Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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Samples were analyzed using adequate analytical methods and the sample storage intervals are 

supported by the available storage stability data. Adequate storage stability data are available 

indicating that residues of propiconazole are stable at ≤-15 C from 4-39 months in a variety of

commodities, including corn commodities.

The submitted processing studies are adequate in providing a determination of residue 

concentration factors for propiconazole in citrus processed commodities. Processing of the 

orange RAC bearing quantifiable residues indicate that levels of propiconazole are reduced in 

juice (<0.01x), slightly concentrate in citrus dried pulp (1.4x) and concentrate in citrus oil

(185x). These data, along with the Highest Average Field Trial (HAFT) residue, indicate that a 

tolerance is needed for propiconazole in citrus oil at 1000 ppm with no tolerances being required 

for the other citrus processed commodities. 

Adequate confined rotational crop studies are available indicating that the residues in rotational 

crops are similar to the primary crops. The confined studies also support the 105-day plant-back 

interval (PBI) currently listed on product labels for crops without direct uses. Currently,

propiconazole tolerances for inadvertent residues in/on alfalfa forage and hay at 0.1 ppm.

Residue Chemistry Deficiencies

The Interregional Research Project No. 4 (IR-4) has submitted a request to add additional uses of 

propiconazole using Tilt (EPA Reg. No. 100-617), Tilt 45W (EPA Reg. No. 100-780), Quilt® 

(EPA Reg. No. 100-1178) and QuiltXcelTM (EPA Reg. No. 100-1324).

Conclusion: No deficiencies were noted in this request that would preclude granting these 

proposed uses.

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for propiconazole. Pending submission of a 

revised Section F (see requirements below) and a revised Section B (PHI must be changed to 7 

days for succulent beans) , there are no residue chemistry issues that would preclude granting an 

unconditional registration for the requested uses of propiconazole on snap beans, succulent 

shelled beans, dry beans, citrus fruit, tomato, stone fruit, and plum or establishment of tolerances 

for residues of propiconazole in/on the following commodities as follow:

Bean, snap.......................................................................... 0.70 ppm

Bean, succulent shelled...................................................... 0.10 ppm

Legume, foliage .................................................................... 30 ppm

Bean, dry seed.................................................................... 0.40 ppm

Tomato ................................................................................. 3.0 ppm

Fruit, citrus, group 10-10 ..................................................... 8.0 ppm

Fruit, stone, group 12, except plum ..................................... 4.0 ppm

Plum................................................................................... 0.60 ppm

Citrus oil............................................................................ 1000 ppm

A human health risk assessment is forthcoming.
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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860.1550 Proposed Tolerances

The proposed tolerances for snap bean, succulent shelled beans, stone fruit group 12 

except plum, and plum must be reduced to 0.70 ppm, 0.10 ppm, 4.0 ppm, and 0.60 ppm, 

respectively.

The proposed tolerances for foliage of legume vegetables and tomato must be increased

to 30 ppm and 3.0 ppm, respectively.

A tolerance for citrus oil must be proposed at 1000 ppm.
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Background

Propiconazole is a triazole-type fungicide (Group 3) that provides broad spectrum disease control 

through inhibition of sterol biosynthesis in fungi. It is registered to Syngenta for the control of 

fungal diseases on a variety of crops. It is formulated as emulsifiable concentrates under the 

trade names Quilt® (EPA Reg. No. 100-1178) and QuiltXcelTM (EPA Reg. No. 100-1324). 

These formulations also contain a co-ingredient, i.e., azoxystrobin. However, this memo will 

only address propiconazole.

Permanent tolerances are currently established for the combined residues of propiconazole, 1-

[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole, and its 

metabolites determined as 2,4-DCBA and expressed in parent equivalents, at levels ranging from 

0.1 ppm on numerous plant commodities to 40 ppm in/on grass straw [40 CFR §180.434(a)]. 

Permanent tolerances are also established for the combined residues of propiconazole and its 

metabolites determined as 2,4-DCBA at 0.1 ppm in fat, meat, and meat byproducts (except liver 

and kidney) of livestock, 2.0 ppm in liver and kidney of livestock, and at 0.05 ppm in milk; 

however, no tolerances have been established for eggs and poultry commodities. Time-limited 

tolerances are established for combined propiconazole residues in/on a variety of plant 

commodities at level of 2.0 ppm in/on nectarine and peach [40 CFR §180.434(b)]. In addition, 

tolerances with regional restrictions have been established for combined propiconazole residues 

at 1.0 ppm in/on cranberry and at 0.5 in/on wild rice grain[40 CFR §180.434(c)]. Tolerances 

with inadvertent residues have been established for combined propiconazole residues at 0.1 ppm 

in/on alfalfa forage and alfalfa hay.

Table 1. Nomenclature of Propiconazole

Compound

N

N N

O

O

Cl

Cl

Common name Propiconazole

Company experimental names CGA-64250

IUPAC name 1-[2-(2,4_dichlorophenyl)-4-propyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4_triazole

CAS name 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole

CAS # 60207-90-1

End-use products/EP 3.6 lb/gal EC (EPA Reg. Nos. 100-617 
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Table 2. Physicochemical Properties of Technical Grade Propiconazole.

