Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 1 of 47

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

CHEMICAL SAFETY AND

POLLUTION PREVENTION

MEMORANDUM

Date: 21-MAY-2012

SUBJECT: Fludioxonil. Tolerance Petitions for Residues in/on Ginseng, Leafy Petioles 

Crop Subgroup 4B, Pineapple (post-harvest treatment), Tuberous and Corm 

Vegetable Subgroup 1C, Tropical Fruit (post-harvest treatment), Bulb Onion 

Subgroup 3-07A, Green Onion subgroup 3-07B, Caneberry Subgroup 13-07A, 

Bushberry Subgroup 13-07B, Small Fruit Vine Climbing Subgroup 13-07F

(except fuzzy kiwifruit), Low-Growing Berry Subgroup 13-07G (except 

cranberry), Fruiting Vegetable Group 8-10 (except tomato), Citrus Fruit Group 

10-10, Pome Fruit Group 11-10, Leafy Vegetable (except Brassica) Subgroup 4A, 

Dragon Fruit, and Tomato (post-harvest treatment). Summary of Analytical 

Chemistry and Residue Data. 

PC Code: 071503 DP Barcode: D389980

Decision Nos.: 447549, 448805 Registration Nos.: 100-953, 100-1242, 100-969, 100-

1308

Petition Nos.: 1E7853, 1E7870 Regulatory Action: Section 3 Registration

Risk Assessment Type: NA Case No.: 7017

TXR No.: NA CAS No.: 131341-86-1

MRID Nos.: 48437101, 484373-01 thru -05, 

48438204, 48478501

40 CFR: §180.516

From: George F. Kramer, Ph.D., Senior Chemist

Risk Assessment Branch 1 (RAB1)

Health Effects Division (HED, 7509P)

Through: David E. Hrdy, Acting Branch Chief

RAB1/HED (7509P)

To: Barbara Madden/Laura Nollen, RM 05

Mary Waller/Lisa Jones, RM 21

Registration Division (RD, 7505P)

Executive Summary

Fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, is a phenylpyrrole, is a fungicide registered for use on a variety of field and vegetable crops, fruit trees, 

berries, herbs, and grasses. It can be applied as a seed treatment, an at-planting soil application, 

and broadcast foliar applications. Post-harvest uses are also allowed on selected fruit and root 

crops. A total of 26 end-use products (EPs) containing fludioxonil are currently registered to 

Syngenta Crop Protection for use on food/feed crops. These EPs contain 0.13 to 50% 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 2 of 47

fludioxonil as the ai and are formulated as wettable-powders (WP), water-dispersible granules 

(WDG), flowable-concentrates (FlC), and dusts. A human-health assessment scoping document 

in support of fludioxonil registration review has recently been completed (DP# 384857, W. 

Wassell et al., 6/13/2011).

Permanent tolerances have been established for residues of fludioxonil per se in/on a variety of 

plant commodities, ranging from 0.01 ppm on numerous commodities to 500 ppm on citrus oil 

[40 CFR §180.516(a)]. There are currently no tolerances for fludioxonil residues in livestock 

commodities.

Interregional Research Project No. 4 (IR-4) has submitted a petition (1E7853) for the use of 

fludioxonil on ginseng, pineapple (post-harvest treatment), tuberous and corm vegetable 

subgroup 1C, spinach, tropical fruit (post-harvest treatment), bulb onion, green onion, caneberry, 

bushberry, small fruit vine climbing (except fuzzy kiwifruit), low-growing berry (except 

cranberry), fruiting vegetables, citrus fruit, pome fruit, leafy vegetables (except Brassica), 

dragon fruit, and tomato (post-harvest treatment). In addition, Syngenta has submitted a petition 

(1E7870) for the use of fludioxonil on leafy petioles. The petitioners request that the following 

tolerances be established as a result of the proposed uses for the residues of fludioxonil (4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile) in/on:

PP# 1E7853

Guava 5 ppm

Feijoa 5 ppm

Jaboticaba 5 ppm

Wax jambu 5 ppm

Starfruit 5 ppm

Passionfruit 5 ppm

Acerola 5 ppm

Avocado 5 ppm

Black sapote 5 ppm

Mamey sapote 5 ppm

Canistel 5 ppm

Mango 5 ppm

Papaya 5 ppm

Sapodilla 5 ppm

Star apple 5 ppm

Lychee 20 ppm

Longan 20 ppm

Spanish lime 20 ppm

Rambutan 20 ppm

Pulasan 20 ppm

Sugar apple 20 ppm

Atemoya 20 ppm

Custard apple 20 ppm

Cherimoya 20 ppm

Ilama 20 ppm

Soursop 20 ppm

Biriba 20 ppm

Ginseng 3.0 ppm

Onion, bulb subgroup 3-07A 0.2 ppm

Onion, green subgroup 3-07B 7.0 ppm

Caneberry subgroup 13-07A 5.0 ppm

Bushberry subgroup 13-07B 2.0 ppm
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 3 of 47

Small fruit vine climbing subgroup 13-07F, except 

fuzzy kiwifruit 1.0 ppm

Low growing berry subgroup 13-07G, except 

cranberry 2.0 ppm

Vegetable, fruiting group 8-10, except tomato 0.7 ppm

Tomato 3.0 ppm

Fruit, citrus, group 10-10 10 ppm

Fruit, pome, group 11-10 5 ppm

Vegetable, leafy, except brassica, subgroup 4A 30 ppm

Vegetable, tuberous and corm, subgroup 1C 6.0 ppm

Pineapple 8.0 ppm

Dragon-fruit 1.0 ppm

PP# 1E7870

Leafy petioles crop subgroup 4B 14 ppm

No new data were submitted to support tolerances for residues in/on onion, bulb, subgroup 3-

07A; onion, green, subgroup 3-07B; low-growing berry 13-07G crop subgroup; caneberry

subgroup 13A; bushberry subgroup 13-07B; fruit, citrus, group 10-10; fruit, pome, group 11-10;

or small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit. IR-4 has requested that 

existing tolerances be expanded to their respective crop groups or crop subgroups. Residue data 

for spinach, pepper, ginseng, and potato were reviewed with the Pest Management Regulatory

Agency (PMRA) of Canada as part of a joint review.

The nature of the fludioxonil residues in plants is adequately understood based on adequate 

metabolism studies on peaches, grapes, onions, and head lettuce. Based on the results from these 

studies, HED has determined that the residue of concern in plants following foliar applications, 

for tolerance enforcement and risk assessment purposes, is fludioxonil per se.

The nature of the residues in livestock is also understood based on the adequate goat and hen 

metabolism studies. For purposes of tolerance enforcement and risk assessment, the residues of 

concern in ruminants are fludioxonil and Metabolite B-1, and the residues of concern in poultry

are fludioxonil, CGA-344623, and Metabolite I-1.

Adequate high-performance liquid chromatography/ultraviolet light detector (HPLC/UV) 

methods (Syngenta Methods AG-597 and AG-597B) are available for enforcing tolerances for 

residues of fludioxonil in/on plant commodities. In the current field trials and processing studies, 

residues of fludioxonil were determined using a liquid chromatography and tandem massspectrometry detection (LC-MS/MS) method, which is a modified version of Method AG-597B. 

The LC-MS/MS method was adequately validated in conjunction with the analysis of field trial 

and processing study samples. The validated limit of quantitation (LOQ) for fludioxonil was 

0.01 or 0.02 ppm in each matrix, and the limit of detection (LOD) was 0.003 or 0.006 ppm. 

Based on the available goat and poultry metabolism data and the previously calculated dietary

exposures of livestock to fludioxonil residues, HED had concluded that quantifiable residues of 

fludioxonil were unlikely to occur in livestock commodities. As processed potato waste is a 

significant feedstuff for livestock (ruminants only), the dietary burden of fludioxonil was 

recalculated using the Agency’s most recent guidance on constructing reasonably balanced 

livestock diets (Memo, 6/30/08). Based upon this diet and the results of a newly submitted 

ruminant feeding study, tolerances for total fludioxonil residues should be established at 0.05 

ppm for residues in fat and meat byproducts of cattle, goats, horses, and sheep and at 0.01 ppm 

for milk and for the meat of cattle, goats, horses, and sheep.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 4 of 47

LC-MS/MS Analytical Method GRM025.03A (as modified in MRID# 48526508) is suitable as 

an enforcement method for livestock commodities as defined in Standard Operating Procedure 

(SOP) No. ACB-019 (9/15/08). This is a common-moiety method in which fludioxonil and its 

metabolites of regulatory concern are converted to CGA192155 (2,2-difluoro-1,3-benzodioxole4-carboxylic acid).

The submitted field trial residue data for ginseng, celery as a representative crop of the leaf 

petioles crop subgroup 4B, bell and non-bell peppers as a representative crop of the fruiting 

vegetable group 8-10 (except tomato), pineapple, potatoes as a representative crop of the 

tuberous and corm vegetable subgroup 1C, spinach as a representative commodity of leafy

vegetable (except Brassica) subgroup 4A, and tomatoes are adequate. The field trial data reflect 

the proposed use pattern; an adequate number of trials were conducted in the appropriate 

geographic regions; and samples were analyzed for the residue of concern using validated datacollection methods. The storage intervals were also validated. Using the Organization for 

Economic Co-operation and Development (OECD) tolerance calculation procedures for the 

residue data sets indicate that the requested tolerance levels are not appropriate for several 

commodities (see below). A revised Section F is requested.

The submitted pineapple and potato processing studies are also adequate. Separate tolerances are 

not required for any of the processed fractions.

Adequate confined and limited field rotational crop trials are available and support the labelspecified 30-day plant-back interval (PBI) for crops without uses on the fludioxonil label. The 

available data indicate that tolerances are not currently required for rotational crops.

There are currently no established Codex, Canadian, or Mexican maximum residue limits

(MRLs) for fludioxonil on tropical fruits. The following U.S., Canadian, and Codex 

tolerances/MRLs for residues of fludioxonil are harmonized: bushberries, grapes, citrus fruits, 

and pome fruits. Additionally, the U.S. and Canadian tolerances/MRLs for tuberous and corm 

vegetables subgroup 1C, spinach, fruiting vegetables except tomato, and ginseng are being 

harmonized as part of this joint review. 

The U.S., Canadian, and Codex tolerances/MRLs for residues of fludioxonil in/on bulb onions, 

caneberries, grapes (small vine climbing fruit, subgroup 13-07F), strawberries (low-growing 

berry subgroup 13-07G), tomatoes, and leafy vegetables cannot be harmonized as the Canadian, 

and Codex MRLs differ. For leafy vegetables except Brassica subgroup 4A, the U.S. and 

Canada are harmonized at 30 ppm, but a Codex MRL is established for head lettuce at 10 ppm. 

For the bulb onion subgroup 3-07A, small vine climbing fruit subgroup 13-07F, and lowgrowing berry subgroup 13-07G, HED recommends that the U.S. tolerances be increased in 

order to harmonize with Codex; bulb onion subgroup 3-07A from 0.20 to 0.50 ppm, small vine 

climbing fruit subgroup 13-07F from 1.0 to 2.0 ppm and low-growing berry subgroup 13-07G

from 2.0 to 3.0 ppm. The tolerances/MRLs cannot be harmonized for green onions, tomatoes,

leafy vegetables except Brassica subgroup 4A, and leafy petioles as the U.S. residue data/use 

patterns necessitate a higher value. For livestock commodities, the U.S. and Codex residue 

definitions are harmonized; however, the Canadian residue definition is not harmonized. The 

numerical values for the U.S. and Canadian livestock tolerances/MRLs are harmonized. 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 5 of 47

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of revised Sections B (see requirements under Directions for Use) and F (see 

requirements under Proposed Tolerances) and submission of an analytical reference standard of 

CGA192155 (2,2-difluoro-l,3-benzodioxole-4-carboxylic acid) to the EPA Repository, there are 

no residue chemistry issues that would preclude granting the requested registrations and the 

following permanent tolerances:

The residue definition for the tolerance expression for “40 CFR §180.516 (a) General. (1)”

should be as follows: Tolerances are established for residues of the fungicide fludioxonil, 

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

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

fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile).

Guava 5.0 ppm

Feijoa 5.0 ppm

Jaboticaba 5.0 ppm

Wax jambu 5.0 ppm

Starfruit 5.0 ppm

Passionfruit 5.0 ppm 

Acerola 5.0 ppm

Avocado 5.0 ppm

Black sapote 5.0 ppm

Mamey sapote 5.0 ppm

Canistel 5.0 ppm

Mango 5.0 ppm

Papaya 5.0 ppm

Sapodilla 5.0 ppm

Star apple 5.0 ppm

Lychee 20 ppm

Longan 20 ppm

Spanish lime 20 ppm

Rambutan 20 ppm

Pulasan 20 ppm

Sugar apple 20 ppm

Atemoya 20 ppm

Custard apple 20 ppm

Cherimoya 20 ppm

Ilama 20 ppm

Soursop 20 ppm

Biriba 20 ppm

Ginseng 4.0 ppm

Onion, bulb subgroup 3-07A 0.50 ppm

Onion, green subgroup 3-07B 7.0 ppm

Caneberry subgroup 13-07A 5.0 ppm 

Bushberry subgroup 13-07B 2.0 ppm

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

Low growing berry subgroup 13-07G, except cranberry 3.0 ppm

Vegetable, fruiting group 8-10, except tomato 0.50 ppm

Tomato 5.0 ppm

Fruit, citrus, group 10-10 10 ppm

Fruit, pome, group 11-10 5.0 ppm

Vegetable, Leafy, except Brassica, subgroup 4A 30 ppm

Vegetable, tuberous and corm, subgroup 1C 6.0 ppm

Pineapple 20 ppm
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 6 of 47

Dragon fruit 1.0 ppm

Leafy petioles crop subgroup 4B 15 ppm

Note to RD: With the establishment of these tolerances, the following tolerances should be 

removed: strawberry; grape; onion, bulb; onion, green; Caneberry subgroup 13A; bushberry 

subgroup 13B; juneberry; lingonberry; salal; vegetable, fruiting group 8; tomatillo; fruit, citrus, 

group 10; fruit, pome, group 11; vegetable, tuberous and corn, except potato, subgroup 1D;

vegetable, bulb, group 3; and leafy greens subgroup 4A, except spinach.

