Pyraclostrobin DP 410737

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

Date: 04/30/2013 

SUBJECT: Pyraclostrobin: Petition for the Establishment of Permanent Tolerances and 

Registration for Use on Belgium Endive, Persimmon, and Globe Artichoke. 

Request for Crop Group Expansions/Revisions for Bulb Vegetable Group 3-07, 

Fruiting Vegetable 8-10, Citrus Fruit Group 10-10, Pome Fruit Group 11-10, 

Berry Subgroups 13-07A, B, F, and G, and Oilseed Group 20. Summary of 

Analytical Chemistry and Residue Data.

PC Code: 099100 DP Barcode: D410737,405065

Decision No.: 468304 Registration Nos.: 7969-187; 7969-199; 7969-186; 

7969- 289

Petition No.: 2F8069 Regulatory Action: Section 3 Registration

Risk Assessment Type: Single Chemical/Aggregate Case No.: N/A

TXR No.: N/A CAS No.: 175013-18-0

MRID Nos: 48897401, 48897402, 48897403 40 CFR: 180.582

 

 

FROM: Stephen Funk, Senior Chemist

Risk Assessment Branch III (RAB III)

Health Effects Division (HED; 7509P)

THROUGH: Christine Olinger, Branch Chief

Risk Assessment Branch III (RABIII)

Health Effects Division (HED; 7509P)

TO: Barbara Madden 

Andrew Ertman

Registration Division (RD; 7505P)

And

Barry O’Keefe, Senior Biologist

Risk Assessment Branch III (RABIII)

Health Effects Division (HED; 7509P)
Pyraclostrobin DP 410737

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Executive Summary

Pyraclostrobin, or methyl [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]

phenyl]methoxycarbamate belongs to the strobilurin class of fungicides. The fungicide is 

currently registered to BASF Corporation (BASF) for use on a variety of field, vegetable, fruit, 

and nut crops. It is formulated as water-dispersible granules (WDG) or an emulsifiable 

concentrate (EC) and is typically applied as foliar applications using ground or aerial equipment 

at maximum seasonal rates of 0.3-3.0 lb ai/A. The 20% WDG formulation is also registered for 

use as a seed treatment on some crops.

The Interregional Research Project Number 4 (IR-4) is proposing new uses for pyraclostrobin on 

globe artichoke, Belgian endive, and persimmon and is requesting certain crop group 

conversions. The proposed use for persimmon and globe artichoke is up to three applications of 

a WG formulation with a seasonal maximum rate of 0.55 lb ai/acre and a 0 day PHI. The 

proposed use for Belgium endive is a root treatment with a WG formulation with a total 

application rate of about 0.027 lb ai/1000 lbs of root.

IR-4 has proposed the establishment of a tolerance for the combined residue of the fungicide 

pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-

yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite methyl-N-[[[1-(4-

chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate, expressed as parent compound, in or on the 

following raw agricultural commodities:

Artichoke, globe........................................3.0 ppm

Endive, Belgium........................................3.0 ppm

Persimmon...............................................3.0 ppm

IR-4 has also proposed updating the existing crop groups to vegetable, bulb, group 3-07 at 0.9 

ppm; vegetable, fruiting, group 8-10 at 1.4 ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit, 

pome, group 11-10 at 1.5 ppm; oilseed, group 20 at 0.45 ppm; caneberry subgroup 13-07A at 4.0 

ppm; bushberry subgroup 13-07B at 4.0 ppm; small fruit, vine climbing subgroup (except fuzzy

kiwi) 13-07F at 2.0 ppm; and low growing berry subgroup 13-07G except cranberry at 1.2 ppm. 

IR-4 has also proposed removing tolerances for berry, group 13 at 4.0 ppm; fruit, citrus, group 10 

at 2.0 ppm; fruit, pome, group 11 at 1.5 ppm; grape at 2.0 ppm; strawberry at 1.2 ppm; vegetable, 

bulb, group 3 at 0.9 ppm; vegetable, fruiting, group 8 at 1.4 ppm; borage, seed at 0.45 ppm; 

castor oil plant, seed at 0.45 ppm; Chinese tallowtree, seed at 0.45 ppm; crambe, seed at 0.45 

ppm; cuphea, seed at 0.45 ppm; echium, seed at 0.45 ppm; euphorbia, seed at 0.45 ppm; evening 

primrose, seed at 0.45 ppm; flax seed at 045 ppm; gold of pleasure, seed at 0.45 ppm; hare’s ear 

mustard, seed at 0.45 ppm; jojoba, seed at 0.45 ppm; lesquerella, seed at 0.45 ppm; lunaria, seed 

at 0.45 ppm; meadowfoam, seed at 0.45 ppm; milkweed, seed at 0.45 ppm; mustard, seed at 0.45 

ppm; niger seed, seed at 0.45 ppm; oil radish, seed at 0.45 ppm; poppy, seed at 0.45 ppm; 

rapeseed, seed at 0.45 ppm; rose hip, seed at 0.45 ppm; safflower, seed at 0.45 ppm; stokes aster, 

seed ato 0.45 ppm; sunflower, seed at 0.45 ppm; sweet rocket, seed at 0.45 ppm; tallowwood, 

seed at 0.45 ppm; tea oil plant, seed ato 0.45 ppm; and vernonia, seed at 0.45 ppm. 

Tolerances have been established in 40 CFR §180.582 for residues of the fungicide 
Pyraclostrobin DP 410737

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pyraclostrobin, including its metabolites and degradates. Compliance with the tolerance levels is 

to be determined by measuring only the sum of pyraclostrobin (carbamic acid, [2-[[[1-(4-

chlorophenyl)-1H- pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy

metabolite (methyl N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), 

calculated as the stoichiometric equivalent of pyraclostrobin . The established tolerances for 

plant food commodities range from 0.02 ppm in/on wheat grain to 29 ppm in/on leafy vegetables, 

except Brassica. A Section 18 tolerance exists for Belgian endive. Tolerances for livestock

commodities are listed in 40 CFR §180.582 (a)(2) and are expressed in terms of the combined 

residues of the fungicide pyraclostrobin and its metabolites convertible to 1-(4-chlorophenyl)-

1H-pyrazol-3-ol and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent 

compound. The established tolerances for livestock commodities range from 0.1 to 1.5 ppm; no 

tolerances are established for poultry commodities. 

HED (D278044, Metabolism Assessment Review Committee (MARC), 10/09/01) has 

determined that for purposes of tolerance and dietary risk assessments, the residues of concern in 

plant and rotational crop commodities include pyraclostrobin and desmethoxy metabolite (BF 

500-3). The residues of concern in livestock commodities include pyraclostrobin and its 

metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol (BF 500-5) and 1-(4-chloro-2-

hydroxyphenyl)-1H-pyrazol-3-ol (BF 500-8).

