vines” is actually hay (i.e., desiccated vines). The recommended tolerance for the combined residues of saflufenacil and its metabolites M800H11 and M800H35, expressed as parent equivalents, is 17 ppm for pea hay . Soy bean DER Reference List 48080904 .der.doc 

### Field trial data have been generated for saflufenacil on soy bean. A total of 20 field trials on soy bean (dried) were conducted during the 2009 growing season in 

### NAFTA Growing Zones 2 (SC and GA, one trial each); 4 (MO, AR and MS, one trial each); and 5 (IA, KS, MN, MO, ND, and WI , two trials each; IL, OH, and ON, one trial each). Each trial location consisted of one untreated and one treated plot. Each treated plot received a single harvest aid/desiccant , broadcast application of the 70% WG formulation of saflufenacil at 0.043 - 0.046 lb ai/A (1X , Treatment 02 ) . In addition, at three trial sites, a “side -by- side” bridging comparison plot was treated in the same manner with a single late - season, broadcast application of the 342 g/LSC formulation of safluf enacil applied at 0.046 lb ai/A ( 1X , Treatment 03). The applications were made using ground equipment with 14 - 38 gal/A spray volumes. An adjuvant (methylated seed oil, Merge ® 

### ) was included in the spray mixture, together with ammonium sulfate fertilizer. Samples of mature so ybean dried seed were harvested at a 2 - to 4 - day PHI. At two trials, including one at which both formulations were tested, additional treated samples were collected at 0, 1, 7, and 10 days after the last application, in addition to th e targeted 3±1 day PHI, to evaluate residue decline. The results from these trials on soy bean show that after a single late - season, broadcast application of saflufenacil applied at 0.045 lb ai/A, maximum saflufenacil residues were 0.05 ppm in/on soy

bean dried seed samples harvested at a 2 - 4 day PHI; M800H11 and M800H35 residues were below the LOQ (<0.01 ppm each) in/on all samples (Table 16) . Maximum combined residues of saflufenacil in/on dried seed were <0.07 ppm at the 2 - 4 day PHI. The "side -by- side" bridging trials comparing the two formulations (WG vs. SC) demonstrated thatSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 21 of 43 

### there was no substantial difference in residues in soy bean treated with the two formulations. The residue decline data suggest that residues of saflufenacil decrease at longer PH Is . Table 16 . Summary of Residue Data fromCrop Field Trials with Soybeans . Commodity ; Treatment Total Applic.

Rate (lb ai/A) [kg ai/ha] PHI

(days) Analyte Residue Levels (ppm) 1 n Min. Max. HAFT 2 Median Mean Std. Dev. Soybean, dried seed; Treatment 2 (WG formulation) 0. 043 - 0.0 46

[0.0 4 9 - 0.0 51 ] 2 - 4 Saflufenacil 40 <0.01 0.05 0.05 <0.01 <0.01 0.01 M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Combined 3 <0.03 <0.07 <0.07 <0.03 <0.03 0.03 Soybean, dried seed; Treatment 3 (SC formulation) 0.0 46

[0.0 51 ] 3 Saflufenacil 6 <0.01 0.03 0.02 <0.01 0.02 0.01 M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Combined 3 <0.03 <0.05 <0.04 <0.03 <0.04 0.04 Soybean, dried seed; Both Treatments 0.043 - 0.046

[0.049 - 0.051] 2 - 4 Saflufenacil 46 <0.01 0.05 0.05 <0.01 <0.01 0.01 M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Combined 3 <0.03 <0.07 <0.07 < 0.03 <0.03 0.03 1 For calcu lation of the HAFT, median, mean, and standard deviation, seed residue values of <0.01 ppm ( <LOQ) were considered to be 0.01 ppm (LOQ) . 2 HAFT = highest - average field trial. 3 Combined residues of saflufenacil (parent + M800H11 + M800H35). ** Note that additional samples collected to examine residue decline are not shown; only those samples collected at the targ eted 3 - day PHI. 

### Conclusions : The submitted field trial data for soy bean are adequate to fulfill data requirements. The number and locations of the trials are in accordance with OPPTS Guideline 860.1500 (Table 1 7 ). The available data will support the proposed use pattern. Table 17 . Trial Numbers and Geographical Locations . NAFTA Growing Zones Soybean (dried) Submitted Requested 1 Canada U.S. 2 2 2 4 3 3 5 15 11 15 5B 1 Total 20 2 12 20 1 The requested number and geographic distribution of field trials for soybean, according to US EPA OPPTS 860.1500 and PMRA Directive 98 - 2. 2 One bridging trial in each region (three total trials) included side -by- side test plots comparing the WG and SC formulations . 

### The residue data for soy

bean were not entered into the Agency ’s tolerance spreadsheet as specified b y the Guid

ance for Setting Pesticide Tolerances Based on Field Trial Data SOP as >75% of the residues were <LOQ. The recommended tolerances for the combined residues of saflufenacil and its metabolites M800H11 and M800H35, expressed as parent equivalents, are 0.10 ppm for soy

bean seed .Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 22 of 43 

### Cotton DER Reference List 48080906 .de 1 .doc 

### Field trial data were generated for saflufenacil on cotton and conducted during the 2009 growing season at the following 12 locations: NAFTA Growing Zone 2 (GA; one trial); Zone 4 (AR; 3 trials); Zone 6 (OK; one trial); Zone 8 (TX; 4 trials); and Zone 10 (CA; 3 trials). Each location consisted of an untreated control plot (Treatment 1) and at least one treated plot (Treatment 2) at a plot size large enough to yi eld the required cotton samples. One of the four sites in Region 8 collected additional samples to determine a residue decline profile. Two sites, one each in Regions 2 and 8, had a second treated plot treated with an exaggerated rate to generate bulk samples of undelinted seed for simulated commercial processing. The treated plots received a single harvest aid/desiccant broadcast application of BAS 800 00 H 70% WG at a target rate of 0.045 lb ai/A ( 1X). The second treated plot at the trial locations in Regions 2 and 8 received an exaggerated rate targeted at 0.225 lb ai/A ( 5X ). The applications were made using ty