Parameter Value Reference

Boiling point 120 C at 1.9 Pa, >250 C at 101.325 kPa MRID No. 43698701

pH 4.9 at 25 C (1% aqueous dispersion) MRID No. 43698701

Density 1.289 g/cm3at 20 C MRID No. 43698701

Water solubility 0.10 g/L at 20 C MRID No. 41720301

Solvent solubility (temperature not specified)

Completely miscible in ethanol, acetone, 

toluene and n-octanol. hexane = 47 g/L MRID No. 42030201

Vapor pressure 4.2 x 10-7 mm Hg at 25 C MRID No. 41720301

Dissociation constant (pKa) 1.09 MRID No. 43698701

Octanol/water partition coefficient Log(KOW) 3.72 at pH 6.6 and 25 C MRID No. 43698701

UV/visible absorption spectrum ( max, nm) Data needed MRID No. 40583703

860.1200 Directions for use

Several current end-use product containing propiconazole that is registered for use on feed/food 

crops is marketed under the trade names Tilt® Fungicide (EPA Reg. No. 100-617), Tilt® 45W 

Fungicide (EPA Reg. No. 100-780), Quilt® (EPA Reg. No. 100-1178) and QuiltXcelTM (EPA 

Reg. No. 100-1324) (See Table 3.). 
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Table 3. Summary of Proposed Directions for Use of Propiconazole.

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

Beans, Dry and Succulent

Postemergence

Broadcast foliar

Ground or 

aerial 

1.04 lb/gal 

Quilt

EC

[100-1178]

3.6 lb/gal

Tilt

EC

[100-617]

1.02 lb/gal 

Quilt Xcel

EC

[100-1324]

0.114

0.113

0.084-0.112

3

3

3

0.34

0.34

0.34

7

7

7

A minimum retreatment 

interval (RTI) of 7 days is 

proposed. Contains 

azoxystrobin also. Not 

for use on cowpea 

cultivars intended for 

livestock feeding.

A minimum retreatment 

interval (RTI) of 7 days is 

proposed.

A minimum retreatment 

interval (RTI) of 7 days is 

proposed. Contains 

azoxystrobin also. Not 

for use on cowpea 

cultivars intended for 

livestock feeding.

Citrus Post-Harvest

In-Line 

Dip/Drench

Inline Aqueous 

or Fruit Coating 

Spray 

Application

45% WSP

[100-780]

0.225-0.45 

lb ai/100gal

0.225-0.45 

lb ai/ 

250,000 lb 

fruit

2

2

NS

NS

NS

NS

Dip for a minimum of 30 

seconds and allow to 

drain.

Use T-jet, CDA, or 

similar application 

system.

Tomato Post-Harvest
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Table 3. Summary of Proposed Directions for Use of Propiconazole.

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

Stone Fruit Post-Harvest

In-Line 

Dip/Drench

Inline Aqueous 

or Fruit Coating 

Spray 

Application 

45% WSP

[100-780]

0.007-

0.11 lb 

ai/100gal

0.007-

0.11 lb ai/ 

250,000 

lb fruit

1

1

NS

NS

NS

NS

Dip for a minimum of 30 

seconds and allow to 

drain.

Use T-jet, CDA, or 

similar application 

system.

860.1300 Nature of the Residue – Plants.

The nature of propiconazole residues in plants is adequately understood (DP D329394, Y. 

Donovan, 6/15/06). These data indicate that the major metabolic pathway in plants appears to 

involve hydroxylation of the n-propyl group on the dioxolane ring of the cis/trans isomers of 

propiconazole, with subsequent conjugation to sugars. A possible alternative pathway involves 

reductive deketalization of the dioxolane ring and sugar conjugation of the resulting metabolite. 

The alkyl bridge between the phenyl and triazole rings is metabolized and free 1H-1,2,4-triazole 

is released. The free triazole is readily conjugated with the amino acid, serine/alanine, forming 

triazole aniline which is further metabolized to triazole acetic acid possibly through the 

intermediate formation of triazole lactic acid. 

HED has concluded that the residues of concern should include propiconazole and all its 

metabolites containing the 2,4-DCBA moiety, including conjugates for dietary risk assessment of 

food, as virtually all the residue data have been generated using a common moiety method that 

converts parent and all of the metabolites of concern to 2,4-DCBA. The tolerance expression 

should also be amended to include only propiconazole per se because 1) there are a number of 

pesticides that have 2,4-DCBA as common metabolite, and an enforcement agency may not be 

able to determine if residues are due to misuse of propiconazole or the proper use of other 

pesticides containing 2,4-DCBA; 2) propiconazole per se can be detected by FDA multiresidue 

methods; and 3) inclusion of only parent allows harmonization with the residue definition for the 

Codex MRLs. 

