Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date: 24-MAR-2011

Subject: Saflufenacil in/on Vegetable, Legume, Subgroup 6C, pea and bean (except 

soybean); Soybean; Rapeseed Subgroup 20A; Sunflower Subgroup 20B; and 

Cottonseed Subgroup 20C. Summary of Analytical Chemistry and Residue 

Data.

PC Code: 118203 DP Barcodes: D381129, D381977

Decision Nos.: 436793, 437943 Registration No.: 7969-278

Petition Nos.: 0F7744, 0F7766 Regulatory Action: Sec. 3 Registration

Risk Assessment Type: NA Case No.: NA

TXR No.: NA CAS No.: 372137-35-4

MRID Nos.: 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: Kathryn 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 membrane damage and 

subsequent plant death. SharpenTM Powered by 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 soybean (PP#0F7744). The amended tolerances on these crops are the 

result of the proposed harvest aid/desiccation use pattern for SharpenTM Powered by Kixor
Saflufenacil 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 subgroup 

20A as harvest aid/desiccant (PP#0F7744). 

SharpenTM is proposed for up to 2 foliar spray applications 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.

Concurrently, BASF has petitioned 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)-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}carbonyl)phenyl]urea, calculated as the stoichiometric 

equivalent of saflufenacil” in/on the following raw agricultural commodities (RACs):

PP#0F7744

Oilseeds, Cottonseed Subgroup 20C, gin 

byproducts 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

Soybean, aspirated grain fractions 4.52 ppm

Soybean, hulls 0.42 ppm

Soybean, seed 0.1 ppm

Vegetable, Legume, Subgroup 6C, beans, dry 0.5 ppm

Vegetable, Legume, Subgroup 6C, peas, dry 0.1 ppm

PP#0F7766

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), soybean (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 Ndemethylation at the uracil ring, stepwise degradation (N-dealkylation) of the N-methyl-Nisopropyl group, hydrolytic opening of the uracil ring generating a urea side chain, and 

hydroxylation of the phenyl ring. M800H11 was found in all corn and soybean matrices from 

both 14C-labeled uracil and 14C-labeled phenyl saflufenacil. M800H11 is formed when 

saflufenacil undergoes demethylation at both nitrogen atoms. M800H35 was detected only after 

14C-labeled phenyl saflufenacil treatment and was detected at higher levels in soybean 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 Knowledgebase 

Subcommittee (ROCKS) determined that residues of concern for the tolerance expression and 
Saflufenacil 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; 

D359645). An additional major metabolite (M800H02) that is not included in the tolerance 

expression was observed in soybean 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 M800H02 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 residues of concern for rotational crops are 

saflufenacil, M800H11, and M800H35 (Memo, B. Daiss, 1/6/09; D359645). 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 dealkylation steps occurring at two 

different sites in the molecule (N-isopropyl-N-methylsulfamide side chain and at the uracil ring) 

and via hydrolytic 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 only 

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; D359645). 

The petitioner has submitted two liquid chromatography/mass spectroscopy/mass spectroscopy

(LC-MS/MS) analytical 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 analyte in food matrices (human consumption) and 0.025 ppm for each analyte in feed 

matrices (livestock consumption). BASF analytical 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 analysis 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. L0073/01 was also adequately 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 commodities, 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 soybean 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 soybean hulls and aspirated grain fractions (AGFs), 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 

byproducts except liver of cattle, 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 Analytical 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)-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}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

Soybean, hulls 0.50 ppm

Soybean, 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 

seed" 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)-

pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, in or on the 

commodities.”

Cattle, liver 2.5 ppm

Cattle, meat byproducts, except liver 0.05 ppm
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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Goat, liver 2.5 ppm

Goat, meat byproducts, except liver 0.05 ppm

Sheep, liver 2.5 ppm

Sheep, meat byproducts, except liver 0.05 ppm

Horse, liver 2.5 ppm

Horse, meat byproducts, except liver 0.05 ppm

860.1650 Submittal of Analytical Reference Standards

 Analytical standards of saflufenacil, M800H11, and M800H35 are currently available in 

the National Pesticide Standards Repository [source: personal communication with T. 

