Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 3 of 37 Potato

................................ ................................ .......... 0.03 ppm Onion, bulb

................................ ................................ ... 1.0 ppm Onion, green

................................ ................................ .. 7.5 ppm Vegetable, fruiting, group 8, except tomato

.................. 2.0 ppm Tomato

................................ ................................ .......... 0.2 ppm Fruit, citrus, group 10

................................ .................. 10.0 ppm Caneb e rry subgroup 13

- A

................................ ............. 5.0 ppm Bushberry subgroup 13

- B

................................ ............. 3.0 ppm Grape

................................ ................................ ............. 1.0 ppm Strawberry

................................ ................................ ... 10.0 ppm Juneberry

................................ ................................ ....... 3.0 ppm Lingonberry

................................ ................................ ... 3.0 ppm Salal

................................ ................................ ............... 3.0 ppm Cotton, undelinted seed

................................ ................. 0.6 ppm Canola, seed

................................ ................................ .. 1.0 ppm Sunflower, seed

................................ ............................. 0.5 ppm Crambe, seed

................................ ................................ . 0.5 ppm Flax, seed

................................ ................................ ...... 0.5 ppm Rapeseed, seed

................................ .............................. 0.5 ppm Rapeseed, Indian

................................ ........................... 0.5 ppm Mustard, field, seed

................................ ....................... 0.5 ppm Mustard, Indian, seed

................................ .................... 0.5 ppm Safflower, seed

................................ .............................. 0.5 ppm

Under PP#1E7851

, IR

- 4

, on behalf of the Agricultural Experiment Stations

, is requesting use of

azoxys trobin, difenoconazole, or the three

- way mixture of azoxystrobin + difenoconazole + fludioxonil on tuberous and corm vegetables subgroup 1C as a postharvest treatment. Syngenta Crop Protection, Inc. (Syngenta) s ubmitted residue data for difenoconazole, az oxystrobin, and fludioxonil on potatoes following postharvest treatment. The s ubject review addresses the adequacy of the magnitude of the residues of azoxystrobin and the Z

- isomer (R230310) only; difenoconazole and fludioxonil results are reported in sep arate DERs

.

In addition, Syngenta has requested amendment of the product label for Abound® Flowable Fungicide (EPA Reg. No. 100

- 1098), a n SC formulation containing 22.9% ai (2.08 lb ai/gal) azoxystrobin

, to add u se s on tuberous and corm vegetables subgrou p 1C as a postharvest

treatment

, dragon fruit, and wasabi

. T he petitioner has also requested amendment of the label s for Abound® Flowable Fungicide (EPA Reg. No. 100

- 1098)

, Quilt® (EPA Reg. No. 100

- 1178 )

, Graduate A+ TM (EPA Reg. No. 100

- 1308) , Quadris TopTM (EPA Reg. No. 100

- 1313 ) , Quilt XcelTM (EPA Reg. No. 100

- 1324 )

, and azoxystrobin dry technical manufacturing use concentrate (EPA Reg. No. 100

- 1120) to incorporate the crop group /subgroup or representative commodity expansions.

Azoxy strobin tolerances have been established in 40 CFR §180.507. T olerances for crop commodities are listed in 40 CFR §180.507(a)(1) and are expressed in terms of residues of the fungicide azoxystrobin and the Z

- isomer of azoxystrobin. Tolerances are current ly established for azoxystrobin in/on various plant commodities at levels ranging from 0.01 ppm in/on pecans and to

420 ppm in/on aspirated grain fractions

.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 4 of 37 Tolerances for livestock commodities are listed in 40 CFR §180.507(a)(2) and are expressed in

term s of residues of azoxystrobin and its Z

- isomer; the Z

- isomer should be removed from the tolerance expression. The established tolerances for livestock commodities range from 0.006 ppm for milk to 0.07 ppm for the meat byproducts of cattle, goat, horse, an d sheep; no tolerances are currently established for poultry commodities.

The existing established tolerances on onion, bulb (1.0 ppm) (for onion, bulb subgroup 3

- 07A); onion, green (7.5 ppm) ( for onion, bulb subgroup 3

- 07B); tomato (0.2 ppm ) ( for tomato subgroup

8

- 10A); vegetable, fruit ing , group 8, except tomato (2.0 ppm ) ( for pepper/eggplant subgroup 8

- 10B); fruit

, citrus

, group 10 (10.0 ppm ) ( for fruit, citrus, group 10

- 10); caneberry subgroup 13A (5 ppm ) ( for caneberry subgroup 13

- 07A); bushberry subg roup 13

- 07 B (3.0 ppm) and juneberry, lingonberry, and sala l (3.0 ppm ) ( for bushberry subgroup 13

- 07 B); grape (1.0 ppm ) ( for f r uit

, small vine climbing, except fuzzy kiwifruit

, subgroup 13

- 07F); strawberry (10.0 ppm ) ( for berry, low growing

, subgroup 13

- 07G , except cranberry) ; canola seed (1.0 ppm ) (for r apeseed subgroup 20A) ; safflower, seed and sunflower, seed ( 0.5 ppm ) ( for sunflower subgroup 20B) ; and cotton

, undelinted seed (0.6 ppm) (for cottonseed subgroup 20C) were used to establish the proposed

tole rances. The proposed tolerance changes are a result of revisions in the crop groups and are conversions from existing groups/subgroups or representative commodities. The proposed

tolerance s for the dragon fruit and wasabi are extrapolated from existing a zoxystrobin tolerances

on mango (2.0 ppm) and the herb subgroup 19A, fresh leaves (50 ppm), respectively. HED

concludes that the available data on these commodities and / or crop group s /subgroup s are adequate to establish the tolerance s on the proposed crop groups/subgroups. No new residue data

are submitted or are needed for the se changes.

The nature of the residue in plants, rotational crops, and livestock is adequately understood. Acceptable metabolism studies have been conducted on primary crops of grapes, peanuts, and wheat as well as on representative rotational crops. Acceptable metabolism studies on goats and laying hens are also available. The residues of concern in/on primary and rotational crop commodities, for tolerance expression and risk assessment purposes, are azoxystrobin and its Z

isomer. The residue of concern in livestock is parent azoxystrobin only.

A dequate residue analytical methods are available for tolerance enforcement : a gas chromatography method with nitrogen

- phosphorus d etection (GC/NPD), RAM 243/04, f or the analysis of crop commodities for residues of azoxystrobin and its Z

- isomer ; and a GC/NPD method, RAM 255/01

, f

or analysis of livestock commodities for residues of azoxystrobin

.

For analysis of samples from the pota to postharvest field trials associated with the current petition, a high performance liquid chromatography method with tandem mass spectro metric detection ( LC/ MS/MS), Method 305/03 , was used as the data

- collection method. RAM 305/03 was adequately validat ed at fortification levels ranging from 0.01

- 10 ppm on potato tubers, potato flakes, and potato chips.

There is an existing use for azoxystrobin on potatoes and corm vegetables subgroup 1C with an established tolerance of 0.03 ppm. Acceptable field tria l studies have been submitted to support the requested tolerance increase of the established tol erance on tuberous and co r m vegetables subgroup 1C from 0. 0 3 ppm to 6.0 ppm ; the studies are supported by adequate existing storage stability data. T he Organiz ation for Economic Cooperation and Development ( OECD ) statisticalAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 5 of 37 calculation procedures w ere used to determine appropriate tolerance levels . Based on the available data, the proposed tolera nce for vegetable, tuberous and corm, subgroup 1C must be

revised to reflect the appropriate tolerance level estimate d using the OECD statistical calculation procedures

. HED recommends a tolerance of 8 .0 ppm for vegetable, tuberous and corm, subgroup 1C

.

The submitted postharvest potato processing study is acceptable

. Residues of azoxystrobin did

not concentrate in potato c akes, potato chips, and potato peel following processing of the raw agricultural commodity ( RAC ) ( pre

- process ed tubers) with quantifiable residues . No tolerances are required for these processed c ommodities.

Adequate cattle and poultry feeding studies are available to support the proposed uses. No changes to the existing livestock commodity tolerances are needed.

A dequate field rotational crop data are available to support the existing rotati onal crop restrictions on the product labels : a 12

- month plantback interval has been established for buckwheat, millet, oats, and rye ; and a 36

- day plantback interval has been established for the leafy vegetables (except Brassica ) group, the Brassica leafy greens subgroup, the root vegetables subgroup, the tuberous and corm vegetable s subgroup, and the leaves of root and tuber vegetables group.

There are Canadian and Codex MRLs for residues of azoxystrobin and its (Z)

- isomer for most of the requested crops . The Codex MRLs (JMPR Report 2008) are based on US field trials, except for subgroup 8

- 10A and 8

- 10B which were conducted in Europe. Even though the Codex MRLs are based on US field trials, there is a slight difference between MRLs of Codex/US due in pa rt
to the difference in the residue definition. The US residue definition includes both the predominant E isomer and the minor Z isomer. The Codex residue definition includes only the E

isomer. The difference in Codex and US MRL estimates, based on the same data set, is based on the JMPR rounding procedures and the tendency to increase the estimate for small data sets.

The US and Codex MRLs are in harmony for subgroup 13

- 07A, strawberries, and sunflower seeds. The US and Codex MRLs are not in harmony f or subgroup 13

- 07G; dragon

- fruit (mango); onion, bulb dry and g reen; vegetable subgroup 8

- 10A; tuberous and corm vegetables subgroup 1C and wasabi (herbs, fresh and dry).

HED recommends increasing the US tolerances for bu shberry, subgroup 13

- 07B, cotton se ed, citrus fruit, 10

- 10, fruit vine climbing 13

- 07F [grape], and pepper/eggplant 8

- 10B to harmonize

with Codex.

The US and Canadian MRLs are in harmony on all proposed crops, except subgroup 13

- 07F, 13

- 07G, and cotton seed

. There are no Canadian toleranc es on cottonseed. Canadian tolerances were not established as subgroups for 13

- 07F and 13

- 07G and were established on grapes (3 ppm) and lowbush blueberries and li n gonberries (subgroup 13

- 07B) at 3 ppm; US tolerances

were established at 1 ppm for 13

- 07F a nd at 10 ppm for 13

- 07G. The current post

- harvest use of the tuberous and corm vegetables subgroup 1C, recommends increasing the US tolerance for vegetable tuberous and corm, subgroup 1C to 8 ppm , which is in agreement with the proposed

Canad ian MRL

.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 6 of 37 An alytical reference standard s for azoxystrobin and its Z

- isomer are currently available at the EPA National Pesticide Standards Repository.

Regulatory Recommendations and Residue Chemistry Deficiencies

Pending submission of a revised Section s B and F , there are no residue chemistry issues that will preclude establish ment of permanent tolerance s for azoxy strobin in/ on the following crops or crop groups/subgroups :

Onion, bulb, subgroup 3

- 07A

................................ ....... 1.0 ppm Onion, green, subgroup 3

- 07B

................................ ...... 7.5 ppm Tomato subgroup 8

- 10A

................................ ............... 0.2 ppm Pepper/eggplant subgroup 8

- 10B

................................ .. 3 .0 ppm Fruit, citrus, group 10

- 10

................................ ............ 15 .0 ppm Caneberry subgroup 13

- 07A

................................ ......... 5.0 ppm Bushberry subgroup 13

- 07B

................................ ......... 5 .0 ppm Fruit, s mall vine climbing, except fuzzy kiwifruit

, subgroup

13

- 07F

................................ ................................ ........... 2 .0 ppm Berry, l ow growing

, subgroup 13

- 07G, except cranberry

.. 10.0

ppm Rapeseed subgroup 20A

................................ ................ 1.0 ppm Sunflower subgroup 20B

................................ .............. 0.5 ppm Cottonseed subgroup 20C

................................ ............. 0.7 ppm Wasabi , fresh

................................ ................................ .. 50 ppm Wasabi, dry

................................ ................................ .. 260 ppm Dragon

- fruit

................................ ................................ .. 2.0 ppm Vegetable, tuberous and corm, subgroup 1C

................ 8. 0 ppm

Note to R M: In conjunction with establishment of the above tolerances, t he existing tolerances for potato; onion, bulb; onion, green; vegetable, fruiting, group 8, except
tomato; okra; tomato; fruit, citrus, group 10; caneberry subgroup 13A; bushbe rry subgroup 13B; grape; strawberry; juneberry; lingonberry; salal; cotton, undelinted seed; canola, seed; sunflower, seed; crambe, seed; flax, seed; rapeseed, seed; rapeseed, Indian; mustard, field, seed; mustard, Indian, seed; mustard, seed; and safflowe r, seed need to be removed from 40 CFR §180.507( a )

.

