Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PREVENTION, PESTICIDE

AND TOXIC SUBSTANCES

MEMORANDUM

Date: October 16, 2009

SUBJECT: Boscalid; Petition for Establishing Permanent Tolerances on Alfalfa and the 

Citrus Crop Group 10, and Amending the Established Tolerance on the Stone 

Fruit Crop Group 12. Summary of Analytical Chemistry and Residue Data.

PC Code: 128008 DP Barcode: 364447

Decision No.: 405556 Registration No.: 7969-198, 7968-197, 7969-199

Petition Nos.: 9F7527, 9F7529 Regulatory Action: Section 3 Registration

Risk Assessment Type: NA Case No.: NA

TXR No.: NA CAS No.: 188425-85-6

MRID No.: see MRID Summary Table 40 CFR: 180.589

 Ver.Apr.08

FROM: Amelia M. Acierto, Chemist

Risk Assessment Branch III

Health Effects Division (7509P)

THROUGH: Stephen Funk, Senior Science Advisor

Risk Assessment Branch III

Health Effects Division (7509P

TO: Tony Kish, Risk Manager Team #22

Fungicide Branch

Registration Division (7505P)

MRID Summary Table

MRID No. Study Type Comments

45903601 860.1500/1520 Citrus New DER; 45903601.der.doc

47470201 860.1500 Stone Fruit New DER; 47470201.der.doc

47584401 860.1500 Alfalfa New DER; 47584401.der.doc

47584402 860.1520 Citrus New DER; 47584402.der.doc

47584403 860.1480 Cattle New DER; 47584403.der.doc
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This document was originally prepared under contract by Dynamac Corporation (1910 Sedwick 

Road, Building 100, Suite B; Durham, NC 27713). 

The document has been reviewed by the Health Effects Division (HED) and revised to reflect 

current Office of Pesticide Programs for (OPP) policies.

Executive Summary

Boscalid, 2-chloro-N-(4 ́-chloro[1,1 ́-biphenyl]-2-yl)-3-pyridinecarboxamide, is a carboxamide 

(anilide) class fungicide that inhibits mitochondrial respiration, thereby inhibiting spore 

germination, germ tube elongation, mycelial growth, and sporulation in all major stages of fungal 

development and reproduction necessary for disease development in a variety of vegetable, fruit 

and row crops. There are currently two water-dispersible granular (WDG) boscalid end-use 

products (EPs) registered to BASF in the US for use on food/feed crops, one containing only

boscalid and one which is a mixture of two active ingredients. The single active ingredient 

formulation is a 70% WDG (Endura®Fungicide; EPA Reg. No. 7969-197) and the mixture 

formulation is a WDG containing 25.2% boscalid and 12.8% pyraclostrobin (Pristine®Fungicide;

EPA Reg. No. 7969-199). Only boscalid is addressed in this document; pyraclostrobin is being 

evaluated separately. 

Permanent tolerances have been established under 40 CFR §180.589(a)(1) for plant 

commodities, ranging from 0.05 ppm in/on peanuts and tuberous and corm vegetables (subgroup 

1C) to 60 ppm in/on leafy greens except head and leaf lettuce (subgroup 4A). Separate 

tolerances have also been established for indirect or inadvertent residues of boscalid in rotational 

crops 40 CFR §180.589(d) at levels ranging from 0.05 to 8.0 ppm. Tolerances for livestock 

commodities have been established under 40 CFR §180.589 (a)(2) for the combined residues of 

boscalid, and its metabolites 2-chloro-N-(4′-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide and 

the glucuronic acid conjugate of the 5-hydroxy metabolite at levels ranging from 0.02 ppm in 

eggs to 0.35 ppm in meat byproducts of cattle, goats, horses, and sheep. 

BASF is proposing new uses for boscalid on alfalfa using the 25% and 70% WDG formulations 

and on citrus fruits using the 25% WDG formulation. The proposed uses on alfalfa are for 

repeated broadcast foliar applications at up to 0.28 lb ai/A for the 25% WDG and 0.48 lb ai/A for 

the 70% WDG, with a minimum retreatment interval (RTI) of 14 days, for a maximum of 0.85 or 

1.44 lb ai/A/season for the 25% and 70% WDG, respectively. A maximum of 3 applications to 

alfalfa are allowed per season with no more than 2 applications per cutting. The proposed use on 

citrus fruits is for up to four broadcast foliar applications during fruit development at rates up to 

0.29 lb ai/A with a minimum RTI of 10 days, for a maximum of 1.17 lb ai/A/season. All 

applications can be made using ground or aerial equipment, and the proposed PHIs are 14 days 

for alfalfa and 0 days for citrus fruits. In conjunction with these uses, BASF is proposing the 

following permanent tolerances for boscalid:

Alfalfa forage .................................................................35 ppm

Alfalfa hay......................................................................85 ppm

Citrus Crop Group 10....................................................2.0 ppm
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Based on residue data from new stone fruit field trials conducted using the maximum labeled use 

rate for boscalid (25% WDG) on stone fruits, BASF is also requesting that the existing 1.7 ppm 

tolerance on the stone fruits crop group be increased as follows:

Stone Fruit Crop Group 12 ...........................................5.0 ppm

The registrant has also submitted FIFRA Section 3 registration requests to add the uses for alfalfa 

forage and hay and citrus fruits, crop group 10 on the labels of BAS 510F (EPA Reg. No. 7969-

198) and Pristine® Fungicide (EPA Reg. No. 7969-199), and the uses for alfalfa forage and hay

on the label of Endura® Fungicide (EPA Reg. No. 7969-197).

In addition, based on the potential increase in dietary exposure of livestock to boscalid due to the 

new use on alfalfa, BASF is proposing new or amended boscalid tolerances on the following 

livestock commodities:

 

Milk...............................................................................0.2 ppm

Milk fat (cream)............................................................1.5 ppm

Fat (cattle, goat, horse, and sheep)................................1.5 ppm

Meat (cattle, goat, horse, and sheep).............................0.2 ppm

Meat byproducts (cattle, goat, horse, and sheep)..........1.5 ppm

Kidney (cattle, goat, horse, and sheep) .........................1.0 ppm

Liver (cattle, goat, horse, and sheep) ............................1.0 ppm

Liver (poultry) ..............................................................0.2 ppm

Fat (poultry) ..................................................................0.2 ppm

Meat byproducts (poultry).............................................0.2 ppm

Fat (hogs) ......................................................................0.2 ppm

Meat byproducts (hogs).................................................0.2 ppm

Kidney (hogs)................................................................0.2 ppm

Liver (hogs)...................................................................0.2 ppm

The nature of boscalid residues in primary crops and livestock is considered adequately

understood, based on the acceptable metabolism studies on lettuce, grapes, beans, goats and hens. 

For purposes of tolerances and dietary risk assessment, the HED, through its Metabolism 

Assessment Review Committee (MARC), has concluded that the residue of concern in plant 

commodities is boscalid, and the residue of concern in livestock commodities include boscalid, 

its 5-hydroxy metabolite (M510F01) and the glucuronic acid conjugate of the 5-hydroxy

metabolite (M510F02).

An adequate gas chromatograph/mass spectrometric (GC/MS) method (Method D0008) is 

available for enforcing boscalid tolerances in plant commodities, and an adequate GC/electron 

capture detection method (Method DFG S19) is available for enforcing the current tolerances in 

livestock commodities. These methods have been found adequate by the Analytical Chemistry

Branch (ACB) of BEAD.

An adequate data collection method is available for plant commodities. Boscalid residues in

plant commodities were determined using liquid chromatography with tandem mass 

spectrometric detection (LC/MS/MS) method (BASF Method D9908). This method was 
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adequately validated in conjunction with the analysis of field trial and processing study samples, 

and the validated limit of quantitation (LOQ) is 0.05 ppm for boscalid in all plant commodities 

tested.

For data collection in livestock, residues of boscalid and its hydroxy metabolite M510F01 

(including its glucuronide conjugate) were determined using a LC/MS/MS method (BASF 

Method 471/0, modified), which was adequately validated in conjunction with analysis of 

feeding study samples. The validated LOQ for each analyte is 0.01 ppm in milk and 0.025 ppm 

in tissues, for combined LOQs of 0.02 ppm in milk and 0.05 ppm in tissues. The combined 

residues are expressed in parent equivalents.

The data requirements for testing with the multiresidue methods in the Pesticide Analytical 

Method (PAM I) have been fulfilled and were discussed in the earlier petitions. Residues of 

boscalid and its metabolite M510F01 were not adequately recovered using multiresidue method. 

Protocol A was not applicable. Protocol B was not applicable for boscalid and yielded 

inconsistent recoveries of M510F01. Residues of boscalid and M510F01 had good responses 

with GC/ECD on a DB-1 column under Protocol C but neither analyte was recovered at ≥30% 

using Protocol D, E, and F.

Adequate cattle and poultry feeding studies are available covering the potential levels of dietary

exposure for livestock to boscalid residues. Considering the existing and recommended 

tolerances for all feedstuffs, the dietary burden of livestock for boscalid residues in a reasonably

balanced diet are 10.8 ppm for beef cattle, 22.5 ppm for dairy cattle, 4.0 ppm for poultry and 5.3

ppm for swine. Based on these levels of dietary exposure and the residue data from the feeding 

studies, the existing tolerances for milk, and fat, meat and meat byproducts of cattle, goats, 

horses and sheep are adequate. The existing tolerances for eggs, poultry meat, and meat and 

meat byproducts of hogs are also adequate; however, the tolerances for hog fat, poultry fat, and 

poultry meat byproducts should each be increased to 0.20 ppm.

The data generated from alfalfa, orange, lemon, and grapefruit field trials are adequate and 

support the proposed uses of the 25% WDG formulation of boscalid on alfalfa and citrus fruits.

An adequate number of tests were conducted on the representative crops in the appropriate 

geographic regions, and the tests were conducted at ~1x the proposed use rate. Samples were 

collected around the proposed preharvest interval (PHI) and analyzed for residues of boscalid. 

The available field trial data support tolerances of 30 ppm for alfalfa forage, 65 ppm for alfalfa 

hay, and 1.6 ppm for the citrus fruit crop group 10.

An adequate citrus processing study is available indicating that boscalid residues are reduced in 

juice (<0.2x); therefore, a separate tolerance is not required for citrus juice. However, residues 

were shown to concentrate in both dried pulp (3.1x) and oil (59x). Based on the processing 

factors for dried pulp and oil and the highest average field trial (HAFT) residues for citrus fruits 

(1.39 ppm), the maximum expected boscalid residues would be 4.31 ppm in dried pulp and 82 

ppm in oil, which would support tolerances of 4.5 ppm for dried citrus pulp and 85 ppm for 

citrus oil.
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The new stone fruit field data are adequate. When residue data from all the stone fruit field 

trials at the 1x rate with 0-day PHI are pooled together by crop, the data support a tolerance of 

3.5 ppm for the stone fruit crop group 12.

Adequate confined, limited and extensive field rotational crop studies are available supporting 

the existing tolerances for indirect residues of boscalid in rotational crops. These data support 

the 14-day plant-back interval currently specified for crops without boscalid uses. No additional 

rotational crop data are required for purposes of this petition. 

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for boscalid and concludes that pending 

submission of a revised Section B for alfalfa, a revised Section F for alfalfa, citrus fruit, stone 

fruit and livestock as noted below, and provided the forthcoming Human Health Risk 

Assessment does not identify any risks of concern, there are no residue chemistry deficiencies

that would preclude establishing permanent tolerances for boscalid on alfalfa forage and hay and 

on the citrus fruits crop group 10, and for increasing the existing tolerance on the stone fruit crop 

group 12, and the existing tolerances on hog fat, poultry fat, and poultry meat byproducts. 

However, the deficiencies noted below must be resolved as a condition of registration.

Note to PM: HED recommends that the following tolerance definition entries in 40 CFR 

180.589 be revised and that tolerances for the listed commodities be established, as follows:

(a) General. (1) Tolerances are established for residues of the fungicide boscalid,

including its metabolites and degradates, in or on the commodities listed below. 

Compliance with the tolerance levels specified below is to be determined by measuring

only -pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) in or on the 

commodity. 

Alfalfa, forage ......................................... 30.0 ppm

Alfalfa, hay ............................................. 65.0 ppm

Citrus, dried pulp ................................ ....... 4.5 ppm

Citrus, oil................................................ 85.0 ppm

Fruit, citrus, group 10 ......................... 1.6 ppm

Fruit, stone, group 12 ............... ............ 3.5 ppm

(2) Tolerances are established for residues of the fungicide boscalid, including its 

metabolites and degradates, in or on the food commodities listed below. Compliance 

with the tolerance levels specified below is to be determined by measuring only the sum 

of 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) and metabolites 2-

chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide and glucuronic acid 

conjugate of 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide, calculated as 

the stoichiometric equivalent of boscalid, in or on the commodity.

Hog, fat.......................................................0.20 ppm

Poultry, fat .................................................................0.20 ppm

Poultry, meat byproducts.................................0.20 ppm
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The established tolerances of the following commodities remain unchanged. 

Cattle, fat................................................ . 0.30 ppm

Cattle, meat................................................ 0.10 ppm

Cattle, meat byproducts .................................0.35 ppm

Egg .........................................................0.02 ppm

Goat, fat.................................................... 0.30 ppm

Goat, meat................................................. 0.10 ppm

Goat, meat byproducts ................................... 0.35 ppm

Hog, meat....................................................0.05 ppm

Hog, meat byproducts.....................................0.10 ppm

Horse, fat....................................................0.30 ppm

Horse, meat.................................................0.10 ppm

Horse, meat byproducts .................................0.35 ppm

Milk.........................................................0.10 ppm

Poultry, meat..............................................................0.05 ppm

Sheep, fat .................................................. 0.30 ppm

Sheep, meat.............................................. . 0.10 ppm

Sheep, meat byproducts .............................. . . 0.35 ppm

The recommended tolerances in/on alfalfa, citrus and stone fruits are based on the crop field trial 

data. The appropriate tolerance levels were determined using the Agency’s Standard Operating 

Proceedure (SOP) “Guidelines for Setting Pesticide Tolerances Based on Field Trial Data”. 

