Document ID: EPA-HQ-OPP-2011-0395-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-08-15T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                               WASHINGTON, D.C.  20460
                                       
	OFFICE OF
	CHEMICAL SAFETY AND
	POLLUTION PREVENTION

MEMORANDUM

Date:		21-MAY-2012

SUBJECT:	Fludioxonil.  Tolerance Petitions for Residues in/on Ginseng, Leafy Petioles Crop Subgroup 4B, Pineapple (post-harvest treatment), Tuberous and Corm Vegetable Subgroup 1C, Tropical Fruit (post-harvest treatment), Bulb Onion Subgroup 3-07A, Green Onion subgroup 3-07B, Caneberry Subgroup 13-07A, Bushberry Subgroup 13-07B, Small Fruit Vine Climbing Subgroup 13-07F (except fuzzy kiwifruit), Low-Growing Berry Subgroup 13-07G (except cranberry), Fruiting Vegetable Group 8-10 (except tomato), Citrus Fruit Group 10-10, Pome Fruit Group 11-10, Leafy Vegetable (except Brassica) Subgroup 4A, Dragon Fruit, and Tomato (post-harvest treatment).  Summary of Analytical Chemistry and Residue Data. 

PC Code:  071503
DP Barcode:  D389980
Decision Nos.:  447549, 448805
Registration Nos.:  100-953, 100-1242, 100-969, 100-1308
Petition Nos.:  1E7853, 1E7870
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  NA
Case No.:  7017
TXR No.:  NA
CAS No.:  131341-86-1
MRID Nos.:  48437101, 484373-01 thru -05, 48438204, 48478501
40 CFR:  §180.516

From:		George F. Kramer, Ph.D., Senior Chemist
		Risk Assessment Branch 1 (RAB1)
		Health Effects Division (HED, 7509P)

Through:	David E. Hrdy, Acting Branch Chief
		RAB1/HED (7509P)
         
To:		Barbara Madden/Laura Nollen, RM 05
         		Mary Waller/Lisa Jones, RM 21
	Registration Division (RD, 7505P)

Executive Summary

Fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile, is a phenyl-pyrrole, is a fungicide registered for use on a variety of field and vegetable crops, fruit trees, berries, herbs, and grasses.  It can be applied as a seed treatment, an at-planting soil application, and broadcast foliar applications.  Post-harvest uses are also allowed on selected fruit and root crops.  A total of 26 end-use products (EPs) containing fludioxonil are currently registered to Syngenta Crop Protection for use on food/feed crops.  These EPs contain 0.13 to 50% fludioxonil as the ai and are formulated as wettable-powders (WP), water-dispersible granules (WDG), flowable-concentrates (FlC), and dusts.  A human-health assessment scoping document in support of fludioxonil registration review has recently been completed (DP# 384857, W. Wassell et al., 6/13/2011).

Permanent tolerances have been established for residues of fludioxonil per se in/on a variety of plant commodities, ranging from 0.01 ppm on numerous commodities to 500 ppm on citrus oil [40 CFR §180.516(a)].  There are currently no tolerances for fludioxonil residues in livestock commodities.

Interregional Research Project No. 4 (IR-4) has submitted a petition (1E7853) for the use of fludioxonil on ginseng, pineapple (post-harvest treatment), tuberous and corm vegetable subgroup 1C, spinach, tropical fruit (post-harvest treatment), bulb onion, green onion, caneberry, bushberry, small fruit vine climbing (except fuzzy kiwifruit), low-growing berry (except cranberry), fruiting vegetables, citrus fruit, pome fruit, leafy vegetables (except Brassica), dragon fruit, and tomato (post-harvest treatment).  In addition, Syngenta has submitted a petition (1E7870) for the use of fludioxonil on leafy petioles.  The petitioners request that the following tolerances be established as a result of the proposed uses for the residues of fludioxonil (4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile) in/on:

                                  PP# 1E7853
Guava
                                     5 ppm
Feijoa
                                     5 ppm
Jaboticaba
                                     5 ppm
Wax jambu
                                     5 ppm
Starfruit
                                     5 ppm
Passionfruit
                                     5 ppm
Acerola
                                     5 ppm
Avocado
                                     5 ppm
Black sapote
                                     5 ppm
Mamey sapote
                                     5 ppm
Canistel
                                     5 ppm
Mango
                                     5 ppm
Papaya
                                     5 ppm
Sapodilla
                                     5 ppm
Star apple
                                     5 ppm
Lychee
                                    20 ppm
Longan
                                    20 ppm
Spanish lime
                                    20 ppm
Rambutan
                                    20 ppm
Pulasan
                                    20 ppm
Sugar apple
                                    20 ppm
Atemoya
                                    20 ppm
Custard apple
                                    20 ppm
Cherimoya
                                    20 ppm
Ilama
                                    20 ppm
Soursop
                                    20 ppm
Biriba
                                    20 ppm
Ginseng
                                    3.0 ppm
Onion, bulb subgroup 3-07A
                                    0.2 ppm
Onion, green subgroup 3-07B
                                    7.0 ppm
Caneberry subgroup 13-07A
                                    5.0 ppm
Bushberry subgroup 13-07B
                                    2.0 ppm
Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit
                                    1.0 ppm
Low growing berry subgroup 13-07G, except cranberry
                                    2.0 ppm
Vegetable, fruiting group 8-10, except tomato
                                    0.7 ppm
Tomato
                                    3.0 ppm
Fruit, citrus, group 10-10
                                    10 ppm
Fruit, pome, group 11-10
                                     5 ppm
Vegetable, leafy, except brassica, subgroup 4A
                                    30 ppm
Vegetable, tuberous and corm, subgroup 1C
                                    6.0 ppm
Pineapple
                                    8.0 ppm
Dragon-fruit
                                    1.0 ppm
                                  PP# 1E7870
Leafy petioles crop subgroup 4B
                                    14 ppm

No new data were submitted to support tolerances for residues in/on onion, bulb, subgroup 3-07A; onion, green, subgroup 3-07B; low-growing berry 13-07G crop subgroup; caneberry subgroup 13A; bushberry subgroup 13-07B; fruit, citrus, group 10-10; fruit, pome, group 11-10; or small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit.  IR-4 has requested that existing tolerances be expanded to their respective crop groups or crop subgroups.  Residue data for spinach, pepper, ginseng, and potato were reviewed with the Pest Management Regulatory Agency (PMRA) of Canada as part of a joint review.

The nature of the fludioxonil residues in plants is adequately understood based on adequate metabolism studies on peaches, grapes, onions, and head lettuce.  Based on the results from these studies, HED has determined that the residue of concern in plants following foliar applications, for tolerance enforcement and risk assessment purposes, is fludioxonil per se.

The nature of the residues in livestock is also understood based on the adequate goat and hen metabolism studies.  For purposes of tolerance enforcement and risk assessment, the residues of concern in ruminants are fludioxonil and Metabolite B-1, and the residues of concern in poultry are fludioxonil, CGA-344623, and Metabolite I-1.

Adequate high-performance liquid chromatography/ultraviolet light detector (HPLC/UV) methods (Syngenta Methods AG-597 and AG-597B) are available for enforcing tolerances for residues of fludioxonil in/on plant commodities.  In the current field trials and processing studies, residues of fludioxonil were determined using a liquid chromatography and tandem mass-spectrometry detection (LC-MS/MS) method, which is a modified version of Method AG-597B.  The LC-MS/MS method was adequately validated in conjunction with the analysis of field trial and processing study samples.  The validated limit of quantitation (LOQ) for fludioxonil was 0.01 or 0.02 ppm in each matrix, and the limit of detection (LOD) was 0.003 or 0.006 ppm. 

Based on the available goat and poultry metabolism data and the previously calculated dietary exposures of livestock to fludioxonil residues, HED had concluded that quantifiable residues of fludioxonil were unlikely to occur in livestock commodities.  As processed potato waste is a significant feedstuff for livestock (ruminants only), the dietary burden of fludioxonil was recalculated using the Agency's most recent guidance on constructing reasonably balanced livestock diets (Memo, 6/30/08).  Based upon this diet and the results of a newly submitted ruminant feeding study, tolerances for total fludioxonil residues should be established at 0.05 ppm for residues in fat and meat byproducts of cattle, goats, horses, and sheep and at 0.01 ppm for milk and for the meat of cattle, goats, horses, and sheep.
LC-MS/MS Analytical Method GRM025.03A (as modified in MRID# 48526508) is suitable as an enforcement method for livestock commodities as defined in Standard Operating Procedure (SOP) No. ACB-019 (9/15/08).  This is a common-moiety method in which fludioxonil and its metabolites of regulatory concern are converted to CGA192155 (2,2-difluoro-1,3-benzodioxole-4-carboxylic acid).

The submitted field trial residue data for ginseng, celery as a representative crop of the leaf petioles crop subgroup 4B, bell and non-bell peppers as a representative crop of the fruiting vegetable group 8-10 (except tomato), pineapple, potatoes as a representative crop of the tuberous and corm vegetable subgroup 1C, spinach as a representative commodity of leafy vegetable (except Brassica) subgroup 4A, and tomatoes are adequate.  The field trial data reflect the proposed use pattern; an adequate number of trials were conducted in the appropriate geographic regions; and samples were analyzed for the residue of concern using validated data-collection methods.  The storage intervals were also validated.  Using the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedures for the residue data sets indicate that the requested tolerance levels are not appropriate for several commodities (see below).  A revised Section F is requested.

The submitted pineapple and potato processing studies are also adequate.  Separate tolerances are not required for any of the processed fractions.

Adequate confined and limited field rotational crop trials are available and support the label-specified 30-day plant-back interval (PBI) for crops without uses on the fludioxonil label.  The available data indicate that tolerances are not currently required for rotational crops.

There are currently no established Codex, Canadian, or Mexican maximum residue limits (MRLs) for fludioxonil on tropical fruits.  The following U.S., Canadian, and Codex tolerances/MRLs for residues of fludioxonil are harmonized:  bushberries, grapes, citrus fruits, and pome fruits.  Additionally, the U.S. and Canadian tolerances/MRLs for tuberous and corm vegetables subgroup 1C, spinach, fruiting vegetables except tomato, and ginseng are being harmonized as part of this joint review.  

The U.S., Canadian, and Codex tolerances/MRLs for residues of fludioxonil in/on bulb onions, caneberries, grapes (small vine climbing fruit, subgroup 13-07F), strawberries (low-growing berry subgroup 13-07G), tomatoes, and leafy vegetables cannot be harmonized as the Canadian, and Codex MRLs differ.  For leafy vegetables except Brassica subgroup 4A, the U.S. and Canada are harmonized at 30 ppm, but a Codex MRL is established for head lettuce at 10 ppm.  For the bulb onion subgroup 3-07A, small vine climbing fruit subgroup 13-07F, and 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 0.20 to 0.50 ppm, small vine climbing fruit subgroup 13-07F from 1.0 to 2.0 ppm and low-growing berry subgroup 13-07G from 2.0 to 3.0 ppm.  The tolerances/MRLs cannot be harmonized for green onions, tomatoes, leafy vegetables except Brassica subgroup 4A, and leafy petioles as the U.S. residue data/use patterns necessitate a higher value.  For livestock commodities, the U.S. and Codex residue definitions are harmonized; however, the Canadian residue definition is not harmonized.  The numerical values for the U.S. and Canadian livestock tolerances/MRLs are harmonized.  

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of revised Sections B (see requirements under Directions for Use) and F (see requirements under Proposed Tolerances) and submission of an analytical reference standard of CGA192155 (2,2-difluoro-l,3-benzodioxole-4-carboxylic acid) to the EPA Repository, there are no residue chemistry issues that would preclude granting the requested registrations and the following permanent tolerances:

The residue definition for the tolerance expression for "40 CFR §180.516 (a) General. (1)" should be as follows:  Tolerances are established for residues of the fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile).

Guava
5.0 ppm
Feijoa
5.0 ppm
Jaboticaba
5.0 ppm
Wax jambu
5.0 ppm
Starfruit
5.0 ppm
Passionfruit
5.0 ppm 
Acerola
5.0 ppm
Avocado
5.0 ppm
Black sapote
5.0 ppm
Mamey sapote
5.0 ppm
Canistel
5.0 ppm
Mango
5.0 ppm
Papaya
5.0 ppm
Sapodilla
5.0 ppm
Star apple
5.0 ppm
Lychee
20 ppm
Longan
20 ppm
Spanish lime
20 ppm
Rambutan
20 ppm
Pulasan
20 ppm
Sugar apple
20 ppm
Atemoya
20 ppm
Custard apple
20 ppm
Cherimoya
20 ppm
Ilama
20 ppm
Soursop
20 ppm
Biriba
20 ppm
Ginseng
4.0 ppm
Onion, bulb subgroup 3-07A
0.50 ppm
Onion, green subgroup 3-07B
7.0 ppm
Caneberry subgroup 13-07A
5.0 ppm 
Bushberry subgroup 13-07B
2.0 ppm
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit
2.0 ppm
Low growing berry subgroup 13-07G, except cranberry
3.0 ppm
Vegetable, fruiting group 8-10, except tomato
0.50 ppm
Tomato
5.0 ppm
Fruit, citrus, group 10-10
10 ppm
Fruit, pome, group 11-10
5.0 ppm
Vegetable, Leafy, except Brassica, subgroup 4A
30 ppm
Vegetable, tuberous and corm, subgroup 1C
6.0 ppm
Pineapple
20 ppm
Dragon fruit
1.0 ppm
Leafy petioles crop subgroup 4B
15 ppm
            Note to RD:  With the establishment of these tolerances, the following tolerances should be removed:  strawberry; grape; onion, bulb; onion, green; Caneberry subgroup 13A; bushberry subgroup 13B; juneberry; lingonberry; salal; vegetable, fruiting group 8; tomatillo; fruit, citrus, group 10; fruit, pome, group 11; vegetable, tuberous and corn, except potato, subgroup 1D; vegetable, bulb, group 3; and leafy greens subgroup 4A, except spinach.

