Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

Page 1 of 14

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

 POLLUTION PREVENTION

MEMORANDUM

Date: 04-AUG-2011

Subject: Saflufenacil in/on Imported Coffee, Banana, and Mango. Summary of Analytical 

Chemistry and Residue Data.

PC Code: 118203 DP Barcode: D390922

Decision No.: 442242 Registration No: NA

Petition No.: 0E7806 Regulatory Action: Tolerances With No U.S.

Registration

Risk Assessment Type: NA Case No.: NA

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

MRID Nos.: 482398-01 thru -07 40 CFR: §180.649

From: George F. Kramer, Ph.D., Senior 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 establish tolerances for saflufenacil in/on imported coffee, 

banana, and mango (PP#0E7806). The tolerance petition on these crops is the result of the use of 

Heat®, a 70% water-dispersible granule (WDG) formulation, in Central and South America. 

Heat®is proposed for up to three foliar spray applications directed to the base of the plants with a 

total maximum application rate of 0.131 lb ai/A, and use of an adjuvant is required. Preharvest 

intervals (PHIs) of 7-30 days are proposed.
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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BASF has petitioned for the establishment of permanent tolerances for “saflufenacil, including 

its metabolites and degradates, in or on the imported agricultural commodities listed 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):

Coffee, green bean 0.03 ppm

Banana, whole fruit 0.03 ppm

Mango, fruit 0.03 ppm

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 HED Residues of Concern Knowledgebase Subcommittee (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). This conclusion was translated 

to perennial crops (i.e., tree fruits and tree nuts) where saflufenacil application is directed to the 

weeds on the orchard floor (Memo, G. Kramer, 7/22/09; D349938). As the proposed use on 

coffee, banana, and mango is also directed to weeds at the base of the plants, HED concludes that 

the residues of concern for the tolerance expression and risk assessment also consist of 

saflufenacil, M800H11, and M800H35 for these crops.

The nature of the residue in livestock is adequately understood based on acceptable metabolism 

studies conducted on lactating goats and laying hens. There are no livestock feedstuffs 

associated with the proposed uses; therefore, no changes in the existing tolerances for livestock 

commodities are needed.

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). This method was used as the data-collection method in the 

analysis of samples for residues of concern from the various studies associated with the current 

petition. HED has determined that Method D0603/02 is a suitable enforcement method for plant 

commodities as defined in Standard Operating Procedure (SOP) No. ACB-019 (9/15/08). 

The submitted magnitude of the residue data for coffee, banana, and mango are adequate. There 

are also adequate storage stability data to validate the storage conditions and intervals of samples 

collected from the field trials. Quantifiable residues were not found in coffee RAC samples 

(green beans) even after application of saflufenacil at exaggerated rates (~3X); therefore, 

analysis of coffee processed fractions (roasted beans, instant coffee) was not necessary and 

separate tolerances for processed fractions are not required.
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of a revised Section F (see requirements under Proposed Tolerances), there 

are no residue chemistry issues that would preclude granting permanent tolerances for residues 

of saflufenacil on the requested crops. The submitted data support: “Tolerances are established 

for residues of the herbicide 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 following commodities.”

Coffee, green bean 0.03 ppm

Banana 0.03 ppm

Mango 0.03 ppm

Note to RD: These tolerances should include a footnote stating “No U.S. registrations as of 

[date of FR notice].”

860.1550 Proposed Tolerances

 The petitioner is requested to submit a revised Section F specifying the revised 

definitions summarized above.

A human-health risk assessment is forthcoming in a separate document (DP# 384602).

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)

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# 390922

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Table 1. Saflufenacil and Metabolite Nomenclature.

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

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 a draft Brazilian label for the 70% WDG formulation (Heat®), which is 

representative of the Central and South American labels. Information pertaining to the proposed 

end-use product is listed in Table 3. A summary of the proposed use patterns 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# 390922

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Table 3. Summary of Proposed End-Use Product.

Trade Name

Reg. 

No.

ai (% of 

formulation)

Formulation 

Type Target Crops

Target 

Pests Label Date

Heat® NA 70 WDG coffee, banana, and 

mango

Broadleaf 

weeds

Draft label 

submitted 11/10

Table 4. Summary of Directions for Use of Saflufenacil.

Applic. Timing, 

Type, and Equip. Formulation

App. rate

(lb ai/acre)

Max. No. 