The residue definition for the tolerance expression for “40 CFR §180.516 (a) General. (2)”

should be as follows: Tolerances are established for residues of the fungicide fludioxonil, 

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

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

sum of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile), and its 

metabolites converted to 2,2-difluoro-l,3-benzodioxole-4-carboxylic acid, calculated as the 

stoichiometric equivalent of fludioxonil.

Milk 0.01 ppm

Cattle, meat byproducts 0.05 ppm

Cattle, meat 0.01 ppm

Cattle, fat 0.05 ppm

Goat, meat byproducts 0.05 ppm

Goat, meat 0.01 ppm

Goat, fat 0.05 ppm

Horse, meat byproducts 0.05 ppm

Horse, meat 0.01 ppm

Horse, fat 0.05 ppm

Sheep, meat byproducts 0.05 ppm

Sheep, meat 0.01 ppm

Sheep, fat 0.05 ppm

860.1200 Directions for Use

Adjuvants were not used in all of the submitted residue field trials. Since adjuvants were not 

used in the ginseng, fruiting vegetables, bulb onion subgroup 3-07A, green onion subgroup 3-

07B, caneberry subgroup 13-07A, bushberry subgroup 13-07B, small fruit vine climbing 

subgroup 13-07F (except fuzzy kiwifruit), low-growing berry subgroup 13-07G (except 

cranberry), and fruiting vegetable group 8-10 residue field trials, the label should prohibit 

adjuvant use on these crops.

860.1650 Submittal of Analytical Reference Standards

An analytical reference standard for fludioxonil is currently available at the EPA National 

Pesticide Standards Repository (personal communication with Theresa Cole, 8/15/11) with an 

expiration date of 5/30/13. However, a reference standard of CGA192155 (2,2-difluoro-l,3-

benzodioxole-4-carboxylic acid) should be sent to the Repository, which is located at Fort 

Meade, to the attention of Theresa Cole at the following address:

USEPA

National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350

(Note that the mail will be returned if the extended zip code is not used.)
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 7 of 47

The letter of transmittal should include the assay of the standards, names of the analytical 

methods used, a statement of principal impurities, purification procedures employed, storage 

requirements, and special precautions for safe handling. Replacement of standards may be 

required periodically if supplies are exhausted or if decomposition occurs during storage. 

Material Safety Data Sheets (MSDSs) must accompany all analytical standards as specified by

Occupational Safety and Health Administration (OSHA) in 29 CFR §1910.1200.

860.1550 Proposed Tolerances

A summary of the recommended tolerance levels along with recommendations for commodity

definitions are presented in Table 23. The petitioner is required to submit a revised Section F to 

reflect the recommendations in Table 23.

A human-health risk assessment will be prepared as a separate document.

Background

Fludioxonil is a contact, phenyl-pyrrole fungicide which inhibits protein kinase (Group 12), 

leading to reduced fungal growth and development. In the U.S., fludioxonil is registered to 

Syngenta for use on a wide variety of field and vegetable crops, fruit trees, berries, herbs, and 

grasses. Fludioxonil is applied to food/feed crops as a seed treatment, at-planting soil 

application, and broadcast foliar applications. Post-harvest uses are also allowed on selected 

fruit and root crops. A human-health assessment scoping document in support of fludioxonil

registration review has recently been completed (DP# 384857, W. Wassell et al., 6/13/2011). 

The chemical structure, nomenclature, and physicochemical properties of fludioxonil are 

presented in Tables 1 and 2. 

Table A.1. Fludioxonil Nomenclature.

Compound

Common name Fludioxonil

Company experimental name CGA-173506

IUPAC name 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

CAS name 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile

CAS registry number 131341-86-1

End-use product (EP) Switch®62.5WG Fungicide (25% WDG; EPA Reg. No. 100-953)

Scholar®230SC Fungicide (20.5% SC; EPA Reg. No. 100-1242)

Scholar®50 WP Fungicide (50% WP; EPA Reg. No. 100-969)

Cannonball® WP (50% WP; EPA Reg. No. 100-1360)

Graduate A+TM (20.6% SC; EPA Reg. No. 100-1308)

Compound

Company experimental name CGA192155

IUPAC name 2,2-difluoro-benzo[l,3]dioxole-4-carboxylic acid

O

O

F

F

N

H

CN
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 8 of 47

Table A.1. Fludioxonil Nomenclature.

CAS name 2,2-difluoro-1,3-benzodioxole-4-carboxylic acid

CAS registry number 126120-85-2

Table 2. Physicochemical Properties of Fludioxonil.

Parameter Value Reference

Melting point 199.8 °C DP# 348539, D. Rate, 

09/10/08 pH 8-9 @ 25 °C (1% aqueous dispersion)

Density 1.54 g/cm3typical at 23 °C

Water solubility (25 C) 1.8 mg/L

Solvent solubility (g/L at 20 C) Ethanol 44,000

Acetone 190,000

Toluene 2,700

n-Octanol 20,000

n-Hexane 7.8

Vapor pressure at 25 C 2.9 x 10-9 mm Hg

Dissociation constant (pKa) pKa1 <0

pKa2 ~ 14.1

Octanol/water partition coefficient, Log(KOW) 4.12 @ 25 °C

UV/visible absorption spectrum 12,384 L/mol x cm @ 266 nm (neutral solution)

12,327 L/mol x cm @ 265 nm (acidic solution)

11,790 L/mol x cm @ 271 nm (basic solution)

860.1200 Directions for Use

There are currently 26 EPs containing fludioxonil that are registered to Syngenta Crop Protection 

in the U.S. for use on food/feed crops. These EPs contain 0.13 to 50% fludioxonil and are 

formulated as WPs, WDGs, FlCs, and dusts. One of the formulations registered for foliar 

application on a variety of fruit, nut, vegetable, and herb crops is a 62.5% WDG, a multipleactive-ingredient (MAI) formulation that contains 25% fludioxonil and 37.5% cyprodinil. This 

formulation is registered in the U.S. under the trade name Switch®62.5 WG (EPA Reg. No. 100-

953). Other formulations include Cannonball® WP (EPA Reg. No. 100-1360), Scholar®(EPA 

Reg. No. 100-969), Graduate A+TM (EPA Reg. No. 100-1308), and Scholar®SC (EPA Reg. No. 

100-1242). Information pertaining to the proposed end-use product is listed in Table 3. A 

summary of the proposed use patterns detailed in Table 4. 

Table 3. Summary of Proposed End-Use Products.

Trade Name

Reg. 

No.

ai (%

fludioxonil of

formulation)

Formulation 

Type Target Crops

Target 

Pests Label Date

Switch®

62.5WG

100-

953 25 WG A variety of fruit, nut, vegetable, and herb crops

Soil, 

crown, and 

foliar 

diseases.

Draft labels 

submitted 

3/28/11

Cannonball®

WP

100-

1360 50 WP Onions, berries, ginseng

Scholar® 100-

969 50 WP Postharvest fruit, 

potatoes, tomatoes Postharvest 

fungal 

diseases

Scholar®SC 100-

1242 20.4 SC

Graduate A+TM 100-

1308 20.6 SC Citrus
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 9 of 47

Table 4. Summary of Directions for Use of Fludioxonil.

Applic. Timing, 

Type, and Equip.

Formulation

[EPA Reg. No.] App. Rate

Max. No. 

App. per 

Season

Max. Seasonal 

App. Rate

PHI

(days)

Use Directions and 

Limitations

Leafy Vegetables (except Brassica)

Broadcast foliar 

application, 

ground 

equipment only

25% WDG1

[100-953]

0.225

(lb ai/acre) 4

0.9

(lb ai/acre) 0

7- to 10-day retreatment 

interval (RTI)

Fruiting Vegetables

Broadcast foliar 

application, 

ground 

equipment only

25% WDG1

[100-953]

0.225

(lb ai/acre) 4

0.9

(lb ai/acre) 0

14- to 21-day RTI

Do not apply to small 

tomatoes in greenhouse

Ginseng

Drip irrigation or 

ground 

drenching

50% WP

[100-1360]

0.25

(lb ai/acre) 4

1.0

(lb ai/acre) 14

Applications are to be 

made in ≥3 gal/acre using 

ground or aerial 

equipment. 

Pineapple

Postharvest

High-Volume 

(dilute)

20.4% SC

[100-1242]

0.24 lb 

ai/50 gal

1

0.24 lb ai/50 gal

Mix in water or wax/water 

50% WP emulsion.

[100-969]

0.25 lb 

ai/50 gal 0.25 lb ai/50 gal

Postharvest

Peduncle Spray 

(dilute)

20.4% SC

[100-1242]

0.24 lb 

ai/50 gal

1

0.24 lb ai/50 gal Mix in water or wax/water 

emulsion.

Use T-jet application 

system

50% WP

[100-969]

0.25 lb 

ai/50 gal 0.25 lb ai/50 gal

Potato

Postharvest

In-line Aqueous 

Spray

20.4% SC

[100-1242]

0.009 lb

ai/ton 

tubers

1

0.009 lb ai/ton 

tubers

Must tank mix with 

difenoconazole or 

azoxystrobin.

Use T-jet application 

system.

50% WP

[100-969]

0.009 lb 

ai/ton 

tubers

0.009 lb ai/ton 

tubers

Tomato

Postharvest

In-line 

Drip/Drench

20.4% SC

[100-1242]

0.48 lb

ai/100 gal

1

0.48 lb ai/100 

gal

Mix in water or wax/water 

emulsion.

Must tank mix with 

propiconazole.

50% WP

[100-969]

0.5 lb

ai/100 gal 0.5 lb ai/100 gal

Postharvest

High-Volume 

(dilute)

20.4% SC

100-1242

0.25 lb 

ai/50,000 

lbs fruit

1

0.25 lb 

ai/50,000 lbs 

fruit

Mix in water or wax/water 

emulsion.

Use T-jet application 

system. 

Must tank mix with 

propiconazole.

Not for processing 

tomatoes.

50% WP

[100-969]

0.24 lb 

ai/50,000 

lbs fruit

0.24 lb 

ai/50,000 lbs 

fruit

Tropical Fruit 

Postharvest

In-line 

Drip/Drench

20.4% SC

[100-1242]

0.48 lb 

ai/100 gal

1

0.48 lb ai/100 

gal Mix in water or wax/water 

emulsion.

Dip for ~30 seconds. 50% WP

[100-969]

0.5 lb 

ai/100 gal 0.5 lb ai/100 gal
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 10 of 47

Table 4. Summary of Directions for Use of Fludioxonil.

Applic. Timing, 

Type, and Equip.

Formulation

[EPA Reg. No.] App. Rate

Max. No. 

App. per 

Season

Max. Seasonal 

App. Rate

PHI

(days)

Use Directions and 

Limitations

Citrus Fruit

Postharvest

In-line 

Drip/Drench

20.4% SC

[100-1242]

1.0 lb 

ai/100 gal

2

2.0 lb ai/100 gal

Mix in water or wax/water 

emulsion. 

Dip for 30 seconds 

minimum.

50% WP

[100-969]

1.0 lb 

ai/100 gal 2.0 lb ai/100 gal

20.6% SC

[100-1308]

1.0 lb 

ai/100 gal 2.0 lb ai/100 gal

Postharvest

In-line Aqueous 

Fruit Coating 

Spray 

Application

20.4% SC

100-1242

1.0 lb 

ai/250,000 

lbs fruit

2

2.0 lb 

ai/250,000 lbs 

fruit

Mix in water or wax/water 

emulsion.

Use T-jet application 

system. 

50% WP

[100-969]

1.0 lb 

ai/250,000 

lbs fruit

2.0 lb 

ai/250,000 lbs 

fruit

20.6% SC

[100-1308]

1.0 lb 

ai/250,000 

lbs fruit

2.0 lb 

ai/250,000 lbs 

fruit

1

 Switch®62.5 WG is an MAI formulation containing 25% fludioxonil and 37.5% cyprodinil.

2

 A minimum PBI is 30 days for crops not listed on the label.

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

residue data. Provided that the use directions for ginseng, fruiting vegetables, bulb onion 

subgroup 3-07A, green onion subgroup 3-07B, caneberry subgroup 13-07A, bushberry subgroup 

13-07B, small fruit vine climbing subgroup 13-07F (except fuzzy kiwifruit), low-growing berry

subgroup 13-07G (except cranberry), and fruiting vegetable group 8-10 are revised to prohibit 

the use of adjuvants, the available field trial data support the use directions for the proposed uses.

HED notes that postharvest uses are proposed for both SC and WP formulations; but residue data 

were provided for only the SC formulation. However, HED previously concluded that the 

formulation type (SC vs. WP) had no consistent effect on fludioxonil residues from postharvest 

uses (DP# 325160, G. Kramer, 11/16/2006). Data reflecting use of the WP formulation are thus 

not necessary. 