There are adequate residue analytical methods for tolerance enforcement. The analytical 

methods for plant commodities are liquid chromatography with tandem mass spectrometry

(LC/MS/MS) and high pressure liquid chromatography with ultraviolet detector (HPLC/UV),

which both measure pyraclostrobin and its desmethoxy metabolite. The analytical methods for 

livestock commodities, gas chromatography with mass spectrometry (GC/MS) and LC/MS/MS,

convert pyraclostrobin and related metabolites to chlorophenylpyrazolol (BF 500-5) and 

hydroxylated chlorophenylpyrazolol (BF 500-8) in goats and chlorophenylpyrazolol (BF 500-5) 

and a hydroxylated chlorophenylpyrazolol isomer of BF 500-8 (BF 500-9) in poultry. 

Samples (artichoke, persimmon, Belgium endive) were analyzed for pyraclostrobin and 

metabolite BF 500-3 using BASF Analytical Method Number D9908 (Version 2), "Method for 

Determining BAS 500 F, BF 500-3 and BAS 510 F Residues in Plant Matrices using 

LC/MS/MS." (MRID 4670001). The lower limit of method validation (LLMV) in this study was 

0.02 ppm for both pyraclostrobin and BF 500-3. The LC/MS/MS method used to determine 

residues of pyraclostrobin and BF 500-3 were adequately validated in conjunction with the field 

sample analyses. The average recovery of all pyraclostrobin and BF 500-3 fortifications was 

adequate. The method is adequate for data collection.

The requirements for multiresidue methods testing data are fulfilled. Pyraclostrobin was 

successfully evaluated through several of the FDA protocols (complete recovery through 

protocols D and E), while recovery of metabolite BF 500-3 was unsuccessful in all protocols.

Samples of artichoke from field trials were stored frozen for up to 21 months prior to analysis.

Samples of Belgium endive from field trials were stored frozen for up to 10 months. Samples of 

persimmon from field trials were stored frozen for up to 18.4 months. Adequate storage stability

data are available demonstrating that residues of pyraclostrobin and its metabolite BF 500-3 are 
Pyraclostrobin DP 410737

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stable under frozen conditions in/on the representative crop commodities of grape juice, sugar 

beet tops and roots, tomatoes, and wheat grain and straw for up to 25 months, and in peanut 

nutmeat and processed oil for up to 19 months (DP 269668, L. Cheng, 11/28/01). These data are 

adequate to support the storage conditions and durations of samples from the submitted field 

trials.

There are no feed commodities associated with persimmon, artichoke, or Belgium endive. 

Therefore, the livestock diets are not impacted, and the existing livestock commodity tolerances 

remain adequate.

IR-4 has submitted field trial data for three trials each for pyraclostrobin in persimmon, in 

Belgium endive, and in globe artichoke in the USA. At each persimmon and artichoke trial 

location, the treated plots received three foliar directed applications of a 12.8% WDG

formulation (Pristine®) of pyraclostrobin at 0.19 lb ai/A, for a total application rate of 0.55 lb 

ai/A. The retreatment interval was 6 – 8 days. Applications were made using ground equipment 

in spray volumes of 10-75 gal/acre for artichoke and 55 – 97 gal/acre for persimmon. Maturing 

commodities were present. No adjuvants were used. Samples of mature commodities were 

taken at a PHI of 0 days. For Belgium endive (witloof chicory), two applications were made

with a 12.8% WDG formulation (Pristine®) of pyraclostrobin. The first was a broadcast 

application to dormant chicory roots at a rate of 0.58 g ai/100 lbs of root. The second was a 

broadcast application to roots packed in forcing trays at budding stage at a rate of 0.092 g ai/ft2

or 8.8 lb ai/acre. The PHI was 17 - 19 days for the pre-forcing application.

Residues (and per trial averages) of pyraclostrobin, BF 500-3, and combined pyraclostrobin and 

BF 500-3 in/on artichoke flower heads harvested at a 0-day PHI were 0.514-1.110 (0.618-1.045), 

<0.02-0.056 (<0.02-0.056), and <0.534-1.166 (<0.638-1.101) ppm, respectively. Residues (and 

per trial averages) of pyraclostrobin, BF 500-3, and combined pyraclostrobin and BF 500-3 in/on 

persimmon fruit harvested at a 0-day PHI were 0.421-1.278 (0.092-1.155), <0.02-0.077 (<0.02-

0.073), and <0.103-1.355 (<0.112-1.228) ppm, respectively. Following a broadcast application 

of the 12.9% WDG formulation of pyraclostrobin to post-dormancy chicory roots in packing 

trays, applied just before forcing began, at 0.089-0.097 g ai/ft2(treatment 03), residues (and per 

trial averages) of pyraclostrobin and of combined pyraclostrobin and BF 500-3 in/on endive 

heads harvested at PHIs of 17-19-days were 0.1239-1.7620 (0.150-1.347) and <0.144-<1.782 

(<0.170-<1.367) ppm, respectively. Residues were lower from a combined treatment of a single 

broadcast application of the same formulation to dormant chicory roots at 0.584-0.591 g ai/100 lb 

of roots, followed by a broadcast application of the same formulation to post-dormancy chicory

roots in packing trays, applied just before forcing began at 0.092-0.101 g ai/ft2.

Analytical reference standards for pyraclostrobin and its regulated metabolites are available at the 

EPA National Pesticide Standards Repository. 

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

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

support the 14-day plant-back interval currently specified for crops without pyraclostrobin uses. 

No additional rotational crop data are required for purposes of this petition. 
Pyraclostrobin DP 410737

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Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for pyraclostrobin, and there are no residue 

chemistry deficiencies that would preclude granting Section 3 registration for the requested crop 

commodity uses of pyraclostrobin, or establishment of tolerances for residues of pyraclostrobin. 

It is recommended that a tolerance be established for residues of the fungicide pyraclostrobin, 

including its metabolites and degradates, in or on globe artichoke at 3.0 ppm, in or on persimmon 

at 3.0 ppm, and in or on Belgium endive at 4.0 ppm. Compliance with the tolerance levels is to 

be determined by measuring only the sum of pyraclostrobin (carbamic acid, [2-[[[1-(4-

chlorophenyl)-1H- pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy

metabolite (methyl N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl carbamate), 

calculated as the stoichiometric equivalent of pyraclostrobin. 

The proposed updating of certain existing crop groups and the removal of certain oilseed 

tolerances and certain previous crop group/subgroup tolerances are acceptable. However, an

additional oilseed tolerance will need to be removed, and IR-4 should request the following 

removal: cotton undelinted cotton seed (0.3 ppm). 

The Section 18 tolerance for Belgian endive should be removed concurrent with the 

establishment of the Section 3 tolerance for Belgium endive

See Table 7 for details of the recommendations. 

A human health risk assessment is forthcoming.

