Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

MEMORANDUM

Date: May 3, 2012

SUBJECT: Cyprodinil. Amended Use. Expansions of Existing Crop Group/Representative 

Commodity Uses to Numerous Crop Subgroups, Adding Use on Leafy Petiole 

Subgroup 4B, and Adding Use on the Remaining Crops in Fruiting Vegetables 

Group 8-10. Summary of Analytical Chemistry and Residue Data.

PC Code: 288202 DP Barcode: 389554 & 391680

Decision No.: 447576 & 448809 Registration Nos.: 100-828, 100-953, and 100-1317

Petition No.: 1E7854 & 1E7869 Regulatory Action: Amended Section 3

Risk Assessment Type: NA Case No.: 7025

TXR No.: NA CAS No.: 121552-61-2

MRID No.: 48437401 – 05; 48478501 40 CFR: 180.532

 

FROM: Thurston G. Morton, Chemist

Risk Assessment Branch 4

Health Effects Division (7509P)

THROUGH: Susan V. Hummel, Chemist, Senior Scientist

Elissa Reaves, PhD., Branch Chief

Risk Assessment Branch 4

Health Effects Division (7509P)

TO: Rebecca Daiss, Risk Assessor

Risk Assessment Branch 4

Health Effects Division (7509P)

and

Lisa Jones/Shaja Joyner, RM20

Fungicide Branch

Registration Division (7505P)
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

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Executive Summary

Under PP#1E7854, Interregional Research Project No. 4 (hereafter referred to as IR-4), on behalf 

of the Agricultural Experiment Stations, is requesting the establishment of tolerances for residues 

of cyprodinil [4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamin] in/on the following raw 

agricultural commodities:

Onion, bulb subgroup 3-07A..... ..............................................0.6 ppm

Onion, green subgroup 3-07B...................................................4.0 ppm

Caneberry subgroup 13-07A........................................10 ppm

Bushberry subgroup 13-07B..................................................3.0 ppm

Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit.....2.0 ppm

Low growing berry subgroup 13-07G, except cranberry..........5.0 ppm

Dragon fruit ..............................................................................2.0 ppm

Fruit, pome, group 11-10 ..........................................................1.7 ppm

Vegetable, fruiting, group 8-10.................................................1.3 ppm

Vegetable, leafy, except brassica, subgroup 04A..................40 ppm

In addition, IR-4 is requesting to amend the currently established tolerance for residues of 

cyprodinil in/on Citrus oil by decreasing it to 60 ppm. 

Citrus oil...............................................................60 ppm

In addition, IR-4 is requesting the removal of the currently established tolerances for residues of 

cyprodinil in/on Onion, bulb (0.6 ppm); Onion, green (4.0 ppm); Caneberry subgroup 13A (10.0

ppm); Bushberry subgroup 13B (3.0 ppm); Juneberry (3.0 ppm); Lingonberry (3.0 ppm); Salal 

(3.0ppm); Grape (2.0 ppm); Strawberry (5.0 ppm); Fruit, pome (1.7 ppm); Tomatilla (0.45 ppm); 

Tomato (0.45 ppm); and Leafy greens subgroup 4A, except spinach (30 ppm).

In conjunction with PP#1E7854, IR-4 is requesting an amended Section 3 registration for Switch 

62.5 WGTM Fungicide (EPA Reg. No. 100-953), a 37.5% water dispersible granule (WDG) 

formulation of cyprodinil; VanguardTM WG (EPA Reg. No. 100-828), a 75% water dispersible 

granule (WDG) formulation; and Inspire Super TM Fungicide (EPA Reg. No. 100-1317), a 2.09 lb 

ai/gallon emulsifiable concentrate to the remaining fruiting vegetable crops and to spinach. In 

support of this new use, IR-4 has submitted new pepper and spinach magnitude of the residue 

data for cyprodinil using the WDG formulation of cyprodinil at the proposed use rate.
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In addition, IR-4 is requesting amendments for the Section 3 registrations for VanguardTM WG 

(EPA Reg. No. 100-828), Switch 62.5 WGTM Fungicide (EPA Reg. No. 100-953), and Inspire 

Super TM Fungicide (EPA Reg. No. 100-1317) to expand currently registered foliar uses for bulb 

vegetables, fruiting vegetables, berry and small fruits, dragon fruit, pome fruits, and leafy

vegetables to include the additional commodities specified under the following new crop 

groups/subgroups, respectively: Onion, bulb subgroup 3-07A, Onion, green subgroup 3-07B, 

Caneberry subgroup 13-07A, Bushberry subgroup 13-07B, Small fruit vine climbing subgroup 

13-07F, except fuzzy kiwifruit, Dragon fruit, Vegetable, fruiting, group 8-10, Vegetable, leafy, 

except brassica, subgroup 04A, Pome Fruits Group 11-10, and Low growing Berry Subgroup 13-

07G, Except Cranberry. No amendments to the use patterns (i.e., maximum use rates, 

retreatment intervals, preharvest intervals, use of adjuvants, etc.) on the subject crops have been 

proposed. No new residue chemistry data were submitted to support these uses. Instead the 

petitioner wishes to rely on previously submitted residue chemistry data which support the 

currently registered uses of cyprodinil.

One of the products (EPA Reg. No. 100-1317) addressed herein contains a second active 

ingredient (difenoconazole) and another product (EPA Reg. No. 100-953) contains 

fludioxonil. Difenoconazole and fludioxonil are addressed under separate reviews. The 

subject review addresses the proposed uses and supporting data for cyprodinil only. 

Under PP#1E7869, Syngenta Crop Protection, Inc, is requesting the establishment of tolerances 

for residues of cyprodinil [4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamin] in/on the 

following raw agricultural commodities:

Leafy petiole subgroup 04B....................................................30 ppm

Syngenta Crop Protection, Inc. is requesting a Section 3 request for the use of Vangard®WG

Fungicide (EPA Reg. No. 100-828) and Switch 62.5 WGTM Fungicide (EPA Reg. No. 100-953)

on the leafy petiole subgroup 04B. In support of this new use, Syngenta has submitted celery

magnitude of the residue data for cyprodinil using the WDG formulation of cyprodinil at the 

proposed use rate.

Note: This review only addresses the proposed uses for cyprodinil only. Related issues for coingredient fludioxonil in Switch 62.5 WGTM Fungicide (EPA Reg. No. 100-953) will be 

discussed in a separate memo.