Cole of Analytical Chemistry Laboratory/Biological and Economics Analysis Division 

(ACL/BEAD), 10/28/10]. However, since the standards for M800H11 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 revised 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 

symptoms 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 physicochemical properties 

of the technical grade of saflufenacil, are presented in Tables 1 and 2.

Table 1. Saflufenacil and Metabolite Nomenclature.

Chemical Structure

Common name Saflufenacil

Company experimental name BAS 800 H (synonyms: AC 433 379, BASF Reg. No. 4054449)

IUPAC name N'-[2-Chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-

pyrimidinyl)benzoyl]-N-isopropyl-N-methylsulfamide

CAS name 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

CAS registry number 372137-35-4

F Cl

N

N

O

O

CH3

F

F

F

O

N

H

S

N

O

O

CH3

CH3

CH3
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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Table 1. Saflufenacil and Metabolite Nomenclature.

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-Chloro-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-Chloro-2-fluoro-5-({[(isopropylamino)sulfonyl]amino}carbonyl)phenyl]urea

Table 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-octanol; <0.005 n-heptane

Vapor 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 Pow = 2.6 (Pow = 368.3)

UV/visible absorption 

spectrum

wavelength maximum: λmax = 271.6 nm

extinction coefficient: ε = 9709 L/mol-cm

Reference: BASF Registration Document Number (DocID) 2005/1026464.

860.1200 Directions for Use

BASF has submitted draft labels dated 6/24/10 for the 2.85 lb ai/gal SC formulation (SharpenTM

Powered by 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. 

F Cl

N

N

H

O

O

F

F

F

O

N

H

S

N

H

O

O

CH3

CH3

F Cl

N

H

O

O

N

H

S

N

H

O

O

CH3

CH3

H2N
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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Table 3. Summary of Proposed End-Use Products.

Trade Name

Reg. 

No.

ai (% of 

formulation)

Formulation 

Type Target Crops

Target 

Pests Label Date

SharpenTM

Powered by 

Kixor 

Herbicide

7969-

278 29.74 SC legume vegetables, oilseeds

Broadleaf 

weeds

Draft labels

submitted 

6/24/10

Table 4. Summary of Directions for Use of Saflufenacil.

Applic. Timing, 

Type, and Equip.

Formulation

[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 SC

[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). 

Oilseeds, Sunflower Subgroup 20B

Preharvest

Desiccation

Broadcast,

Ground or aerial

SharpenTM

Herbicide

2.85 lb/gal SC

[7969-278]

0.0225-

0.045 2 0.090 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 SC

[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 SC

[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 Peas (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 SC

[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). Desiccationtreated pea vines may be 

grazed or fed to livestock

Soybeans

Preharvest

Desiccation

Broadcast,

Ground or aerial

SharpenTM

Herbicide

2.85 lb/gal SC

[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.
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Table 5. Rotational Crop PBIs for Saflufenacil (from Master Label, no changes proposed).

Crop

PBI (months)

Application rate (lb ai/acre)

0.0225 0.045 0.067 0.089 0.112 0.134

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

Soybean 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 uses. 

860.1300 Nature of the Residue - Plants

DER Reference List: Soybean (48080901.der.doc)

Soybean

The metabolism of saflufenacil was investigated in soybean following a single post-emergent 

spray of [uracil-4-

14C]-saflufenacil to soybean plants at BBCH growth stage 87-89 at an 

application rate of 0.089 lb/A (2X). Soybean matrices (stem, pod, seed, and leaves) were 

sampled 7 days after application. The soybean plants were cultivated in containers in climatic 

chambers (phytotrons) under simulated conditions for a typical U.S. soybean growing area. The 

interval of frozen storage of samples for both labels was supported by the re-extraction and 

analysis of soybean seed and leaves samples at the end of the analytical phase.