860.1200 Direction for Use

The proposed labels for Reg. No. 7969-199 (Pristine® fungicide), and 7969-187(Cabrio® EG 

fungicide) provide directions for use on the low growing berry subgroup. Cranberry must be 

removed from the list of crops. The title “low growing berry subgroup” should be changed to 

“low growing berry subgroup except cranberry.”

860.1550 Proposed Tolerances

The available data for Belgium endive will not support a tolerance level of 3.0 ppm. A revised 

Section F should be submitted with a tolerance for endive, Belgium at 4.0 ppm. The existing

tolerance for undelinted cottonseed seed should be removed as it is replaced by the proposed and 

recommended tolerance for oilseed group 20. See Table 7.

Background

Pyraclostrobin belongs to the strobilurin class of fungicides. Strobilurins are synthetic analogs of 

a natural antifungal substance which inhibits spore germination and mycelial growth and 

sporulation of the fungus on the leaf surface. The chemical structure and nomenclature of 

pyraclostrobin are presented in Table 1. The physicochemical properties of the technical grade of 

pyraclostrobin are presented in Table 2.
Pyraclostrobin DP 410737

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TABLE 1. Test Compound Nomenclature.

Compound

N

N

Cl

O

N O

H3C

O

OCH3

Common name Pyraclostrobin

Company experimental name BAS 500 F

IUPAC name methyl 2-[1-(4-chlorophenyl)pyrazol-3-yloxymethyl]-N-methoxycarbanilate

CAS name methyl N-[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]-Nmethoxycarbamate

CAS registry number 175013-18-0

End-use product (EP) Headline® EC Fungicide, EPA Reg. No. 7969-186.

Cabrio® EG fungicide, EPA Reg. No. 7969-187

Pristine® fungicide, EPA Reg. No. 7969-199

,Headline® SC fungicide, EPA Reg. No 7969-289

TABLE 2. Physicochemical Properties of Technical Grade Pyraclostrobin.

Parameter Value References1 (MRID)

Melting point/range 63.7-65.2oC 45118213

pH Not applicable

Density 1.367 g/cm345118214

Water solubility at 20 oC 1.9 ± 0.17 mg/L (deionized water, pH 5.8) 45118233

Solvent solubility n-heptane (0.37 g/100mL); 2-propanol (3.0 

g/100mL); 1-octanol (2.42 g/100mL); olive oil 

(2.80 g/100m/L); methanol (10.08 g/100mL); 

>50 g/100mL in acetone, ethyl acetate , 

acetonitrile, dichloromethane and toluene.

45118228

Vapor pressure 2.6 x 10-10 hPa at 20 oC 45118214

Dissociation constant, pKa None (no dissociable moieties)

Octanol/water partition coefficient, 

Log(KOW) at room temperature

3.990 mean log Pow; Pow is 9772 45118215

UV/visible absorption spectrum The structural identity of BAS 500 F was 

confirmed by NMR and MS spectra. UV 

molecular extinction (e [1 mol-1cm-1]): 2.5x104

at 205 nm; 2.4x104at 275 nm.

1996/109552

1

Product Chemistry data were reviewed by the Registration Division (DP# 269848 and DP# 274191, 5/3/01, 5/15/01, and 

6/7/01, S. Malak). 

2 BASF Document Number.

860.1200 Directions for Use
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Proposed supplemental labels were provided for end use products 7969-186 (Headline® 

Fungicide), 7969-187 (Cabrio® EG fungicide) , 7969-199 (Pristine® fungicide), and 7969-289 

(Headline® SC fungicide). Only Pristine® fungicide is proposed for use on globe artichoke, 

persimmon, and Belgium endive. The remaining labels are associated with crop group 

conversions.

Pristine® contains two active ingredients, pyraclostrobin and boscalid. Only pyraclostrobin is 

considered in this document; boscalid is being evaluated separately.

TABLE 3. Summary of Proposed Use Patterns of Pyraclostrobin.

Applic. Timing, 

Type, and 

Equip.

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

Globe Artichoke

Foliar with 

ground 

equipment, aerial

equipment, or 

sprinkler 

irrigation

12.8% 

Pristine® WG

7969-199

0.148- 0.184 3 0.55 0 Apply at 7-14 day intervals 

Belgium Endive

Root spray-

(1)Pre-cold 

storage

(2) Forcing

12.8% 

Pristine® WG

7969-199

(1) 0.0064 –

0.0128 lb 

ai/1000 lbs 

root

(2) 0.0072 –

0.0144 lb 

ai/70 square 

feet forcing 

tray

[4.4 – 8. 9 

lbs ai/acre]

1

0.0272 lb 

ai/1000 lbs 

root 

(approximate)

19

Make one application (1) to the roots 

when brought into cold storage prior to 

forcing. Apply in 3.0 to 3.5 gals of water 

per 1000 lbs. root. Make a second 

application (2) at the beginning of 

forcing after the roots have been packed 

into forcing trays. Apply in about 100 fl 

ozs water per 70 square feet of forcing 

tray. A 70 square feet forcing tray 

contains approximately 1000 lbs of 

roots.

Do not apply after the beginning of 

forcing.

Persimmon

Foliar with 

ground 

equipment, aerial 

equipment, or 

sprinkler 

irrigation

12.8% 

Pristine® WG

7969-199

0.148 –

0.184 3 0.55 0 Apply at 7-14 day intervals

The proposed labels end use products7969-186 (Headline® Fungicide), 7969-187(Cabrio® EG 

fungicide) , 7969-199 (Pristine® fungicide), and 7969-289 (Headline® SC fungicide) include 

changes for crop group/subgroup conversions. 

.

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

residue data relative to the proposed use pattern for persimmon, Belgium endive, and globe 

artichoke. The proposed label changes related to crop group/subgroup conversions are 

acceptable.
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860.1300 Nature of the Residue - Plants

HED MARC, DP# 278044, L. Cheng, 10/9/01 

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

Adequate metabolism studies with pyraclostrobin on grapes, potatoes, and wheat have been 

reviewed (D269668, 11/28/01, L. Cheng) in conjunction with PP#0F06139. The results of these 

studies indicate that the metabolism of pyraclostrobin is similar in the three crops investigated. 

The HED Metabolism Assessment Review Committee (MARC) discussed the results of these 

studies on 9/20/01, and concluded that the nature of the residue in plants is understood. For the 

purpose of tolerance and risk assessment, the terminal residues of concern in plants consist of 

pyraclostrobin and its desmethoxy metabolite (BF 500-3).