860.1300 Nature of the Residue - Plants

DP# 261603, W. Donovan, 12/14/1999

DP# 287808, T. Bloem, 2/12/2003

MARC Decision Memo, DP# 262022, W. Donovan, 1/18/2000

The nature of fludioxonil in plants is understood based on the adequate metabolism studies on 

peaches, grapes, onions, and head lettuce. Based on the results from these studies, HED has 

determined that the residue of concern in plants following foliar applications, for tolerance 

enforcement and risk assessment purposes, is fludioxonil per se.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 11 of 47

860.1300 Nature of the Residue - Livestock

DP# D210762, S. Willet, 12/18/1995

MARC Decision Memo, DP# D262022, W. Donovan, 1/18/2000

Adequate poultry and ruminant metabolism studies are available. The metabolism of fludioxonil 

in ruminants involves hydroxylation of the pyrrole ring followed by formation of glucuronide or 

sulfate conjugates. In poultry, fludioxonil is metabolized by oxidation, ring hydroxylation, 

degradation of the pyrrole moiety, and formation of glucuronide or sulfate conjugates. Based on 

the results of these studies, HED has concluded that the residues of concern in ruminants, for 

purposes of tolerance expression and risk assessment, are fludioxonil and Metabolite B-1 [4-

(2',2'-difluoro-1',3'-benzdioxol-4'-yl)-1H-pyrrole-3-carbonitrile, 2-O-glucuronide]. The residues 

of concern in poultry, for purposes of tolerance expression and risk assessment, are fludioxonil, 

CGA-344623 [2-cyano-3-(2,2-difluoro-1,3-benzdioxol-4-yl)succinamic acid], and Metabolite I-1 

[4-(2',2'-difluoro-1',3'-benzdioxol-4'-yl)-pyrrole-3-carbonitrile, 1-O-sulfate ester]. See Appendix 

III for chemical structures.

860.1340 Residue Analytical Methods

Plants

Enforcement methods: Adequate HPLC/UV methods (Methods AG-597 and AG-597B) are 

available for enforcing tolerances of fludioxonil on plant commodities. The LOQs for these 

methods range from 0.008 to 0.05 ppm depending on the plant commodity. In addition, the 

QuEChERS method has been shown to adequately quantify residues of fludioxonil

(http://www.crl-pesticides.eu/library/docs/fv/CRLFV_Multiresidue_methods.pdf). 

Data collection methods: In the submitted field trials and processing studies, residues of 

fludioxonil were determined using a LC-MS/MS method, which is a modified version of Method 

AG-597B. The modifications included performing one extraction instead of two, eliminating a

solid-phase extraction column cleanup steps, and using MS/MS quantitation instead of an 

ultraviolet (UV) detector. 

For determination of fludioxonil, a ten-gram sample was extracted with a acetonitrile:water 

(90:10, v/v). This mixture was vacuum filtered and concentrated by rotary evaporation. 

Residues were diluted with a saturated sodium chloride solution and partitioned into methyl tertbutyl ether. The extracts were then solvent exchanged into toluene, diluted with hexane, and 

cleaned up using a silica solid-phase extraction cartridge eluted with dichloromethane:toluene 

(50:50, v/v). The cleaned extract was evaporated to dryness, reconstituted in acetonitrile:water 

and analyzed by LC-MS/MS in the negative electrospray ionization mode. The validated LOQ

(determined as the lowest level of method validation (LLMV)) is 0.01 or 0.02 ppm for each 

matrix, and the LOD (standard deviation at the LLMV multiplied by the one-tailed t-statistic at 

the 99% confidence level for n-1 replicates) is 0.006 or 0.003 ppm. 

Conclusions: Adequate HPLC/UV methods are available for enforcing the proposed tolerances

and the residue data and processing studies were determined using an adequate LC-MS/MS

method. 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 12 of 47

Livestock

DP# 392314, G. Kramer, in preparation.

Samples were analyzed using Syngenta Analytical Method GRM025.03A, “FludioxonilAnalytical Method for the Determination of Residues of Total Fludioxonil (CGA173506) and 

Metabolites as CGA192155 in Animal Matrices (milk, eggs, muscle, fat, liver, kidney, and 

whole blood). Final Determination by LC-MS/MS,” Version 2. Method modifications were 

issued by the laboratory to add a solid-phase extraction (SPE) cleanup step. In brief, 10-g 

subsamples of milk or tissue samples were placed either in a 500-mL round bottom flask (milk 

and fat) or in a 250-mL centrifuge bottle (muscle, liver, and kidney). Acetonitrile was added to 

all samples. Muscle, liver, and kidney samples underwent high-speed homogenization and the 

homogenate was transferred to a 250-mL round bottom flask. Milk and fat samples were not 

homogenized. Concentrated ammonium hydroxide was added to all samples. All samples then 

underwent ammonium hydroxide:acetonitrile (80:20, v/v) mixture reflux extraction. The 

resulting extract was filtered, acidified, and partitioned with toluene following the addition of 

salt water in a separatory funnel. The toluene layer was filtered, and an aliquot of the filtrate was 

evaporated to dryness and reconstituted in a KMnO4/NaOH solution. Conversion of fludioxonil 

and its metabolites of regulatory concern to CGA192155 (2,2-difluoro-1,3-benzodioxole-4-

carboxylic acid) was carried out by heating the resulting mixture at 60 °C for 15 minutes. The 

oxidation was quenched with sodium metabisulfite. The oxidized extract was then filtered and 

acidified prior to partitioning into dichloromethane:ethyl acetate (80:20, v/v). The 

dichloromethane:ethyl acetate extract was evaporated to dryness, reconstituted in 

acetonitrile:water (50:50, v/v), then processed through Bond Elut®-C18 SPE cartridge clean-up. 

Final determination was by LC-MS/MS. The LOQ for fludioxonil and its metabolites was 0.01 

ppm in all matrices. The method was validated concurrently with the ruminant feeding study by 

spiking untreated control samples (n = 14 per spiking level for whole milk and n = 2 per spiking 

level for tissues) with fludioxonil at 0.01 ppm and 1.0 ppm. Recoveries of fludioxonil in milk 

and tissues were acceptable, ranging from 85-104% at the 0.01-ppm level and from 66-104% at 

the 1.0-ppm spiking level. The LOQ was reported as 0.01 ppm for fludioxonil in milk and 

tissues. 

An earlier version of this method (HPLC/UV instead of LC-MS/MS detection) was evaluated by

JMPR and found to be acceptable based on acceptable recoveries, and successful independent 

laboratory validation and radiovalidation 

(http://www.fao.org/ag/AGP/AGPP/Pesticid/JMPR/Download/2004_eva/JMPR2004eva.pdf). 

HED notes that Analytical Method GRM025.03A was modified by Morse Laboratories during 

analysis of samples from ruminant feeding study (MRID# 48526508) to include a SPE clean-up 

step. This revision eliminated the need for using matrix-matched standards.

Conclusions: LC-MS/MS Analytical Method GRM025.03A (as modified in MRID# 48526508) 

is suitable as an enforcement method for livestock commodities as defined in Standard Operating 

Procedure (SOP) No. ACB-019 (9/15/08). This is a common-moiety method in which 

fludioxonil and its metabolites of regulatory concern are converted to and determined as

CGA192155 (2,2-difluoro-1,3-benzodioxole-4-carboxylic acid).
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 13 of 47

860.1360 Multiresidue Methods

DP# 206301, S. Willett, 3/01/1995

Multiresidue method testing data are available for fludioxonil. Fludioxonil was tested according 

to Protocols C, D, and E using sorghum, corn, and potatoes. Recoveries were inadequate using 

corn and sorghum; however, fludioxonil was recovered from potatoes, a representative nonfatty

crop. Testing was not conducted according to protocols A and B as fludioxonil does not have an 

N-methylcarbamate structure (protocol A) nor is it an acid or phenol (protocol B). Recoveries 

from potatoes (using multiresidue protocol D) were 49 to 121% at the 0.05-ppm fortification 

level, and 78 to 87% at the 0.5-ppm fortification level.

860.1380 Storage Stability

DP# 216233, S. Willett, 8/17/1995

DP# 258870, W. Donovan, 12/20/1999

DP# 258861, W. Donovan, 11/29/1999

DP# 280799, W. Donovan, 2/28/2002

DP# 287808, T. Bloem, 2/12/2003

Adequate storage stability data are available indicating that fludioxonil is completely stable at 

-20 °C for at least 24 months in corn grain and forage, sweet corn ears, sorghum hay, and 

potatoes; 28.5 months in grapes; 12 months in carrots, broccoli, cabbage, and mustard greens; 6 

months in corn meal, sorghum flour and potato flakes; and 4 months in stone fruits and 

raspberries. To date, no decline of fludioxonil during frozen storage has been observed in any 

plant commodities tested. 

Table 5. Summary of Storage Conditions and Intervals of Samples from Crop Field Trial and Processing 

Studies.

Matrix 

Storage 

Temperature (°C) Actual Storage Duration

Interval of Demonstrated 

Storage Stability

Ginseng (MRID 48437301)

Ginseng, Dried Root -29 to -15 407-760 days 716 days1

Leaf Petioles Crop Subgroup 4B (MRID 48478501)

Celery <-5 31-220 days

Pepper (bell and non-bell) (MRID 48437303 & 48437304)

Pepper ~-20 oC 209-824 days 823 days1

Pineapple (post-harvest treatment) (MRID 48437302)

Pineapple

<-20

545 days

Pineapple Juice, Process 

residue 573 days

Potato (MRID 48437101)

Potato

<-10

14-348 days

Potato Flakes, Chips, Wet 

peel 146-153 days

Spinach (MRID 48437305)

Spinach ~-20 oC 134-568 days 578 days1

Tomato (MRID 48438204)

Tomato -20 ± 5 199-274 days 475 days

1

 Concurrent storage stability study.

Conclusions: Adequate storage stability data have been submitted. Residues of fludioxonil were 

stable in all plant matrices during freezer storage for up to 823 days. These data support the 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 14 of 47

storage conditions and intervals of samples collected from the various crop field trials. There are 

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

magnitude of the residue studies. 

860.1480 Meat, Milk, Poultry, and Eggs

DP# 392314, G. Kramer, in preparation.

Based on the available goat and poultry metabolism data and the previously calculated dietary

exposures of livestock to fludioxonil residues, HED had concluded that quantifiable residues of 

fludioxonil were unlikely to occur in livestock commodities (DP# 287808, T. Bloem, 2/12/2003). 

The maximum dietary burdens of livestock to fludioxonil residues were previously calculated to 

be 0.13 ppm for beef cattle, 0.11 ppm for dairy cattle, 0.03 ppm for poultry, and 0.02 ppm for 

swine.

As processed potato waste is a significant feedstuff for livestock (ruminants only), the dietary

burden of fludioxonil was recalculated for this petition using the Agency’s most recent guidance 

on constructing reasonably balanced livestock diets (Memo, 6/30/08), the recalculated dietary

burdens for fludioxonil residues are 11 ppm for beef and 3.7 ppm for dairy cattle (Table 6). 

Table 6. Calculation of Dietary Burdens of Fludioxonil Residues for Livestock.

Feedstuff

Dietary 

Component

% Dry 

Matter1 % Diet1

Residues

(ppm)

2

Dietary Contribution 

(ppm)

3

Beef Cattle

Alfalfa, hay R 89 15 0.01 0.002

Corn, grain CC 88 25 0.02 0.006

Sorghum, grain CC 86 25 0.02 0.006

Potato, processed 

waste

CC 15 30 2.745.3

Flax, meal PC 88 5 0.05 0.003

TOTAL BURDEN 100 5.4

Dairy Cattle5

Alfalfa, forage R 35 20 0.01 0.006

Grass, hay R 88 25 0.01 0.003

Sorghum, grain CC 86 35 0.02 0.008

Potato, processed 

waste

CC 15 10 2.741.8

Flax, meal PC 88 10 0.05 0.006

TOTAL BURDEN 100 1.8

1

Potential dietary burdens for livestock were determined using recent Agency guidance on calculating reasonably 

balanced diets for livestock (Memo, 6/30/2008).

2 The tolerance level for the RAC was used for any associated processed fractions unless otherwise indicated.

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

poultry and swine.

4 Multiplication of the potato median residue (1.57 ppm) by the wet peel processing factor of 1.7X = 2.7 ppm.

5 Although there is a 30-ppm tolerance for leaves of root and tuber vegetables, turnips tops were not included in the 

diet for dairy cattle as the label prohibits the feeding of leaves of root and tuber vegetables to livestock.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 15 of 47

Dairy cattle feeding study (MRID# 48526508)

Fludioxonil was administered orally in treated feed to dairy cows for 28 consecutive days. The 

target doses were 20 (5.4X for dairy, 1.8X for beef cattle) and 100 ppm (27X for dairy, 9.1X for 

beef cattle). In whole milk samples, maximum total residues of fludioxonil and its metabolites 

converted to CGA192155 were 0.030 ppm in day-28 samples from the 20-ppm dosing group and 

0.153 ppm in day-17 samples from the 100-ppm dosing group. In muscle, total residues of 

fludioxonil and its metabolites converted to CGA192155 were not quantifiable in either dosing 

group. In fat, total residues of fludioxonil and its metabolites converted to CGA192155 were 

<0.01 ppm at the 20-ppm dose level and 0.032 ppm at the 100-ppm dose level. There was a 

linear relationship between the feeding level and total fludioxonil in kidney and liver. Total 

residues of fludioxonil in kidney were 0.062 ppm at the 20-ppm dose level and 0.266 ppm at the 

100-ppm dose level. In liver, total fludioxonil residues were 0.055 ppm at the 20-ppm dose level 

and 0.293 ppm at the 100-ppm dose level.

Table 7. Summary of Residue Data from Ruminant Feeding Study with Fludioxonil.1

Matrix

Target Feeding Level 

(ppm)

Residue Levels (ppm)2

n Min. Max. Median Mean

Std. 

Dev.