14C-Residues in homogenates of soybean stem, pod, seed, and leaves were extracted sequentially 

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 by incubation with macerozyme/cellulase, amylase/amyloglucosidase, 

tyrosinase/laccase, and HCl (seed only). The accountabilities, 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 (LSC). 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 the 

respective radiolabeled reference standards; and by comparison of the metabolite profiles. 

The total radioactive residues (TRR) in soybean matrices were determined directly by

combustion analyses and indirectly by the sum of the extractable and unextractable 14C-residues. 

The TRR were similar using either method of determination. The TRRs, as determined by direct 

combustion analyses, were 19.6 ppm (leaves), 1.74 ppm (pod), 0.412 ppm (stem), and 0.049 ppm 
Saflufenacil 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 soybean 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 soybean seed, the major residues identified were saflufenacil (26.1% of the TRR; 

0.011 ppm), M800H02 (26.3% of the TRR; 0.011 ppm), and M800H11 (10.9% of the TRR; 

0.004 ppm). The only major residue identified in soybean pod was saflufenacil (76.4% of the 

TRR; 1.42 ppm). In soybean 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-emergence Treatment with [Uracil-U14C]-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)10.009 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 soybean following postemergence treatment is outlined in Figure 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

 Demethylation of the N-isopropyl-N-methylsulfamide side chain and Ndemethylation of the uracil ring to generate M800H11.
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FIGURE 1. Metabolic Profile of Saflufenacil in Soybean following Post-emergence

Treatment.

Conclusions: The previously-submitted metabolism data for corn, soybean, and tomato were 

adequate to elucidate the nature of the residue in plants resulting from pre-plant/pre-emergence

application. The main reactions involved in the metabolic pathway of saflufenacil were Ndemethylation at the uracil ring, stepwise degradation (N-dealkylation) of the N-methyl-Nisopropyl group, hydrolytic cleavage of the uracil ring generating a urea side chain, and 

hydroxylation 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, 1/6/09; D359645). The proposed metabolic pathway of radiolabeled 

saflufenacil in soybean 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 tolerance expression, was observed in soybean 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-
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assessment purposes in seed crops following post-emergence treatment.

FIGURE 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 800H 1 1

F C l

N

N O

O

F

F

F

O

N

S

N

O

O

H

H

H O

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

H 2N 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

metabolites
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 12 of 43

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 hydrolytic 

opening of the uracil ring (goat only). In the ruminant metabolism study, saflufenacil was a 

major residue in all matrices. Only M800H04, a ring opening product, exceeded 10% of the 

TRR and 0.05 ppm (liver; 14.2% of the TRR, 0.543 ppm). In the poultry metabolism study,

saflufenacil 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; D359645). 

The decision to exclude the plant metabolites M800H11 and M800H35 as residues of concern in 

livestock was 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 with action do result in a 

significant increase in the livestock dietary burden; however, metabolites M800H11 and 

M800H35 are not major residues in soybeans following a desiccation application. M800H02

does not need to be included as a residue of concern as its concentration in soybean 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. Oily 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 ethyl acetate-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 residues 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 determination. 

Two transitions per analyte were monitored for the quantitation and confirmation of saflufenacil, 

M800H11 and M800H35. The residues of each analyte 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 analyte in food matrices (human consumption) 

and 0.025 ppm for each analyte 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 10X 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

Page 13 of 43

860.1360 Multiresidue 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 Analytical 

Manual, Vol. I (PAM I). Saflufenacil and the metabolites were tested 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 analytes 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 soybean (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 metabolites M800H11 and M800H35 by LC-MS/MS using BASF Analytical 

Method Number D0603/02. The freezer storage stability results were corrected for mean 

concurrent recovery values obtained from freshly fortified samples.

Under these conditions, residues of saflufenacil and its metabolites M800H11 and M800H35 are 

stable in/on corn (grain, forage, stover); soybean (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 Storage Conditions and Intervals of Samples from Crop Field Trial, Processing, and 

Field Rotational Crop Studies.