App. per 

Season

Max. Seasonal 

App. Rate

(lb ai/acre)

PHI

(days)

Use Directions and 

Limitations

Coffee, Banana, and Mango

Ground directed 

to weeds Heat®

0.022-0.044 3 0.131

7 (coffee)

15 (mango)

30 (banana)

Applications are to be 

made in 16-43 gal/acre

Note: A non-ionic adjuvant system is required for optimum activity.

Conclusions: The submitted use directions for Heat®are adequate to allow evaluation of the 

residue data relative to the proposed uses. 

860.1300 Nature of the Residue - Plants

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 N-demethylation at 

the uracil ring, stepwise degradation (N-dealkylation) of the N-methyl-N-isopropyl 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). This conclusion was translated to perennial crops (i.e., tree fruits and tree nuts) 

where saflufenacil application is directed to the weeds on the orchard floor (Memo, G. Kramer, 

7/22/09; D349938). As the proposed use on coffee, banana, and mango is also directed to weeds 

at the base of the plants, HED concludes that the residues of concern for the tolerance expression 

and risk assessment also consist of saflufenacil, M800H11, and M800H35 for these crops.

860.1300 Nature of the Residue - Livestock/

860.1480 Meat, Milk, Poultry, and Eggs

The nature of the residue in livestock is adequately understood based on acceptable metabolism 

studies conducted on lactating goats and laying hens. There are no livestock feedstuffs 

associated with the proposed uses; therefore, no changes in the existing tolerances for livestock 

commodities are needed.

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 with methanol:water 

(70:30; v:v). The methanol extract was evaporated and reconstituted in methanol:water (50:50; 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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v:v) for LC-MS/MS analysis. 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. The 

limit of detection (LOD) was reported to be 3X the standard deviation (SD) at the LOQ for each 

analyte (0.002-0.003 ppm).

Recovery samples, prepared at levels of LOQ and 10X LOQ in each matrix, were generally

within the acceptable range of 70-120%. 

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

Storage stability data have been submitted for residues of saflufenacil and its metabolites 

M800H11 and M800H35 in/on various crop commodities [corn (grain, forage, stover); soybean 

(seed, forage, hay); orange (fruit, pulp, juice, oil); radish (root); grape (raisin); and garbanzo 

bean (seed)] indicating that residues of saflufenacil, M800H11, and M800H35 are stable in/on all 

tested commodities during frozen storage for up to 548 days (MRID No. 47523801). There are 

no unresolved storage stability issues, and no corrections need to be applied to the various 

magnitude of the residue studies. 

860.1500 Crop Field Trials

Banana

DER Reference List 48239801.der.doc

48239802.der.doc

48239803.der.doc

MRID No. 48239801: BASF Corporation has submitted field trial data for saflufenacil on 

banana. Two banana field trials were conducted during the 2008 growing season in Brazil. Each 

trial location consisted of one untreated and one treated plot. Each treated plot received three 

applications of the 70% WDG formulation of saflufenacil at 0.044 lb ai/A (1X) directed to the 

base of the plants, with a 30-day retreatment interval (RTI), for a total application rate of 0.131 

lb ai/A (1X). The applications were made using ground equipment with 21 gallons per acre 

(GPA) spray volumes. An adjuvant (surfactant, Dash®) was included in the spray mixture. 

Samples of mature bananas were harvested at a 30-day PHI. 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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The results from these trials on banana show that after three applications of saflufenacil at 0.044 

lb ai/A (0.049kg ai/ha), residues of saflufenacil, M800H11, and M800H35 were below the LOQ 

(<0.01 ppm each) in banana samples harvested at a 30-day PHI. Therefore, the maximum 

combined residues of saflufenacil and its metabolites was <0.03 ppm.

MRID No. 48239802: BASF Corporation has submitted field trial data for saflufenacil on 

banana. Two banana field trials were conducted during the 2010 growing season in Brazil. Each 

trial location consisted of one untreated and one treated plot. Each treated plot received five 

applications of the 70% WDG formulation of saflufenacil at 0.0667 lb ai/A (1.5X) directed to the 

base of the plants, with a 3-week RTI, for a total application rate of 0.333 lb ai/A (2.5X). The 

applications were made using ground equipment with 21 GPA spray volumes. An adjuvant 

(surfactant, Dash®) was included in the spray mixture. Samples of mature bananas were 

harvested at 0- and 1-day PHIs. 