The adequacy of the existing livestock tolerances were assessed using the available cattle and 

poultry feeding studies that cover the potential levels of dietary exposure of livestock to boscalid 

residues. The data indicate that the existing tolerances for meat (0.05 ppm) and meat byproducts 

(0.10 ppm) of hogs are adequate; however, the tolerance for hog fat should be increased to 0.20 

ppm. The adequacy of the existing tolerances for poultry were assessed using residue data from 

the 5.31 ppm dose group in the poultry feeding studies; this group represents 1.3x the calculated 

dietary burden for poultry. Maximum combined residues for this dose group were <0.02 ppm in 

eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in fat. Average combined 

residues were 0.02 ppm in eggs, 0.136 ppm in liver, 0.05 ppm in muscle, and 0.081 ppm in fat. 

These data indicate that the existing tolerances for eggs (0.02 ppm) and poultry meat (0.05 ppm) 

are adequate; however, the tolerances for poultry fat and meat byproducts should each be 

increased to 0.20 ppm. 
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Note to PM: HED recommends that the tolerance definition entry in 40 CFR 180.589 (d) 

Indirect or inadvertent residues should be revised to read as follows:

(d) Indirect or inadvertent residues. Tolerances are established for residues of the 

fungicide boscalid, including its metabolites and degradates, in or on the 

commodities listed below. Compliance with the tolerance levels specified below is 

to be determined by measuring only -pyridinecarboxamide, 2-chloro-N-(4'-

chloro[1,1'-biphenyl]-2-yl) in or on the commodity. 

Commodity Parts per million

Animal feed, nongrass, group 18, forage, excluding alfalfa 1.0

Animal feed, nongrass, group 18, hay, excluding alfalfa 2.0

Animal feed, nongrass, group 18, seed, excluding alfalfa

860.1200 Direction for Use

● A revised Section B for alfalfa is required to amend the label direction for the 70% WDG 

formulation since it could not be supported by the field trial data generated with a 

maximum seasonal use rate of 0.9 lb ai/A. The proposed label rate for the 70%

formulation is 1.7x higher; the label should be revised to match the field trial rate.

860.1550 Proposed Tolerances

● Boscalid residues concentrate in citrus dried pulp (3.1x) and citrus oil (59x). A revised 

Section F is required to propose separate tolerances for citrus, dried pulp at 4.5 ppm, 

citrus, oil at 85 ppm, and Fruit, citrus, group 10 at 1.6 ppm. 

 ● The available data for stone fruits will not support a tolerance level of 5.0 ppm. A 

revised Section F should be submitted with a tolerance for Fruit, stone, group 12 at 3.5 

ppm..
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● The available data will not support the proposed tolerances for meat, meat byproducts, 

and fat of cattle goat, horse, and sheep at 0.2, 1.5, and 1.5 ppm , respectively. The 

existing tolerances will be maintained for meat, meat byproducts and fat of cattle, goat, 

horse and sheep at 0.10 ppm, 0.35 ppm, and 0.30 ppm, respectively. The available data

will not support the proposed tolerance of 0.2 ppm for milk and the proposed tolerance of 

1.5 for milk fat. The existing tolerance of 0.10 ppm will be maintained for milk, and it is 

adequate to cover milk fat. For all remaining livestock commodities, the proposed 

tolerances must be revised to reflect the recommended tolerance levels as specified in 

Table 11.

Note to PM: Revisions of the livestock commodities data collection methods have been 

included in the registrant’s submissions. However, BASF have not indicated whether any of the 

changes were made in their attempt to resolve any of the deficiencies noted by the Agency in 

their 2003 petition (DP# 278385, M. Nelson, 8/15/2003). If the methods have been revised and 

finalized, this should be clarified and the entire final versions of the enforcement and the data 

collection methods should be submitted to the Agency. Otherwise, registration for the new or 

amended use patterns for the boscalid products should be made conditional until the deficiencies 

noted above are fully resolved.

Background

The chemical structure and nomenclature of boscalid and its hydroxyl metabolite and 

physicochemical properties of the technical grade of boscalid are presented in Tables 1 and 2.

Table 1. Nomenclature of Boscalid and its Hydroxy Metabolite.

Compound

N

N

O

Cl

Cl

Common name Boscalid; Nicobifen

Company experimental name BAS 510 F

IUPAC name 2-chloro-N-(4'-chlorobiphenyl-2-yl)-nicotinamide

CAS name 3-pyridinecorboxamide,2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl

Molecular weight 343.2

CAS registry number 188425-85-6

End-use product (EPs) 25.2% WDG (Pristine®Fungicide; EPA Reg. No. 7969-199, also contains 12.8% 

pyraclostrobin)

70% WDG (Endura®Fungicide; EPA Reg. No. 7969-197)
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Table 1. Nomenclature of Boscalid and its Hydroxy Metabolite.

Hydroxy-metabolite

N

N

O

Cl

Cl

OH

Common name Boscalid hydroxy metabolite

Company experimental name M510F01 (glucuronide conjugate – M510F02)

CAS name 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl)nicotinamide

Molecular weight 359.2

Table 2. Physicochemical Properties of Boscalid.

Parameter Value References

Melting point/range 142.8-143.8 C MRIDs 45404802 and 

pH NA (does not dissociate in water) 45404804-45404809

Relative Density (20oC) 1.381g/cm3

Water solubility (20oC) 4.64 mg/L at pH 6

Solvent solubility (g/100 mL at 20oC) acetone 16-20 ethyl acetate 6.7-8.0 

methanol 4-5 2-propanol <0.01 

acetonitrile 4-5 dichloromethane 20-25 

toluene 2-5 n-heptane <0.01

1-octanol <0.01 olive oil 2.9

N,N-DMF >25

Vapor pressure 7 x 10-9

hPa 

Dissociation constant, pKa None (does not dissociate in water)

Octanol/water partition coefficient, 

Log(KOW)

2.96 

UV/visible absorption spectrum UV molecular extinction (e[lmol-1cm-1]): 3.15 

x104at 228 nm; 1.53 x103at 290 nm

860.1200 Directions for Use

BASF is proposing new uses for the 25% WDG on alfalfa and citrus fruits and for the 70% WDG 

formulation on alfalfa. Supplemental labels were provided. The use directions for alfalfa and 

citrus, including the directions for stone fruits are summarized below in Table 3. 
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Table 3. Summary of Directions for Use of Boscalid.

Applic. Timing, Type, 

and Equip.1

Formulation

[EPA Reg. 

No.]

Applic. 

Rate 

(lb ai/A)

Max. No. 

Applic. per 

Season

Max. Seasonal 

Applic. Rate

(lb ai/A)

PHI

(days)

Use Directions and 

Limitations 2

Alfalfa 3

Broadcast foliar applications 

when conditions are 

favorable to disease 

development; ground or 

aerial equipment. 

70% WDG

[7969-197] 0.09-0.48

3 

(2 per cutting) 1.44 14

The minimum RTI is 14 days. 

For aerial applications, use a 

minimum of 10 gal/A

Do not make more than 2 

applications per cutting or 3 

applications per season.

25.2% WDG

[7969-199]

0.19-0.28 3 

(2 per cutting) 0.85 14

Citrus Fruits

Broadcast foliar applications 

prior to infection; ground or 

aerial equipment

25.2% WDG

[7969-199] 0.25-0.29 4 1.17 0

The minimum RTI is 10 days. 

For aerial applications, use a 

minimum of 10 gal/A

Stone Fruits

Broadcast foliar applications 

from pink bud through fruit 

development; ground or 

aerial equipment

25.2% WDG

[7969-199] 0.17-0.23 5 1.14 0

The minimum RTI is 7 days.

For aerial applications, use a 

minimum of 10 gal/A

1 Ground application may be made through the following types of irrigation systems: center pivot, lateral move, end tow, side 

wheel roll, traveler, big gun, solid set, or hand move. 

2 Use directions allow for the use of spray adjuvants, and specify a 14-day plant-back interval for rotational crops without 

registered uses for boscalid.

3

For stand establishment of fall seeded alfalfa, begin applications in fall through early winter prior to first snowfall or 

extended cool, wet conditions. For seed pod protection, begin applications at 10% to 30% bloom.

Conclusions. The submitted use directions are sufficient to allow for evaluation of the submitted 

residue data relative to the proposed use pattern. The available field trial data support the 

proposed use directions for the 25% WDG formulation on alfalfa and citrus fruits, and the 

supplemental field trail data on stone fruits support the current use on stone fruits. 

However, a revised Section B for alfalfa is required to amend the label direction for the 

70% WDG formulation since it could not be supported by the field trial data generated 

with a maximum seasonal use rate of 0.9 lb ai/A. The proposed label rate for the 70% 

formulation is 1.7x higher; the label should be revised to match the field trial rate.

860.1300 Nature of the Residue - Plants

PP#1F6313; DP# 278385; M. Nelson; 8/15/2003

HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003

The nature of boscalid residues in primary crops is adequately understood, based upon acceptable 

grape, lettuce and bean metabolism studies; these studies were reviewed in the initial boscalid 

petition, PP#1F6313. No significant metabolism of boscalid occurred in grapes or lettuce; 

unchanged parent was the only component identified, accounting for 92-98% and 99% total 

radioactive residues (TRR), respectively. In bean plants, boscalid metabolized slowly; 

unchanged parent was the major component identified, accounting for up to 72% TRR in dry

bean seeds, and 99% TRR in bean plants. Cleavage products, 1-(chlorophenyl)-2-aminobenzene 

and 2-chloronicotinic acid, were present in small amounts, accounting for <1% and <10% TRR, 

respectively.
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HED has concluded that the parent compound, boscalid, is the sole residue of concern in primary

crop for purposes of risk assessment and the tolerance expression. The cleavage products were 

not included, based on the limited cleavage which occurred, and the low levels of their ingestion 

expected from dietary and environmental sources. 

860.1300 Nature of the Residue - Livestock

PP#1F6313; DP# 278385; M. Nelson; 8/15/2003

HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003

The nature of boscalid residues in livestock is adequately understood, based upon acceptable 14C 

metabolism studies conducted on lactating goats and laying hens. In both goats and hens, parent 

boscalid, M510F01 (hydroxy metabolite), and M510F 02 (M510F01 glucuronide) were identified 

as the major residues, each with ≥10% TRR. No amide bridge cleavage products were identified. 

Based on the structural similarity of boscalid and M510F 01, and the fact that the enzymatic 

hydrolysis step in the proposed enforcement method will release M510F 02 back to free M510F 

01, HED concluded that the combined residues of parent boscalid, M510F 01 and M510F02 are 

the residues of concern in livestock matrices for purposes of risk assessment and the tolerance 

expression. 

860.1340 Residue Analytical Methods - Plants

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

DP# 284510; D. Swineford and E. Kolbe; 8/12/2003 (PMV memo)

An adequate GC/MS method (Method D0008) is available for enforcing boscalid tolerances in

plant commodities. The Analytical Chemistry Branch of the Biological and Economic Analysis 

Division (ACB/BEAD) concluded that the method is acceptable for enforcement purposes in 

plants without the need for an EPA validation (DP# 284510; D. Swineford and E. Kolbe,

8/12/2003, PMV memo).

 

An adequate LC/MS/MS method (BASF Method D9908, Version II) is also available for 

collecting residue data on plant commodities. Boscalid residues in all of the plant commodities 

associated with the current field trials and the citrus processing study were determined using this 

LC/MS/MS method. Briefly, the residues were extracted from plant commodities, except citrus 

oil, with methanol (MeOH):water:2 N HCl (70:25:5; v/v/v) and centrifuged. For oil, samples 

were initially dissolved in hexane, and residues were partitioned into acetonitrile, concentrated to 

dryness and the re-dissolved in MeOH:water:2 N HCl (70:25:5; v/v/v). Residues from each 

commodity were then diluted with 1N HCl saturated with NaCl, and partitioned into 

cyclohexane. Residues were concentrated to dryness, re-dissolved in MeOH:water:4 mM 

ammonium formate (80:20:0.1, v/v/v), and analyzed by LC/MS/MS using the m/z 343→307 

transition to detect and quantify boscalid. Residues are quantified using an external calibration 

curve of boscalid standards. The validated LOQ was 0.05 ppm for each plant commodity and the

LOD was reported to be 0.01 ppm for alfalfa forage and hay, citrus fruits and citrus fruit 

processed fractions. 
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The method was adequately validated in conjunction with each field trial, using control samples 

of each plant matrix fortified with boscalid at levels ranging from 0.05 to 50 ppm.

860.1340 Residue Analytical Methods - Livestock

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

DER Reference 47584403

An enforcement method is available for determining the residues of concern in livestock. 

Method DFG S19 is a GC/electron capture detection method that was successfully validated by

ACB/BEAD. 

For the current livestock feeding study, residues of boscalid and its hydroxy metabolite M510F01 

(including the glucuronide conjugate M510F02) were determined using a LC/MS/MS method 

(BASF Method 471/0, modified) which was previously reviewed in conjunction with earlier 

feeding studies.

For this method, residues in milk and tissue matrices were extracted with MeOH, filtered and 

concentrated. To convert the glucuronide conjugate (M501F02) to the free hydroxy metabolite 

(M501F01), residues were re-dissolved in 0.1M sodium acetate buffer and incubated with 

β-glucuronidase/arylsulphatase for 1 hour at 37°C. The resulting hydrolysate was diluted with 

water, salinized, and acidified with 1M HCl. Residues were then partitioned into ethyl acetate 

and concentrated to dryness. Residues were re-dissolved in water:MeOH (7:3, v/v) and cleaned 

up by elution through a C-18 SPE cartridge using water:MeOH (3:7, v/v). Residue samples from 

muscle also underwent an additional cleanup step using a silica gel SPE cartridge eluted with 

dichloromethane:acetone (8:2, v/v). Residues in the final eluates were concentrated to dryness 

and re-dissolved in acetonitrile:water (1:1, v/v) for analysis. Residues of boscalid and M510F01 

were determined by LC/MS/MS using the m/z 343→140 transition for boscalid and the 

359→140 transition for M501F01, with external standardization. Residues are expressed in 

terms of the individual analytes, and the validated LOQs for each analyte are 0.01 ppm in milk 

matrices and 0.025 ppm in tissues. The reported LODs for each analyte were 0.0067 ppm in milk

and 0.0167 ppm in tissues. For calculating combined residues, Metabolite M510F01 residues 

are converted to parent equivalents using a conversion factor of 0.96.