Matrix Storage 

Temperature (°C)

Actual Storage Duration for 

Most Samples

Interval of Demonstrated 

Storage Stability

Dry Bean (MRID 48080902)

Bean, Dried Seed <-5 69-163 days 548 days

Dry Pea (MRID 48080903)

Pea, dried seed (dried 

shelled peas) <-5

122-189 days 548 days

Pea, vines 151-269 days
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 14 of 43

Table 7. Summary of Storage Conditions and Intervals of Samples from Crop Field Trial, Processing, and 

Field Rotational Crop Studies.

Matrix Storage 

Temperature (°C)

Actual Storage Duration for 

Most Samples

Interval of Demonstrated 

Storage Stability

Soybean (MRID 48080904 & 48080905)

Soybean, seed (dried)

<-5

93-181 days

548 days Flour, Hulls, Meal, 

Refined Oil, Soy milk, 

Tofu, AGFs

15-30 days

Canola (MRID 48135201 & 48135202)

Canola, seed (dried)

<-5

Maximum, 299 days 548 days Meal, Refined oil 98-217 days

Cotton (MRID 48080906)

Undelinted seed 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 548 days. These data support the storage conditions and intervals of samples 

collected from the various crop field trials. There are no unresolved storage 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 metabolites are presented in Tables 8a-8d and 

reflect the most recent guidance from HED (June, 2008) concerning revisions of feedstuff 

percentages in Table 1 and constructing RBDBs. The calculated total dietary burdens of 

saflufenacil and its metabolites (based on tolerance-level residues) are 0.13 ppm for beef cattle, 

0.77 ppm for dairy cattle, 0.27 ppm for poultry, and 0.18 ppm for swine. 

Table 8a. Beef Cattle Dietary Burden Contribution for Saflufenacil. 

Feedstuff Type1

Tolerance

(ppm)

% Dry 

Matter % Diet2

Dietary Contribution 

(ppm)

3

Target % Diet Roughage 15

Corn, field, forage R 0.10 40 10 0.025

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 0.13
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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Table 8b. Dairy Cattle Dietary Burden Contribution for Saflufenacil.

Feedstuff Type1

Tolerance

(ppm)

% Dry

Matter % Diet2

Dietary Contribution 

(ppm)

3

Target % Diet Roughage 45

Field pea, hay R 4.88488 10 0.55

Corn, field, forage R 0.10 40 35 0.09

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 8c. Poultry Dietary Burden Contribution for Saflufenacil.

Feedstuff Type1

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 8d. Swine Dietary Burden Contribution for Saflufenacil. 

Feedstuff Type1

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 2008). 

3

 Dietary contribution = 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 (0.13X), 0.3 (0.39X), and 1.0 ppm (1.3X). 

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

Page 16 of 43

Following withdrawal of the dose, residues of saflufenacil 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 from Ruminant Feeding 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 secondary residues in meat 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 8b). 

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. = 

0.04 1.0 0.04 0.054

Liver

0.26 0.1 2.6

0.88 0.3 2.9 Ave. = 3.0

3.49 1.0 3.49

1 Calculated from the maximum residues divided by the dose 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

Established Tolerance 

(ppm)

Recommended 

Tolerance (ppm)

Milk 

0.77

<0.0077 0.01 0.01

Fat <0.0077 0.01 0.01

Kidney 0.042 0.0220.05

2

Muscle <0.0077 0.01 0.01

Liver 2.3 0.80 2.5

1

 Calculated from dietary burden x average transfer coefficient from Table 10. 

2

 Meat 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 0.05 ppm for residues in meat byproducts 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 need to be increased as the hog RBDB did not increase. 

Poultry feeding study waiver request

HED previously 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 appropriate.

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 applications were made using ground 

equipment with 16-30 gal/A spray volumes. An adjuvant (methylated seed oil, MergeTM) 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 immediately
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 18 of 43

following application, saflufenacil residues decreased 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 M800H35 were <0.01 ppm each in all samples at all sampling intervals.

Table 12. Summary of Residue Data from Crop Field Trials with Saflufenacil.

Commodity

Total Applic. 