Cyprodinil was applied in four applications of Switch 62.5 WGTM at a rate of approximately 0.5 

lb cyprodinil a.i./A per application with a 6-8 day retreatment interval (RTI) for a maximum 

seasonal rate of 2.2 lb a.i./A to celery. Celery samples were harvested at a PHI of 0 days. 

The nature of cyprodinil residues in plants is understood based on adequate metabolism studies 

on apple, peach, potato, tomato, and wheat. Only residues of parent cyprodinil need to be 

included in the tolerance expression and considered for risk assessment for plant commodities.

The nature of cyprodinil residues in ruminants is also understood based on an adequate goat 

metabolism study. The residues of concern in ruminants are cyprodinil and its hydroxylated 

metabolite CGA-304075 (free and conjugated). No poultry metabolism study is available, but 
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

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HED has concluded that none is required for this action since there are no poultry feed stuffs

associated with the proposed new use of cyprodinil on leafy petiole group 4B.

Adequate HPLC/UV methods (Methods AG-631 and AG-631B) are available for enforcing 

tolerances of cyprodinil in/on plant commodities. The limits of quantitation (LOQ) for the plant

methods range from 0.01 to 0.05 ppm depending on the commodity. An adequate LC/MS 

method (GRM010.01A) is also available for enforcing tolerances of cyprodinil residues in

livestock commodities. The method LOQ for this method is 0.02 ppm for the combined residues 

of cyprodinil and its metabolite CGA-304075 (free and conjugated), expressed as parent. 

In the submitted field trial study, residues of cyprodinil in/on spinach, pepper, and lemon were 

determined with a method using high performance liquid chromatography with a tandem mass 

spectrometer (LC/MS/MS), which is a modified version of the HPLC/UV Syngenta Method AG631B, “Analytical Method for the Determination of Residues of CGA-219417 in Crops by High 

Performance Liquid Chromatography with Column Switching.” Syngenta Methods AG-631 and 

AG-631B are the current tolerance enforcement methods for determining cyprodinil in plant 

commodities. In the submitted field trial study for celery, residues were analyzed by using a high 

performance liquid chromatography method with tandem mass spectrometric detection 

(LC/MS/MS), Syngenta method AG-597B. This method is actually the current tolerance 

enforcement method for fludioxonil in plant commodities and was modified by NCL to enable 

simultaneous extraction of both cyprodinil and fludioxinil from celery obviating Syngenta 

Method AG-631B which is the current tolerance enforcement method for determining cyprodinil 

in plant commodities.

Peppers, spinach, lemon, lemon dried pulp, lemon juice, lemon oil, and celery samples were 

stored frozen (-20°C ± 10°C) for up to 9, 22, 3.5, 4.8, 5.6, 10.3, and 7.2 months before analysis, 

respectively. Demonstrated storage stability for the submitted field trial samples include 9 

months for peppers, 5.8 months for dried lemon pulp, 5.9 months for lemon juice, and 10.6 

months for lemon oil. The stability of cyprodinil has been demonstrated in a variety of other 

crops, including mustard greens for 20 months and grape, wine, apple, wheat (ear and stalk), 

strawberry, and potato for up to 2 years (D233182, G. Kramer, 02/20/98; D288706, T. Bloem 

,7/24/03). Therefore, the submitted field trial data are supported by acceptable storage stability

data.

The HAFT residue level of cyprodinil in bell peppers, non-bell peppers, and spinach resulting 

from four applications for a seasonal rate of 1.3 lb cyprodinil a.i./A was 0.682, 0.668, and 32.1

ppm, respectively. Maximum residue levels of cyprodinil were 0.697 ppm in bell pepper, 0.818

ppm in non-bell pepper, and 37 ppm in spinach. There are an adequate number of bell pepper, 

non-bell pepper, and spinach field trials with acceptable field trial from representative 

geographical locations. The trials were conducted with Switch 62.5WG to support the requested 

crop group tolerance, for a 0-day PHI. No adjuvant or surfactant was used in the bell pepper or 

non-bell pepper field trials. Non-ionic surfactant or a crop oil concentrate were used in the 

spinach field trials.

The HAFT residue level of cyprodinil in celery resulting from four applications for a seasonal 

rate of 2.2 lb cyprodinil a.i./A was 17ppm. Maximum residue levels of cyprodinil were 17 ppm 

in celery. There are an adequate number of celery field trials with acceptable field trial from 
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

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representative geographical locations. The trials were conducted with Switch 62.5WG to support 

the requested crop group tolerance, for a 0-day PHI. Non-ionic surfactant or a crop oil 

concentrate were used in the spinach field trials.

The OECD Maximum Residue Limit Calculator was used to determine appropriate tolerance 

levels. A tolerance level of 50 ppm for Vegetable, leafy, except brassica, subgroup 4A and a 

tolerance of 1.5 ppm for the Vegetable, fruiting, group 8-10 is appropriate to cover the proposed 

amended uses of cyprodinil. Note that these tolerance levels are different than those 

proposed by the registrant. This is due to calculating the MRLs with the OECD MRL 

calculator and harmonizing with proposed Canadian MRLs.

There are currently established Codex maximum residue limits (MRLs) for residues of cyprodinil 

in/on eggplant (0.2 mg/kg), peppers, sweet (0.5 mg/kg), and tomato (0.5 mg/kg). Neither Codex 

nor Canada has MRLs for the leafy petioles crop group.

It is not possible to harmonize with Codex MRLs for residues of cyprodinil in/on eggplant, 

peppers, and tomato. It is not possible to harmonize with Codex and Canadian MRLs for 

residues of cyprodinil in/on these commodities because the US is recommending the 

establishment of a fruiting vegetable group 8 tolerance at 1.5 ppm, and removal of the existing 

0.45 ppm tolerance in/on tomato and tomatillo, along with the 1.0 ppm tolerance on tomato 

paste. Canada will be establishing an MRL on the fruiting vegetable crop group also.

There are no tolerances established in Mexico. 