The above method was adequately validated prior to and in conjunction with the analysis of 

feeding study samples, using control samples fortified with boscalid and M510F01 at 0.01-2.5 

ppm for milk, skim milk and cream, and 0.025-2.5 ppm for liver, kidney, muscle and fat samples.

860.1360 Multiresidue Methods

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

Residues of boscalid and its metabolite M510F01 were not adequately recovered using the 

multiresidue methods. Protocol A was not applicable. Protocol B was not applicable for 

boscalid and yielded inconsistent recoveries of M510F01. Residues of boscalid and its hydroxy

metabolite M510F01 had good responses with GC/ECD on a DB-1 column under Protocol C. 

Neither analyte was recovered at ≥30% using Protocols D, E, and F. The study has been 

forwarded to FDA for a future updating of PAM, Vol. I.
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 13 of 48

860.1380 Storage Stability

DP# 322235, D. Dotson, 11/03/2005

MRID 47584402.der

Adequate storage stability studies are available indicating that boscalid is relatively stable at 

≤-20oC in fortified samples of cabbage (leafy vegetables), canola seed (oil seed), peach 

(fruit/fruiting vegetable), sugar beet roots (root crop), peas (legume vegetable), wheat grain (nonoily grain), wheat forage (foliage), and wheat straw (dry feed) for up to 24 months.

In addition to the above data, a concurrent storage stability study was conducted in conjunction 

with the orange processing study (MRID 47584402.der). Homogenized control samples of 

orange fruits, dried pulp, juice and oil were each fortified with boscalid at 0.5 ppm and placed in 

storage at ≤-5°C. No zero-day analysis was conducted on the fortified samples prior to storage. 

The stored samples were analyzed in duplicate along with control samples freshly fortified with 

boscalid at 0.05 ppm and 2.0 ppm. The average recovery from the stored orange fruit, dried pulp, 

juice and oil samples (corrected for concurrent recoveries) were 117%, 109%, 119%, and 126%, 

respectively. These data indicate that boscalid is stable at -5°C for up to 109 days (3.6 months) 

in orange fruit, dried pulp, juice and oil.

The storage durations and conditions of samples from the crop field trials submitted to support 

this petition are presented in Table 4. 

Table 4. Summary of Storage Conditions and Durations of Samples from Crop Field Trial and 

Processing Studies. 

Matrix Storage Temperature

(°C)

Actual Storage 

Duration

Interval of Demonstrated Storage Stability

(months)

Alfalfa Forage <-5 5-13 24 – wheat forage

Alfalfa Hay <-5 5-13 24 – wheat straw

Orange <-10 1.0-6.2 24 – peach

Orange Peel <-10 1.0-5.3 24 – peach 

Orange Pulp <-10 1.0-6.0 24 – peach 

Orange Dried Pulp <-5 3.4 3.6

Orange Juice <-5 3.4-3.5 3.6

Orange Oil <-5 3.4 3.6

Grapefruit <-10 2.8-4.9 24 – peach 

Lemon <-10 0.8-4.5 24 – peach 

Cherry (Sweet and Tart) <-5 3.3-8.6 24 – peach 

Peach <-5 4.9-8.0 24 – peach 

Plum <-5 4.5-6.3 24 – peach 

Conclusions. The available storage stability data are adequate and support the storage conditions 

and durations for samples of alfalfa, citrus fruits, and stone fruits from the current field trials and 

the acceptable citrus processing study.

860.1400 Water, Fish, and Irrigated Crops
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 14 of 48

There are no proposed/registered uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed/registered uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

DP# 322235; D. Dotson, 11/03/2005

45405110.der (cattle feeding study)

45643801.der (poultry feeding study)

47584403.der (cattle feeding study)

Adequate cattle and poultry feeding studies are available. The current tolerances for livestock 

commodities are based on the residue data from the earlier cattle and poultry feeding studies and 

the previously calculated dietary burdens of livestock for boscalid. The maximum dietary burden 

for poultry was originally calculated to be 1.85 ppm (DP# 278385, M. Nelson, 8/15/2003), and 

the maximum dietary burdens for other livestock were most recently calculated to be 16.4 ppm 

for beef cattle, 13.2 ppm for dairy cattle, and 1.79 ppm for swine (DP# 322235, D. Dotson, 

11/03/2005).

Cattle Feeding Studies. BASF Corporation submitted a new cattle feeding study conducted in 

2008 in which two groups of lactating dairy cows were administered with encapsulated boscalid 

via balling gun for 29 consecutive days at the target doses of 35 ppm (Group 2; 3 cows) or 105 

ppm (Group 3; 7 cows). Based on the average feed consumption, these dose levels are

equivalent to 35.8 and 116.3 mg ai/kg feed (dry feed weight basis) or 1.22 and 3.56 mg ai/kg 

body weight/day for the low and high dose groups, respectively. These dose levels are intended 

to represent 1x and 3x the anticipated EU dietary burden of 35 ppm in the feed on a dry weight 

basis. The four additional cows in the high dose group were used to assess residue decline 

(depuration) following the final dosing. However, one of the four cows developed John’s disease 

and was euthanized. 

The cows were milked twice a day, and samples composited daily for each cow from the 1x and 

3x dose groups on day -1, 1, 4, 7, 10, 13, 16, 19, 22, 25 and 28. Three cows each from the 1x 

and 3x groups were sacrificed 24 hours after the final dose period. One cow in the high-dose 

group was sacrificed at days 36, 39 and 43 (i.e., 7, 10 and 14 days after the final dose). Samples 

of liver (representative samples from each lobe), both kidneys, muscle (composite of round, 

flank, and loin), omental fat, perirenal fat, and subcutaneous fat were collected. 

The LC/MS/MS method (BASF No. 471/0, modified) was used for determining the residues of 

boscalid and its hydroxy metabolite M510F01 (including glucoronide conjugate M519F02) in 

milk and tissues. The modified method was adequately validated based on acceptable method 

validation and concurrent method recovery data. The limit of quantitation (LOQ) for each 

analyte in milk was 0.01 ppm (0.02 ppm combined) and 0.025 ppm (0.05 ppm combined) for 

each analyte in tissues. 

All milk and tissue samples were stored frozen from collection to analysis. Milk, skim milk, 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 15 of 48

and cream were analyzed within 4.76 days; liver, kidney and muscle, within 35-48 days; and fat 

within 48-70 days. The available storage stability data from earlier studies (DER for MRID 

45405108) demonstrate that residues of boscalid and M510F01 are stable for up to 5.5 months in 

cow milk, liver, and muscle, and are adequate to support the storage intervals and conditions of 

milk, skim milk, muscle, liver, fat and kidney samples from this study. 

For the low dose group, the combined residues of boscalid in milk samples collected over the 

course of the dosing period were <0.02-0.03 ppm (parent, <0.01-0.023 ppm; M510F01, <0.01 

ppm). For the high dose group, the combined residues were 0.03-0.12 ppm (parent, <0.021-

0.112 ppm; M510F01, <0.01-0.017 ppm). Milk samples from day 22 and 28 of the study, and 

from the depuration cow remaining at day 42 of the study, were separated into skim milk and 

cream. Residues of boscalid and M510F01 in skim milk from all dosed groups were each <LOQ 

(<0.01 ppm) or at LOQ (0.012 ppm for parent boscalid in one high dose sample). Combined 

residues for boscalid and M510F01 in cream were 0.06-0.08 ppm for the low dose group and 

0.14-0.50 ppm for the high dose group. Residues appeared to peak on day 7 and then plateau at a 

lower level for the remainder of the dosing period. 

For the residue decline study in the high dose cows, boscalid and M510F01 residues were each 

<LOQ (<0.01 ppm) in milk samples collected at days 2,7,10 after the dosing period with 

excepton of a sample from day 31 where the residues of boscalid were 0.037 ppm 2 days after 

dosing ceased. The residue declined to below the LOQ in milk 7,10 and 14 days after dosing. 

In skim milk and cream samples collected during the depuration phase 14 days after dosing, the 

residues of boscalid and M510F01 were each <LOQ (<0.01 ppm). In all tissue samples collected 

7,10, and 14 days after dosing of the high dose group, the residues of boscalid and M510F01 

were each <LOQ (<0.025 ppm) except in omental and perirenal fat in samples collected 7 days 

after dosing, where parent boscalid residues were 0.033 and 0.037 ppm, respectively. The 

residues declined to <LOQ in these matrices 10 and 14 days after dosing.

Residues of boscalid and M510F01 in tissue samples collected immediately after 29 days of 

dosing at 1x and 3x the EU anticipated dietary burden were determined.. Combined residues of 

boscalid and M510F01in liver samples from the low and high dose groups were 0.08-0.11 ppm 

and 0.15-0.24 ppm, respectively. In kidney samples, combined residues were 0.10-0.11 and 

0.11-0.24 ppm from the low and high dose groups, respectively. In muscle samples from both 

dosing groups, residues of boscalid and M510F01 were below the LOQ (<0.025 ppm each). In 

omental fat samples, combined residues were 0.08-0.23 ppm and 0.18-0.23 ppm from the low 

and high dose groups, respectively. In perirenal fat samples, combined residues of boscalid and 

M501F01 were 0.12-0.24 ppm and 0.199-0.28 ppm from the low and high dose groups, 

respectively. In subcutaneous fat samples, the combined residues were 0.10-0.20 ppm and 0.08-

0,18 ppm from the low and high dose groups, respectively.

The combined residue data from the 2008 dairy cattle feeding study are summarized in Table 5. 

The potential for secondary transfer of boscalid residue of concern in meat, milk, poultry, swine, 

and eggs exists since livestock feedstuffs that are associated with the proposed uses. Grain, 

aspirated fractions are no longer used and was replaced with cotton, gin byproducts as the latter 

yields higher contributions to the diet (beef cattle only). The calculated dietary burdens of 

boscalid to livestock are 10.8 ppm for beef cattle, 22.5 ppm for dairy cattle, 4.0 ppm for poultry, 

and 5.3 ppm for swine (Table 8).
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 16 of 48

Table 5. Summary of Combined Residue Data from Recent Dairy Cattle Feeding Study with Boscalid.

Matrix Feeding 

Level (ppm)

Residue Levels (ppm) 1

n Min. Max. Median

(STMdR)

Mean

(STMR) Std. Dev.

Milk 35.8

(1.0x) 3

30 <0.02 <0.03 0.02 0.02 0.008

Skim Milk 6 <0.02 <0.02 0.02 0.02 NA2

Cream 6 <0.06 <0.08 0.07 0.07 0.006

Liver 3 0.08 0.11 0.09 0.10 0.015

Kidney 3 <0.10 <0.11 0.11 0.11 0.009

Muscle 3 <0.05 <0.05 0.05 0.05 NA

Fat (omental, perirenal, 

subcutaneous) 9 <0.08 <0.24 0.20 0.18 0.059

Milk 116.3

(3.3x) 3

60 <0.03 <0.12 0.06 0.06 0.018

Skim Milk 12 <0.02 <0.02 0.02 0.02 NA

Cream 12 <0.14 <0.50 0.25 0.26 0.111

Liver 3 0.15 0.24 0.21 0.20 0.043

Kidney 3 <0.11 0.24 0.19 0.18 0.065

Muscle 3 <0.05 <0.05 0.05 0.05 NA

Fat (omental, perirenal, 

subcutaneous) 9 <0.08 <0.28 0.19 0.20 0.057

1 The combined LOQ (0.02 ppm for milk matrices and 0.05 ppm for tissues) was used for values <LOQ when calculating the 

median, mean and standard deviation. Residue are expressed in parent equivalents.

2 NA = Not applicable.

3 Dose level compared to the calculated maximum dietary burden of 35.18 ppm for diary cattle. 

In the earlier cattle feeding study, three groups of dairy cows (3-4 cows/dose group) were dosed 

orally with boscalid for 29-30 consecutive days at levels equivalent to 1.8, 5.9, and 20.2 ppm in 

the diet. These dose levels are respectively equivalent to 0.05x, 0.17x, and 0.57x the current 

maximum dietary burden for dairy cattle. Cows were milked twice daily, and the pooled daily

milk samples for each cow from Study Days 1, 3, 6, 9, 12, 15, 18, 21, 24 and 28 were sampled 

for analysis. Whole milk samples from Day 21 were also separated into skim milk and cream. 

Animals were sacrificed within 24 hours of receiving the final dose and samples of muscle, fat, 

liver, and kidney were collected.

Samples of milk and tissues were analyzed for residues of boscalid and M510F01 (free and 

conjugated) using an LC/MS/MS method (BASF Method 471/0), which was adequately validated

in conjugation with the analysis of feeding study samples. The method LOQ for each analyte is 

0.01 ppm in milk and 0.025 ppm in tissues, for combined LOQs of 0.02 ppm in milk and 0.05 

ppm in tissues. Samples of milk and liver were also analyzed for non-extractable conjugated 

residues, determined as M510F53, using a GC/MS method (BASF Method 476/0), which was 

also adequately validated. The method LOQ for M510F53 is 0.01 ppm in milk and 0.05 ppm in 

tissues. The sample storage durations and conditions for the feeding study were adequately

supported by the available storage stability data.

The data on residues of M510F53 in milk and liver will not be summarized in this report as 

M510F53 is not a residue of concern. For the low-dose group (1.8 ppm), the combined residues 

of boscalid and M510F01 (free and conjugated) were <0.02 ppm in all milk samples and skim 

milk, and <0.05 ppm in all samples of muscle, liver and kidneys. However, quantifiable residues 

of the parent, boscalid were detected at 0.023-0.045 ppm in the low-dose cream samples and at 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 17 of 48

0.053 ppm in one of three fat samples. Residues of boscalid were generally <LOQ in kidneys, 

and residues of M510F01 were <LOQ in milk, cream, fat and muscle. In liver, residues consisted

primarily of M510F01, with only liver from the high-dose group having residues of boscalid 

above the LOQ. A summary of the residue data from the 5.9 and 20.2 ppm dose groups are 

presented in Table 6.

Table 6. Summary of Combined Residue Data from Earlier Dairy Cattle Feeding Study with Boscalid.

Matrix Feeding 

Level (ppm)

Residue Levels (ppm) 1

n Min. Max. Median

(STMdR)

Mean

(STMR) Std. Dev.