860.1300 Nature of the Residue – Livestock.

The nature of propiconazole residues in livestock is adequately understood based on acceptable 

goat and poultry metabolism studies (DP D329394, Y. Donovan, 6/15/06). The Agency 

concluded that parent and all metabolites convertible to 2,4-DCBA are residues of concern for 

risk assessment, as the analytical method is a common moiety method that detects all residues 
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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convertible to 2,4-DCBA. However, for tolerance enforcement purposes, the current tolerance 

expression should be amended to include only propiconazole per se.

860.1340 Residue Analytical Methods.

Snap bean, lima bean, and dry bean samples were analyzed for residues of propiconazole using 

gas chromatography with mass selective detection (GC/MSD) and its triazole metabolites 1,2,4-

triazole (T), triazole alanine (TA), and triazole acetic acid (TAA) using High Pressure Liquid 

Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS); modified Novartis Crop 

Protection Analytical Method AG-626 and Morse Laboratories, Inc. Analytical Method No. 160 

Revision 2, respectively. The limit of quantitation (LOQ; determined as the lowest limit of 

method validation, LLMV) was 0.05 ppm for propiconazole, 0.01 ppm for T and TAA, and 0.03 

ppm for TA.

Samples of tomatoes were analyzed for residues of propiconazole and total propiconazole (as 

2,4-DCBA, expressed as propiconazole equivalents) using a LC-MS/MS method modified from 

Morse Labs Analytical Method Meth-180 and a GC/MSD method modified from Novartis Crop 

Protection Analytical Method AG-626, respectively.

Samples of citrus (RAC) and its processed fractions (juice, dried pulp, and oil) were analyzed for 

residues of propiconazole using a LC-MS/MS method modified from Syngenta Analytical 

Method REM 130.11, entitled “Residue Analytical Method for the Determination of Residues of 

Propiconazole (CGA 64250) in Crop Samples. Final Determination by LC-MS/MS”. 

Samples of stone fruit were analyzed for residues of propiconazole (as propiconazole) and 

propiconazole (as 2,4-DCBA expressed as propiconazole equivalents) using a LC-MS/MS 

method modified from Morse Labs Analytical Method Meth-180 and a GC method modified 

from Novartis Crop Protection Analytical Method AG-626, respectively, and for residues of 

propiconazole triazole metabolites T, TA, and TAA using a method modified from Morse 

Laboratories, Inc. Analytical Method No. 160 Revision 2. 

GLN 860.1360: Multiresidue Methods

The FDA PESTDATA database (PAM Volume I, Appendix I) indicates that propiconazole is 

completely recovered (>80%) using Multiresidue Methods Section 302. The recovery of 

propiconazole metabolites CGA-91305, CGA-118244, and 1,2,4-triazole is variable using 

Section 302. Propiconazole and metabolites CGA-91305, CGA-118244, and 1,2,4-triazole are 

not recovered using Multiresidue Methods Sections 303 and 304.

860.1380 Storage Stability.

Snap bean samples were stored for up to 1704 days, lima beans for up to 1396 days, dry beans 

for up to 338 days, tomato for up to 138 days, citrus for up to 184 days, and stone fruit for up to 

217 days for the analysis of propiconazole residues. Adequate storage stability data are available 

indicating that residues of propiconazole and its metabolites determined as 2,4-DCBA are stable 

at ≤-15 C for up to 39 months in a variety of commodities. (D329394, Y. Donovan, 6/15/06). 
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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860.1400 Water, Fish, and Irrigated Crops

This guideline requirement is not relevant to the proposed use for propiconazole.

860.1460 Food Handling

This guideline requirement is not relevant to the proposed use for propiconazole. 

860.1480 Meat, Milk, Poultry, and Eggs

Note: This previous dietary burden (See Y. Donovan, D238458, Table 4 below) assessment was 

presented using Table 1 data published in 1996 (OPPTS 180.860.1000). The maximum 

theoretical dietary burdens (MTDB) for combined propiconazole residues were calculated to be 

29.0 ppm for beef and 18.5ppm for dairy cattle, 2.3 ppm for swine and 2.0 ppm for poultry. 

HED has issued a memo entitled, “Revisions of Feedstuffs in Table 1 of OPPTS Test Guideline 

860.1000 and Guidance on Constructing Maximum Reasonably Balanced Diets (MRBD)” in 

June 30, 2008 which includes revised definitions for the Table 1 reference animals, and 

refinement of feedstuffs availabilities and percentages fed. The livestock dietary burdens 

calculated by the revised guidelines are 9.8 ppm for beef and 18.5ppm for dairy cattle, 1.9 ppm 

for swine and 2.2 ppm for poultry. 
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Table 4. Calculation of Maximum Dietary Burdens of Livestock for Propiconazole 

Residues.