pical ground boom equipment with a tank mix spray volume of about 30 - 40 gal/A , along with an adjuvant. At five trial locations, samples of seed onl y were collected. At the remaining seven trial locations, seed and gin byproducts consisting of stems, leaves, burrs, immature seed, and dust were collected including one trial which was sampled at five time points to generate a residue decline profile. Mature seed cotton was harvested at a 5 - day PHI, except for the decline trial in which mature seed cotton was collected at 1 - , 4 - , 5 - , 10 - , and 15 - day PHIs. Additionally , one untreated and one treated bulk samples were collected from the additional exaggerated rate treated plots at two trial locations. After a single late - season, broadcast application of saflufenacil targeting 0.045 lb ai/A, maximum combined residues of saflufenacil were <0.14 ppm in/on undelinted seed samples harvested at a targeted 5 - day PHI(parent, 0.12 ppm; M800H11, <0.01 ppm; M800H35, <0.01 ppm) (Table 18) . Maximum combined residues of saflufenacil were <2.30 ppm in/on cotton gin by products samples harvested at a targeted 5 - day PHI(parent, 2.25 ppm; M800H11, <0.025 ppm; M800H35, <0.025 ppm). The res idue decline data indicated that residues of saflufenacil in undelinted seed RAC samples decrease at longer PHIs and for cotton gin by products residues decrease from days 1 - 4 and remain constant thereafter.Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 23 of 43 Table 18 . Summary of Residue Data fromCrop Field Trials with Cotton. Commodity; Treatment Total Applic.

Rate (lb ai/A) [kg ai/ha] PHI

(days) Analyte Residue Levels (ppm) 1 n Min. Max. HAFT 2 Median Mean Std. Dev. Cotton, Undelinted seed 0.043 - 0.046

[0.050] 5 Saflufenacil 24 <0.01 0.12 0.11 0.03 0.04 0.03 M800H11 24 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 M800H35 24 <0.01 <0.01 <0.01 <0.01 <0.01 0.00 Combined 3 24 <0.03 <0.14 <0.13 <0.05 <0.06 0.0 3 Cotton gin byproducts; stripper 0.043 - 0.045

[0.050] 5 Saflufenacil 8 0. 14 0.29 0.22 0.165 0.188 0.05 M800H11 8 <0.025 <0.025 <0.025 <0.025 <0.025 0.00 M800H35 8 <0.025 <0.025 <0.025 <0.025 <0.025 0.00 Combined 3 8 <0.19 <0.34 <0.27 <0.215 <0.234 0.05 Cotton gin byproducts; picker 0.043 - 0.04 6

[0.050] 5 Saflufenacil 6 0.0 8 2 .2 5 2.08 1.83 1.34 0.98 M800H11 6 <0.025 <0.025 <0.025 <0.025 <0.025 0.00 M800H35 6 <0.025 <0.025 <0.025 <0.025 <0.025 0.00 Combined 3 6 <0.13 <2.30 <2.13 <1.88 <1.34 0.98 1 For calcu lation of the HAFT, median, mean, and standard deviation, seed residue values of <0.01 ppm ( <LOQ) were considered to be 0.01 ppm (LOQ) and <0.025 for gin byproducts . 2 HAFT = highest - average field trial. 3 Combined residues of saflufenacil (parent + M800H11 + M800H35). ** Note that additional samples collected to examine residue decline are not shown; only those samples collected at the targeted 5 - day PHI. 

### Conclusions : The submitted field trial data for cotton are adequate to fulfill data requirements. The number and locations of the trials are in accordance with O PPTS Guideline 860.1500 (Table 1 9 ). The available data will support the proposed use pattern. Table 19 . Trial Numbers and Geographical Locations . NAFTA Growing Zones Cotton Submitted Requested 1 Canada U.S. 2 1 - 1 4 3 - 3 6 1 - 1 8 4 - 4 10 3 - 3 Total 12 - 12 1 The requested number and geographic distribution of field trials for cotton , according to US EPA OPPTS 860.1500 and PMRA Directive 98 - 2. OPPTS 860.1000, Table 1, specifies that two field trials must be cond ucted for cotton gin byproducts using stripper harvesting equipment . 

### The residue data for cotton seed were entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix II. The recommended tolerance for the combined residues of saflufenacil and its metabolites M800H11 and M800H35, expre ssed as parent equivalents, is 0 . 2 0 ppm for cotton seed . The residue data fo r cotton gin b yproducts ( stripper h arvest) were entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine appropriate tolerance levels; see Appendix II. In one of the trials, residues were higher at a PHI (10 days) that is greater than the proposed PHI ( 5 days). In thi s case , the higher values were entered into the spreadsheet . The recommended tolerance for the combined residues ofSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 24 of 43 

### saflufenacil and its metaboli tes M800H11 and M800H35, expressed as parent equivalents, is 0.45 ppm for cotton gin by products . Rapeseed Subgroup 20A Canola (representative crop for rapeseed s ubgroup 20A) DER Reference List 48135201 .der.doc 

### BASF Corporation has submitted field trial data for saflufenacil on rapeseed ( canola varieties only). Sixteen canola field trials were conducted during the 2009 growing season in NAFTA Growing Zones 2 ( GA ; one trial), 5 (MI , one trial), 7 (NE , one trial), 11 ( ID , two trial s ), and 1 4 (MB , two trials; SK, four trials; and AB, five trials ). Each trial location consisted of one untreated and one treated plot. Each treated plot received a single harvest aid/desiccant , broadcast application of the 70% WG formulation of saflufenacil at 0.044 - 0.046 lb ai/A ( 1X , Treatment 02 ) . In addition, at three trial sites, a “side -by- side” bridging comparison plot was treated in the same manner with a single late - season, broadcast application of the 342 g/LSC formulation of saflufenacil (BAS 800 04 H, SHARPENTM 

### Powered by KIXOR® 

### Herbicide , EPA Reg. No. 7969 - 278) applied as a harvest aid/desiccant at 0.041 - 0.046 lb ai/A ( 1X , Treatment 03). The applications were made using ground equipment with 14 - 33 gal/A spray

volumes. An adjuvant (methylated seed oil, Merge ®

### ) was included in the spray mixture, together with ammonium sulfate fertilizer. Samples of mature canola dried seed were harvested at a 2 - 3 day

PHI . At two trials, additional treated samples were collected at 0, 1, 7, and 10 days after treatment, in addition to the targeted 3±1 day PHI, to evaluate residue decline. The results from these trials on canola show that after a single harvest aid/desiccant broadcast application of saflufenacil applied at 0.045 lb ai/A, maximum saflufenacil residues were 0.48 ppm in/on canola dried seed samples harvested at a 2 - 3 day PHI; the metabolite M800H11 and M800H35 residues in/on canola seed samples were below the LOQ (<0.01 ppm each), with the exception of five isolated samples that bore M800H11 residues at 0.01 - 0.05 ppm (Table 20) . Maximum combin ed residues of saflufenacil in/on dried seed were <0.55 ppm at the 2 - 3 day PHI . The "side -by- side" bridging trials comparing the two formulations (WG vs. SC) demonstrated that there was no substantial difference in residues in canola treated with the two formulations. The residue decline data indicated that residues of saflufenacil decrease or remained relativel y constant at longer PHIs (at one site the residues increased from 0 - 7 days then decreased slightly

from 7 - 10 days).Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 25 of 43 Table 20 . Summary of Residu e Data fromCrop Field Trials with Canola . Commodity ; Treatment Total Applic.

