Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

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### UNITED STA**TES ENVIRONMENTA L PROTECTION A** **GENCY**

**WA SHINGTON, D.C. 20460**  **OFFICE OF CHEMICAL SAFETY AND**  **POLLUTION PREVENTION** 

### MEMORANDUM **Date:** 21 - MAY - 201 2 **SUBJECT: Fludioxonil**  **.** Tolerance Petition s for Residues in/on Ginseng, Leaf y Petioles Crop Subgroup 4B, Pineapple (post - harvest treatment), Tuberous and Corm Vegetable Subgroup 1C , Tropical Fruit (post - harvest treatment), B ulb Onion S ubgroup 3 - 07A , Green Onion subgroup 3 - 07B , Caneberry Subgroup 13 - 07A , Bushberry

Subgroup 13 - 07B , Small Frui t Vine Climbing Subgroup 13 - 07F ( except fuzzy

kiwifruit), Low - Growing Berry Subgroup 13 - 07G ( except cranberry), Fruiting Vegetable Group 8 - 10 ( except tomato ), Citrus Frui t Group 10 - 10 , Pome Fruit Group 11 - 10 , Leaf y Vegetable ( except Brassica ) Subgroup 4A , Dragon Fruit , and Tomato (post - harvest treatment) . **Summary of Analytical Chemistry and Residue Data.**  **PC Code:** 071503 **DP Barcode:** D 389980 **Decision No s**  **.:** 44 7 5 49 , 448805 **Registration No s**  **. :**  100 - 953 , 100 - 1242 , 100 - 969 , 100 - 1308 **Petition No s**  **.:** 1E7853 , 1E7870 **Regulatory Action:** Section 3 Registration **Risk Assessment Type:** NA **Case No.:** 7017 **T XR No.:**  NA **CAS No.:** 131341 - 86 - 1 **MRID No s**  **.:** 48437101, 484373 - 01 thru - 0 5 , 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/L aura 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 ) - 1 H -py rrole - 3 - carbonitrile, is a phenyl py rrole, 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 Sy ngenta 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

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### 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 /1 3 /20 11 ) . Permanent tolerances have been established for res idues 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. Interregio nal 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 (ex cept Brassica ), dragon fruit, and tomato (post - harvest treatment) . Inaddition , Sy ngenta has submitted a petition (1E7870) for the use of fludioxonil on leafy petioles. The petitioner s 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 ) - 1 H -py rrole - 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 ppmFludioxonil 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 Lo w 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, le afy, 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 - 07 B ; 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 sub groups. Residue d ata for spinach, pepper, ginseng, and potato were reviewed with the Pest Management Regulatory Agency (PM RA) of Canada as part of a joint review. The nature of the fludioxonil residues in plants is adequatel y 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 (HPL C/UV) methods (Sy

ngenta 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 mass spectrometry

detection ( LC - MS/MS ) method, which is a modified version of Method AG - 597B. The LC - MS/MS method was adequatel y 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 o r 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 unlikel y 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 (M emo, 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 by products 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

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### LC - MS/MS Analy

tical 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 - benzodioxole 4 - carbox yl ic 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 a s 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 anal yz ed 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 set s 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 label specified 30 - day

plant -back interval (PBI) for crops without uses on the fludioxonil label. The available data indicate that to lerances are not currently required for rotational crops. There are currently

no established Codex, Canadian, or Mexican maximum residue limit s (MRL s ) for fludioxonil on tropical fruits. The following U.S., Canadian, and Codex tolerances/MRLs for residue s of fludioxonil are harmonized: bushberries, grapes, citrus fruits, and pome fruits. Additionally , the U.S. and Canadian tolerances/MRL s for tuberous and corm vegetables subgroup 1C , spinach, fruiting vegetables except tomato, and ginseng are being harm onized as part of this joint review. The U.S., Canadian, and Codex tolerances/MRL s for residues of fludioxonil in/on bulb onions, caneberries, grapes (small vine climbing f ruit, subgroup 13 - 07F) , strawberries (low - growing berry subgroup 13 - 07G), tomato e s, and leafy vegetables cannot be harmonized as the Canadian, and Codex MRL s 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 o nion subgroup 3 - 07A , small vine climbing f ruit subgroup 13 - 07F , and low growing 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. 2 0 to 0. 5 0 ppm , small vine climbing f

ruit 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/MRL s cannot be harmonized for green onions , tomato es , 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/MRL s are harmonized.Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