Milk 5.9

(0.2x) 4

33 <0.02 0.023 0.02 0.02 <0.001

Skim Milk 3 <0.02 <0.02 0.02 0.02 NA 

Cream 3 <0.110 <0.125 0.123 0.119 0.008

Liver 3 <0.051 <0.064 0.055 0.057 0.007

Kidney 3 <0.063 <0.090 0.071 0.075 0.014

Muscle 3 <0.05 <0.05 0.05 0.05 NA

Fat 3 <0.082 <0.12 0.11 0.104 0.020

Milk (Days 15-28) 320.2

(0.6x) 4

22 <0.021 <0.096 0.040 0.042 0.015

Skim Milk 4 <0.02 <0.021 0.02 0.02 <0.001

Cream 4 <0.25 <0.38 0.37 0.34 0.062

Liver 3 0.17 0.18 0.18 0.18 0.006

Kidney 3 <0.17 <0.32 0.22 0.24 0.076

Muscle 3 <0.05 <0.058 0.05 0.053 0.005

Fat 3 <0.24 <0.29 0.28 0.27 0.026

1 The combined LOQ (0.02 ppm for milk matrices and 0.05 ppm for tissues) was used for values <LOQ when calculating the 

median, mean and standard deviation. Residues are expressed in parent equivalents.

2 NA = Not applicable.

3 Residues in milk plateaued by Day 15.

4 Dose level compared to calculated maximum dietary burden of 35.18 ppm for diary cattle. 

Poultry feeding study. In the poultry feeding study, three groups of laying hens were dosed 

orally once a day for 29 consecutive days with boscalid at levels equivalent to of 1.02, 5.31, and 

19.6 ppm in the diet, which are respectively equivalent to 0.25x, 1.3x, and 4.8x of the maximum 

dietary burden of poultry to boscalid. Each group consisted of 3 or 5 subgroups with 4 hens per 

subgroup. During the dosing period, eggs were collected twice each day and pooled by day and 

subgroup. Hens were sacrificed within 5 hours of the final dose, with the exception of hens in 

two subgroups from the high-dose that were sacrificed at 3 and 10 days post-dose to study

depuration. Samples of muscle, fat and liver were collected at sacrifice and pooled by subgroup.

Residues of boscalid and M510F01 (free + conjugated) in eggs and tissues were determined 

using an LC/MS/MS method (BASF No. 471/0, modified), which was adequately validated in 

conjunction with the analysis of feeding study samples. The validated LOQ for each analyte is 

0.01 ppm in eggs and 0.025 ppm in tissues, for combined LOQs of 0.02 ppm in eggs and 0.05 

ppm in tissues. The sample storage durations and conditions for the feeding study were 

adequately supported by the available storage stability data.

For the low-dose group (1.02 ppm), the combined residues of boscalid and M510F01 (free and 

conjugated) were <0.02 ppm in all samples of eggs, and <0.05 ppm in all muscle and fat samples. 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 18 of 48

In liver, boscalid residues were <LOQ in all samples, and residues of M510F01 were quantifiable 

in only one sample at 0.026 ppm, for combined residues of <0.051 ppm. In the mid- and highdose groups, residues of boscalid were <LOQ in liver and muscle, and residues of M510F01 

were generally <LOQ in muscle and fat. Residues in eggs from the high-dose group were 

comprised of approximately equal amounts of boscalid and M510F01. A summary of the residue 

data from the 5.31 and 19.6 ppm dose groups are presented in Table 7. 

Table 7. Summary of Combined Residue Data from Poultry Feeding Study with Boscalid.

Matrix Feeding 

Level (ppm)

Residue Levels (ppm) 1

n Min. Max. Median

(STMdR)

Mean

(STMR) Std. Dev.

Eggs (Days 1-28) 5.31

(1.3x) 3

30 <0.02 <0.02 0.02 0.02 NA

Liver 3 <0.106 <0.175 0.126 0.136 0.036

Muscle 3 <0.05 <0.05 0.05 0.05 NA

Fat 3 <0.052 <0.124 0.066 0.081 0.038

Eggs (Days 7-28) 419.6

(4.8x) 3

34 0.027 0.065 0.049 0.047 0.012

Liver 3 <0.316 <0.466 0.429 0.404 0.078

Muscle 3 <0.05 <0.05 0.05 0.05 NA

Fat 3 <0.135 <0.196 0.186 0.172 0.033

1 The combined LOQ (0.02 ppm for eggs and 0.05 ppm for tissues) was used for values <LOQ when calculating the median, 

mean and standard deviation. Residue are expressed in parent equivalents.

2 NA = Not applicable.

3 Dose level compared to the calculated maximum dietary burden of 4.10 ppm for poultry. 

4 Residues in eggs plateaued by Day 7.

Livestock Dietary Burdens. As alfalfa forage and hay are major livestock feedstuffs, the 

dietary burdens for livestock were recalculated for this petition. Based on the recent changes in 

calculating residues in reasonably balanced livestock diets (Table 1, Feedstuffs, June 2008), the 

dietary burden for livestock from boscalid residues was recalculated to be 10.8 ppm for beef 

cattle, 22.5 ppm for dairy cattle, 4.0 ppm for poultry and 5.3 ppm for swine (Table 8). 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 19 of 48

Table 8. Calculation of Dietary Burdens of Boscalid Residues to Livestock.

Feedstuff Type 1 % Dry 

Matter2 % Diet 2 Recommended Tolerance (ppm)

Dietary Contribution 

(ppm) 3

Beef Cattle

Alfalfa, hay R 89 10 65 7.3

Cotton, gin byproducts R 90 5 55 3.06

Field corn, grain CC 88 80 0.2 0.18

Canola, meal PC 88 5 3.5 40.2

TOTAL BURDEN -- -- 100 -- 10.8

Dairy Cattle

Alfalfa, forage R 35 20 30 17.2

Grass, hay R 88 25 8.0 2.27

Apple, wet pomace CC 40 10 10 2.50

Field corn, grain CC 88 35 0.2 0.08

Canola, meal P 88 10 3.5 40.4

TOTAL BURDEN -- -- 100 -- 22.5

Poultry

Field corn, grain CC 88 75 0.2 0.15

Alfalfa, meal PC 90 5 65 43.25

Canola, meal PC 89 15 3.5 40.53

Peanut, meal PC 85 5 0.15 0.0075

TOTAL BURDEN -- -- 100 -- 4.0

Swine

Field corn, grain CC 88 85 0.2 1.70

Alfalfa, meal PC 90 5 65 43.25

Canola, meal PC 89 10 3.5 40.35

TOTAL BURDEN -- -- 100 -- 5.3

1 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate.

2 OPPTS 860.1000 Table 1 Feedstuffs (June 2008). 

3 Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle; contribution = ([tolerance] X % diet) for 

poultry and swine.

4 The tolerance for canola seed (3.5 ppm) was used for meal, and the tolerance for alfalfa hay (65 ppm) was used for 

alfalfa meal.

Conclusions. The available cattle and poultry feeding studies are adequate and cover the 

potential levels of dietary exposure of livestock to boscalid residues. 

The magnitude of the residues of boscalid and M510F01 was adequately determined in the new 

(2008) feeding study with lactating diary cows dosed orally for 29 consecutive with boscalid at 

levels equivalent to 35.8 ppm (low dose, 1x the anticipated dietary burden) and 116.3 ppm (high 

dose, 3x the anticipated dietary burden) in the diet (dry feed weight basis). Over the entire 

dosing period, the maximum combined residues in milk samples were 0.03 and 0.12 ppm for the 

low and high dose group, respectively. Following 29 days of dosing, the combined residues in 

tissues from the low and high dose groups were, respectively, 0.11 and 0.24 in liver and kidney

samples; less than the combined LOQ (<0.05 ppm) in muscle samples; 0.23 ppm in omental fat; 

0.24 and 0.28 ppm in perirenal fat; and 0.20 and 0.18 ppm in subcutaneous fat. 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 20 of 48

For hogs, the adequacy of the existing tolerances were assessed using residue data from the 5.9 

ppm dose group in the cattle feeding studies; this group represents 1.1x the calculated dietary

burden for swine. Maximum combined residues for this dose group were <0.064 ppm in liver, 

<0.090 ppm in kidney, <0.05 ppm in muscle, and <0.12 ppm in fat. Average combined residues 

were 0.057 ppm in liver, 0.075 ppm in kidneys, 0.05 ppm in muscle, and 0.104 ppm in fat. 

The data indicate that the existing tolerances for meat (0.05 ppm) and meat byproducts (0.10 

ppm) of hogs are adequate; however, the tolerance for hog fat should be increased to 0.20 ppm.

For poultry, the adequacy of the existing tolerances were assessed using residue data from the 

5.31 ppm dose group in the poultry feeding studies; this group represents 1.3x the calculated 

dietary burden for poultry. Maximum combined residues for this dose group were <0.02 ppm in 

eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in fat. Average combined 

residues were 0.02 ppm in eggs, 0.136 ppm in liver, 0.05 ppm in muscle, and 0.081 ppm in fat. 

These data indicate that the existing tolerances for eggs (0.02 ppm) and poultry meat (0.05 ppm) 

are adequate; however, the tolerances for poultry fat and meat byproducts should each be 

increased to 0.20 ppm. 

860.1500 Crop Field Trials

DP# 278385, M. Nelson, 8/15/2003

DP# 323288, D. Soderberg, 6/14/2007

47584401.der (alfalfa)

45903601.de1 (citrus fruits)

47470201.de2 (stone fruits)

BASF submitted field trial data on alfalfa, oranges, lemons and grapefruits in support of new 

uses for boscalid (WDG) on alfalfa and the citrus fruits crop group. BASF also submitted new 

stone fruit field trial data supporting an amended tolerance for stone fruits. The results from the

new field trials and the previously submitted stone fruit field trails are summarized in Table 9

and discussed below.

Table 9. Summary of Residue Data from Crop Field Trials with Boscalid (WDG).

Crop matrix

(DER)

Treatment 

Info.

Total 

Applic. Rate 

(lb ai/A)

PHI 

(days) 1

Residue Levels (ppm) 2

n Min. Max. HAFT 3 Median Mean Std. 

Dev.

Citrus Fruits (proposed use = 1.17 lb ai/A total application rate, 0-day PHI) 4

Orange

(45903601.de1)

Concentrated 1.19-1.22 0 12 0.179 1.425 1.393 0.388 0.610 0.467

Dilute 1.20-1.21 0 14 0.238 0.676 0.588 0.353 0.418 0.146

Grapefruit

(45903601.de1)

Concentrated 1.20 0 6 0.115 0.847 0.836 0.143 0.365 0.364

Dilute 1.20 0 6 0.064 0.272 0.261 0.125 0.155 0.086

Lemon

(45903601.de1)

Concentrated 1.18-1.23 0 6 0.522 1.51 1.239 0.671 0.822 0.370

Dilute 1.18-1.20 0 4 0.600 0.936 0.872 0.775 0.771 0.140

Stone Fruits (proposed use = 1.15 lb ai/A total application rate, 0-day PHI) 5

Cherry 

(47470201.de2)

NA

1.15

0 14 <0.05 2.98 1.63 1.47 1.57 0.89

1 14 <0.05 2.69 1.95 1.09 1.28 0.81

Peach

(47470201.de2) 1.15

0 12 0.56 3.79 1.94 0.76 1.15 1.03

1 12 0.46 3.87 2.74 0.75 1.19 1.15

Plum

(47470201.de2) 1.15

0 10 <0.05 0.79 0.67 0.14 0.34 0.31

1 10 <0.05 0.57 0.71 0.11 0.26 0.24
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 21 of 48

Table 9. Summary of Residue Data from Crop Field Trials with Boscalid (WDG).

Crop matrix

(DER)

Treatment 

Info.

Total 

Applic. Rate 

(lb ai/A)

PHI 

(days) 1

Residue Levels (ppm) 2

n Min. Max. HAFT 3 Median Mean Std. 

Dev.

Cherry

(45405121.der)

NA

1.35

0

2 1.28 1.70 1.49 1.49 1.49 NA

Peach

(45405121.der) 1.14-1.17 8 0.47 1.20 1.19 0.74 0.77 0.29

Plum

(45405121.der) 1.15-1.17 8 0.09 0.85 0.70 0.50 0.47 0.23

Cherry

(46665505.der)

Concentrated 1.15-1.16 0 6 0.641 1.635 1.635 0.999 1.056 0.370

Dilute 1.15 0 6 0.736 1.505 1.505 1.313 1.229 0.309

Peach

(46665505.der)

Concentrated 1.14-1.16 0 9 0.157 0.663 0.663 0.479 0.450 0.157

Dilute 1.14-1.17 0 9 0.193 0.746 0.746 0.422 0.434 0.203

Plum

(46665505.der)

Concentrated 1.14-1.15 0 6 0.081 0.566 0.566 0.154 0.214 0.182

Dilute 1.14-1.15 0 6 0.103 0.344 0.344 0.198 0.211 0.105

Alfalfa (proposed use = 0.85 lb ai/A total application rate, 14-day PHI) 6

Alfalfa Forage

(47584401.der) Trt #2 7

0.88-0.92

12-15 24 1.10 20.30 17.67 5.04 7.05 5.20

12-16 24 0.81 19.40 17.23 4.98 6.25 5.09

43-73 22 <0.05 0.53 0.37 0.12 0.17 0.14

Trt #3 0.86-0.93

19-23 24 0.11 6.16 6.10 1.94 2.05 1.66

20-23 24 0.32 5.59 5.06 2.12 2.29 1.62

49-76 22 <0.05 0.50 0.50 0.11 0.16 0.13

Trt #4 0.59-0.62

12-15 24 0.97 15.68 14.47 3.95 4.94 3.78

12-16 24 0.85 15.32 15.07 3.59 5.56 4.51

43-70 22 <0.05 0.38 0.32 0.08 0.12 0.09

Trt #5 0.57-0.62

19-23 24 0.05 5.44 5.38 1.21 1.75 1.58

20-23 24 0.29 3.64 3.46 2.12 2.03 1.07

49-76 22 <0.05 0.44 0.44 0.07 0.14 0.14

Alfalfa Hay

(47584401.der) Trt #2 7

0.88-0.92

12-15 24 3.36 43.02 42.62 14.00 17.37 11.19

12-16 24 5.22 51.12 48.91 16.10 20.93 13.64

43-73 22 0.07 3.63 2.38 0.37 0.62 0.78

(Trt #3 0.86-0.93

19-23 24 0.14 20.84 19.84 6.37 6.97 5.93

20-23 24 1.52 15.26 14.72 6.72 7.24 4.44

49-76 22 <0.05 1.36 1.17 0.24 0.49 0.45

Trt #4 0.59-0.62

12-15 24 3.11 33.78 31.34 10.80 15.30 9.21

12-16 24 4.48 40.06 39.33 16.89 18.23 11.40

43-70 22 <0.05 0.72 0.70 0.27 0.31 0.19

Trt #5 0.57-0.62

19-23 24 0.42 12.46 12.23 3.80 5.29 4.45

20-23 24 1.88 21.60 18.31 7.44 7.50 4.76

49-76 22 <0.05 1.12 1.10 0.25 0.45 0.40

1

For the alfalfa field trials, the three separate harvest intervals are the PHIs for the 1st, 2nd and 3rd cuttings.