Rate (lb ai/A) [kg ai/ha] PHI

(days) Analyte Residue Levels (ppm) 1 n Min. Max. HAFT 2 Median Mean Std. Dev. Canola, dried seed; Treatment 2 (WG formulation) 0. 044 - 0.0 46

[0.0 4 9 - 0.0 5 2] 2 - 3 Saflufenacil 32 0.01 0.33 0.29 0.06 0.08 0.06 M800H11 <0.01 0.03 0.02 0.01 0.01 0.00 M800H35 <0.01 <0.01 0.01 0.01 0.01 0.00 Combined 3 <0.01 <0.35 0.32 0.08 0.10 0.07 Canola, dried seed; Treatment 3 (SC formulation) 0. 041 - 0.0 46

[0.0 46 - 0.0 5 2] 3 Saflufenacil 6 0.02 0.48 0.43 0.05 0.17 0.21 M800H11 <0.01 0.05 0.05 0.01 0.02 0.02 M800H35 <0.01 <0.01 0.01 0.01 0.01 0.00 Combined 3 <0.04 <0.55 0.49 0.07 0.20 0.23 Canola, dried seed; Both Treatments 0.041 - 0.046

[0.046 - 0.052] 2 - 3 Saflufenacil 38 0.01 0.48 0.43 0.06 0.09 0.10 M800H11 <0.01 0.05 0.05 0.01 0.01 0.01 M800H35 <0.01 <0.01 0.01 0.01 0.01 0.00 Combined 3 <0.03 <0.55 0.49 0.08 0.12 0.11 1 For calcu lation of the HAFT, median, mean, and standard deviation, seed residue values of <0.01 ppm ( <LOQ) were considered to be 0.01 ppm (LOQ) . 2 HAFT = highest - average field trial. 3 Combined residues of saflufenacil (parent + M800H11 + M800H35). ** Note that additional samples collected to examine residue decline are not shown; only those samples collected at the targeted 3 - day PHI. 

### Conclusions : The submitted field trial data for c anola seed are adequate to fulfill data requirements. The number and locations of the trials are in accordance with OPPTS Guideline 860.1500 (Table 21 ). Table 21 . Trial Numbers and Geographical Locations . NAFTA Growing Zones Canola Submitted Requested 1 Canada U.S. 2 1 1 5 1 1 2 7 1 1 2 11 2 3 1 4 11 14 Total 16 2 16 8 1 The requested number and geographic distribution of field trials for canola, according to US EPA OPPTS 860.1500 and PMRA Directive 98 - 2. 2 Three bridging trials (one in Zone 11, two in Zone 14) included side - by- side test plots comparing the WG and SC formulations . 

### The residue data for c anola seed were entered into the Agency ’s tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field T rial Data SOP to determine appropriate tolerance levels; see Appendix II . In one of the trials, residues were higher at a PHI (7 days) that is greater than the proposed PHI( 3 days). In thi s case , the higher values were entered into the spreadsheet . The recommended tolerance for the combined residues of saflufenacil and its metabolites M800H11 and M800H35, expressed as parent equivalents, is 0 . 45 ppm for rapeseed s ubgroup 20A .Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 26 of 43 

### Sunflower Subgroup 20B, seed A tolerance of 1.0 ppm is already established for saflufenacil residues in/on sunflower seed, the only representative crop for sunflower s ubgroup 20B . As the proposed use directions for oilseeds, sunflower subgroup 20B are identical to the registered use directions for sunflower, the est ablished tolerance of 1.0 ppm for saflufenacil residues in/on sunflower seed can be expanded to sunflower subgroup 20B . 860.1520 Processed Food and Feed Soy bean DER Reference List 48080905 .der.doc 

### Soy bean processing studies were conducted to determine the potential for concentration of residues of saflufenacil in/on the processed fractions of soy bean and to determine the magnitude of the residue of saflufenacil in/on AGF samples. In two field trial s conducted during the 2009 growing season NAFTA Growing Zones 2 (GA, one trial) and 5 (IA, one trial), saflufenacil (formulation, BAS 800 00 H; 70% WG) was applied as a single late - season, broadcast foliar application to soy bean at a rate of 0.225 lb ai/A ( 5X) . In addition, a separate plot at the trial located in GA was treated with one application of saflufenacil at 0.045 lb ai /A ( 1X) to generate AGF samples. The applications were made in approximately 11 - 19 gal/A using ground equipment. An adjuvant (methylated seed oil, Merge ®

### ) was included in the spray

mixture, together with ammonium sulfate fertilizer. Bulk samples of mature soy bean dried seed (RAC) were harvested at a 2 - or 3 - day PHI. Processing Studies: The results from these trials show that a fter one application of saflufenacil to soy bean t argeting 0.223 lb ai/A/season (5X), combined residues of saflufenacil in two treated soy bean seed RAC samples were <0.06 ppm (from GA site) and <0.08 ppm (from IA site), each collected at a 2 - or 3 - day

PHI . For the individual analy tes, parent saflufenacil residues were 0.04 and 0.06 ppm, respectively , and both M800H11 and M800H35 were <LOQ (<0.01 ppm) in/on the two treated so yb ean seed RAC samples collected 2 - 3 days after treatment. The two exaggerated - rate treated, bulk seed RAC samples, described above, were separatel y processed using simulated commercial processing procedures into meal, hulls, and refined oil, the currently

EPA - regulated commodities of soy bean. In addition, flour, soy milk, and tofu samp les were collected for anal ys is. A comparison of the residues in the RAC with those in each processed fraction indicate s that the combined residues of saflufenacil concentrate in hulls (5.0 - 6.9 X, average processing factor of 6.0x), but do not concentrate appreciably (on average) in meal, flour, refined oil, soy milk, or tofu. The reported processing factor for hulls does not exceed the theoretical concentration factor. According to Table 3 of OPPTS 860.1520, the theoretical concentration factor based on component separation is 11.3 X for soy bean hulls . AGFs: Combined residues were <4.52 ppm in/on one treated AGF sample derived from a seed sample treated with a single broadcast foliar application of saflufenacil targeting 0.045 lb ai/A (0.50 kg ai/ha/season, Treatment 2) and harvested at a 3 - day PHI. Residues of parent were 4.50 ppm and residues of the metabolites M800H11 and M800H35 were each <0.01 ppm (<LOQ)Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 27 of 43 