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry database for cyprodinil. With regards to cyprodinil for 

PP#1E7854, pending submission of a revised Section B (see requirements under Directions for 

Use) and a revised Section F (see requirements under Proposed Tolerances), there are no residue 

chemistry issues that would preclude granting amended registrations for VanguardTM WG (EPA 

Reg. No. 100-828), Switch 62.5 WGTM Fungicide (EPA Reg. No. 100-953), and Inspire Super TM

Fungicide (EPA Reg. No. 100-1317) to expand currently registered foliar uses for bulb 

vegetables, fruiting vegetables, berry and small fruits, dragon fruit, pome fruits, and leafy

vegetables to include the additional commodities specified under the following new crop 

groups/subgroups, respectively: Onion, bulb subgroup 3-07A, Onion, green subgroup 3-07B, 

Caneberry subgroup 13-07A, Bushberry subgroup 13-07B, Small fruit vine climbing subgroup 

13-07F, except fuzzy kiwifruit, Dragon fruit, Vegetable, fruiting, group 8-10, Vegetable, leafy, 

except brassica, subgroup 04A, Pome Fruits Group 11-10, and Low growing Berry Subgroup 13-

07G, Except Cranberry or establishment of tolerances for residues of cyprodinil only in/on the 

following commodities:
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

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Onion, bulb, subgroup 3-07A..... .............................................0.6 ppm

Onion, green, subgroup 3-07B..................................................4.0 ppm

Caneberry subgroup 13-07A........................................10 ppm

Bushberry subgroup 13-07B..................................................3.0 ppm

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F, .....2.0 ppm

Berry, low growing subgroup 13-07G, except cranberry..........5.0 ppm

Dragon fruit ..............................................................................2.0 ppm

Fruit, pome, group 11-10 ..........................................................1.7 ppm

Vegetable, fruiting, group 8-10.................................................1.5 ppm

Vegetable, leafy, except brassica, subgroup 4A..................50 ppm

Citrus, oil................................................................60 ppm

The approved amended registrations for VanguardTM WG (EPA Reg. No. 100-828), Switch 62.5 

WGTM Fungicide (EPA Reg. No. 100-953), and Inspire Super TM Fungicide (EPA Reg. No. 100-

1317) are limited to expansions to add the commodities specified under the new crop 

groups/subgroups and do not include substantive changes to currently registered use patterns 

(i.e., maximum use rates, retreatment intervals, preharvest intervals, use of adjuvants, etc.). 

With regards to cyprodinil for PP#1E7869, pending submission of a revised Section F (see 

requirements under Proposed Tolerances), there are no residue chemistry issues that would 

preclude granting an amended registration for Vangard®WG Fungicide (EPA Reg. No. 100-828) 

and Switch 62.5 WGTM Fungicide (EPA Reg. No. 100-953) to permit a new use on leafy petioles 

subgroup 4B or establishing a tolerance for residues of cyprodinil only in/on the following 

commodities:

Leaf petioles subgroup 4B..............................30 ppm

A human health risk assessment is forthcoming.

Notes to PM:

1. A tolerance of 60 ppm was listed for citrus oil in the Notice of Filing but a tolerance of 

100 ppm was listed in Section F of the petition.

 

2. Use information was taken from Section B of the petition. 

Tolerances should be revised, as needed, to reflect the correct commodity definitions as specified 

in Table 8. 

These recommendations are made concerning cyprodinil only. Issues concerning co-ingredient 

difenoconazole or fludioxonil will be discussed in a separate memo.

A human heath risk assessment is forthcoming.
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

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Background

Cyprodinil is an anilino-pyrimidine fungicide used to control various plant diseases on a wide 

variety of fruit, nut, vegetable and herb crops. Tolerances for residues of cyprodinil have been 

established in/on a variety of crop commodities at levels ranging from 0.02-340 ppm [40 CFR 

§180.532]. Tolerances have also been established at 0.02 ppm for cyprodinil residues in meat 

byproducts of cattle, goats, horses, and sheep. No tolerance is established for poultry byproducts. 

The chemical structure, nomenclature, and physicochemical properties of the technical grade of 

cyprodinil are presented in Tables 1 and 2.

Table 1. Cyprodinil Nomenclature.

Compound

N

N

CH3

N

H

Common name Cyprodinil

Company experimental name CGA219417

IUPAC name (4-cyclopropyl-6-methyl –pyrimidin-2-yl)-phenyl-amine

CAS name 2-pyrimidinamine, 4-cyclopropyl-6-methyl-N-phenylCAS registry number 121552-61-2

End-use product (EP) 75% water-dispersible granule formulation (Vangard® WG Fungicide; EPA Reg. No. 

100-828); a multiple active ingredient (MAI) end-use product (Inspire Super TM Fungicide; 

EPA Reg. No. 100-1317) formulated as an emulsion [oil] in water (EW), containing 8.4% 

difenoconazole and 24.1% cyprodinil
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Table 2. Physicochemical Properties of Technical Grade of Cyprodinil.

Parameter Value Reference

Melting point/range 75.9 C DP#s 345970 and 345182, W. 

Cutchin, 6/4/08 pH 9.5 at 25 C (1% aqueous dispersion)

Density 1.21 g/cm3at 20 C

Water solubility (mg/L at 25 C) pH 7.6 16

pH 5 20

pH 7 13

pH 9 15

Solvent solubility (g/L at 25 C) ethanol 160

acetone 610

toluene 460

n-octanol 160

n-hexane 30

Vapor pressure 3.8 x 10-6 mm Hg at 25 C

Dissociation constant, pKa 4.44 at 20 C

Octanol/water partition coefficient, Log(KOW) 

at 25 C

3.9 at pH 5

4.0 at pH 7

4.0 at pH 9

UV/visible absorption spectrum

(molar absorption coefficients for the 

absorbance maximum)

29,200 l/mol·cm at 270.8 nm (neutral)

29,200 l/mol·cm at 251.6 nm (acidic)

29,200 l/mol·cm at 316.8 nm (acidic)

28,400 l/mol·cm at 270.8 nm (basic)
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

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860.1200 Directions for Use

Table 3. Summary of Proposed Directions for Use of Cyprodinil

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

Spinach

Broadcast foliar

Ground/Aerial/

Chemigation

 Vangard 

WG

75% WDG

[100-828]

0.114 4 0.34 0

A minimum retreatment 

interval (RTI) of 7 days is 

proposed. 

Broadcast foliar

Ground Only

Switch 

62.5WG

37.5% WDG

[100-953]

0.33 4 implied 1.31 0

A minimum retreatment 

interval (RTI) of 7-10 

days is proposed.

Celery

Broadcast foliar

Ground/Aerial/

Chemigation

Vangard WG

75% WDG

[100-828]

0.33 2 by aerial

4 implied 1.3 0

A minimum retreatment 

interval (RTI) of 7-10 

days is proposed.