Feed Commodity % Dry Matter 1 % Diet 1

Current or Recommended 

Tolerance (ppm)

Dietary Contribution 

(ppm)2

Beef Cattle

Grass, hay [R] 88 15 40 6.8

Corn field, grain [CC] 88 80 0.3 0.27

Aspirated grain fractions [CC] 85 5 45 2.65

Soybean seed [PC] 89 5 2.0 0.11

TOTAL 100 9.8

Dairy Cattle

Grass, hay [R} 88 30 40 13.6

Corn, field, stover [R] 83 15 25.0 4.52

Corn, field, grain [CC] 88 45 0.3 0.15

Soybean seed [PC] 89 10 2.0 0.22

TOTAL 100 18.5

Poultry

Wheat grain [CC] 89 55 0.5 0.28

Rice, grain [CC] 88 20 7.0 1.4

Soybean, seed [PC] 89 25 2.0 0.50

TOTAL 100 2.2

Swine

Corn field, grain [CC] 88 65 0.3 0.20

Rice, grain [CC] 88 20 7.0 1.4

Soybean, seed [PC] 89 15 2.0 0.30

TOTAL 100 1.9

1

 Table 1 (OPPTS Guideline 860.1000). 

2

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

swine.

NA = not applicable.
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860.1500 Crop Field Trials (48438201, 48438202, 48438203, 48438204, 48438205, & 48438206.der.doc)

Field trials have submitted supporting the new uses for propiconazole. The results from these 

studies are discussed in the appropriate data evaluation report (DER) and summarized in the 

following tables. 

TABLE C.4.1 Summary of Residue Data from Snap Bean Crop Field Trials with Propiconazole.

Commodity Analyte Total App. 

Rate

(lb ai/A)

PHI

(days)

Residue Levels (ppm)1

n Sample 

Min.

Sample 

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Snap beans Propiconazole 0.3370-0.350946-8 7 0.0866 0.390 0.0883 0.375 0.230 0.222 0.115

T 7 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A3

TA 7 0.0408 0.180 0.0414 0.166 0.0853 0.0945 0.0463

TAA 7 <0.01 0.0127 0.01 0.0121 0.0100 0.0106 0.0009

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 LOQ (0.05 ppm for propiconazole, 0.01 ppm for T and TAA, and 0.03 ppm for TA) was used for any 

results reported as <LOQ in Table C.3.

2

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

3 N/A = Not applicable.

4 Three applications of approximately 0.11 lb ai/A.

TABLE C.4.2 Summary of Residue Data from Lima Bean Crop Field Trials with Propiconazole.

Commodity Analyte Total App. 

Rate

(lb ai/A)

PHI

(days)

Residue Levels (ppm)1

n Sample 

Min.

Sample 

Max.

LAFT2 HAFT2 Median Mean Std. Dev.

Seed Propiconazole 0.3327-0.574446-8 5 <0.05 0.0878 0.05 0.0723 0.05 0.0545 0.010

T 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A3

TA 5 0.134 0.870 0.147 0.833 0.282 0.376 0.267

TAA 5 <0.01 0.0106 0.01 0.0104 0.01 0.0101 0.0002

Foliage Propiconazole 0.3327-0.5744 6-8 5 1.83 12.8 3.36 12.4 6.29 6.67 3.73

T 5 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

3

TA 5 <0.01 0.138 <0.01 0.0108 0.0159 0.0409 0.0466

TAA 5 <0.01 0.0291 0.0108 0.0264 0.0143 0.0171 0.0068

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 LOQ (0.05 ppm for propiconazole, 0.01 ppm for T and TAA, and 0.02 ppm for TA) was used for any 

results reported as <LOQ in Table C.3.

2

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

3 N/A = Not applicable.

4 Three applications of approximately 0.11 lb ai/A.
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TABLE C.4.3 Summary of Residue Data from Dry Bean Crop Field Trials with Propiconazole.

Commodity Analyte Total App. 

Rate

(lb ai/A)

PHI

(days)

Residue Levels (ppm)1

n Sample 

Min.

Sample 

Max.

LAFT2 HAFT2 Median Mean Std. Dev.

Dry bean 

seed

Propiconazole 0.3285-0.364145-8 12 <0.05 0.253 0.05 0.248 0.0796 0.0985 0.0593

T 12 <0.01 <0.01 0.01 0.01 0.01 0.01 N/A3

TA 12 <0.04 0.233 0.04 0.226 0.111 0.115 0.065

TAA 12 <0.01 <0.01 0.01 0.01 0.01 0.01 N/A3

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 LOQ (0.05 ppm for propiconazole, 0.01 ppm for T and TAA, and 0.04 ppm for TA) was used for any 

results reported as <LOQ in Table C.3.

2

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

3 N/A = Not applicable.

4 Three applications of approximately 0.11 lb ai/A.

TABLE C.4.4 Summary of Residue Data from Tomato Crop Field Trials with Propiconazole.

Commodity Treatment 

Type

Analyte Total 

App. 

Rate

lb a.i./

100 gal

DAA Residue Levels (ppm)1

n Sample 

Min.