### in/on the treated AGF sample. Total residues of saflufenacil concentrate in AGF by a factor of 150 X . The residue samples were stored frozen (< - 5oC) for a maximum of 189 days (6.2 months), from harvest to extraction for anal ys is, for soy bean seed RAC samples, an d 32 days (1.1 months), from fraction collection to extraction for anal ys is, for AGF s and processed commodity samples. Adequate storage stability data are available to support the storage conditions and durations for the samples in the present study . Conclusions : The submitted soy bean processing data are adequate to fulfill data requirements. Based on the average processing factors of 6 X and 150 X and a HAFT residue of 0.07 ppm for soy bean seed, the processing data will support a tolerances of 0.50 pp m and 1 0 ppm for soy bean hulls and AGF s , respectively . S eparate tolerance s are not required for meal or refined oil . Cotton DER Reference List 48080906 .de 2 .doc 

### In two field trials conducted during the 2009 growing season in NAFT) Growing Zones 2 ( GA , one trial) and 8 ( TX , one trial), saflufenacil (formulation, BAS 800 00 H; 70% WG) was applied as a single late - season, broadcast application to c otton at a rate of 0.225 - 0.234 lb ai/A ( 5X). The applications were made using typical ground boom equipment with a tank mix spray volume of 32.5 - 40.7 gal/A for thorough coverage of the plot area. All applications were made using water as the carrier. In addition to the test substance, the tank mix for the GA trial contained 1% (v/v) MSO and 15 - 17 lbs/100 gallons of AMS and the tank mix for the TX trial contained 1% (v/v) MSO only

in the final spray

mixture. Undelinted cottonseed samples were mechanically harvested 5 days after application using either a cotton picker (GA trial) or cotton stripper (TX trial). The results for the cotton processed fractions from the two field trials show that after a single application of BAS 800 00 H at a target rate of 0.225 lb ai/A with a target 5 - day PHI, the individual res idues of saflufenacil, M800H11, and M800H035 ranged from < LOQ (0.0 1 ppm) to 0.08 ppm for undelinted seed. T otal residues were <0.04 o r <0.10 ppm . For processed fractions of hulls, meal, crude oil , and refined oil, individual residues ranged from <LO Q ( 0.01 ppm) to 0.04 ppm. Total residues ranged from <0.03 to <0.06 ppm in all processed fractions [combined residues of saflufenacil (parent + M800H11 + M800H35) are expressed as parent equivalents]. A comparison of the residues in the seed with those in e ach processed fraction indicates that residues of saflufenacil do not concentrate in cotton processed commodities (refined oil, crude oil, meal , and hulls). Conclusions : The submitted cotton processing data are adequate to fulfill data requirements. As residues of saflufenacil do not concentrate in cotton processed commodities , separate tolerances for refined oil, meal , or hulls will not be required. Canola DER Reference List 48135202 .der.doc 

### Canola processing studies were conducted to determine the potential for concentration ofSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 28 of 43 

### residues of saflufenacil in the processed fractions of canola (rapeseed, canola varieties onl y, as the representative crop of Oilseeds Rapeseed Subgroup 20A). In two field trials conducted during the 2009 growing season in NAFTA Growing Zones 5 (ND, one trial) and 11 (ID, one trial), saflufenacil (formulation, BAS 800 00 H; 70% WG) was applied as a single late - season, broadcast application to canola at a rate of 0.220 - 0.234 lb ai/A ( 5X) . The applications were made in approximately

14 - 23 gal/A using ground equipment. An adjuvant ( MSO , Merge ®

### ) was included in the spray

mixture, together with ammonium sulfate fertilizer. Bulk samples of mature canola dried seed (RAC) were harvested at a 3 - day PHI. One untreated and one treated bulk seed sample from each trial site were later processed into canola processed fractions. The results from these trials show that after one application of saflufenacil to canola targeting 0.225 lb ai/A/season, parent saflufenacil residues in/on two treated canola seed RAC samples were 0.04 ppm (from ND site, mean of two replicate subsamples A and B) and 1.73 ppm (from ID site, mean of two replicate subsamples A and B), each collected at a 3 - day PHI ; M800H11 and M800H35 residues were non - quantifiable (<0.01 ppm each) in the treated canola seed samples collected at a 3 - day PHIand in all processed fractions collected during the study . The two treated bulk seed RAC samples, described above, bearing quantifiable saflufenacil residues were separatel y processed using simulated commercial processing procedures into meal and refined oil. A comparison of the residues in the seed with those in each processed fraction indicates that residues of saflufenaci l do not concentrate in canola processed commodities (meal and refined oil). Conclusions : The submitted c anola processing data are adequate to fulfill data requirements. As residues of saflufenacil do not concentrate in c anola processed commodities , separate tolerances for residues in meal or oil will not be required. 860.1650 Submittal of Analytical Reference Standards Analy tical standards of saflufenacil, M800H11, and M800H35 are currently available in the National Pesticide Standards Repository [ s ource: personal communication with T . Cole of AC L/BEAD , 1 0 /28 / 1 0 ] . However, since the standards for M800H11 and M800H35 expired on 10/ 1 /10 , the petitioner is requested to provide an updated COA or a new supply to the Repository . The reference standards should be sent to the ACL , which is located at Fort Meade, to the attention of Theresa Cole at the following address: USEPA National Pesticide Standards Repository /Anal ytical Chemistry

Branch/OPP 701 Mapes Road Fort George G. M eade, MD 20755 - 5350 (Note that the mail will be returned if the extended zip code is not used.) 860.1850 Confined Accumulation in Rotational Crops The metabolism of saflufenacil in rotational crops was investigated using lettuce, radish and wheat after a single spray application of the test substance in the EC formulation BAS 800 UBH at a nominal application rate of 0.134 lbs. ai/A (1X the pre - emergent rate, 0.67X the post emergent rate ).Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 29 of 43 

### Saflufenacil in rotational crops was metabolized by : a) stepw ise degradation ( N - dealkyl ation) of the N - methyl -N