The results from these trials on banana show that after five applications of saflufenacil at 0.0667 

lb ai/A (0.0749 kg ai/ha), residues of saflufenacil, M800H11, and M800H35 were below the 

LOQ (<0.01 ppm each) in banana samples harvested at 0- and 1-day PHIs. Therefore, the 

maximum combined residues of saflufenacil and its metabolites was <0.03 ppm.

MRID No. 48239803: BASF Corporation has submitted field trial data for saflufenacil on 

banana. A total of 10 field trials were conducted on bananas during the 2008 growing season in 

Costa Rica (2 trials), Colombia (1 trial), Ecuador (3 trials), Guatemala, (1 trial), Honduras (2 

trials), and Panama (1 trial).

Each trial location consisted of one untreated and one treated plot. Each treated plot received 

five applications of the 70% WDG formulation of saflufenacil directed to the base of the plants 

at 0.064-0.071 lb ai/A (1.5X-1.6X), with 11- to 28-day retreatment intervals (RTIs), for a total 

application rate of 0.33-0.35 lb ai/A/season (2.8X-3.0X). The applications were made using 

ground equipment with approximately 20-23 GPA spray volumes. An adjuvant [crop-oil 

concentrate (COC)] was included in the spray mixture, together with ammonium sulfate (AMS)

fertilizer. Duplicate samples of commercially mature banana were harvested at a 0- or 1-day

PHI.

The results from these trials on banana show that after five applications of saflufenacil directed 

to the base of the plants at 0.067 lb ai/A/application (0.075 kg ai/ha/application), for a total 

seasonal rate of 0.33 lb ai/A (0.375 kg ai/ha), maximum saflufenacil, M800H11, and M800H35 

residues were <LOQ (<0.01 ppm each) in/on banana whole fruit samples harvested at a 0-day

PHI (n=20) or 1-day PHI (n=20). Therefore, the maximum combined residues of saflufenacil 

and its metabolites was <0.03 ppm at the 0- and 1-day PHIs.

TABLE 5. Summary of Residue Data from Crop Field Trials with Banana (MRID#s 48239801 thru -03).

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.

Proposed Use = 0.131 lb ai/acre Max. Seasonal App. Rate, 30-Day PHI

Banana 0.33-0.35

[0.372-0.392] 0

Saflufenacil

22

<0.01 <0.01 <0.01 <0.01 <0.01 -

M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 -

M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 -

Combined3<0.03 <0.03 <0.03 <0.03 <0.03 -
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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TABLE 5. Summary of Residue Data from Crop Field Trials with Banana (MRID#s 48239801 thru -03).

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.

Proposed Use = 0.131 lb ai/acre Max. Seasonal App. Rate, 30-Day PHI

Banana 0.33-0.35

[0.372-0.392] 1

Saflufenacil

22

<0.01 <0.01 <0.01 <0.01 <0.01 -

M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 -

M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 -

Combined3<0.03 <0.03 <0.03 <0.03 <0.03 -

Banana 0.131

[0.147] 30

Saflufenacil

2

<0.01 <0.01 <0.01 <0.01 <0.01 -

M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 -

M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 -

Combined3<0.03 <0.03 <0.03 <0.03 <0.03 -

1

 For calculation of the HAFT, median, mean, and standard deviation, 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 bananas

imported from Central/South America. Even though all major exporting countries were not 

represented (Table 6), HED will not require additional data as all residues were <LOQ, even at 

~3X exaggerated use rate. Also, HED generally requires residue data for both bagged and 

unbagged bananas. The fruit in these trials were “grown and maintained according to typical 

agricultural practices for each region,” which HED interprets to mean bagged. As saflufenacil is 

not applied directly to the plants and there is no evidence of systemic activity in fruit/tree crops, 

additional data on un-bagged bananas will not be required. The available data will thus support 

the proposed use pattern.

TABLE 6. Trial Numbers and Geographical Locations.

Country

Banana

Submitted

Requested1

U.S.

Brazil 4

Columbia 1 2

Costa Rica 2 3

Ecuador 3 3

Guatemala 1 0

Honduras 2 2

Mexico 0 2

Panama 1 0

Total 14 12

1

 The requested number and geographic distribution of field trials for bananas, according to the NAFTA Guidance Document on 

Data Requirements for Tolerances on Imported Commodities in the United States and Canada, 12/05.