The residue definition for the tolerance expression for "40 CFR §180.516 (a) General. (2)" should be as follows:  Tolerances are established for residues of the fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile), and its metabolites converted to 2,2-difluoro-l,3-benzodioxole-4-carboxylic acid, calculated as the stoichiometric equivalent of fludioxonil.

Milk
0.01 ppm
Cattle, meat byproducts
0.05 ppm
Cattle, meat 
0.01 ppm
Cattle, fat 
0.05 ppm
Goat, meat byproducts
0.05 ppm
Goat, meat 
0.01 ppm
Goat, fat 
0.05 ppm
Horse, meat byproducts
0.05 ppm
Horse, meat 
0.01 ppm
Horse, fat 
0.05 ppm
Sheep, meat byproducts
0.05 ppm
Sheep, meat 
0.01 ppm
Sheep, fat 
0.05 ppm

860.1200 Directions for Use

Adjuvants were not used in all of the submitted residue field trials.  Since adjuvants were not used in the ginseng, fruiting vegetables, bulb onion subgroup 3-07A, green onion subgroup 3-07B, caneberry subgroup 13-07A, bushberry subgroup 13-07B, small fruit vine climbing subgroup 13-07F (except fuzzy kiwifruit), low-growing berry subgroup 13-07G (except cranberry), and fruiting vegetable group 8-10 residue field trials, the label should prohibit adjuvant use on these crops.

860.1650 Submittal of Analytical Reference Standards

An analytical reference standard for fludioxonil is currently available at the EPA National Pesticide Standards Repository (personal communication with Theresa Cole, 8/15/11) with an expiration date of 5/30/13.  However, a reference standard of CGA192155 (2,2-difluoro-l,3-benzodioxole-4-carboxylic acid) should be sent to the Repository, which is located at Fort Meade, to the attention of Theresa Cole at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350
(Note that the mail will be returned if the extended zip code is not used.)

The letter of transmittal should include the assay of the standards, names of the analytical methods used, a statement of principal impurities, purification procedures employed, storage requirements, and special precautions for safe handling.  Replacement of standards may be required periodically if supplies are exhausted or if decomposition occurs during storage.  Material Safety Data Sheets (MSDSs) must accompany all analytical standards as specified by Occupational Safety and Health Administration (OSHA) in 29 CFR §1910.1200.

860.1550 Proposed Tolerances

A summary of the recommended tolerance levels along with recommendations for commodity definitions are presented in Table 23.  The petitioner is required to submit a revised Section F to reflect the recommendations in Table 23.

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

Background

Fludioxonil is a contact, phenyl-pyrrole fungicide which inhibits protein kinase (Group 12), leading to reduced fungal growth and development.  In the U.S., fludioxonil is registered to Syngenta for use on a wide variety of field and vegetable crops, fruit trees, berries, herbs, and grasses.  Fludioxonil is applied to food/feed crops as a seed treatment, at-planting soil application, and broadcast foliar applications.  Post-harvest uses are also allowed on selected fruit and root crops.  A human-health assessment scoping document in support of fludioxonil registration review has recently been completed (DP# 384857, W. Wassell et al., 6/13/2011).  The chemical structure, nomenclature, and physicochemical properties of fludioxonil are presented in Tables 1 and 2. 

Table A.1.  Fludioxonil Nomenclature.
Compound
                                       
Common name
Fludioxonil
Company experimental name
CGA-173506
IUPAC name
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile
CAS name
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile
CAS registry number
131341-86-1
End-use product (EP)
Switch[(R)] 62.5WG Fungicide (25% WDG; EPA Reg. No. 100-953)
Scholar[(R)] 230SC Fungicide (20.5% SC; EPA Reg. No. 100-1242)
Scholar[(R)] 50 WP Fungicide (50% WP; EPA Reg. No. 100-969)
Cannonball[(R)] 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
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/cm[3] typical at 23 °C

Water solubility (25 C)
1.8 mg/L

Solvent solubility (g/L at 20 C)
Ethanol	44,000
Acetone	190,000
Toluene	2,700
n-Octanol	20,000
n-Hexane	7.8

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

Dissociation constant (pKa)
pKa1 <0
pKa2 ~ 14.1

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

UV/visible absorption spectrum
12,384 L/mol x cm @ 266 nm (neutral solution)
12,327 L/mol x cm @ 265 nm (acidic solution)
11,790 L/mol x cm @ 271 nm (basic solution)

860.1200  Directions for Use

There are currently 26 EPs containing fludioxonil that are registered to Syngenta Crop Protection in the U.S. for use on food/feed crops.  These EPs contain 0.13 to 50% fludioxonil and are formulated as WPs, WDGs, FlCs, and dusts.  One of the formulations registered for foliar application on a variety of fruit, nut, vegetable, and herb crops is a 62.5% WDG, a multiple-active-ingredient (MAI) formulation that contains 25% fludioxonil and 37.5% cyprodinil.  This formulation is registered in the U.S. under the trade name Switch[(R)] 62.5 WG (EPA Reg. No. 100-953).  Other formulations include Cannonball[(R)] WP (EPA Reg. No. 100-1360), Scholar[(R)] (EPA Reg. No. 100-969), Graduate A+[(TM)] (EPA Reg. No. 100-1308), and Scholar[(R)] SC (EPA Reg. No. 100-1242).  Information pertaining to the proposed end-use product is listed in Table 3.  A summary of the proposed use patterns detailed in Table 4.  

Table 3.  Summary of Proposed End-Use Products.
Trade Name
                                   Reg. No.
                       ai (% fludioxonil of formulation)
                               Formulation Type
                                 Target Crops
                                 Target Pests
                                  Label Date
Switch[(R)] 62.5WG
                                    100-953
                                      25
                                      WG
              A variety of fruit, nut, vegetable, and herb crops
Soil, crown, and foliar diseases.
                        Draft labels submitted 3/28/11
Cannonball[(R)] WP
                                   100-1360
                                      50
                                      WP
                           Onions, berries, ginseng

Scholar[(R)]
                                    100-969
                                      50
                                      WP
                     Postharvest fruit, potatoes, tomatoes
Postharvest fungal diseases

Scholar[(R)] SC 
                                   100-1242
                                     20.4
                                      SC
                                       

Graduate A+[(TM)]
                                   100-1308
                                     20.6
                                      SC
                                    Citrus

Table 4.  Summary of Directions for Use of Fludioxonil.
                       Applic. Timing, Type, and Equip.
                                  Formulation
                                [EPA Reg. No.]
                                   App. Rate
                           Max. No. App. per Season
                            Max. Seasonal App. Rate
                                      PHI
                                    (days)
                        Use Directions and Limitations
                      Leafy Vegetables (except Brassica)
Broadcast foliar application, ground equipment only
                                  25% 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 emulsion.
                                       
                                    50% WP
                                   [100-969]
                               0.25 lb ai/50 gal
                                       
                               0.25 lb ai/50 gal
                                       

                                  Postharvest
                            Peduncle Spray (dilute)
                                   20.4% SC
                                  [100-1242]
                               0.24 lb ai/50 gal
                                       1
                               0.24 lb ai/50 gal
                                       
Mix in water or wax/water emulsion.
Use T-jet application system
                                       
                                    50% WP
                                   [100-969]
                               0.25 lb ai/50 gal
                                       
                               0.25 lb ai/50 gal
                                       

                                    Potato
                                  Postharvest
                             In-line Aqueous Spray
                                   20.4% SC
                                  [100-1242]
                            0.009 lb ai/ton tubers
                                       1
                            0.009 lb ai/ton tubers
                                       
Must tank mix with difenoconazole or azoxystrobin.
Use T-jet application system.
                                       
                                    50% WP
                                   [100-969]
                            0.009 lb ai/ton tubers
                                       
                            0.009 lb ai/ton tubers
                                       

                                    Tomato
                                  Postharvest
                              In-line Drip/Drench
                                   20.4% SC
                                  [100-1242]
                              0.48 lb ai/100 gal
                                       1
                              0.48 lb ai/100 gal
                                       
Mix in water or wax/water emulsion.
Must tank mix with propiconazole.
                                       
                                    50% WP
                                   [100-969]
                               0.5 lb ai/100 gal
                                       
                               0.5 lb ai/100 gal
                                       

                                  Postharvest
                             High-Volume (dilute)
                                   20.4% SC
                                   100-1242
                          0.25 lb ai/50,000 lbs fruit
                                       1
                          0.25 lb ai/50,000 lbs fruit
                                       
Mix in water or wax/water emulsion.
Use T-jet application system. 
Must tank mix with propiconazole.
Not for processing tomatoes.
                                       
                                    50% WP
                                   [100-969]
                          0.24 lb ai/50,000 lbs fruit
                                       
                          0.24 lb ai/50,000 lbs fruit
                                       

                                Tropical Fruit 
                                  Postharvest
                              In-line Drip/Drench
                                   20.4% SC
                                  [100-1242]
                              0.48 lb ai/100 gal
                                       1
                              0.48 lb ai/100 gal
                                       
Mix in water or wax/water emulsion.
Dip for ~30 seconds.
                                       
                                    50% WP
                                   [100-969]
                               0.5 lb ai/100 gal
                                       
                               0.5 lb ai/100 gal
                                       

                                 Citrus Fruit
                                  Postharvest
                              In-line Drip/Drench
                                   20.4% SC
                                  [100-1242]
                               1.0 lb ai/100 gal
                                       2
                               2.0 lb ai/100 gal
                                       
Mix in water or wax/water emulsion. 
Dip for 30 seconds minimum.
                                       
                                    50% WP
                                   [100-969]
                               1.0 lb ai/100 gal
                                       
                               2.0 lb ai/100 gal
                                       

                                       
                                   20.6% SC
                                  [100-1308]
                               1.0 lb ai/100 gal
                                       
                               2.0 lb ai/100 gal
                                       

                                  Postharvest
                In-line Aqueous Fruit Coating Spray Application
                                   20.4% SC
                                   100-1242
                          1.0 lb ai/250,000 lbs fruit
                                       2
                          2.0 lb ai/250,000 lbs fruit
                                       
Mix in water or wax/water emulsion.
Use T-jet application system. 
                                       
                                    50% WP
                                   [100-969]
                          1.0 lb ai/250,000 lbs fruit
                                       
                          2.0 lb ai/250,000 lbs fruit
                                       

                                       
                                   20.6% SC
                                  [100-1308]
                          1.0 lb ai/250,000 lbs fruit
                                       
                          2.0 lb ai/250,000 lbs fruit
                                       

[1]  Switch[(R)] 62.5 WG is an MAI formulation containing 25% fludioxonil and 37.5% cyprodinil.
[2]  A minimum PBI is 30 days for crops not listed on the label.

Conclusions:  The proposed use directions are sufficient to allow for evaluation of the available residue data.  Provided that the use directions for ginseng, fruiting vegetables, bulb onion subgroup 3-07A, green onion subgroup 3-07B, caneberry subgroup 13-07A, bushberry subgroup 13-07B, small fruit vine climbing subgroup 13-07F (except fuzzy kiwifruit), low-growing berry subgroup 13-07G (except cranberry), and fruiting vegetable group 8-10 are revised to prohibit the use of adjuvants, the available field trial data support the use directions for the proposed uses.

HED notes that postharvest uses are proposed for both SC and WP formulations; but residue data were provided for only the SC formulation.  However, HED previously concluded that the formulation type (SC vs. WP) had no consistent effect on fludioxonil residues from postharvest uses (DP# 325160, G. Kramer, 11/16/2006).  Data reflecting use of the WP formulation are thus not necessary.  

860.1300 Nature of the Residue - Plants

DP# 261603, W. Donovan, 12/14/1999
DP# 287808, T. Bloem, 2/12/2003
MARC Decision Memo, DP# 262022, W. Donovan, 1/18/2000

The nature of fludioxonil in plants is understood based on the adequate metabolism studies on peaches, grapes, onions, and head lettuce.  Based on the results from these studies, HED has determined that the residue of concern in plants following foliar applications, for tolerance enforcement and risk assessment purposes, is fludioxonil per se.

