Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### MEMORANDUM

Date: Marc h -21-2013 OFFICE OF CHEM I CAL SAFETY AND
POLLUTION PREVENTION



### SUBJECT : Azoxystrobin. Revised Section 3 Petitions for the Establishment of Tolerances on Imported Ginseng (PP#1E7945), Rye, and Oats (PP#2F7976), and Section 3

Amendments to Revise the Established Tol erances on Cereal Grains (Barley and Wheat) Due to Changes of Pre-Harvest Interva ls (PP# 2F7984). Summary of Analytical Chemistry and Residue Data.



### PC Code: 1288 1 0 

### DP Barcodes: D397692

, D400604, D400626 

### Registration Nos.: 100-1098, 100-1178, 100-

1324 

### Decision Nos.: 458947, 459651, 460759



### Regulatory Action: Tolerance Petition



### Petition Nos

. : 1 E7945, 2F7976, 2F7984



### Risk Assessment Type: N/A 

### Case No.: N/A

TXR 

### No.: N / A 

### CAS No.: 131860-33-8

40 

### CFR: §180.507 

### MRID Nos.: See MRID Summary Table



### FROM: Meheret Negussie, Chemist 

# / 1 e,/,e.v-d ,Je 

# 0 W'I-t "><L



### Risk Assessment Branch III

Health Effects Division (HED 7509P)



### THROUGH: Steve Funk, Senior Chemist /j 

# ?f!-

. Christine Olinger, Branch Chief

, 

# /}j(

...**~** 

# · , Risk Assessment Branch III 

## {_;k-7-

,**~** 

### Health Effects Division (HED 7509P)



### TO: Erin Malone/Marcel Howard, RM# 20

F ungicide Branch Registration Division (7505P)

Note: The DERs were originally prepared under contract by Versar, Inc

. (6850 Versar Center, Springfield, VA 22151; submitted 5/23112). The documen t has been reviewed by the Health

E ffects Division (HED) and re vised to reflect current Office of Pesticide Programs (OPP)

Page 1 of 58Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 2 of 58 policies. This document reflects revisions to a previous version (Oct- 11-2012) to the tolerance

recommendations.

MRID Summary Table

MRID No. Study Type Comments

48601201 860.1500 Ginseng (Korea) New DER; 4860 1201.der (includes review of 48601202)

48601202

48601203 860.1500 Ginseng (Korea)) New DER; 48601203.der

48681701 860.1500 Rye New DE R; 48681701.der.doc

48681702 860.1500 Barley New DER; 48681702.der.doc

48681703 860.1500 Oats New DE R; 48681703.der.doc

48681704 860.1500 Wheat New DE R; 48681704.der.doc

48681704 860.1520 Wheat New DER; 48681704.der1.docAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 3 of 58 Executive Summary

Azoxystrobin is a broad-spectrum fungicide and belongs to a cl ass of pesticidal compounds

called β -methoxyacrylates, which are derived from the naturally occurring st robilurins (Group 11 fungicide). The biochemical mode of action is inhibition of electr on transport. The fungicide is currently registered for use on a variety of field, vegetable, fruit, and nut crops as well as on ornamental plants and turf. End-use products of azoxystrobin are typically formulated as water dispersible granular (WDG), suspension concentr ate (SC; previously referenced as flowable concentrate), and soluble emulsion (SE) formulat ions. These products may be applied as infurrow at-planting or postemergence foliar app lications using ground or aerial equipment at maximum seasonal rates of 0.40-2.0 lb ai/A. Azoxystr obin is also registered for seed treatment of many food/feed crops as well as for postharvest uses on bananas/plantains and citrus fruits.

Under PP#1E7945, Syngenta Crop Protection, Inc. (Synge nta) has requested the establishment of an import tolerance for the resi dues of azoxystrobin [methyl( E )-2-(2-(6-(2- cyanophenoxy)pyrimidin-4-yloxy)phe nyl)-3-methoxyacrylate] and the Z -isomer of azoxystrobin, [methyl( Z )-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yl oxy)phenyl)-3-methoxyacrylate] in/on the following agricultural commodities:

Ginseng Extract (Red Ginseng Extract and Ginseng Extract) ............0.5 ppm

Under PP#2F7976 Syngenta has requested the establ ishment of tolerances for the residues of azoxystrobin and its Z -isomer in/on the following agricultural commodities:

Oat, forage ................................................................4 ppm Oat, hay ....................................................................7 ppm Oat, straw .................................................................3 ppm Oat, grain..................................................................1 ppm Rye, forage ...............................................................4 ppm Rye, straw...............................................0.8 ppm Rye, grain ..............................................0.07 ppm

Under PP# 2F7984 Syngenta is requesting revision of the established tolerances on wheat and barley commodities as follows:

Barley, hay ...............................................................7 ppm Barley, straw ............................................................8 ppm Barley, grain .............................................................2 ppm Wheat, forage .........................................................10 ppm Wheat, straw ............................................................6 ppm Wheat, hay .............................................................20 ppm Grain, Aspirated fractions...........................460 ppm