860.1300 Nature of the Residue – Livestock

HED MARC, DP# 278044, L. Cheng, 10/9/01 

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

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

poultry metabolism studies. In goat, the major residues are pyraclostrobin and BF 500-3 in 

muscle and fat; pyraclostrobin, BF 500-3, and BF 500-5 and its sulfate conjugate in milk; 

pyraclostrobin, BF 500-3, and BF 500-5 and its sulfate conjugate, and hydroxylated desmethoxy

metabolite (500M67) in kidney; and metabolites hydrolyzed to BF 500-5 and its hydroxylated 

compound (BF 500-8) in liver. In poultry, the major residues are pyraclostrobin and BF 500-3 in 

eggs; pyraclostrobin, BF 500-3, and hydroxylated BF 500-3 (500M64) in fat; and the glucuronic 

acid conjugate of hydroxylated BF 500-3 (500M32) in liver. Radioactive residues were below 

detection in muscle. The main degradation reactions in livestock consist of demethoxylation, 

hydroxylation, and conjugation, and breaking of the ether bond.

HED has determined that for the tolerance and risk assessment, the residues of concern in 

livestock commodities consist of pyraclostrobin and its metabolites convertible to 1-(4-

chlorophenyl)-1H-pyrazol-3-ol (BF 500-5) and 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol 

(BF 500-8).

860.1340 Residue Analytical Methods

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

PP#0F6139, DP# 269850, L. Cheng, 11/8/00

MRID: 48049201, W. Cutchin, in process

Enforcement: Two adequate methods are available for enforcement purposes for residues of 

pyraclostrobin and the metabolite BF 500-3 in/on plant commodities: an LC/MS/MS method 

(BASF Method D9908) and an HPLC/UV method (Method D9904). The validated method LOQ 

for both pyraclostrobin and BF 500-3 is 0.02 ppm in all tested plant matrices, for a combined 

LOQ of 0.04 ppm. Adequate independent method validation and radiovalidation data were 

submitted for both methods and forwarded to Analytical Chemistry Branch/Biological and 

EconomicAnalysis Division (ACB/BEAD) for a petition method validation.

Data Collection: Samples from field trial studies were analyzed for pyraclostrobin and its 

metabolite BF 500-3 using BASF Analytical Method Number D9908, "Method for Determining 
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BAS 500 F, BF 500-3 and BAS 510 F Residues in Plant Matrices using LC/MS/MS." Briefly, 

residues of pyraclostrobin and BF 500-3 were extracted from the commodity samples with a 

70:25:5 methanol/water/2 N HCI mixture. An aliquot of the extract was removed and cleaned by

liquid/liquid partition with cyclohexane and 1N HCl saturated with NaCl. An aliquot of the 

cyclohexane phase was taken, evaporated to dryness, and re-dissolved in a buffered 

methanol:water (80:20, v:v, each containing 0.1% formic acid and 4 mM ammonium formate)

for analysis by LC/MS/MS. The final chromatographic analysis of residues was determined by

MS/MS detection using the positive ionization mode monitored ion transitions from m/z 

388→194 for pyraclostrobin and m/z 358→164 for BF 500-3.

The LLMV in the studies was 0.02 ppm for each of pyraclostrobin and BF 500-3. Concurrent 

recovery experiments were conducted at spiking levels of 0.02 ppm and 2.0 ppm for each of 

pyraclostrobin and its metabolite BF-500-3. Concurrent recoveries from fortifications of 

artichoke ranged from 73 98% for pyraclostrobin and from 70 – 101% for BF-500-3. Concurrent 

recoveries from fortifications of Belgium endive ranged from 78 – 97% for pyraclostrboin and 

from 86 – 97% for BF-500-3. Concurrent recoveries from fortifications of persimmon ranged 

from 76 – 97% for pyraclostrobin and from 73 – 89% for BF-500-3. 

Conclusions: There are adequate residue analytical methods for tolerance enforcement and data 

collection.

860.1360 Multiresidue Methods

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

Pyraclostrobin was successfully evaluated through several of the FDA protocols, while recovery

of BF 500-3 was unsuccessful in all protocols. Pyraclostrobin was completely recovered through 

Protocol D (in grape) and E (in grape), and partially recovered through Protocol F (in peanut). 

Metabolite BF 500-3 had poor peak shape and inadequate sensitivity with Protocol C columns, 

and therefore, was not further analyzed under Protocol D, E, and F. The results of the 

multiresidue testing for pyraclostrobin were forwarded to FDA on 1/4/02 for the purpose of 

updating the Pesticide Analytical Manual, Volume I (PAM I).

860.1380 Storage Stability

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

Artichoke samples were stored frozen at <-5 °C from collection to extraction for 628-644 days 

(20.6-21.2 months). Samples were analyzed within 0-1 days of extraction. Belgium endive 

samples were stored frozen (generally <-5 °C) from collection to extraction for 290-304 days 

(9.5-10.0 months). Samples were analyzed within 0-2 days of extraction. Persimmon samples 

were stored frozen at <-5 °C from collection to extraction for 532-560 days (17.5-18.4 months). 

Samples were analyzed within 0-1 days of extraction Adequate storage stability data are 

available demonstrating that residues of pyraclostrobin and its metabolite BF 500-3 are stable 

under frozen conditions in/on fortified samples of grape juice, sugar beet tops and roots, 

tomatoes, and wheat grain and straw for up to 25 months, and in/on fortified samples of peanut 

nutmeat and processed oil for up to 19 months. It was concluded that the plant commodities 

chosen for the storage stability study were representative of all crops: an oilseed (peanut 

nutmeat), a non-oily grain (wheat grain), a leafy vegetable (sugar beet tops), a root crop (sugar 
Pyraclostrobin DP 410737

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beet roots), a fruit/fruiting vegetable (tomatoes), a dry feed (wheat straw), and processed oil 

(peanut) and juice (grape) commodities (DP#s 269668 etc., L. Cheng, 11/28/01). These data are 

adequate to support the storage conditions and durations of samples from the submitted field 

trials.

Conclusions: These data are adequate to support the storage conditions and durations of samples 

from the artichoke, persimmon, and Belgium endive studies. No correction to residue values for 

loss during storage are necessary.

860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the current petitions as there are no aquatic uses 

being proposed for pyraclostrobin.

860.1460 Food Handling

This guideline requirement is not relevant to the current petitions as there are no food-handling 

uses being proposed for pyraclostrobin.

860.1480 Meat, Milk, Poultry, and Eggs

There are no feed items associated with the requested new uses (artichoke, Belgium endive, 

persimmon). The replacement of individual oilseed tolerances with the oil seed crop group 20 

tolerance effectively raises the tolerance of undelinted cotton seed from 0.3 to 0.45 ppm. This 

will have no effect on the calculated diets of livestock, which are based on high residues from the 

field trials and processing studies. Therefore, no new considerations are required for residues in 

meat, milk, poultry, and eggs.