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### 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 analy tical reference standard of CGA192155 (2,2 - difluoro - l,3 -benzodioxole - 4 - carbox yl ic acid) to the EPA Repository , there are no residue chemistry

issues that would preclude granting the requested registrations and the fol lowing permanent tolerances: The residue definition for the tolerance expression for “ 40 CFR § 180.51 6 (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 -py rrole - 3 - carbonitrile). Guava 5.0 ppm Feijoa 5.0 ppm Jabotic aba 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 Lo w 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 ppmFludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 6 of 47 Dragon fruit 1.0 ppm Leafy petiol es 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 ; v egetable, tuberous and corn, except potato, subgroup 1D ; v egetable, bulb, group 3; and leafy greens subgroup 4A, except spinach . 

### The re sidue definition for the tolerance expression for “ 40 CFR § 180.51 6 (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 -py rrole - 3 - carbonitrile), and its metabolites converted to 2,2 - difluoro - l,3 - benzodioxole - 4 - carbox yl ic 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 s ubgroup 3 - 07A , green onion subgroup 3 - 07B , caneberry

subgroup 13 - 07A , bushberry subgroup 13 - 07B , small frui t 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 Analy tical Reference Standards An anal ytical reference standard for fludioxonil is currentl y 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 - carbox yl ic 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 /Anal ytical 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

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### The letter of transmittal should include the assay of the standards, names of the anal ytical methods used, a statement of principal impurities, purification procedures employed, storage requirements, and special precautions for safe handling. Replacement of standards may be required periodicall y if supplies are exhausted or if decomposition occurs during storage. Material Safety Data Sheets (MSDSs) must accompany all anal ytical 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 level s 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 -py rrole fungicide which inhibits protein kinase (Group 12) , leading to reduced fungal growth and development. Inthe U.S., fludioxonil is registered to Sy ngenta 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 /1 3 /20 11 ) . The chemical structure, nomenclature, and phys icochemical 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 C NFludioxonil 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/cm3 ty pical 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 S yngenta 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 multiple active - ingredient (MAI) formulation that contains 25% fludioxonil and 37.5% cy prodinil. 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) Form

ulation Ty pe Target Crops Target Pests Label Date Switch® 62.5WG 100 -

953 25 WG A variety of fruit, nut, vegetable, and herb crops Soil, crow n, 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 CitrusFludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 9 of 47 **Table 4. Summary of Directions for Use of Fludioxonil.**  Applic. Timing, Ty pe, and Equip. Form

ulation [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% WDG 1

[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% WDG 1

[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 em ulsion. 50% WP [ 100 - 969 ] 0. 2 5 lb

ai/50 gal 0. 2 5 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 em ulsion. Use T - jet application system 50% WP [ 100 - 969 ] 0. 2 5 lb

ai/50 gal 0. 2 5 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 **Tom ato**  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

em ulsion. 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

em ulsion. 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

em ulsion. Dip for ~30 seconds. 50% WP [ 100 - 969 ] 0.5 lb

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

Page 10 of 47 **Table 4. Summary of Directions for Use of Fludioxonil.**  Applic. Timing, Ty pe, and Equip. Form

ulation [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 em ulsion. 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

em ulsion. 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 s ubgroup 3 - 07A , green onion subgroup 3 - 07B , caneberry subgroup 13 - 07A , bushberry subgroup 13 - 07B , small frui t vine climbing subgroup 13 - 07F ( except fuzzy kiwifruit), low - growing berry subgroup 13 - 07G ( except cranberry), and fruiting vegetable group 8 - 10 are revi sed 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 onl y the SC formulation. However, HED previously concluded that the formulation ty

pe (SC vs. WP) had no consistent effect on fludioxonil residues from postharvest uses (DP# 325160 , G . Kramer , 11 /1 6 /200 6 ) . 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