Broadcast foliar

Ground Only

Switch 

62.5WG

37.5% WDG

[100-953]

0.33 4 implied 1.31 0

A minimum retreatment 

interval (RTI) of 7-10 

days is proposed.

Pepper

Broadcast foliar

Ground/Aerial/

Chemigation

Vangard WG

75% WDG

[100-828]

0.33 2 by aerial

4 implied 1.3 0

A minimum retreatment 

interval (RTI) of 7-10 

days is proposed.

Broadcast foliar

Ground Only

Switch 

62.5WG

37.5% WDG

[100-953]

0.33 4 implied 1.31 0

A minimum retreatment 

interval (RTI) of 7-10 

days is proposed.

Broadcast foliar

Ground/Aerial/

Chemigation

Inspire Super

2.09 lb/gal 

EW

[100-1317]

0.33 2 by aerial

4 implied 1.3 0

A minimum retreatment 

interval (RTI) of 7-10 

days is proposed.

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

residue data. The submitted field trials for spinach and celery used adjuvants, while the field 

trials for peppers did not. Thus, a revised section B must be submitted prohibiting the use of 

adjuvants for peppers. In addition, no pepper field trials were conducted with the Inspire Super 

EW formulation. Therefore, peppers must be removed from the label for Inspire Super.
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860.1300 Nature of the Residue - Plants

DP# 219794, G. Kramer, 2/13/96

DP# 233182, G. Kramer, 2/20/98 

MARC Decision Memo, DP# 243198, G. Kramer, 3/11/98

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

studies on apple, peach, potato, tomato, and wheat. These studies indicated that cyprodinil is 

metabolized primarily by hydroxylation followed by sugar conjugation. Cleavage of the amino 

bridge, opening of the pyrimidine ring, opening of the cyclopropyl ring and formation of 

thiolactic acid conjugates are minor pathways. Incorporation into starch was observed in potato 

tubers and wheat grain. The MARC reviewed these studies and determined that the residue of 

concern, for purposes of tolerance enforcement and risk assessment, is cyprodinil. 

860.1300 Nature of the Residue - Livestock

DP# 233182, G. Kramer, 2/20/98 

MARC Decision Memo, DP# 243198, G. Kramer, 3/11/98

DP# 345970 and 345182, G. Kramer, 6/4/08

DP# 362486, J. Stokes, 9/15/09

The nature of the residue in ruminants is adequately understood based on acceptable lactating 

goat metabolism studies using [14C-phenyl] and [14C-pyrimidinyl] cyprodinil. The metabolism of 

cyprodinil in ruminants proceeds predominantly via hydroxylation followed by conjugation with 

sulfuric and glucuronic acid. Breakdown of the pyrimidinyl ring was seen only in the liver and 

resulted in Metabolite L1. Cleavage of the amino bridge between the phenyl and the pyrimidinyl 

rings was only a minor reaction as indicated by the small amounts of CGA 249287 found in the 

liver and kidneys of goats dosed with [14C-pyrimidinyl]cyprodinil.

HED originally concluded that were no cyprodinil metabolites of toxicological or regulatory

concern in ruminant milk and tissues based on the dietary burden associated with the registered 

cyprodinil uses at that time (362486, J. Stokes, 09/15/09; 378920, B. Cropp-Kohlligian, 

10/27/10). However, HED noted that if future uses significantly increase the potential livestock

dietary burden, then a new cyprodinil feeding study would be required in which residues of 

cyprodinil and CGA 304075 (both free and conjugated) are determined. ARIA subsequently has 

concluded that the residues of concern for both risk assessment and the tolerance definition 

should include the combined residues of cyprodinil and metabolite CGA-304075 (free and 

conjugated), expressed in parent equivalents.

A poultry metabolism for cyprodinil has not been submitted and none has been requested since 

the potential dietary exposure of poultry to cyprodinil residues is extremely low (estimated at 

0.005 ppm based on canola meal consumption). Since there are no poultry feedstuffs associated 

with the proposed amended uses of cyprodinil on tree nuts, then at this time a poultry metabolism 

study is not needed and the uses cannot be considered “Category 3 for poultry. However, if 

future crop are added that produce poultry feedstuffs, then HED may require a study.
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860.1340 Residue Analytical Methods

Enforcement methods. Adequate HPLC/UV methods with column switching (Syngenta Methods 

AG-631 and AG-631B) are available for enforcing tolerances of cyprodinil on plant 

commodities. The LOQs for these methods range from 0.01 to 0.05 ppm depending on the plant 

commodities. Method AG-631B also contains procedures for confirmatory analysis by GC/NPD.

An adequate HPLC/MS method (GRM010.01A) is also available for enforcing tolerances in 

livestock commodities. This method determines residues of both parent and the metabolite 

CGA-304075 (free and conjugated), expressed as parent. The LOQ is 0.01 ppm for each analyte 

for a combined LOQ of 0.02 ppm.

Data collection methods. In the submitted field trial study, residues of cyprodinil in/on spinach, 

pepper, and lemon were determined with a method using high performance liquid 

chromatography with a tandem mass spectrometer (LC/MS/MS), which is a modified version of 

the HPLC/UV Syngenta Method AG-631B, “Analytical Method for the Determination of 

Residues of CGA-219417 in Crops by High Performance Liquid Chromatography with Column 

Switching.” Syngenta Methods AG-631 and AG-631B are the current tolerance enforcement 

methods for determining cyprodinil in plant commodities. In the submitted field trial study for 

celery, residues were analyzed by using a high performance liquid chromatography method with 

tandem mass spectrometric detection (LC/MS/MS), Syngenta method AG-597B. This method is 

actually the current tolerance enforcement method for fludioxonil in plant commodities and was 

modified by NCL to enable simultaneous extraction of both cyprodinil and fludioxinil from 

celery obviating Syngenta Method AG-631B which is the current tolerance enforcement method 

for determining cyprodinil in plant commodities. To further verify the suitability of the method 

for analysis of cyprodinil, a side-by-side comparison of the extraction solutions used in Methods 

AG-597B (acetonitrile:water, 90:10, v/v) and AG-631B (methanol:water, 80:20, v/v) was 

conducted to determine the relative performance of the two methods and to provide bridging data 

to support Method AG-597B modified for LC/MS/MS. The ACN/water extraction provided 

acceptable recoveries (84.2-85.2%) of cyprodinil at the 0.05 and 25 ppm fortification levels. In 

addition, the ACN/water extraction procedure extracted more incurred residues of cyprodinil 

with less variability than the methanol/water extraction procedure (i.e., 1.1 and 5.4% RSD for 

cyprodinil). 