860.1500 Crop Field Trials

MRIDs: 48897401 - 48897403

Artichoke, Globe

A total of 3 crop field trials on artichoke (globe) were conducted in the United States during the 

2006 growing season in the North American Free Trade Agreement (NAFTA) Growing Zone 10 

(CA). Each trial consisted of one untreated (control) plot and one treated plot. At each trial 

location, the treated plots received three foliar directed applications of the 12.8% WDG 

formulation of pyraclostrobin (Pristine®) during the producing growth stage at rates of 0.178-

0.188 lb ai/A/application (0.199-0.211 kg ai/ha/application), for total seasonal rates of 0.549-

0.562 lb ai/A (0.615-0.630 kg ai/ha). Retreatment intervals (RTIs) were 6-8 days. Applications 

were made using backpack sprayers, with CO2 as the propellant, in spray volumes of 10-75 gal/A 

of water (94-702 L/ha), without any adjuvant. Samples of mature artichoke buds were harvested 

after the spray had dried following the final application, reflecting a PHI of 0 days. 

Following three foliar directed applications of the 12.8% WDG formulation of pyraclostrobin at 

total rates of 0.549-0.562 lb ai/A, residues (and per trial averages) of pyraclostrobin, BF 500-3, 

and combined pyraclostrobin and BF 500-3 in/on artichoke flower heads harvested at a 0-day
Pyraclostrobin DP 410737

Page 11 of 22

PHI were 0.514-1.110 (0.618-1.045), <0.02-0.056 (<0.02-0.056), and <0.534-1.166 (<0.638-

1.101) ppm, respectively. 

Results are summarized in Table 4. 

TABLE 4. Summary of Residue Data from Globe Artichoke Crop Field Trials with Pyraclostrobin.

Commodity Total Applic. 

Rate

(lb ai/A)

[kg ai/ha]

PHI 

(days)

Analyte Residue Levels1

(ppm)

n

Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Artichoke 

Flower 

Head

0.549-0.562

(0.615-0.630) 0

Pyraclostrobin 3 0.514 1.110 0.618 1.045 0.759 0.807 0.218

BF 500-3 3 <0.02 0.056 <0.02 0.056 <0.028 <0.035 0.019

Combined 3 <0.534 1.166 <0.638 1.101 <0.787 <0.842 0.236

1

 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and 

standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3.

2

 LAFT = lowest average field trial; HAFT = highest average field trial.

Conclusions: 

The number and geographic distribution of the trials are adequate. The analytical method was 

demonstrated to be acceptable via concurrent recoveries of fortified control samples. The 

intervals of frozen storage of samples are covered by previous storage stability studies, and no 

corrections for loss of residue are needed. The trials were conducted according to the proposed 

label for the WG formulation (single and seasonal application rates, PHI). The results of the 

field trials are acceptable for estimation of an artichoke tolerance and for dietary risk assessment 

purposes.

Belgium endive (witloof chicory)

A total of 3 crop field trials on endive were conducted in the United States during the 2008 

growing season in NAFTA Growing Zone 10 (CA). 

Endive is not grown in plots; all treatments occurred indoors. The production of Belgium endive 

requires the growing of a crop of chicory plants in the field, harvesting the roots, and placing the 

chicory roots in cold storage to break dormancy, which can occur in as little as one week. After 

dormancy is broken, the roots are packed in a tray standing vertically, and the tray is placed in a 

forcing room, which is dark, cool and moist. Belgium endive heads then develop on the roots 

within approximately 17 to 19 days.

Each trial for this study consisted of one untreated (control) group (treatment 01) and three 

separate treatment groups (treatments 02, 03, and 04). Broadcast spray applications were made 

in two different ways. In Treatment 02, dormant roots (before being placed into cold storage) 

were sprayed as they passed by the sprayer on a conveyer belt. For this treatment, the rate of 

application was reported as the amount of product applied per pound of roots. In Treatment 03, 

roots were sprayed after they had been broken from dormancy, removed from cold storage, and 

packed vertically into forcing trays. After they were sprayed, they were placed into a forcing 

room. For this treatment, the rate of application was reported as the amount of product applied 
Pyraclostrobin DP 410737

Page 12 of 22

per ft2of sprayed trays. Treatment 04 was a combination of the treatment 02 and 03 scenarios. 

All applications were made using a 12.9% water dispersible granule (WDG) formulation of 

pyraclostrobin (Pristine®). Samples of mature endive heads were harvested at preharvest 

intervals (PHIs) of 25-27 days for treatment 02 and of 17-19 days for treatments 03 and 04. 

Following a single broadcast application of a 12.9% WDG formulation of pyraclostrobin to 

dormant chicory roots at 0.578-0.597 g ai/100 lb of roots (treatment 02), residues (and per trial 

averages) of pyraclostrobin and of combined pyraclostrobin and BF 500-3 in/on endive heads 

harvested at PHIs of 25-27-days were <0.02-0.0679 (<0.023-0.059) and <0.04-<0.088 (<0.043-

<0.079) ppm, respectively. Following a broadcast application of the same formulation to postdormancy chicory roots in packing trays, applied just before forcing began, at 0.089-0.097 g ai/ft2

(treatment 03), residues (and per trial averages) of pyraclostrobin and of combined pyraclostrobin 

and BF 500-3 in/on endive heads harvested at PHIs of 17-19-days were 0.1239-1.7620 (0.150-

1.347) and <0.144-<1.782 (<0.170-<1.367) ppm, respectively. Following the combined 

treatment (treatment 04) of a single broadcast application of the same formulation to dormant 

chicory roots at 0.584-0.591 g ai/100 lb of roots, followed by a broadcast application of the same 

formulation to post-dormancy chicory roots in packing trays, applied just before forcing began, at 

0.092-0.101 g ai/ft2, residues (and per trial averages) of pyraclostrobin and of combined 

pyraclostrobin and BF 500-3 in/on endive heads harvested at PHIs of 17-19-days were 0.2250-

0.8710 (0.256-0.771) and <0.245-<0.891 (<0.276-<0.791) ppm, respectively. No residues of 

metabolite BF 500-3 were found at or above the LLMV (0.02 ppm) in/on endive heads harvested 

following any of the three treatments. 

The results are summarized in Table 5.
Pyraclostrobin DP 410737

Page 13 of 22

TABLE 5 Summary of Residue Data from Belgium Endive Crop Field Trials with Pyraclostrobin.

Commodity Rate1 PHI 

(days) Analyte

Residue Levels2

(ppm)

n

Sample

Min.

Sample

Max. LAFT3 HAFT3 Median Mean Std. Dev.