860.1300 Nature of the Residue - Livestock

DP# D210762, S. Willet, 12/18/1995
MARC Decision Memo, DP# D262022, W. Donovan, 1/18/2000

Adequate poultry and ruminant metabolism studies are available.  The metabolism of fludioxonil in ruminants involves hydroxylation of the pyrrole ring followed by formation of glucuronide or sulfate conjugates.  In poultry, fludioxonil is metabolized by oxidation, ring hydroxylation, degradation of the pyrrole moiety, and formation of glucuronide or sulfate conjugates.  Based on the results of these studies, HED has concluded that the residues of concern in ruminants, for purposes of tolerance expression and risk assessment, are fludioxonil and Metabolite B-1 [4-(2',2'-difluoro-1',3'-benzdioxol-4'-yl)-1H-pyrrole-3-carbonitrile, 2-O-glucuronide].  The residues of concern in poultry, for purposes of tolerance expression and risk assessment, are fludioxonil, CGA-344623 [2-cyano-3-(2,2-difluoro-1,3-benzdioxol-4-yl)succinamic acid], and Metabolite I-1 [4-(2',2'-difluoro-1',3'-benzdioxol-4'-yl)-pyrrole-3-carbonitrile, 1-O-sulfate ester].  See Appendix III for chemical structures.

860.1340 Residue Analytical Methods

Plants

Enforcement methods:  Adequate HPLC/UV methods (Methods AG-597 and AG-597B) are available for enforcing tolerances of fludioxonil on plant commodities.  The LOQs for these methods range from 0.008 to 0.05 ppm depending on the plant commodity.  In addition, the QuEChERS method has been shown to adequately quantify residues of fludioxonil (http://www.crl-pesticides.eu/library/docs/fv/CRLFV_Multiresidue_methods.pdf).  

Data collection methods:  In the submitted field trials and processing studies, residues of fludioxonil were determined using a LC-MS/MS method, which is a modified version of Method AG-597B.  The modifications included performing one extraction instead of two, eliminating a solid-phase extraction column cleanup steps, and using MS/MS quantitation instead of an ultraviolet (UV) detector.  

For determination of fludioxonil, a ten-gram sample was extracted with a acetonitrile:water (90:10, v/v).  This mixture was vacuum filtered and concentrated by rotary evaporation.  Residues were diluted with a saturated sodium chloride solution and partitioned into methyl tert-butyl ether.  The extracts were then solvent exchanged into toluene, diluted with hexane, and cleaned up using a silica solid-phase extraction cartridge eluted with dichloromethane:toluene (50:50, v/v).  The cleaned extract was evaporated to dryness, reconstituted in acetonitrile:water and analyzed by LC-MS/MS in the negative electrospray ionization mode.  The validated LOQ (determined as the lowest level of method validation (LLMV)) is 0.01 or 0.02 ppm for each matrix, and the LOD (standard deviation at the LLMV multiplied by the one-tailed t-statistic at the 99% confidence level for n-1 replicates) is 0.006 or 0.003 ppm.  

Conclusions:  Adequate HPLC/UV methods are available for enforcing the proposed tolerances and the residue data and processing studies were determined using an adequate LC-MS/MS method.  
Livestock

DP# 392314, G. Kramer, in preparation.

Samples were analyzed using Syngenta Analytical Method GRM025.03A, "Fludioxonil-Analytical Method for the Determination of Residues of Total Fludioxonil (CGA173506) and Metabolites as CGA192155 in Animal Matrices (milk, eggs, muscle, fat, liver, kidney, and whole blood).  Final Determination by LC-MS/MS," Version 2.  Method modifications were issued by the laboratory to add a solid-phase extraction (SPE) cleanup step.  In brief, 10-g subsamples of milk or tissue samples were placed either in a 500-mL round bottom flask (milk and fat) or in a 250-mL centrifuge bottle (muscle, liver, and kidney).  Acetonitrile was added to all samples.  Muscle, liver, and kidney samples underwent high-speed homogenization and the homogenate was transferred to a 250-mL round bottom flask.  Milk and fat samples were not homogenized.  Concentrated ammonium hydroxide was added to all samples.  All samples then underwent ammonium hydroxide:acetonitrile (80:20, v/v) mixture reflux extraction.  The resulting extract was filtered, acidified, and partitioned with toluene following the addition of salt water in a separatory funnel.  The toluene layer was filtered, and an aliquot of the filtrate was evaporated to dryness and reconstituted in a KMnO4/NaOH solution.  Conversion of fludioxonil and its metabolites of regulatory concern to CGA192155 (2,2-difluoro-1,3-benzodioxole-4-carboxylic acid) was carried out by heating the resulting mixture at 60 °C for 15 minutes.  The oxidation was quenched with sodium metabisulfite.  The oxidized extract was then filtered and acidified prior to partitioning into dichloromethane:ethyl acetate (80:20, v/v).  The dichloromethane:ethyl acetate extract was evaporated to dryness, reconstituted in acetonitrile:water (50:50, v/v), then processed through Bond Elut[(R)]-C18 SPE cartridge clean-up.  Final determination was by LC-MS/MS.  The LOQ for fludioxonil and its metabolites was 0.01 ppm in all matrices.  The method was validated concurrently with the ruminant feeding study by spiking untreated control samples (n = 14 per spiking level for whole milk and n = 2 per spiking level for tissues) with fludioxonil at 0.01 ppm and 1.0 ppm.  Recoveries of fludioxonil in milk and tissues were acceptable, ranging from 85-104% at the 0.01-ppm level and from 66-104% at the 1.0-ppm spiking level.  The LOQ was reported as 0.01 ppm for fludioxonil in milk and tissues.  

An earlier version of this method (HPLC/UV instead of LC-MS/MS detection) was evaluated by JMPR and found to be acceptable based on acceptable recoveries, and successful independent laboratory validation and radiovalidation (http://www.fao.org/ag/AGP/AGPP/Pesticid/JMPR/Download/2004_eva/JMPR2004eva.pdf).  HED notes that Analytical Method GRM025.03A was modified by Morse Laboratories during analysis of samples from ruminant feeding study (MRID# 48526508) to include a SPE clean-up step.  This revision eliminated the need for using matrix-matched standards.

Conclusions:  LC-MS/MS Analytical Method GRM025.03A (as modified in MRID# 48526508) is suitable as an enforcement method for livestock commodities as defined in Standard Operating Procedure (SOP) No. ACB-019 (9/15/08).  This is a common-moiety method in which fludioxonil and its metabolites of regulatory concern are converted to and determined as CGA192155 (2,2-difluoro-1,3-benzodioxole-4-carboxylic acid).
860.1360 Multiresidue Methods

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

Multiresidue method testing data are available for fludioxonil.  Fludioxonil was tested according to Protocols C, D, and E using sorghum, corn, and potatoes.  Recoveries were inadequate using corn and sorghum; however, fludioxonil was recovered from potatoes, a representative nonfatty crop.  Testing was not conducted according to protocols A and B as fludioxonil does not have an N-methylcarbamate structure (protocol A) nor is it an acid or phenol (protocol B).  Recoveries from potatoes (using multiresidue protocol D) were 49 to 121% at the 0.05-ppm fortification level, and 78 to 87% at the 0.5-ppm fortification level.

860.1380 Storage Stability

DP# 216233, S. Willett, 8/17/1995
DP# 258870, W. Donovan, 12/20/1999
DP# 258861, W. Donovan, 11/29/1999
DP# 280799, W. Donovan, 2/28/2002
DP# 287808, T. Bloem, 2/12/2003

Adequate storage stability data are available indicating that fludioxonil is completely stable at 
-20 °C for at least 24 months in corn grain and forage, sweet corn ears, sorghum hay, and potatoes; 28.5 months in grapes; 12 months in carrots, broccoli, cabbage, and mustard greens; 6 months in corn meal, sorghum flour and potato flakes; and 4 months in stone fruits and raspberries.  To date, no decline of fludioxonil during frozen storage has been observed in any plant commodities tested.  

Table 5.  Summary of Storage Conditions and Intervals of Samples from Crop Field Trial and Processing Studies.
Matrix 
                           Storage Temperature (°C)
                            Actual Storage Duration
                  Interval of Demonstrated Storage Stability
Ginseng (MRID 48437301)
Ginseng, Dried Root
                                  -29 to -15
                                 407-760 days
                                  716 days[1]
Leaf Petioles Crop Subgroup 4B (MRID 48478501)
Celery
                                    <-5
                                  31-220 days
                                       
Pepper (bell and non-bell) (MRID 48437303 & 48437304)
Pepper
                                   ~-20 ºC
                                 209-824 days
                                  823 days[1]
Pineapple (post-harvest treatment) (MRID 48437302)
Pineapple
                                    <-20
                                   545 days
                                       
Pineapple Juice, Process residue
                                       
                                   573 days
                                       
Potato (MRID 48437101)
Potato
                                    <-10
                                  14-348 days
                                       
Potato Flakes, Chips, Wet peel
                                       
                                 146-153 days

Spinach (MRID 48437305)
Spinach
                                   ~-20 ºC
                                 134-568 days
                                  578 days[1]
Tomato (MRID 48438204)
Tomato
                                   -20 +- 5
                                 199-274 days
                                   475 days
[1]  Concurrent storage stability study.

Conclusions:  Adequate storage stability data have been submitted.  Residues of fludioxonil were stable in all plant matrices during freezer storage for up to 823 days.  These data support the storage conditions and intervals of samples collected from the various crop field trials.  There are no unresolved storage stability issues, and no corrections need to be applied to the various magnitude of the residue studies.  

860.1480 Meat, Milk, Poultry, and Eggs

DP# 392314, G. Kramer, in preparation.

Based on the available goat and poultry metabolism data and the previously calculated dietary exposures of livestock to fludioxonil residues, HED had concluded that quantifiable residues of fludioxonil were unlikely to occur in livestock commodities (DP# 287808, T. Bloem, 2/12/2003).  The maximum dietary burdens of livestock to fludioxonil residues were previously calculated to be 0.13 ppm for beef cattle, 0.11 ppm for dairy cattle, 0.03 ppm for poultry, and 0.02 ppm for swine.

As processed potato waste is a significant feedstuff for livestock (ruminants only), the dietary burden of fludioxonil was recalculated for this petition using the Agency's most recent guidance on constructing reasonably balanced livestock diets (Memo, 6/30/08), the recalculated dietary burdens for fludioxonil residues are 11 ppm for beef and 3.7 ppm for dairy cattle (Table 6).  

Table 6.  Calculation of Dietary Burdens of Fludioxonil Residues for Livestock.
Feedstuff
                               Dietary Component
                                % Dry Matter[1]
                                   % Diet[1]
                                   Residues
                                   (ppm)[2]
                         Dietary Contribution (ppm)[3]
Beef Cattle
  Alfalfa, hay
                                       R
                                      89
                                      15
                                     0.01
                                     0.002
  Corn, grain
                                      CC
                                      88
                                      25
                                     0.02
                                     0.006
  Sorghum, grain
                                      CC
                                      86
                                      25
                                     0.02
                                     0.006
  Potato, processed waste
                                      CC
                                      15
                                      30
                                    2.7[4]
                                      5.3
  Flax, meal
                                      PC
                                      88
                                       5
                                     0.05
                                     0.003
TOTAL 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
                                      35
                                     0.02
                                     0.008
  Potato, processed waste
                                      CC
                                      15
                                      10
                                    2.7[4]
                                      1.8
  Flax, meal
                                      PC
                                      88
                                      10
                                     0.05
                                     0.006
TOTAL BURDEN
                                      100
                                       
                                      1.8
[1]  Potential dietary burdens for livestock were determined using recent Agency guidance on calculating reasonably balanced diets for livestock (Memo, 6/30/2008).
[2]  The tolerance level for the RAC was used for any associated processed fractions unless otherwise indicated.
[3]  Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle; contribution = ([tolerance] X % diet) for poultry and swine.
[4]  Multiplication of the potato median residue (1.57 ppm) by the wet peel processing factor of 1.7X = 2.7 ppm.
[5]  Although there is a 30-ppm tolerance for leaves of root and tuber vegetables, turnips tops were not included in the diet for dairy cattle as the label prohibits the feeding of leaves of root and tuber vegetables to livestock.

Dairy cattle feeding study (MRID# 48526508)

Fludioxonil was administered orally in treated feed to dairy cows for 28 consecutive days.  The target doses were 20 (5.4X for dairy, 1.8X for beef cattle) and 100 ppm (27X for dairy, 9.1X for beef cattle).  In whole milk samples, maximum total residues of fludioxonil and its metabolites converted to CGA192155 were 0.030 ppm in day-28 samples from the 20-ppm dosing group and 0.153 ppm in day-17 samples from the 100-ppm dosing group.  In muscle, total residues of fludioxonil and its metabolites converted to CGA192155 were not quantifiable in either dosing group.  In fat, total residues of fludioxonil and its metabolites converted to CGA192155 were <0.01 ppm at the 20-ppm dose level and 0.032 ppm at the 100-ppm dose level.  There was a linear relationship between the feeding level and total fludioxonil in kidney and liver.  Total residues of fludioxonil in kidney were 0.062 ppm at the 20-ppm dose level and 0.266 ppm at the 100-ppm dose level.  In liver, total fludioxonil residues were 0.055 ppm at the 20-ppm dose level and 0.293 ppm at the 100-ppm dose level.