Note to RM: The e

- CFR includes the Z

- isomer in the tolerance expression for livestock. The Z

isomer should be removed from the tolerance expression for livestock.

A human health risk assessment is for thcoming.

Residue Chemistry Deficienc ies

860.1200 Directions for Use

The proposed use directions for post

- harvest potatoes should be revised to indicate post

harvest use on tuberous and corm vegetables, subgroup 1C rather than on potatoes only

.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 7 of 37 860.155 0 Proposed Tolerances

A revised Section F must be submitted to reflect the recommended tolerance for vegetable, tuberous and corm, subgroup 1C at 8.0 ppm and the correct commodity

definitions as shown in Table 9

.

A revised Section F must be submitted to propose a tolerance for wasabi, dry at 260 ppm

.

Background

The chemical structure and nomenclature of azoxystrobin and its Z

- isomer, and the physicochemical properties of the technical grade of azoxystrobin are presented in Tables 1 and 2, respectively.

Table 1. Azoxystrobin Nomenclature.

Compound

Common name Azoxystrobin

Company experimental name ICIA5504 (Zeneca), R215504 (Syngenta)

IUPAC name methyl ( E )

- 2

- {2

- [6

- (2

- cyanophenoxy)pyr i midin

- 4

- yloxy]phenyl}

- 3

- methoxyacrylate

CAS name methyl ( α E )

- 2

- [[6

- (2

- cyanophenoxy)

- 4

- pyrimidinyl]oxy]

- α

- (methoxymethylene)

- benzeneacetate

CAS registry number 131860

- 33

- 8

End

- use products (EP) Abound® Flowable Fungicide (EPA Reg. No. 100

- 1098) ; Quilt® (EPA Reg. No. 100

- 1178), Graduate A+TM (EPA Reg. No. 100

- 13 08), Quadris TopTM (EPA Reg. No. 100

- 1313), and Quilt XcelTM (EPA Reg. No. 100

- 1324)

Regulated metabolite

, Z

isomer

Common name Azoxystrobin, Z

- isomer

Chemical name methyl ( Z )

- 2

- {2

- [6

- (2

- cyanophenoxy)pyr i midin

- 4

- yloxy]phenyl}

- 3

- methoxyacrylateAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 8 of 37 Table 2

. Physicochemical Properties of Technical Grade Azoxystrobin.

Parameter Value Reference

Melting point/range 114

- 116oC DP#s 218318 and 218448, 3/19/96, J. Garbus pH 6.4

Density 1.25 g/cm 3

Water solubility (20°C) pH 5.2 6.7 mg/L pH 7.0 6.7 mg/L pH 9.2 5.9 mg/L

Solvent solubility (20°C) Hexane 0.057 mg/L

Octanol 1.4 mg/L

Methanol 20 mg/L

Toluene 55 mg/L

Acetone 86 mg/L Ethyl Acetate 130 mg/L

Acetonitrile 340 mg/L

Dichloromethane 400 mg/L

Vapor pressure (20°C) 1.1x10 - 13 kPa (8.2x10 - 13 mm Hg)

Dissoc iation constant, pK

a Not dissociable

Octanol/water partition coefficient, Log(K OW ) log P OW = 2.5

UV/visible absorption spectrum Not available

860.1200 Directions for Use

In Section B of the petition, IR

- 4 submitted amended label s for Abound® Flowab le Fungicide (EPA Reg. N o. 100

- 1098), to add new use s o n potatoes (post

- harvest), dragon fruit, wasabi, and

crop group expansions. T he petitioner has also requested amendment of the label s for Quilt® (EPA Reg. No. 100

- 1178 )

, Graduate A+ TM (EPA Reg. No. 100

- 1308) , Quadris TopTM (EPA Reg.

No. 100

- 1313 )

, and Quilt XcelTM (EPA Reg. No. 100

- 1324 ) to reflect the revision/ expansion of the crop group s.

Table 3. Summary of Directions for Use of Azoxystrobin.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] App. Rate

(lb ai/A) Max.

No. App. /

Season Max.

Seasonal App.

Rate (lb ai/A) PHI

(days) Use Directions and

Limitations

Potatoes ( Post Harvest )

In

- line

aqueous spray application 2.08 lb

ai/gal SC [100

- 1098] 0.6 fl.

oz./t on of

tubers

0.0098 lb

ai/2000

pound

potatoes 1 N/A N/A Ensure proper coverage of

the tubers. Tubers should be tumbling as they are treated.

Mix the fungicide solution in an appropriate amount of water for the crop being

treated.

Use a T

- jet, CDA, or simi lar application system.

Must be used in tank mixture

with difenoconazole andAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 9 of 37 Table 3. Summary of Directions for Use of Azoxystrobin.

Applic. Timing, Type, and Equip. Formulation

[EPA Reg. No.] App. Rate

(lb ai/A) Max.

No. App. /

Season Max.

Seasonal App.

Rate (lb ai/A) PHI

(days) Use Directions and

Limitations

fludioxonil.

Do not make more than one postharvest application to

tubers.

Ensure the A bound solution remains in suspension by using agitation.

Herbs & Spices (except black peppe r) Crop Group 19 (Existing)

, Wasabi (proposed)

Begin making applications at

the onset of

disease development by ground

. For Wasabi

Apply by ground or through irrigation
system (chemigation) Abound ®

Fungicide [100

- 1098 ] 0.1 0

- 0.25 N/S 1.5 0 Applications s hould continue throughout the season on 7

- day inter val s following the resistance management guidelines. Adjuvant may be added at specified rates. Use a minimum of 30 gallons of
water per acre.

Acerola, Atemoya, Avocado, Biriba, Canistel, Cherimoya, Cust ard apple

, Dragon Fruit (proposed) ; Feijoa, Guava, Ilama, Jaboticaba, Jackfruit, Longan, Loquat, Lychee, Mango, Papaya, Passionfruit, Pawpaw, Persimmon, Pulasan, Rambutan, Sapodilla, Sapote black, Sapote, mamey, Sapote white, Soursop, Star apple,

Starfruit , Sugar apple, Spanish lime, and Tamarind ( Existing)

Apply by ground, air, or chemigation prior to

disease development Abound ®

Fungicide [100

- 1098 ] 0.10

- 0.25 N/S 1.5 0 Applications should continue throughout the season on 7

- 10

- day inter val following the resistance management guidelines. Adjuvant may be added at specified rates.

Resistance Management: The l abel for Abound® (EPA Reg. No. 100

- 1098 ) specif ies that the product should be integrated into an overall disease and pest management strategy and that for resistance management, no more than two foliar applications of Abound® Flowable Fungicide (one application for bulb vegetables, peppers and other fruiting vegetables) or other Group 11 fungicides should be made before alternating with a fungicide having a different mod e of action (not in Group 11).

T he following plantback interval s (PBI s ) have been established : 12 months for buckwheat, millet, oats

, and rye ; 36 days for leafy vegetables (except Brassica ) group

, Brassica leafy greens subgroup

, r oot vegetables subgroup

, tuberous and corm vegetable subgroup , and leaves of root
and tuber vegetables group ; and 0 days for all other crops

.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 10 of 37 C onclusions: The label directions are adequate to allow evaluation of the residue data relative to the proposed use s

. The proposed supplemental label for dragon

- fruit and wasabi is adequate

. The proposed use directions for post

- harvest potatoes should be revised to indicate post

- harvest

use on tuberous and corm vegetables, subgroup 1C rather than on potatoes only

.

860.1300 Nature of the Residue

- Plants

PP#5F4541 ; DP#s 218318 and 218448, 3/19/96, J. Garbus

PP#6F4762 ; DP#s 230634, 230635, 230636, and 230637 ; 4/25/97 ; L. Kutney

HED Metabolism Assessment Review Committee Decision Memo ; DP# 251683, 1 2/30/98, W. W assell

Adequate metabolism studies on grapes, peanuts, and wheat were submitted in conjunction with earlier azoxystrobin petitions, PP#s 5F4541 and 6F4762. Azoxystrobin undergoes photochemical isomerization to produce the Z

- isomer and is extensively meta bolized in plants. The parent compound undergoes cleavage of the ether linkages between the phenylacrylate and pyrimidinyl rings and the cyanophenyl and pyrimidinyl rings, with subsequent oxidation, hydrolysis, and/or reduction of the primary metabolites to form numerous secondary metabolites. Azoxystrobin is systemic. HED has determined that the residues of concern in/on plants for tolerance expression and risk assessment purposes are azoxystrobin and its Z

- isomer.

860.1300 Nature of the Residue

- Live stock

PP#5F4541; DP#s 218318 and 218448, 3/19/96, J. Garbus PP#6F4762; DP#s 230634, 230635, 230636, and 230637; 4/25/97; L. Kutney HED Metabolism Assessment Review Committee Decision Memo; DP# 251683, 12/30/98, W. Wassell

The nature of the residue in l ivestock is adequately understood based on acceptable metabolism studies conducted on goats and laying hens. HED has determined that the residue of concern in livestock is parent azoxystrobin only.

860.1340 Residue Analytical Me thods

Enforcement methods

PP#s 5F4541 & 6F4762 ; DP# 235342, 5/30/97, C. Stafford

PP# 7F4864 ; DP#s 249657 and 249668, 1/25/99, D. Dotson

PP# s 6F7106 & 7F7198 ; DP# s 334571 & 340016, 3/12/08, W. Cutchin

Crop commodities : A GC/NPD method, RAM 243/04, is av ailable for the enforcement of

tolerance s for residues of azoxystrobin and its Z

- isomer in crop commodities . The method has undergone method validation by Analytical Chemistry Branch/Biological and Economic Analysis Division ( ACB/BEAD )

. The method was re vised to incorporate comments made by BEAD, and the revised method (designated RAM 243, dated 5/15/98) has been submitted to FDA for

inclusion in Pesticide Analytical Manual ( PAM )

, Volume II. The limit of quantitation (LOQ) is 0.01 ppm for each analyte in crop commodities

.

Livestock commodities : A GC/NPD method, RAM 255/01, is available for the enforcement of tolerances for residues of azoxystrobin in livestock commodities. The method has been validatedAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 11 of 37 by ACB/BEAD for the analysis of milk and liver. The method LOQ is 0.0025 ppm and 0.01 ppm for each analyte in milk and tissues, respectively.

Data

- collection method

Samples from the potato postharvest trial submitted with the current petition were analyzed for residues of azoxystrobin and its Z

- isome r using LC/MS/MS Method RAM 305/03. This method has been reviewed previously by HED, under PP#s 6F7106 and 7F7198.

Briefly, samples were extracted with acetonitrile (ACN):water (90:10, v:v) . After centrifugation,

a n aliquot of the extract was cleaned up on a C18 solid phase extraction column and analyzed using LC

- MS/MS detection. The LC/MS/MS method uses a single ion transition, m/z 404.1→372.1, to quantitate azoxystrobin and R230310 residues in/on plant commodities. For confirmation, the LC/MS/MS me thod may be used to monitor additional ion transitions, m/z
404.1→344.0 and 404.1→329.0.

F or potato postharvest samples , t he LOQ

, determined as the lower limit of method validation (LLMV)

, was 0.01 ppm for each analyte; the limit of detection ( LOD ) was no t reported.

The method was verified prior to and in conjunction with sample analys e s and is considered adequate based on acceptable method validation and concurrent recovery data. S amples of potato were fortified with azoxystrobin and its Z

- isomer each at 0.01

- 10 ppm. T he fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels.