Sample 

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Tomatoes (large and small)

Tomato Dip Propiconazole 

Only

0.2242-

0.2249

0 6 0.412 1.12 0.469 1.12 0.676 0.702 0.254

Drench 0.2246-

0.2249

0 3 0.394 1.50 0.457 1.38 0.865 0.901 0.463

Spray 0.2250-

0.22563

0 3 0.324 1.53 0.366 1.47 0.743 0.860 0.561

Tomato Dip Total 

Propiconazole 

(as 2,4-

DCBA, 

expressed as 

propiconazole

equivalents)

0.2242-

0.2249

0 6 0.331 1.23 0.423 1.13 0.602 0.679 0.259

Drench 0.2246-

0.2249

0 3 0.331 1.52 0.379 1.44 1.04 0.953 0.536

Spray 0.2250-

0.22563

0 3 0.284 1.76 0.324 1.51 0.715 0.850 0.604

1

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

2

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

3 The application rate was lb propiconazole/50,000 lb fruit.

4 N/A = Not applicable.
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TABLE C.4.5 Summary of Residue Data from Citrus Crop Field Trials with Propiconazole.

Commodity

Treatment 

Type

Analyte Total 

App. 

Rate

lb a.i./

100 gal5

DAA Residue Levels (ppm)1

n Sample 

Min.

Sample 

Max.

LAFT2 HAFT2 Median Mean Std. 

Dev.

Orange Dip Propiconazole 0.80405-

0.80743

0 8 0.77 5.66 0.87 4.91 2.425 2.79 1.20

Spray 0.81752-

0.827613

0 4 1.03 2.32 1.08 2.28 1.23 1.46 0.56

Grapefruit Dip Propiconazole 0.80405-

0.80768

0 2 0.90 1.44 0.92 1.31 1.12 1.12 0.28

Spray 0.8243730 1 1.19 1.41 1.30 1.30 N/A4 N/A N/A

Lemon Dip Propiconazole 0.80405 0 2 1.92 3.19 2.11 2.99 2.55 2.55 0.62

Spray 0.82131-

0.826223

0 2 0.92 1.14 0.93 1.12 1.03 1.03 0.13

1

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

2

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

3 The application rate was lb propiconazole/250,000 lb fruit.

4 N/A = Not applicable.

5 Two applications of approximately 0.4 lb ai/100 gal.

TABLE C.4.6. Summary of Residue Data for Propiconazole (as Propiconazole and as 2,4-DCBA) from Stone 

Fruit Crop Field Trials with Propiconazole.

Commodity Analyte1 Total App. 

Rate1 

DAA Residue Levels (ppm)2

n Sample 

Min.

Sample 

Max.

LAFT3 HAFT3 Median Mean Std. 

Dev.

TRT 02 (Peach High-Volume Spray)

Peach, Fruit Propiconazole 0.11415-0.11861 0 2 0.14 0.20 0.14 0.20 0.17 0.17 0.04

Propiconazole 

(as, 2,4-DCBA)

2 0.13 0.33 0.13 0.33 0.23 0.23 0.14

TRT 03 (Peach Low-Volume Spray)

Peach, Fruit Propiconazole 0.11365-0.11445 0 2 0.43 0.56 0.49 0.50 0.50 0.50 0.01

Propiconazole 

(as, 2,4-DCBA)

2 0.42 0.43 0.42 0.43 0.43 0.43 0.01

TRT 04 (Peach Dip)

Peach, Fruit Propiconazole 0.11252-0.11285 0 4 1.16 2.17 1.17 2.11 1.54 1.59 0.42

Propiconazole 

(as, 2,4-DCBA)

4 0.73 2.52 0.73 2.52 1.68 1.65 0.89

TRT 05 (Plum Low-Volume Spray)

Plum, Fruit Propiconazole 0.11384-0.11596 0 2 0.15 0.20 0.16 0.19 0.18 0.18 0.02

Propiconazole 

(as, 2,4-DCBA)

2 0.13 0.40 0.13 0.40 0.27 0.27 0.19

TRT 06 (Plum Dip)

Plum, Fruit Propiconazole 0.11265 0 2 0.16 0.22 0.18 0.20 0.19 0.19 0.01

Propiconazole 

(as, 2,4-DCBA)

2 0.11 0.13 0.11 0.13 0.12 0.12 0.01
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TABLE C.4.6. Summary of Residue Data for Propiconazole (as Propiconazole and as 2,4-DCBA) from Stone 

Fruit Crop Field Trials with Propiconazole.

Commodity Analyte1 Total App. 

Rate1 

DAA Residue Levels (ppm)2

n Sample 

Min.

Sample 

Max.

LAFT3 HAFT3 Median Mean Std. 

Dev.