Table 7.  Summary of Residue Data from Ruminant Feeding Study with Fludioxonil.[1]
Matrix
                          Target Feeding Level (ppm)
                            Residue Levels (ppm)[2]

                                       n
                                     Min.
                                     Max.
                                    Median
                                     Mean
                                   Std. Dev.
Whole milk/day 17
                                       0
                                       2
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                       -

                                      20
                                       6
                                     0.012
                                     0.056
                                     0.019
                                     0.029
                                     0.020

                                      100
                                       6
                                     0.099
                                     0.255
                                     0.130
                                     0.153
                                     0.063
Fat
                                       0
                                       2
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                       -

                                      20
                                       6
                                   <0.010
                                     0.011
                                     0.010
                                     0.010
                                     0.000

                                      100
                                       6
                                     0.030
                                     0.033
                                     0.031
                                     0.032
                                     0.001
Muscle
                                       0
                                       2
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                       -

                                      20
                                       6
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                       0

                                      100
                                       6
                                     0.010
                                     0.012
                                     0.011
                                     0.011
                                     0.001
Liver
                                       0
                                       2
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                       -

                                      20
                                       6
                                     0.038
                                     0.079
                                     0.051
                                     0.055
                                     0.014

                                      100
                                       6
                                     0.263
                                     0.349
                                     0.281
                                     0.293
                                     0.031
Kidney
                                       0
                                       2
                                   <0.01
                                   <0.01
                                   <0.01
                                   <0.01
                                       -

                                      20
                                       6
                                     0.048
                                     0.082
                                     0.056
                                     0.062
                                     0.015

                                      100
                                       6
                                     0.236
                                     0.289
                                     0.273
                                     0.266
                                     0.024
[1]  The LOQ for fludioxonil in all matrices analyzed was reported as 0.01 ppm.
[2]  Total residues of fludioxonil and its metabolites converted to CGA192155.

Expected secondary residues in meat and milk

To determine the need for tolerances for fludioxonil residues in milk and tissues, the anticipated secondary residues in cattle matrices were estimated using transfer coefficient factors calculated from the maximum residues of fludioxonil observed in the ruminant feeding study.  The transfer coefficients (calculated as residue-level-to-feed ratios) are presented in Table 8.  The transfer coefficient for each matrix was then used to calculate the expected secondary residues by multiplying the transfer coefficient by the calculated dietary burden (Table 6).  

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
                                    0.00280
                                 Ave. = 0.0027

                                     0.255
                                      100
                                    0.00255
                                       
Fat
                                     0.011
                                      20
                                    0.00055
                                Ave. = 0.00044

                                     0.033
                                      100
                                    0.00033
                                       
Muscle 
                                   <0.01
                                      20
                                  <0.0001

                                     0.012
                                      100
                                    0.00012
Kidney
                                     0.082
                                      20
                                    0.00410
                                 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
                                    0.00487
                                       -
                                     0.01
Fat
                                      5.4
                                    0.00238
                                       -
                                    0.05[2]
Kidney
                                       
                                    0.0189
                                       -
                                    0.05[3]
Meat 
                                       
                                    0.00065
                                       -
                                     0.01
Liver
                                       
                                    0.0200
                                       -
                                    0.05[3]
[1]  Calculated from dietary burden x average transfer coefficient from Table 10.  
[2]  Level chosen to harmonize with Canadian MRL.
[3]  Meat byproducts, level chosen to harmonize with Canadian and Codex MRLs.

Conclusions:  The feeding study data indicate that tolerances for total fludioxonil residues should be established at 0.05 ppm for residues in fat and meat byproducts of cattle, goats, horses, and sheep and at 0.01 ppm for milk and for the meat of cattle, goats, horses, and sheep.  

860.1500 Crop Field Trials

Ginseng

DER Reference List	48437301.der.doc

Four ginseng field trials were conducted for fludioxonil (Scholar[(R)] 50 WP) encompassing North American Free Trade Agreement (NAFTA) Growing Regions 5 (WI, two trials; Ontario (ON), one trial) and 11 (British Columbia (BC), one trial), the major ginseng growing regions of the U.S. and Canada, during the 2005 (WI and ON) and 2006 (BC) growing seasons.

Each field trial site consisted of one untreated control plot and one treated plot.  Common cultural practices were followed to maintain the ginseng crop.  Additional maintenance pesticides and fertilizers were used at all of the sites to produce a commercial quality crop.

At each trial location, the treated plot received four foliar broadcast applications (ground equipment) of fludioxonil (Scholar[(R)] 50 WP formulation) at 0.162-0.260 lb ai/A, with a 12- to 15-day retreatment interval (RTI), for a total seasonal rate of 0.910-1.012 lb ai/A (1X).  No adjuvants were used in any of the trials.  At all of the trials, the applications were made when the ginseng plants were blooming to early senescence, with the last application 14 to 15 days before harvest.  At the ON trial, additional harvests of the ginseng root were made at 2, 7, and 21 days after the last application.  All applications were made using appropriate equipment, and the carrier volume was sufficient to provide adequate dispersal of the test substance [96-196 gallons per acre (GPA); 903-1830 liters per hectare (LPH)].

Ginseng samples were harvested using techniques simulating commercial practices.  The roots were dried in commercial drying facilities or in research facilities simulating commercial drying practices.  The roots were dried to a commercially acceptable texture.

Per-trial-average residues of fludioxonil residues ranged from 0.165 ppm to 1.695 ppm in/on four ginseng trials with samples harvested at a 14- to 15-day pre-harvest interval (PHI; highest individual residue of 1.75 ppm).  For the samples from the ON trial, the reported fludioxonil residues in the treated samples increased with time after the last application.  For this trial, residues in the treated samples harvested at a PHI of 2 days averaged 0.09 ppm and the residues in the dried root samples harvested at a PHI of 21 days averaged 0.26 ppm.  No apparent explanation was provided for this observation.  Residues in controls were <LOD.

Table 10.  Summary of Residue Data from Crop Field Trials with Ginseng.
Commodity; Treatment
                                    Analyte
                         Total Applic. Rate (lb ai/A)
                                  [kg ai/ha]
                                  PHI (days)
                             Residue Levels (ppm)

                                       n
                                  Sample Min.
                                  Sample Max.
                                    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]  LAFT = lowest-average field trial.
[2]  HAFT = highest-average field trial.

Conclusions:  The submitted residue data are adequate to fulfill data requirements for ginseng.  The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 11).  The available data will support the proposed use pattern.

Table 11.  Trial Numbers and Geographical Locations.
NAFTA Growing Zones
                                    Ginseng
                                       
                                   Submitted
                                   Requested
                                       
                                       
                                    Canada
                                     U.S.
5
                                       3
                                       2
                                       3
11
                                       1
                                       1
                                      --
Total
                                       4
                                       3
                                       3

The residue data for ginseng were analyzed using the OECD tolerance calculation procedures (see Appendix II).  The recommended tolerance for residues of fludioxonil is 4.0 ppm for ginseng. 

Leaf Petioles Crop Subgroup 4B

DER Reference List	48478501.der.doc

Syngenta Crop Protection has submitted field trial data for fludioxonil on celery.  Eight field trials were conducted in the U.S. during the 2009 growing season in NAFTA Growing Zones 3 (FL; 2 trials), 5 (WI; 1 trial), and 10 (CA; 5 trials).

Each trial consisted of one untreated plot and one treated plot.  At each trial location, four foliar broadcast applications of a WG MAI product formulation (Switch[(R)] 62.5WG), containing 25% fludioxonil and 37.5% cyprodinil were made to celery at a target rate of 0.219 lb fludioxonil/A/application with 7-day RTI, for a total seasonal rate of 0.864-0.892 lb ai/A (1X).  All applications were made using ground equipment in concentrated spray volumes of 15-40 GPA.  A non-ionic surfactant (NIS) or crop oil concentrate (COC) was included in all of the tank mixes.  Samples of mature celery were harvested from all trials at a PHI of 0 days.  Celery samples were also collected from one trial site (CA; W29-9145) at 0, 3, 7, and 10 days after the last application to generate residue-decline data.  

Residues of fludioxonil (and per-trial averages) were 2.0-8.8 ppm (2.0-8.6 ppm) in/on celery harvested 0 days following the last of four foliar broadcast applications of a WG MAI product formulation (25% fludioxonil and 37.5% cyprodinil) at a total rate of 0.864-0.892 lb ai/A (fludioxonil).  

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

Table 12.  Summary of Residue Data from Crop Field Trials with Celery.
Commodity
                           Total App. Rate (lb ai/A)
                                  PHI (days)
                            Residue Levels (ppm)[1]

                                       n
                                    Sample
                                     Min.
                                    Sample
                                     Max.
                                    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]  LAFT = lowest-average-field-trial; HAFT = highest-average-field-trial.

Conclusions:  The submitted residue data are adequate to fulfill data requirements for celery as a representative crop of the leaf petioles crop subgroup 4B.  The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 13).  The available data will support the proposed use pattern.

Table 13.  Trial Numbers and Geographical Locations.
NAFTA Growing Zones
                                    Celery

                                   Submitted
                                 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 analyzed using the OECD tolerance calculation procedures (see Appendix II).  The recommended tolerance for residues of fludioxonil is 15 ppm in/on leafy petioles crop subgroup 4B. 

Pepper (bell and non-bell)

DER Reference List	48437303.der.doc

IR-4 has submitted outdoor field and greenhouse trial data for fludioxonil on peppers (bell and 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 MAI product formulation (Switch[(R)] 62.5WG), containing 25% fludioxonil and 37.5% cyprodinil were made to peppers at a target rate of 0.219 lb fludioxonil/A/application, for a total seasonal rate of 0.868-0.945 lb ai/A (fludioxonil).  The RTI ranged from 5 to 7 days between the first and second applications, 18 to 23 days between the second and third applications, and 6 to 8 days between the third and fourth applications.  All applications were made using tractor-mounted or portable ground equipment in spray volumes of 25-214 GPA without an adjuvant.  Samples of mature peppers were harvested from all trials at a PHI of 0 days.  Samples were also collected to generate residue decline data from one outdoor trial site (09567.06-ON03) at 0, 1, 3, 6, and 13 days after the last application and from one greenhouse trial site (09140.06-ON01) at 0, 3, 7, and 12 days after the last application.

Following four foliar applications of a WG MAI product formulation (25% fludioxonil and 37.5% cyprodinil) at a total rate of 0.868-0.945 lb ai/A (fludioxonil), residues of fludioxonil (and per-trial averages) in/on bell and non-bell peppers, respectively, at a 0-day PHI were <0.02-0.29 ppm and 0.05-0.31 ppm (<0.02-0.28 ppm and 0.06-0.28 ppm) from the outdoor trials and 0.10-0.27 ppm and 0.15-0.25 ppm (0.11-0.23 ppm and 0.20 ppm) from the greenhouse trials.

The submitted fludioxonil residue decline data from the outdoor trial were all <LOQ (<0.02 ppm); therefore, residue decline could not be assessed.  At the greenhouse trial, residues of fludioxonil generally decreased with increasing PHI.

Table 14.  Summary of Residue Data from Pepper Outdoor Crop and Greenhouse Field Trials with Fludioxonil.
Commodity
                           Total App. Rate (lb ai/A)
                                  PHI (days)
                            Residue Levels (ppm)[1]

                                       n
                                    Sample
                                     Min.
                                    Sample
                                     Max.
                                    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]  LAFT = lowest-average-field-trial; HAFT = highest-average-field-trial.

Conclusions:  The submitted residue data are adequate to fulfill data requirements for bell and non-bell peppers.  The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 15).  The available data will support the proposed use pattern.
Table 15.  Trial Numbers and Geographical Locations.
NAFTA Growing Zones
                                    Pepper

                                     Bell
                                   Non-bell

                                   Submitted
                                 Requested[1]
                                   Submitted
                                 Requested[2]

                                       
                                    Canada
                                     U.S.
                                       
                                    Canada
                                     U.S.
2
                          2 (1 outdoor, 1 greenhouse)
                                      --
                                      2/1
                                      --
                                      --
                                      --
3
                                 1 (1 outdoor)
                                      --
                                      2/1
                                 1 (1 outdoor)
                                      --
                                      --
4
                               1 (1 greenhouse)
                                      --
                                      --
                                      --
                                      --
                                      --
5
                                 3 (3 outdoor)
                                      --
                                      1/1
                                 1 (1 outdoor)
                                      --
                                      --
5A
                               2 (2 greenhouse)
                                      --
                                      --
                                      --
                                      --
                                      --
5B
                                 1 (1 outdoor)
                                      --
                                      --
                                      --
                                      --
                                      --
6
                                 1 (1 outdoor)
                                      --
                                      1/1
                                 2 (1 outdoor,
                                 1 greenhouse)
                                      --
                                      --
8
                                      --
                                      --
                                      --
                                 2 (2 outdoor)
                                      --
                                      --
10
                                 2 (2 outdoor)
                                      --
                                      2/2
                                      --
                                      --
                                      --
Total
                                      13
                           (9 outdoor, 4 greenhouse)
                                       
                                      8/6
                                      6 
                           (5 outdoor, 1 greenhouse)
                                       -
                                     3[3]
[1]  As per OCSPP 860.1500, Tables 1 and 5 for bell pepper; the second number reflects a 25% reduction in the number of trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifiable residues.
[2]  As per OCSPP 860.1500, Table 1, three trials are requested for non-bell peppers.  The geographical locations are not specified.