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### 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 py rrole ring followed b y formation of glucuronide or sulfate conjugates. In poultry , fludioxonil is metabolized by oxidation, ring hydrox yl ation, degradation of the p yrrole 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 purpose s of tolerance expression and risk assessment, are fludioxonil and Metabolite B - 1 [4 - (2',2' - difluoro - 1' ,3' -benzdioxol - 4' - yl ) - 1 H -py rrole - 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 ) -py rrole - 3 - carbonitrile, 1 - O - sulfate ester]. See Appendix I I I for chemical structure s. **860.1340 Residue Analytical Methods** Plants **Enforcement methods :**  Adequate HPLC/UV methods (Metho ds AG - 597 and AG - 597B) are available for enforcing tolerances of fludioxonil on plant commodities. The LOQs for these methods range from 0.0 08 to 0.05 ppm depending on the plant commodity . Inaddition, the QuEChERS method has been shown to adequately quantify residues of fludioxonil (http://www.crl -pesticides.eu/library /docs/fv/CRLFV_Multiresidue_method s.pdf ). **Data collection methods :**  In the submitted field trials and processing studies, residues of fludioxonil w ere determined using a LC - MS/MS method, which is a modified version of Method AG - 597 B. The modifications included performing one extraction instead of two, eliminating a solid -phase extraction column cleanup step s , 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 hex ane, and cleaned up using a silica solid -phase extraction cartridge eluted with dichloromethane:toluene (50:50, v/v). The cleaned extract was evaporated to dry ness, reconstituted in acetonitrile:water and anal yz ed b y 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 r eplicates) is 0.006 or 0.003 ppm. Conclusions : Adequate HPL C/UV methods are available for enforcing the proposed tolerance s 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 anal yz ed using Sy ngenta Analy

tical Method GRM025.03A, “Fludioxonil Analy tical Method for the Determination of Residues of Total Fludioxonil (CGA173506) and Metabolites as CGA192155 in Animal Matrices (mi lk, eggs, muscle, fat, liver, kidney , and whole blood). Final Determination by L C - 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 sampl es were placed either in a 500 - mLround bottom flask (milk and fat) or in a 250 - mLcentrifuge bottle (muscle, liver, and kidney). Acetonitrile was added to all samples. Muscle, liver, and kidney samples underwent high - speed homogenization and the homogen ate was transferred to a 250 - mLround 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 dry

ness and reconstituted in a KMnO 4

### / NaOH solution. Conversion of fludioxonil and its metabolites of regulatory concern to CGA192155 (2,2 - difluoro - 1 ,3 - benzodioxole - 4 - carbox yl ic acid) was carried out by heating the resulting mixture at 60 °C for 15 minutes. The oxidation was quenched with so dium metabisulfite. The oxidized extract was then filtered and acidified prior to partitioning into dichloromethane:ethyl acetate (80:20, v/v). The dichloromethane:ethylacetate extract was evaporated to dry ness, reconstituted in acetonitrile:water (50:5 0, v/v), then processed through Bond Elut®



### - C18 SPE cartridge clean - up. Final determination was by L C - MS/MS. The LOQ for fludioxonil and its metabolites was 0.01 ppm in all matrices. The method was validated concurrentl y with the ruminant feeding study b y 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 (HPL C/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_ev a/JMPR2004eva.pdf ). HED notes that Anal ytical Method GRM025.03A was modified by Morse Laboratories during anal ys is 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 Analy tical 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 c onverted to and determined as CGA192155 (2,2 - difluoro - 1 ,3 -benzodioxole - 4 - carbox yl ic 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/ 19 95 DP# 258870, W. Donovan, 12/20/ 19 99 DP# 258861, W. Donovan, 11/29/ 19 99 DP# 280799, W. Donovan, 2/28/20 02 DP# 287808, T. Bloem, 2/12/20 0 3 

### 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 month s 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 ob served in any plant commodities tested. **Table 5**  **. Summary of Storage Conditions and Intervals o f Sam** **ples from Crop Field Trial and**  **Processing**