Treatment 02: One pre-cold-storage application to roots

Belgium

endive 

heads

0.578-0.597 g 

ai/100 lb of 

roots

25-27

Pyraclostrobin 3 <0.02 0.0679 <0.023 0.059 <0.040 <0.041 0.018

BF 500-3 3 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 N/A

Combined 3 <0.04 <0.088 <0.043 <0.079 <0.06 <0.061 0.018

Treatment 03: One pre-forcing application to roots in packing tray

Belgium

endive 

heads

0.089-0.097 g 

ai/ft2 17-19

Pyraclostrobin 3 0.1239 1.7620 0.150 1.347 0.900 0.799 0.605

BF 500-3 3 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 N/A

Combined 3 <0.144 <1.782 <0.170 <1.367 <0.920 0.819 0.605

Treatment 04: One pre-cold-storage application to roots + One pre-forcing application to roots in packing tray

Belgium

endive 

heads

0.584-0.591 g 

ai/100 lb of 

roots and3

0.092-0.101 g 

ai/ft2

17-19

Pyraclostrobin 3 0.2250 0.8710 0.256 0.771 0.551 0.526 0.258

BF 500-3 3 <0.02 <0.02 <0.02 <0.02 <0.02 <0.02 N/A

Combined 3 <0.245 <0.891 <0.276 <0.791 <0.571 <0.546 0.258

1

 Rate for pyraclostrobin, as calculated by the study reviewer based on the certificate of analysis of applied product in the study 

report.

2

 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and 

standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3. N/A = Not Applicable.

3

 LAFT = lowest average field trial; HAFT = highest average field trial.

Conclusions: 

The number and geographic distribution of the trials are adequate. The analytical method was 

demonstrated to be acceptable via concurrent recoveries of fortified control samples. The 

intervals of frozen storage of samples are covered by previous storage stability studies, and no 

corrections for loss of residue are needed. The trials were conducted according to the proposed 

label for the WG formulation (single and seasonal application rates, PHI). The trials were preforcing stage treatment only (treatment 3) yielded commodities with higher residues than the 

combined pre-cold storage treatment and pre-forcing stage treatment (treatment 4). The results 

of the field trials are acceptable for estimation of a Belgium endive tolerance and for dietary risk 

assessment purposes.

Persimmon

A total of 3 crop field trials on persimmon were conducted in the United States during the 2006 

growing season in North American Free Trade Agreement (NAFTA) Growing Zones 3 (FL), 10 

(CA), and 13 (HI).

Each trial consisted of one untreated (control) plot and one treated plot. At each trial location, 

the treated plots received three foliar directed applications of the 12.8% water dispersible granule 

(WDG) formulation of pyraclostrobin (Pristine®) during the fruiting stage at rates of 0.185-0.199 

lb ai/A/application (0.207-0.223 kg ai/ha/application), for total seasonal rates of 0.564-0.573 lb 
Pyraclostrobin DP 410737

Page 14 of 22

ai/A (0.632-0.642 kg ai/ha). Retreatment intervals (RTIs) were 7-8 days. Applications were 

made using a backpack sprayer, a tractor-mounted sprayer, or a Mistblower sprayer in spray

volumes of 55-97 gal/A of water (514-907 L/ha), without any adjuvant. Samples of 

commercially mature persimmon fruit were harvested after the spray had dried following the 

final application, reflecting a preharvest interval (PHI) of 0 days. 

Following three foliar directed applications of the 12.8% WDG formulation of pyraclostrobin at 

total rates of 0.564-0.573 lb ai/A, residues (and per trial averages) of pyraclostrobin, BF 500-3, 

and combined pyraclostrobin and BF 500-3 in/on persimmon fruit harvested at a 0-day PHI were 

0.421-1.278 (0.092-1.155), <0.02-0.077 (<0.02-0.073), and <0.103-1.355 (<0.112-1.228) ppm, 

respectively. There was no residue decline study.

Results are summarized in Table 6.

TABLE 6. Summary of Residue Data from Persimmon Crop Field Trials with Pyraclostrobin.

Commodity Total Applic. 

Rate

(lb ai/A)

[kg ai/ha]

PHI 

(days)

Analyte Residue Levels1

(ppm)

n

Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Persimmon 

Fruit

0.564-0.573

(0.632-0.642)

0

Pyraclostrobin 3 0.421 1.278 0.092 1.155 0.437 0.561 0.542

BF 500-3 3 <0.02 0.077 <0.02 0.073 <0.02 <0.038 0.031

Combined 3 <0.103 1.355 <0.112 1.228 <0.457 <0.599 0.571

1

 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and 

standard deviation, the LLMV (0.02 ppm) was used for any results reported as <LLMV in Table C.3. N/A = Not Applicable.

2

 LAFT = lowest average field trial; HAFT = highest average field trial.

Conclusions: 

The number and geographic distribution of the trials are adequate. The analytical method was 

demonstrated to be acceptable via concurrent recoveries of fortified control samples. The 

intervals of frozen storage of samples are covered by previous storage stability studies, and no 

corrections for loss of residue are needed. The trials were conducted according to the proposed 

label for the WG formulation (single and seasonal application rates, PHI). The results of the 

field trials are acceptable for estimation of a persimmon tolerance and for dietary risk assessment 

purposes.

860.1520 Processed Food and Feed

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

MRID 48237401

No processing studies were submitted. None are necessary for persimmon, globe 

artichoke, or Belgium endive (witloof chicory).

860.1650 Submittal of Analytical Reference Standards

Analytical standards for pyraclostrobin and regulated metabolites (BF 500-3; BF 500-5; BF 500-

8) are currently available in the EPA National Pesticide Standards Repository (e-mail 

correspondence with T. Cole, 01/14/2013). 
Pyraclostrobin DP 410737

Page 15 of 22

860.1850 Confined Accumulation in Rotational Crops

MARC, DP# 278044, L. Cheng, 10/9/01

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

An adequate confined rotational crop study was reviewed in PP#0F6139. The study showed that 

the metabolism of pyraclostrobin in rotated crops is similar but more extensive than that in 

primary crops. Pyraclostrobin undergoes demethoxylation to yield BF 500-3, followed by further 

degradation to medium polar and polar metabolites, and subsequent conjugation reactions and 

incorporation into natural products. The HED MARC has determined that the residues of 

concern in rotational crops consist of pyraclostrobin and metabolite BF 500-3.

860.1900 Field Accumulation in Rotational Crops

PP#0F6139, DP# 269668, L. Cheng, 11/28/01

A limited field rotational crop study was reviewed in PP#0F6139. The results indicate that 

residues of pyraclostrobin and its metabolite BF 500-3 were each less than the method LOQ 

(<0.02 ppm) in/on rotational crop matrices (radish, roots and tops; cabbage, with and without 

wrapper leaves; and wheat forage, hay, and grain) planted 14 days following the last of six 

sequential foliar applications to the primary crop, cucumbers, of the 2 lb/gal EC formulation at 

0.19 - 0.20 lb ai/A/application. Residues of pyraclostrobin in/on one sample of wheat straw from 

the CA test site were at the LOQ (0.02 ppm), but residues of pyraclostrobin in/on a replicate 

sample from the same plot were below the LOQ (0.012 ppm) for an average residue of <0.02 

ppm. Residues of metabolite BF 500-3 were nondetectable (<0.02 ppm) in/on all samples of 

wheat straw.