Conclusions: There are adequate residue analytical methods for tolerance enforcement in crop and livesto ck commodities. The LC/MS/MS method used for determination of azoxystrobin and

its Z

- isomer in potato , RAM 305/03, w as adequate for data collection purposes based on acceptable c oncurrent method recoveries.

860.1360 Multiresidue Methods

PP#5F4541 ; DP#s 218318 and 218448, 3/19/96, J. Garbus

Data have previously been submitted pertaining to the multiresidue methods testing of azoxystrobin in conjunction with the grape petition (PP#5F4541). The data indicate that azoxystrobin could not be recovered thro ugh application of the multiresidue protocols. These

data have been forwarded to FDA for inclusion in PAM I.

860.1380 Storage Stability

PP# 7F4864 ; DP#s 248887 and 249671, 10/14/98, D. Dotson, et al

. PP# 7F4864 ; DP#s 249657 and 249668, 1/25/99, D. Dotson

Adequate storage stability data are available indicating that azoxystrobin and its Z

- isomer are reasonably stable under frozen conditions in/on fortified samples of diverse crops. In previous studies, residues were determined to be stable for two years i n/on apple, banana, carrot, cucumber, grape, leaf lettuce, rape seed , peach, winter wheat straw, wheat forage, and wine.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 12 of 37 Over the two

- year period, residues of both azoxystrobin and its Z

- isomer decreased by up to 20% in winter wheat grain and by up to 27% (azoxystrobin only) in tomato, peanut, and pecan, but all recoveries were >70%; residues in these crops were stable (without decrease) for up to 6

- 8

months of storage

.

Previous studies conducted on processed commodities demonstrated that fortified residu es of azoxystrobin and its Z

- isomer were generally stable under frozen conditions in peanut oil and meal, tomato juice and paste, and wheat bran for up to one year, and in soybean meal, corn grits, and orange oil, juice and pulp for at least two years.

Sa mples of postharvest potatoes from the submitted field trial study were stored frozen from harvest to analysis for up to 258 days ( 8.5 months). The available storage stability data on

carrots may be translated to postharvest potatoes.

Table 4. Summary o f Storage Conditions and Durations of Samples from Crop Field Trial Study.

Matrix Analyte Storage Temperature (°C) Actual Storage Duration 1 Limit of Demonstrated Storage Stability

Potato Azoxystrobin <

- 10 10

- 258 days (0.3

- 8.5 months) Adequate storage sta bility data are

available indicating that residues of azoxystrobin and R230310 are stable at

<

- 15 C for at least two years in/on soybean meal, corn grits, carrot root, leaf lettuce, grain sorghum forage, orange oil, and orange juice. 2
Additionally, data o n file indicate residues of azoxyst r obin and R230310 are stable for up to 2 years in cucumbers, apples, grapes, peaches, peanuts, pecans, rapeseed, tomatoes, bananas, and wheat grain. 3 R230310

1 Interval from sampling to analysis. Extracts were stor ed 0

- 3 days prior to analysis.

2 Refer to DER for MRID 45738101 (DP# 287062 ; PMRA # 956496 )

. 3 Refer to DER for MRID 44452303; PMRA # 1191031.

Conclusions : There are adequate storage stability data from previous submissions to validate the storage cond itions and durations of samples from the submitted postharvest potatoes . Residues of azoxystrobin and its Z

- isomer were found to be relatively stable over a wide range of commodities under frozen storage conditions for up to 2 years. The potato residue d ata will not need to be corrected for loss of residue during frozen storage.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses relevant to this guideline topic.

860.1460 Food Handling

There are no proposed uses relevant to this guid eline topic.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 13 of 37 860.1480 Meat, Milk, Poultry, and Eggs

PP#6F4762; DP#s 230634, 230635, 230636, and 230637; 4/25/97; L. Kutney PP#7F4864; DP#s 249657 and 249668, 1/25/99, D. Dotson

Tolerances for residues of azoxystrobin are currently established [40 CFR §180.507(a)(2)] for the fat (0.03 ppm), meat (0.01 ppm), and meat byproducts (0.07 ppm) of cattle, goat, horse, and sheep. A tolerance of 0.01 ppm each has been established for hog fat, meat, and meat byproducts. A milk tolerance of 0.006 ppm is also est ablished. No tolerances for eggs and poultry meat and meat byproducts have been established.

Previously, the maximum theoretical dietary burdens (MTDBs) of azoxystrobin were estimated to be 51.3 ppm for beef, 40.4 for dairy cattle, 14.4 ppm for poultry

, and 15.0 ppm for swine ( DP#

362963 & 363046, M. Negussie

, 08/20/09 ). The livestock feedstuffs associated with this petition

are potato culls and processed potato waste ; i n addition, there are established tolerances for

numerous livestock feedstuffs. Us ing Table 1 Feedstuffs ( June 2008 ) and constructing reasonably balanced livestock diets, th e previously estimated livestock dietary burdens of azoxystrobin w ere revised to include the processed potato waste (dairy cattle only) and are presented in Table 5

. The dietary burdens of azoxystrobin are estimated at 51.3 ppm (beef), 4 4 .4

ppm ( dairy cattle ) , 14.4 ppm (poultry), and 15 ppm ( swine )

.

Table 5. Calculation of Dietary Burdens of Azoxystrobin Residues to Livestock.

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 Recommended/

Established Tolerance (ppm) Dietary Contribution (ppm) 3

Beef Cattle

Alfalfa hay R 89 15 120 20.2

Aspirated grain fractions CC 85 5 420 24.7

Barley grain CC 88 35 3.0 1.19

Sorghum grain CC 86 40 11 5.12

Canola meal PC 88 5 1.0 0.057

T OTAL BURDEN

-- -- 100

-- 51.3

Dairy Cattle

Alfalfa hay R 89 20 120 27.0

Corn, field, silage R 40 25 12 7.5

Sorghum grain CC 86 35 11 4.5

Processed p otato waste CC 15 10 8 5.3

Canola meal PC 88 10 1.0 0.114

TOTAL BURDEN

-- -- 100

-- 44.4

Poultry

So rghum grain CC 86 75 11 8.25

Alfalfa meal PC 89 5 120 6.0

Cottonseed meal PC 88 20 0.6 0.12

TOTAL BURDEN

-- -- 100

-- 14.4

Swine

Barley grain CC 88 5 3.0 0.15

Sorghum grain CC 86 80 11 8.8Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 14 of 37 Table 5. Calculation of Dietary Burdens of Azoxystrobin Residues to Livestock.

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 Recommended/

Established Tolerance (ppm) Dietary Contribution (ppm) 3

Alfalfa meal PC 89 5 120 6.0

Soybean meal PC 92 10 0.5 0.05

TOTAL BURDEN

-- -- 100

-- 15.0

1 R: Roughage; CC: Carbohydrate concentrate; PC: Protein concentrate.

2 OPPTS 860.1000 Table 1 Feedstuffs ( June 2008 ).

3 Contribution = ([tolerance /% DM] X % diet) for beef and dairy cattle; contributio n = ([tolerance] X % diet) for poultry and swine.

Comments 1) Alfalfa hay is chosen because it is the most widely used hay for cattle across the US. 2) Normally alfalfa hay will be given over alfalfa forage mainly because many production animals are in co nfined spaces and not grazing i n pastures. 3) Canola and cottonseed meals are listed in diets, but could be replace d with soybean meal and not affect the proposed diets and total dietary burdens. 4) Rice grain could replace the barley grain for swine, but would not affect the total estimated dietary burden.

Adequate livestock feeding studies have been submitted previously for azoxystrobin. A dairy cattle feeding study was reviewed in conjunction with PP#6F4762 and a study with laying hens

was reviewed in conjunction with PP#7F4864

. In the cattle feeding study

, cattle were dosed at

levels of 5, 25, 75, and 250 ppm for 28

- 30 consecutive days

. T he dosing levels represent ~0.1x, 0.5x, 1.5x, and 4.9x the dietary burden f or beef cattle

, ~0. 1 x, 0. 6 x , 1. 7 x, and 5.6 x the dietary

burden for dairy cattle, and ~0.3x, 1.7x, 5x, and 16.7x the dietary burden for swine . Milk and tissue samples were analyzed for residues of azoxystrobin using the enforcement method for

livestock commodities , w ith LOQs of 0.00 1 ppm for milk and 0.01 ppm for tissues and cream. The results of the cattle feeding study are summarized in Table 6.

In the poultry study, hens were dosed at levels of 60 ppm for 28 consecutive days; the dosing level represents 4.2x the dietary burden to poultry (the study included lower dose rates of 6.0 and

18 ppm; however, these samples were not analyzed). Egg and tissue samples were analyzed for residues of azoxystrobin using the enforcement method for livestock commodities , with an LOQ of 0.01 pp m for each matrix. No quantifiable residues were found in any poultry commodity (see Table 6).

T able 6

. Summary of Azoxystrobin Residues in Livestock Matrices Following the Oral

Administration of Azoxystrobin over 28

- 30 Consecutive Days

. Dose Rate in

Di et (mg/kg) Azoxystrobin Residue s (ppm)

Milk /Eggs Muscle Fat Kidney Liver

Dairy Cattle

5 <0.001

- 0.003 <0.01 <0.01 <0.01 <0.01

25 <0.001

- 0.006 <0.01 <0.01 <0.01 <0.01

- 0.01

75 <0.001

- 0.004 <0.01 <0.01

- 0.03 <0.01

- 0.01 0.01

- 0.05

250 0.002

- 0.009 <0.01 0.0 1

- 0.03 0.01

- 0.02 0.03

- 0.07

Laying Hens

60 <0.01 <0.01 <0.01 Not analyzed <0.01Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 15 of 37 Conclusions: The existing azoxystrobin tolerances for milk and the fat, meat, and meat byproducts of cattle, goat, hog, horse, and sheep are adequate; no revision to the ex isting tolerances is needed to support the proposed uses of azoxystrobin.

The proposed uses of azoxystrobin addressed in this document do not alter the Agency’s previous conclusion that there is no reasonable expectation of finite residues in poultry co mmodities [Category 3 of §180.6(a)]. No tolerances are needed for poultry tissues or eggs.

860.1500 Crop Field Trials

Other than the postharvest potato field trial data (MRID 48437101 )

, no new residue field trial

data were submitted to support the p ro posed tolerances. T he changes are a result of revised crop groups and are conversions from existing groups/subgroups or representative commodities

. The proposed tolerances for the dragon fruit and wasabi are extrapolated from existing azoxystrobin

tolera nces on mango (2.0 ppm) and herb subgroup 19A, fresh (50 ppm), respectively.

Tuberous and corm vegetables subgroup 1C ( Potato

- Post Harvest )

DER Reference : 48437101 .der1.doc

Syngenta submitted residue data for azoxystrobin on potatoes foll owing postha rvest treatment. Five postharvest trials were conducted in the United States and Canada in 2009

- 2010 in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (ME; 1 trial), 5 A (WI ; 1 trial), 5 ( ON; 1 trial), and 11 (WA and ID; 2 trials ).

Potat oes were grown on

- site by the trial personnel in the US 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 wi th a spray mixture containing a 3.00 lb ai /gal (360 g a.i./L) difenoconazole flowable suspension (FS) formulation, a

2.0 9 lb ai /gal (250 g a.i./L) azoxystrobin soluble concentrate (SC) formulation, and a 1. 92 lb

ai /gal (230 g a.i./L) fludioxonil SC formula tion.

In all trials, the test mixture was applied as a postharvest 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 spra y directed to tubers on a tarp (TRT 03); spray directed to tubers in a spray chamber (TRT 04); and spray directed to tubers on a brush table (TRT 05). For each treatment, azoxystrobin was applied at a rate of 0.0089

- 0.0099 lb ai/2000 lb potatoes (4.0309

- 4 .5105 g ai/2000 lb potatoes , ( 0.44

- 0.50 g a.i./100 kg potatoes ) using

water as the carrier ; the delivery rate was 0.22

- 0.54 gal/2000 lb potatoes (0.09

- 0.23 L/100 kg potatoes).