Rate (lb ai/A)

[kg ai/ha]

PHI 

(days) Analyte

Residue Levels (ppm)1

n Min. Max. HAFT2 Median Mean

Std. 

Dev.

Bean, 

Dried, Seed

0.044-0.046

[0.049-0.052]

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

Combined320 <0.03 <0.25 <0.18 <0.03 <0.07 0.07

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).

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 

soybean) 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

Requested1

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 by 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 0.30 ppm for Crop 

Subgroup 6C, Dried shelled pea and bean (except soybean) subgroup.

Dry Peas

DER Reference List 48080903.der.doc

BASF Corporation has submitted field trial data for saflufenacil on dried shelled peas (Pisum 
Saflufenacil 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 of 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, MergeTM) 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 these 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 ppm.

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 vines 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) collected from the residue decline experiment. The residue 

decline data indicate that residues of saflufenacil in pea seed and vines decrease at longer PHIs.

Table 14. Summary of Residue Data from Crop Field Trials with Saflufenacil.

Commodity

Total Applic. 

Rate (lb ai/A)

[kg ai/ha]

PHI 

(days) Analyte

Residue Levels (ppm)1

n Min. Max. HAFT2 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

Combined3<0.03 <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

Combined3<0.23 <4.88 <4.61 1.95 2.31 1.61

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 

soybean) subgroup. The number and locations of the trials are in accordance with OPPTS 

Guideline 860.1500 (Table 15). The available data will support 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

Requested1

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 

highest crop production for dried shelled peas.

The residue data for dried shelled peas were not entered into the Agency’s tolerance spreadsheet

as specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP as 

the residues significantly were less than those in dried shelled beans. The results from the dried 

shelled bean trials will thus be used to set the pea and bean, dried shelled, except soybean, 

subgroup 6C subgroup tolerance. The residue data for dried pea vines were entered into the 

Agency’s tolerance spreadsheet as specified by 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 by 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.

Soybean

DER Reference List 48080904.der.doc

Field trial data have been generated for saflufenacil on soybean. A total of 20 field trials on 

soybean (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/L SC formulation of saflufenacil 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 soybean 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 the targeted 3±1 day PHI, 

to evaluate residue decline.

The results from these trials on soybean 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 soybean 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 that 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 21 of 43

there was no substantial difference in residues in soybean treated with the two formulations. The 

residue decline data suggest that residues of saflufenacil decrease at longer PHIs.

Table 16. Summary of Residue Data from Crop 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. HAFT2 Median Mean

Std. 

Dev.

Soybean, dried 

seed; 

Treatment 2

(WG formulation)

0.043-0.046

[0.049-0.051]

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

Combined3<0.03 <0.07 <0.07 <0.03 <0.03 0.03

Soybean, dried 

seed; 

Treatment 3 

(SC formulation)

0.046

[0.051]

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

Combined3<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

Combined3<0.03 <0.07 <0.07 <0.03 <0.03 0.03

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).

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 soybean are adequate to fulfill data requirements. 

The number and locations of the trials are in accordance with OPPTS Guideline 860.1500 (Table 

17). The available data will support the proposed use pattern.

Table 17. Trial Numbers and Geographical Locations.

NAFTA Growing Zones

Soybean (dried)

Submitted

Requested1

Canada U.S.

2 2 2

4 3 3

5 15 11 15

5B 1

Total 20212 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 soybean were not entered into the Agency’s tolerance spreadsheet as 

specified by the Guidance 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 soybean seed.
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 22 of 43

Cotton

DER Reference List 48080906.de1.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 yield 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 typical 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 only 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 

byproducts samples harvested at a targeted 5-day PHI (parent, 2.25 ppm; M800H11, <0.025 

ppm; M800H35, <0.025 ppm).