**Studies .**  Matrix Storage Tem perature (°C) Actual Storage Duration Interval of Demonstrated Storage Stability **Ginseng (MRID**  **48437301** ) Ginseng , Dried Root - 29 to - 15 407 - 760 days 716 days 1 **Leaf Petioles Crop Subgroup 4B (M**  **RID 48478501** ) Celery < - 5 31 - 220 days **Pepper (bell and non -**  **bell) (MRID**  **48437303 &**  **48437304 )**  Pepper ~ - 20 oC 209 - 824 days 823 days 1 **Pineapple (post -**  **harvest treatm ent)**  **(M RID**  **48437302 )**  Pineapple < - 20 545 days Pineapple Juice, Process residue 573 days **Potato (M**  **RID 48437101**  **)** Potato < - 10 14 - 348 days Potato Flakes, Chips, Wet peel 146 - 153 days **Spinach (MRID**  **48437305 )**  Spinach ~ - 20 oC 134 - 568 days 578 days 1 **Tom ato**  **(MRID 48438204**  **)** To mato - 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 8 23 days. These data support theFludioxonil 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 t o the various magnitude of the residue studies. **860.1480 Meat, Milk, Poultry, and Eggs** DP# 39 2 314 , 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 h ad concluded that quantifiable residues of fludioxonil were unlikel y to occur in livestock commodities (DP# 287808, T. Bloem, 2/12/2003 ). The maximum dietary

burdens of liv estock 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 (M emo, 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 Com ponent % Dry

Matter 1 % Diet 1 Residues (ppm) 2 Dietary Contribution

(ppm) 3 **Beef Cattle** Alfalfa , hay R 8 9 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 wa ste CC 15 30 2.7 4 5.3 Flax , meal PC 88 5 0.0 5 0.00 3 TO TAL BURDEN **100 5**  **. 4**  **Dairy Cattle 5**  Alfalfa, forage R 35 20 0.01 0.006 Grass, hay R 88 25 0.01 0.003 Sorghum, grain CC 86 3 5 0.02 0.0 08 Potato, processed wa ste CC 15 10 2.7 4 1 . 8 Flax, meal PC 88 10 0.05 0.006 TO TAL BURDEN **100 1**  **. 8**  1 Potential dietary burdens for livestock were determined using recent Agency guidance on calculating reasonably balanced diets for livestock ( M emo, 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 day s. The target doses were 20 (5.4X for dairy , 1.8X for beef cattle) and 100 ppm ( 27 X for dairy , 9 . 1 X 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 fludioxoni l 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 Rumi**  **nant 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 (c alculated 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 0.0028 0 Ave. = 0.002 7

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 0.0041 0 Ave. = 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 0.00 487 - 0.01 Fat 5.4 0.00 238 - 0.05 2 Kidney 0.0189 - 0.0 5 3 M eat 0.00065 - 0.01 Liver 0.0 200 - 0.0 5 3 1 Calculated from dietary burden x average transfer coefficient from Table 10. 2 L evel 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 0.0 5 ppm for residues in fat and meat by products 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 (WIand 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 retre atment 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 earl y s enescence, with the last applicati on 14 to 15 days beforeFludioxonil 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 day s 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 commerciall y 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 day s averaged 0.26 ppm. No apparent explanation was provided for this observation. Residues in controls were <LOD. **Table 1**  **0 . 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. LAFT 1 HAFT 2 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 LAF T = 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 1 1 ). 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 anal yz ed using the OECD tolerance calculation procedures (see Appendix I I) . The recommended tolerance for residues of fludioxonil is 4 .0 ppm for ginseng . Leaf Petioles Crop Subgroup 4B DER Reference List 48478501.der.doc 