Whole milk/day 17 0 2 <0.01 <0.01 <0.01 <0.01 -

20 6 0.012 0.056 0.019 0.029 0.020

100 6 0.099 0.255 0.130 0.153 0.063

Fat 0 2 <0.01 <0.01 <0.01 <0.01 -

20 6 <0.010 0.011 0.010 0.010 0.000

100 6 0.030 0.033 0.031 0.032 0.001

Muscle 0 2 <0.01 <0.01 <0.01 <0.01 -

20 6 <0.01 <0.01 <0.01 <0.01 0

100 6 0.010 0.012 0.011 0.011 0.001

Liver 0 2 <0.01 <0.01 <0.01 <0.01 -

20 6 0.038 0.079 0.051 0.055 0.014

100 6 0.263 0.349 0.281 0.293 0.031

Kidney 0 2 <0.01 <0.01 <0.01 <0.01 -

20 6 0.048 0.082 0.056 0.062 0.015

100 6 0.236 0.289 0.273 0.266 0.024

1 The LOQ for fludioxonil in all matrices analyzed was reported as 0.01 ppm.

2 Total residues of fludioxonil and its metabolites converted to CGA192155.

Expected secondary residues in meat and milk

To determine the need for tolerances for fludioxonil residues in milk and tissues, the anticipated 

secondary residues in cattle matrices were estimated using transfer coefficient factors calculated 

from the maximum residues of fludioxonil observed in the ruminant feeding study. The transfer 

coefficients (calculated as residue-level-to-feed ratios) are presented in Table 8. The transfer 

coefficient for each matrix was then used to calculate the expected secondary residues by

multiplying the transfer coefficient by the calculated dietary burden (Table 6). 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 16 of 47

Table 8. Residue-Level-to-Feed Ratios (Transfer Coefficients) in Dairy Cattle Milk and Tissues.1

Matrix

Maximum Residue 

(ppm) Feeding Level, ppm Transfer Coefficient

Milk 0.056 20 0.00280Ave. = 0.0027

0.255 100 0.00255

Fat 0.011 20 0.00055 Ave. = 0.00044 0.033 100 0.00033

Muscle <0.01 20 <0.0001

0.012 100 0.00012

Kidney 0.082 20 0.00410Ave. = 0.0035 0.289 100 0.00289

Liver 0.079 20 0.00395 Ave. = 0.0037 0.349 100 0.00349

1

 Calculated from the maximum residues divided by the dose level.

Table 9. Expected Secondary Residues in Meat and Milk.

Matrix

Dietary burden 

(ppm)

Secondary Residues 

(ppm)

1

Established Tolerance 

(ppm)

Recommended 

Tolerance (ppm)

Milk 1.8 0.00487 - 0.01

Fat

5.4

0.00238 - 0.052

Kidney 0.0189 - 0.05

3

Meat 0.00065 - 0.01

Liver 0.0200 - 0.05

3

1

 Calculated from dietary burden x average transfer coefficient from Table 10. 

2

 Level chosen to harmonize with Canadian MRL.

3

 Meat byproducts, level chosen to harmonize with Canadian and Codex MRLs.

Conclusions: The feeding study data indicate that tolerances for total fludioxonil residues should 

be established at 0.05 ppm for residues in fat and meat byproducts of cattle, goats, horses, and 

sheep and at 0.01 ppm for milk and for the meat of cattle, goats, horses, and sheep. 

860.1500 Crop Field Trials

Ginseng

DER Reference List 48437301.der.doc

Four ginseng field trials were conducted for fludioxonil (Scholar®50 WP) encompassing North 

American Free Trade Agreement (NAFTA) Growing Regions 5 (WI, two trials; Ontario (ON), 

one trial) and 11 (British Columbia (BC), one trial), the major ginseng growing regions of the 

U.S. and Canada, during the 2005 (WI and ON) and 2006 (BC) growing seasons.

Each field trial site consisted of one untreated control plot and one treated plot. Common 

cultural practices were followed to maintain the ginseng crop. Additional maintenance 

pesticides and fertilizers were used at all of the sites to produce a commercial quality crop.

At each trial location, the treated plot received four foliar broadcast applications (ground 

equipment) of fludioxonil (Scholar®50 WP formulation) at 0.162-0.260 lb ai/A, with a 12- to 15-

day retreatment interval (RTI), for a total seasonal rate of 0.910-1.012 lb ai/A (1X). No 

adjuvants were used in any of the trials. At all of the trials, the applications were made when the 

ginseng plants were blooming to early senescence, with the last application 14 to 15 days before 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 17 of 47

harvest. At the ON trial, additional harvests of the ginseng root were made at 2, 7, and 21 days 

after the last application. All applications were made using appropriate equipment, and the 

carrier volume was sufficient to provide adequate dispersal of the test substance [96-196 gallons 

per acre (GPA); 903-1830 liters per hectare (LPH)].

Ginseng samples were harvested using techniques simulating commercial practices. The roots 

were dried in commercial drying facilities or in research facilities simulating commercial drying 

practices. The roots were dried to a commercially acceptable texture.

Per-trial-average residues of fludioxonil residues ranged from 0.165 ppm to 1.695 ppm in/on 

four ginseng trials with samples harvested at a 14- to 15-day pre-harvest interval (PHI; highest 

individual residue of 1.75 ppm). For the samples from the ON trial, the reported fludioxonil 

residues in the treated samples increased with time after the last application. For this trial, 

residues in the treated samples harvested at a PHI of 2 days averaged 0.09 ppm and the residues 

in the dried root samples harvested at a PHI of 21 days averaged 0.26 ppm. No apparent 

explanation was provided for this observation. Residues in controls were <LOD.

Table 10. Summary of Residue Data from Crop Field Trials with Ginseng.

Commodity; 

Treatment Analyte

Total Applic. 

Rate (lb ai/A)

[kg ai/ha]

PHI 

(days)

Residue Levels (ppm)

n

Sample 

Min.

Sample 

Max. LAFT1 HAFT2 Median Mean

Std. 

Dev.

Ginseng (proposed use = 1.0 lb ai/acre application rate, 14-day PHI)

Dried Ginseng 

Root

Fludioxonil 0.910-1.012

[1.020-1.134]

14-15 4 0.09 1.75 0.165 1.695 0.288 0.609 0.732

1

 LAFT = lowest-average field trial.

2

 HAFT = highest-average field trial.

Conclusions: The submitted residue data are adequate to fulfill data requirements for ginseng. 

The number and locations of the crop field trials are in accordance with OPPTS Guideline 

860.1500 (Table 11). The available data will support the proposed use pattern.

Table 11. Trial Numbers and Geographical Locations.

NAFTA Growing Zones

Ginseng

Submitted

Requested

Canada U.S.

5 3 2 3

11 1 1 --

Total 4 3 3

The residue data for ginseng were analyzed using the OECD tolerance calculation procedures

(see Appendix II). The recommended tolerance for residues of fludioxonil is 4.0 ppm for 

ginseng. 

Leaf Petioles Crop Subgroup 4B

DER Reference List 48478501.der.doc

Syngenta Crop Protection has submitted field trial data for fludioxonil on celery. Eight field 

trials were conducted in the U.S. during the 2009 growing season in NAFTA Growing Zones 3 

(FL; 2 trials), 5 (WI; 1 trial), and 10 (CA; 5 trials).
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 18 of 47

Each trial consisted of one untreated plot and one treated plot. At each trial location, four foliar 

broadcast applications of a WG MAI product formulation (Switch®62.5WG), containing 25% 

fludioxonil and 37.5% cyprodinil were made to celery at a target rate of 0.219 lb 

fludioxonil/A/application with 7-day RTI, for a total seasonal rate of 0.864-0.892 lb ai/A (1X). 

All applications were made using ground equipment in concentrated spray volumes of 15-40 

GPA. A non-ionic surfactant (NIS) or crop oil concentrate (COC) was included in all of the tank 

mixes. Samples of mature celery were harvested from all trials at a PHI of 0 days. Celery

samples were also collected from one trial site (CA; W29-9145) at 0, 3, 7, and 10 days after the 

last application to generate residue-decline data. 

Residues of fludioxonil (and per-trial averages) were 2.0-8.8 ppm (2.0-8.6 ppm) in/on celery

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

formulation (25% fludioxonil and 37.5% cyprodinil) at a total rate of 0.864-0.892 lb ai/A 

(fludioxonil). 

The submitted residue decline data indicate that residues of fludioxonil decrease with increasing 

PHI.

Table 12. Summary of Residue Data from Crop Field Trials with Celery.

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 (proposed use = 0.9 lb ai/acre application rate, 0-day PHI)

Celery 0.864-0.892 0 8 2.0 8.8 2.0 8.6 5.0 4.9 2.2

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.

Conclusions: The submitted residue data are adequate to fulfill data requirements for celery as a 

representative crop of the leaf petioles crop subgroup 4B. The number and locations of the crop 

field trials are in accordance with OPPTS Guideline 860.1500 (Table 13). The available data 

will support the proposed use pattern.

Table 13. Trial Numbers and Geographical Locations.

NAFTA 

Growing 

Zones

Celery

Submitted

Requested1

Canada U.S.

3 2 -- 2

5 1 -- 1

10 5 -- 5

Total 8 -- 8

1

 As per Table 5 of 860.1500 for celery.

The residue data for celery were analyzed using the OECD tolerance calculation procedures (see 

Appendix II). The recommended tolerance for residues of fludioxonil is 15 ppm in/on leafy

petioles crop subgroup 4B. 

Pepper (bell and non-bell)

DER Reference List 48437303.der.doc

IR-4 has submitted outdoor field and greenhouse trial data for fludioxonil on peppers (bell and 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 19 of 47

non-bell). Fourteen outdoor field trials were conducted in the U.S. and Canada during the 2006 

growing season in NAFTA Growing Zones 2 (NC; 1 trial), 3 (FL; 2 trials), 5 (OH and ON; 4 

trials), 5B (QC; 1 trial), 6 (TX; 2 trials), 8 (NM; 2 trials), and 10 (CA; 2 trials). Additionally, 

five greenhouse trials were conducted in the U.S. and Canada during the 2005 and 2006 growing 

seasons in the NAFTA Growing Zones 2 (NJ; 1 trial), 4 (TN; 1 trial), 5 (ON; 2 trials), and 6 (TX; 

1 trial). The trials included 13 bell pepper trials (9 outdoor and 3 greenhouse) and 6 non-bell 

trials (5 outdoor and 1 indoor). 

Each trial consisted of one untreated plot and one treated plot. At each trial location, four foliardirected applications of a WG MAI product formulation (Switch®

62.5WG), containing 25% 

fludioxonil and 37.5% cyprodinil were made to peppers at a target rate of 0.219 lb 

fludioxonil/A/application, for a total seasonal rate of 0.868-0.945 lb ai/A (fludioxonil). The RTI

ranged from 5 to 7 days between the first and second applications, 18 to 23 days between the 

second and third applications, and 6 to 8 days between the third and fourth applications. All 

applications were made using tractor-mounted or portable ground equipment in spray volumes of 

25-214 GPA without an adjuvant. Samples of mature peppers were harvested from all trials at a 

PHI of 0 days. Samples were also collected to generate residue decline data from one outdoor 

trial site (09567.06-ON03) at 0, 1, 3, 6, and 13 days after the last application and from one 

greenhouse trial site (09140.06-ON01) at 0, 3, 7, and 12 days after the last application.

Following four foliar applications of a WG MAI product formulation (25% fludioxonil and 

37.5% cyprodinil) at a total rate of 0.868-0.945 lb ai/A (fludioxonil), residues of fludioxonil (and 

per-trial averages) in/on bell and non-bell peppers, respectively, at a 0-day PHI were <0.02-0.29 

ppm and 0.05-0.31 ppm (<0.02-0.28 ppm and 0.06-0.28 ppm) from the outdoor trials and 0.10-

0.27 ppm and 0.15-0.25 ppm (0.11-0.23 ppm and 0.20 ppm) from the greenhouse trials.

The submitted fludioxonil residue decline data from the outdoor trial were all <LOQ (<0.02 

ppm); therefore, residue decline could not be assessed. At the greenhouse trial, residues of 

fludioxonil generally decreased with increasing PHI.

Table 14. Summary of Residue Data from Pepper Outdoor Crop and Greenhouse Field Trials with 

Fludioxonil.

Commodity

Total App. 

Rate (lb ai/A)

PHI 

(days)

Residue Levels (ppm)1

n

Sample

Min.

Sample

Max. LAFT2 HAFT2 Median Mean Std. Dev.

Outdoor Field Trials (proposed use = 0.9 lb ai/acre application rate, 0-day PHI)

Bell Pepper 0.868-0.945 0 9 <0.02 0.29 <0.02 0.28 0.13 0.11 0.08

Non-bell 

Pepper

0.872-0.893 0 5 0.05 0.31 0.06 0.28 0.12 0.13 0.09

Greenhouse Trials (proposed use = 0.9 lb ai/acre application rate, 0-day PHI)

Bell Pepper 0.870-0.877 0 4 0.10 0.27 0.11 0.23 0.21 0.19 0.05

Non-bell 

Pepper

0.884 0 1 0.15 0.25 0.20 0.20 0.20 0.20 --

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 or between the LLMV and LOD in Table 

C.3.

2

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

Conclusions: The submitted residue data are adequate to fulfill data requirements for bell and 

non-bell peppers. The number and locations of the crop field trials are in accordance with 

OPPTS Guideline 860.1500 (Table 15). The available data will support the proposed use 

pattern.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 20 of 47

Table 15. Trial Numbers and Geographical Locations.

NAFTA 

Growing 

Zones

Pepper

Bell Non-bell

Submitted

Requested1

Submitted

Requested2

Canada U.S. Canada U.S.