The residue decline data indicated that residues of saflufenacil in undelinted seed RAC samples 

decrease at longer PHIs and for cotton gin byproducts residues decrease from days 1-4 and 

remain constant thereafter.
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

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Table 18. Summary of Residue Data from Crop 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. HAFT2 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

Combined324 <0.03 <0.14 <0.13 <0.05 <0.06 0.03

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

Combined38 <0.19 <0.34 <0.27 <0.215 <0.234 0.05

Cotton gin 

byproducts; 

picker

0.043-0.046

[0.050]

5 Saflufenacil 6 0.08 2.25 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

Combined36 <0.13 <2.30 <2.13 <1.88 <1.34 0.98

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 <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 OPPTS Guideline 860.1500 (Table 

19). The available data will support the proposed use pattern.

Table 19. Trial Numbers and Geographical Locations.

NAFTA Growing Zones

Cotton

Submitted

Requested1

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 conducted for cotton gin byproducts using

stripper harvesting equipment.

The residue data for cottonseed were entered into the Agency’s tolerance spreadsheet as 

specified by 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, expressed as 

parent equivalents, is 0.20 ppm for cottonseed. The residue data for cotton gin byproducts 

(stripper harvest) were entered into the Agency’s tolerance spreadsheet as specified by 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 this case, the higher values were 

entered into the spreadsheet. The recommended tolerance for the combined residues of 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 24 of 43

saflufenacil and its metabolites M800H11 and M800H35, expressed as parent equivalents, is 

0.45 ppm for cotton gin byproducts.

Rapeseed Subgroup 20A

Canola (representative crop for rapeseed subgroup 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 trials), and 14

(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/L SC 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 combined 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 relatively 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

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Table 20. Summary of Residue Data from Crop 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. HAFT2 Median Mean

Std. 

Dev.

Canola, dried 

seed; 

Treatment 2 (WG 

formulation)

0.044-0.046

[0.049-0.052]

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

Combined3<0.01 <0.35 0.32 0.08 0.10 0.07

Canola, dried 

seed; 

Treatment 3 (SC 

formulation)

0.041-0.046

[0.046-0.052]

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

Combined3<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

Combined3<0.03 <0.55 0.49 0.08 0.12 0.11

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).

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 canola 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

Requested1

Canada U.S.

2 1 1

5 1 1 2

7 1 1 2

11 2 3

14 11 14

Total 16216 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 canola seed were entered into the Agency’s tolerance spreadsheet as 

specified by 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 (7 days) that is greater than the proposed PHI (3 days). In this 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 subgroup 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 subgroup 20B. As the proposed use directions for 

oilseeds, sunflower subgroup 20B are identical to the registered use directions for sunflower, the 

established 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

Soybean

DER Reference List 48080905.der.doc

Soybean processing studies were conducted to determine the potential for concentration of 

residues of saflufenacil in/on the processed fractions of soybean and to determine the magnitude 

of the residue of saflufenacil in/on AGF samples.

In two field trials 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 soybean 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 

soybean dried seed (RAC) were harvested at a 2- or 3-day PHI.

Processing Studies: The results from these trials show that after one application of saflufenacil 

to soybean targeting 0.223 lb ai/A/season (5X), combined residues of saflufenacil in two treated 

soybean 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 analytes, 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 soybean seed RAC samples collected 2-3 days after treatment.

The two exaggerated-rate treated, bulk seed RAC samples, described above, were separately 

processed using simulated commercial processing procedures into meal, hulls, and refined oil, 

the currently EPA-regulated commodities of soybean. In addition, flour, soy milk, and tofu 

samples were collected for analysis. A comparison of the residues in the RAC with those in each 

processed fraction indicates that the combined residues of saflufenacil concentrate in hulls (5.0-

6.9X, 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 11.3X for soybean 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

150X.

The residue samples were stored frozen (<-5oC) for a maximum of 189 days (6.2 months), from 

harvest to extraction for analysis, for soybean seed RAC samples, and 32 days (1.1 months), 

from fraction collection to extraction for analysis, for AGFs 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 soybean processing data are adequate to fulfill data requirements. 

Based on the average processing factors of 6X and 150X and a HAFT residue of 0.07 ppm for 

soybean seed, the processing data will support a tolerances of 0.50 ppm and 10 ppm for soybean 

hulls and AGFs, respectively. Separate tolerances are not required for meal or refined oil.