- isopropyl group to NH 2 

### , forming a sul f onamide group; b) a N

- demethyl ation at the uracil ring; and c) a hydrol ytic opening of the uracil ring generating a urea side chain. The metabolite M800H35 was identified as a metabolite in which the methyl group of the N - methyl N - isopropyl unit was lost and the uracil ring was cleaved generating a urea side chain. Metabolites M800H01 and M800H05 resulted from stepwise demethyl ation and dealkyl ation of the N - methyl -N

- isopropyl group to NH 2 

### . Metabolite M800H11 was formed by demethylation of the methyl group of the N - methyl -N

- isopropyl unit and demethylation of the N - methyl group in the uracil ring. M800H10 was identified as a derivativ e of saflufenacil in which the N - isopropyl group was lost and the uracil ring was demethylated. The metabolite TFA was only found in the uracil label. Based on the quantitative difference in TRR and the comparison of the metabolite patterns from both lab els, the study authors suggested that the metabolite TFA originate from an uptake of the metabolite or a precursor molecule from the soil into the plants. Conclusions : The submitted confined rotational crop study is adequate to satisfy data requirements. The metabolism of saflufenacil in rotational crops appears to be consistent with the pathway

observed in the plant metabolism studies . The HED ROCKS determined that residues of concern for rotational crops consist of saflufenacil, M800H11, and M800H35 (Memo , B. Daiss , 1/6/09; D 359645 ) . 860.1900 Field Accumulation in Rotational Crops The field rotational study was conducted in NAFTA Growing Region s 2 (3 trials in GA) and 10 (three trials in C A) . Saflufenacil (70% WG , formulation code BAS 800 00 H) was applied as a single pre - emergence application to the soil, after planting of the primary crop wheat, at 0.132 - 0.137 lb ai/A ( 1X the pre - emergent rate, 0.67X the post - emergent rate ) . The representative rotational crops radish, lettuce, and wheat (spring and winter) were grown at PBIs of 4 months (119 - 125 days), 6 months (180 - 183 days) , and 9 months (270 - 274 days) . Residues of saflufenacil and its metabolites M800H11 and M800H35 were all below the LOQ in rotated wheat (<0.025 ppm for wheat forage, hay , and straw, <0.01 ppm for grain), radish (<0.01 ppm, top and roots) , and lettuce (<0.01 ppm, leaves). Conclusions : The submitted field rotational crop data are adequate to satisfy data requirements. The available data indicate that residues of saflufenacil and its metabolites M800H11 and M800H35 w ere each < LOQ in/on all rotational crop matrices at a 120 - day PBI . These data support the labeled rotational crop restriction of 4 months fo r all non - labeled crops . Unless the petitioner requests PBI s shorter than 12 0 days, no additional data are required, and tolerances for inadvertent residues in/on rotational crops need not be established in conjunction with the currentl y proposed uses. 860.1550 Proposed Tolerances A summary

of the recommended tolerances for the current petition are listed in Table 22 . The petitioner should submit a revised section F reflecting the recommended tolerances and commodity

definitions presented in Table 22 .Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 30 of 43 

### There are no Codex maximum residue limits (MRLs) established for residues of s aflufenacil and its metabolite s in crop or livestock commodities. Canadian MRL s are established for vegetable, legume, subgroup 6c ; cotton, undelinted seed ; and livestock commodities , all at levels lower than those recommended to support the current action. Canada is currentl y in the process of reviewing the proposed harvest - aid uses use of saflufenacil . EPA and Canadian tolerance/MRL recommendations will be harmonized as part of the joint - review process. The Agency ’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels for sunflower seed ; s ee Appendix II for tolerance calculations. A detailed discus sion of the assessment of livestock commodity tolerances is presented in the “860.1480 Meat, Milk, Poultry , and Eggs” section of this Summary Document. Table 22 . Tolerance Summary for Saflufenacil . Commodity Proposed Tolerance (ppm) HED - Recommended

Tolerance (ppm) Correct Commodity

Definition

/Comments Oilseeds, Cottonseed Subgroup 20C, gin byproducts 3.5 0.45 Cotton, gin byproducts Oilseeds, Cottonseed Subgroup 20C, undelinted seed 0.2 0.20 Cottonseed Subgroup 20C Oilseeds, Sunflower Subgroup 20B, seed 1.0 1.0 Sunflower Subgroup 20B Pea, vines 8.0 17 Pea, hay Soy bean, aspirated grain fractions 4.52 10 Grain, aspirated fractions Soy bean, hulls 0.42 0.50 Soy bean, seed 0.1 0.10 Vegetable, Legume, Subgroup 6C, beans, dry 0.5 0.30 Pea and bean, dried shelled, except soy bean, subgroup 6C Vegetable, Legume, Subgroup 6C, peas, dry 0.1 Oilseeds, Rapeseed Subgroup 20A, seed 0.8 0.45 Rapeseed Subgroup 20A Cattle, liver - 2.5 Cattle, meat by

products , except liver - 0.05 Goat, liver - 2.5 Goat, meat by

products , except liver - 0.05 Sheep, liver - 2.5 Sheep, meat by

products , except liver - 0.05 Horse, liver - 2.5 Horse, meat by

products , except liver - 0.05 

### Note: In conjunction with establishing these tolerances, the existing tolerance for “Vegetable, foliage of legume, group 7 ” should be modified to “Vegetable, foliage of legume, group 7 (except pea hay)”; the existing tolerance for “Vegetable, legume, group 6 ” should be replaced with " Vegetable, legume, edible podded, subgroup 6A " plus " Pea and bean, succulent shelled, subgroup 6B "; and the existing tolerances for “ Sunflower, seed” and " Cotton, undelinted seed "Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 31 of 43 

### should be deleted.

Attachments: International Residue Limit Status (IRLS) sheet . Appendix I - Chemical Name and Structure Table . Appendix II - Tolerance Assessment Calculations .

cc: G. Kramer (RAB1) RDI: RAB1 Chemists ( 1 2 /1 / 1 0 ) G.F. Kramer:S10 95 7:PY - S :(703)305 - 5079:7509P:RAB1Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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## IRLS Sheet. Saflufenacil (118203; Date of Request: 11/04/2010) Summary of U . S . and International Tolerances and Maximum Residue Limits Residue Definition : U . S . Canada Mexico 2 

### Codex 

### 40 CFR 180. 64 9: Plant: saflufenacil, including its metabolites and degradates, sum of saflufenacil, 2 - chloro - 5 - [3,6 - dihydro - 3 - methyl - 2,6 - dioxo - 4 - (trifluoromethyl) - 1(2H ) -pyrimidinyl] - 4 - fluoro -N - [[methyl(1 - methylethyl)amino]sulfonyl]benzamide, and its metabolites N