The registered pyraclostrobin end-use product labels presently specify a 14-day plantback 

interval restriction for all crops that are not registered. 

860.1550 Proposed Tolerances
Pyraclostrobin DP 410737

Page 16 of 22

For the use of pyraclostrobin on globe artichoke, Belgium endive, and persimmon, tolerances are 

required. Based on evaluation of the field trial data with the Organization of Economic 

Cooperation and Development (OECD) tolerance calculation procedure (Appendix I), the 

tolerances listed in Table 7 are appropriate.

Codex MRLs have been established for pyraclostrobin in/on globe artichoke at 2 ppm. The 

recommended US tolerance is 3 ppm. Residue definitions are different in the US and in Codex, 

and the US tolerance is based on application of the OECD calculation procedure to the validated 

field trial data. The tolerance cannot be lowered to the Codex level as this could result in 

apparent violations for crops treated in accordance with the label. Canada does not have 

pyraclostrobin tolerances for globe artichoke, Belgium endive, or persimmon. Therefore, there is 

no issue of harmonization with Canada.

Several crop group conversions were requested. Most were crop group updates. One request was 

to replace individual oilseed tolerances with an oilseed crop group 20 tolerance. This was 

accompanied by a request to remove numerous individual commodity oilseed tolerances. These 

changes have been made to the proposed labels. In addition to the requested removals, the 

tolerance for cotton undelinted seed will be replaced by oilseed, group 20, and IR-4 needs to 

make this request. The tolerance covering undelinted cotton seed is raised from 0.3 ppm to 0.45 

ppm. This is acceptable as cottonseed is one of the three representative commodities for the 

oilseed group (cottonseed, rapeseed, sunflower), and the highest estimate from the three 

commodities is adopted for the group. The changes are acceptable, as detailed in Table 7.

Table 7 Tolerance Summary for Pyraclostrobin.

Commodity Proposed/Existing

Tolerance (ppm)

Recommended/ 

Harmonized

Tolerance (ppm)

Comments; Correct Commodity 

Definition

40CFR§180.582(a) It is recommended that a tolerance be established for residues of the fungicide pyraclostrobin, 

including its metabolites and degradates, as indicated below. . Compliance with the tolerance levels is to be 

determined by measuring only the sum of pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H- pyrazol-3-

yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl N-[[[1-(4-chlorophenyl)-1Hpyrazol-3-yl]oxy]methyl]phenyl carbamate), calculated as the stoichiometric equivalent of pyraclostrobin 

Artichoke, globe 3.0 3.0

Endive, Belgium 3.0 4.0 OECD statistical calculation 

estimates 4.0 ppm.

Persimmon 3.0 3.0

Vegetable, bulb, group 3-07 0.9 0.9 Group update

Vegetable, bulb, group 3 0.9 Remove Group update

Vegetable, fruiting, group 8-10 1.4 1.4 Group update

Vegetable, fruiting, group 8 1.4 Remove Group update

Fruit, citrus, group 10-10 2.0 2.0 Group update

Fruit, citrus, group 10 2.0 Remove Group update

Fruit, pome, group 11-10 1.5 1.5 Group update

Fruit, pome, group 11 1.5 Remove Group update

Oilseed group 20 0.45 0.45 Group creation.
Pyraclostrobin DP 410737

Page 17 of 22

Table 7 Tolerance Summary for Pyraclostrobin.

Commodity Proposed/Existing

Tolerance (ppm)

Recommended/ 

Harmonized

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Cotton, undelinted seed 0.3 Remove To be replaced by oilseed, group 

20. IR-4 needs to request this 

removal.

Borage, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Castor oil plant, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Chinese tallowtree, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Crambe, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Cuphea, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Echium, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Euphorbia, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Evening primrose, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Flax, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Gold of pleasure, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Hare's ear mustard, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Jojoba, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Lesquerella, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Lunaria, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Meadowfoam, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Milkweed, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Mustard, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Niger seed, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Oil radish, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Poppy, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Rapeseed, seed 0.45 Remove To be replaced by oilseed, group 

20. 
Pyraclostrobin DP 410737

Page 18 of 22

Table 7 Tolerance Summary for Pyraclostrobin.

Commodity Proposed/Existing

Tolerance (ppm)

Recommended/ 

Harmonized

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Rose hip, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Safflower, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Stokes aster, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Sunflower, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Sweet rocket, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Tallowwood, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Tea oil plant, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Vernonia, seed 0.45 Remove To be replaced by oilseed, group 

20. 

Caneberry subgroup 13-07A 4.0 4.0 Group update

Bushberry subgroup 13-07B 4.0 4.0 Group update

Small fruit, vine climbing 

subgroup (except fuzzy kiwi)

13-07F

2.0 2.0 Group update

Low growing berry subgroup 

13-07G except cranberry

1.2 1.2 Group update

Berry, group 13 4.0 Remove Group update. Replaced with 

subgroups 13-07A and 13-07B

Grape 2.0 Remove Group update. Replaced with 

subgroup 13-07F

Strawberry 1.2 Remove Group update. Replaced with 

subgroup 13-07G

40CFR§180.582(b) Section 18 emergency exemptions

Endive, Belgian 11.0 Remove Replaced with Section 3 

tolerance for endive, Belgium

References

DP#s: 367409

Subject: Pyraclostrobin. Petition for New Uses and Tolerances on Alfalfa. Summary of 

Analytical Chemistry and Residue Data.

From: W. Cutchin

To: T. Kish/J. Bazuin

Dated: 10/19/09

MRIDs: 47584401
Pyraclostrobin DP 410737

Page 19 of 22

DP#s: 281042, 286732, 287729, 288459, 290342, 290343, 290369, 292440, 293088, 

293684, 295893, 298178

Subject: Pyraclostrobin. PP#3F06581, 2F06431, 2E6473, 3E6548, 3E6553, 3E6774, and 

2F06139. Petitions for the establishment of permanent tolerances to allow uses on 

corn (field, sweet, and pop), hops, mint, pome fruits, edible-podded legume 

vegetables, succulent peas, sunflower, Brassica leafy greens, soybeans, succulent 

beans, broccoli, cabbage, lettuce (head and leaf), spinach, celery, turnip greens, 

and the import commodities mango and papaya. Application for amended Section 

3 registration for citrus (reduced PHI). Petitioner’s response to data deficiencies 

identified in PP#0F06139 regarding storage stability data, dried shelled peas and 

beans (reduced PHI), and uses on dry and succulent peas. Summary of Analytical 

Chemistry and Residue Data.