For method AG-631B, residues of cyprodinil were extracted with methanol:water (8:2, v/v), 

filtered, and acidified with dilute HCl. Residues were then cleaned-up by elution through a SPE 

column with ammoniated methanol. Residues were concentrated, reconstituted with 0.1% 

ammonium acetate, and analyzed by LC/MS/MS using a Phenomenex Synergi 4 micron PolarRP 80A column (75 x 2.00 mm) and a multi-component mobile phase (Component A was 0.1% 

ammonium acetate in water and Component B was 90/10 acetonitrile:water plus 0.1% 

ammonium acetate) with gradient elution. The m/z 226.1→93.1 ion transition was used for 

detection and quantitation of cyprodinil. Residues were quantified using external standards. The 

validated LOQ was 0.01 ppm for almond and pecan; the LOD was not reported. For method AG597B, residues of cyprodinil were extracted with acetonitrile (ACN):water (90:10, v:v) by

shaking at room temperature. An aliquot of each extract was centrifuged and filtered. An aliquot 

of the filtered extract was diluted 1:5 with 0.1% acetic acid in water and vortex mixed and then 

analyzed by LC/MS/MS.
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Both methods was validated in conjunction with the analysis of field trial samples. Control 

samples of peppers were fortified with cyprodinil at 0.01-2.1 ppm. Recoveries ranged from 71-

112. Control samples of spinach were fortified with cyprodinil at 0.02-51 ppm. Recoveries 

ranged from 73-113. Control samples of lemon, lemon dried pulp, lemon juice, and lemon oil 

were fortified with cyprodinil at 0.02 ppm, 0.01-2 ppm, 0.01-2.0 ppm, and 0.02-51 ppm, 

respectively. Recoveries ranged from 73-117.Control samples of celery were fortified with 

cyprodinil at 0.05-0.5 ppm. Recoveries ranged from 85-107.

Conclusions. Adequate HPLC/UV methods are available for enforcing the proposed new uses. 

All residues of cyprodinil were determined using an adequate LC/MS/MS method. The 

LC/MS/MS method LOQ for residues of cyprodinil in/on peppers, spinach, lemon, lemon dried 

pulp, lemon juice, lemon oil, and celery is 0.01, 0.02, 0.02, 0.01, 0.01, 0.02, and 0.05 ppm, 

respectively.

860.1360 Multiresidue Methods

Data are available depicting the recovery of cyprodinil and its metabolite CGA-232449 through 

FDA Multiresidue method testing protocols (C through E). Acceptable recoveries were obtained 

for cyprodinil in apple fortified at 0.50 ppm using Protocol D. These data were forwarded to 

FDA (G. Kramer, 11/28/1995).

860.1380 Storage Stability

DER 47161101-7, W. Cutchin,, 04/18/08)

Peppers, spinach, lemon, lemon dried pulp, lemon juice, lemon oil, and celery samples were 

stored frozen (-20°C ± 10°C) for up to 9, 22. 3.5, 4.8, 5.6, 10.3, and 7.2 months before analysis, 

respectively. Demonstrated storage stability for the submitted field trial samples include 9 

months for peppers, 5.8 months for dried lemon pulp, 5.9 months for lemon juice, and 10.6 

months for lemon oil. The stability of cyprodinil has been demonstrated in a variety of other 

crops, including mustard greens for 20 months and grape, wine, apple, wheat (ear and stalk), 

strawberry, and potato for up to 2 years (D233182, G. Kramer, 02/20/98; D288706, T. Bloem 

,7/24/03). Therefore, the submitted field trial data are supported by acceptable storage stability

data. 

860.1400 Water, Fish, and Irrigated Crops

The proposed uses are not relevant to this guideline.

860.1460 Food Handling

The proposed uses are not relevant to this guideline.
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 13 of 27

860.1480 Meat, Milk, Poultry, and Eggs

DP#s 345970 and 345182, W. Cutchin, 6/4/08

DP# 362484, J. Stokes, 9/15/09

DP# 378920, B. Cropp-Kohilligian, 10/27/10

Adequate cattle feeding studies are available for cyprodinil, and tolerances for cyprodinil

residues in livestock commodities were assessed in conjunction with petitions for tolerances on 

various plant commodities (DP#s 345970, 345182, and 378920). Using the Agency’s most 

recent guidance on constructing reasonably balanced livestock diets the maximum reasonably

dietary burdens (MRDBs) of livestock for cyprodinil residues were calculated to be 0.88 ppm for 

beef cattle, 1.2 ppm for dairy cattle, and 0.005 ppm for poultry and swine. Based on these 

MDBs, tolerances for residues of cyprodinil and free and conjugated CGA-304075, expressed in 

parent equivalents, were required on meat byproducts of cattle, goats, horses, and sheep at 0.02 

ppm (LOQ). 

Based on the proposed modified use pattern of cyprodinil on almond and consequently a 

proposed increase in the established almond hull 8.0 ppm tolerance to 20 ppm, HED recalculated 

the dietary burden using almond hull in place of wet apple pomace. The dietary contribution 

from the almond hulls alone did not increase the total dietary burden. However, this proposed 

amended use on almonds was withdrawn and the increased tolerance for almond hulls did not 

occur.

Conclusions. The proposed new uses do not contain any livestock feed stuffs, therefore, HED 

has determined that the currently established 0.02 ppm tolerance levels for meat byproducts of

cattle, goats, horses, and sheep are adequate.
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 14 of 27

860.1500 Crop Field Trials – Peppers, Spinach, & Celery

MRID #s 48437401, 48437402, 48437403, & 48478501

The results from the field trials are summarized below.

TABLE 4 Summary of Residue Data from Pepper Field and Greenhouse Trials with Cyprodinil.

Commodity Total App. 

Rate (lb ai/A)

[g a.i./ha]

PHI 

(days)

Residue Levels (ppm)1

n Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. Dev.

Field Trials

Bell Pepper 1.302-1.417

[1459.0-

1588.3]

0 18 0.023 0.697 0.036 0.682 0.149 0.201 0.191

Nonbell 

Pepper

1.308-1.339

[1466.1-

1500.8]

0 10 0.119 0.818 0.169 0.668 0.225 0.318 0.209

Greenhouse Trials

Bell Pepper 1.304-1.315

[1461.6-

1473.9]

0 8 0.04 0.32 0.08 0.27 0.21 0.20 0.09

Nonbell 

Pepper

1.327

[1487.4] 0 2 0.58 0.60 0.59 0.59 0.59 0.59 --

1

 n = no. of samples. 