Samples of potatoes from each trial site were collected after the test substa nce 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 days after application to generate residue decli ne data.

Potato samples were analyzed for residues of azoxystrobin and its metabolite R230310 using

LC/MS/MS ; modified Syngenta Analytical Method RAM 305/03 (MRID# 47096401; PMRA #Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 16 of 37 2044022). This method has been reviewed previously and deemed acceptabl e for data gathering.

The limit of quantitation ( LOQ ; determined as the lowest limit of method validation, LLMV) was 0.01 ppm for both analytes. The method was verified prior to and in conjunction with sample analys e s and is considered adequate based on acceptable method validation and concurrent recovery data. The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels.

Potato s amples were stored at <

- 10 °C prior to analysis for a m aximum of 258 days (8.5 months)

. All samples were analyzed within 0 to 3 day s of extraction. Adequate storage stability data are available indicating that residues of azoxystrobin and R230310 are stable at <

- 15 C for at least 24 months in/on soybean mea l, corn grits, carrot root, leaf lettuce, grain sorghum forage, orange oil, and orange juice (MRID 45738101; PMRA # 956496)

. Additionally, data on file indicate residues of azoxyst r obin and R230310 are stable for up to 2 years in cucumbers, apples, grapes

, peaches, peanuts, pecans, rapeseed, tomatoes, bananas, and wheat grain (MRID 44452303;

PMRA # 1191031 )

. These data may be translated to potatoes to validate the storage durations and conditions of azoxystrobin and R230310 for the potato field trial samp les (OECD Guidelines for the Testing of Chemicals, Test No. 506, Adopted 16 October, 2007)

.

Residues of azoxystrobin were 0. 992

- 4.15 ppm (per trial average residues were 0. 994

- 3.79 ppm) in/on potatoes collected 0 DAA following one postharve st spray trea tment application of azoxystrobin formulated as a 2. 09 lb ai/gal (250 g a.i./L) SC at a total seasonal rate of 0.00 8 9

- 0.00 99 lb ai/2000 lb potatoes (0.44

- 0.50 g a.i./100 kg potatoes)

. Residues of R230310 were all <LOQ (0.01 ppm ). All application methods (directed spray to tubers on a conveyor belt, roller table, stationary surface, spray chamber, or brush table) resu lted in similar residue levels.

In the ON decline trial, residues of azoxystrobin remained constant; residues of azoxystrobin

from the WA a nd ID trials generally decreased with increasing DAA

. Residues of R230310 were <LOQ at each sampling interval; therefore, residue decline could not be assessed for the

metabolite

.

Table 7. Summary of Residue Data from Potato Crop Field Trials with Azo xystrobin.

Commodity Analyte Total App.

Rate DAA Residue Levels (ppm) 1

g a.i./

20 00 lb lb a.i./

20 00 lb [g

a.i./100 kg n Sample

Min. Sample

Max. L AFT 3 HAFT 3 Median Mean Std. Dev

. 4

TRT 02 (Conveyor Belt or Roller Table)

Potato

tubers Azoxystrobin 4.0473

- 4.5105 0.0089

-

0.0099 [0.45

- 0.50] 0 10 0.992 4.15 0.994 3.79 2.22 2.40 1.20

R230310 10 <0.01 <0.01 0.01 0.01 0.01 0.01 N/A

Total Residues 10 <1.002 <4.16 1.004 3.80 2.23 2.41 1.20

TRT 0 3 ( Surface ) /Stationary

Potato

tubers Azoxystrobin 4.0 997 0.0090 [0.45] 0 2 1.05 1.22 1.14 1.14 N/A N/A N/A

R230310 2 <0.01 <0.01 0.01 0.01 N/A N/A N/A

Total Residues 2 <1.06 <1.23 1.15 1.15 N/A N/A N/A

TRT 0 4 ( Spray Chamber )

Potato

tubers Azoxystrobin 4.0309 0.0089 [0.44] 0 2 3.50 3.57 3.54 3.54 N/A N/A N/A

R230310 2 <0.01 <0.01 0.01 0.01 N/A N/A N/AAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 17 of 37 Table 7. Summary of Residue Data from Potato Crop Field Trials with Azo xystrobin.

Commodity Analyte Total App.

Rate DAA Residue Levels (ppm) 1

g a.i./

20 00 lb lb a.i./

20 00 lb [g

a.i./100 kg n Sample

Min. Sample

Max. L AFT 3 HAFT 3 Median Mean Std. Dev

. 4

Total Residues 2 <3.51 <3.58 3.55 3.55 N/A N/A N/A

TRT 0 5 ( Brush Table )

Potato

tubers Azoxystrobin 4.0850 0.0090 [0.45] 0 2 2.23 2.31 2.27 2.27 N/A N/A N/A

R230310 2 <0.01 <0.01 0.01 0.01 N/A N/A N/A

Total Residues 2 <2.24 <2.32 2.28 2.28 N/A N/A N/A

Combined Treatments

Potato

tubers Azoxystrobin 4.0309

- 4.5105 0.0089

-

0.0099 [0.44

- 0.50] 0 16 1 0.992 4.15

-- -- 2.25 2.37 1.12

8 2

-- -- 0.994 3.79 2.25 2.37 1.15

R230310 16 1 <0.01 <0.01

-- -- 0.01 0.01 N/A

8 2

-- -- 0.01 0.01 0.01 0.01 N/A

Total Residues 16 1 <1.002 <4.16

-- -- 2.26 2.38 1.12

8 2

-- -- 1.004 3.80 2.25 2.37 1.15

1 n = no. of samples. 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 n = no. of field trials ; statistical calculations are based on per

- trial average values

. 3 LAFT = lowest

- average

- field

- trial; HAFT = highest

- a verage

- f ield

- t rial.

4 N/A = Not applic able.

Conclusions: The supervised residue trials on potato are considered scientifically acceptable. Based on the study results, residues of azoxystrobin may be up to 4.15 ppm (per trial average maximum of 3.79 ppm) in/on potato collected at 0 DAA follow ing postharvest spray application

of azoxystrobin , formulated as a 2.09 lb ai/ gal SC , at a total rate of 0.0089

- 0.0099 lb ai/ 2000 lb
potatoes ( 4.0309

- 4.5105 g a.i./ 2000 lb potatoes ); maximum residues of metabol ite R230310 in potatoes were <0.01 ppm

. Sampl es were analyzed for azoxystrobin and the metabolite R230310 using acceptable method s. T he study is supported by adequate storage stability data for azoxystrobin and R230310

.

The average residue values for the potato postharvest use were used to calcul ate the tolerance. Using the OECD statistical procedures , the recommended tolerance is 8 ppm. T he recommended tolerance is higher than the proposed tolerance ( 6 ppm). Thus, a revised Section F is required to
reflect this determination.

Note to PM: The existing separate tolerance on potato should be removed and the established vegetable, tuberous and corm, subgroup 1C need to be revised.

Crop Field Trial Data in Support of Crop Group /Subgroup Expansions.

The adequacy of the available data to support t he c rop g roup /subgroup e xpansions is discussed below for each crop and/or crop group /subgroup

.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 18 of 37 Caneberry subgroup 13

- 07A
Residue Chemistry Memo DP# 279210

, N. Dodd

, 06/19/02

DER Reference: 45522301

Tolerances have been established for the combined resi dues of azoxystrobin and its Z

- isomer in/on caneberry subgroup 13A at 5 .0 ppm. T olerances were established based on t he results from three crop field trials conducted in OR (2 trials) and WA (1 trial) in /on raspberry or blackberry

an d cranberry. Azoxystrobin (80% WDG) was applied to raspberry or blackberry plants as 6 or 7 foliar directed spray applications at 0.24

- 0.26 lb ai/A /application , for a total of 1.5

- 1.8 lb ai/A/season (1

- 1.2x the maximum proposed rate). Caneberry fruits we re harvested on the day of the last application (0

- day PHI). The combined residues of azoxystrobin and R230310 were

<0.69

- 3.69 ppm in/on samples of caneberry (4 raspberry and 2 blackberry) fruit.

The required number of field trials for blackberry or rasp berry as representative crops to establish

a tolerance for the caneberry subgroup 13

- 07A is 3 trials for any one blackberry or raspberry (ChemSAC 7/8/2009).

Bushberry subgroup 13

- 07B
Residue Chemistry Memo DP# 274312

, G. J. Herndon

, 07/10/2001

DER Refere nce: 4 5 253901

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer in/on bushberry subgroup 13B at 3 .0 ppm. The tolerances were established based on t he results from the supervised crop field t rials in blueberr ies. S even trials conducted in R egion s 1 ( ME; 1 trial), 2 ( NC; 2 trials), 5 ( MI; 3 trials), and 12 ( OR; 1 trial) were submitted. The results have shown that the maximum residues in blueberry treated six times with Quadris 80WG at 0.25 lb s ai/A / application ( equivalent to 1X the proposed rate ) and collected 0 days following the last application were 1.63 ppm.

The required number of field trials for highbush blueberry as the representative crop to establish

a tolerance for the bushberry s ubgroup 13

- 07B is 8 trials for highbush blueberry (ChemSAC 7/8/2009).

Small fruit vine climbing, except fuzzy kiwifruit subgroup 13

- 07F
Residue Chemistry Memo DP# 218318 & 218448

, DP#226232 , J. Garbus, 3/19/96

DER Reference s : 436 78209 , 43678210 and 44002 2 00

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer

in/on grapes at 1.0 ppm based on trials conducted in Europe and the US . Seven of the trials were conducted in the US at 6 sites; R egion s 1 (NY; 1trial); 11 (WA; 1 trial); 10 (CA; 3 trials) and 1

trial each in AK and MI

, areas not genera lly associated with viticulture. In addition, n ine field

trials were conducted in the US in Region 1 (NY; 1 trial), Region 10 (CA; 6 trials), and Region

1 1 (OR and WA; 2 trials) to satisfy the requirement for geographic representation. T he results of 10 other trials conducted in Europe are also available

. The results from the US trials have

shown that the maximum residues in grapes
, harvested 12 to 19 days following the last application of a wettable granular (WG) formu la tion

, and treated six times at 0.25 lbs

ai/A / application

, equivalent for a total of 1.5 lbs ai/A /season ( 1X the proposed rate )

, were 0.81

ppm.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 19 of 37 The required numb er of field trials for grapes as the representative crop to establish a tolerance

for the fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F is 12 trials for grapes (ChemSAC 7/8/2009).

Note to PM: The existing separate tolerance on grap e should be removed when the subgroup

tolerance is established.

Berry, l ow growing

, subgroup 13

- 07G, except cranberry.
Residue Chemistry Memo DP# 274312

, G. J. Herndon

, 07/10/2001

DER Reference: 4520560 4

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer in/on strawberry at 10.0 ppm. The tolerance s w ere established based on t he results from the supervised crop field trials on strawberries. Seven trials conducted in R eg ion s 3 ( FL; 2 trial s ), 5 ( WI; 1 trial), 10 ( CA; 3 trial s ), and 12 ( OR; 1 trial) were submitted. The results from the crop field trials on strawberry have shown that the maximum residues in strawberry treated six times

with Quadris 80WG at 0.25 lbs ai/A / ap plication ( equivalent to 1X the proposed rate ) and collected 0 days following the last application were 5.11 ppm.

The required number of field trials for strawberry as the representative crop for the berry, low growing, subgroup 13

- 07G, except cranberry is 8 trials for strawberry (ChemSAC 7/8/2009).

Note to PM: The existing separate tolerance on strawberry should be removed when the subgroup tolerance is established.