2 2 (1 outdoor, 1 greenhouse) -- 2/1 -- -- --

3 1 (1 outdoor) -- 2/1 1 (1 outdoor) -- --

4 1 (1 greenhouse) -- -- -- -- --

5 3 (3 outdoor) -- 1/1 1 (1 outdoor) -- --

5A 2 (2 greenhouse) -- -- -- -- --

5B 1 (1 outdoor) -- -- -- -- --

6 1 (1 outdoor) -- 1/1 2 (1 outdoor,

1 greenhouse)

-- --

8 -- -- -- 2 (2 outdoor) -- --

10 2 (2 outdoor) -- 2/2 -- -- --

Total 13

(9 outdoor, 4 greenhouse)

8/6 6 

(5 outdoor, 1 greenhouse)

- 3

3

1

 As per OCSPP 860.1500, Tables 1 and 5 for bell pepper; the second number reflects a 25% reduction in the number of trials 

allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in 

no quantifiable residues.

2

 As per OCSPP 860.1500, Table 1, three trials are requested for non-bell peppers. The geographical locations are not specified.

The residue data for peppers were analyzed using the OECD tolerance calculation procedures

(see Appendix II). Based on the combined field and greenhouse bell pepper data, the 

recommended tolerance for residues of fludioxonil is 0.50 ppm in/on pepper. The same value 

(0.50 ppm) was also obtained using the combined field and greenhouse non-bell pepper data.

Pineapple (post-harvest treatment)

DER Reference List 48437302.de1.doc

Four pineapple post-harvest field trials were conducted for fludioxonil (Scholar®230 SC) 

encompassing NAFTA Growing Region 13, the major pineapple growing region of the U.S., 

during the 2009 growing season.

Each trial consisted of mature untreated control pineapple obtained from local growers. 

Common cultural practices were followed to maintain the crop, and additional maintenance 

pesticides and fertilizers were used at the sites to produce a commercial quality crop.

In each trial, a portion of the harvested pineapples was not treated (control, TRT01), and the 

remaining pineapples were treated twice with fludioxonil (Scholar®230SC formulation) in either 

a dip plus wax followed by a spray directed to the peduncle (TRT02) or a drench plus wax 

followed by a spray directed to the peduncle (TRT03). The test substance was applied at 

approximate rates of 0.507 lb ai/100 gal (dip and drench, 1X) and 0.507 lb ai/7 gal (spray). The 

fruit was allowed to air dry with a 0.75- to 3.25-hour RTI between the dip/drench and spray

applications, and samples of pineapple fruit without crowns were collected following the spray

application after the test substance had dried. Additional samples were collected from the 

TRT01 untreated and TRT03 lot of HI05 pineapples to generate samples for processing into juice 

and process residue. Fruit wax (Sta-Fresh 7051 or Sta-Fresh 7055) was used as an adjuvant at all 

trials.

Per-trial-average-residues of fludioxonil residues were 4.76-5.46 ppm (highest individual residue 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 21 of 47

of 6.50 ppm; average 5.26 ppm) in/on four pineapple trials with post-harvest samples treated 

with a dip application of approximately 0.507 lb ai + fruit wax per 100 gal solution and a spray

application of approximately 0.507 lb ai/7 gal; and from 4.96 ppm to 6.62 ppm (highest 

individual residue of 7.18 ppm; average 6.02 ppm) in/on four pineapple trials with post-harvest 

samples treated with a drench application of approximately 0.507 lb ai + fruit wax per 100 gal 

solution and a spray application of approximately 0.507 lb ai/7 gal. Residues in controls were 

<0.02 ppm.

The maximum storage interval for treated samples in this study was 545 days (approximately 18 

months). Adequate storage stability data are available to support the storage conditions and 

durations for the samples in the present study.

Table 16. Summary of Residue Data from Post-harvest Pineapple Field Trials with Fludioxonil.

Commodity; 

Treatment Analyte

Total 

Application 

Rate (lb ai)1

PHI 

(days)

Residue Levels (ppm)

n

Sample 

Min.

Sample 

Max. LAFT2 HAFT3 Median Mean

Std. 

Dev.

Pineapple (proposed use = 0.50 lb ai/100 gal (dip and drench), no PHI)

Pineapple 

without crowns;

TRT02

Fludioxonil 0.5069

+

0.5071

NA44 4.41 6.50 4.76 5.46 5.41 5.26 0.337

Pineapple 

without crowns;

TRT03

Fludioxonil 0.5070

+

0.5071

NA 4 4.57 7.18 4.96 6.62 6.26 6.02 0.751

1

 Rates are expressed in lb ai/100 gallons for the dip and drench applications and in lb ai/7 gallons for the spray application.

2

 LAFT = lowest-average field trial.

3

 HAFT = highest-average field trial.

4

 NA = not applicable.

Conclusions: HED notes that the label directions specify that only a single post-harvest 

treatment is permitted and that the residue trials employed a second treatment. However, the 

second treatment was directed to the peduncle and did not result in treatment of the whole fruit. 

The submitted residue data are adequate thus to fulfill data requirements for pineapple. The 

number of the crop field trials is adequate for a post-harvest treatment. The available data will 

support the proposed use pattern.

The residue data for pineapple were analyzed using the OECD tolerance calculation procedures

(see Appendix II). Based on both data sets, the recommended tolerance for residues of 

fludioxonil is 20 ppm in/on pineapple.

Vegetable, tuberous and corm, subgroup 1C

DER Reference List 48437101.der.doc

Syngenta Crop Protection, Inc. submitted residue data for fludioxonil on potatoes following postharvest treatment. Five post-harvest trials were conducted in the U.S. and Canada in 2009-2010 

in NAFTA Growing Zones 1 (ME; 1 trial), 5 (WI and ON; 2 trials), and 11 (WA and ID; 2 

trials).

Potatoes were grown on-site by the trial personnel in the U.S. trials and were obtained from a 

commercial grower in the Canadian trial. Samples of mature potato tubers were harvested from 

all trials, placed in on-site storage for ~1-4 months, and then treated with a spray mixture 

containing a 1.92 lb ai/gal fludioxonil SC formulation. In all trials, fludioxonil was applied as a 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 22 of 47

post-harvest treatment spray directed to tubers falling from a conveyor belt or moving along a 

roller table (TRT 02). At the ID trial, three additional treatment scenarios were included: 

surface spray (TRT 03); spray chamber (TRT 04); and brush table (TRT 05). For each treatment, 

fludioxonil was applied at a rate of 0.0088-0.0099 lb ai/2000 lb potatoes (1X); the delivery rate 

was 0.22-0.54 gal/2000 lb potatoes. 

Samples of potatoes from each trial site were collected after the test substance had dried on the 

day of application [0 days after application (DAA)]. At three sites (WA, ON, and ID), additional 

treated samples were collected and placed in storage for 13-14, 30-32, 59-61, and/or 231 DAA to 

generate residue-decline data. 

Residues of fludioxonil were 0.530-3.35 ppm (per-trial average residues were 0.664-3.23 ppm) 

in/on potatoes collected 0 DAA following one post-harvest treatment application of fludioxonil 

formulated as a 1.92 lb ai/gal SC at a total seasonal rate of 0.0088-0.0099 lb ai/2000 lb potatoes. 

All application methods (directed spray to tubers on a conveyor belt, roller table, stationary

surface, spray chamber, or brush table) resulted in similar residue levels. 

The submitted residue decline data from the WA and ID trials indicate that residues of 

fludioxonil generally decrease with increasing DAA (0 to 61 DAA for the WA trial and 0 to 231 

DAA for the ID trial). For the ON trial, residues of fludioxonil remained relatively constant (0 to 

59 DAA). 

Table 17. Summary of Residue Data from Potato Crop Field Trials with Fludioxonil.

Commodity Analyte

Total App. Rate 

DAA

Residue Levels (ppm)1

g ai/

2000 lb

lb ai/

2000 lb n

Sample 

Min.

Sample 

Max. LAFT2 HAFT2 Median Mean Std. Dev.

Potato (proposed use = 0.009 lb ai/ton tubers, no PHI)

TRT 02 (Conveyor Belt or Roller Table)

Potato 

tubers

Fludioxonil 4.0752-

4.5098

0.0090-

0.0099

0 5 0.530 3.25 0.664 2.91 1.46 1.73 0.943

TRT 03 (Surface)

Potato 

tubers

Fludioxonil 4.1280 0.0091 0 1 0.970 1.04 1.01 1.01 N/A3 N/A N/A

TRT 04 (Spray Chamber)

Potato 

tubers

Fludioxonil 3.9989 0.0088 0 1 3.10 3.35 3.23 3.23 N/A N/A N/A

TRT 05 (Brush Table)

Potato 

tubers

Fludioxonil 4.1132 0.0091 0 1 1.45 1.90 1.68 1.68 N/A N/A N/A

Combined Treatments

Potato 

tubers

Fludioxonil 3.9989-

4.5098

0.0088-

0.0099

0 8 0.530 3.35 0.664 3.23 1.57 1.82 0.945

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 (0.01 ppm) 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.

Conclusions: The submitted residue data are adequate to fulfill data requirements for potatoes. 

The number of the crop field trials is adequate for a post-harvest treatment. The available data 

will support the proposed use pattern.

The residue data for potato were analyzed using the OECD tolerance calculation procedures (see 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 23 of 47

Appendix II). The recommended tolerance for residues of fludioxonil is 6.0 ppm in/on

vegetable, tuberous and corm, subgroup 1C.

Spinach

DER Reference List 48437305.der.doc

IR-4 has submitted field trial data for fludioxonil on spinach. Eleven field trials were conducted 

in the U.S. and Canada during the 2008 and 2009 growing seasons in NAFTA Growing Zones 1 

(NY; 1 trial), 2 (MD and SC; 2 trials), 5 (ON; 1 trial), 5B (QC; 1 trial), 6 (TX; 2 trials), 8 (CO; 1 

trial), 10 (CA; 2 trials), and 11 (BC; 1 trial).

Each trial consisted of one untreated plot and one treated plot. At each trial location, four foliar 

broadcast applications of a WG MAI product formulation (Switch®62.5WG), containing 25% 

fludioxonil and 37.5% cyprodinil were made to spinach at a target rate of 0.219 lb 

fludioxonil/A/application, for a total seasonal rate of 0.867-0.911 lb ai/A (1X). The RTIs ranged 

from 6 to 8 days between the first and second applications and the third and fourth applications, 

and from 13 to 16 days between the second and third applications. All applications were made 

using tractor-mounted or portable ground equipment in concentrated spray volumes of 21-45 

GPA. A NIS or COC was included in all of the tank mixes at seven of the trials and in tank 

mixes for 1-3 of the applications at three of the trials. An adjuvant was not used in any tank mix 

at one trial. Samples of mature spinach leaves were harvested from all trials at a PHI of 0 days. 

Spinach samples were also collected from one trial site (Ontario, Canada; 10006.08-ON13) at 0, 

2, 6, 12, and 14 days after the last application to generate residue-decline data. 

Residues of fludioxonil (and per-trial averages) were 1.8-16 ppm (1.9-16 ppm) in/on spinach 

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

formulation (25% fludioxonil and 37.5% cyprodinil) at a total rate of 0.867-0.911 lb ai/A 

(fludioxonil). 

The submitted residue decline data indicate that residues of fludioxonil decrease with increasing 

PHI.

Table 18. Summary of Residue Data from Spinach Crop Field Trials with Fludioxonil.

Commodity

Total App. 

Rate (lb ai/A)

PHI 

(days)

Residue Levels (ppm)1

n

Sample

Min.

Sample

Max. LAFT2 HAFT2 Median Mean Std. Dev.

Spinach (proposed use = 0.9 (lb ai/acre application rate, 0-day PHI)

Spinach 0.867-0.911 0 11 1.8 16 1.9 16 5.8 7.1 4.0

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.

2

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

Conclusions: The submitted residue data are adequate to fulfill data requirements for spinach as 

a representative commodity of leafy vegetable (except Brassica) subgroup 4A. The number and 

locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 19). 

The available data will support the proposed use pattern.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 24 of 47

Table 19. Trial Numbers and Geographical Locations.

NAFTA 

Growing 

Zones

Spinach

Submitted

Requested1

Canada U.S.

1 1 -- 1/1

2 2 -- 2/1

5 1 -- --

5B 1 -- --

6 2 -- 2/1

8 1 -- --

9 -- -- 1/1

10 2 -- 2/2

11 1 -- --

Total 11 -- 8/6

1

 As per Table 5 of 860.1500 for spinach; the second number reflects a 25% reduction in the number of trials allowed for the 

crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifiable 

residues.

The residue data for spinach were analyzed using the OECD tolerance calculation procedures

(see Appendix II). The recommended tolerance for residues of fludioxonil is 30 ppm in/on

spinach (representative commodity of vegetable, leafy, except Brassica, subgroup 4A, a 30-ppm 

tolerance is currently established for leafy greens subgroup 4A, except spinach). 

Tomato (post-harvest treatment)

DER Reference List 48438204.der.doc

Syngenta Crop Protection, LLC has submitted field trial data for residues of fludioxonil in/on 

tomato following post-harvest treatment. Six field trials were conducted in the U.S. during the 

2009 growing season in NAFTA Growing Zones 1 (NY; 1 trial), 2 (NC; 2 trials), 3 (FL; 2 trials), 

and 10 (CA; 1 trial). Four of the trials were conducted using large variety tomatoes and two of 

the trials were conducted using small variety tomatoes.

Tomatoes were grown on-site by the trial personnel or were obtained from a local commercial 

grower. Samples of mature tomatoes were harvested from all trials, rinsed with water, allowed 

to dry, and then treated with a spray mixture containing a 1.92 lb ai/gal fludioxonil SC

formulation and a 45% propiconazole WP formulation. In the NC19 and NC32 trials only, the 

collected tomatoes were placed in on-site storage (58-68 °F) for approximately 1-3 days prior to 

post-harvest treatment. In all trials, fludioxonil was applied as a post-harvest dip treatment (TRT 

02). At the NC and CA trial sites, two additional treatment scenarios were included: drench 

treatment (TRT 03) and packing-line spray treatment (TRT 04). For the dip and drench 

treatments, fludioxonil was applied at a rate of 0.479-0.481 lb ai/100 gal (1X) using a delivery

rate of 943.70-948.00 mL/100 gal. For the packing-line spray treatment, fludioxonil was applied 

at a rate of 0.240-0.241 lb ai/50,000 lb fruit (1X) using a delivery rate of 35.78-47.14 gal/50,000 

lb fruit. For all applications, a NIS was added to each spray mix. Samples of tomatoes from 

each trial site were collected after the test substance had dried on the day of application (0 DAA). 