2

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

TABLE 5 Summary of Per Trial Average Residue Data from Crop Field Trials with Cyprodinil.

Commodity Total App. 

Rate (lb ai/A)

[g a.i./ha]

PHI 

(days)

Residue Levels (ppm)1

n Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. Dev.

Spinach 1.300-1.367

[1457.1-

1532.2]

0 22 4.58 36.9 5.64 32.1 10.3 11.8 7.36

1

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

2

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

TABLE 6 Summary of Per Trial Average Residue Data from Crop Field Trials with Cyprodinil.

Commodity Total App. 

Rate (lb ai/A)

PHI 

(days)

Residue Levels (ppm)1

n Sample

Min.

Sample

Max.

LAFT2 HAFT2 Median Mean Std. Dev.

Celery 2.16-2.23 0 8 3.2 17 3.5 17 8.5 8.7 4.5

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.

Following four foliar applications of the MAI product formulation at a total rate of 1.302-1.417 

lb cyprodonil/A (1459.0-1588.3 g cyprodinil/ha), residues of cyprodinil (and per trial averages) 

in/on bell and nonbell peppers, respectively, at a 0-day PHI were 0.023-0.697 ppm and 0.119-

0.818 ppm (0.036-0.682 ppm and 0.169-0.668 ppm) from the field trials and 0.04-0.32 ppm and 

0.58-0.60 ppm (0.08-0.27 ppm and 0.59 ppm) from the greenhouse trials.
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 15 of 27

Residue decline data show that cyprodinil decreases in field bell peppers and greenhouse bell 

peppers with increasing pre-harvest intervals.

Residues of cyprodinil (and per trial averages) were 4.58 -36.9 ppm (5.64-32.1 ppm) in/on 

spinach samples harvested 0 days following the last of four foliar broadcast applications of the 

MAI product formulation at a total seasonal rate of 1.300-1.367 lb cyprodonil/A (1457.1-1532.2 

g cyprodinil/ha).

Residue decline data show that cyprodinil decreases in spinach with increasing pre-harvest 

intervals.

Residues of cyprodinil (and per trial averages) were 3.2 -17 (3.5-17) ppm in/on celery samples 

harvested 0 days following the last of four foliar broadcast applications of the WG MAI product 

formulation (37.5% cyprodinil and 25% fludioxonil) at a total seasonal rate of 2.16-2.23 lb ai/A

(cyprodinil). 

Residue decline data show that cyprodinil decreases in celery with increasing pre-harvest 

intervals.

Conclusion: The data adequately support the requested crop group tolerance and proposed use 

patterns. 

860.1520 Processed Food and Feed

MRID #s 48437404 and 48437405

The results from the lemon processing study are summarized below.

Table 7 Residue Data from Lemon Processing Study with Cyprodinil.

RAC Processed Commodity Total Rate

(lb ai/A)

PHI 

(days)

Residues (ppm)1Processing Factor2

Lemon Lemon (RAC) 0.336 0 0.185

0.214

(0.200)

--

Dried Pulp 0.578

0.639

(0.609)

3x

Juice <0.01

<0.01

(<0.01)

<0.05x

Oil 34.6

35.2

32.5

(34.1)

171x

1 LOQ (LLMV) was 0.01 ppm for lemon dried pulp and lemon juice, and 0.02 ppm for lemon oil. Average residues are 

bolded and reported in parenthesis.

2

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

Residues of cyprodinil concentrated in dried lemon pulp and oil, but did not concentrate in lemon 

juice.

Conclusion: The submitted lemon processing study is adequate. The tolerance for citrus oil can 

be decreased to 60 ppm (0.34 ppm x 171= 58 ppm).
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 16 of 27

860.1550 Harmonization with Codex

There are currently established Codex maximum residue limits (MRLs) for residues of cyprodinil 

in/on eggplant (0.2 mg/kg), peppers, sweet (0.5 mg/kg), and tomato (0.5 mg/kg). Neither Codex 

or Canada have MRLs for the leafy petioles crop group.

It is not possible to harmonize with Codex MRLs for residues of cyprodinil in/on eggplant, 

peppers, and tomato. It is not possible to harmonize with Codex and Canadian MRLs for 

residues of cyprodinil in/on these commodities because the US is recommending the 

establishment of a fruiting vegetable group 8 tolerance at 1.5 ppm, and removal of the existing 

0.45 ppm tolerance in/on tomato and tomatillo, along with the 1.0 ppm tolerance on tomato 

paste. Canada is proposing a fruiting vegetable crop group 8-10 MRL and an MRL for the 

Vegetable, leafy, except brassica, subgroup 4A.

860.1650 Submittal of Analytical Reference Standards

Analytical standards for cyprodinil (expiration date 9/30/2012) and CGA-304075 (expiration 

date 8/31/2012) are currently available in the EPA National Pesticide Standards Repository

(email communication with T. Cole, ACB, 09/xx/2011). 

860.1850/1900 Confined and Field Accumulation in Rotational Crops

DP# D257898, S. Levy, 2/8/2000

DP# D326346, W. Wassell, 10/18/2006

Adequate confined and limited field rotational crop studies are available and were conducted at 

2.2x and 1.5x the current maximum use rate for rotated crops (1.3 lb ai/A). On the basis of these

studies, the HED requested a field rotational crop study which also monitored for residues of 

CGA-232449, NOA-422054, CGA-249287, and CGA-263208. 

In the subsequent field accumulation study, cyprodinil (WDG) was applied to mustard greens at 

four test sites in CA (2 tests) and NY (2 tests) as four broadcast foliar applications at 0.328 lb 

ai/A/application at 7-day retreatment intervals for a total of 1.31 lb ai/A (1x rate). The primary

mustard greens crop was destroyed and removed 7 days after the final application, and rotational 

crops of wheat, lettuce and garden beets were planted at PBIs of 27 to 32 days. Samples of 

lettuce, garden beet roots and tops, and wheat forage, hay, straw and grain were collected from 

each test at the appropriate stage of maturity. All samples were analyzed for residues of parent 

and each metabolite (CGA-232449, NOA-422054, CGA-249287, and CGA-263208) using an 

adequate HPLC/MS method (Method 2213-01), which has a validated LOQ of 0.05 ppm for 

parent and each metabolite. 