- [2 - chloro - 5 - (2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro 1(2H ) -pyrimidinyl) - 4 - fluorobenzoyl] -N ' - isopropylsulfamide and N - [4 - chloro - 2 - fluoro - 5 - ({[(isopropylamino)sulfonyl]amino}carbon yl)phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil Livestock: saflufenacil 2 - chloro - 5 - [3,6 - dihydro - 3 - me thyl - 2,6 - dioxo - 4 - (trifluoromethyl) - 1(2H ) - pyrimidinyl] - 4 - fluoro -N

- [[methyl(1 - methylethyl)amino]sulfonyl]benzamide, including the metabolites N' - {2 - chloro - 4 - fluoro - 5 - [1,2,3,6 - tetrahydro - 2,6 - dioxo - 4 - (trifluoromethyl)pyrimidin - 1 - yl]benzoyl} - N - isopropyl sulfamide and N - [4 - chloro - 2 - fluoro - 5 - ({[(isopropylamino)sulfonyl] amino}carbonyl)phenyl]urea Livestock: 2 - chloro - 5 - [3,6 - dihydro - 3 - methyl - 2,6 - dioxo - 4 - (trifluoromethyl) - 1(2H ) -pyrimidinyl] - 4 - fluoro -N - [[methyl(1 - methylethyl)amino]sulfonyl]benzamide 

### None



### Commodity 1 

### Tolerance (ppm)/Maximum Residue Limit (mg/kg) U . S . Canada Mexico 2 

### Codex Cotton, gin byproducts 0.45 Cottonseed Subgroup 20C 0.20 0.03 Undelinted cotton seeds Sunflower Subgroup 20B 1.0 1.0 Sunflower seeds Pea, hay 17 Grain, aspirated fractions 10 Soy bean, hulls 0.50 Soy bean, seed 0.10 0.03 Pea and bean, dried shelled, except soy bean, subgroup 6C 0.30 0.03 (includes dry soybeans) Rapeseed Subgroup 20A 0.45 Cattle, goat, sheep, and horse; liver 2.5 0.8 Cattle, goat, sheep, and horse; meat byproducts, except liver 0.05 0.02 

### Completed: M. Negussie; 11/04/2010 1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant. 2 Mexico adopts U . S . tolerances and/or Codex MRLs for its export purposes.Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 33 of 43 

### APPENDIX I. Chemical Names an d Structures of Saflufenacil and Metabolites. Common name/code Figure C.3.1 ID No. Chemical name Chemical structure Saflufenacil 2 - chloro - 5 - [3,6 - dihydro - 3 - methyl - 2,6 - dioxo 4 - (trifluoromethyl) - 1(2H

) -pyrimidinyl] - 4 - fluoro -N - [[methyl(1 - methylethyl)amino] sulfonyl]benzamide M800H01 N'- [2 - chloro - 4 - fluoro - 5 - (3 - methyl - 2,6 - dioxo 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) - pyrimidinyl)benzoyl] -N

- isopropylsulfamide

M800H02 N'- [2 - chloro - 5 - (2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) - pyrimidinyl) - 4 - fluorobenzoyl] -N - isopropyl N - methylsulfamide M800H03 N'- [2 - chloro - 4 - fluoro - 5 - (3 - methyl - 2,6 - dioxo 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) - pyrimidinyl)benzoyl] -N

- methylsulfamide M800H04 (2E) - 3 - {4 - chloro - 2 - fluoro - 5 - [({[isopropyl(methyl)amino]sulfonyl}amino) carbonyl]phenyl)amino]carbonyl(methylamin o)} - 4,4,4 - trifluorobut - 2 - enoic acid M800H05 N'- [2 - chloro - 4 - fluoro - 5 - (3 - methyl - 2,6 - dioxo 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) - pyrimidinyl)benzoyl] - sulfamide

M800H10 N'- [2 - chloro - 5 - (2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) - pyrimidinyl) - 4 - fluorobenzoyl] -Nmethylsulfamide M800H11 N ' - [2 - chloro - 5 - (2,6 - dioxo - 4 - (trifluoromethyl) - 3,6 - dihydro - 1(2H ) - pyrimidinyl) - 4 - fluorobenzoyl] -Nisopropylsulfamide M800H35 N - [4 - chloro - 2 - fluoro - 5 - ({[(isopropylamino) sulfonyl]amino} carbonyl)phenyl] urea Cl F N N O

O C H 3 F F F O N H S N O O C H

3 C H 3 C H 3

F Cl N N O O F F F O N S N O O H H

F Cl N N O O F F F O N S N O O

H H

F Cl N N O O F F F O N S N O O H H

F Cl N H N O F F F O N S N O O H O H O

F

N Cl

O N S N H 2 N O

O F F F H O O

F Cl N N O O F F F O N S N H O O

H H

F Cl N N O O F F F O N S N O O

H H H

F Cl N H N H 2 O O N S N O O H HSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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### Appendix II. Tolerance -Assessment Calculations. Bean, Dried Seed The dataset used to establish a tolerance for saflufenacil and its metabolites on bean, dried seed consisted of bean field trial data representing application rates of 0.044 - 0.046 lb ai/A with a 2 - day PHI . As specified by

the Guidance for Setting Pesticid e Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate. The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II - 1. 12 out of 20 of the field trial sample results were below the combined LOQ of 0.03 ppm. However, as this action is a joint review with Canada, maximum - likelihood estimation (MLE) procedures were not used to imput e censored values. The saflufenacil bean seed dataset was entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP. Visual inspection of the lognormal probability plot (Figure II - 1) provided in the spreadsheet indicates that the dataset is not lognormal. The result from the approximate Shapiro - Francia test statistic (Figure II - 2) confirmed that the assumption of lognormality should be rejected. Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the California Method (μ + 3σ) estimate round s to the value 0.30 ppm (Figure II - 2 ). Therefore, 0.30 ppm is the recommended tolerance level for saflufenacil and its met abolites in/on bean, dried seed . Table II - 1. Residue Data Used to Calculate Tolerance for Combined Total

Residues of Saflufenacil in/on Bean, Dried Seed . Chemical: Saflufenacil Crop: Bean, Dried, Seed PHI: 2 Days App. Rate: 0.044 - 0.046 lb ai/A Submitter: BASF MRID Citation: MRID 48080902 Total Residues of Saflufenacil (ppm)

0.030 0.030 0.030 0.030 0.080 0.230 0.030 0.030 0.050 0.080 0.030 0.030 0.100Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 35 of 43 0.250 0.030 0.030 0.170 0.060 0.030 0.030 Figure II - 1. Lognorm al Probability Plot of Combined Total Residues of Saflufenacil in/on Bean, Dried Seed.