TRT 07 (Cherry Dip)

Cherry, 

Fruit

Propiconazole 0.11244-0.11265 0 2 0.65 1.00 0.67 0.85 0.76 0.76 0.13

Propiconazole 

(as, 2,4-DCBA)

2 0.78 2.23 0.78 2.23 1.51 1.51 1.03

TRT 07 (Cherry High-Volume Spray)

Cherry, 

Fruit

Propiconazole 0.11208 0 1 0.16 0.17 0.17 0.17 0.17 0.17 N/A

Propiconazole 

(as, 2,4-DCBA)

1 0.24 0.24 0.24 0.24 0.24 0.24 N/A

1

Spray application rate = lb ai/200,000 lb fruit for peach and plum and lb ai/25,000 lb fruit for cherry for the packing-line 

treatment applications and lb ai/100 gal water for the dip treatment applications. 

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 LOQ (0.05 ppm for all analytes) was used for any results reported as <LOQ in Table C.3. N/A = Not 

applicable.

3

 LAFT = lowest-average-field-trial; HAFT = highest-average-field-trial.
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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TABLE C.4.7. Summary of Residue Data for Triazole Metabolites from Stone Fruit Crop Field Trials with 

Propiconazole.

Commodity Analyte Total App. 

Rate1 

DAA Residue Levels (ppm)2

n Sample 

Min.

Sample 

Max.

LAFT3 HAFT3 Median Mean Std. 

Dev.

TRT 02 (Peach High-Volume Spray)

Peach, Fruit T 0.11415-0.11861 0 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TA 2 0.06 0.06 0.06 0.06 0.06 0.06 0.00

TAA 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TRT 03 (Peach Low-Volume Spray)

Peach, Fruit T 0.11365-0.11445 0 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TA 2 0.06 0.09 0.07 0.08 0.08 0.08 0.01

TAA 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TRT 04 (Peach Dip)

Peach, Fruit T 0.11252-0.11285 0 4 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TA 4 0.07 1.94 0.08 1.83 0.13 0.54 0.86

TAA 4 <0.05 0.17 0.05 0.16 0.05 0.08 0.06

TRT 05 (Plum Low-Volume Spray)

Plum, Fruit T 0.11384-0.11596 0 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TA 2 <0.05 0.09 0.05 0.08 0.07 0.07 0.02

TAA 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TRT 06 (Plum Dip)

Plum, Fruit T 0.11265 0 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TA 2 <0.05 0.08 0.05 0.08 0.07 0.07 0.02

TAA 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TRT 07 (Cherry Dip)

Cherry, 

Fruit

T 0.11244-0.11265 0 2 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TA 2 0.10 0.59 0.12 0.47 0.30 0.30 0.25

TAA 2 0.05 0.08 0.05 0.07 0.06 0.06 0.01

TRT 07 (Cherry High-Volume Spray)

Cherry, 

Fruit

T 0.11208 0 1 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TA 1 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

TAA 1 <0.05 <0.05 0.05 0.05 0.05 0.05 N/A

1

Spray application rate = lb ai/200,000 lb fruit for peach and plum and lb ai/25,000 lb fruit for cherry for the packing-line 

treatment applications and lb ai/100 gal water for the dip treatment applications. 

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 LOQ (0.05 ppm for all analytes) was used for any results reported as <LOQ in Table C.3. N/A = Not 

applicable.

3

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

Conclusions: The available field trial data are adequate and support the proposed use patterns 

for propiconazole on dry beans, snap beans, succulent shelled beans, and postharvest use on 

citrus fruit, stone fruit and tomato. The number and typical geographical regions for the field 

trials are adequate and the appropriate samples were collected at a PHI of 6-8 days. With regard 

to lima bean field trial number, six field trials are required however, only five were submitted 

due to two field trials being from the same area. The PHI for succulent beans must be changed 

to 7 days since residue data were collected at this PHI. 
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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860.1520 Processed Food and Feed 48438205.der.doc

The submitted citrus processing study is acceptable. Processing of the orange RAC with 

quantifiable residues of propiconazole resulted in the concentration of residues in dried pulp 

(1.4x processing factor) and oil (185x processing factor), but not in juice (<0.01x processing 

factor). The observed concentration factors were less than the theoretical concentration factors.

TABLE C.5. Residue Data from Citrus Processing Study with Propiconazole.

RAC Processed Commodity Total Rate

(lb a.i./250,000 lb fruit) 

DAA Propiconazole

Residues 

(ppm)

Processing 

Factor1

Orange Fruit (RAC) 0.40844 0 0.94 --

Juice <0.01 <0.01x

Dried pulp 1.29 1.4x

Oil 174 185x

1 Processing Factor = [Measured residue for analyte in the processed fraction] / [Measured residue for analyte in the RAC].

The observed processing factors for juice and oil are less than the theoretical concentration 

factors, based on separation into components, of 2x for juice and 1000x for oil (OPPTS 

860.1520, Table 3).

Conclusions: The citrus processing results acquired in this study are adequate for satisfying 

these data requirements. It produced sufficient data at the 1x application rate which is reflective 

of the proposed treatment program for evaluating the potential concentration of residues. These 

results indicate that propiconazole residues do not appear to concentrate in citrus juice, but do so 

in oil at a processing factor of 185x. Based on the HAFT residue for oranges (4.91 ppm) and the 

processing factor, expected residues are 908 ppm in citrus oil. A citrus oil tolerance of 1000

ppm is therefore concluded to be appropriate with no limits being recommended for its other 

processed commodities. 