From: L. Cheng

To: C. Giles-Parker/J. Bazuin

Dated: 7/26/04

MRIDs: 45596211, 45623406, 45623407, 45623408, 45623410, 45645801, 45645802, 

45645803, 45645804, 45702901, 45765401, 45832001, 45858801, 45858802, 

45903601, 45903602, 46033901-04, 46084401-04, 46109101, 46109102

DP#s: 269668, 272771, 272789, 274095, 274192, 274471, 274957, 275843, and 278429

Subject: PP#0F06139. Pyraclostrobin on Various Crops: Bananas (import), Barley, 

Berries, Bulb Vegetables, Citrus Fruits, Cucurbit Vegetables, Dried Shelled Pea & 

Bean (except Soybean), Fruiting Vegetables, Grapes, Grass, Peanut, Pistachio, 

Root Vegetables (except Sugar Beet), Rye, Snap Beans, Stone Fruits, Strawberry, 

Sugar Beet, Tree Nuts, Tuberous and Corm Vegetables, and Wheat. Review of 

Analytical Methods and Residue Data. 

From: L. Cheng

To: C. Giles-Parker/J. Bazuin

Dated: 11/28/01

MRIDs: 45118428-451184-37, 45118501-45118512, 45118514-45118537, 45118601-

45118625, 45160501, 45272801, 45274901, 45321101, 45367501, 45399401, and 

45429901

DP#: 278044

Subject: PP# 0F06139. PC Code 099100. Pyraclostrobin. Outcome of the HED 

Metabolism Assessment Review Committee (MARC) Meeting Held on 

September 20, 2001.

From: L. Cheng

To: Y. Donovan

Dated: 10/09/01

MRIDs: None
Pyraclostrobin DP 410737

Page 20 of 22

DP#: 269850

Subject: PP# 0F06139. Pyraclostrobin (BAS 500F) in or on Various Crops. Request for 

Tolerance Method Validation (TMV) Trial.

From: L. Cheng

To: F. D. Griffith, Jr.

Dated: 11/8/00

MRIDs: 45118505, 45118504, 45118509, 45118510, 45118501, 45118503, 45118507, 

45118514

DP#: 281042, 286732, 287729, 288459, 290342, 290343, 290369, 292440, 293088, 

293684, 295893, 298178

Subject: Pyraclostrobin. PP#3F06581, 2F06431, 2E6473, 3E6548, 3E6553, 3E6774, and 

2F06139. Petitions for the establishment of permanent tolerances to allow uses on 

corn (field, sweet, and pop), hops, mint, pome fruits, edible-podded legume 

vegetables, succulent peas, sunflower, Brassica leafy greens, soybeans, succulent 

beans, broccoli, cabbage, lettuce (head and leaf), spinach, celery, turnip greens, 

and the import commodities mango and papaya. Application for amended Section 

3 registration for citrus (reduced PHI). Petitioner’s response to data deficiencies 

identified in PP#0F06139 regarding storage stability data, dried shelled peas and 

beans (reduced PHI), and uses on dry and succulent peas. Summary of Analytical 

Chemistry and Residue Data.

From: L. Cheng

To: Cynthia Giles-Parker

Dated: 7/26/04

MRIDs: 45596211, 45623406, 45623407, 45623408, 45623410, 45645801, 45645802, 45645803, 

45645804, 45702901, 45765401, 45832001, 45858801, 45858802, 45903601, 45903602, 

46033901-04, 46084401-04, 46109101, 46109102 
Pyraclostrobin DP 410737

Page 21 of 22

International Residue Limits

Pyraclostrobin (099100; 02/19/2013)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

40 CFR §180.582. Plants: Tolerances are 

established for residues of the fungicide 

pyraclostrobin, including its metabolites and 

degradates. Compliance with the tolerance levels 

is to be determined by measuring on the sum of 

pyraclostrobin (carbamic acid, [2-[[[1-(4-

chlorophenyl)-1H- pyrazol-3-

yl]oxy]methyl]phenyl]methoxy-, methyl ester) and 

its desmethoxy metabolite (methyl N-[[[1-(4-

chlorophenyl)-1H-pyrazol-3-

yl]oxy]methyl]phenyl carbamate), calculated as 

the stoichiometric equivalent of pyraclostrobin

methyl [2-

[[[1-(4-

chlorophen

yl)-1Hpyrazol-3-

yl]oxy]met

hyl]phenyl]

methoxycar

bamate, 

including 

the 

metabolite 

[2-[[[1-(4-

chlorophen

yl)-1Hpyrazol-3-

yl]oxy]met

hyl]phenyl]

carbamate

- Pyraclostrobin. Residue is NOT fat soluble.

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

US Canada Mexico2 Codex3

Artichoke, globe 3.0 None 2. 

Belgium endive

(witloof chicory)

4.0 None None

Persimmon 3.0 None None

1

Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and 

not those proposed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = 

processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the 

fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.
Pyraclostrobin DP 410737

Page 22 of 22

Appendix I: Determination of Tolerance for Pyraclostrobin in/on Sugarcane and Its 

Processed Fractions

The Organization for Economic Cooperation and Development statistical procedure was used to 

calculate tolerances for artichoke, Belgium endive, and persimmon. The estimates agree with 

the proposals of IR-4 for persimmon and artichoke. For Belgium endive, the IR-4 tolerance 

estimate is 3.0 ppm from application before cold storage and again at pre-forcing. However, the 

single application at pre-forcing yielded higher residues, and these data were used to derive the 

tolerance estimate of 4.0 ppm. The average combined residue of pyraclostrobin and BF 500-3 

from each trial (n = 3)was used as the calculator entry value. 

Compound

Crop

Region / Country

GAP

Total number of data (n)

Percentage of censored data

Number of non-censored data

Lowest residue

Highest residue

Median residue

Mean

Standard deviation (SD)

Correction factor for censoring (CF)

Proposed MRL estimate

- Highest residue

- Mean + 4 SD

- CF x 3 Mean

Unrounded MRL

Rounded MRL

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.638 0.920 0.112

1.101 0.170 1.228

0.787 1.367 0.457

3

0%

Pyraclostrobin

Persimmon

Pyraclostrobin

Artichoke

USA

3X0.19 ll ai/A, 0 d

USA

3X0.19 ll ai/A, 0 d

3

0.638

1.101

0.787

0.842

0.236

2.526

3

High uncertainty of 

MRL estimate due to 

small dataset.

1.000

1.101

1.787

2.526

0.170

1.367

0.920

0.819

0.605

1.000

1.367

3.238

2.457

3.238

4

High uncertainty of 

MRL estimate due to 

small dataset.

3

0.112

3

0%

1.228

0.457

0.599

0.571

1.000

1.228

2.885

1.797

2.885

3

High uncertainty of 

MRL estimate due to 

small dataset.

3

Pyraclostrobin

Belgium Endive

USA

0.6 g ai/100 lbs root + 0.1 lb ai/ft2

3

0%