2 The validated LOQ for boscalid is 0.05 ppm in plant commodities. For all calculations, the LOQ (0.05 ppm) was 

used for all values reported as <LOQ.

3 HAFT = Highest average field trial result.

4 The citrus field trails were conducted using either concentrate or dilute spray volumes.

5

For stone fruits, the data are reported separately for the three MRIDs (47470201, 46665505, and 45405121). In 

MRID 45405121, applications to stone fruits were made using either concentrate or dilute spray volumes.
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 22 of 48

6

For the alfalfa field trials, Treatments #2 and #3 included three boscalid applications at ~0.3 lb ai/A/application 

with the first and second applications made prior to the 1st cutting and the final application made prior to the 2nd 

cutting. Treatments #4 and #5 included two applications at ~0.3 lb ai/A/application, with the first application 

made prior to the 1st cutting and the second application made prior to the 2nd cutting.

7 Treatment #2 represents the worse case use on alfalfa and reflects the proposed use pattern. As residues (bolded)

from the 1st and 2nd cutting were similar in magnitude and both reflected the proposed 14-day PHI, all values from 

these two cutting were used to access tolerances for forage and hay.

Citrus Fruits, Crop Group 10. BASF submitted field trial data for boscalid on citrus fruits. 

Twenty four field trials conducted in the US in Zones 3, 6, and 10 during the 2001-2002 growing 

season on oranges (13 trials), grapefruit (6 trails), and lemons (5 trials). In each test, boscalid 

(70% WDG) was applied to citrus trees as four broadcast foliar applications during fruit 

development and maturation at rates of 0.294-0.320 lb ai/A/application and RTIs of 7-11 days, 

for total rates of 1.18-1.23 lb ai/A/season (1x proposed use rate). Applications were made with 

ground equipment using either concentrate spray volumes of 74-93 gal/A (12 trials) or dilute 

spray volumes of 149-362 gal/A (12 trials). All applications included the use of adjuvants (rates 

not reported). Single control and duplicate treated samples of citrus fruits were harvested at 

maturity on the day of the final application (0-day after treatment [DAT], proposed PHI). 

Samples were stored frozen for up to 6.2 months prior to analysis, an interval supported by

available storage stability data.

Citrus fruit samples were analyzed for residues of boscalid using an LC/MS/MS method (BASF 

Method D9908), which was adequately validated in conjunction with the analysis of field trial 

samples. The method limit of quantitation (LOQ) for boscalid is 0.05 ppm in citrus fruits.

Following four concentrated spray applications of boscalid (WDG) at rates totaling 1.18-1.23 lb 

ai/A (1x rate), boscalid residues at 0 DAT were 0.179-1.43 ppm in/on 12 orange samples, 0.115-

0.847 ppm in/on 6 grapefruit samples, and 0.522-1.51 ppm in/on 6 lemon samples. Following 

four dilute spray applications of boscalid (WDG) at rates totaling 1.18-1.20 lb ai/A (1x rate), 

boscalid residues at 0 DAT were 0.238-0.676 ppm in/on 14 orange samples, 0.064-0.272 ppm 

in/on 6 grapefruit samples, and 0.936-0.872 ppm in/on 4 lemon samples. No residue decline data 

were provided.

Average boscalid residues for the concentrated sprays were 0.610 ppm for oranges, 0.365 ppm 

for grapefruit, and 0.822 ppm for lemons, and average boscalid residues for the dilute sprays 

were 0.418 ppm for oranges, 0.155 ppm for grapefruit, and 0.771 ppm for lemons. Based on the 

average residues, the concentrated sprays resulted in higher residue levels on all three types of 

citrus fruits, although the difference was marginal for lemons which had the highest residues of 

any of the citrus fruits. Compared to the dilute sprays, average residues from the concentrated 

sprays were 1.45x higher for oranges, 2.35x higher for grapefruit and 1.07x higher in lemons. .

Some of the oranges were separated into wet peel and pulp. Following four foliar applications 

of boscalid (WDG) to orange trees at rates totaling 1.19-1.22 lb ai/A, average boscalid residues at 

0 DAT from each field trial were 0.206-1.39 ppm for whole orange fruit (RAC), 0.661-5.40 ppm 

for peel, and <0.05-0.151 ppm for wet pulp. As compared to the whole fruit, Boscalid residues 

were lower in orange pulp and higher in peel. 

When the residue data are pooled for both spray volume types, the average boscalid residues 

were 0.507 ppm for oranges, 0.260 ppm for grapefruit, and 0.802 ppm for lemons, and HAFT 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 23 of 48

residues were 1.39 ppm for oranges, 0.836 ppm for grapefruit, and 0.710 ppm for lemons. The 

pooled residue data for each commodity will be used to assess separate possible tolerances on 

oranges, lemons and grapefruits.

Conclusion. The submitted field trial data are adequate and support the use of boscalid (WDG) 

on citrus fruits as either dilute or concentrated broadcast foliar applications during fruit 

development and maturation at rates of up to 0.29 lb ai/A. The highest residues which were 

found were 1.43 ppm in oranges, 0.85 ppm in grapefruit, and 1.51 ppm in lemons The data 

support a maximum of 4 applications per season and a maximum seasonal use rate of 1.16 lb 

ai/A, a minimum RTI of 10 days, and a minimum PHI of 0 days. 

Some of the oranges were separated into wet peel and pulp. As compared to the whole fruit, 

boscalid residues were lower in orange pulp and higher in peel.

 

Stone Fruits, Crop Group 12. Adequate field trial data supporting the use of boscalid (WDG) 

on stone fruits were previously submitted (DP# 278385, M. Nelson, 8/15/2003; and DP# 323288, 

D. Soderberg, 6/14/2007). These earlier studies supported the use of boscalid on stone fruits as 

up to 5 broadcast foliar applications during fruit development at rates of up to 0.23 lb ai/A, at a 

minimum RTI of 7 days, for a total of 1.15 lb ai/A/season. The label specified PHI for stone 

fruits is 0 days. The previously submitted residue data on stone fruits (Table 9) support the 

current 1.7 ppm tolerance on stone fruits.

BASF has submitted additional field trial data for boscalid on stone fruits from eighteen field 

trials conducted in the U.S. and Canada during 2007 on representative stone fruit species, 

including 5 trials on sweet cherries in Zones 5 and 10; 2 trials on tart cherries in Zone 5; 6 trials 

on peaches in Zones 1, 2, 5, 6 and 10; and 5 trials on plums in Zones 5 and 10. The end-use 

product, Pristine, EPA Reg. No. 7969-199, a water-dispersible granular (WDG) formulation 

containing 25.2% boscalid and 12.8% pyraclostrobin, was applied to the stone fruits as five 

broadcast foliar applications during fruit development at a target rate of 0.23 lb ai/A and at 

retreatment intervals (RTIs) of 7 days between crop growth stages BBCH 75 and 89 (i.e., 28, 21, 

14, 7, and 0 days before harvest), for a total rate of 1.15 lb ai/A/season. All applications were 

made using ground equipment in volumes of 20-150 gal/A (187-1403 L/ha). No adjuvants were 

used. 

Single control and duplicate treated samples of each type of stone fruit were harvested from each 

test on the day of the last application (0 DAT) and at 1 DAT. To evaluate residue decline, 

additional duplicate treated samples were harvested at 5 and 10 DAT from one test each on 

cherry, peach and plum. Samples were stored frozen (≤-5°C) for up to 8.6 months prior to 

analysis, an interval supported by available storage stability data.

Stone fruit samples were analyzed for residues of boscalid using an adequate LC/MS/MS method 

(BASF Method D9908, Ver. II). The method was validated for data collection based on 

acceptable concurrent method recoveries. The limit of quantitation (LOQ) is 0.05 ppm for 

boscalid in/on stone fruits, and the limit of detection (LOD) was not reported.

Following five foliar applications of boscalid (WDG) at rates totaling 1.15 lb ai/A, boscalid 

residues at 0 DAT were <0.05-2.84 ppm in sweet cherries, 1.22-2.98 ppm in sour cherries, 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 24 of 48

0.56-3.79 ppm in peaches, and <0.05-0.79 ppm in plums harvested at 0 DAT. Residues at 1 

DAT were <0.05-2.69 ppm in 14 samples of sweet cherries, 0.96-2.62 ppm in sour cherries, 0.46-

3.87 ppm in 12 samples of peaches, and <0.05-0.57 ppm in 10 samples of plums. Average 

boscalid residues at 0 and 1 DAT were respectively 1.57 and 1.28 ppm in sweet cherries, 1.15 

and 1.19 ppm in peaches, and 0.34 and 0.26 ppm in plums. The highest average field trial 

(HAFT) residues at 0 and 1 DAT were respectively 1.63 and 1.95 ppm for cherries, 1.94 and 2.74 

ppm for peaches, and 0.67 and 0.71 ppm for plums.

Data from the residue decline tests indicated that average boscalid residues in/on cherries, 

peaches, and plums decreased over time.

Conclusion. The available stone fruit field trial data are adequate to support a tolerance increase 

from 1.7 ppm to 3.5 ppm for the stone fruits crop group 12. The recommended tolerance is 

based on the tolerance spreadsheet using the pooled data from field trials for representative crops 

of cherries, peaches, and plum treated at 1x rate with the PHI of 0 day. When residue data from 

all the adequate stone fruit field trials (1x rate with 0-day PHI) are pooled by crop, the data 

support 

The data support the use of boscalid (WDG) on stone fruits up to five broadcast foliar 

applications during fruit development at 0.23 lb ai/A/application, for a total application rate of 

1.15 lb ai/A. The data support a minimum RTI of 7 days and a minimum PHI of 0 days. 

Alfalfa. BASF submitted field trial data for boscalid from 12 alfalfa field trials conducted in the 

United States in Zones 1, 2, 5, 7, 9, 10, and 11 and Canada in Zones 5 and 5B during the 2007 

growing season. Each test site included one control plot (Treatment #1) and four treated plots

(Treatments #2-5). The treated plots received 2 or 3 broadcast foliar applications of boscalid 

during vegetative development using ground equipment at volumes of 20-34 gal/A. All 

applications included the use of adjuvants. The application rates and timing of applications were 

as follows:

Treatment #2 received a total of 3 applications at the rate of 0.28 – 0.32 lbs ai/A/application or a 

total of 0.88-0.92 lb ai/A with retreatment intervals (RTI) of 12-15 and 28-53 days. Applications 

1, 2, and 3 were made approximately 28 days before the 1

st cutting, 14 days before the 1st cutting, 

and 14 days before the 2nd cutting. 

Treatment #3 received a total of 3 applications as in treatment #2 with RTI of 13-14 and 29-53 

days. Applications 1, 2 and 3 were made approximately 35 days before the 1st cutting, 21 days 

before the 1st cutting, and 21 days before 2nd cutting.

Treatment #4 received a total of 2 applications at the rate of 0.29-0.31 lbs ai/A/application or a 

total of 0.59 – 0.62 lb ai/A with RTI of 28-53 days. Applications were made 14 days before the 

1

st cutting and 14 days before the 2nd cutting.

Treatment #5 received a total of 2 applications at the rate of 0.28-0.32 lbs ai/A/application or a 

total of 0.57– 0.62 lb ai/A with RTI of 29-53 days. Applications were made 21 days before the 

1

st cutting and 21 days before the 2nd cutting.
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Page 25 of 48

With the exception of one test site, three cuttings of alfalfa were harvested from each plot 

according to typical agricultural practices, with the 3rd cutting being made at normal maturity

(beginning bloom stage). The exact treatment-to-harvest intervals for each cutting are presented 

below along with the residue levels in forage and hay. At each cutting, single control and 

duplicate treated samples of alfalfa forage and hay were collected from each test, with hay

samples being field-dried to a moisture content of ~10-20% prior to sampling. After sampling, 

forage and hay samples were held in frozen (<-5°C) storage for up to 13 months prior to 

extraction for analysis. This duration is supported by the available storage stability data.

Samples of alfalfa forage and hay were analyzed for residues of boscalid using an LC/MS/MS 

method (BASF Method D9908), which was adequately validated for data collection based on 

acceptable concurrent method recoveries. The limit of quantitation (LOQ) was 0.05 ppm for 

boscalid in alfalfa forage and hay, and the reported limit of detection (LOD) was 0.004 ppm.

For Treatment #2 (3 applications each at ~0.3 lb ai/A with an ~14-day PHI), residues of boscalid

in/on forage were 1.10-20.3 ppm at 12-15 days after the second application (1st cutting), 0.81-

19.4 ppm at 12-16 days after the third application (2nd cutting), and <0.05-0.53 ppm at 43-73 

days after the third application (3rd cutting). Residues of boscalid in/on hay were 3.36-43.02 ppm 

at 12-15 days after the second application (1st cutting), 5.22-51.12 ppm at 12-16 days after the 

third application (2nd cutting), and 0.07-3.63 ppm at 43-73 days after the third application (3rd

cutting). For the 1st, 2nd, and 3rd cuttings, boscalid residues averaged, respectively, 7.05, 6.25 and 

0.17 ppm in/on forage and 17.37, 20.93 and 0.62 ppm in/on hay.