Figure II - 2. Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Bean, Dried Seed.



### Dry Pea Vines (hay) The dataset used to establish a tolerance for saflufenacil and its metabolites on dry pea vines (hay) consisted of pea hay field trial data representing application rates of 0.044 - 0.046 lb ai/A with a 2 - to 4 - day

PHI. As specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate. The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II - 2. All 18 field trial sample results were above the combined LOQ of 0.03 ppm. Since there were no Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156 y = 0.6614x - 2.9935 R 2 = 0.7343

PercentilesConcentrations EPA Saflufenacil Dry Beans 2-day 0.044-0.046 lb ai/A

Regulator: EPA Chemical: Saflufenacil Crop: Dry Beans PHI: 2-day App. Rate: 0.044-0.046 lb ai/A Submitter:

n: 20 min: 0.03 max: 0.25 median; 0.03 average: 0.07 95th Percentile 99th Percentile 99.9th Percentile EU Method I 0.20 0.25 0.30 Normal (0.25) (0.30) (--) 0.20 0.30 0.50 (0.30) (0.60) (--) 0.20 0.30 UPLMedian 95th 0.20 0.7343 p-value <= 0.01: Reject lognormality assumption EU Method I Log Normal EU Method II Distribution-Free California Method μ + 3 σ Approximate Shapiro-Francia Normality TestSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 36 of 43 

### values (combined residues) reported below the LOQ, MLE procedures were not needed to impute censored values. The saflufenacil pea hay dataset was entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP. Visual inspection of the lognormal probability plot (Figure II - 3) provided in the spreadsheet indicates that the dataset is reasonabl y lognormal. The result from the approximate Shapiro - Francia test statistic (Figure II - 4) confirmed that the assumption of lognormality should not be rejected. Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the lognormal EU Method I and the point estimate of the 99 th 

### percentile round s to the value 17 ppm (Figure II - 4 ). Therefore, 17 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on pea hay . Table II - 2. Residue Data Used to Calculate Tolerance for Combined Total

Residues of Saflufenacil in/on Dry Pea Vines (hay). Chemical: Saflufenacil Crop: Dry

Pea Vines PHI: 2 - to 4 - day App. Rate: 0.044 - 0.046 lb ai/A Submitter: BASF MRID Citation: MRID 48080903 Total Residues of Saflufenacil (ppm)

1.650 1.970 0.460 0.510 2.120 2.420 1.930 1.350 0.240 0.230 4.880 3.720 4.590 4.630 3.780 4.350 1.380 1.370Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 37 of 43 Figure II - 3. Lognorm al Probability Plot of Combined Total Residues of Saflufenacil in/on Dry Pea Vines.

Figure II - 4. Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Dry Pea Vines.



### Cotton, Undelinted Seed The dataset used to establish a tolerance for saflufenacil and its metabolites on cotton, undelinted seed consisted of pea hay field trial data representing application rates of 0.04 3 - 0.046 lb ai/A with a 5 - day PHI . As specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate. The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to c alculate the tolerance are provided in Table II - 3. Since all except two of the 24 field trial sample results were above the combined L OQ of 0.03 ppm, MLE procedures were not needed to impute censored values. The saflufenacil cotton, undelinted seed dat aset was entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP. Visual inspection of the lognormal probability plot (Figure II - 5) provided in the spreadsheet indicates that the dataset is not lognormal. The result from the approximate Shapiro - Francia test statistic (Figure II - 6) confirmed that the assumption of lognormality should be rejected. Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 5.0000

2.5000 1.2500

0.6250

0.3125 0.1563 y = 0.9721x + 0.4898 R 2 = 0.8952

PercentilesConcentrations EPA Saflufenacil Dry Pea Vines 2- to 4-day 0.044-0.046 lb ai/A

Regulator: EPA Chemical: Saflufenacil Crop: Dry Pea Vines PHI: 2- to 4-day App. Rate: 0.044-0.046 lb ai/A Submitter:

n: 18 min: 0.23 max: 4.88 median; 1.95 average: 2.31 95th Percentile 99th Percentile 99.9th Percentile EU Method I 5.0 7.0 8.0 Normal (7.0) (8.0) (--) 9.0 17 35 (19) (50) (--) 8.0 8.0 UPLMedian 95th 13 0.8952 p-value > 0.05 : Do not reject lognormality assumption EU Method I Log Normal EU Method II Distribution-Free California Method μ + 3 σ Approximate Shapiro-Francia Normality TestSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 38 of 43 

### on Field Trial Data SOP, the California Method (μ + 3σ) estimate round s to the value 0.20 ppm (Figure II - 6 ). Therefore, 0.20 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on cotton, undelinted seed . Table II - 3. Residue Data Used to Calculate Tolerance for Combined Total

Residues of Saflufenacil in/on Cotton, Undelinted Seed . Chemical: Saflufenacil Crop: Cotton, Undelinted Seed PHI: 5 - day App. Rate: 0.04 3 - 0.046 lb ai/A Submitter: BASF MRID Citation: MRID 48080906

Total Residues of Saflufenacil (ppm) 0.050 0.030 0.050 0.030 0.050 0.040 0.040 0.040 0.090 0.050 0.140 0.040 0.050 0.090 0.050 0.100 0.110 0.040 0.140 0.050 0.050 0.050 0.040 0.050 Figure II - 5. Lognorm al Probability Plot of Combined Total Residues of Saflufenacil in/on Cotton, Undelinted Seed.

Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156 y = 0.4202x - 2.8976 R 2 = 0.8452

PercentilesConcentrations EPA Saflufenacil Cotton, Undelinted seed 5-day 0.044-0.046 lb ai/ASaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 39 of 43 Figure II - 6. Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Cotton, Undelinted Seed.