As residues of parent and each metabolite were <LOQ in/on all lettuce, garden beet and wheat 

RAC samples, HED concluded that rotational crop tolerances are not currently required.
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 17 of 27

860.1550 Proposed Tolerances

The Agency has determined that the residue of concern in plant commodities for the tolerance 

expression is only cyprodinil. Tolerances have been established for residues of cyprodinil in/on 

a variety of crop commodities, at levels ranging from 0.02 ppm in/on almond to 340 ppm in 

citrus oil [40 CFR §180.532(a)]. Tolerances have also been established at 0.02 ppm for 

cyprodinil and its metabolite CGA-304075 residues in meat byproducts of cattle, goats, horses 

and sheep. 
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 18 of 27

Table 8. Tolerance Summary for Cyprodinil

Commodity Established/Proposed 

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Comments; Correct Commodity 

Definition

Tolerances Proposed Under PP#1E7854

Onion, bulb subgroup 

3-07A

0.6 0.6 Onion, bulb, subgroup 3-07A

Onion, bulb subgroup 

3-07B

4.0 4.0 Onion, green, subgroup 3-07B

Caneberry subgroup 

13-07A

10.0 10 ---

Bushberry subgroup 

13-07B

3.0 3.0 ---

Small fruit vine 

climbing subgroup 13-

07F, except fuzzy 

kiwifruit

2.0 2.0 Fruit, small vine climbing, except fuzzy 

kiwifruit, subgroup 13-07F

Low growing berry 

subgroup 13-07G, 

except cranberry

5.0 5.0 Berry, low growing, subgroup 13-07G

Vegetable, fruiting, 

group 8-10

1.3 1.5 ---

Vegetable, leafy, 

except Brassica, 

subgroup 04A

40 50 Vegetable, leafy, except brassica, 

subgroup 4A

Fruit, pome, group 11-

10

1.7 1.7 ---

Dragonfruit 2.0 2.0 Dragon fruit

Tolerances That Need Amended Under PP#1E7854

Citrus, oil 100 ppm Section F

60 ppm NOF

60 ---

Tolerances That Need Removed Under PP#1E7854

Onion, bulb 0.60

Onion, green 4.0

Caneberry subgroup 

13A

10

Bushberry subgroup 

13B

3.0

Grape 2.0

Strawberry 5.0

Tomato 0.45

Tolerances Proposed Under PP#1E7869

Leafy petioles 

subgroup 04B

30 30 Leaf petiole subgroup 4B
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 19 of 27

References

DP Numbers: 378920

Subject: Cyprodinil. Cyprodinil. Amended Use and Amended Tolerance Petition for Pome Fruit. 

Summary of Analytical Chemistry and Residue Data. 

From: B. Cropp-Kohlligian

To: L. Jones

Dated: 10/27/10

MRID(s): 47644301

DP Numbers: 362486

Subject: Cyprodinil. Petition for Tolerance on Canola Seed Imported from Canada. Summary of 

Analytical Chemistry and Residue Data. 

From: J. Stokes

To: L. Jones

Dated: 09/15/09

MRID(s): 47644301

DP Numbers: 345970 and 345182

Subject: Cyprodinil. Section 3 Requests for Uses on Tomato, Avocado, Herbs, Root Vegetables, Leaves of 

Root and Tuber Vegetables, Lemon, Lime, Cucurbits, Kiwifruit, Green and Dry Bulb Onions, and 

Strawberries. Registrant’s Response to Conditional Registration on Carrots and Brassica 

Vegetables and Livestock Feeding Study. Summary of Analytical Chemistry and Residue Data. 

From: W. Cutchin

To: W. Cutchin/B. Madden

Dated: 06/04/08

MRID(s): 47161101-47161107 and 47169305-47169311

DP Number: 326346

Subject: Registration: 100-953; PP#8E05012; Cyprodinil on Onions. Review of Revised Label, Field 

Accumulation in Rotational Crops, Storage Stability, and Analytical Methods Data Requested as 

Conditions of Registration.

From: W. Wassell

To: L. Jones/M. Waller

Dated: 10/18/06

MRID(s): 46078901, 46078903, 46165901

DP Number: 288706, 288708, 288710, and 288773

Subject: Cyprodinil (PC Code 288202). Section 3 Registration for Application of Cyprodinil to Lychee, 

Longan, Spanish Lime, Rambutan, and Pulasan (ID# - 2E06447); Brassica Leafy Greens Crop 

Subgroup, Head and Stem Brassica Crop Subgroup, and Turnip Greens (ID# - 2E06485); Carrot 

(ID# - 2E06461); and Herb Crop Subgroup (ID# - 3E06529). Summary of Residue Chemistry 

Data.

From: T. Bloem

To: R. Forrest

Dated: 07/24/03

MRID(s): 45682401, 45721502, 45726101, 45726102, 45795301, 45795302, and 45839801

DP Number: 257898

Subject: PP# 8E05012. Cyprodinil in/on Strawberries and Bulb Vegetables (Crop Group 3). Evaluation of 

Residue Data and Analytical Methods. 

From: S. Levy

To: R. Forrest/S. Brothers

Dated: 02/08/00

MRID(s): 44615602, 44615601, 44867312, 44867314
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 20 of 27

DP Numbers: 243198

Subject: Cyprodinil. HED Metabolism Assessment Review Committee Meeting of 02/10/98.

From: G. Kramer

To: HED MARC Members

Dated: 03/11/98

MRID(s): None

DP Numbers: 233561, 233562, 233928, 233182, 239674, and 236086

Subject: PP# 6F04656. New Chemical- Cyprodinil (i.e., Vangard®) in/on Stone Fruit, Pome Fruit, 

Almonds and Grapes. Evaluation of Residue Data and Analytical Methods. 

From: G. Kramer

To: M. Waller/T. Ellwanger

Dated: 02/20/98

MRID(s): 44186401, 44186404 and 44186410 thru 44186420; 43908402, 43908403 and 43908438 thru 

43908445; 44382601; and 44275401 and 44275402

DP Number: 219794

Subject: PP#s 5G04553. New Chemical – Cyprodinil and Propiconazole in or on Stone Fruit. Evaluation 

of Residue Data and Analytical Methods.