For Treatment #3 (3 applications each at ~0.3 lb ai/A with an ~21-day PHI), residues of boscalid

in/on forage were 0.11-6.16 ppm at 19-23 days after the second application (1st cutting), 0.32-

5.59 ppm at 20-23 days after the third application (2nd cutting), and <0.05-0.50 ppm at 49-76 

days after the third application (3rd cutting). Residues of boscalid in/on hay were 0.14-20.84 ppm 

at 19-23 days after the second application (1st cutting), 1.52-15.26 ppm at 20-23 days after the 

third application (2nd cutting), and <0.05-1.36 ppm at 49-76 days after the third application (3rd

cutting). For the 1st, 2nd, and 3rd cuttings, boscalid residues averaged, respectively, 2.05, 2.29 

and 0.16 ppm in/on forage and 6.97, 7.24 and 0.49 ppm in/on hay. 

For Treatment #4 (2 applications each at ~0.3 lb ai/A with an ~14-day PHI), residues of boscalid 

in/on forage were 0.97-15.68 ppm at 12-15 days after the first application (1st cutting), 0.85-

15.32 ppm at 12-16 days after the second application (2nd cutting), and <0.05-0.38 ppm at 43-70

days after the second application (3rd cutting). Residues of boscalid in/on hay were 3.11-33.78

ppm at 12-15 days after the first application (1st cutting), 4.48-40.06 ppm at 12-16 days after the 

second application (2nd cutting), and <0.05-0.72 ppm at 43-70 days after the second application 

(3rd cutting). For the 1st, 2nd, and 3rd cuttings, boscalid residues averaged, respectively, 4.94, 5.56

and 0.12 ppm in/on forage and 15.30, 18.23 and 0.31 ppm in/on hay.

For Treatment #5 (2 applications each at ~0.3 lb ai/A with an ~21-day PHI), residues of boscalid 

in/on forage were <0.05-5.44 ppm at 19-23 days after the first application (1st cutting), 0.29-3.64

ppm at 20-23 days after the second application (2nd cutting), and <0.05-0.44 ppm at 49-76 days 

after the second application (3rd cutting). Residues of boscalid in/on hay were 0.42-12.46 ppm at 

19-23 days after the first application (1st cutting), 1.88-21.60 ppm at 20-23 days after the second

application (2nd cutting), and <0.05-1.12 ppm at 46-76 days after the second application (3rd
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Page 26 of 48

cutting). For the 1st, 2nd, and 3rd cuttings, boscalid residues averaged, respectively, 1.75, 2.03 and 

0.14 ppm in/on forage and 5.29, 7.50 and 0.45 ppm in/on hay.

Overall, boscalid residues were higher in/on forage and hay from the treatments using 3 

applications rather than 2 applications, and the residues were higher in forage and hay from 

treatments having the ~14-day PHI rather than the ~21-day PHI. The worst-case treatment for 

residues was Treatment #2, and the highest residues were found in forage and hay from 1st and 

2

nd cuttings. For Treatment #2, average boscalid residues from the 1st and 2nd cuttings were 7.05 

and 6.25 ppm for forage and 17.37 and 20.93 ppm for hay.

Conclusion. The maximum residues of boscalid were found in the treatment (Treatment 2) after 

2 or 3 foliar applications of boscalid at ~0.3 lb ai/A/application. The residues collected at 12-16 

days DALA after the 1st and 2nd cutting were 20.30 and 19.40 ppm, respectively in/on forage and 

43.02 and 51.12 ppm in/on hay. In general, boscalid residue decline occurred after the 3rd cutting 

of forage and hay.

The submitted alfalfa field trial data are adequate and would support the use of two or three 

broadcast foliar applications of boscalid (25.2% ,WDG formulation) to alfalfa at up to ~0.30 lb 

ai/A/application, with no more than two applications per cutting, for maximum seasonal use rates 

0.6 or 0.9 lb ai/A. The data also support a minimum RTI of 14 days and minimum PHIs of either 

14 or 21 days. However, the alfalfa field trial data will not support the proposed use rates of the 

70% WDG as the proposed maximum single (0.48 lb ai/A) and seasonal (1.44 lb ai/A) 

application rates for the 70% WDG are approximately 1.6x higher than the rates used in the 

alfalfa field.

860.1520 Processed Food and Feed

47584402.der (citrus)

BASF submitted residue data from an orange processing study conducted in FL (Zone 3) during 

2008. A 70% water dispersible granule (WDG) formulation of boscalid was applied to Valencia 

orange trees during fruit maturation as two broadcast foliar applications at rates of 0.30 lb 

ai/A/application at a retreatment interval (RTI) of 10 days, for a total rate of 0.60 lb ai/A. 

Applications were made using airblast ground equipment in volumes of ~100 gal/A of water and 

included the use of Crossfire® adjuvant (0.5% v/v). Single control and treated bulk samples of 

oranges were harvested one day after the second application (1 DAT), and were processed within 

4 days into dried pulp, juice, and oil using commercial processing procedures. 

The data collection LC/MS/MS method (BASF Method D9908, Version II) used to analyze 

boscalid residues in/on orange fruit and processed commodities was adequately validated prior to 

and in conjunction with the analysis of processing samples. The limit of quantitation (LOQ) was 

0.05 ppm in citrus fruits, and the limit of detection (LOD) was 0.01 ppm.
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Following two broadcast foliar applications of boscalid (WDG) at rates totaling ~0.60 lb ai/A, 

boscalid residues averaged 0.22 ppm in/on whole fruit. The average boscalid residues in the 

processed commodities were 0.694 ppm in dried pulp, <0.05 ppm in juice, and 13.1 ppm in oil. 

These data indicate that boscalid residues were reduced in juice by 0.23x, but concentrated 3.2x 

in dried pulp and 59x in oil. The theoretical processing factors for citrus are 2x for juice, 3.3x for

dried pulp and 1000x for oil (OPPTS 860.1520, Table 3).

For the storage stability study, whole orange fruits, dried pulp and oil were stored at <-5°C for up 

to 3.6 months prior to analysis. The conditions and duration for sample storage are supported by

a concurrent storage stability study in which control samples of each matrix were fortified with 

boscalid at 0.5 ppm and stored under the same conditions as the RAC and processing study

samples. After 3.6 months of frozen storage, the corrected recoveries of boscalid were 109-

126% from all four citrus matrices. 

Table 10. Residue Data from Orange Processing Study with Boscalid (WDG)

RAC Processed

Commodity

Total Rate

(lb ai/A)

PHI

(days) Residues (ppm) 1

Processing Factor3

Orange Fruit (RAC) 0.602 1 0.2210, 0.2209 (0.2210) --

Dried Pulp 0.5884, 0.8002 (0.694) 22.7x, 3.6x (3.2x)

Juice <0.05, <0.05 (<0.05) <0.23x, <0.23x (<0.23x)

Oil 13.6, 12.49 (13.05) 26.1x 5.7x (59x)

1 The LOQ is 0.05 ppm for all commodities. 

2 Residues are average of 3 replicates each. Mean of multiple analyses are in parenthesis. 

2 The processing factor was calculated by dividing the residue in the processed commodity by the residue in the associated RAC 

sample. The LOQ was used to calculate the processing factor for the value below the LOQ. Mean processing factors are in 

parenthesis.. 

Conclusions. The orange processing study is adequate. As boscalid residues were reduced in 

juice (<0.2x), a separate tolerance is not required for citrus juice. However, separate tolerances 

are required for citrus dried pulp and oil. Based on the processing factors for dried pulp (3.1x) 

and oil (59x) and the HAFT residues (see Table 9) for citrus fruits (orange – 1.39 ppm), the 

maximum expected boscalid residues would be 4.31 ppm in dried pulp and 82 ppm in oil. These 

data support tolerances of 4.5 ppm for dried citrus pulp and 85 ppm for citrus oil.

860.1650 Submittal of Analytical Reference Standards

Analytical reference standards for boscalid and its hydroxy metabolite (with an expiration dates

of 4/1/2014) are currently available in the EPA National Pesticide Standards Repository

(personal communication with Dallas Wright; ACB/BEAD; 7/22/09). 

860.1850 Confined Accumulation in Rotational Crops

PP#1F6313; DP# 278385, M. Nelson, 8/15/03
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Page 28 of 48

HED MARC Decision Memo; DP# 286786; M. Nelson; 1/09/2003

The nature of the residue in rotational crops is adequately understood and was summarized in a 

previous residue chemistry summary document. The MARC has concluded that the residue of 

concern in rotated crops for purposes of risk assessment and the tolerance expression is parent 

compound.

860.1900 Field Accumulation in Rotational Crops

PP#1F6313; DP# 278385, M. Nelson, 8/15/2003

DP# 322235, D. Dotson, 11/03/2005

DP# 323288, D. Soderberg, 6/14/2007 

Adequate limited and extensive field rotational crop studies are available supporting the existing 

tolerances for indirect residues in rotational crops. These data support the label-specific plant 

back interval of 14 days for crops without boscalid uses. No additional rotational crop data are 

required for purposes of this petition.

860.1550 Proposed Tolerances

For purposes of both the tolerance expression and dietary risk assessment, HED has concluded 

that the residues of concern in plant commodities include only boscalid, and the residues of 

concern in livestock commodities include boscalid, its 5-hydroxy metabolite, and the glucuronide 

conjugate of the 5-hydroxy metabolite.

Permanent tolerances are established for residues of boscalid in/on various plant commodities at 

levels ranging from 0.05 to 60 ppm [40 CFR §180.589(a)(1)]. Separate tolerances are also 

established for indirect or inadvertent residues of boscalid in rotational crops at levels ranging 

from 0.05 to 8.0 ppm [40 CFR §180.589(d)]. Tolerances are also established for the combined 

residues of boscalid, its 5-hydroxy metabolite and the glucuronic acid conjugate of the 5-hydroxy

metabolite, at levels ranging from 0.02 ppm to 0.35 ppm [40 CFR §180.589(a)(2)]. The 

proposed and recommended tolerances for boscalid are presented in Table 11.

An adequate number of field trials conducted at ~1x the existing or proposed use rates are 

available on alfalfa, citrus fruits (orange, lemon, grapefruit) and stone fruits (cherry, peach and 

plum) to support permanent tolerances. The Agency’s SOP “Guidelines for Setting Pesticide 

Tolerances Based on Field Trial Data” was utilized for determining the appropriate tolerance 

level for each commodity (Appendix II). For alfalfa forage and hay, residue data from both the 

1

st and 2nd cuttings of Treatment #2 (1x rate) were used to assess tolerances as both cuttings were 

collected around the proposed 14-day PHI, and residue levels were similar for the two cuttings. 

The recommended tolerances for alfalfa forage and hay are 30 and 65 ppm, respectively.

For the citrus fruits, the residue data were pooled by crop, and separate possible tolerances were 

calculated for oranges (1.6 ppm), lemons (1.6 ppm), and grapefruits (1.1 ppm) using the 

tolerance spreadsheet. As the minimum and maximum recommended tolerances differ by less 

than 5x, a crop group tolerance is appropriate for citrus, and the recommended tolerance is 1.6 

ppm.
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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For stone fruits, all the adequate residue data were pooled by crop (including previously reviewed 

studies), and separate possible tolerances were calculated for cherry (3.5 ppm), peach (3.0 ppm) 

and plum (1.6 ppm) using the tolerance spreadsheet. As the minimum and maximum 

recommended tolerances differ by less than 5x, a crop group tolerance is appropriate for stone 

fruits, and the recommended tolerance is 3.5 ppm.

As boscalid residues were reduced in orange juice (<0.2x), a separate tolerance is not required for 

citrus juice. However, boscalid residues were shown to concentrate in dried pulp (3.1x) and oil 

(59x). Based on these processing factors and the HAFT residues for citrus fruits (1.39 ppm), the 

maximum expected boscalid residues would be 4.31 ppm in dried pulp and 82 ppm in oil. These 

data support tolerances of 4.5 ppm for dried citrus pulp and 85 ppm for citrus oil.

For assessing the existing tolerances on livestock commodities, adequate cattle and poultry

feeding studies are available that cover the potential levels of dietary exposure of livestock to 

boscalid residues. The 35.8 ppm dose group (1x dietary burden) from the cattle feeding study

was used to assess the current tolerances on milk (0.10 ppm) and on the fat (0.30 ppm), meat 

(0.10 ppm) and meat byproducts (0.35 ppm) of cattle, goats, horses, and sheep. For this dose 

group, the maximum combined residues of boscalid and M510F01 (free and conjugated) were 

<0.03 ppm in milk, <0.08 ppm in cream, ≤0.11 ppm in liver and kidneys, <0.05 ppm in muscle 

and <0.24 ppm in fat. These data indicate that the existing tolerances for milk and fat, meat and 

meat byproducts of cattle, goats, horses and sheep are more than adequate. Separate tolerances 

for liver and kidney are not required.

For hogs, the adequacy of the existing tolerances were assessed using residue data from the 5.9 

ppm dose group (1.1x dietary burden for swine) in the cattle feeding studies. Maximum 

combined residues for this dose group were <0.064 ppm in liver, <0.090 ppm in kidney, <0.05 

ppm in muscle, and <0.12 ppm in fat. These data indicate that the existing tolerances for meat 

(0.05 ppm) and meat byproducts (0.10 ppm) of hogs are adequate; however, the tolerance for hog 

fat should be increased to 0.20 ppm. Separate tolerances of hog liver and kidney are not 

necessary.

For poultry, the adequacy of the existing tolerances were assessed using residue data from the 

5.31 ppm dose group in the poultry feeding studies; this group represents 1.3x the calculated 

dietary burden for poultry. Maximum combined residues for this dose group were <0.02 ppm in 

eggs, <0.175 ppm in liver, <0.05 ppm in muscle, and <0.124 ppm in fat. These data indicate that 

the existing tolerances for eggs (0.02 ppm) and poultry meat (0.05 ppm) are adequate; however, 

the tolerances for poultry fat and meat byproducts should each be increased to 0.20 ppm. A 

separate tolerance for liver is not necessary.

The Codex Alimentarius Commission, Canada and Mexico have not established any maximum 

residue limits (MRLs) for residues of boscalid in/on alfalfa forage and hay or citrus fruits 

(Appendix I). However, there is an existing Codex MRL for stone fruits at 3 mg/kg, and Canada 

has established MRLs at 1.7 mg/kg for the various member of the stone fruits crop group. 