### Cotton Gin By

products ( stripper) The dataset used to establish a tolerance for saflufenacil and its metabolites on cotton gin byproducts (stripper) consisted of pea hay field trial data representing application rates of 0.04 3 - 0.046 lb ai/A with a 5 - or 10 - day PHI. In one of the trials, r esidues were higher at a PHI (10 days) that is greater than the proposed PHI ( 5 days). In thi s case , the higher values were entered into the spreadsheet . As specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the fie ld trial application rates are within 25% of the maximum label application rate. The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table II - 4. All 8 f ield trial sample results were above the combined LOQ of 0.03 ppm. Since there were no values (combined residues) reported below the LOQ, MLE procedures were not needed to impute censored values. The cotton gin b yp roducts (stripper) dataset was entered into the tolerance spreadsheet as specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP. Visual inspection of the lognormal probability plot (Figure II - 7) provided in the spreadsheet indicates that the dataset is reason abl y lognormal. The result from the approximate Shapiro Francia test statistic (Figure II - 8) confirmed that the assumption of lognormality should not be rejected. Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the lognormal EU Method I and the point estimate of the 99 th 

### percentile round s to the value 0.45 ppm (Figure II - 8 ). Therefore, 0.45 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on cotton gin by products . Regulator: EPA Chemical: Saflufenacil Crop: Cotton, Undelinted seed PHI: 5-day App. Rate: 0.044-0.046 lb ai/A Submitter:

n: 24 min: 0.03 max: 0.14 median; 0.05 average: 0.06 95th Percentile 99th Percentile 99.9th Percentile EU Method I 0.15 0.15 0.20 Normal (0.15) (0.20) (--) 0.15 0.20 0.25 (0.20) (0.25) (--) 0.20 0.20 UPLMedian 95th 0.30 0.8452 p-value <= 0.01: Reject lognormality assumption EU Method I Log Normal EU Method II Distribution-Free California Method μ + 3 σ Approximate Shapiro-Francia Normality TestSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 40 of 43 Table II - 4. Residue Data Used to Calculate Tolerance for Combined Total

Residues of Saflufenacil in/on Cotton Gin Byproducts (stripper) . Chemical: Saflufenacil Crop: Cotton Gin Byproducts (stripper) PHI: 5 - or 10 - day App. Rate: 0.04 3 - 0.046 lb ai/A Submitter: BASF MRID Citation: MRID 48080903 Total Residues of Saflufenacil (ppm)

0.200 0.280 0.190 0.340 0.200 0.260 0.300 0.230 Figure II - 7. Lognorm al Probability Plot of Combined Total Residues of Saflufenacil in/on Cotton Gin Byproducts (stripper).

Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250 y = 0.2241x - 1.4065 R 2 = 0.9487

PercentilesConcentrations EPA Saflufenacil Cotton gin byproducts; stripper 5- or 10-day 0.044-0.046 lb ai/ASaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 41 of 43 Figure II - 8. Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Cotton Gin Byproducts (stripper).



### Canola Seed The dataset used to establish a tolerance for saflufenacil and its metabolites on canola seed consisted of pea hay field trial data representing application rates of 0.04 1 - 0.046 lb ai/A with a 2 - to 7 - day PHI . In one of the trials, residues were higher at a PHI (7 days) that is greater than the proposed PHI ( 3 days). In thi s case , the higher values were entered into the spreadsheet . As specified b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates are within 25% of the maximum label application rate. The residue values (total of saflufenacil and its metabolites M800H11 and M800H35, as parent equivalents) used to calculate the tolerance are provided in Table I I - 5. Since all except two of the 32 field trial sample results were above the combined L OQ of 0.03 ppm, MLE procedures were not needed to impute censored values. The saflufenacil canola seed dataset was entered into the tolerance spreadsheet as specifi ed b y the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP. Visual inspection of the lognormal probability plot (Figure II - 9) provided in the spreadsheet indicates that the dataset is not lognormal. The result from the approximate Shapiro - Francia test statistic (Figure II - 10) confirmed that the assumption of lognormality should be rejected. Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the California Metho d (μ + 3σ) estimate round s to the value 0.45 ppm (Figure II - 10 ). Therefore, 0.45 ppm is the recommended tolerance level for saflufenacil and its metabolites in/on canola seed . Regulator: EPA Chemical: Saflufenacil Crop: Cotton gin byproducts; stripper PHI: 5- or 10-day App. Rate: 0.044-0.046 lb ai/A Submitter:

n: 8 min: 0.19 max: 0.34 median; 0.25 average: 0.25 95th Percentile 99th Percentile 99.9th Percentile EU Method I 0.35 0.40 0.45 Normal (0.45) (0.50) (--) 0.35 0.45 0.50 (0.50) (0.70) (--) 0.60 0.45 UPLMedian 95th 2.5 0.9487 p-value > 0.05 : Do not reject lognormality assumption EU Method I Log Normal EU Method II Distribution-Free California Method μ + 3 σ Approximate Shapiro-Francia Normality TestSaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 42 of 43 Table II - 5. Residue Data Used to Calculate Tolerance for Combined Total

Resid ues of Saflufenacil in/on Canola Seed . Chemical: Saflufenacil Crop: Canola Seed PHI: 2 - to 7 - day App. Rate: 0.04 3 - 0.046 lb ai/A Submitter: BASF MRID Citation: MRID 48135201

Total Residues of Saflufenacil (ppm) 0.070 0.140 0.060 0.140 0.070 0.070 0.060 0.110 0.030 0.100 0.040 0.080 0.550 0.070 0.430 0.090 0.200 0.040 0.170 0.040 0.030 0.090 0.130 0.090 0.110 0.070 0.130 0.080 0.090 0.060 0.070 0.060 Figure II - 9. Lognorm al Probability Plot of Combined Total Residues of Saflufenacil in/on Canola Seed.

Lognormal Probability Plot

99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156 y = 0.6362x - 2.4411 R 2 = 0.9206

PercentilesConcentrations EPA Saflufenacil Canola seed 2- to 7-day 0.041-0.046 lb ai/ASaflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 43 of 43 Figure II - 10. Tolerance Spreadsheet Summary of Combined Total Residues of Saflufenacil in/on Canola Seed. Regulator: EPA Chemical: Saflufenacil Crop: Canola seed PHI: 2- to 7-day App. Rate: 0.041-0.046 lb ai/A Submitter:

n: 32 min: 0.03 max: 0.55 median; 0.08 average: 0.11 95th Percentile 99th Percentile 99.9th Percentile EU Method I 0.30 0.40 0.45 Normal (0.35) (0.45) (--) 0.30 0.40 0.70 (0.40) (0.70) (--) 0.25 0.45 UPLMedian 95th 0.45 0.9206 0.05 >= p-value > 0.01 : Reject lognormality assumption EU Method I Log Normal EU Method II Distribution-Free California Method μ + 3 σ Approximate Shapiro-Francia Normality Test