### Sy ngenta 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 fo liar broadcast applications of a WG MAIproduct 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 - 0.89 2 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 MAIproduct formulation (25% fludioxonil and 37.5% cy prodinil) 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. LAFT 2 HAFT 2 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 LAF T = 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 Gro wing Zones Celery Submitted Requested 1 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 anal yz ed using the OECD tolerance calculation procedures (see Appendix II) . The recommended tolerance for residues of fludioxonil is 15 ppm in/on leaf y 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 andFludioxonil 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 foliar directed applications of a WG MAIproduct 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 seas onal 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 day s between the second and third applications, and 6 to 8 days between the third and fourth applications. All application s 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 PHIof 0 days. Samples were also collected to generate residue decline data f rom 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 day s after the last application. Following four foliar applications of a WG MAI product formulation (25% fludioxonil and 37.5% cy prodinil) 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, respectivel y, at a 0 - day PHIwere <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); therefor e, residue decline could not be assessed. At the greenhouse trial, residues of fludioxonil generall y decreased with increasing PHI. **Table 1**  **4. 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. LAFT 2 HAFT 2 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 LAF T = 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 1 5 ). 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 Gro wing Zones Pepper Bell Non - bell Submitted Requested 1 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 I I) . Based on the combined field and greenhouse bell pepper data, the recommended tolerance for residues of fludioxonil is 0 . 5 0 ppm in/on pepper . The same value ( 0. 5 0 ppm) was also obtained using the combined field and greenhouse non -bell pepper data . Pineapple (post - harvest treatment) DER Reference List 48437302.de 1 .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 b y 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 RTIbetween 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 co llected 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 fludiox onil residues were 4.76 - 5.46 ppm (highest individual residueFludioxonil 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 appli cation 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. LAFT 2 HAFT 3 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 NA4 4 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 LAF T = lowest - average field trial. 3 HAFT = highest - average field trial. 4 NA = not applicable. 

### Conclusions : HED notes that the label directions specify that onl y 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 I I) . 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 

### Sy ngenta Crop Protection, Inc. submitted residue data for fludioxonil on potatoes following post harvest 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. Inall trials, fludioxonil was applied as aFludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

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### 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 avera ge 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 generall y 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 F**  **ludioxonil.** Commodity Analyte Total App. Rate DAA Residue Levels (ppm) 1 g ai/ 2000 lb lb ai/

2000 lb n Sample

Min. Sample

Max. LAFT 2 HAFT 2 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 Treat me**  **nts** 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 LAF T = lowest - average - field - tri al; HAFT = highest - average - field - trial. 3 N/A = n ot 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 anal yz ed using the OECD tolerance calculation procedures (seeFludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

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### Appendix II) . The recommended tolerance for residues of fludioxonil is 6 . 0 ppm in/on v egetable, 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 MAIproduct 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 RTI s ranged from 6 to 8 days between the first and second app lications 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 NI S 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 MAIproduct formulation (25% fludioxonil and 37.5% cy prodinil) at a total rate of 0.867 - 0.911 lb ai/A (fludioxonil). The submitted residue de cline 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. LAFT 2 HAFT 2 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 LAF T = 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 1 9 ). 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 Gro wing Zones Spinach Submitted Requested 1 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 anal yz ed using the OECD tolerance calculation procedures (see Appendix I I) . The recommended tolerance for residues of fludioxonil is 3 0 ppm in/on spinach (representative commodity of vegetable, leafy , except Brassica , subgroup 4A, a 30 -ppm tolerance is currently

established for l eafy

greens subgroup 4A, except spinach) . Tomato (post - harvest tre atment) DER Reference List 48438204.der.doc 

### Sy ngenta 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 t omatoes 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. Inthe 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, f ludioxonil 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, f

ludioxonil 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, f

ludioxonil 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 f ruit. For all applications, a NI S 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, andFludioxonil 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 (~2 X) 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. LAFT 2 HAFT 2 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)** To mato (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 - 0.241 3 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 LAF T = 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 tom atoes. 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 tom ato 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 tom ato. 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 f or f ludioxonil 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 m ethod 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 surf ace 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 supp ort 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 reco mmendation : 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 b y 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 f ruit 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 p omegranate 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 p omegranate 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 c itrus cro p group tolerance and the use of the 1.0 lb ai rate. Guava guava; feijoa; jaboticaba; wax jam bu; starfruit; passionfruit; acerola 5.0 ppm based on the stone fruit, pome fruit, and p omegranate 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 c onvert 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 label s 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 reco mmends that the tolerance be increased from 0.20 to 0.50Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 27 of 47 