860.1650 Submittal of Analytical Reference Standards

An analytical reference standard for propiconazole is available at the EPA National Pesticide 

Standards Repository.

860.1850/860.1900 Confined and Field Accumulation in Rotational Crops

The nature of the residue in confined rotational crops is understood (D329394, Y. Donovan, 

6/15/06). Based on acceptable studies previously reviewed by EFED, the metabolism of 

propiconazole in rotational crops is similar to that in primary crops. Plant-back restrictions have 

been established for propiconazole products registered for use on rotational crops based on the 

confined rotational crop studies. Labels specify that any food/feed crops not listed on the label 

should not be planted within 105 days of treatment. Tolerances for inadvertent residues of 

propiconazole in/on alfalfa planted in rotation with propiconazole-treated crops have been 

established at 0.1 ppm for alfalfa forage and hay. 
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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860.1550 Proposed Tolerances

Permanent tolerances are currently established for the combined residues of propiconazole and 

its 2,4-DCBA containing metabolites at levels ranging from 0.1-40 ppm in/on plant commodities 

[40 CFR §180.434(a)]. Permanent tolerances are also established for the combined residues of 

propiconazole and its 2,4-DCBA containing metabolites at 0.1 ppm in fat, meat, and meat 

byproducts (except liver and kidney) of livestock, 2.0 ppm in liver and kidney of livestock, and 

at 0.05 ppm in milk; however, no tolerances have been established for eggs and poultry 

commodities. However, HED has determined that the current tolerance expression for plant and 

livestock commodities is not appropriate and has previously recommended that the tolerance 

expression be revised to include only parent.

The Codex Alimentarius Commission has established several maximum residue limits (MRLs) 

for propiconazole in/on various raw agricultural commodities. The Codex MRLs are expressed 

in terms of propiconazole per se, which is the same as the US tolerance expression, 

recommended by the RED for existing tolerances and for the new uses. In addition, both Canada 

and Mexico have established MRLs/tolerances on several commodities which also have U.S. 

tolerances. To the extent possible, U.S. tolerances have been harmonized with Codex, Canadian, 

and Mexican MRLs. 

Adequate crop field trial data reflecting the proposed use patterns were submitted for purposes of 

establishing tolerances. The Organization for Economic Cooperation and Development 

tolerance calculation procedures were utilized in determining the appropriate tolerance level for 

the requested new uses.

References

DP Barcode: D329394

Subject: Propiconazole (122101): Reregistration Eligibility Decision (RED) Document; 

Revised Residue Chemistry Considerations.

From: Y. Donovan

To: M. Goodis and C. Scheltema

Dated: 6/15/06

MRID(s): None

RDI: T. Morton(2/16/2012); S. Hummel (2/16/2012) & E. Reaves (2/16/2012)

Petition Number: 1E7855

DP Barcode(s): 389670

PC Code: 122101
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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Attachment 1: Organization for Economic Cooperation and Development tolerance calculation 

procedures

Propiconazole

Snap Beans

US

6-8 day PHI

Total number of data (n) 7

Percentage of censored data 0%

Number of non-censored data 7

Lowest residue 0.088

Highest residue 0.375

Median residue 0.230

Mean 0.222

Standard deviation (SD) 0.115

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.375

- Mean + 4 SD 0.683

- CF x 3 Mean 0.667

Unrounded MRL 0.683

Rounded MRL 0.7

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.0883 1

0.11 1

0.135 1

0.23 1

0.269 1

0.348 1

0.375 1
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Propiconazole

Lima Bean

US

6-8 day PHI

Total number of data (n) 5

Percentage of censored data 80%

Number of non-censored data 1

Lowest residue 0.050

Highest residue 0.072

Median residue 0.050

Mean 0.054

Standard deviation (SD) 0.010

Correction factor for censoring (CF) 0.467

Proposed MRL estimate

- Highest residue 0.072

- Mean + 4 SD 0.094

- CF x 3 Mean 0.076

Unrounded MRL 0.094

Rounded MRL 0.1

High uncertainty of MRL estimate.