Canada also has also established MRLs for various livestock commodities. The Canadian MRLs 

for stone fruits and livestock commodities are currently harmonized with the respective US 

tolerances; however, once the recommended increases are made to US tolerances, the US 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 30 of 48

tolerances on stone fruits, poultry fat and meat byproducts and hog fat will no longer be 

harmonized with the Canadian MRLs.

Table 11. Tolerance Summary for Boscalid.

Commodity Proposed 

Tolerance 

(ppm

Existing 

Tolerance 

(ppm)

Recommended 

Tolerance 

(ppm)

Comments; Correct Commodity 

Definition

40 CFR 180.589(a)(1)

Alfalfa, forage 35 -- 30 Adequate alfalfa forage and hay 

Alfalfa residue data are available., hay 85 -- 65

Citrus, dried pulp None -- 4.5 An adequate orange processing study 

is available indicating that boscalid 

residues can concentrate in dried 

pulp (3.1x) and oil (59x) Citrus, oil None -- 85

Fruit, citrus, group 10 2.0 -- 1.6

Adequate orange, grapefruit, and 

lemon residue data are available.

Fruit, stone, group 12 5.0 1.7 3.5

An increase in the established 

tolerance is required based on 

adequate cherry, peach and plum 

residue data.

40 CFR 180.589(a)(2)

Cattle, fat 1.5 0.30 0.30 Based on the residue data from the 

35.8 ppm dose group in the cattle 

feeding studies and the calculated 

dietary burden for dairy cattle (35.2 

ppm), the existing tolerances are 

adequate. Separate tolerances for 

liver and kidney are not necessary.

Cattle, kidney 1.0 -- None

Cattle, liver 1.0 -- None

Cattle, meat 0.2 0.10 0.10

Cattle, meat byproducts 1.5 0.35 0.35

Egg 0.02 0.02 0.02 The existing tolerance on eggs is 

adequate.

Goat, fat 1.5 0.30 0.30 See Cattle above.

Goat, kidney 1.0 -- None

Goat, liver 1.0 -- None

Goat, meat 0.2 0.10 0.10

Goat, meat byproducts 1.5 0.35 0.35

Hog, fat 0.2 0.10 0.20 Based on the residue data from the 

5.9 ppm dose group in the cattle 

feeding studies and the calculated 

dietary burden for swine (5.30 ppm), 

the existing tolerances on hog meat 

and meat byproducts are adequate. 

However, the tolerance for hog fat 

should be increased to 0.20 ppm.

Hog, meat 0.05 0.05 0.05

Hog, meat byproducts 0.2 0.10 0.10

Hog, kidney 0.2 -- None

Hog, liver 0.2 -- None

Horse, fat 1.5 0.30 0.30 See Cattle above.

Horse, kidney 1.0 -- None

Horse, liver 1.0 -- None

Horse, meat 0.2 0.10 0.10

Horse, meat byproducts 1.5 0.35 0.35

Milk 0.2 0.10 0.10 The existing tolerance for milk will 
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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Table 11. Tolerance Summary for Boscalid.

Commodity Proposed 

Tolerance 

(ppm

Existing 

Tolerance 

(ppm)

Recommended 

Tolerance 

(ppm)

Comments; Correct Commodity 

Definition

Milk, fat (cream) 1.5 -- None adequately cover residues in both 

whole milk and milk fat

Poultry, liver 0.2 -- None Based on the residue data from the 

5.31 ppm dose group in the poultry 

feeding study and the calculated 

dietary burden for poultry (4.10 

ppm), the existing tolerance for meat 

is adequate and the tolerances of fat 

and meat byproducts should be 

increased to 0.20 ppm. A separate 

tolerance for liver is not necessary.

Poultry, fat 0.2 0.05 0.20

Poultry, meat 0.05 0.05 0.05

Poultry, meat byproducts 0.2 0.10 0.20

Sheep, fat 1.5 0.30 0.30 See Cattle above.

Sheep, kidney 1.0 -- None

Sheep, liver 1.0 -- None

Sheep, meat 0.2 0.10 0.10

Sheep, meat byproducts 1.5 0.35 0.35

References

DP Numbers: 278385, 282532, 286787, 287829

Subject: PP#1F06313. BAS 510 F (Common Name: Boscalid), New Fungicide Active 

Ingredient. Residue Chemistry Summary Document.

From: M. Nelson

To: M. Rodriquez/C. Giles-Parker

Dated: 08/15/2003

MRIDs: 45405021-45405028, 45405101-45405128, 45405202-45405204, 45623401-

45623413, and 45643801

DP Number: 322235

Subject: PP#s 1F6313, 3E6791, 4F6875, and 5E6933: Boscalid, Registrant’s Response to 

Deficiencies Cited in Tolerance Petition 1F6313. Summary of Analytical 

Chemistry and Residue Data for Rotational Root Crops, Direct Uses on Celery, 

Spinach, Bananas, Strawberries, Almonds, and Potatoes, and Seed Treatment 

Uses on Bulb Vegetables, Brassica Leafy Vegetables, Legume Vegetables, 

Peanuts, and Sunflowers.

From: D. Dotson

To: J. Bazuin/T. Kish

Dated: 11/3/2005

MRIDs: 46145101, 46145102, 46160103, 46210606, and 46351401-46351405
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 32 of 48

DP Number: 323288

Subject: Boscalid. Petition for a Tolerance for Belgian Endive; Petition for Increased 

Tolerances on Strawberry and the Berries Crop Group; Submission of Requested 

Field Trial Data on Cucumber, Mustard Greens and Sunflower; and Supplemental 

Field Trial Data on Fruiting Vegetables, Radishes, Spearmint, Peppermint, 

Grapes, and Stone Fruits; and Submission of Field Trials and a Processing Study

for Cotton. Summary of Analytical Chemistry and Residue Data.

From: D. Soderberg

To: C. Swartz

Dated: 6/04/2007

MRIDs: 46512002, 46512003, 46637701, 46665501, 46665502, 46665503, 46665504, 

46665505, 46665506, 46713801, 46685902, 46685901

Attachments: 

Appendix I - International Residue Limits 

Appendix II - Tolerance Assessment Calculations

Template Version April 2008
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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Appendix I – International Residue Limits

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 

3-pyridinecarboxamide, 2-chloroN-(4'-chloro[1,1'-biphenyl]-2-yl

Common Name:

Boscalid

X Proposed tolerances

X Reevaluated tolerance

 Other

Date: 8/05/09

Codex Status (Maximum Residue Limits) U. S. Tolerances

□ No Codex proposal step 6 or above

□ No Codex proposal step 6 or above for the crops 

requested

Petition Numbers: PP#9F7527 and PP#9F9529

DP#: 364447 

Other Identifier: 

Residue definition (step 8/CXL): Boscalid Reviewer/Branch: P. Deschamp/RAB3

Residue definition: boscalid for plant commodities; 

and combined residues of boscalid and M510F01 (free 

and conjugates) for animal commodities

Crops/Commodities MRL (mg/kg) Crops/Commodities Recommended 

Tolerance (ppm)

Alfalfa, forage 35

Alfalfa, hay 85

Fruit, citrus, group 10 2.0

Stone fruits 3.0 Fruit, stone, group 12 5.0

Egg 0.02 Egg 0.02

Fat of cattle, goat, horse and 

sheep 0.30

Meat (mammalian other than 

marine)

0.7 Meat of cattle, goat, horse and 

sheep 0.20

Edible offal, mammalian 0.2 Meat byproducts (cattle, goat, 

horse and sheep) 1.5

Milks 0.1 Milk 0.20

Hog, Fat 0.20

Hog, kidney 0.2

Hog, meat byproducts 0.20

Hog, liver 0.20

Poultry fat/meat 0.02 Poultry, fat 0.20

Poultry, liver 0.20

Poultry, edible offal 0.02 Poultry, meat byproducts 0.20
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: 

3-pyridinecarboxamide, 2-chloroN-(4'-chloro[1,1'-biphenyl]-2-yl

Common Name:

Boscalid

X Proposed tolerances

X Reevaluated tolerance

 Other

Date: 8/05/09

Limits for Canada Limits for Mexico

□ No Limits

□ No Limits for the crops requested

X No Limits

□ No Limits for the crops requested

Residue definition: boscalid for plant commodities; 

and combined residues of boscalid and M510F01 (free 

and conjugates) for animal commodities

Residue definition: NA. Mexico defers to US 

tolerances or Codex MRLs for its export purposes.

Crops/Commodities MRL (mg/kg) Crops/Commodities MRL (ppm)

apricot, plumcot, plum, 

peach, sweet cherry, and tart 

cherry

1.7

Eggs 0.02

Fat of cattle, goats, hogs, 

horses, and sheep 0.3

Fat of poultry 0.05

Meat of cattle, goats, hogs, 

horses, and sheep 0.1

Meat of poultry 0.05

Meat byproducts of cattle, 

goats, hogs, horses, and sheep 0.35

Meat byproducts of poultry 0.1

Milk 0.1

Notes/Special Instructions: S.Funk, 10/14/2009.
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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Appendix II. Tolerance Assessment Calculations.

For each of the crops listed below, the Guidance for Setting Pesticide Tolerances Based on Field 

Trial Data (SOP), along with the tolerance spreadsheet, was used for calculating recommended 

tolerances. As specified in the SOP, the minimum of the 95% upper confidence limit (UCL) on 

the 95th percentile and the point estimate of the 99th percentile was selected as the tolerance value 

in cases when the dataset was large (greater than 15 samples) and reasonably lognormal. For 

datasets that were small (≤15 samples) and reasonably lognormal, the upper bound estimate of 

the 95th percentile based on the median residue value was compared to the minimum of the 95% 

UCL on the 95th percentile and the point estimate of the 99th percentile, and the minimum value 

was selected as the tolerance value. For datasets that were not lognormal, the upper bound on the 

89th percentile was selected as the tolerance value (distribution-free method). The rounding 

procedures specified in the SOP were also used.

Citrus, Crop Group 10

The dataset used to assess a tolerance for boscalid residues in/on citrus fruit consisted of field 

trial data for the representative crops of orange, grapefruit, and lemon, and represented 

application rates of 1.18-1.23 lb ai/A (4 applications at ~0.29-0.32 lb ai/A/application) with a 

PHI of 0 day. As specified by the SOP, the field trial application rates and PHIs are within 25% 

of the maximum label application rate and minimum label PHI, respectively. The residue values 

used to calculate the tolerance are provided in Table II-1. 

All field trial sample results for orange, grapefruit, and lemon were above the LOQ (0.05 ppm). 

The datasets for orange was large (26 samples) and the datasets for grapefruits and lemons were 

relatively small (10-12 samples). The dataset for each crop was entered into the tolerance 

spreadsheet. Visual inspection of the lognormal probability plots for each crop (Figures II-1, II3, and II-5) indicates that the datasets for all three crops are reasonably lognormal. The results 

from the approximate Shapiro-Francia test statistic (Figures II-2, II-4, and II-6) confirmed that 

the assumption of lognormality should not be rejected. 

Using the tolerance spreadsheet, the recommended tolerances are 1.6 ppm for orange and lemon, 

and 1.1 ppm for grapefruit. Because the minimum and maximum recommended tolerances differ 

by less than 5x, a crop group tolerance is appropriate for citrus. The recommended value is 1.6

ppm, the maximum of the recommended individual tolerances.
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Table II-1. Boscalid Residues in/on Citrus Fruits following Four Foliar Applications of Boscalid 

(WDG) at Rates Totaling ~1.20 lb ai/A/season.

Regulator: EPA EPA EPA

Chemical: Boscalid Boscalid Boscalid

Crop: Orange Grapefruit Lemon

PHI: 0 day 0 day 0 day

App. Rate: 4 at 0.29-0.31 lb ai/A 4 at 0.30-0.31 lb ai/A 4 at 0.29-0.32 lb ai/A

Submitter: BASF BASF BASF

MRID Citation: MRID 45903601 MRID 45903601 MRID 45903601

Residues Residues Residues

0.179 0.064 0.522

0.233 0.097 0.590

0.237 0.102 0.664

0.238 0.115 0.677

0.241 0.120 0.742

0.260 0.135 0.807

0.271 0.147 0.936

0.300 0.151 0.968

0.306 0.249 1.510

0.316 0.272

0.326 0.824

0.332 0.847

0.352

0.354

0.469

0.471

0.499

0.544

0.561

0.644

0.676

0.676

0.714

1.190

1.360

1.425
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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Figure II-1. Lognormal Probability Plot of Boscalid Residues in/on Oranges Following Four 

Foliar Applications Totaling ~1.20 lb ai/A.

Lognormal Probability Plot

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

2.0000

1.0000

0.5000

0.2500

0.1250

y = 0.5647x - 0.8496

R

2

 = 0.937

Percentiles

Concentrations

EPA Boscalid Orange 0 day 4 at 0.29-0.31 lb ai/A BASF MRID 45903601

Figure II-2. Data Summary Sheet for Residues of Boscalid in/on Oranges Following Four Foliar 

Applications Totaling ~1.20 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Orange

PHI: 0 day

App. Rate4 at : 0.29-0.31 lb ai/A

Submitter: BASF

MRID Citation: MRID 45903601

n: 26

min: 0.18

max: 1.43

median; 0.35

average: 0.51

95th Percentile 99th Percentile 99.9th Percentile

1.1 1.4 1.6

(1.3) (1.6) (--)

1.1 1.6 2.5

(1.6) (3.0) (--)

1.4

1.6

UPLMedian95th 2.5

0.9370

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Normal

EU Method I

Log Normal

Approximate 

Shapiro-Francia 

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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Figure II-3. Lognormal Probability Plot of Boscalid Residues in/on Grapefruit Following Four 

Foliar Applications Totaling ~1.20 lb ai/A.

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

y = 0.7979x - 1.7092

R

2

 = 0.8631

Percentiles

Concentrations

EPA Boscalid Grapefruit 0 day 4 at 0.30-0.31 lb ai/A BASF MRID 45903601

Figure II-4. Data Summary Sheet for Residues of Boscalid in/on Grapefruit Following Four 

Foliar Applications Totaling ~1.20 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Grapefruit

PHI: 0 day

App. Rate4 at : 0.30-0.31 lb ai/A

Submitter: BASF

MRID Citation: MRID 45903601

n: 12

min: 0.06

max: 0.85

median; 0.14

average: 0.26

95th Percentile 99th Percentile 99.9th Percentile

0.80 1.0 1.2

(1.1) (1.3) (--)

0.70 1.3 2.5

(1.7) (4.0) (--)

0.60

1.1

UPLMedian95th 1.1

0.8631

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Normal

EU Method I

Log Normal

Approximate 

Shapiro-Francia 

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 39 of 48

Figure II-5. Lognormal Probability Plot of Boscalid Residues in/on Lemon Following Four 

Foliar Applications Totaling ~1.20 lb ai/A.