### ppm in order to harmonize with Codex. Onion, Green Subgroup 3 - 07 B No new green onion crop field trial data were submitted. A tolerance for residues of fludioxonil in/on onion, green has been estab lished 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 label s 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 label s 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 13 B has been established at 2 .0 ppm [40 CFR §180.516]. IR- 4 has proposed to convert this tolerance to a crop subgroup 13 - 07 B 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 label s 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 b y 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 1 0 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 fr uit, citrus, group 10 - 10 is identical to the existing use on fruit, citrus, group 10 on the product label s 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 conv ert 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 l ow - 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 F ruit 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: azox ys trobin, cy prodinil, fludioxonil, and chlorothalonil.Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 29 of 47 

### ChemSAC Di **scussion and Recommendations: (3) Fludioxonil:**  Same reasoning as for cy prodinil. 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 an d 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 b y a spray directed to the peduncle (TRT02) or a drench plus wax followed b y 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 slightl y lower than in the proce ssing raw agricultural commodity (RAC; 5.40 ppm compared to 5.62 ppm, processing factor = 0.96), and residues in process residue were slightl y 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 2 1 . **Table 2**  **1 . Residue Data from Post**  **- harvest Pineapple Processing Study with Fludioxonil.**  Processed Commodity Total Application Rate (lb ai) 1 PHI

(days) Fludioxonil Residues 2

(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 RAC 5 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 process ed 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 : The se 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 

### Sy ngenta 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 containin g 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 appl ication 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 b y 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 <0.02 X), 0.0182 ppm in chips (resulting in a processing factor of 0.04 X), and 0.797 ppm in wet peel (resulting in a processing factor of 1.7 X). All of the processing factors calculated in this study were less than the maximum theoretical concentration factors of 4.7 X for dried potatoes (flakes and granules) and 4.0 X for processed waste (based on loss of water and separation of components; OPPTS 860.1520, Tables 2 and 3). The results from the p otato processing studies are discussed below and the residue data are summarized in Table 2 2 . **Table 2**  **2 . Residue Data from**  **Potato Processing Studies with Fludioxonil.** RAC Processed

Commodity Total Rate DAA 1 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 yi elds 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. Inaddition , 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 anal ytical reference standard for fludioxonil is currentl y available at the EPA National Pesticide Standards Repository (pers onal 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 - carbox yl ic 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 /Anal ytical 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 anal ytical methods used, a statement of principal impurities, purification procedures employed, storage requirements, and special precautions for safe handling. Replacement of standards may be required periodicall y if supplies are exhausted or if decomposition occurs during storage. MSDSs must accompany all anal ytical 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 [phenyl 14 

### C]fludioxonil to soil at ~1.0 lb ai/A. Based on the results f rom 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 RTI s , for a total rate of 1.0 lb ai/A (1 X 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 sample s were anal yz ed for residues of fludioxonil using an adequate HPL C/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 currentl y 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 MRL s for f ludioxonil 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/MRL s 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/MRL s for residues of fludioxonil in/on bulb onions, caneberries, grapes (small vine climbing f ruit, subgroup 13 - 07F) , strawberries (low - growing berry subgroup 13 - 07G), tomato es, and leafy vegetables cannot be harmonized as the Canadian, and Codex MRL s 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 f ruit subgroup 13 - 07F , and low growing 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. 2 0 to 0. 5 0 ppm , small vine climbing f

ruit 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/MRL s cannot be harmonized for green onions , tomato es , 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 . Com pliance 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 -py rrole - 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 5.0Fludioxonil 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. Lo w 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, l eafy, 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 . Com pliance 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 -py rrole - 3 - carbonitrile), and its metabolites converted to 2,2 - difluoro - l,3 -benzodioxole - 4 - carboxyli c 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 - 0.05Fludioxonil 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 **Rem ove:**  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 Straw berry 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 Analy tical Methodology . From: S. Willet Dated: 3/01/1995 DP Numbers: 216233 Subject: PP No. 4F43 15/4H5685. MAXIM ( Fludi oxonil; 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: 12/18/1995Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 35 of 47 