[Small dataset and high level of censoring]

Residues (mg/kg) n

< 0.05 4

0.0723 1
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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Propiconazole

Bean Foliage

US

6-8 day PHI

Total number of data (n) 5

Percentage of censored data 0%

Number of non-censored data 5

Lowest residue 3.360

Highest residue 12.400

Median residue 6.290

Mean 6.674

Standard deviation (SD) 3.727

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 12.400

- Mean + 4 SD 21.582

- CF x 3 Mean 20.022

Unrounded MRL 21.582

Rounded MRL 30

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

3.36 1

3.47 1

6.29 1

7.85 1

12.4 1
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Propiconazole

Dry Beans

US

7-8 day PHI

Total number of data (n) 12

Percentage of censored data 25%

Number of non-censored data 9

Lowest residue 0.050

Highest residue 0.248

Median residue 0.080

Mean 0.099

Standard deviation (SD) 0.059

Correction factor for censoring (CF) 0.833

Proposed MRL estimate

- Highest residue 0.248

- Mean + 4 SD 0.336

- CF x 3 Mean 0.246

Unrounded MRL 0.336

Rounded MRL 0.4

Residues (mg/kg) n

< 0.05 3

0.053 1

0.0612 1

0.0677 1

0.0915 1

0.101 1

0.128 2

0.154 1

0.248 1
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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Propiconazole

Tomato

US

Post Harvest

Total number of data (n) 12

Percentage of censored data 0%

Number of non-censored data 12

Lowest residue 0.366

Highest residue 1.470

Median residue 0.769

Mean 0.791

Standard deviation (SD) 0.366

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 1.470

- Mean + 4 SD 2.257

- CF x 3 Mean 2.374

Unrounded MRL 2.374

Rounded MRL 3

Residues (mg/kg) n

0.366 1

0.457 1

0.469 1

0.472 1

0.557 1

0.743 1

0.795 1

0.801 1

0.865 1

1.12 1

1.38 1

1.47 1
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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Propiconazole

Orange

US

Post Harvest

Total number of data (n) 12

Percentage of censored data 0%

Number of non-censored data 12

Lowest residue 0.870

Highest residue 4.910

Median residue 2.310

Mean 2.343

Standard deviation (SD) 1.198

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 4.910

- Mean + 4 SD 7.133

- CF x 3 Mean 7.028

Unrounded MRL 7.133

Rounded MRL 8

Residues (mg/kg) n

0.87 1

1.08 1

1.11 1

1.35 1

2.25 1

2.28 1

2.34 1

2.39 1

2.46 1

3.38 1

3.69 1

4.91 1
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Propiconazole

Grapefruit

US

Post Harvest

Total number of data (n) 3

Percentage of censored data 0%

Number of non-censored data 3

Lowest residue 0.920

Highest residue 1.310

Median residue 1.300

Mean 1.177

Standard deviation (SD) 0.222

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 1.310

- Mean + 4 SD 2.066

- CF x 3 Mean 3.530

Unrounded MRL 3.530

Rounded MRL 4

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.92 1

1.3 1

1.31 1
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Propiconazole

Lemon

US

Post Harvest

Total number of data (n) 4

Percentage of censored data 0%

Number of non-censored data 4

Lowest residue 0.930

Highest residue 2.990

Median residue 1.615

Mean 1.788

Standard deviation (SD) 0.954

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 2.990

- Mean + 4 SD 5.604

- CF x 3 Mean 5.363

Unrounded MRL 5.604

Rounded MRL 6

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.93 1

1.12 1

2.11 1

2.99 1
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Propiconazole

Peach

US

Post harvest

Total number of data (n) 8

Percentage of censored data 0%

Number of non-censored data 8

Lowest residue 0.140

Highest residue 2.110

Median residue 0.835

Mean 0.961

Standard deviation (SD) 0.736

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 2.110

- Mean + 4 SD 3.906

- CF x 3 Mean 2.884

Unrounded MRL 3.906

Rounded MRL 4

Residues (mg/kg) n

0.14 1

0.2 1

0.49 1

0.5 1

1.17 1

1.35 1

1.73 1

2.11 1
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Propiconazole

Plum

US

Post Harvest

Total number of data (n) 4

Percentage of censored data 0%

Number of non-censored data 4

Lowest residue 0.160

Highest residue 0.200

Median residue 0.185

Mean 0.183

Standard deviation (SD) 0.017

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.200

- Mean + 4 SD 0.251

- CF x 3 Mean 0.548

Unrounded MRL 0.548

Rounded MRL 0.6

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.16 1

0.18 1

0.19 1

0.2 1
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Propiconazole

Cherry

US

Post Harvest

Total number of data (n) 3

Percentage of censored data 0%

Number of non-censored data 3

Lowest residue 0.170

Highest residue 0.850

Median residue 0.670

Mean 0.563

Standard deviation (SD) 0.352

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.850

- Mean + 4 SD 1.973

- CF x 3 Mean 1.690

Unrounded MRL 1.973

Rounded MRL 2

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.17 1

0.67 1

0.85 1
Propiconazole 122101 Summary of Analytical Chemistry and Residue Data DP# 389670

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Attachment 2: International Residue Limits 

Propiconazole (122101; 12/8/2011)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico1 Codex2

40 CFR 180.434:

Plant: propiconazole per se

Livestock: propiconazole per se

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

US Canada Mexico1 Codex

Bean, snap 0.70 

Bean, succulent shelled 0.10 

Legume, foliage 30

Bean, dry seed 0.40

Tomato 3.0 

Fruit, citrus, group 10-10 8.0 

Fruit, stone, group 12, except 

plum

4.0 

Plum 0.60

Completed: 

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

2

* = 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.