Citrus Fruits
Residue Chemistry Memo DP# 260134

, M. J. Nelson

, 0 9 / 06 /200 0

Residue Ch emistry Memo DP# 312949

, W. Cutchin

, 01/23/2006

DER References: 44915217, 44915224, and 44915225

DER Reference: 46509101CFT

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer

in/on f ruit, citrus, group 10 at 10 p pm. Twenty

- three field trials were conducted on the representative crops (sweet orange, lemon, and grapefruit)

. Six trials were conducted on grapefruit in Regions 3 (FL; 3 trials), 6 (TX; 1 trial), and 10 (CA; 2 trials); 5 trials were conducted on lemons in Regions 3 (FL; 1 trial) and 10 (CA, AZ; 4 trials); and 12 trials were conducted on oranges in Regions 3 (FL; 8 trials), 6 (TX; 1 trial), and 10 (CA ; 3 trials). Residues of azoxystrobin were 0.16

- 0.41 ppm in/on grapefruit, 0.27

- 0.74 ppm in/on lemons, a nd 0.09

- 0.53

F ppm in/on oranges harvested 0 days following the last of six applications, with 6

- to 8

- day retreatment intervals, of the 80% WDG formulation at 0.25 lb ai/A/application, for a total application rate of 1.5 lb ai/A /season (1x the maximum prop osed seasonal application rate).

In addition, citrus field trials treated with both preharvest and postharvest applications were

submitted. The submitted data were obtained from trials conducted in Regions 3 (FL; 1 trial), 6 (TX; 1 trial), and 10 (CA; 4 trials). For pre

- harvest

, treated plot received two foliar applications

at ~ 0.25 lb a.i./A/A and harvested at 0

- day PHI.

All post

- harvest test solutions contained Azoxystrobin 80WG a nd were applied at 1.0 lb a.i./100 gal water (dip) and 1.0 lb a.i./250,000 lb fruits (packing

- line spray). C itrus field trials wereAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 20 of 37 conducted using simulated postharvest applications (using six different postharvest methods)

followin g normal pre

- harvest use. The highest azoxystrobin residues were detected in grapefruit,

orange
, and lemon samples that received pre

- harvest as well as post harvest dip treatments ranging from 1.185 to 5.427 ppm, 1.213 to 3.994 ppm, and 1.466 to 9.182 ppm, respectively.

Based on these field trial data

, the tolerance was established on the citrus fruit group 10 at 10.0

ppm.

Onion, bulb, subgroup 3

- 07A and Onion, green, subgroup 3

- 07 B
Residue Chemistry Memo DP# 260134

, M. J. Nelson

, 0 9 / 06 /200 0

DER Referenc es: 44915210 and 44915226

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer in/on onion, bulb and onion, green at 1 .0 and 7.5 ppm, respectively. The tolerances were

established based on t he results from crop field trials on bulb onions and green onions. Eight bulb onion field trials were conducted in Regions 1 (NY; 1 trial), 5 ( IL; 1 trial), 6 (TX; 1 trial), 8 ( CO; 1 trial), 10 (CA; 2 trials), 11 (WA; 1 trial), and 12 (OR; 1 trial). Three green onion trials were conducted in Regions 6 ( TX; 1 trial) and 10 ( CA and AZ; 1 trial each ).

The results have shown that the maximum residues in bulb onions and green onions treated six

times with Quadris 80 WDG at 0.25 lbs ai/A /application ( equivalen t to 1X the proposed rate of

1.5 lb ai/A / season ) and collected 0 days following the last application were 0.67 and 6.91 ppm
, respectively

.

Rapeseed subgroup 20A
Residue Chemistry Memo DP# 312949

, W. Cutchin

, 01/23/2006

D ER Reference: 4604660 4 CFT

Residue Chemistry Memo PP#s 7F4864 & 8F4995, DP Barcode: D249657 & D249668, D. Dotson, 1/25/99

DER References: 44613502 and 44595108

Canola is the representative crop for the rapeseed subgroup 20A. Tolerances have been

established for the combined residues of azoxystrobin and its Z

- isomer in/on canola

, seed at 1.0 ppm and rapeseed

, seed at 0.5 ppm. Eleven crop field trial s s for azoxystrobin in/on canola were

submitted. Nine of these trials were conducted in Canada a nd two were conducted in the U.S.

, in

R eg ion s 7 (ND) and 11 (WA). A zoxystrobin was applied ( WDG 80% ) as a foliar broadcast spray at the target rate of 0.1 5 lb ai/A

- 0.34 lb ai/A /application

. The label specifies a use rate of

0.1

- 0.25 lb ai/acre /application with a maximum of three applications and a maximum rate of 0.45

lb ai/acre/ season. T he highest application rate was three applications of 0.17, 0.34, and 0.34 lb ai/acre which result in a total application of 0.85 lb ai/acre/ season . This rate is 1.9x the maximum rate specified on the label (0.45 lb ai/acre/ season ). The highest field trial value for the combined residues of azoxystrobin and R230310 was 0.80

, which was obtained from application of azoxystrobin at a rate of 1.9x the maximum rate specified on the label

.

In addition, there is existing field trial data from nine trials conducted in Canada encompassing Region s V (MB), VII (SK), and XIV (AB [3], SK [2], MB [2]) in or on canola treated with Quadris 2.08 SC . This formulation was applied three times as a foliar broadcast spray at the target rate of ~0.11 lb ai/A (0.123 kg ai/ha) for the first and third applications and at the target rate of ~0.23 lb ai/A (0.258 kg ai/ha) for the second application. T he target seasonal application rate for the treated plots was 0.45 lb ai/A (0.504 kg ai/ha). The maximum residues found for azoxystrobin and R230310 were 0.23 ppm and 0.02 ppm, respectively. Based on these data,Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 21 of 37 tolerances were esta blished at 0.5 ppm in Indian rapeseed

, Indian mustard seed, field mustard seed, black mustard seed, flax seed, sunflower seed, safflower seed, and crambe seed.

Tolerances on canola seed were established at 1.0 ppm using the highest u se rate tested . The 1.0 ppm tolerance level is adequate to cover the rapeseed subgroup 20A

.

Note to PM: The existing separate tolerances on canola, seed; crambe, seed; flax, seed; rapeseed, seed; rapeseed, Indian; mustard, field seed; and mustard, I ndian, seed should be removed when the subgroup tolerance is established.

Sunflower subgroup 20B

Residue Chemistry Memo DP# 312949

, W. Cutchin

, 01/23/2006

D ER Reference s : 46046601CFT and 46046602

Tolerances have been established for the combined residue s of azoxystrobin and its Z

- isomer

in/on sunflower seeds at 0.5 ppm. T he tolerances were established based on submitted data from six trials in the USA encompassing R egion s 5 (MN and ND; 2 trials), 7 (NE, ND, and SD; 3 trials), 8 (TX ; 1 trial), and four trials in Canada encompassing R egion s 5 (MB; 1 trial), 7 (SK; 1 trial), 14 (AB and MB; 2 trials)

. In the USA, azoxystrobin was applied as Quadris 80 WG, containing 81.4% azoxystrobin. In Canada, azoxystrobin was applied as Quadris 2. 08 SC, which is a soluble concentrate containing 22.8% azoxystrobin. Both formulations were applied three times as a foliar broadcast spray at the target rate of ~0.11 lb ai/A /application for the first and third applications and at the target rate of ~0.2 3 lb ai/A /application for the second application. The target seasonal application rate for the treated plots was ~0.45 lb ai/A. The results from

these trials have shown that the maximum residues in sunflower seeds collected 28

- 30 days following the last application are 0.24 ppm and 0.01 ppm for azoxystrobin and R230310, respectively.

Note to PM: The existing separate tolerances on sunflower, seed and safflower, seed should be removed when the subgroup tolerance is established.

Co ttonseed subgroup 20C

Cotton
Residue Chemistry Memo DP# 334571

, W. Cutchin

, 03/12/2008

DER Reference : 47096402

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer

in/on cotton, undelinted seed at 0.6 ppm and in/on cotton

, gin byproducts at 45 ppm. T welve

cotton field trials were conducted in the United States in Regions 2 (SC; 1 trial), 4 (AR, LA, MS; 3 trials), 6 (TX; 1 trial), 8 (NM, OK, TX; 4 trials), and 10 (CA; 3 trials). The treated plot

received one in

- furr ow application of a 2.08 lb/gal FlC formulation of azoxystrobin at planting of cotton at a target rate 0.15 lb ai/A /application , followed by three foliar broadcast applications of the 2.08 lb/gal FlC formulation at a rate of 0.14

- 0.16 lb ai/A/application. The in

- furrow rate and foliar treatment rates are equivalent to 1

- 1.9x the proposed maximum seasonal rate. Cottonseed

was harvested 45 days after last application ( DALA ) , and samples from 6 trials (3 picker harvested; 3 stripper harvested) were ginned fo r cotton gin byproducts (trash). The results fromAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 22 of 37 the crop field trials on cotton have shown that maximum combined residues (azoxystrobin + R230310) were 0.62 ppm in/on cottonseed and 34.4 ppm in/on cotton gin byproducts.

Note to PM: The existing sepa rate tolerance on undelinted, seed should be removed when the subgroup tolerance is established.

Tomato subgroup 8

- 10A
Residue Chemistry Memo DP# 328984; W. Cutchin ; 0 6 / 19 /200 6

DER Reference s : 44058730 and 44058731

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer in/on tomato at 0.2 ppm

. A total of 16 field trials were conducted in Regions 1 ( NJ ; 1 trial), 2 ( NC; 1 trial), 3 ( FL; 2 trials), 5 ( IN ; 1 trial), and 10 (CA; 11 trials). T he results from the crop fi eld trial on

tomatoes have shown that the maximum combined residue s in/on tomatoes treated eight times with Quadris 80W D G at 0.1 lb ai / A /application (e quivalent to 1X the proposed rate) and collected 1 day following the last application w ere 0.18 ppm

.

Pe pper/eggplant subgroup 8

- 10B
Residue Chemistry Memo DP# 274312

, G. J. Herndon

, 07/10/2001 Residue Chemistry Memo DP# 328984

, W. Cutchin

, 0 6 / 19 /200 6 ( PP# 1E06264)

DER Reference : 45332502

Tolerances have been established for the combined residues of azoxy strobin and its Z

- isomer in/on vegetable, fruiting, group 8, except tomato at 2.0 ppm. The tolerances were established

based on t he results from eight supervised field trials on peppers ( bell and non

- bell) conducted in

R egion s 1 ( NY ; 2 trials)

, 2 (GA; 1 trial), 3 (FL; 2 trials), 5 (OH; 1 trial), 6 (T X ; 1 trial)

, and 10 (CA; 2 trial s ). Bell and non

- bell pepper data (PP# 1E6264 ) were used to establish the okra and eggplant tolerances as a result of a previous reque st from IR

- 4 ( DP# 274312, G. Herndon, 4/30/01). The results from the crop field trial on peppers have shown that the maximum residues in bell peppers and non

- bell peppers treated six times with Quadris 80WDG at 0.25 lbs

ai/A /applicat ion ( equivalent to 1X the proposed rate ) and collected 0 days following the last application were 0.40 ppm and 0.92 ppm, respectively.

Note to PM: The existing separate tolerance on okra should be removed when the subgroup

tolerance is established.

Dra gon

- f ruit
Residue Chemistry Memo DP# 274312

, G. J. Herndon

, 07/10/2001

DER Reference: 4 5205606

Tolerances have been established for the combined residues of azoxystrobin and its Z

- isomer in/on mango at 2 ppm. The tolerance w as established based on t he results from the supervised crop field trials on mango conducted in R egion 13 (FL; 3 trials)

. T he results from the crop field

trial s have sh own that the maximum residues in mango treated six times with 80WG (containing

80% a.i. ) at 0 .25 lbs ai/A /application ( equivalent to 1X t he proposed rate ) and collected 0 days following the last application were 0.48 ppm. T he mango tolerance of 2.0 ppm can be translated to dragon

- fruit ; b oth are classified as tropical fruit with inedible peels ( ChemSAC 2/9/2011).Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 23 of 37 Wasabi
Residue Chemistry Memo DP# 285603

, N. Dodd

, 0 1/22/2003 Residue Chemistry Memo DP# 312949

, W. Cutchin

, 01/23/2006

DER Reference s : 45736301, 46006901, and 46219201

IR

- 4 is proposing to extrapolate the established tolerance s of az oxystrobin on the herb subgroup 19A, fresh leaves at 50 ppm

. In addition, IR

- 4 is requesting that application be allowed through chemigation for wasabi. The existing herb and spice tolerances were established using crop field

trials (basil, chive and dil l seed) conducted using foliar broadcast sprays at 0.25 lb ai/A/application with a maximum seasonal rate of 1.25 lb ai/A, with a pre

- harvest interval of 0

- days. The use pattern proposed for wasabi is similar to the current use direction s for herbs and spi ces except for addition of application through chemigation

. The tolerances on the herb subgroup 19A, fresh leaves a re adequate to cover a tolerance of 50 ppm for wasabi , fresh and the herb subgroup 19A, dried leaves at 260 ppm to establish tolerances on w asabi, dry (ChemSAC

, 2/23/2011). The petitioner is required to submit a revised Section F to propose a tolerance for

residues of azoxystrobin in/on wa sabi, dry at 260 ppm.