Lognormal Probability Plot

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

2.0000

1.0000

0.5000

y = 0.316x - 0.2687

R

2

 = 0.9132

Percentiles

Concentrations

EPA Boscalid Lemon 0 day 4 at 0.29-0.32 lb ai/A BASF MRID 45903601

Figure II-6. Data Summary Sheet for Residues of Boscalid in/on Lemon Following Four Foliar 

Applications Totaling ~1.20 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Lemon

PHI: 0 day

App. Rate:4 at 0.29-0.32 lb ai/A

Submitter: BASF

MRID Citation: MRID 45903601

n: 10

min: 0.52

max: 1.51

median; 0.71

average: 0.80

95th Percentile 99th Percentile 99.9th Percentile

1.3 1.5 1.7

(1.7) (2.0) (--)

1.3 1.6 2.0

(1.9) (3.0) (--)

1.9

1.7

UPLMedian95th 6.0

0.9132

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Normal

EU Method I

Log Normal

Approximate 

Shapiro-Francia 

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ

Stone Fruits, Crop Group 12
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The datasets used to assess a tolerance for boscalid residues on stone fruits consisted of field trial 

data for the representative crops of cherries, peaches and plums, and represented application rates 

of 1.15 lb ai/A (5 applications at ~0.230 lb ai/A/application) with a PHI of 0 day. As specified 

by the SOP, the field trial application rates and PHIs are within 25% of the maximum label 

application rate and minimum label PHI, respectively. The residue values used to calculate the 

tolerance are provided in Table II-2. HED notes that the dataset includes values from all 

adequate cherry, peach and plum field trials, including the previously reviewed stone fruit data. 

(DP# 278385, M. Nelson, 8/15/03; and DP# 323288, D. Soderberg, 6/14/2007).

With the exception of on cherry sample and two plum samples, the field trial sample results were 

above the LOQ (0.05 ppm). The datasets for cherries, peaches, and plums were each relatively

large (28-38 samples). The dataset for each crop was entered into the tolerance spreadsheet. 

Visual inspection of the lognormal probability plots for each crop (Figures II-7, II-9, and II-11) 

indicates that the datasets for cherry and peach are not lognormal; whereas, the dataset for plum 

is reasonably lognormal. The results from the approximate Shapiro-Francia test statistic (Figures 

II-8, II-10, and II-12) confirmed that the assumptions of lognormality. 

Using the tolerance spreadsheet, the recommended tolerances are 3.5 ppm for cherry, 3.0 ppm for 

peaches, and 1.6 ppm for plums. Because the minimum and maximum recommended tolerances 

differ by less than 5x, a crop group tolerance is appropriate for stone fruits. The recommended 

value is 3.5 ppm, the maximum of the recommended individual tolerances.
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

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Table II-2. Boscalid Residues in/on Stone Fruits following Five Foliar Applications of Boscalid 

(WDG) at Rates Totaling ~1.15 lb ai/A/season.

Regulator: EPA EPA EPA

Chemical: Boscalid Boscalid Boscalid

Crop: Cherry Peach Plum

PHI: 0 day 0 day 0 day

App. Rate: 5 at 0.23 lb ai/A 5 at 0.23 lb ai/A 5 at 0.23 lb ai/A

Submitter: BASF BASF BASF

MRID 

Citation:

MRIDs 45405121, 

46665505, 47470201

MRIDs 45405121, 

46665505, 47470201

MRIDs 45405121, 

46665505, 47470201

Residues Residues Residues

0.050 1.360 0.157 0.590 0.050 0.245

0.060 1.415 0.193 0.636 0.050 0.246

0.641 1.460 0.194 0.640 0.081 0.315

0.736 1.470 0.315 0.663 0.088 0.344

0.756 1.500 0.315 0.700 0.090 0.455

0.906 1.505 0.334 0.723 0.100 0.461

1.004 1.580 0.395 0.730 0.103 0.537

1.030 1.635 0.400 0.730 0.109 0.549

1.092 1.700 0.422 0.746 0.130 0.553

1.211 1.760 0.472 0.751 0.130 0.566

1.220 2.300 0.476 0.780 0.135 0.590

1.270 2.530 0.479 0.800 0.149 0.620

1.280 2.840 0.486 0.819 0.150 0.740

1.307 2.980 0.492 0.900 0.172 0.790

0.512 0.920 0.240 0.851

0.514 1.170

0.518 1.200

0.560 2.820

0.580 3.790

1 Residue values <LOQ are listed in bold.
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Page 42 of 48

Figure II-7. Lognormal Probability Plot of Boscalid Residues in/on Cherries (Sweet and Tart) 

Following Five Foliar Applications Totaling ~1.15 lb ai/A.

Lognormal Probability Plot

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

3.0000

1.5000

0.7500

0.3750

0.1875

0.0938

0.0469

y = 0.7749x + 0.0893

R

2

 = 0.6638

Percentiles

Concentrations

EPA Boscalid Cherry 0 day 5 at 0.23 lb ai/A BASF MRID 45405121, 46665505, 47470201

Figure II-8. Data Summary Sheet for Residues of Boscalid in/on Cherries (Sweet and Tart) 

Following Five Foliar Applications Totaling ~1.15 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Cherry

PHI: 0 day

App. Rate: 5 at 0.23 lb ai/A

Submitter: BASF

MRID Citation: MRID 45405121, 46665505, 47470201

n: 28

min: 0.05

max: 2.98

median; 1.33

average: 1.38

95th Percentile 99th Percentile 99.9th Percentile

3.0 3.0 4.0

(3.0) (4.0) (--)

5.0 10 19

(9.0) (20) (--)

3.5

3.5

UPLMedian95th 8.0

0.6638

p-value <= 0.01: Reject lognormality assumption

EU Method I

Normal

EU Method I

Log Normal

Approximate 

Shapiro-Francia 

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 43 of 48

Figure II-9. Lognormal Probability Plot of Boscalid Residues in/on Peaches Following Five 

Foliar Applications Totaling ~1.15 lb ai/A.

Lognormal Probability Plot

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

4.0000

2.0000

1.0000

0.5000

0.2500

0.1250

y = 0.5998x - 0.5239

R

2

 = 0.916

Percentiles

Concentrations

EPA Boscalid Peach 0 day 5 at 0.23 lb ai/A BASF MRID 45405121, 46665505, 47470201

Figure II-10. Data Summary Sheet for Residues of Boscalid in/on Peaches Following Five Foliar 

Applications Totaling ~1.15 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Peach

PHI: 0 day

App. Rate: 5 at 0.23 lb ai/A

Submitter: BASF

MRID Citation: MRID 45405121, 46665505, 47470201

n: 38

min: 0.16

max: 3.79

median; 0.59

average: 0.73

95th Percentile 99th Percentile 99.9th Percentile

1.9 2.5 3.0

(2.5) (3.0) (--)

1.7 2.5 4.0

(2.5) (4.0) (--)

1.6

3.0

UPLMedian95th 3.5

0.9160

0.05 >= p-value > 0.01 : Reject lognormality assumption

EU Method I

Normal

EU Method I

Log Normal

Approximate

Shapiro-Francia

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 44 of 48

Figure II-11. Lognormal Probability Plot of Boscalid Residues in/on Plums Following Five Foliar 

Applications Totaling ~1.15 lb ai/A.

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

y = 0.8637x - 1.4629

R

2

 = 0.9486

Percentiles

Concentrations

EPA Boscalid Plum 0 day 5 at 0.23 lb ai/A BASF MRID 45405121, 46665505, 47470201

Figure II-12. Data Summary Sheet for Residues of Boscalid in/on Plums Following Five Foliar 

Applications Totaling ~1.15 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Plum 

PHI: 0 day

App. Rate: 5 at 0.23 lb ai/A

Submitter: BASF

MRID Citation: MRID 45405121, 46665505, 47470201

n: 30

min: 0.05

max: 0.85

median; 0.24

average: 0.32

95th Percentile 99th Percentile 99.9th Percentile

0.80 0.90 1.1

(0.90) (1.1) (--)

1.0 1.8 3.5

(1.6) (3.5) (--)

1.1

1.1

UPLMedian95th 1.4

0.9486

p-value > 0.05 : Do not reject lognormality assumption

EU Method I

Normal

EU Method I

Log Normal

Approximate 

Shapiro-Francia 

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ

Alfalfa Forage and Hay
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 45 of 48

The dataset used to establish tolerances for boscalid on alfalfa forage and hay consisted of field 

trial data representing the three applications of boscalid (WDG) at rates of 0.28-0.32 lb ai/A 

(~0.85 lb ai/A/season) and a 14-day PHI. The residues from the 1st and 2nd cuttings of Treatment 

#2 had similar levels of residues; therefore, values from both cuttings were used in the tolerance 

calculations. As specified by the SOP, the field trial application rates and PHIs are within 25% 

of the maximum label application rate and minimum label PHI, respectively. The residue values 

used to calculate the tolerance are provided in Table II-3. 

The forage and hay datasets (48 samples each) were entered into the tolerance spreadsheet. 

Visual inspection of the lognormal probability plots (Figures II-13 and II-15) provided in the 

spreadsheet indicate that the datasets are reasonably lognormal. The result from the approximate 

Shapiro-Francia test statistic (Figures II-14 and II-16) confirmed that the assumption of 

lognormality should not be rejected. 

Using the tolerance spreadsheet, the recommended tolerances are 30 ppm for alfalfa forage and 

65 ppm for alfalfa hay.
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 46 of 48

Table II-3. Boscalid Residues in/on Alfalfa Forage and Hay following Three Foliar Applications of 

Boscalid (WDG) at Rates Totaling ~0.85 lb ai/A/season.

Regulator: EPA EPA

Chemical: Boscalid Boscalid

Crop: Alfalfa Forage Alfalfa Hay

PHI: 12-16 days (Cuttings 1+2) 12-16 days (Cuttings 1+2)

App. Rate: 3 at 0.28-0.32 lb ai/A 3 at 0.28-0.32 lb ai/A

Submitter: BASF BASF

MRID Citation: MRID 47584401 MRID 47584401

Residues Residues

0.81 5.07 3.36 15.00

1.04 5.10 3.92 16.64

1.10 5.39 5.22 16.72

1.32 5.42 5.33 17.35

1.35 5.48 5.65 18.07

1.49 5.98 7.66 19.11

1.69 6.06 7.72 19.53

2.42 6.39 7.91 19.99

2.47 7.96 8.08 20.31

2.51 8.06 9.47 21.64

2.73 8.56 9.74 21.96

2.82 8.79 11.41 23.00

2.93 8.79 11.45 24.22

2.97 11.11 11.54 25.22

3.09 11.82 11.59 31.13

3.42 12.98 11.82 31.23

3.45 13.17 12.39 32.64

3.78 14.06 12.90 35.77

4.21 15.04 12.99 42.22

4.39 15.05 13.01 42.38

4.41 15.12 13.22 43.02

4.57 15.21 13.83 45.77

4.93 19.40 14.13 46.69

5.00 20.30 14.13 51.12
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 47 of 48

Figure II-13. Lognormal Probability Plot of Boscalid Residues in/on Alfalfa Forage Following 

Three Foliar Applications Totaling ~0.85 lb ai/A.

Lognormal Probability Plot

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

21.0000

10.5000

5.2500

2.6250

1.3125

0.6563

y = 0.8336x + 1.5899

R

2

 = 0.979

Percentiles

Concentrations

EPA Boscalid Alfalfa Forage 12-16 days (Cuttings 1+2) 3 at 0.28-0.32 lb ai/A BASF MRID

47584401

Figure II-14. Data Summary Sheet for Residues of Boscalid in/on Alfalfa Forage Following Three 

Foliar Applications Totaling ~0.85 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Alfalfa Forage

PHI:

App. Rate:

Submitter: BASF

MRID Citation: MRID 47584401

n: 48

min: 0.81

max: 20.30

median; 5.04

average: 6.65

95th Percentile 99th Percentile 99.9th Percentile

16 19 25

(18) (25) (--)

20 35 65

(30) (55) (--)

18

25

UPLMedian95th 30

0.9790

p-value > 0.05 : Do not reject lognormality assumption

12-16 days (Cuttings 1 + 2)

3 at 0.28-0.32 lb ai/A

EU Method I

Normal

EU Method I

Log Normal

Approximate

Shapiro-Francia

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ
Boscalid Summary of Analytical Chemistry and Residue Data DP#: 364447

Page 48 of 48

Figure II-15. Lognormal Probability Plot of Boscalid Residues in/on Alfalfa Hay Following Three 

Foliar Applications Totaling ~0.85 lb ai/A.

Lognormal Probability Plot

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

52.0000

26.0000

13.0000

6.5000

3.2500

y = 0.6712x + 2.7472

R

2

 = 0.9829

Percentiles

Concentrations

EPA Boscalid Alfalfa Hay 12-16 days (Cuttings 1+2) 3 at 0.28-0.32 lb ai/A BASF MRID

47584401

Figure II-16. Data Summary Sheet for Residues of Boscalid in/on Alfalfa Hay Following Three 

Foliar Applications Totaling ~0.85 lb ai/A.

Regulator: EPA

Chemical: Boscalid

Crop: Alfalfa Hay

PHI:

App. Rate:

Submitter: BASF

MRID Citation: MRID 47584401

n: 48

min: 3.36

max: 51.12

median; 14.57

average: 19.15

95th Percentile 99th Percentile 99.9th Percentile

40 50 60

(50) (60) (--)

50 75 130

(65) (110) (--)

50

60

UPLMedian95th 80

0.9829

p-value > 0.05 : Do not reject lognormality assumption

12-16 days (Cuttings 1 + 2)

3 at 0.28-0.32 lb ai/A

EU Method I

Normal

EU Method I

Log Normal

Approximate

Shapiro-Francia

Normality Test 

EU Method II

Distribution-Free

California Method

μ + 3σ