Cotton

DER Reference List 48080906.de2.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 cotton 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 residues of saflufenacil, M800H11, and M800H035 ranged from <LOQ (0.01 ppm) to

0.08 ppm for undelinted seed. Total residues were <0.04 or <0.10 ppm.

For processed fractions of hulls, meal, crude oil, and refined oil, individual residues ranged from 

<LOQ (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 each 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 of 
Saflufenacil 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 only, 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 PHI and in all processed fractions collected during the study. The 

two treated bulk seed RAC samples, described above, bearing quantifiable saflufenacil residues 

were separately 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 saflufenacil do not concentrate in canola processed commodities (meal 

and refined oil).

Conclusions: The submitted canola processing data are adequate to fulfill data requirements. As 

residues of saflufenacil do not concentrate in canola processed commodities, separate tolerances 

for residues in meal or oil will not be required.

860.1650 Submittal of Analytical Reference Standards

Analytical standards of saflufenacil, M800H11, and M800H35 are currently available in the 

National Pesticide Standards Repository [source: personal communication with T. Cole of 

ACL/BEAD, 10/28/10]. 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/Analytical Chemistry Branch/OPP

701 Mapes Road

Fort George G. Meade, 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 postemergent rate). 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 29 of 43

Saflufenacil in rotational crops was metabolized by: a) stepwise degradation (N-dealkylation) of 

the N-methyl-N-isopropyl group to NH2, forming a sulfonamide group; b) a N-demethylation at 

the uracil ring; and c) a hydrolytic 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-methylN-isopropyl unit was lost and the uracil ring was cleaved generating a urea side chain. 

Metabolites M800H01 and M800H05 resulted from stepwise demethylation and dealkylation of 

the N-methyl-N-isopropyl group to NH2. 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 derivative 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 labels, 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; D359645). 

860.1900 Field Accumulation in Rotational Crops

The field rotational study was conducted in NAFTA Growing Regions 2 (3 trials in GA) and 10 

(three trials in CA). 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 were each <LOQ in/on all rotational crop matrices at a 120-day PBI. These data 

support the labeled rotational crop restriction of 4 months for all non-labeled crops. Unless the 

petitioner requests PBIs shorter than 120 days, no additional data are required, and tolerances for 

inadvertent residues in/on rotational crops need not be established in conjunction with the 

currently 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 saflufenacil and 

its metabolites in crop or livestock commodities. Canadian MRLs 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 currently 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; see Appendix II for tolerance 

calculations. A detailed discussion 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

Soybean, aspirated grain 

fractions 4.52 10 Grain, aspirated fractions

Soybean, hulls 0.42 0.50

Soybean, seed 0.1 0.10

Vegetable, Legume, 

Subgroup 6C, beans, dry 0.5

0.30 Pea and bean, dried shelled, except 

Vegetable, Legume, soybean, subgroup 6C

Subgroup 6C, peas, dry 0.1

Oilseeds, Rapeseed 

Subgroup 20A, seed 0.8 0.45 Rapeseed Subgroup 20A

Cattle, liver - 2.5

Cattle, meat byproducts, 

except liver - 0.05

Goat, liver - 2.5

Goat, meat byproducts, 

except liver - 0.05

Sheep, liver - 2.5

Sheep, meat byproducts, 

except liver - 0.05

Horse, liver - 2.5

Horse, meat byproducts, 

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 (12/1/10)

G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 32 of 43

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 Mexico2 Codex

40 CFR 180.649:

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-dihydro1(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-methyl-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

Commodity1 Tolerance (ppm)/Maximum Residue Limit (mg/kg)

U.S. Canada Mexico2 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

Soybean, hulls 0.50

Soybean, seed 0.10 0.03

Pea and bean, dried shelled, except 

soybean, 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 and 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-dioxo4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-

fluoro-N-[[methyl(1-methylethyl)amino]

sulfonyl]benzamide

M800H01 N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo4-(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-isopropylN-methylsulfamide

M800H03 N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo4-(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-dioxo4-(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

F Cl

N

N

O

O

CH3

F

F

F

O

N

H

S

N

O

O

CH3

CH3

CH3

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

OH H

O

F

N

Cl

O

N

S

NH2

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

H2N O

O

N

S

N

O

O

H

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

Page 34 of 43

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 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-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 impute censored values. 