Conclusions

. The existing azoxystrobin tolerances on onion, bulb; onion, green; tomato; grape ; strawberry ; juneberry ; lingonberry ; salal ; cotton, undelinted seed ; canola, seed ; crambe, seed ; flax, seed ; rapeseed, seed ; rapeseed, Indian ; mustard, field seed ; mustard, Indian, seed;

s unflower, seed ; safflower, seed; vegetable, fruitin g, group 8, except tomato ; f ruit, citrus, group

10 ; c aneberry subgroup 13

- A ; and b ushberry subgroup 13

- B are sufficient to support the proposed revisions to tolerances. Adequate geographic representation and residue data are available

.

860.1520 Processed Food and Feed

DER Reference : 48437101.der 2 .doc

Syngenta submitted a processing study for azoxystrobin on potato foll owing postharvest

treatment. One postharvest trial was conducted in Kimberley, ID, in 2009. Potatoes were grown

on

- site and mature pot ato tubers were harvested, placed in on

- site storage for ~2 months, and then treated with a spray mixture containing a 3.00 lb ai /gal (360 g a.i./L) difenoconazole

flowable suspension (FS) formulation, a 2.09 lb ai/gal (250 g a.i./L) azoxystrobin soluble

c oncentrate (SC) formulation, and a 1.92 lb ai/gal (230 g a.i./L) fludioxonil SC formulation. The

test mixture was applied as a postharvest treatment spray directed to tubers falling from a conveyor belt at 1X the application rate of 0.0091 lb azoxystrobin /2000 lb potatoes (4.1357 g azoxystrobin /2000 lb potatoes [0.46 g a.i./100 kg potatoes] ) using water as the carrier . The delivery rate was 0.51 gal/2000 lb potatoes (0.21 L/100 kg potatoes). Potato samples were collected after the spray had dried on the day of application [0 days after application (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 processin g procedures, including material balance summaries

.

Potato raw agricultural commodity (RAC) and processed fraction samples were analyzed for

residues of azoxystrobin and its metabolite R230310 using modified Syngenta Method RAM 305/03 (MRID 47096401; PM RA # 2044022), a n LC/MS/MS method. This method has been reviewed previously and deemed acceptable for data gathering. The limit of quantitation ( LOQ ;Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 24 of 37 determined as the lowest limit of method validation, LLMV) was 0.01 ppm for azoxystrobin and

R230310 in all potato matrices. The method w as verified prior to and in conjunction with sample analysis and is considered adequate based on acceptable method validation and concurrent recovery data. The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels.

The maximum storage durations of samples from collection/processing to analysis w ere 140 days (4.6 months) for potato (RAC), 209 days ( 6.9 months) for flakes, 222 days (7.3 months) for

chi ps , and 166 days ( 5.5 months) for wet peel. Analysis took place between 0 and 3 days after

extraction. Adequate storage stability data are available indicating that residues of azoxystrobin

and R230310 are stable at <

- 15 C for at least 24 months in/on s oybean meal, corn grits, carrot root, leaf lettuce, grain sorghum forage, orange oil, and orange juice (MRID 45738101; PMRA # 956496)

. Additionally, data on file indicate residues of azoxyst r obin and R230310 are stable for up to 2 years in cucumbers, appl es, grapes, peaches, peanuts, pecans, rapeseed, tomatoes, bananas, and wheat grain (MRID 44452303; PMRA # 1191031 )

. According to the OECD Guidelines for the Testing of Chemicals (Test No. 506, Adopted 16 October, 2007), if there is no

observed decline of residues across the range of five different commodity categories (high water content, high oil content, high protein content, high starch content, and high acid content), then residues are stable in all commodities, and specific freezer storage stability d ata for processed

foods are not needed. Therefore

, there are no concerns regarding the stability of azoxystrobin and R230310 residues in any samples in this study.

Concentration of residues in potatoes treated with one postharvest treatment of azoxystrob in (4.1357 g azoxystrobin /2000 lb potatoes [0.46 g a.i./100 kg potatoes] ) following processing was

not observed in potato processed fractions

. Mean residues of azoxystrobin were 0.938 ppm for potato tuber (RAC), <0.01 ppm for flakes, 0.0111 ppm for chips (resulting in a processing factor of 0.01x), and 0.846 ppm for wet peel (resulting in a processing factor of 0.90x). Residues of metabolite R230310 were below the LOQ (<0.01 ppm) in/on all samples of potato RAC, flakes, chips, and wet peel. Therefore, no processing factors were calculated for R230310. All of the processing factors calculated in this study were less than the maximum theoretical concentration

factor s of 4.7 x for dried potatoes (flakes and granules) and 4.0x for processed waste ( based on

lo ss of water and separation of components; OPPTS 860.1520, Table s 2 and 3 ; DIR98

- 02,

Section 10 ).

Table 8. Residue Data from Potato Processing Studies with Azoxystrobin.

RAC Processed Commodity Total Rate DAA Residues (ppm) Processing Factor 1,2

g a.i ./

2000

lb lb a.i./

2000 lb Azoxystrobin R230310 Total

Residues Azoxystrobin R230310 Total

Residues

Potato Tubers

(RAC) 4.1357 0.00 91 0 0.938 <0.01 <0.948

-- -- --

Flakes <0.01 <0.01 <0.02 <0.01x NC <0.02x Chips 0.0111 <0.01 <0.0211 0.01x NC <0.02x Wet peel 0.846 <0.01 <0.856 0.90x NC <0.90x

1 NC = Not calculated; residues were below the LOQ (<0.01 ppm for all in analytes) in the RAC and processed fraction.

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

Conclusion : The submitted potato processing study is acceptable. Processing of the tuber RACAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 25 of 37 with quantifiable residues of azoxystrobin did not result in the concentration of residues in potato fractions (proc essing factors were all <1x). Residues of R230310 were below the LOQ in/on all samples of potato RAC, flakes, chips, and wet peel. Therefore, processing factors were not

calculated. The observed concentration factors were less than the theoretical conce ntration

factors.

Acceptable methods were used for the determination of residues of azoxystrobin and the Z

isomer metabolite. The sample storage conditions and durations for azoxystrobin analyses are supported by adequate storage stability data.

860.1650 Submittal of Analytical Reference Standards

Analytical standards for azoxystrobin and its Z

- isomer are currently available in the EPA National Pesticide Standards Repository (personal communication with Charles Stafford , ACB,

07/ 07/2011 ) with an expiration date of 11/30/2014

.

860.1850 Confined Accumulation in Rotational Crops

PP#6F4762 ; DP#s 230634, 230635, 230636, and 230637

, L. Kutney , 4/25/97 PP#9F6058; DP# 260134, 9/6/00, M. Nelson

Adequate confined studies have previously been presented in PP#6F4762 and re

- evaluated in

PP#9F6058. T otal radioactive residues , expressed as [ 14 C]azoxystrobin equivalents, accumulated at >0.01 ppm in the raw agricultural commodities of lettuce, radishes, and wheat planted in sandy loam soil 30, 200, and 365 days after treatment of the soil with [ 14 C]azoxystrobin at 1.8 lb ai/A. Residues were highest in rotated crop commodities from the 30

- day PBI and declined in subsequent PBIs.

Azoxystrobin was identified in all rotat ed crop commodities at the 30

- day PBI . In 30

- day PBI samples, the Z

- isomer was only identified in wheat forage and straw. Compound 42 was the major metabolite identified in 30

- day PBI lettuce and wheat forage and straw. In 30

- day PBI radish roots, azoxy strobin was the major metabolite and in 30

- day PBI radish tops, metabolites

G 2 , N 1 , and N 2 were the major metabolites. In 30

- day PBI wheat grain, 14 C

- starch was found to account for the largest portion of radioactivity. Several conjugated metabolites (co mpound 42 and the M, N, and O metabolites) of primary crop metabolites were identified, indicating that azoxystrobin is more extensively metabolized in rotational crops than in primary crops. HED has

concluded that t he residues of concern in rotational cr ops are parent and the Z

- isomer.

860.1900 Field Accumulation in Rotational Crops

PP#6F4762 ; DP#s 230634, 230635, 230636

, and 230637

, 4/25/97

, L. Kutney

PP#9F6058 ; DP#s 283588 and 287062, N. Dodd

, 2/6/03

PP#9F6058 ; DP# 298114, L. Cheng , 12/20/05

PP# s 6F 7106 & 7F7198 ; DP# 334571 & 340016, W. Cutchin , 3/12/08

Limited field rotational crop studies, reflecting applications made to the primary crop at a seasonal rate of 0.8 lb ai/A, were initially submitted in PP#6F4762. Subsequently, additional

limited fie ld rotational crop studies, with applications made to the primary crop at seasonal ratesAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 26 of 37 of 1.6 or 2.0 lb ai/A, were submitted and reviewed in PP#9F6058. Under PP# s 6F7106 and 7F7198, HED concluded that the following PBI s were appropriate to support a max imum seasonal application rate of 2.0 lb ai/A to rotated crops : 12 months for buckwheat, millet, oats and rye ; and 36 days for the leafy vegetables (except Brassica ) crop group; the Brassica leafy greens subgroup; the root vegetables subgroup; the tuberou s and corm vegetable subgroup; and

the leaves of root and tuber vegetables group. Crops with registered uses may be planted immediately after the last treatment unless otherwise specified. For crops not on the label, a 12

- month PBI must be observed unles s otherwise specified.

Conclusions: Because t he proposed amended uses do not result in increased maximum seasonal application rates of azoxystrobin, no changes to the existing rotational crop restrictions are

needed. T he rotational crop restrictions on the label for EPA Reg. No. 100

- 1098 is adequate.

860.1550 Proposed Tolerances

HED has determined that the residues of concern in/on crop commodities for tolerance expression and risk assessment purposes are azoxystrobin and its Z

- isomer. The toleranc e expression proposed by IR

- 4 for the proposed/ revised tolerances is adequate.

Adequate field trial data have been submitted for the postharvest use o f tuberous and corm vegetables subgroup 1C . The OECD statistical calculation procedures was utilized f or determining appropriate tolerance levels; see Appendix I I for tolerance calculations. The petitioner should submit a revised section F reflecting the recommended tolerance for the vegetable, tuberous and corm, subgroup 1C and the correct commodity defi nitions as presented

in Table 9

.

No changes to the existing tolerances for livestock commodities are needed as a result of the proposed uses.

There are Canadian and Codex MRLs for residues of azoxystrobin and its (Z)

- isomer for most of the requested crop s. The Codex MRLs (JMPR Report 2008) are based on US field trials, except for subgroup 8

- 10A and 8

- 10B which were conducted in Europe. Even though the Codex MRLs are based on US field trials, there is a slight difference between MRLs of Codex/US due in p art
to the difference in the residue definition. The US residue definition includes both the predominant E isomer and the minor Z isomer. The Codex residue definition includes only the E

isomer. The difference in Codex and US MRL estimates, based on th e same data set, is based on the JMPR rounding procedures and the tendency to increase the estimate for small data sets.

The US and Codex MRLs are in harmony for subgroup 13

- 07A, strawberries, and sunflower seeds. The US and Codex MRLs are not in harmony for subgroup 13

- 07G; dragon

- fruit (mango); onion, bulb dry and green; vegetable subgroup 8

- 10A; tuberous and corm vegetables subgroup 1C

, and wasabi (herbs, fresh and dry).