Residues of fludioxonil (and per-trial average residues) in/on large and small tomatoes collected 

0 DAA following one post-harvest application of fludioxonil formulated as a 1.92 lb ai/gal SC 

were 0.275-1.19 ppm (0.283-1.04 ppm) from the dip treatments at 0.479-0.481 lb ai/100 gal, 

0.237-1.16 ppm (0.249-1.11 ppm) from the drench treatments at 0.479-0.481 lb ai/100 gal, and 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 25 of 47

0.170-1.97 ppm (0.175-1.83 ppm) from the spray treatments at 0.240-0.241 lb ai/50,000 lb 

tomatoes. All application methods (dip, drench, and spray) resulted in similar residue levels. In 

general, fludioxonil residues were higher (~2X) in small tomatoes than in large tomatoes.

Table 20. Summary of Residue Data from Tomato Crop Field Trials with Fludioxonil.

Commodity

Treatment 

Type Analyte

Total 

App. 

Rate

lb ai/

100 gal DAA

Residue Levels (ppm)1

n

Sample 

Min.

Sample 

Max. LAFT2 HAFT2 Median Mean Std. Dev.

Tomato (proposed use = 0.50 lb ai/100 gal (dip and drench), 0.25 lb ai/50,000 lb fruit (spray), no PHI)

Tomato 

(large and 

small)

Dip Fludioxonil 0.479-

0.481

0 6 0.275 1.19 0.283 1.04 0.474 0.577 0.276

Drench 0.479-

0.481

0 3 0.237 1.16 0.249 1.11 0.729 0.694 0.429

Spray 0.240-

0.2413

0 3 0.170 1.97 0.175 1.83 0.657 0.887 0.851

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 units for the spray application rate was lb fludioxonil/50,000 lb fruit.

Conclusions: The submitted residue data are adequate to fulfill data requirements for tomatoes. 

The number of the crop field trials is adequate for a post-harvest treatment. The available data 

will support the proposed use pattern.

The residue data for tomato from the dip and spray treatment were analyzed using the OECD 

tolerance calculation procedures (see Appendix II). Based on spray treatment data set, the

recommended tolerance for residues of fludioxonil is 5.0 ppm in/on tomato.

Tropical Fruit

Reference Minutes of 06/02/2010 ChemSAC Meeting

Agenda item #4: IR-4 referred the following proposal to the ChemSAC for review on the 

translation of tolerances for fludioxonil to include tropical fruits. Presented by W. Wassell for D. 

Thompson, IR-4. 

From the Minutes of the 09/26/2007 ChemSAC Meeting:

IR-4 proposes that EPA allow the presently established tolerances for fludioxonil on stone fruit, 

pome fruit, pomegranate, kiwifruit and citrus to be used to establish tolerances on the ChemSAC 

approved tropical fruit groups at the levels identified below. These tolerances were developed 

for post-harvest use and will be used only for post-harvest use on tropical fruits. Extensive data 

have been developed for registered crops using a number of post-harvest methods of application. 

The proposed tolerances for tropical fruit crops will be used to allow labeling of the dip method 

of post-harvest application. This method of application was included in all previous studies. 

The directions for use will be to mix 0.5 to 1.0 lb active fludioxonil into 100 gallons of water plus 

coating wax. Fruit will be dipped in this solution for approximately 30 seconds and then surface 

dried before packing. 

ChemSAC agreed that the IR-4 proposal seems reasonable based on the data provided. 

However, the SAC would like to review the additional, more specific data cited by IR-4 to 

confirm that the data are sufficiently robust to support the proposed extension of tolerances to 

tropical fruit.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 26 of 47

IR-4 provided the following data:

 Peach: 1 ultra-low-volume (ULV) trial, 2 dip trials, and 2 high-volume drench trials.

 Cherry: 2 high-volume drench trials.

 Plums: 1 ULV trial and 1 high-volume drench trials.

 Apple: 2 ULV trials and 4 dip trials.

 Pear: 2 ULV trials, 4 dip trials, and 6 high-volume drench trials.

 Orange: 3 ULV trials, 5 dip trials, and 1 high-volume drench trial.

 Lemon: 4 ULV trials, 5 dip trials, and 1 high-volume drench trial.

 Grapefruit: 3 ULV trials, 4 dip trials, and 2 high-volume drench trials.

 Pomegranate: 2 dip trials, and 6 high-volume drench trials.

 Kiwifruit: 4 ULV trials and 5 dip trials.

 Yam: 2 dip trials.

 Sweet potato: 2 dip trials.

ChemSAC’s recommendation: Upon review of the submitted data comparing residue levels from 

dip, ULV, and high-volume or drench applications, the ChemSAC agreed with the tolerance 

translations proposed by IR-4 (see table below). It was noted that the available data generally

indicate that the highest residue levels resulted from dip applications made using wax. 

Tropical fruit commodity definitions and proposed tolerances.

Commodity Specific commodities included in definition Proposed tolerance and basis

Avocado avocado; black sapote; canistel; mamey 

sapote; mango; papaya; sapodilla; star apple

5.0 ppm based on the stone fruit, pome fruit, 

and pomegranate tolerances and use of the 0.5 

lb ai rate

Papaya black sapote; canistel; mamey sapote; 

mango; papaya; sapodilla; star apple

5.0 ppm based on the stone fruit, pome fruit, 

and pomegranate tolerances and use of the 0.5 

lb ai rate

Grapefruit grapefruit; pummelo, and their citrus 

cultivars and/or hybrids of these including 

Uniq fruit

10 ppm based on citrus crop group tolerance 

and the use of the 1.0 lb ai rate.

Guava guava; feijoa; jaboticaba; wax jambu; 

starfruit; passionfruit; acerola

5.0 ppm based on the stone fruit, pome fruit, 

and pomegranate tolerances and use of the 0.5 

lb ai rate

Lychee lychee; longan; Spanish lime; rambutan;

pulasan

20 ppm based on kiwifruit tolerance and 0.5 

lb ai rate

Sugar apple sugar apple; atemoya; custard apple; 

cherimoya; ilama; soursop; birida

20 ppm based on kiwifruit tolerance and 0.5 

lb ai rate

The amount of data submitted was considered sufficient.

Onion, Bulb Subgroup 3-07A

No new bulb onion crop field trial data were submitted. A tolerance for residues of fludioxonil 

in/on onion, bulb has been established at 0.20 ppm [40 CFR §180.516]. IR-4 has proposed to 

convert this individual tolerance to a crop subgroup 3-07A tolerance at the same level. The 

representative commodity of the onion, bulb subgroup 3-07A is onion, bulb.

As the proposed use on the onion, bulb subgroup 3-07A is identical to the existing use on bulb 

onions on the product labels for Switch®62.5 WG (EPA Reg. No. 100-953) and Cannonball®

WP (EPA Reg. No. 1360), the existing bulb onion tolerance can be translated to the onion, bulb 

subgroup 3-07A. However, HED recommends that the tolerance be increased from 0.20 to 0.50 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 27 of 47

ppm in order to harmonize with Codex.

Onion, Green Subgroup 3-07B

No new green onion crop field trial data were submitted. A tolerance for residues of fludioxonil 

in/on onion, green has been established at 7.0 ppm [40 CFR §180.516]. IR-4 has proposed to 

convert this individual tolerance to a crop subgroup 3-07B tolerance at the same level. The 

representative commodity of the onion, green subgroup 3-07B is onion, green.

As the proposed use on the onion, green subgroup 3-07B is identical to the existing use on green 

onions on the product labels for Switch®62.5 WG (EPA Reg. No. 100-953) and Cannonball®

WP (EPA Reg. No. 1360), the existing green onion tolerance can be translated to the onion, 

green subgroup 3-07B.

Caneberry subgroup 13-07A

No caneberry field trial data were submitted. A tolerance for residues of fludioxonil in/on the 

caneberry subgroup 13A has been established at 5.0 ppm [40 CFR §180.516]. IR-4 has proposed 

to convert this tolerance to a crop subgroup 13-07A tolerance at the same level. 

As the proposed use on the caneberry subgroup 13-07A is identical to the existing use on 

caneberry subgroup 13A on the product labels for Switch®62.5 WG (EPA Reg. No. 100-953) 

and Cannonball® WP (EPA Reg. No. 1360), the existing caneberry subgroup 13A tolerance can 

be translated to caneberry subgroup 13-07A.

Bushberry subgroup 13-07B

No bushberry field trial data were submitted. A tolerance for residues of fludioxonil in/on the 

bushberry subgroup 13B has been established at 2.0 ppm [40 CFR §180.516]. IR-4 has proposed 

to convert this tolerance to a crop subgroup 13-07B tolerance at the same level. 

As the proposed use on the bushberry subgroup 13-07B is identical to the existing use on 

bushberry subgroup 13B on the product labels for Switch®62.5 WG (EPA Reg. No. 100-953) 

and Cannonball® WP (EPA Reg. No. 1360), the existing bushberry subgroup 13B tolerance can 

be translated to bushberry subgroup 13-07B. Note that the soil-directed application was 

approved by ChemSAC (Minutes of 4/1/2009, 2011 Meeting).

Fruit, citrus, group 10-10

No citrus fruit field trial data were submitted. A tolerance for residues of fludioxonil in/on the 

fruit, citrus, group 10 has been established at 10 ppm [40 CFR §180.516]. IR-4 has proposed to 

convert this tolerance to a fruit, citrus, group 10-10 tolerance at the same level. 

As the proposed use on fruit, citrus, group 10-10 is identical to the existing use on fruit, citrus, 

group 10 on the product labels for Scholar®(EPA Reg. No. 100-969) and Scholar®SC (EPA 

Reg. No. 100-1242), the existing fruit, citrus, group 10 tolerance can be translated to fruit, citrus, 

group 10-10.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 28 of 47

Fruit, pome, group 11-10

No pome fruit field trial data were submitted. A tolerance for residues of fludioxonil in/on the 

fruit, pome, group 11 has been established at 5.0 ppm [40 CFR §180.516]. IR-4 has proposed to 

convert this tolerance to a fruit, pome, group 11-10 tolerance at the same level. 

As the proposed use on fruit, pome, group 11-10 is identical to the existing use on fruit, pome, 

group 11 on the product labels for Scholar®(EPA Reg. No. 100-969) and Scholar®SC (EPA 

Reg. No. 100-1242), the existing fruit, pome, group 11 tolerance can be translated to fruit, pome, 

group 11-10.

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

No new small fruit vine climbing field trial data were submitted. A tolerance for residues of 

fludioxonil in/on grape has been established at 1.0 ppm [40 CFR §180.516]. IR-4 has proposed 

to convert this individual tolerance to subgroup 13-07F, except fuzzy kiwifruit tolerance at the 

same level. The representative commodity of the small fruit vine climbing subgroup 13-07F, 

except fuzzy kiwifruit is grape.

As the proposed use on the small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit is

identical to the existing use on grape on the product label for Switch®62.5 WG (EPA Reg. No. 

100-953), the existing grape tolerance can be translated to the small fruit vine climbing subgroup 

13-07F, except fuzzy kiwifruit. However, HED recommends that the tolerance be increased 

from 1.0 to 2.0 ppm in order to harmonize with Codex.

Low-growing berry subgroup 13-07G, except cranberry

No new low-growing berry field trial data were submitted. A tolerance for residues of 

fludioxonil in/on strawberry has been established at 2.0 ppm [40 CFR §180.516]. IR-4 has 

proposed to convert this individual tolerance to a low-growing berry subgroup 13-07G, except 

cranberry tolerance at the same level. The representative commodity of the low-growing berry

subgroup 13-07G, except cranberry is strawberry.

As the proposed use on the low-growing berry subgroup 13-07G, except cranberry is identical to 

the existing use on strawberry on the product labels for Switch®62.5 WG (EPA Reg. No. 100-

953) and Cannonball® WP (EPA Reg. No. 1360), the existing strawberry tolerance can be 

translated to the low-growing berry subgroup 13-07G, except cranberry. However, HED 

recommends that the tolerance be increased from 2.0 to 3.0 ppm in order to harmonize with 

Codex.

Dragon Fruit

Reference Minutes of February 09, 2011 ChemSAC Meeting

Topic for ChemSAC: Review an IR-4 proposal that requests the use of tropical fruit tolerances 

to obtain tolerances for a new developing crop, dragon fruit. There are four active ingredients 

requested: azoxystrobin, cyprodinil, fludioxonil, and chlorothalonil. 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 29 of 47

ChemSAC Discussion and Recommendations:

(3) Fludioxonil: Same reasoning as for cyprodinil. Lychee tolerance would cover the variation 

even though mango could also be used if based on actual field data. The recommendation is 1.0 

ppm.

860.1520 Processed Food and Feed

Pineapple

DER Reference List 48437302.de2.doc

Pineapple processing studies were conducted to determine the potential for concentration of 

residues of fludioxonil (Scholar®230 SC) in the processed fractions of pineapple. In four 

pineapple post-harvest field trials conducted during the 2009 growing season in NAFTA 

Growing Region 13, fludioxonil (Scholar®230 SC; 20.5% active ingredient) was applied as 

either a dip plus wax followed by a spray directed to the peduncle (TRT02) or a drench plus wax 

followed by a spray directed to the peduncle (TRT03). The test substance was applied at 

approximate rates of 0.507 lb ai/100 gal (dip and drench) and 0.507 lb ai/7 gal (spray). Fruit wax 

(Sta-Fresh 7051 or Sta-Fresh 7055) was used as an adjuvant at all trials. The fruit was allowed 

to air dry with a 0.75- to 3.25-hour RTI between the dip/drench and spray applications, and 

samples of pineapple fruit without crowns were collected following the spray application after 

the test substance had dried. One untreated and one TRT03 treated sample were collected from 

the HI05 trial site for processing into juice and process residue.