The residue data for bananas were not entered into the OECD MRL Calculator as all of the 

residues were <LOQ. The recommended tolerance for the combined residues of saflufenacil and 

its metabolites M800H11 and M800H35, expressed as parent equivalents, is 0.03 ppm for 

banana.
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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Coffee

DER Reference List 48239804.der.doc

48239805.der.doc

MRID No. 48239804: BASF Corporation has submitted field trial data for saflufenacil on 

coffee. Three coffee field trials were conducted during the 2008 growing season in Brazil. Each 

trial location consisted of one untreated and one treated plot. Each treated plot received three 

applications of the 70% WDG formulation of saflufenacil at 0.044 lb ai/A (1X) directed to the 

base of the plants, with a 4-week RTI, for a total application rate of 0.131 lb ai/A (1X). The 

applications were made using ground equipment with 21 GPA spray volumes. An adjuvant 

(surfactant, Dash®) was included in the spray mixture. Samples of mature coffee beans were 

harvested at a 7-day PHI. 

The results from these trials on coffee show that after three applications of saflufenacil at 0.044 

lb ai/A (0.049 kg ai/ha), residues of saflufenacil, M800H11, and M800H35 were below the LOQ 

(<0.01 ppm each) in coffee samples harvested at a 7-day PHI. Therefore, the maximum 

combined residues of saflufenacil and its metabolites was <0.03 ppm.

MRID No. 48239805: BASF Corporation has submitted field trial data for saflufenacil on 

coffee. Five coffee field trials were conducted during the 2008 growing season in Costa Rica (2 

trials), Colombia (2 trials), and Mexico (1 trial). Each trial location consisted of one untreated 

and one treated plot. Each treated plot received four applications of the 70% WDG formulation 

of saflufenacil at 0.087-0.092 lb ai/A (2.0-2.1X) directed to the base of the plants, with 8- to 35-

day RTIs, for a total application rate of 0.35-0.36 lb ai/A (2.7X). The applications were made 

using ground equipment with 21-22 GPA spray volumes. An adjuvant (COC) was included in 

the spray mixture. Samples of mature coffee beans were harvested at 0-day or 1-day PHIs. 

The results from these trials on coffee show that after four applications of saflufenacil (70% 

WDG) directed to the base of the plants targeting 0.087 lb ai/A/application (0.098 kg

ai/ha/application), for a total seasonal rate of 0.35 lb ai/A (0.392 kg ai/ha), maximum

saflufenacil, M800H11, and M800H35 residues were <LOQ (<0.01 ppm each) in/on coffee 

green bean samples harvested at a 0-day PHI (n=10) or 1-day PHI (n=10). Therefore, the 

maximum combined residues of saflufenacil and its metabolites was <0.03 ppm at the 0- or 1-

day PHI.

TABLE 7. Summary of Residue Data from Crop Field Trials with Coffee (MRID#s 48239804 and -05).

Commodity

Total Rate (lb 

ai/A)

[g ai/ha]

PHI 

(days) Analyte

Residue Levels (ppm)1

n Min. Max. HAFT2 Median Mean

Std. 

Dev.

Proposed Use = 0.131 lb ai/acre Max. Seasonal App. Rate, 7-Day PHI

Coffee, green 

bean

0.35-0.36

[392-400]

0

Saflufenacil

10

<0.01 <0.01 <0.01 <0.01 <0.01 -

M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 -

M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 -

Combined3<0.03 <0.03 <0.03 <0.03 <0.03 -

0.35-0.36

[392-400]

1

Saflufenacil

10

<0.01 <0.01 <0.01 <0.01 <0.01 -

M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 -

M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 -

Combined3<0.03 <0.03 <0.03 <0.03 <0.03 -
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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TABLE 7. Summary of Residue Data from Crop Field Trials with Coffee (MRID#s 48239804 and -05).

Commodity

Total Rate (lb 

ai/A)

[g ai/ha]

PHI 

(days) Analyte

Residue Levels (ppm)1

n Min. Max. HAFT2 Median Mean

Std. 

Dev.

Proposed Use = 0.131 lb ai/acre Max. Seasonal App. Rate, 7-Day PHI

Coffee, green 

bean

0.131

[0.147] 7

Saflufenacil

3

<0.01 <0.01 <0.01 <0.01 <0.01 -

M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 -

M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 -

Combined3<0.03 <0.03 <0.03 <0.03 <0.03 -

1

 For calculation of the HAFT, median, mean, and standard deviation, 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 coffee 

imported from Central/South America. Even though all major exporting countries were not 

represented (Table 8), HED will not require additional data as all residues were <LOQ, even at 

~3X exaggerated use rate. The available data will thus support the proposed use pattern.