HED recommends increasing the US MRLs for bushberry, subgroup 13

- 07B, cottonseed, citrus fruit, 10

- 10, fruit vine climbing 13

- 07F [grape], and pepper/eggplant 8

- 10B to harmonize with

Codex.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 27 of 37 The US and Canadian MRLs are in harmony on all proposed crops, except subgroup 13

- 07F, 13

- 07G, and cottonseed. There are no Canadian MRLs on cott onseed. Canadian MRLs were not established as subgroups for 13

- 07F and 13

- 07G and were established on grapes (3 ppm) and lowbush blueberries and ligonberries (subgroup 13

- 07B) at 3 ppm; US MRLs were established at

1 ppm for 13

- 07F and at 10 ppm for 13

- 07G

. The current post

- harvest use on vegetable tuberous and corm, subgroup 1C recommends increasing the established US MRL on vegetable tuberous and corm, subgroup 1C to 8 ppm , which is in agreement with the proposed Canadian MRL.

Citrus fruit : The Codex MRL is based on field trials conducted in the USA

. The MRL was estimated at 15 ppm using the post

- harvest dip results with one and two applications on the smaller citrus fruits (lemon, tangerine, and mandarin). The highest residue was 8.8 ppm. The 2008 JMPR Report (General Consideration 2.7) indicates that statistical evaluation of the data with the NAFTA calculator produced an estimate of 12.3 mg/kg. JMPR decided upon a higher value because of

the small size of the data set. The US MRL (10.0 ppm) was based on field trial data that received preharvest as well as post harvest dip treatments on grapefruit, orange, and lemon samples; highest residue was 9.18 ppm.

Berries and other small fruits : The Codex MRL for berries and other small fruits except cr anberry, grapes, and strawberry is based on field trials conducted in the USA (blackberry, raspberry, and blueberry). The estimated MRL is 5 ppm which is in harmony with US MRL for subgroup 13

- 07A.

For grapes and strawberries, the Codex MRL is based on field trials conducted in the USA. The Codex estimated MRLs were 2 ppm (1 ppm US) and 10 ppm, respectively; highest residues were 0.81 ppm for grapes and 4.5 ppm for strawberries. The 2008 JMPR Report (General Consideration 2.7) indicates that statistica l evaluation of the data for grapes with the NAFTA calculator produced an estimate of 1.63 mg/kg, rounded to 2 mg/kg. The US tolerance is 1 ppm. A similar analysis for strawberries yielded an MRL estimate of 9.43 mg/kg, rounded to 10 mg/kg. The US stra wberry MRL is in agreement with Codex MRL.

Mango The Codex MRL is based on field trials conducted in the USA. The highest residue was 0.48 ppm; the MRL was estimated at 0.7 ppm. The 2008 JMPR Report (General Consideration 2.7)

indicates that statistic al evaluation of the data with the NAFTA calculator produced an estimate of 1.67 mg/kg, which JMPR discarded because of the small data set and the use of professional judgment. The US MRL was established at 2.0 ppm

Onion, bulb (dry) and green onion

The Codex MRL is based on field trials conducted in the USA which includes a trial with higher application rate (about 2x). The MRL was estimated at 10 ppm for bulb vegetables based on the result on spring onions; highest residue was 6.3 ppm. The 2008 JMPR Re port (General Consideration 2.7) indicates that statistical evaluation of the data with the NAFTA calculator produced an estimate of 11.1 mg/kg, which JMPR decided to reduce to 10 mg/kg. The US MRL is established at 1 ppm for subgroup 3

- 07A and 7.5 ppm fo r subgroup 3

- 07B; highest residues were 0.67 and 6.9 ppm, respectively.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 28 of 37 Vegetables Fruiting, subgroup 8

- 10A and 8

- 10B The Codex MRL is based on field trials conducted on sweet pepper and tomatoes grown in an indoor environment in Europe. The data on swe et pepper and tomatoes were combined (n = 11). The maximum residue was 1.4 mg/kg on pepper. The 2008 JMPR Report (General Consideration 2.7) indicates that statistical evaluation of the data with the NAFTA calculator produced an estimate of 2.17 mg/kg. The MRL was estimated at 3 ppm for f ruiting vegetables,

other than cucurbits , except fungi and sweet corn. The US MRLs (0.2 tomatoes and 2.0 for group 8, except tomato) were based on trials conducted on tomatoes, bell peppers and non

bellpeppers; maximum residues were 0.18 and 0.40 and 0.92, respectively.

Root and tuber vegetables The Codex MRL is based on field trials conducted on beetroot, carrot, and radish conducted in the USA. Results of these trials were combined and the highest residue was 0.45 p pm. The MRL was estimated at 0.7 ppm for r oot and tuber vegetables

. The 2008 JMPR Rep ort (General Consideration 2.7) indicates that statistical evaluation of the data with the NAFTA calculator produced an estimate of 0.57 mg/kg based on 15 trials. JMPR r ounded the value up slightly. The US MRL was established for vegetable, root subgroup 1A at 0.5 ppm (based on beetroot, carrot, and radish) and vegetable tuberous and corm, subgroup 1C at 0.03 ppm (based on potato); highest residues were 0.46 and 0.02 ppm , respectively. MRL was also established for potato at 0.03 ppm.

Oilseeds (Cotton seed)

The Codex MRL is based on field trials conducted on cotton as in

- furrow and foliar treatments

conducted in the USA. The results were combined and the maximum resid ue was 0.54 ppm. The 2008 JMPR Rep ort (General Consideration 2.7) indicates that statistical evaluation of the data with the NAFTA calculator produced an estimate of 0.51 mg/kg based on 12 trials. JMPR selected an MRL of 0.7 mg/kg. The US highest residu e was 0.62 ppm; tolerance was established at 0.6 ppm.

Sunflower seed

The Codex MRL is based on field trials conducted on sunflower in the USA. The 2008 JMPR Report (General Consideration 2.7) indicates that statistical evaluation of the data with the

NAF TA calculator produced an estimate of 0.31 mg/kg based on 6 trials. JMPR selected an MRL of 0.5 mg/kg and noted the unreliability of the statistical method because of the relatively small number of data points. The MRL was estimated at 0.5 ppm for sunflo wer seed; the Codex/US highest residue was 0.24 ppm. The US tolerance was established at 0.6 ppm.

Herbs ( For Wasabi

- extrapolation from subgroup 19A, fresh and dry ) The Codex MRL is based on field trials conducted on basil, mint, and parsley conducted in the USA (chive was not included since the residues were much lower). The highest residue was 48 ppm. The 2008 JMPR Rep ort (General Consideration 2.7) indicates that statistical evaluation of the data with the NAFTA calculator produced an estimate of 52. 3 mg/kg based on 7 trials. The MRL was estimated at 70 ppm for fresh herbs. T he US MRL was estimated at 50 ppm for subgroup 19A, fresh; the highest residue on basil was 49 ppm.

Dried herbs The Codex MRL is based on field trials conducted on basil, chiv es, a nd parsley conducted in theAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 29 of 37 USA (chive was not included since the residues were much lower). The highest residue was 235

ppm . The 2008 JMPR Report (General Consideration 2.7) indicates that statistical evaluation of

the data with the NAFTA calculato r produced an estimate of 297 (307) mg/kg based on 4 trials.

The MRL was estimated at 300 ppm for dried herbs , except dry hops . The US MRL was

estimated at 26 0 ppm for subgroup 19A, dried leaves based on dried basil (257 ppm )

.

Table 9

. Tolerance Summ ary for Azoxystrobin

Commodity Established Tolerance (ppm) Proposed

Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition

Onion, bulb, subgroup 3

- 07A Onion, bulb 1.0 1.0 1.0

Onion, green, subgroup

3

- 07B Onion, green 7.5 7. 5 7.5

Vegetable, fruiting, subgroup 8

- 10A Tomato 0.2 0.2 0.2 Tomato subgroup 8

- 10A

Vegetable, fruiting, subgroup 8

- 10B Ve g etable, fruiting, group 8,
except tomato 2.0 2.0 3.0 Pepper/eggplant subgoup 8

- 10B

Tolerance i ncrease to harmonize with

Codex.

Fr uit, citrus, group 10

- 10 Fruit, citrus, group 10

10.0 10.0 15.0 Tolerance increase to harmonize with

Codex.

Caneberry subgroup 13

- 07A Caneberry subgroup 13A 5.0 5.0

Bushberry subgroup 13

- 07B Bushberry subgroup 13B, Juneberry, Lingonberry, and

Salal at 3.0 3.0 5.0 Tolerance increase to harmonize with

Codex.

Small fruit vine climbing, except fuzzy kiwifruit subgroup 13

- 07F Grape 1.0 1.0 2.0 Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F

Tolerance increase to harmonize with

Codex.

Low growing berry subgroup 13

- 07G, except cranberry Strawberry 10.0 10.0 10.0 Berry, low growing, subgroup 13

- 07G, except cranberry

Rapeseed subgroup 20A Canola, seed 1.0 1.0 1.0

Sunflower subgroup 20B Safflower, seed and sunflower,

seed 0.5 0.5 0.5

C ottonseed subgroup 20C Cotton,

undelinted seed

0.6 0.6 0.7 Tolerance increase to harmonize with

Codex.

Wasabi Herb subgroup 19A, fresh leaves

50 50 50 Wasabi, fresh

Wasabi , dry Herb subgroup 19A, dried leaves

260 Not

proposed 260 Wasabi, dryAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 30 of 37 Dragon

- frui t Mango 2.0 2.0 2.0

Vegetable, tuberous and corm, subgroup 1C 0.03 6.0 8.0

References

DP#s: 2 18318 and 218448 Subject: PP No. 5F4541: New Chemical: Azoxystrobin (ICIA5504) in/on Grape RACs.

Evaluation of Analytical Methods and Residue Data. CBTS Nos. 16051 & 16092

. From: J. Garbus

To: J. Bazuin/C. Giles

- Parker

Dated: 3/19/96

MRIDs: 43678102

- 436781 07, 43678193

- 436781 95, 43678200

- 436782 10 and 43694201

-

436942 06

DP#s: 2 26232 Subject: PP No. 5F4541: New Che mical: Azoxystrobin (ICIA5504) in/on Grape Rac's.

Chemical No. 128810. Revised Sections B and F and Additional Field Trial

Residue

From: J. Garbus

To: D. McCall / B. Madden

Dated: 6/26 /96

MRIDs: 440022

- 00 and 440022

- 01

DP#s: 230634, 230635, 230636, and 230637 Subject: PP#6F4762. Azoxystrobin . Permanent Tolerance Petition for Use on Bananas,

Peaches, Peanuts, Tomatoes, and Wheat. Evaluation of Analytical Methodology

and Residue Data. Chemical# 128810

. CBTS#: None.

From: L. Kutney

To: C. Giles

- Parker, J. Bazuin, and B. Madden

Dated: 4/25/97

MRIDs: 44058715

- 44058730, 44058732

- 44058736, and 44073203

- 44073205

DP#s: 248887 and 249671 Subject: PP#7F4864. Tolerance Petition for use of Azoxystrobin on Cucurbits.

PP#8F4995. Tolerance Petition for use of Azoxystrobin on Bananas, Potatoes,

and Ston e Fruits.

From: D. Dotson, M. Doherty, and Y. Donovan

To: C. Giles

- Parker/J. Bazuin

Dated: 10/14/98

MRIDs: 44319305, 44452303, 44595105, 44595109

- 44595111, 44595114, 44595116,

44613501, and 44613503Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 31 of 37 DP#: 251683 Subject: Azoxystrobin. Conclusions of the M etabolism Assessment Review Committee at

Meeting of 11/10/98.

From: W. Wassell

To: G. F. Kramer, MARC

Dated: 12/30/98

MRIDs: None

DP#s: 249657 and 249668 Subject: PP# 7F4864. Tolerance Petition for use of Azoxystrobin on Peanut Hay,

Pistachios, Rice, Tre e Nuts, and Wheat. PP# 8F4995. Tolerance Petition for use of Azoxystrobin on Canola.