Per-trial-average-residues of fludioxonil residues were 4.95 ppm in/on the HI05 pineapple trial 

with samples that were treated with a drench application of approximately 0.5072104 lb ai + fruit 

wax per 100 gal solution and a spray application of approximately 0.5072104 lb ai/7 gal (highest 

individual residue of 5.34 ppm). The residues in juice were slightly lower than in the processing 

raw agricultural commodity (RAC; 5.40 ppm compared to 5.62 ppm, processing factor = 0.96), 

and residues in process residue were slightly higher than in the processing RAC (6.60 ppm 

compared to 5.62 ppm, processing factor = 1.17). The theoretical concentration factor (based on 

separation into components; OPPTS 860.1520, Table 3) is 3.8x for process residue. Residues in 

controls were <0.02 ppm.

The results from the pineapple processing studies are discussed below and the residue data are 

summarized in Table 21.

Table 21. Residue Data from Post-harvest Pineapple Processing Study with Fludioxonil.

Processed 

Commodity

Total Application Rate 

(lb ai)1

PHI

(days)

Fludioxonil Residues2

(ppm) Processing Factor3

Trial Location: Lahaina, HI (09-HI05)

Pineapple without 

crowns (TRT03) 0.5070

+

0.5071

NA4 5.34, 4.57

(4.96)

NA

Processing RAC5 NA 5.62 NA

Juice NA 5.40 0.96

Process residue NA 6.60 1.17

1

 Rates are expressed in lb ai/100 gallons for the drench application and in lb ai/7 gallons for the spray application.

2

 The average residues value is reported in parentheses.

3

 The processing factor was calculated by dividing the residue in the processed fraction by the residue in the processing RAC.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 30 of 47

4

 NA = not applicable.

5

 RAC = raw agricultural commodity.

Conclusions: These data indicate that significant concentration of fludioxonil residues are 

unlikely to occur in the processed fractions of pineapple; therefore, separate tolerances are not 

required for pineapple juice and process residue.

Potato

DER Reference List 48437101.de2.doc

Syngenta Crop Protection, Inc. submitted a processing study for fludioxonil on potato following 

post-harvest treatment. One post-harvest trial was conducted in Kimberley, ID, in 2009. 

Potatoes were grown on-site by the trial personnel and mature potato tubers were harvested, 

placed in on-site storage for ~2 months, and then treated with a spray mixture containing a 3.00 

lb/gal difenoconazole FS formulation, a 2.09 lb/gal azoxystrobin SC formulation, and a 1.92 lb 

ai/gal fludioxonil SC formulation. Fludioxonil was applied as a post-harvest treatment spray

directed to tubers falling from a conveyor belt at an application rate of 0.0092 lb ai/2000 lb 

potatoes (1X). The delivery rate was 0.51 gal/2000 lb potatoes. Potato samples were collected 

after the spray had dried on the day of application (0 DAA) and processed into flakes, chips, and 

wet peel by the University of Idaho Food Technology Center (Caldwell, ID) using simulated 

commercial procedures. Adequate descriptions were provided of the processing procedures, 

including material balance summaries. 

Concentration following processing was observed in wet peel but not in flakes or chips. 

Residues of fludioxonil were 0.472 ppm in/on potato tuber (RAC), <0.01 ppm in flakes 

(resulting in a processing factor of <0.02X), 0.0182 ppm in chips (resulting in a processing factor 

of 0.04X), and 0.797 ppm in wet peel (resulting in a processing factor of 1.7X). All of the 

processing factors calculated in this study were less than the maximum theoretical concentration 

factors of 4.7X for dried potatoes (flakes and granules) and 4.0X for processed waste (based on 

loss of water and separation of components; OPPTS 860.1520, Tables 2 and 3).

The results from the potato processing studies are discussed below and the residue data are 

summarized in Table 22.

Table 22. Residue Data from Potato Processing Studies with Fludioxonil.

RAC

Processed 

Commodity

Total Rate

DAA1 Residues (ppm)

Mean 

Residues 

(ppm)

Processing 

Factor2

g ai/

2000 lb

lb ai/2000 lb

[g a.i./100 kg]

Potato Tubers (RAC) 4.1642 0.0092

[0.46]

0 0.502, 0.442 0.472 --

Flakes <0.01, <0.01 <0.01 <0.02X

Chips 0.0181, 0.0182 0.0182 0.04X

Wet peel 0.788, 0.805 0.797 1.7X

1

 DAA = Days after application.

2

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

Conclusions: Concentration following processing was observed in wet peel but not in flakes or 

chips. Multiplication of the potato HAFT residue (3.32 ppm) by the wet peel processing factor 

of 1.7X yields a value (5.5 ppm) which is less than the recommended RAC tolerance (6.0 ppm); 

therefore, separate tolerances are not required for potato processed fractions.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 31 of 47

Tomato

Post-harvest use on processing tomatoes is prohibited. In addition, available data indicate that 

significant concentration of fludioxonil residues are unlikely to occur in the processed fractions 

of tomato (47161101PFF.der.doc); therefore, separate tolerances are not required for tomato 

paste and puree.

860.1650 Submittal of Analytical Reference Standards

An analytical reference standard for fludioxonil is currently available at the EPA National 

Pesticide Standards Repository (personal communication with Theresa Cole, 8/15/11) with an

expiration date of 5/30/13. However, a reference standard of CGA192155 (2,2-difluoro-l,3-

benzodioxole-4-carboxylic acid) should be sent to the Repository, which is located at Fort 

Meade, to the attention of Theresa Cole at the following address:

USEPA

National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

701 Mapes Road

Fort George G. Meade, MD 20755-5350

(Note that the mail will be returned if the extended zip code is not used.)

The letter of transmittal should include the assay of the standards, names of the analytical 

methods used, a statement of principal impurities, purification procedures employed, storage 

requirements, and special precautions for safe handling. Replacement of standards may be 

required periodically if supplies are exhausted or if decomposition occurs during storage. 

MSDSs must accompany all analytical standards as specified by OSHA in 29 CFR §1910.1200.

860.1850/1900 Confined and Field Accumulation in Rotational Crops

DP# 258865, W. Donovan, 12/17/1999

MARC Decision Memo, DP# 262022, W. Donovan, 1/18/2000

An adequate confined rotational crop study is available reflecting the application of [phenyl14C]fludioxonil to soil at ~1.0 lb ai/A. Based on the results from this study, HED has concluded 

that the residue of concern in rotational crops is fludioxonil per se.

An adequate limited field rotational crop study is also available. At two test sites in CA and NY, 

fludioxonil (50% WP) was applied to bare soil as four broadcast applications at 0.25 lb 

ai/A/application at 7-day RTIs, for a total rate of 1.0 lb ai/A (1X maximum seasonal rate). 

Rotational crops of lettuce, turnips, and wheat were planted at each site at PBIs of 27 to 30 days. 

Single control and duplicate treated samples of lettuce, turnip roots and tops, and wheat forage, 

hay, grain, and straw were harvested from each trial at the appropriate stage for maturity, and 

samples were analyzed for residues of fludioxonil using an adequate HPLC/UV method (Method 

AG-597B). Residues of fludioxonil were <LOQ (<0.01 ppm) in/on all samples of each 

rotational crop matrix.

These data support the 30-day PBI on the current fludioxonil labels and indicate that rotational 

crop tolerances are not currently required.
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 32 of 47

860.1550 Proposed Tolerances

The Agency has determined that the residue of concern in plant commodities is fludioxonil per 

se. Permanent Tolerances have been established for residues of fludioxonil per se in/on a variety 

of crop commodities, at levels ranging from 0.01 ppm in/on numerous commodities to 500 ppm 

in citrus oil [40 CFR §180.516(a)]. There are currently no tolerances for fludioxonil in livestock 

commodities.

There are currently no established Codex, Canadian, or Mexican MRLs for fludioxonil on 

tropical fruits. The following U.S., Canadian, and Codex tolerances/MRLs for residues of 

fludioxonil are harmonized: bushberries, grapes, citrus fruits, and pome fruits. Additionally, the 

U.S. and Canadian tolerances/MRLs for tuberous and corm vegetables subgroup 1C, spinach, 

fruiting vegetables except tomato, and ginseng are being harmonized as part of this joint review. 

The U.S., Canadian, and Codex tolerances/MRLs for residues of fludioxonil in/on bulb onions, 

caneberries, grapes (small vine climbing fruit, subgroup 13-07F), strawberries (low-growing 

berry subgroup 13-07G), tomatoes, and leafy vegetables cannot be harmonized as the Canadian, 

and Codex MRLs differ. For leafy vegetables except Brassica subgroup 4A, the U.S. and 

Canada are harmonized at 30 ppm, but a Codex MRL is established for head lettuce at 10 ppm. 

For the bulb onion subgroup 3-07A, small vine climbing fruit subgroup 13-07F, and lowgrowing berry subgroup 13-07G, HED recommends that the U.S. tolerances be increased in 

order to harmonize with Codex; bulb onion subgroup 3-07A from 0.20 to 0.50 ppm, small vine 

climbing fruit subgroup 13-07F from 1.0 to 2.0 ppm and low-growing berry subgroup 13-07G

from 2.0 to 3.0 ppm. 

The tolerances/MRLs cannot be harmonized for green onions, tomatoes, leafy vegetables except 

Brassica subgroup 4A, and leafy petioles as the U.S. residue data/use patterns necessitate a 

higher value. 

For livestock commodities, the U.S. and Codex residue definitions are harmonized; however, the 

Canadian residue definition is not harmonized. The numerical values for the U.S. and Canadian 

livestock tolerances/MRLs are harmonized. 

Table 23. Tolerance Summary for Fludioxonil. 

Commodity

Proposed 

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Correct Commodity 

Definition/Comments

To be established under 40 CFR §180.516 (a) General. (1) Tolerances are established for residues of the 

fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the table below. 

Compliance with the tolerance levels specified below is to be determined by measuring only fludioxonil, 4-(2,2-

difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile):

Guava 5 5.0

Feijoa 5 5.0

Jaboticaba 5 5.0

Wax jambu 5 5.0

Starfruit 5 5.0

Passionfruit 5 5.0

Acerola 5 5.0

Avocado 5 5.0

Black sapote 5 5.0

Mamey sapote 5 5.0

Canistel 5 5.0

Mango 5 5.0
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 33 of 47

Table 23. Tolerance Summary for Fludioxonil. 

Commodity

Proposed 

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Correct Commodity 

Definition/Comments

Papaya 5 5.0

Sapodilla 5 5.0

Star apple 5 5.0

Lychee 20 20

Longan 20 20

Spanish lime 20 20

Rambutan 20 20

Pulasan 20 20

Sugar apple 20 20

Atemoya 20 20

Custard apple 20 20

Cherimoya 20 20

Ilama 20 20

Soursop 20 20

Biriba 20 20

Ginseng 3.0 4.0

Onion, bulb subgroup 3-07A 0.2 0.50 Increased in order to harmonize 

with Codex MRL.

Onion, green subgroup 3-

07B 7.0 7.0

Caneberry subgroup 13-07A 5.0 5.0

Bushberry subgroup 13-07B 2.0 2.0

Small fruit vine climbing 

subgroup 13-07F, except 

fuzzy kiwifruit

1.0 2.0

Fruit, small, vine climbing, 

subgroup 13-07F, except fuzzy 

kiwifruit. Increased in order to 

harmonize with Codex MRL.

Low growing berry subgroup 

13-07G, except cranberry 2.0 3.0 Increased in order to harmonize with Codex MRL.

Vegetable, fruiting group 8-

10, except tomato 0.7 0.50

Tomato 3.0 5.0

Fruit, citrus, group 10-10 10 10

Fruit, pome, group 11-10 5 5.0

Vegetable, leafy, except 

brassica, subgroup 04A 30 30 Vegetable, leafy, except Brassica, subgroup 4A

Vegetable, tuberous and 

corm, subgroup 1C 6.0 6.0

Pineapple 8.0 20

Dragon-fruit 1.0 1.0 Dragon fruit

Leafy petioles crop subgroup 

4B 14 15

To be established under 40 CFR §180.516 (a) General. (2)” Tolerances are established for residues of the 

fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the table below. 

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

fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile), and its metabolites converted to 

2,2-difluoro-l,3-benzodioxole-4-carboxylic acid, calculated as the stoichiometric equivalent of fludioxonil:

Milk - 0.01

Cattle, meat byproducts - 0.05

Cattle, meat - 0.01

Cattle, fat - 0.05

Goat, meat byproducts - 0.05

Goat, meat - 0.01

Goat, fat - 0.05

Horse, meat byproducts - 0.05
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 34 of 47

Table 23. Tolerance Summary for Fludioxonil. 

Commodity

Proposed 

Tolerance (ppm)

Recommended 

Tolerance (ppm)

Correct Commodity 

Definition/Comments

Horse, meat - 0.01

Horse, fat - 0.05

Sheep, meat byproducts - 0.05

Sheep, meat - 0.01

Sheep, fat - 0.05

Remove:

Onion, bulb 0.20

These tolerances should be removed 

from 40 CFR §180.516 because 

tolerances are being established for 

crop groups that contain these 

RACs or a higher tolerance is 

required based on the proposed use 

pattern. 