The residue data for peppers were analyzed using the OECD tolerance calculation procedures (see Appendix II).  Based on the combined field and greenhouse bell pepper data, the recommended tolerance for residues of fludioxonil is 0.50 ppm in/on pepper.  The same value (0.50 ppm) was also obtained using the combined field and greenhouse non-bell pepper data.

Pineapple (post-harvest treatment)

DER Reference List	48437302.de1.doc

Four pineapple post-harvest field trials were conducted for fludioxonil (Scholar[(R)] 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[(R)] 230SC formulation) in either a dip plus wax followed by a spray directed to the peduncle (TRT02) or a drench plus wax followed by a spray directed to the peduncle (TRT03).  The test substance was applied at approximate rates of 0.507 lb ai/100 gal (dip and drench, 1X) and 0.507 lb ai/7 gal (spray).  The fruit was allowed to air dry with a 0.75- to 3.25-hour RTI between the dip/drench and spray applications, and samples of pineapple fruit without crowns were collected following the spray application after the test substance had dried.  Additional samples were collected from the TRT01 untreated and TRT03 lot of HI05 pineapples to generate samples for processing into juice and process residue.  Fruit wax (Sta-Fresh 7051 or Sta-Fresh 7055) was used as an adjuvant at all trials.

Per-trial-average-residues of fludioxonil residues were 4.76-5.46 ppm (highest individual residue of 6.50 ppm; average 5.26 ppm) in/on four pineapple trials with post-harvest samples treated with a dip application of approximately 0.507 lb ai + fruit wax per 100 gal solution and a spray application of approximately 0.507 lb ai/7 gal; and from 4.96 ppm to 6.62 ppm (highest individual residue of 7.18 ppm; average 6.02 ppm) in/on four pineapple trials with post-harvest samples treated with a drench application of approximately 0.507 lb ai + fruit wax per 100 gal solution and a spray application of approximately 0.507 lb ai/7 gal.  Residues in controls were <0.02 ppm.

The maximum storage interval for treated samples in this study was 545 days (approximately 18 months).  Adequate storage stability data are available to support the storage conditions and durations for the samples in the present study.

Table 16.  Summary of Residue Data from Post-harvest Pineapple Field Trials with Fludioxonil.
Commodity; Treatment
                                    Analyte
                       Total Application Rate (lb ai)[1]
                                  PHI (days)
                             Residue Levels (ppm)

                                       n
                                  Sample Min.
                                  Sample Max.
                                    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
                                     NA[4]
                                       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]  LAFT = lowest-average field trial.
[3]  HAFT = highest-average field trial.
[4]  NA = not applicable.

Conclusions:  HED notes that the label directions specify that only a single post-harvest treatment is permitted and that the residue trials employed a second treatment.  However, the second treatment was directed to the peduncle and did not result in treatment of the whole fruit.  The submitted residue data are adequate thus to fulfill data requirements for pineapple.  The number of the crop field trials is adequate for a post-harvest treatment.  The available data will support the proposed use pattern.

The residue data for pineapple were analyzed using the OECD tolerance calculation procedures (see Appendix II).  Based on both data sets, the recommended tolerance for residues of fludioxonil is 20 ppm in/on pineapple.

Vegetable, tuberous and corm, subgroup 1C

DER Reference List	48437101.der.doc

Syngenta Crop Protection, Inc. submitted residue data for fludioxonil on potatoes following 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.  In all trials, fludioxonil was applied as a post-harvest treatment spray directed to tubers falling from a conveyor belt or moving along a roller table (TRT 02).  At the ID trial, three additional treatment scenarios were included:  surface spray (TRT 03); spray chamber (TRT 04); and brush table (TRT 05).  For each treatment, fludioxonil was applied at a rate of 0.0088-0.0099 lb ai/2000 lb potatoes (1X); the delivery rate was 0.22-0.54 gal/2000 lb potatoes.  

Samples of potatoes from each trial site were collected after the test substance had dried on the day of application [0 days after application (DAA)].  At three sites (WA, ON, and ID), additional treated samples were collected and placed in storage for 13-14, 30-32, 59-61, and/or 231 DAA to generate residue-decline data.  

Residues of fludioxonil were 0.530-3.35 ppm (per-trial average residues were 0.664-3.23 ppm) in/on potatoes collected 0 DAA following one post-harvest treatment application of fludioxonil formulated as a 1.92 lb ai/gal SC at a total seasonal rate of 0.0088-0.0099 lb ai/2000 lb potatoes.  All application methods (directed spray to tubers on a conveyor belt, roller table, stationary surface, spray chamber, or brush table) resulted in similar residue levels. 

The submitted residue decline data from the WA and ID trials indicate that residues of fludioxonil generally decrease with increasing DAA (0 to 61 DAA for the WA trial and 0 to 231 DAA for the ID trial).  For the ON trial, residues of fludioxonil remained relatively constant (0 to 59 DAA).  

Table 17.  Summary of Residue Data from Potato Crop Field Trials with Fludioxonil.
Commodity
                                    Analyte
                               Total App. Rate 
                                      DAA
                            Residue Levels (ppm)[1]

                                     g ai/
                                    2000 lb
                                    lb ai/
                                    2000 lb

                                       n
                                  Sample Min.
                                  Sample Max.
                                    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/A[3]
                                      N/A
                                      N/A
                            TRT 04 (Spray Chamber)
Potato tubers
                                  Fludioxonil
                                    3.9989
                                    0.0088
                                       0
                                       1
                                     3.10
                                     3.35
                                     3.23
                                     3.23
                                      N/A
                                      N/A
                                      N/A
                             TRT 05 (Brush Table)
Potato tubers
                                  Fludioxonil
                                    4.1132
                                    0.0091
                                       0
                                       1
                                     1.45
                                     1.90
                                     1.68
                                     1.68
                                      N/A
                                      N/A
                                      N/A
                              Combined Treatments
Potato tubers
                                  Fludioxonil
                                 3.9989-4.5098
                                 0.0088-0.0099
                                       0
                                       8
                                     0.530
                                     3.35
                                     0.664
                                     3.23
                                     1.57
                                     1.82
                                     0.945
[1]  Except for sample min/max, values reflect per-trial averages; n = no. of field trials.  For calculation of median, mean, and standard deviation, the LOQ (0.01 ppm) was used for any results reported as <LOQ in Table C.3.
[2]  LAFT = lowest-average-field-trial; HAFT = highest-average-field-trial.
[3]  N/A = not applicable.

Conclusions:  The submitted residue data are adequate to fulfill data requirements for potatoes.  The number of the crop field trials is adequate for a post-harvest treatment.  The available data will support the proposed use pattern.

The residue data for potato were analyzed using the OECD tolerance calculation procedures (see Appendix II).  The recommended tolerance for residues of fludioxonil is 6.0 ppm in/on vegetable, tuberous and corm, subgroup 1C.

Spinach

DER Reference List	48437305.der.doc

IR-4 has submitted field trial data for fludioxonil on spinach.  Eleven field trials were conducted in the U.S. and Canada during the 2008 and 2009 growing seasons in NAFTA Growing Zones 1 (NY; 1 trial), 2 (MD and SC; 2 trials), 5 (ON; 1 trial), 5B (QC; 1 trial), 6 (TX; 2 trials), 8 (CO; 1 trial), 10 (CA; 2 trials), and 11 (BC; 1 trial).

Each trial consisted of one untreated plot and one treated plot.  At each trial location, four foliar broadcast applications of a WG MAI product formulation (Switch[(R)] 62.5WG), containing 25% fludioxonil and 37.5% cyprodinil were made to spinach at a target rate of 0.219 lb fludioxonil/A/application, for a total seasonal rate of 0.867-0.911 lb ai/A (1X).  The RTIs ranged from 6 to 8 days between the first and second applications and the third and fourth applications, and from 13 to 16 days between the second and third applications.  All applications were made using tractor-mounted or portable ground equipment in concentrated spray volumes of 21-45 GPA.  A NIS or COC was included in all of the tank mixes at seven of the trials and in tank mixes for 1-3 of the applications at three of the trials.  An adjuvant was not used in any tank mix at one trial.  Samples of mature spinach leaves were harvested from all trials at a PHI of 0 days.  Spinach samples were also collected from one trial site (Ontario, Canada; 10006.08-ON13) at 0, 2, 6, 12, and 14 days after the last application to generate residue-decline data.  

Residues of fludioxonil (and per-trial averages) were 1.8-16 ppm (1.9-16 ppm) in/on spinach harvested 0 days following the last of four foliar broadcast applications of a WG MAI product formulation (25% fludioxonil and 37.5% cyprodinil) at a total rate of 0.867-0.911 lb ai/A (fludioxonil).  

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

Table 18.  Summary of Residue Data from Spinach Crop Field Trials with Fludioxonil.
Commodity
                           Total App. Rate (lb ai/A)
                                  PHI (days)
                            Residue Levels (ppm)[1]

                                       n
                                    Sample
                                     Min.
                                    Sample
                                     Max.
                                    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]  LAFT = lowest-average-field-trial; HAFT = highest-average-field-trial.

Conclusions:  The submitted residue data are adequate to fulfill data requirements for spinach as a representative commodity of leafy vegetable (except Brassica) subgroup 4A.  The number and locations of the crop field trials are in accordance with OPPTS Guideline 860.1500 (Table 19).  The available data will support the proposed use pattern.

Table 19.  Trial Numbers and Geographical Locations.
NAFTA Growing 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 analyzed using the OECD tolerance calculation procedures (see Appendix II).  The recommended tolerance for residues of fludioxonil is 30 ppm in/on spinach (representative commodity of vegetable, leafy, except Brassica, subgroup 4A, a 30-ppm tolerance is currently established for leafy greens subgroup 4A, except spinach). 

Tomato (post-harvest treatment)

DER Reference List	48438204.der.doc

Syngenta Crop Protection, LLC has submitted field trial data for residues of fludioxonil in/on tomato following post-harvest treatment.  Six field trials were conducted in the U.S. during the 2009 growing season in NAFTA Growing Zones 1 (NY; 1 trial), 2 (NC; 2 trials), 3 (FL; 2 trials), and 10 (CA; 1 trial).  Four of the trials were conducted using large variety tomatoes and two of the trials were conducted using small variety tomatoes.

Tomatoes were grown on-site by the trial personnel or were obtained from a local commercial grower.  Samples of mature tomatoes were harvested from all trials, rinsed with water, allowed to dry, and then treated with a spray mixture containing a 1.92 lb ai/gal fludioxonil SC formulation and a 45% propiconazole WP formulation.  In the NC19 and NC32 trials only, the collected tomatoes were placed in on-site storage (58-68 °F) for approximately 1-3 days prior to post-harvest treatment.  In all trials, fludioxonil was applied as a post-harvest dip treatment (TRT 02).  At the NC and CA trial sites, two additional treatment scenarios were included:  drench treatment (TRT 03) and packing-line spray treatment (TRT 04).  For the dip and drench treatments, fludioxonil was applied at a rate of 0.479-0.481 lb ai/100 gal (1X) using a delivery rate of 943.70-948.00 mL/100 gal.  For the packing-line spray treatment, fludioxonil was applied at a rate of 0.240-0.241 lb ai/50,000 lb fruit (1X) using a delivery rate of 35.78-47.14 gal/50,000 lb fruit.  For all applications, a NIS was added to each spray mix.  Samples of tomatoes from each trial site were collected after the test substance had dried on the day of application (0 DAA).  

Residues of fludioxonil (and per-trial average residues) in/on large and small tomatoes collected 0 DAA following one post-harvest application of fludioxonil formulated as a 1.92 lb ai/gal SC were 0.275-1.19 ppm (0.283-1.04 ppm) from the dip treatments at 0.479-0.481 lb ai/100 gal, 0.237-1.16 ppm (0.249-1.11 ppm) from the drench treatments at 0.479-0.481 lb ai/100 gal, and 0.170-1.97 ppm (0.175-1.83 ppm) from the spray treatments at 0.240-0.241 lb ai/50,000 lb tomatoes.  All application methods (dip, drench, and spray) resulted in similar residue levels.  In general, fludioxonil residues were higher (~2X) in small tomatoes than in large tomatoes.