The saflufenacil bean seed dataset was entered into the tolerance spreadsheet as specified by 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 rounds to the value 0.30 ppm 

(Figure II-2). Therefore, 0.30 ppm is the recommended tolerance level for saflufenacil and its 

metabolites 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

0.100
Saflufenacil 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. Lognormal 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 by 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

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156

y = 0.6614x - 2.9935

R

2

 = 0.7343

Percentiles

Concentrations

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 + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
Saflufenacil 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 by 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 reasonably 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 99th

percentile rounds 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

1.370
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 37 of 43

Figure II-3. Lognormal 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 0.043-

0.046 lb ai/A with a 5-day PHI. As specified by 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-3.

Since all except two of the 24 field trial sample results were above the combined LOQ of 0.03 

ppm, MLE procedures were not needed to impute censored values. 

The saflufenacil cotton, undelinted seed dataset was entered into the tolerance spreadsheet as 

specified by 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

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

5.0000

2.5000

1.2500

0.6250

0.3125

0.1563

y = 0.9721x + 0.4898

R

2

 = 0.8952

Percentiles

Concentrations

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 + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 381129

Page 38 of 43

on Field Trial Data SOP, the California Method (μ + 3σ) estimate rounds 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: 0.043-0.046 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. Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Cotton, 

Undelinted Seed.

Lognormal Probability Plot

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156

y = 0.4202x - 2.8976

R

2

 = 0.8452

Percentiles

Concentrations

EPA Saflufenacil Cotton, Undelinted seed 5-day 0.044-0.046 lb ai/A
Saflufenacil 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 Byproducts (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 

0.043-0.046 lb ai/A with a 5- or 10-day PHI. In one of the trials, residues were higher at a PHI

(10 days) that is greater than the proposed PHI (5 days). In this case, the higher values were 

entered into the spreadsheet. As specified by 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-4.

All 8 field 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 byproducts (stripper) dataset was entered into the tolerance spreadsheet as 

specified by 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 reasonably lognormal. The result from the approximate ShapiroFrancia 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 99th

percentile rounds 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 byproducts. 

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 + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
Saflufenacil 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: 0.043-0.046 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. Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Cotton Gin 

Byproducts (stripper).

Lognormal Probability Plot

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

1.0000

0.5000

0.2500

0.1250

y = 0.2241x - 1.4065

R

2

 = 0.9487

Percentiles

Concentrations

EPA Saflufenacil Cotton gin byproducts; stripper 5- or 10-day 0.044-0.046 lb ai/A
Saflufenacil 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 0.041-0.046 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 this case, the higher values were entered into the spreadsheet. As 

specified by 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-5.

Since all except two of the 32 field trial sample results were above the combined LOQ 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 specified by 

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 Method (μ + 3σ) estimate rounds 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

Cotton gin byproducts; stripper Crop:

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 + 3σ

Approximate 

Shapiro-Francia 

Normality Test 
Saflufenacil 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 

Residues of Saflufenacil in/on Canola Seed. 

Chemical: Saflufenacil

Crop: Canola Seed

PHI: 2- to 7-day

App. Rate: 0.043-0.046 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. Lognormal Probability Plot of Combined Total Residues of Saflufenacil in/on Canola Seed.

Lognormal Probability Plot

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

1.0000

0.5000

0.2500

0.1250

0.0625

0.0313

0.0156

y = 0.6362x - 2.4411

R

2

 = 0.9206

Percentiles

Concentrations

EPA Saflufenacil Canola seed 2- to 7-day 0.041-0.046 lb ai/A
Saflufenacil 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 + 3σ

Approximate 

Shapiro-Francia 

Normality Test