Onion, green 7.0

Caneberry subgroup 13A 5.0

Bushberry subgroup 13B 2.0

Juneberry 2.0

Lingonberry 2.0

Salal 2.0

Grape 1.0

Strawberry 2.0

Vegetable, fruiting group 8 0.01

Tomatillo 0.50

Fruit, citrus, group 10 10

Fruit, pome, group 11 5.0

Leafy greens subgroup 4A, 

except spinach 30

Vegetable, tuberous and 

corn, except potato, 

subgroup 1D

3.5

References

DP Numbers: 206301, 206304, 206331, and 206328

Subject: PP No. 4F4315/4H5685. MAXIM (New Chemical) Seed Treatment for Field 

Corn, Sweet Corn, Popcorn and Sorghum. Review of Residue Data and 

Analytical Methodology. 

From: S. Willet

Dated: 3/01/1995

DP Numbers: 216233

Subject: PP No. 4F4315/4H5685. MAXIM (Fludioxonil; CGA 173506) Seed Treatment 

for Field Corn, Sweet Corn, Popcorn and Sorghum. Review of Petition 

Amendment dated May 1995. 

From: S. Willet

Dated: 8/17/1995

DP Number: 210762

Subject: PP No. 4F4315/4H5685. Fludioxonil (CGA 173506; MAXIM) Seed Treatment 

for Field Corn, Sweet Corn, Popcorn and Sorghum. Review of Ruminant and 

Poultry Metabolism Studies. 

From: S. Willet

Dated: 12/18/1995
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 35 of 47

DP Number: 258861

Subject: PP# 9E06049. Fludioxonil for use on Stone Fruits. Evaluation of Residue Data 

and Analytical Methods.

From: W. Donovan

Dated: 11/29/99

DP Number: 261603

Subject: Fludioxonil. Issues to be Presented to the HED Metabolism Assessment Review 

Committee (MARC).

From: G. Kramer

Dated: 12/14/1999

DP Number: 258870

Subject: PP# 7E04919. Fludioxonil for use on Grapes. Evaluation of Residue Data and 

Analytical Methods.

From: W. Donovan

Dated: 12/20/99

DP Number: 262022

Subject: Fludioxonil. Results of the HED Metabolism Assessment Review Committee 

(MARC) Meeting Held on 21-DEC-1999.

From: W. Donovan

Dated: 1/18/2000

DP Numbers: 287808, 287810, 287812, and 287814

Subject: Fludioxonil. Section 3 Registration for Application of Fludioxonil to Lychee, 

Longan, Spanish Lime, Rambutan, and Pulasan (ID# - 2E06448); Brassica Leafy

Greens Crop Subgroup, Head and Stem Brassica Crop Subgroup, and Turnip 

Greens (ID# - 2E06486); Carrot (ID# - 2E06462); and Herb Crop Subgroup (ID# 

- 3E06526). Summary of Residue Chemistry Data.

From: T. Bloem

Dated: 2/12/2003

DP Number: 325160

Subject: Registration of Fludioxonil (Scholar SCTM, EPA Registration #100-xxx) for 

Postharvest Use on Stone Fruit, Citrus Fruit, Pome Fruit, Kiwi, & Yam.

From: G. Kramer

Dated: 11/16/2006

DP Numbers: 384857, 387809

Subject: Fludioxonil; Human-Health Assessment Scoping Document in Support of 

Registration Review.

From: W. Wassell, et al.

Dated: 6/13/2011
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 36 of 47

Attachments: 

Appendix I. International Residue Limit Status Sheet.

Appendix II. Tolerance-Assessment Calculations.

Appendix III. Chemical Structures

cc: G. Kramer (RAB1)

RDI: RAB1 Chemists (12/21/2011)

G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 37 of 47

Appendix I. International Tolerances

International Residue Limits 

Fludioxonil (118203; Date of Request: 08/29/2011)

Summary of US and International Tolerances and Maximum Residue Limits 

Residue Definition:

US Canada Mexico2 Codex3

40 CFR 180.516:

Plant: fludioxonil, 4-(2,2-difluoro1,3-benzodioxol-4-yl)-1-H-pyrrole3-carbonitrile)

Livestock: fludioxonil, including its 

metabolites and degradates, in or on 

the commodities in the table below. 

Compliance with the tolerance 

levels specified below is to be 

determined by measuring only the 

sum of fludioxonil, 4-(2,2-difluoro1,3-benzodioxol-4-yl)-1-H-pyrrole3-carbonitrile), and its metabolites 

converted to 2,2-difluoro-l,3-

benzodioxole-4-carboxylic acid, 

calculated as the stoichiometric 

equivalent of fludioxonil

4-(2,2-difluoro-1,3-benzodioxol4-yl)-1H-pyrrole-3-carbonitrilePlant:

fludioxonil.

Livestock : 

fludioxonil and 

metabolites 

determined as 

2,2-difluoro-1,3-

benzodioxole-4-

carboxylic acid 

and calculated as 

fludioxonil.

The residue is 

fat-soluble.

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

US Canada Mexico2 Codex3

Guava 5.0

Feijoa 5.0

Jaboticaba 5.0

Wax jambu 5.0

Starfruit 5.0

Passionfruit 5.0

Acerola 5.0

Avocado 5.0

Black sapote 5.0

Mamey sapote 5.0

Canistel 5.0

Mango 5.0

Papaya 5.0

Sapodilla 5.0

Star apple 5.0

Lychee 20

Longan 20

Spanish lime 20

Rambutan 20

Pulasan 20

Sugar apple 20

Atemoya 20

Custard apple 20

Cherimoya 20

Ilama 20

Soursop 20

Biriba 20
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 38 of 47

Ginseng 4.0

Onion, bulb subgroup 3-07A 0.50

0.02 Chinese onions, 

garlic, great headed 

garlic, potato onions, 

shallots

0.2 dry bulb onions

0.5 onion, bulb

Onion, green subgroup 3-07B 7.0

0.02 Chinese, chives, 

chive leaves, leeks,

green onions, Welsh 

onion tops

Caneberry subgroup 13-07A 5.0

4.2 blackberries, 

loganberries, 

raspberries

5 blackberries, 

raspberries, red, 

black, 

dewberries 

(including 

boysenberry and 

loganberry)

Bushberry subgroup 13-07B 2.0

2.0 blueberries, 

currant, elderberries, 

gooseberries, 

huckleberries, salal 

berries, saskatoon 

berries (juneberries)

2 blueberries

Fruit, small, vine climbing, 

subgroup 13-07F, except fuzzy 

kiwifruit

1.0

1 gooseberries

1 grape

20 kiwifruit

2 grapes

15 kiwifruit Po

Low growing berry subgroup 13-

07G, except cranberry 2.0 2 strawberries 3 strawberry

Vegetable, fruiting group 8-10, 

except tomato 0.50

**0.01 bell peppers, 

eggplants, ground 

cherries, non-bell 

peppers, pepinos, 

pepper hybrids

0.3 eggplant

1 peppers, sweet 

(including 

pimento or 

pimiento)

Tomato 5.0 0.01 tomatoes, 

tomatillos 0.5

Fruit, citrus, group 10-10 10

10 calamondin, citrus 

citron, citrus hybrids, 

grapefruits, 

kumquats, lemons, 

limes, oranges, 

pummelos, 

tangerines, Satsuma 

mandarins

500 citrus oil

10 citrus fruits 

Po

Fruit, pome, group 11-10 5.0

5.0 apples, 

crabapples, loquats, 

mayhaws, pears, 

quinces

5 pome fruits Po

20 apple 

pomace, dry
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 39 of 47

Vegetable, leafy, except Brassica, 

subgroup 4A 30

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

**0.01 New Zealand 

spinach, spinach, 

vine spinach

10 lettuce, head

Vegetable, tuberous and corm, 

subgroup 1C 6.0 **0.02 potato

0.02 potato

10 sweet potato , 

yams Po

Pineapple 20

Dragon fruit 1.0

Leafy petioles crop subgroup 4B 15

0.01 cardoon, celery, 

celtuce, Chinese 

celery, fresh Florence 

fennel leaves and 

stalks, rhubarb, Swiss

chard

Milk 0.01 0.01 0.01 milks

Cattle, Goat, Horse, Sheep: meat 

byproducts 0.05

0.05 kidney and liver 

of cattle, goats, 

horses, sheeps

0.05 edible offal 

(mammalian) (*)

Cattle, Goat, Horse, Sheep: fat 0.05

0.05 fat of cattle, 

goats, horses, sheeps

Cattle, Goat, Horse, Sheep: meat 0.01 0.01 meat of cattle, 

goats, horses, sheeps

0.01 (*) meat 

from mammals 

other than 

marine 

mammals)

Completed: M. Negussie; 05/09/2012

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.

** = Levels to be harmonized as part of this joint review. 
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 40 of 47

Appendix II. Tolerance Assessment Calculations.

Fludioxonil

Celery

U.S.

0.864-0.892 lb ai/A

Total number of data (n) 8

Percentage of censored data 0%

Number of non-censored data 8

Lowest residue 2.000

Highest residue 8.600

Median residue 4.950

Mean 4.888

Standard deviation (SD) 2.224

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 8.600

- Mean + 4 SD 13.782

- CF x 3 Mean 14.663

Unrounded MRL 14.663

Rounded MRL 15

Residues (mg/kg) n

2 1

2.5 1

3.5 1

4.3 1

5.6 1

6.2 1

6.4 1

8.6 1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 41 of 47

Fludioxonil

Ginseng

U.S.

0.910-1.012 lb ai/A

Total number of data (n) 4

Percentage of censored data 0%

Number of non-censored data 4

Lowest residue 0.165

Highest residue 1.695

Median residue 0.288

Mean 0.609

Standard deviation (SD) 0.732

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 1.695

- Mean + 4 SD 3.536

- CF x 3 Mean 1.826

Unrounded MRL 3.536

Rounded MRL 4

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.165 1

0.18 1

0.395 1

1.695 1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 42 of 47

Fludioxonil

Bell Pepper Field + Greenhouse

U.S.

0.868-0.945 lb ai/A

Total number of data (n) 13

Percentage of censored data 15%

Number of non-censored data 11

Lowest residue 0.020

Highest residue 0.280

Median residue 0.130

Mean 0.138

Standard deviation (SD) 0.078

Correction factor for censoring (CF) 0.897

Proposed MRL estimate

- Highest residue 0.280

- Mean + 4 SD 0.449

- CF x 3 Mean 0.371

Unrounded MRL 0.449

Rounded MRL 0.5

Residues (mg/kg) n

<0.02 2

0.08 1

0.09 1

0.11 1

0.13 3

0.16 1

0.2 1

0.21 1

0.23 1

0.28 1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 43 of 47

Fludioxonil

Pineapple (post-harvest)

U.S.

TRT02 + TRT03

Total number of data (n) 8

Percentage of censored data 0%

Number of non-censored data 8

Lowest residue 4.760

Highest residue 6.620

Median residue 5.450

Mean 5.643

Standard deviation (SD) 0.675

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 6.620

- Mean + 4 SD 8.341

- CF x 3 Mean 16.928

Unrounded MRL 16.928

Rounded MRL 20

Residues (mg/kg) n

4.76 1

4.96 1

5.38 1

5.44 1

5.46 1

6.06 1

6.46 1

6.62 1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 44 of 47

Fludioxonil

Potato (post-harvest)

U.S.

all trtmnt

Total number of data (n) 8

Percentage of censored data 0%

Number of non-censored data 8

Lowest residue 0.664

Highest residue 3.230

Median residue 1.570

Mean 1.823

Standard deviation (SD) 0.945

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 3.230

- Mean + 4 SD 5.605

- CF x 3 Mean 5.469

Unrounded MRL 5.605

Rounded MRL 6

Residues (mg/kg) n

0.664 1

1.01 1

1.13 1

1.46 1

1.68 1

2.5 1

2.91 1

3.23 1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 45 of 47

Fludioxonil

Spinach

U.S.

0.867-0.911 lb ai/A

Total number of data (n) 11

Percentage of censored data 0%

Number of non-censored data 11

Lowest residue 1.900

Highest residue 16.000

Median residue 5.800

Mean 7.082

Standard deviation (SD) 4.273

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 16.000

- Mean + 4 SD 24.173

- CF x 3 Mean 21.245

Unrounded MRL 24.173

Rounded MRL 30

Residues (mg/kg) n

1.9 2

4.6 1

4.9 1

5.2 1

5.8 1

7.5 1

8.3 1

9.8 1

12 1

16 1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 46 of 47

Fludioxonil

Tomato (post-harvest)

U.S.

Spray

Total number of data (n) 3

Percentage of censored data 0%

Number of non-censored data 3

Lowest residue 0.175

Highest residue 1.830

Median residue 0.657

Mean 0.887

Standard deviation (SD) 0.851

Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 1.830

- Mean + 4 SD 4.292

- CF x 3 Mean 2.662

Unrounded MRL 4.292

Rounded MRL 5

High uncertainty of MRL estimate.

[Small dataset]

Residues (mg/kg) n

0.175 1

0.657 1

1.83 1
Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 47 of 47

Appendix III. Chemical Structures

Common Name/Code Chemical name Chemical structure

Fludioxonil/CGA 

173506

4-(2,2-difluoro-1,3-benzodioxol-4-

yl)-1H-pyrrole-3- carbonitrile

O

O

N

H

F

F

CN

CGA 344623 4-(2,2-difluoro-1,3-benzdioxol-4-

yl)-2,5-dioxo-3-pyrrolidine 

carboxylic acid O

O

F

F

O NH2

OH

O

CN

B-1 4-(2,2-difluoro-1,3-benzodioxol-4-

yl)-1H-pyrrole-3- carbonitrile, 2-Oglucose

O

O

N

H

F

F

CN

O-glucose

I-1 4-(2,2-difluoro-1,3-benzodioxol-4-

yl)-pyrrole-3- carbonitrile, 1-Osulfate ester

O

O

N

F

F

CN

OSO3H