Table 20.  Summary of Residue Data from Tomato Crop Field Trials with Fludioxonil.
Commodity
                                 Treatment Type
                                    Analyte
                                  Total App. 
                                     Rate
                                     lb ai/
                                    100 gal
                                      DAA
                            Residue Levels (ppm)[1]
                                       
                                       
                                       
                                       

                                       n
                                  Sample Min.
                                  Sample Max.
                                    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)
Tomato (large and small)
                                      Dip
                                  Fludioxonil
                                  0.479-0.481
                                       0
                                       6
                                     0.275
                                     1.19
                                     0.283
                                     1.04
                                     0.474
                                     0.577
                                     0.276

                                    Drench
                                       
                                  0.479-0.481
                                       0
                                       3
                                     0.237
                                     1.16
                                     0.249
                                     1.11
                                     0.729
                                     0.694
                                     0.429

                                     Spray
                                       
                                0.240-0.241[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]  LAFT = lowest-average-field-trial; HAFT = highest-average-field-trial.
[3]  The units for the spray application rate was lb fludioxonil/50,000 lb fruit.
Conclusions:  The submitted residue data are adequate to fulfill data requirements for tomatoes.  The number of the crop field trials is adequate for a post-harvest treatment.  The available data will support the proposed use pattern.

The residue data for tomato from the dip and spray treatment were analyzed using the OECD tolerance calculation procedures (see Appendix II).  Based on spray treatment data set, the recommended tolerance for residues of fludioxonil is 5.0 ppm in/on tomato.

Tropical Fruit

Reference	Minutes of 06/02/2010 ChemSAC Meeting

Agenda item #4:  IR-4 referred the following proposal to the ChemSAC for review on the translation of tolerances for fludioxonil to include tropical fruits.  Presented by W. Wassell for D. Thompson, IR-4.  

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

IR-4 proposes that EPA allow the presently established tolerances for fludioxonil on stone fruit, pome fruit, pomegranate, kiwifruit and citrus to be used to establish tolerances on the ChemSAC approved tropical fruit groups at the levels identified below.  These tolerances were developed for post-harvest use and will be used only for post-harvest use on tropical fruits.  Extensive data have been developed for registered crops using a number of post-harvest methods of application.  The proposed tolerances for tropical fruit crops will be used to allow labeling of the dip method of post-harvest application.  This method of application was included in all previous studies.  The directions for use will be to mix 0.5 to 1.0 lb active fludioxonil into 100 gallons of water plus coating wax.  Fruit will be dipped in this solution for approximately 30 seconds and then surface dried before packing.  

ChemSAC agreed that the IR-4 proposal seems reasonable based on the data provided.  However, the SAC would like to review the additional, more specific data cited by IR-4 to confirm that the data are sufficiently robust to support the proposed extension of tolerances to tropical fruit.
IR-4 provided the following data:
   # Peach:  1 ultra-low-volume (ULV) trial, 2 dip trials, and 2 high-volume drench trials.
   # Cherry:  2 high-volume drench trials.
   # Plums:  1 ULV trial and 1 high-volume drench trials.
   # Apple:  2 ULV trials and 4 dip trials.
   # Pear:  	2 ULV trials, 4 dip trials, and 6 high-volume drench trials.
   # Orange:  3 ULV trials, 5 dip trials, and 1 high-volume drench trial.
   # Lemon:  4 ULV trials, 5 dip trials, and 1 high-volume drench trial.
   # Grapefruit:  3 ULV trials, 4 dip trials, and 2 high-volume drench trials.
   # Pomegranate:  2 dip trials, and 6 high-volume drench trials.
   # Kiwifruit:  4 ULV trials and 5 dip trials.
   # Yam:  2 dip trials.
   # Sweet potato:  2 dip trials.

ChemSAC's recommendation:  Upon review of the submitted data comparing residue levels from dip, ULV, and high-volume or drench applications, the ChemSAC agreed with the tolerance translations proposed by IR-4 (see table below).  It was noted that the available data generally indicate that the highest residue levels resulted from dip applications made using wax.  

Tropical fruit commodity definitions and proposed tolerances.

Commodity
Specific commodities included in definition
Proposed tolerance and basis
Avocado
avocado; black sapote; canistel; mamey sapote; mango; papaya; sapodilla; star apple
5.0 ppm based on the stone fruit, pome fruit, and pomegranate tolerances and use of the 0.5 lb ai rate
Papaya
black sapote; canistel; mamey sapote; mango; papaya; sapodilla; star apple
5.0 ppm based on the stone fruit, pome fruit, and pomegranate tolerances and use of the 0.5 lb ai rate
Grapefruit
grapefruit; pummelo, and their citrus cultivars and/or hybrids of these including Uniq fruit
10 ppm based on citrus crop group tolerance and the use of the 1.0 lb ai rate.
Guava
guava; feijoa; jaboticaba; wax jambu; starfruit; passionfruit; acerola
5.0 ppm based on the stone fruit, pome fruit, and pomegranate tolerances and use of the 0.5 lb ai rate
Lychee
lychee; longan; Spanish lime; rambutan; pulasan
20 ppm based on kiwifruit tolerance and 0.5 lb ai rate
Sugar apple
sugar apple; atemoya; custard apple; cherimoya; ilama; soursop; birida
20 ppm based on kiwifruit tolerance and 0.5 lb ai rate

The amount of data submitted was considered sufficient.

Onion, Bulb Subgroup 3-07A

No new bulb onion crop field trial data were submitted.  A tolerance for residues of fludioxonil in/on onion, bulb has been established at 0.20 ppm [40 CFR §180.516].  IR-4 has proposed to convert this individual tolerance to a crop subgroup 3-07A tolerance at the same level.  The representative commodity of the onion, bulb subgroup 3-07A is onion, bulb.

As the proposed use on the onion, bulb subgroup 3-07A is identical to the existing use on bulb onions on the product labels for Switch[(R)] 62.5 WG (EPA Reg. No. 100-953) and Cannonball[(R)] WP (EPA Reg. No. 1360), the existing bulb onion tolerance can be translated to the onion, bulb subgroup 3-07A.  However, HED recommends that the tolerance be increased from 0.20 to 0.50 ppm in order to harmonize with Codex.

Onion, Green Subgroup 3-07B

No new green onion crop field trial data were submitted.  A tolerance for residues of fludioxonil in/on onion, green has been established at 7.0 ppm [40 CFR §180.516].  IR-4 has proposed to convert this individual tolerance to a crop subgroup 3-07B tolerance at the same level.  The representative commodity of the onion, green subgroup 3-07B is onion, green.

As the proposed use on the onion, green subgroup 3-07B is identical to the existing use on green onions on the product labels for Switch[(R)] 62.5 WG (EPA Reg. No. 100-953) and Cannonball[(R)] WP (EPA Reg. No. 1360), the existing green onion tolerance can be translated to the onion, green subgroup 3-07B.

Caneberry subgroup 13-07A

No caneberry field trial data were submitted.  A tolerance for residues of fludioxonil in/on the caneberry subgroup 13A has been established at 5.0 ppm [40 CFR §180.516].  IR-4 has proposed to convert this tolerance to a crop subgroup 13-07A tolerance at the same level.  

As the proposed use on the caneberry subgroup 13-07A is identical to the existing use on caneberry subgroup 13A on the product labels for Switch[(R)] 62.5 WG (EPA Reg. No. 100-953) and Cannonball[(R)] WP (EPA Reg. No. 1360), the existing caneberry subgroup 13A tolerance can be translated to caneberry subgroup 13-07A.

Bushberry subgroup 13-07B

No bushberry field trial data were submitted.  A tolerance for residues of fludioxonil in/on the bushberry subgroup 13B has been established at 2.0 ppm [40 CFR §180.516].  IR-4 has proposed to convert this tolerance to a crop subgroup 13-07B tolerance at the same level.  

As the proposed use on the bushberry subgroup 13-07B is identical to the existing use on bushberry subgroup 13B on the product labels for Switch[(R)] 62.5 WG (EPA Reg. No. 100-953) and Cannonball[(R)] WP (EPA Reg. No. 1360), the existing bushberry subgroup 13B tolerance can be translated to bushberry subgroup 13-07B.  Note that the soil-directed application was approved by ChemSAC (Minutes of 4/1/2009, 2011 Meeting).

Fruit, citrus, group 10-10

No citrus fruit field trial data were submitted.  A tolerance for residues of fludioxonil in/on the fruit, citrus, group 10 has been established at 10 ppm [40 CFR §180.516].  IR-4 has proposed to convert this tolerance to a fruit, citrus, group 10-10 tolerance at the same level.  

As the proposed use on fruit, citrus, group 10-10 is identical to the existing use on fruit, citrus, group 10 on the product labels for Scholar[(R)] (EPA Reg. No. 100-969) and Scholar[(R)] SC (EPA Reg. No. 100-1242), the existing fruit, citrus, group 10 tolerance can be translated to fruit, citrus, group 10-10.

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[(R)] (EPA Reg. No. 100-969) and Scholar[(R)] 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[(R)] 62.5 WG (EPA Reg. No. 100-953), the existing grape tolerance can be translated to the small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit.  However, HED recommends that the tolerance be increased from 1.0 to 2.0 ppm in order to harmonize with Codex.

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

No new low-growing berry field trial data were submitted.  A tolerance for residues of fludioxonil in/on strawberry has been established at 2.0 ppm [40 CFR §180.516].  IR-4 has proposed to convert this individual tolerance to a low-growing berry subgroup 13-07G, except cranberry tolerance at the same level.  The representative commodity of the low-growing berry subgroup 13-07G, except cranberry is strawberry.

As the proposed use on the low-growing berry subgroup 13-07G, except cranberry is identical to the existing use on strawberry on the product labels for Switch[(R)] 62.5 WG (EPA Reg. No. 100-953) and Cannonball[(R)] WP (EPA Reg. No. 1360), the existing strawberry tolerance can be translated to the low-growing berry subgroup 13-07G, except cranberry.  However, HED recommends that the tolerance be increased from 2.0 to 3.0 ppm in order to harmonize with Codex.

Dragon Fruit

Reference	Minutes of February 09, 2011 ChemSAC Meeting

Topic for ChemSAC:  Review an IR-4 proposal that requests the use of tropical fruit tolerances to obtain tolerances for a new developing crop, dragon fruit.  There are four active ingredients requested:  azoxystrobin, cyprodinil, fludioxonil, and chlorothalonil.   

ChemSAC Discussion and Recommendations: 

(3) Fludioxonil:  Same reasoning as for cyprodinil.  Lychee tolerance would cover the variation even though mango could also be used if based on actual field data.  The recommendation is 1.0 ppm.

860.1520 Processed Food and Feed

Pineapple

DER Reference List	48437302.de2.doc

Pineapple processing studies were conducted to determine the potential for concentration of residues of fludioxonil (Scholar[(R)] 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[(R)] 230 SC; 20.5% active ingredient) was applied as either a dip plus wax followed by a spray directed to the peduncle (TRT02) or a drench plus wax followed by a spray directed to the peduncle (TRT03).  The test substance was applied at approximate rates of 0.507 lb ai/100 gal (dip and drench) and 0.507 lb ai/7 gal (spray).  Fruit wax (Sta-Fresh 7051 or Sta-Fresh 7055) was used as an adjuvant at all trials.  The fruit was allowed to air dry with a 0.75- to 3.25-hour RTI between the dip/drench and spray applications, and samples of pineapple fruit without crowns were collected following the spray application after the test substance had dried.  One untreated and one TRT03 treated sample were collected from the HI05 trial site for processing into juice and process residue.

Per-trial-average-residues of fludioxonil residues were 4.95 ppm in/on the HI05 pineapple trial with samples that were treated with a drench application of approximately 0.5072104 lb ai + fruit wax per 100 gal solution and a spray application of approximately 0.5072104 lb ai/7 gal (highest individual residue of 5.34 ppm).  The residues in juice were slightly lower than in the processing raw agricultural commodity (RAC; 5.40 ppm compared to 5.62 ppm, processing factor = 0.96), and residues in process residue were slightly higher than in the processing RAC (6.60 ppm compared to 5.62 ppm, processing factor = 1.17).  The theoretical concentration factor (based on separation into components; OPPTS 860.1520, Table 3) is 3.8x for process residue.  Residues in controls were <0.02 ppm.

The results from the pineapple processing studies are discussed below and the residue data are summarized in Table 21.

Table 21.  Residue Data from Post-harvest Pineapple Processing Study with Fludioxonil.
                              Processed Commodity
                       Total Application Rate (lb ai)[1]
                                  PHI
(days)
                            Fludioxonil Residues[2]
                                     (ppm)
                             Processing Factor[3]
                    Trial Location:  Lahaina, HI (09-HI05)
Pineapple without crowns (TRT03)
                                   0.5070
+
                                    0.5071
                                     NA[4]
                               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 processed fraction by the residue in the processing RAC.
4  NA = not applicable.
[5]  RAC = raw agricultural commodity.

Conclusions:  These data indicate that significant concentration of fludioxonil residues are unlikely to occur in the processed fractions of pineapple; therefore, separate tolerances are not required for pineapple juice and process residue.