TABLE 8. Trial Numbers and Geographical Locations.

Country

Coffee

Submitted

Requested1

U.S.

Brazil 3 1

Columbia 2 1

Costa Rica 2 1

Guatemala 0 1

Indonesia 0 1

Mexico 1 1

Vietnam 0 1

Total 8 7

1

 The requested number and geographic distribution of field trials for coffee, according to the NAFTA Guidance Document on 

Data Requirements for Tolerances on Imported Commodities in the United States and Canada, 12/05 and import data 

(http://www.ers.usda.gov/Data/FoodImports/Data/2011/CoffeeT1.xls and 

http://www.nationmaster.com/graph/eco_tra_wit_us_us_imp_of_gre_cof-trade-us-imports-green-coffee). All countries (in which 

the pesticide is marketed or intended to be marketed) must be represented if the amount that they export to North America 

represents 5% or more of imports of the subject crop into any of the country in which a tolerance is being sought. 

The residue data for coffee were not entered into the OECD MRL Calculator as all of the 

residues were <LOQ. The recommended tolerance for the combined residues of saflufenacil and 

its metabolites M800H11 and M800H35, expressed as parent equivalents, is 0.03 ppm for coffee, 

green bean.

Mango

DER Reference List 48239806.der.doc

48239807.der.doc

MRID No. 48239806: BASF Corporation has submitted field trial data for saflufenacil on 

mango. Two mango field trials were conducted during the 2008 growing season in Brazil. Each 

trial location consisted of one untreated and one treated plot. Each treated plot received three 

applications of the 70% WDG formulation of saflufenacil at 0.044 lb ai/A (1X) directed to the 

base of the trees, with a 10-day RTI, for a total application rate of 0.131 lb ai/A (1X). The 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

Page 11 of 14

applications were made using ground equipment with 21 GPA spray volumes. An adjuvant 

(surfactant, Dash®) was included in the spray mixture. Samples of mature mango were harvested 

at a 14- or 15-day PHI. 

The results from these trials on mango show that after three applications of saflufenacil at 0.044 

lb ai/A (0.049kg ai/ ha), residues of saflufenacil, M800H11, and M800H35 were below the LOQ 

(<0.01 ppm each) in mango samples harvested at a 14- or 15-day PHI. Therefore, the maximum 

combined residues of saflufenacil and its metabolites was <0.03 ppm.

MRID No. 48239807: BASF Corporation has submitted field trial data for saflufenacil on 

mango. Two mango field trials were conducted during the 2008-2009 growing season in Brazil. 

Each trial location consisted of one untreated and one treated plot. Each treated plot received 

three applications of the 70% WDG formulation of saflufenacil at 0.044 lb ai/A (1X) directed to 

the base of the trees, with a 10-day RTI, for a total application rate of 0.131 lb ai/A (1X). The 

applications were made using ground equipment with 21 GPA spray volumes. An adjuvant 

(surfactant, Dash®) was included in the spray mixture. Samples of mature mango were harvested 

at a 15-day PHI. 

The results from these trials on mango show that after three applications of saflufenacil at 0.044 

lb ai/A/application (0.049kg ai/ha), residues of saflufenacil, M800H11, and M800H35 were 

below the LOQ (<0.01 ppm each) in mango samples harvested at a 15-day PHI. Therefore, the 

maximum combined residues of saflufenacil and its metabolites was <0.03 ppm.

TABLE 9. Summary of Residue Data from Crop Field Trials with Mango.

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.

Proposed Use = 0.131 lb ai/acre Max. Seasonal App. Rate, 15-Day PHI

Mango 0.131

[0.147] 14-15

Saflufenacil

4

<0.01 <0.01 <0.01 <0.01 <0.01 -

M800H11 <0.01 <0.01 <0.01 <0.01 <0.01 -

M800H35 <0.01 <0.01 <0.01 <0.01 <0.01 -

Combined3<0.03 <0.03 <0.03 <0.03 <0.03 -

1

 For calculation of the HAFT, median, mean, and standard deviation, 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 mango

imported from Central/South America. Even though all major exporting countries were not 

represented (Table 10), HED will not require additional data as all residues were <LOQ. The 

available data will thus support the proposed use pattern.
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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TABLE 10. Trial Numbers and Geographical Locations.