Concurrently, Syngenta requests to amend th e tolerances for the following livestock

commodities as follows:Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 4 of 58 Cattle, fat................................................0.3 ppm Hog, fat...................................................0.1 ppm Hog, meat................................................0.02 ppm

In addition, Syngenta requests to establish tole rances for the following livestock commodities:

Poultry, meat...........................................0.01 ppm Poultry, liver..............................................0.2 ppm Poultry, fat..............................................0.01 ppm Egg.........................................................0.1 ppm Cattle, liver................................................0.5 ppm Cattle, Kidney............................................0.1 ppm Hog, liver...................................................0.2 ppm Hog, kidney.............................................0.03 ppm

In support of the requested import tolerance, Syngenta has submitted a draft label with English

translations for the 20% SC formulation of azoxystrobin (Azo xystrobin SC; Ortiva) reflecting established use patterns in Korea. Based on th e submitted label and Section B of the petition, the 20% SC is proposed for up to four foliar applicat ions to ginseng at 10 mL formulated product/20 mL water with a 7-day pre-harv est interval (PHI). Additiona l information was received: azoxystrobin content changed from 20% to 21.7%; application spray volume (3500 L/ha); product rate (1750 g (ml)/ha); and single appl ication rate (379.75 g/ha) (email communication Erin Malone, 10/09/12). Based on these informa tion, the maximum seasonal application rate is 1519 g ai/ha (1.36 lb ai/A).

In conjunction with PP#2F7976 and PP# 2F7984, Synge nta is requesting amended registration of

Abound® Flowable Fungicide (EPA Reg. No. 100-1098), Quilt® Fungicide (EPA Reg. No. 100-1178), and Quilt Xcel® Fungicide (EPA Reg. No. 100-1324) to add uses on oats and rye. Quilt Xcel® Fungicide is a multiple active ingredient (MAI) suspo-emulsion (SE) formulation containing 1.18 lb ai/gal azoxystrobin a nd 1.02 lb ai/gal propiconazole. Quilt ® Fungicide is a MAI suspo-emulsion formulation containing 0.62 lb ai/gal azoxystrobin and 1.04 lb ai/gal propiconazole. The Abound® Flowable Fungicide is a SC formulation containing 2.08 lb ai/gal of azoxystrobin. Only data pertaining to az oxystrobin are reviewed in this document.

For the new uses (oats and rye), the Abound® Flowable Fungicide is proposed for up to two foliar applications at 0.20 lb ai /A/application for a total seasonal application rate of 0.40 lb ai/A; Quilt® Fungicide is proposed for up to two foliar applications at 0.068 lb ai/A/application for a total seasonal application rate of 0.14 lb ai/A. Quilt Xcel® Fungicide is proposed for up to two foliar applications at 0.13 lb ai /A/application for a total seasonal application rate of 0.26 lb ai/A.

Concurrently, in petition PP# 2F7984, the registra nt is requesting to change the PHIs on the registered label for cereals (wheat , barley and triticale) from 14- 30 days to PHIs of 7 days for forage and hay and remove the 45-day PHI for gr ain and straw and replace it with growth stage restriction for the last applica tion on the aforementioned end use products. The limitation is to apply no later than Feekes Growth Stage 10.54.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 5 of 58 Azoxystrobin tolerances have been establis hed in 40 CFR §180.507. Tolerances 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. The esta blished tolerances for plant commodities range from 0.01 ppm for pecan to 420 ppm for grain, aspirated fractions. Tolerances are currently established for barley bran (6.0 ppm), forage ( 25 ppm), grain (3.0 ppm), hay (15 ppm), and straw (7 ppm); wheat bran ( 0.20 ppm), forage (25 ppm), grain (0.10 ppm), hay (15 ppm), and straw (4 ppm). Tolerances for livestock commodities are established under 40 CFR §180.507(a)(2) and are also expressed in terms of residues of azoxystrobin and its Z

isomer; however, the Z -isomer should be removed from the tolerance expression. The

established tolerances for livestock commoditie s range from 0.006 ppm for milk to 0.07 ppm for the meat byproducts of cattle, goa t, horse, and sheep; no tolerances are currently established for poultry commodities.

The nature of the residue in plants, rotational crops, and livestock is adequately understood. Acceptable metabolism studies have been conduct ed on primary crops of grapes, peanuts, and wheat as well as on representativ e 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.

For ginseng, an adequate residue analytical met hod is available for tolera nce enforcement in crop commodities: a gas chromatography method with nitrogen-phosphorus detection (GC/NPD), RAM 243/04, for the analysis of crop commodities for residues of azoxystrobin. Samples from the submitted magnitude of the residue (MOR) studies were analyzed for residues of azoxystrobin using a gas liquid chromatography (G LC) method with electron capture (ECD); the method number was not reported. The method limits of quantitation (LOQs; determined as the lowest level of method validation, LLMV) were 0.003 or 0.02 ppm for ginseng fresh root and 0.007 or 0.04 ppm for dried ginseng, red ginseng, a nd the extracts of dried and red ginseng. The method was adequate for data collection based on acceptable concurrent method recoveries, and

the fortification levels used in concurrent method recovery were adequate to bracket expected

residues.