Potato

DER Reference List	48437101.de2.doc

Syngenta Crop Protection, Inc. submitted a processing study for fludioxonil on potato following post-harvest treatment.  One post-harvest trial was conducted in Kimberley, ID, in 2009.  Potatoes were grown on-site by the trial personnel and mature potato tubers were harvested, placed in on-site storage for ~2 months, and then treated with a spray mixture containing a 3.00 lb/gal difenoconazole FS formulation, a 2.09 lb/gal azoxystrobin SC formulation, and a 1.92 lb ai/gal fludioxonil SC formulation.  Fludioxonil was applied as a post-harvest treatment spray directed to tubers falling from a conveyor belt at an application rate of 0.0092 lb ai/2000 lb potatoes (1X).  The delivery rate was 0.51 gal/2000 lb potatoes.  Potato samples were collected after the spray had dried on the day of application (0 DAA) and processed into flakes, chips, and wet peel by the University of Idaho Food Technology Center (Caldwell, ID) using simulated commercial procedures.  Adequate descriptions were provided of the processing procedures, including material balance summaries.  

Concentration following processing was observed in wet peel but not in flakes or chips.  Residues of fludioxonil were 0.472 ppm in/on potato tuber (RAC), <0.01 ppm in flakes (resulting in a processing factor of <0.02X), 0.0182 ppm in chips (resulting in a processing factor of 0.04X), and 0.797 ppm in wet peel (resulting in a processing factor of 1.7X).  All of the processing factors calculated in this study were less than the maximum theoretical concentration factors of 4.7X for dried potatoes (flakes and granules) and 4.0X for processed waste (based on loss of water and separation of components; OPPTS 860.1520, Tables 2 and 3).

The results from the potato processing studies are discussed below and the residue data are summarized in Table 22.

Table 22.  Residue Data from Potato Processing Studies with Fludioxonil.
RAC
                              Processed Commodity
                                  Total Rate
                                    DAA[1]
                                Residues (ppm)
                              Mean Residues (ppm)
                             Processing Factor[2]

                                       
                                     g ai/
                                    2000 lb
                                 lb ai/2000 lb
                                [g a.i./100 kg]
                                       
                                       
                                       
                                       
Potato
                                 Tubers (RAC)
                                    4.1642
                                    0.0092
                                    [0.46]
                                       0
                                 0.502, 0.442
                                     0.472
                                      --

                                    Flakes
                                       
                                       
                                       
                              <0.01, <0.01
                                   <0.01
                                   <0.02X

                                     Chips
                                       
                                       
                                       
                                0.0181, 0.0182
                                    0.0182
                                     0.04X

                                   Wet peel
                                       
                                       
                                       
                                 0.788, 0.805
                                     0.797
                                     1.7X
[1]  DAA = Days after application.
[2]  Processing Factor = [Measured residue for analyte in the processed fraction] / [Measured residue for analyte in the RAC].  

Conclusions:  Concentration following processing was observed in wet peel but not in flakes or chips.  Multiplication of the potato HAFT residue (3.32 ppm) by the wet peel processing factor of 1.7X yields a value (5.5 ppm) which is less than the recommended RAC tolerance (6.0 ppm); therefore, separate tolerances are not required for potato processed fractions.

Tomato

Post-harvest use on processing tomatoes is prohibited.  In addition, available data indicate that significant concentration of fludioxonil residues are unlikely to occur in the processed fractions of tomato (47161101PFF.der.doc); therefore, separate tolerances are not required for tomato paste and puree.

860.1650 Submittal of Analytical Reference Standards

An analytical reference standard for fludioxonil is currently available at the EPA National Pesticide Standards Repository (personal communication with Theresa Cole, 8/15/11) with an expiration date of 5/30/13.  However, a reference standard of CGA192155 (2,2-difluoro-l,3-benzodioxole-4-carboxylic acid) should be sent to the Repository, which is located at Fort Meade, to the attention of Theresa Cole at the following address:

	USEPA
	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP
	701 Mapes Road
	Fort George G. Meade, MD  20755-5350
(Note that the mail will be returned if the extended zip code is not used.)

The letter of transmittal should include the assay of the standards, names of the analytical methods used, a statement of principal impurities, purification procedures employed, storage requirements, and special precautions for safe handling.  Replacement of standards may be required periodically if supplies are exhausted or if decomposition occurs during storage.  MSDSs must accompany all analytical standards as specified by OSHA in 29 CFR §1910.1200.

860.1850/1900 Confined and Field Accumulation in Rotational Crops

DP# 258865, W. Donovan, 12/17/1999
MARC Decision Memo, DP# 262022, W. Donovan, 1/18/2000

An adequate confined rotational crop study is available reflecting the application of [phenyl-[14]C]fludioxonil to soil at ~1.0 lb ai/A.  Based on the results from this study, HED has concluded that the residue of concern in rotational crops is fludioxonil per se.

An adequate limited field rotational crop study is also available.  At two test sites in CA and NY, fludioxonil (50% WP) was applied to bare soil as four broadcast applications at 0.25 lb ai/A/application at 7-day RTIs, for a total rate of 1.0 lb ai/A (1X maximum seasonal rate).  Rotational crops of lettuce, turnips, and wheat were planted at each site at PBIs of 27 to 30 days.  Single control and duplicate treated samples of lettuce, turnip roots and tops, and wheat forage, hay, grain, and straw were harvested from each trial at the appropriate stage for maturity, and samples were analyzed for residues of fludioxonil using an adequate HPLC/UV method (Method AG-597B).  Residues of fludioxonil were <LOQ (<0.01 ppm) in/on all samples of each rotational crop matrix.

These data support the 30-day PBI on the current fludioxonil labels and indicate that rotational crop tolerances are not currently required.
860.1550 Proposed Tolerances

The Agency has determined that the residue of concern in plant commodities is fludioxonil per se.  Permanent Tolerances have been established for residues of fludioxonil per se in/on a variety of crop commodities, at levels ranging from 0.01 ppm in/on numerous commodities to 500 ppm in citrus oil [40 CFR §180.516(a)].  There are currently no tolerances for fludioxonil in livestock commodities.

There are currently no established Codex, Canadian, or Mexican MRLs for fludioxonil on tropical fruits.  The following U.S., Canadian, and Codex tolerances/MRLs for residues of fludioxonil are harmonized:  bushberries, grapes, citrus fruits, and pome fruits.  Additionally, the U.S. and Canadian tolerances/MRLs for tuberous and corm vegetables subgroup 1C, spinach, fruiting vegetables except tomato, and ginseng are being harmonized as part of this joint review.  

The U.S., Canadian, and Codex tolerances/MRLs for residues of fludioxonil in/on bulb onions, caneberries, grapes (small vine climbing fruit, subgroup 13-07F), strawberries (low-growing berry subgroup 13-07G), tomatoes, and leafy vegetables cannot be harmonized as the Canadian, and Codex MRLs differ.  For leafy vegetables except Brassica subgroup 4A, the U.S. and Canada are harmonized at 30 ppm, but a Codex MRL is established for head lettuce at 10 ppm.  For the bulb onion subgroup 3-07A, small vine climbing fruit subgroup 13-07F, and 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 0.20 to 0.50 ppm, small vine climbing fruit subgroup 13-07F from 1.0 to 2.0 ppm and low-growing berry subgroup 13-07G from 2.0 to 3.0 ppm.  

The tolerances/MRLs cannot be harmonized for green onions, tomatoes, leafy vegetables except Brassica subgroup 4A, and leafy petioles as the U.S. residue data/use patterns necessitate a higher value.  

For livestock commodities, the U.S. and Codex residue definitions are harmonized; however, the Canadian residue definition is not harmonized.  The numerical values for the U.S. and Canadian livestock tolerances/MRLs are harmonized.  

Table 23.  Tolerance Summary for Fludioxonil. 

Commodity
                           Proposed Tolerance (ppm)
                          Recommended Tolerance (ppm)
Correct Commodity Definition/Comments
To be established under 40 CFR §180.516 (a) General. (1) Tolerances are established for residues of the fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile):
Guava
                                       5
                                      5.0

Feijoa
                                       5
                                      5.0

Jaboticaba
                                       5
                                      5.0

Wax jambu
                                       5
                                      5.0

Starfruit
                                       5
                                      5.0

Passionfruit
                                       5
                                      5.0

Acerola
                                       5
                                      5.0

Avocado
                                       5
                                      5.0

Black sapote
                                       5
                                      5.0

Mamey sapote
                                       5
                                      5.0

Canistel
                                       5
                                      5.0

Mango
                                       5
                                      5.0

Papaya
                                       5
                                      5.0

Sapodilla
                                       5
                                      5.0

Star apple
                                       5
                                      5.0

Lychee
                                      20
                                      20

Longan
                                      20
                                      20

Spanish lime
                                      20
                                      20

Rambutan
                                      20
                                      20

Pulasan
                                      20
                                      20

Sugar apple
                                      20
                                      20

Atemoya
                                      20
                                      20

Custard apple
                                      20
                                      20

Cherimoya
                                      20
                                      20

Ilama
                                      20
                                      20

Soursop
                                      20
                                      20

Biriba
                                      20
                                      20

Ginseng
                                      3.0
                                      4.0

Onion, bulb subgroup 3-07A
                                      0.2
                                     0.50
Increased in order to harmonize with Codex MRL.
Onion, green subgroup 3-07B
                                      7.0
                                      7.0

Caneberry subgroup 13-07A
                                      5.0
                                      5.0

Bushberry subgroup 13-07B
                                      2.0
                                      2.0

Small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit
                                      1.0
                                      2.0
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit.  Increased in order to harmonize with Codex MRL.
Low growing berry subgroup 13-07G, except cranberry
                                      2.0
                                      3.0
Increased in order to harmonize with Codex MRL.
Vegetable, fruiting group 8-10, except tomato
                                      0.7
                                     0.50

Tomato
                                      3.0
                                      5.0

Fruit, citrus, group 10-10
                                      10
                                      10

Fruit, pome, group 11-10
                                       5
                                      5.0

Vegetable, leafy, except brassica, subgroup 04A
                                      30
                                      30
Vegetable, leafy, except Brassica, subgroup 4A
Vegetable, tuberous and corm, subgroup 1C
                                      6.0
                                      6.0

Pineapple
                                      8.0
                                      20

Dragon-fruit
                                      1.0
                                      1.0
Dragon fruit
Leafy petioles crop subgroup 4B
                                      14
                                      15

To be established under 40 CFR §180.516 (a) General. (2)" Tolerances are established for residues of the fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the table below.  Compliance with the tolerance levels specified below is to be determined by measuring only the sum of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile), and its metabolites converted to 2,2-difluoro-l,3-benzodioxole-4-carboxylic acid, calculated as the stoichiometric equivalent of fludioxonil:
Milk
                                       -
                                     0.01

Cattle, meat byproducts
                                       -
                                     0.05

Cattle, meat 
                                       -
                                     0.01

Cattle, fat 
                                       -
                                     0.05

Goat, meat byproducts
                                       -
                                     0.05

Goat, meat 
                                       -
                                     0.01

Goat, fat 
                                       -
                                     0.05

Horse, meat byproducts
                                       -
                                     0.05

Horse, meat 
                                       -
                                     0.01

Horse, fat 
                                       -
                                     0.05

Sheep, meat byproducts
                                       -
                                     0.05

Sheep, meat 
                                       -
                                     0.01

Sheep, fat 
                                       -
                                     0.05

Remove:
Onion, bulb
                                     0.20
                                       
These tolerances should be removed from 40 CFR §180.516 because tolerances are being established for crop groups that contain these RACs or a higher tolerance is required based on the proposed use pattern.  
Onion, green
                                      7.0
                                       

Caneberry subgroup 13A
                                      5.0
                                       

Bushberry subgroup 13B
                                      2.0
                                       

Juneberry
                                      2.0
                                       

Lingonberry
                                      2.0
                                       

Salal
                                      2.0
                                       

Grape
                                      1.0
                                       

Strawberry
                                      2.0
                                       

Vegetable, fruiting group 8
                                     0.01
                                       

Tomatillo
                                     0.50
                                       

Fruit, citrus, group 10
                                      10
                                       

Fruit, pome, group 11
                                      5.0
                                       

Leafy greens subgroup 4A, except spinach
                                      30
                                       

Vegetable, tuberous and corn, except potato, subgroup 1D
                                      3.5
                                       

References

            DP Numbers:	206301, 206304, 206331, and 206328
            Subject:	PP No. 4F4315/4H5685.  MAXIM (New Chemical) Seed Treatment for Field Corn, Sweet Corn, Popcorn and Sorghum.  Review of Residue Data and Analytical Methodology. 
            From:	S. Willet
            Dated:	3/01/1995

            DP Numbers:	216233
            Subject:	PP No. 4F4315/4H5685.  MAXIM (Fludioxonil; CGA 173506) Seed Treatment for Field Corn, Sweet Corn, Popcorn and Sorghum.  Review of Petition Amendment dated May 1995. 
            From:	S. Willet
            Dated:	8/17/1995

            DP Number:	210762
            Subject:	PP No. 4F4315/4H5685.  Fludioxonil (CGA 173506; MAXIM) Seed Treatment for Field Corn, Sweet Corn, Popcorn and Sorghum.  Review of Ruminant and Poultry Metabolism Studies. 
            From:	S. Willet
            Dated:	12/18/1995