From: G. Kramer

To: C. Welch/ K. Whitby

Dated: 02/13/96

MRID(s): 43709001 through 43709004, 43709048 through 43709055, and 43737603

DP Number: None

Subject: Multiresidue Method Testing Data for Cyprodinil and CGA-232449

From: G. Kramer

To: B. McMahon, FDA

Dated: 11/28/95

MRID(s): 43709050

Attachments: 

Appendix I - International Tolerances

Appendix II – Tolerance Assessment Calculations

F. DOCUMENT TRACKING

RDI: SHummel 05/3/12

Petition Number: 1E7854 & 1E7869

DP#: 389554 & 391680

PC Code: 288202

Template Version September 2005
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 21 of 27

Appendix I. International Tolerances

Cyprodinil (PC Code 288202; 03/06/12)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition: 

US Canada Mexico2 Codex

40 CFR 180.532:

Plant/Livestock: Sum of cyprodinil 4-

cyclopropyl-6-methyl-N-phenyl-2-

pyrimidinamine and free and 

conjugated CGA-304075 4-(4-

cyclopropyl-6-methyl-pyrimidin-2-

ylamino)-phenol, calculated as the 

stoichiometric equivalent of cyprodinil.

4-cyclopropyl-6-

methyl-N-phenyl -2-

pyrimidinamine

Cyprodinil

The residue is fat 

soluble.

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

US Canada Mexico2 Codex

Onion, bulb subgroup 3-07A 0.60 0.3 onion, bulb

Onion, green subgroup 3-07B 4.0 4.0 green onions

Caneberry subgroup 13-07A

10

6.2 blackberries, 

loganberries, 

raspberries

0.5 raspberries, 

red, black

Bushberry subgroup 13-07B

3.0

2.0 blueberries, 

currants, elderberries, 

gooseberries, 

huckleberries, 

lingonberries, salal 

berries, saskatoon 

berries (juneberries)

Small fruit vine climbing subgroup 

13-07F, except fuzzy kiwifruit 2.0

2.0 gooseberries, grape

3.0 raisins

3 grapes

5 dried grapes 

(=currants, raisins 

and sultanas)

Low growing berry subgroup 13-

07G, except cranberry 5.0

2.0 blueberries, 

lingonberries

3.5 strawberries

2 strawberry

Dragon fruit 2.0

Fruit, pome, group 11-10 1.7 0.1 pome fruit 0.05 apple

1 pear

Vegetable, fruiting, group 8-10

1.5

0.2 eggplant

0.5 Peppers, sweet 

(including pimento or 

pimiento), tomato
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 22 of 27

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition: 

US Canada Mexico2 Codex

Vegetable, leafy, except brassica, 

subgroup 04A

50

30 amaranth, arugula, 

corn salad, dandelion 

leaves, dock, edible 

leaved chrysanthemum, 

endives, fresh chervil 

leaves, fresh parsley 

leaves, garden cress, 

garden purslane , 

garland 

chrysanthemum, head 

lettuce, leaf lettuce, 

orach leaves, radicchio, 

upland cress, winter 

purslane

10 lettuce, head, 

lettuce, leaf

Citrus oil 60

Leafy petioles subgroup 04B 30

Completed: M. Negussie; 03/08/12

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.
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 23 of 27

Appendix II. Tolerance Assessment Calculations.

For each of the crops listed below, the OECD MRL Calculator User Guide (SOP), along with the 

tolerance spreadsheet, was used for calculating recommended tolerances. As specified in the 

SOP, the tolerance calculation is in the region of the 95th percentile of the underlying residue 

distribution, and is more likely to overestimate rather than underestimate the 95th percentile. The 

rounding procedures specified in the SOP were also used. The OECD tolerance spreadsheet does 

not require the use of maximum-likelihood estimation (MLE) procedures for values <LOQ.

Using the OECD MRL Calculator, the recommended tolerances are 50 ppm for spinach, 1.0 ppm 

for peppers and 30 ppm for celery. 
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 24 of 27

Cyprodinil

Spinach

US/PMRA

0 day PHI

Total number of data (n) 11

Percentage of censored data 0%

Number of non-censored data 11

Lowest residue 5.640

Highest residue 32.100

Median residue 10.700

Mean 11.773

Standard deviation (SD) 7.319

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 32.100

- Mean + 4 SD 41.050

- CF x 3 Mean 35.318

Unrounded MRL 41.050

Rounded MRL 50

Residues (mg/kg) n

5.64 1

6.08 1

6.59 1

8.26 1

9.63 1

10.7 1

11.4 1

11.9 1

13 1

14.2 1

32.1 1
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 25 of 27

Cyprodinil

Bell Pepper

US

0-day PHI

Total number of data (n) 13

Percentage of censored data 0%

Number of non-censored data 13

Lowest residue 0.036

Highest residue 0.682

Median residue 0.189

Mean 0.200

Standard deviation (SD) 0.165

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.682

- Mean + 4 SD 0.860

- CF x 3 Mean 0.601

Unrounded MRL 0.860

Rounded MRL 0.9

Residues (mg/kg) n

0.0358 1

0.0383 1

0.08 1

0.1 1

0.134 1

0.152 1

0.189 1

0.21 1

0.23 1

0.234 1

0.248 1

0.27 1

0.682 1
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 26 of 27

Cyprodinil

Non-bell Pepper

US

0-day PHI

Total number of data (n) 6

Percentage of censored data 0%

Number of non-censored data 6

Lowest residue 0.169

Highest residue 0.668

Median residue 0.275

Mean 0.363

Standard deviation (SD) 0.211

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 0.668

- Mean + 4 SD 1.209

- CF x 3 Mean 1.090

Unrounded MRL 1.209

Rounded MRL 1.5

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.169 1

0.202 1

0.273 1

0.277 1

0.59 1

0.668 1
Cyprodinil Summary of Analytical Chemistry and Residue Data DP#: 389554 & D391680

Page 27 of 27

Cyprodinil

Leafy Petioles - Celery

US

0 day PHI

Total number of data (n) 8

Percentage of censored data 0%

Number of non-censored data 8

Lowest residue 3.500

Highest residue 16.500

Median residue 8.450

Mean 8.656

Standard deviation (SD) 4.472

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 16.500

- Mean + 4 SD 26.544

- CF x 3 Mean 25.969

Unrounded MRL 26.544

Rounded MRL 30

Residues (mg/kg) n

3.5 1

3.6 1

5.95 1

7.2 1

9.7 1

10.8 1

12 1

16.5 1