From: D. Dotson

To: C. Giles

- Parker/J. Bazuin

Dated: 1/25/99

MRIDs: 44319303, 44319304, 44319306

- 44319308, 44452303, 44595104

- 44595108,

44595113, 44595115 and 44613502

DP#: 2 54140 Subject: Azoxystrobin on Various Commodities. IR

- 4 Proposal For Reduced Residue

Chemistry Data Set.

From: G. J. Herndon

To: H. Jamerson/R. Forrest

Dated: 3/17/99

MRIDs: 44915206

- 32 and 44983101

DP#s: 260134 Subject: PP#9F06058: Azoxystrobin

. Evaluation of Residue Chemistry Data to Support

Permanent Tolerances for Use of Azoxystrobin on Barley, Bulb Vegetables, Cilantro, Citrus Fruits, Corn, Cotton, Leafy Vegetables (except Brassica ), Leaves of Root and Tuber Vegetables, Peanuts, Root and Tu ber Vegetables, Soybeans, and Wild Rice; Higher Tolerances for the Fat and Meat Byproducts of Cattle, Goats, Horses, and Sheep; and, Apples (Inadvertent Residues).

From: M. J. Nelson

To: J. Bazuin/C. Giles

- Parker

Dated: 09/06/2000

MRIDs: 449152

- 06 thru 44 9152

- 32; 449831

- 01

DP#s: 274312 Subject: PP No. 5F4541: New Chemical: Azoxystrobin (ICIA5504) in/on Grape RACs.

Evaluation of Analytical Methods and Residue Data. CBTS Nos. 16051 & 16092

. From: G. Jeffrey Herndon

To: S. Brot hers/R. Forrest

Dated: 7/10/01

MRIDs: 45205604, 45205606, 45253901, and 45332502Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 32 of 37 DP#s: 279210 Subject: Azoxystrobin. Registration on Caneberry. Summary of Analytical Chemistry and

Residue Data.

From: N. Dodd

To: S. Brothers/R. Forrest

Dated: 6/19/02

MRID: 45522301

DP#s: 285603, 285606, 285607 and 285608 Subject: PP#s 2E06489, 2E06495, 2E06375, and 2E06488. Azoxystrobin. IR

- 4

Permanent Tolerance Petitions with Field Trials on Globe Artichoke, Asparagus,

Basi l, Broccoli, and Cabbage. Summary of Analytical Chemistry and Residue

Data.

From: N. Dodd

To: S. Brothers/R. Forrest

Dated: 1/22/03

MRIDs: 45544901, 45730101, 45730102, 457 31301

, and 45736301

DP#s: 283588 and 287062 Subject: PP#9F06058 and ID#s 000100

- 0 1098 and 000100

- 01093. Azoxystrobin.

Condition

- of

- Registration Data, Including Bridging Data from the 50 WDG Formulation to the 2.08 FlC Formulation on Spinach, Garden Beet, Green Onion and Celery; Storage Stability Data; and Limited Field Rotational Cro p Data.

From: N. Dodd

To: J. Bazuin/C. Giles

- Parker

Dated: 2/6/03

MRIDs: 45640301, 45640302, 45640304

- 465603 07, and 45738101

DP#: 298114 Subject: Azoxystrobin. Heritage Fungicide (EPA Reg. No. 100

- 1093. Condition

- of

Registration Data: Limited Field Rot ational Crop Data. Petition Number 9F6058.

From: L. Cheng

To: J. Bazuin/C. Giles

- Parker

Dated: 12/20/05

MRIDs: 45872401

DP#s: D312949, D312951, D312953, & D317291 Subject: Azoxystrobin Use on Dill, Chive, Sunflowers, Canola, and Post

- Harvest Citrus.

R eview of Analytical Methods and Residue Data. Petition # ’ s 3E6637, 3E6749, 4E6823, & 5E6916.

From: W. Cutchin

To: B. Madden/D. Rosenblatt

Dated: 1/23/06

MRIDs: 46006901, 46219201, 46046603, 46046604, 46046601, 460 46602 & 46509101Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 33 of 37 DP#s: 328984 Subject: Azoxystrobin. Uses on Foliage of Legume Vegetables, Group 7; Fruiting

Vegetables, Group 8 (Except Tomato); Pea and Bean, Succulent and Dried Shelled (Except Soybeans), Sub g roups 6B and 6C; and Nongrass Animal Feeds

, Group 18. Summary of Analytical Chemistry and Residue Data. Petition Number

4E6823.

From: W. Cutchin

To: S. Jackson/D. Rosenblatt

Dated: 6/19/06

MRIDs: 46006901, 46219201, 46046603, 46046604, 46046601, 4604660 2 & 46509101

DP#s: 334571 and 340016 Subject: Azoxystrobin. Petitions for the Establishment of Permanent Tolerances for

New/Amended Uses on Non

- grass Animal Feeds (Crop Group 18), Sorghum, Wheat, Cotton and Wild Rice. PP#s 6F7106 & 7F7198. Summary of A nalytical Chemistry and Residue Data.

From: W. Cutchin

To: S. Piper and T. Kish /J. Bazuin

Dated: 3/12/08

MRIDs: 46924301

- 469243 03, 47096401

- 470964 02

Attachments: Appendix I

- International Residue Limit Status Sheet Appendix I I

- T olerance Assessment Calculations

Template Version September 2005Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 34 of 37 Appendix I

- International Residue Limit Status Sheet

.



### Azoxystrobin (PC Code 12 8810 ; 10/31/ 2011)

Summary of US and International Tolerances and Maximum Res idue Limits Residue Definition :
US Canada Mexico 2 Codex 3

40 CFR 180. 507
Plants: sum of azoxystrobin, [methyl( E )

- 2

- (2

- (6

- (2

- cyanophenoxy) pyrimidin

- 4

- yloxy)phenyl)

- 3

- methoxyacrylate], and

the Z

- isomer of azoxystrobin [methyl(

Z )

- 2

- (2

- (6

- (2

- cyanoph enoxy)pyrimi

din

- 4

- yloxy)phenyl)

- 3 methoxyacrylate] (α E )

- methyl 2

- [[6

- (2

- cyanophenoxy)

-

4

- pyrimidinyl]oxy]

- α

- (methoxymethylene) benzeneacetate, including the isomer ( Z )

- methyl 2

- [[6

- (2

- cyanophenoxy)

- 4

- pyrimidinyl] oxy]

- α

- (methoxymethylene)benzeneacetate Azoxystrobin. The

residue is fat soluble.

Commodity 1 Tolerance (ppm) /Maximum Residue Limit (mg/kg)

US Canada Mexico 2 Codex 3

Berry, low growing, subgroup 13

- 07G, except cranberry 10.0 3.0 lowbush blueberries

, lingonberries 5 berries and other small fruits, except

cr anberry, grapes and strawberry

10 st rawberry

Bushberry subgroup 13

- 07B 5 .0 3.0 bushberries (crop subgroup

13

- 07B) aronia berries, blueberries, buffalo currants, Chilean guava,

currant s , elderberries, European barberries, gooseberries, highbush blueberries, highbush cranberries, honeysuckl e, huckleberries, jostaberries, lingonberries, lowbush blueberries, native currants, salal

berries saskatoon berries (juneberries) , sea buckthorn 5 berries and other small fruits, except cranberry, grapes and strawberry

Caneberry subgroup 13

- 07A 5.0 5 .0 caneberries (crop subgroup

13

- 07A) blackberries, loganberries, raspberries, wild raspberries 5 berries and other small fruits, except cranberry, grapes and strawberry Cottonseed subgroup

20C 0. 7 0.7 cotton seed

Dragon

- fruit 2.0 2 mangoes 0.7 ma ngoAzoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 35 of 37 Summary of US and International Tolerances and Maximum Res idue Limits Residue Definition :
US Canada Mexico 2 Codex 3

Fruit, citrus, group 10

- 10 1 5 .0 10 citrus fruits ; Australian desert limes, Australian finger limes, Australian round limes, Brown River finger limes,

calamondin s , citrus citron s
, citrus hybrids, grapefruits, Japanese summer grapefruits, kumquats, lemons, limes, Mediterranean mandarins, mount White limes, new Guinea wild limes, oranges, pummelos, Russell River limes, Satsuma

mandarins , sweet limes, tachibana oranges, Tahiti limes, tangelo s
, tangerines

, tangor s
, trifoliate oranges, uniq fruits 1 5 citrus fruits

Fruit , small vine climbing, except fuzzy

kiwifruit

, subgroup 13

- 07F 2 .0 3 grapes 2 grapes

Onion, bulb, subgroup

3

- 07A 1.0 1.0 dry bulb onions 10 bulb vegetables

Onion, green, subgroup

3

- 07B 7.5 7.5 green onions

Pepper/eggplant subgr oup 8

- 10B 3 .0 2.0 bell peppers, eggplants, non

bell peppers, pepinos, pepper hybrids, 3 fruiting vegetables

other than cucurbits except mushrooms and sweet corn; 30 peppers chili dried Rapeseed subgroup 20A 1.0 1.0 rapeseeds (canola) Sunflower subg roup 20B 0.5 0.5 sunflower seeds 0.5 sunflower seed

Tomato subgroup 8

- 10A

0.2 2.0 ground cherries, tomatillos

0.2 tomatoes 0.6 tomato paste 3 fruiting vegetables

other than cucurbits except mushrooms

and sweet corn

Vegetable, tuberous and corm, sub group 1C 8.0 8.0 v egetable, tuberous and corm, subgroup 1C (proposed) 0.03 potatoes 1 root and tuber vegetables

Wasabi , fresh 50 50 Herbs (crop subgroup 19A; fresh leaves) 70 herbs

Wasabi , dry 260 260 Herbs (crop subgroup 19A; dried leaves) 300 dried herbs (except hops (dry))

Completed: M. Negussie; 10/31/ 2011

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 tre ated 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.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 36 of 37 Appendix I I . Tolerance Assessment Calculations.

For the pota to postharvest use , the OECD statistical calculation procedure s w ere used for calculating the recommended toleranc e . As specified in the OECD document, the average

residue value was used

. The rounding procedures specified in the OECD guideline were also

used.

The datasets used to establish a tolerance for combined residues of azoxystrobin and its Z

- isomer

for the potato postharvest use c onsisted of field trial data representing application rates of 4 g

ai/ 2000 lb potatoes (0.009 lb ai/2000 lb potatoes ) at a 0

- day PHI.

The average residue values for the potato postharvest use which were used to calculate the tolerance are provided in Table II

- 1 and these values were entered in the OECD statistical

calculation procedures

. Using the OECD statistical cal culation procedures , the recommended tolerance is 8 ppm (Figure II

- 1

- 3 ). The recommended tolerance (8 ppm) is higher than the proposed tolerance ( 6 ppm).

Table II

- 1. Residue data used to calculate tolerance for azoxystrobin on potato postharvest.

Regula tor: EPA

Chemical: Azoxystrobin

Crop: Potato postharvest

PHI: 0

- day

App. Rate: 4 g ai/2000 lb potatoes (0.009 lb ai/2000 lb potatoes )

Submitter: IR

- 4

MRID Citation: MRID 48437101

Average Combined Residues of Azoxystrobin and its Z

- Isomer (ppm)

2. 230

1.420

1.004

3.590

3.800

1.150

3.550

2.280Azoxystrobin Summary of Analytical Chemistry and Residue Data DP #: 390152

Page 37 of 37 Figure II

- 1. Tolerance s preadsheet summary of azoxystrobin field trial data for potato postharvest.

Azoxystrobin

Potato

- post harvest

EPA 4 g ai/2000 lb potatoes; PHI= 0

Total number of data (n) 8

Percentage of censored data 0%

Number of non

- censored data 8

Lowest residue 1.004

Highest residue 3.800

Median residue 2.255

Mean 2.378

Standard deviation (SD) 1.147
Correction factor for censoring (CF) 1.000

Proposed MRL estimate

- Highest residue 3.800

- Mean + 4 SD 6.966

- CF x 3 Mean 7.134

Unrounded MRL 7.134

Rounded MRL 8