### DP Number: 258861 Subject: PP# 9E06049. Fludiox onil for use on Stone Fruits. Evaluation of Residue Data

and Anal ytical Methods . From: W. Donovan Dated: 11/29/99 DP Number: 261603 Subject: Fludioxonil. I ssues 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

Analy tical 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 SC TM 

### , EPA Registration #100 - xxx) for

Postharvest Use on Stone Fruit, Citrus Fruit, Pome Fruit, Kiwi, & Yam. From: G. Kramer Dated: 11/16/2006 DP Number s : 384857, 387809 Subject: **Fludioxonil;** Human - Health Assessment Scoping Document in Support of

Registration Review. From: W. Wassell , et al . Dated: 6 /1 3 /20 11Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 36 of 47 

### Attachments: Appendix I . Inte rnational Residue Limit Status S heet . Appendix II. Tolerance - Assessment Calculations. Appendix II I. Chemical Structures

cc: G. Kramer (RAB1) RDI: RAB1 Chemists (12/21/2011) G.F. Kramer:S10957:PY - S:(703)305 - 5079:7509P:RAB1Fludioxonil 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 Mexico 2 

### Codex 3 

### 40 CFR 180.516: Plant: fludioxonil, 4 - (2,2 - difluoro 1,3 -benzodioxol - 4 - yl) - 1 -H -pyrrole 3 - carbonitrile) Livestock: fludioxonil, including its metabolites and degradates, in or on the commodities in the table below . Com pliance 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 4 - (2,2 - dif luoro - 1,3 -benzodioxol 4 - yl) - 1 H -py

rrole - 3 - carbonitrile Plant: 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.

Commodity 1 Tolerance (ppm)/Maximum Residue Limit (mg/kg) US Canada Mexico 2 Codex 3 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 20Fludioxonil 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, dew berries (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 Lo w growing berry subgroup 13 - 07G, except cranberry 2.0 2 straw berries 3 straw berry Vegetable, fruiting group 8 - 10, except tomato 0. 5 0 ** 0.01 bell peppers, eggplants , ground cherries, non -bell peppers, pepinos, pepper hybrids 0.3 eggplant 1 p eppers, 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, dryFludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 39 of 47 Vegetable, l eafy, 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 p otato 0.02 p otato 10 sweet potato , yams Po Pineapple 20 Dragon fruit 1.0 Leafy petioles crop subgroup 4B 15 0.01 cardoon, ce lery, 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 e dible offal (mammalian) (*) Cattle, Goat, Horse, Sheep: fat 0.0 5 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 revie w.Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 40 of 47 **Appendix I**  **I. 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 1Fludioxonil 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 1Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 42 of 47 **Fludioxonil Bell Pepper Field +**  **Gr ee**  **nh ou**  **s e** 

**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 1Fludioxonil 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 1Fludioxonil 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 1Fludioxonil 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 1Fludioxonil 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 1Fludioxonil Summary of Analytical Chemistry and Residue Data DP# 389980

Page 47 of 47 

### Appendix III. Chemical Structure **s** Common Name/Code Chemical name Chemical structure Fludioxonil/CGA 173506 4 - (2,2 - difluoro - 1,3 -benzodioxol - 4 - yl) - 1 H - py rrole - 3 - carbonitrile O O N H F F C N

CGA 344623 4 - (2,2 - difluoro - 1,3 -benzdioxol - 4 - yl) - 2,5 - dioxo - 3 - pyrrolidine carboxylic acid O O F F O N H 2 O H O C N

B - 1 4 - (2,2 - difluoro - 1,3 -benzodioxol - 4 - yl) - 1 H - py rrole - 3 - carbonitrile, 2 - O glucose O O N H F F C N

O - g l u c o s e I - 1 4 - (2,2 - difluoro - 1,3 -benzodioxol - 4 - yl) - py rrole - 3 - carbonitrile, 1 - O sulfate ester O O N F F C N

O S O 3 H