DP Number:	258861
Subject:	PP# 9E06049.  Fludioxonil for use on Stone Fruits. Evaluation of Residue Data and Analytical Methods.
From: 	W. Donovan
Dated:	11/29/99

            DP Number:	261603
            Subject:	Fludioxonil.  Issues to be Presented to the HED Metabolism Assessment Review Committee (MARC).
            From:	G. Kramer
            Dated:	12/14/1999
            
DP Number:	258870
Subject:	PP# 7E04919.  Fludioxonil for use on Grapes. Evaluation of Residue Data and Analytical Methods.
From: 	W. Donovan
Dated:	12/20/99

            DP Number:	262022
            Subject:	Fludioxonil.  Results of the HED Metabolism Assessment Review Committee (MARC) Meeting Held on 21-DEC-1999.
            From:	W. Donovan
            Dated:	1/18/2000

            DP Numbers:	287808, 287810, 287812, and 287814
            Subject:	Fludioxonil.  Section 3 Registration for Application of Fludioxonil to Lychee, Longan, Spanish Lime, Rambutan, and Pulasan (ID# - 2E06448); Brassica Leafy Greens Crop Subgroup, Head and Stem Brassica Crop Subgroup, and Turnip Greens (ID# - 2E06486); Carrot (ID# - 2E06462); and Herb Crop Subgroup (ID# - 3E06526).  Summary of Residue Chemistry Data.
            From:	T. Bloem
            Dated:	2/12/2003

            DP Number:	325160
            Subject:	Registration of Fludioxonil (Scholar 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 Numbers:	384857, 387809
            Subject:	Fludioxonil; Human-Health Assessment Scoping Document in Support of Registration Review.
            From:	W. Wassell, et al. 
            Dated:	6/13/2011

Attachments:  
Appendix I.  International Residue Limit Status Sheet.
Appendix II.  Tolerance-Assessment Calculations.
Appendix III.  Chemical Structures

cc:  G. Kramer (RAB1)
RDI:  RAB1 Chemists (12/21/2011)
G.F. Kramer:S10957:PY-S:(703)305-5079:7509P:RAB1
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. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile), and its metabolites converted to 2,2-difluoro-l,3-benzodioxole-4-carboxylic acid, calculated as the stoichiometric equivalent of fludioxonil
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-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
                                      20

Ginseng
                                      4.0

Onion, bulb subgroup 3-07A
                                     0.50
   0.02 Chinese onions, garlic, great headed garlic, potato onions, shallots
                                       
                              0.2 dry bulb onions
                                       
                                0.5 onion, bulb
Onion, green subgroup 3-07B
                                      7.0
   0.02 Chinese, chives, chive leaves, leeks, green onions, Welsh onion tops
                                       
                                       
Caneberry subgroup 13-07A
                                      5.0
                  4.2 blackberries, loganberries, raspberries
                                       
5 blackberries, raspberries, red, black, dewberries (including boysenberry and loganberry)
Bushberry subgroup 13-07B
                                      2.0
2.0 blueberries, currant, elderberries, gooseberries, huckleberries, salal berries, saskatoon berries (juneberries)
                                       
                                 2 blueberries
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit
                                      1.0
                                1 gooseberries
                                    1 grape
                                 20 kiwifruit
                                       
                                   2 grapes
                                15 kiwifruit Po
Low growing berry subgroup 13-07G, except cranberry
                                      2.0
                                2 strawberries
                                       
                                 3 strawberry
Vegetable, fruiting group 8-10, except tomato
                                     0.50
**0.01 bell peppers, eggplants, ground cherries, non-bell peppers, pepinos, pepper hybrids
                                       
                                 0.3 eggplant
               1 peppers, sweet (including pimento or pimiento)
Tomato
                                      5.0
                           0.01 tomatoes, tomatillos
                                       
                                      0.5
Fruit, citrus, group 10-10
                                      10
10 calamondin, citrus citron, citrus hybrids, grapefruits, kumquats, lemons, limes, oranges, pummelos, tangerines, Satsuma mandarins
                                       
                                500 citrus oil
                                       
                              10 citrus fruits Po
Fruit, pome, group 11-10
                                      5.0
           5.0 apples, crabapples, loquats, mayhaws, pears, quinces
                                       
                               5 pome fruits Po
                             20 apple pomace, dry
Vegetable, leafy, except Brassica, subgroup 4A
                                      30
30 amaranth, arugula, corn salad, dandelion leaves, dock, edible leaved chrysanthemum, endives, fresh chervil leaves,  fresh parsley leaves, garden cress, garden purslane, garland chrysanthemum, head lettuce, leaf lettuce, orach leaves, radicchio, upland cress, winter purslane
                                       
               **0.01 New Zealand spinach, spinach, vine spinach
                                       
                               10 lettuce, head
Vegetable, tuberous and corm, subgroup 1C
                                      6.0
                                 **0.02 potato
                                       
                                  0.02 potato
                                       
                           10 sweet potato , yams Po
Pineapple
                                      20
                                       
                                       
                                       
Dragon fruit
                                      1.0
                                       
                                       
                                       
Leafy petioles crop subgroup 4B
                                      15
0.01 cardoon, celery, celtuce, Chinese celery, fresh Florence fennel leaves and stalks, rhubarb, Swiss chard
                                       
                                       
Milk
                                     0.01
                                     0.01
                                       
                                  0.01 milks
Cattle, Goat, Horse, Sheep:  meat byproducts
                                     0.05
            0.05 kidney and liver of cattle, goats, horses, sheeps
                                       
                       0.05 edible offal (mammalian) (*)
Cattle, Goat, Horse, Sheep:  fat
                                     0.05
                   0.05 fat of cattle, goats, horses, sheeps
                                       
                                       
Cattle, Goat, Horse, Sheep:  meat
                                     0.01
                  0.01 meat of cattle, goats, horses, sheeps
                                       
             0.01 (*) meat from mammals other than marine mammals)
Completed:  M. Negussie; 05/09/2012
[1] Includes only commodities of interest for this action.  Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains.  PoP = processed postharvest treated commodity, such as processing of treated stored wheat.  (fat) = to be measured on the fat portion of the sample.  MRLs indicated as proposed have not been finalized by the CCPR and the CAC.

** = Levels to be harmonized as part of this joint review.  
Appendix II.  Tolerance Assessment Calculations.

                                  Fludioxonil
                                    Celery
                                     U.S.
                              0.864-0.892 lb ai/A
 
 
Total number of data (n)
                                       8
Percentage of censored data
                                      0%
Number of non-censored data
                                       8
Lowest residue
                                     2.000
Highest residue
                                     8.600
Median residue
                                     4.950
Mean
                                     4.888
Standard deviation (SD)
                                     2.224
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     8.600
- Mean + 4 SD
                                    13.782
- CF x 3 Mean
                                    14.663
Unrounded MRL
                                    14.663
 
                                       
Rounded MRL
                                      15
 
                                       
                               Residues (mg/kg)
                                       n
                                       2
                                       1
                                      2.5
                                       1
                                      3.5
                                       1
                                      4.3
                                       1
                                      5.6
                                       1
                                      6.2
                                       1
                                      6.4
                                       1
                                      8.6
                                       1

                                  Fludioxonil
                                    Ginseng
                                     U.S.
                              0.910-1.012 lb ai/A
 
 
Total number of data (n)
                                       4
Percentage of censored data
                                      0%
Number of non-censored data
                                       4
Lowest residue
                                     0.165
Highest residue
                                     1.695
Median residue
                                     0.288
Mean
                                     0.609
Standard deviation (SD)
                                     0.732
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     1.695
- Mean + 4 SD
                                     3.536
- CF x 3 Mean
                                     1.826
Unrounded MRL
                                     3.536
 
                                       
Rounded MRL
                                       4
 
                                       
 High uncertainty of MRL estimate.
[Small dataset]
                               Residues (mg/kg)
                                       n
                                     0.165
                                       1
                                     0.18
                                       1
                                     0.395
                                       1
                                     1.695
                                       1

                                  Fludioxonil
                        Bell Pepper Field + Greenhouse
                                     U.S.
                              0.868-0.945 lb ai/A
 
 
Total number of data (n)
                                      13
Percentage of censored data
                                      15%
Number of non-censored data
                                      11
Lowest residue
                                     0.020
Highest residue
                                     0.280
Median residue
                                     0.130
Mean
                                     0.138
Standard deviation (SD)
                                     0.078
Correction factor for censoring (CF)
                                     0.897
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     0.280
- Mean + 4 SD
                                     0.449
- CF x 3 Mean
                                     0.371
Unrounded MRL
                                     0.449
 
                                       
Rounded MRL
                                      0.5
                               Residues (mg/kg)
                                       n
                                   <0.02 
                                       2
                                     0.08
                                       1
                                     0.09
                                       1
                                     0.11
                                       1
                                     0.13
                                       3
                                     0.16
                                       1
                                      0.2
                                       1
                                     0.21
                                       1
                                     0.23
                                       1
                                     0.28
                                       1

                                  Fludioxonil
                           Pineapple (post-harvest)
                                     U.S.
                                 TRT02 + TRT03
 
 
Total number of data (n)
                                       8
Percentage of censored data
                                      0%
Number of non-censored data
                                       8
Lowest residue
                                     4.760
Highest residue
                                     6.620
Median residue
                                     5.450
Mean
                                     5.643
Standard deviation (SD)
                                     0.675
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     6.620
- Mean + 4 SD
                                     8.341
- CF x 3 Mean
                                    16.928
Unrounded MRL
                                    16.928
 
                                       
Rounded MRL
                                      20
                               Residues (mg/kg)
                                       n
                                     4.76
                                       1
                                     4.96
                                       1
                                     5.38
                                       1
                                     5.44
                                       1
                                     5.46
                                       1
                                     6.06
                                       1
                                     6.46
                                       1
                                     6.62
                                       1

                                  Fludioxonil
                             Potato (post-harvest)
                                     U.S.
                                  all trtmnt
 
 
Total number of data (n)
                                       8
Percentage of censored data
                                      0%
Number of non-censored data
                                       8
Lowest residue
                                     0.664
Highest residue
                                     3.230
Median residue
                                     1.570
Mean
                                     1.823
Standard deviation (SD)
                                     0.945
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     3.230
- Mean + 4 SD
                                     5.605
- CF x 3 Mean
                                     5.469
Unrounded MRL
                                     5.605
 
                                       
Rounded MRL
                                       6
                               Residues (mg/kg)
                                       n
                                     0.664
                                       1
                                     1.01
                                       1
                                     1.13
                                       1
                                     1.46
                                       1
                                     1.68
                                       1
                                      2.5
                                       1
                                     2.91
                                       1
                                     3.23
                                       1

                                  Fludioxonil
                                    Spinach
                                     U.S.
                              0.867-0.911 lb ai/A
 
 
Total number of data (n)
                                      11
Percentage of censored data
                                      0%
Number of non-censored data
                                      11
Lowest residue
                                     1.900
Highest residue
                                    16.000
Median residue
                                     5.800
Mean
                                     7.082
Standard deviation (SD)
                                     4.273
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                    16.000
- Mean + 4 SD
                                    24.173
- CF x 3 Mean
                                    21.245
Unrounded MRL
                                    24.173
 
                                       
Rounded MRL
                                      30
                               Residues (mg/kg)
                                       n
                                      1.9
                                       2
                                      4.6
                                       1
                                      4.9
                                       1
                                      5.2
                                       1
                                      5.8
                                       1
                                      7.5
                                       1
                                      8.3
                                       1
                                      9.8
                                       1
                                      12
                                       1
                                      16
                                       1

                                  Fludioxonil
                             Tomato (post-harvest)
                                     U.S.
                                     Spray
 
 
Total number of data (n)
                                       3
Percentage of censored data
                                      0%
Number of non-censored data
                                       3
Lowest residue
                                     0.175
Highest residue
                                     1.830
Median residue
                                     0.657
Mean
                                     0.887
Standard deviation (SD)
                                     0.851
Correction factor for censoring (CF)
                                     1.000
 
                                       
Proposed MRL estimate
 
 
                                       
- Highest residue
                                     1.830
- Mean + 4 SD
                                     4.292
- CF x 3 Mean
                                     2.662
Unrounded MRL
                                     4.292
 
                                       
Rounded MRL
                                       5
 
                                       
 High uncertainty of MRL estimate.
[Small dataset]
                               Residues (mg/kg)
                                       n
                                     0.175
                                       1
                                     0.657
                                       1
                                     1.83
                                       1

Appendix III.  Chemical Structures
   
                               Common Name/Code 
                                 Chemical name
                              Chemical structure
Fludioxonil/CGA 173506
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile
--------------------------------------------------------------------------------
\* MERGEFORMAT
CGA 344623
4-(2,2-difluoro-1,3-benzdioxol-4-yl)-2,5-dioxo-3-pyrrolidine carboxylic acid
--------------------------------------------------------------------------------
\* MERGEFORMAT
B-1
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile, 2-O-glucose
--------------------------------------------------------------------------------
\* MERGEFORMAT
I-1
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-pyrrole-3- carbonitrile, 1-O-sulfate ester
--------------------------------------------------------------------------------
\* MERGEFORMAT