Country

Mango

Submitted

Requested1

U.S.

Brazil 4 1

Ecuador 0 1

Mexico 0 1

Peru 0 1

Total 4 4

1

 The requested number and geographic distribution of field trials for mango, according to the NAFTA Guidance Document on 

Data Requirements for Tolerances on Imported Commodities in the United States and Canada, 12/05 and import data (Fruit and 

Tree Nuts Situation and Outlook Yearbook (USDA, 2008)). All countries (in which the pesticide is marketed or intended to be 

marketed) must be represented if the amount that they export to North America represents 5% or more of imports of the subject

crop into any of the country in which a tolerance is being sought. 

The residue data for mango were not entered into the OECD MRL Calculator as all of the 

residues were <LOQ. The recommended tolerance for the combined residues of saflufenacil and 

its metabolites M800H11 and M800H35, expressed as parent equivalents, is 0.03 ppm for 

mango.

860.1520 Processed Food and Feed

Coffee

BASF requested a waiver for residue data for saflufenacil in/on coffee processed fractions. HED

has previously reviewed processing studies for saflufenacil when applied postemergencedirected under the leaf canopy at the base of fruit tree crops: apple (MRID 47128229), orange 

(MRID 47128228), plum (MRID 47128230), and grape (MRID 47128232). In all of these 

studies, the individual residues of saflufenacil and its metabolites M800H11 and M800H35 were 

<LOQ (i.e., 0.01 ppm for each analyte) in/on unwashed RAC samples of apple, orange, plum and 

grape after application of saflufenacil at exaggerated rates of 2-5X. Since quantifiable residues 

were not found in the whole fruit RAC samples, analysis of the processed commodities were not 

necessary (except for orange- residues in citrus oil were also <LOQ). A similar conclusion can 

be reasonably expected for coffee when saflufenacil is applied postemergence-directed beneath 

the leaf canopy of coffee plants. Quantifiable residues were not found in coffee RAC samples 

(green beans) even after application of saflufenacil at exaggerated rates (~3X); therefore,

analysis of coffee processed fractions (roasted beans, instant coffee) is not necessary and 

separate tolerances for processed fractions are not required.

860.1650 Submittal of Analytical Reference Standards

Analytical standards of saflufenacil (expiration date: 2/1/13), M800H11 (expiration date: 

7/1/14), and M800H35 (expiration date: 7/1/14) are currently available in the National Pesticide 

Standards Repository [source: personal communication with T. Cole of ACL/BEAD, 6/20/11]. 

860.1850/860.1900 Confined/Field Accumulation in Rotational Crops

Rotational crop studies are not germane to this petition as coffee, banana, and mango are not 
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

Page 13 of 14

rotated with other crops.

860.1550 Proposed Tolerances

A summary of the recommended tolerances for the current petition are listed in Table 11. The 

petitioner should submit a revised section F reflecting the corrected commodity definitions.

There are no Canadian or Codex maximum residue limits (MRLs) established for residues of 

saflufenacil and its metabolites in coffee, banana, and mango commodities. Harmonization is 

thus not an issue for this petition.

Table 11. Tolerance Summary for Saflufenacil.

Commodity

Proposed 

Tolerance (ppm)

HED-Recommended 

Tolerance (ppm)

Correct Commodity 

Definition/Comments

Coffee, green bean 0.03 0.03

Banana, whole fruit 0.03 0.03 Banana

Mango, fruit 0.03 0.03 Mango

Note to RD: These tolerances should include a footnote stating “No U.S. registrations as of 

[date of FR notice].”

Attachments:

International Residue Limit Status (IRLS) sheet.

cc: G. Kramer (RAB1)

RDI: RAB1 Chemists (7/13/11)

G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1
Saflufenacil Summary of Analytical Chemistry and Residue Data DP# 390922

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IRLS Sheet.

Saflufenacil (118203; Date of Request: 06/20/2011)

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]benz

amide, 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]benz

amide

None

Commodity1

Tolerance (ppm)/Maximum Residue Limit 

(mg/kg)

U.S. Canada Mexico2 Codex

Coffee, green bean 0.03

Banana, whole fruit 0.03

Mango, fruit 0.03

Completed: M. Negussie; 06/21/2011

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.