Samples from the submitted crop field trials (o ats, rye, barley, and wheat) and processing study (wheat) were analyzed for residues of azoxystrobin and its Z -isomer (R230310) using an ultra performance liquid chromatography method w ith tandem mass spectrometry detection (UPLC/MS/MS), Method RAM 305/03. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.01 ppm for each analyte. The method was adequate for data collection based on acceptable c oncurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expe cted residue levels.

The submitted crop field trial data for ginseng co nducted in Korea are acceptable. The submitted ginseng crop field trials reflect the proposed use patterns. Sa mples from the ginseng studies were not analyzed for residues of the Z -isomer; therefore, the pe titioner proposed a worst-case metabolic factor of 0.09x, determined from the ex isting root crop data reflecting analysis for residues of azoxystrobin and the Z -isomer. This factor was app lied to the residue results for

calculation of the recommended tolerance leve l for ginseng. Based on the submitted data,Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 6 of 58 reflecting 1- and 2-year applica tions and extrapolation of residue s of azoxystrobin to account for

the Z -isomer and using the OECD calculation pro cedures an import tolerance of 0.4 ppm for ginseng is recommended for residues resulting from use of azoxystrobin in Korea. HED is recommending a tolerance of 0.5 ppm on ginseng to harmonize with Codex. The Agency considers the raw agricultural commodity (RAC) of ginseng to be the dried root, defined as “ginseng” for tolerance purposes (refer to DP# 225494, dated 5/1/96, B. Schneider).

The data from the ginseng field trial indicate that re sidues of azoxystrobin may concentrate in

ethanol extracts and water extracts of dried a nd red ginseng processed from dried ginseng and red ginseng bearing quantifiable residues.

The maximum expected residue of azoxystrobin in dried and red gins eng ethanol and water extracts were determined by multiplying the average processing factor by the HAFT residue of dried ginseng (1.8 x 0.193 = 0.35 ppm). Since this estimate is below the recommended tolerance for ginseng, a processed commodity tolerance is not needed. Furthermore, the Agency does not typically set tolerances on ginseng processed commodities. The petitioner needs to submit a revised section F to propose a tolerance on ginseng at 0.5 ppm.

The submitted crop field trial data for oats, ry e, barley, and wheat are acceptable pending submission of Section F. Although the number of fi eld trials is technicall y inadequate (oats and rye), HED concludes that the available data ar e sufficient to support re gistration of azoxystrobin on oats and rye because the field trials conducted cover all zones requested. All other trials are adequate with respect to the number and locations of field trials. The crop field trial data for oats and rye reflect the proposed use patterns of (Quilt ® Fungicide (EPA Reg. No. 100-1178) and Quilt Xcel® Fungicide (EPA Reg. No. 100-1324)). The submitted crop field trials were conducted using the Quilt Xcel® with two foliar applications at 0.13 lb ai/A/application for a total seasonal application rate of 0.26 lb ai/A . The crop field trial data on oats and rye does not reflect the proposed use pattern of the A bound® Flowable Fungicide. The Abound® can be applied up to two foliar applications at 0.20 lb ai/A/application for a to tal seasonal application rate of 0.40 lb ai/A. The applica tion rates used in the crop field tr ials are lower than the rates of the Abound® label. Therefore, residue levels we re adjusted using the proportionality principle (ChemSac minutes 03/28/2012; JMPR report 2011) be fore deriving a tolera nce level to reflect the proposed higher application rate.

There are adequate existing storag e stability data to validate the storage conditions and durations of samples from the submitted studies.

The Organization for Economic Cooperation and De velopment (OECD) statistical calculation procedures were used to determin e appropriate tolerance levels. Based on the available data, the proposed tolerances for oat and rye commodities must be revised to reflect the appropriate tolerance levels estimated using the OECD statis tical calculation procedures. HED recommends a tolerance of 5, 10, 3, and 1.5 ppm for oat fora ge, hay, straw, and grain, respectively. The recommended tolerances for rye forage, straw, and grain are 7, 1.5, and 0.1 ppm, respectively. The proposed tolerances do not reflect the proposed highest application rate . A revised Section F

needs to be submitted to reflect the recomm ended tolerances. A summary of tolerance recommendations is presented in Table 16. Re fer to Appendix I for to lerance calculations.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 7 of 58 The submitted wheat and barley data to change the PHI of forage and hay from 14-30 days to 7- days; and replace the 45-day PHI w ith growth stage restriction for grain and straw is acceptable. The existing wheat tolerances we re established using the Abound® Flowable Fungicide with up to two foliar applications at 0.20 lb ai/A/applica tion for a total seasonal application rate of 0.40 lb ai/A. The current tolerances on barley were established based on translation of residue data from wheat. The submitted crop field trials on barley and wheat were conducted with the Quilt Xcel® with lower application rate s (0.13 lb ai/A/application for a total seasonal application rate of 0.26 lb ai/A). The application rates used in the field trials are lower than the rates of the Abound® label. Therefore, the residue levels we re adjusted using the proportionality principle to reflect the proposed application rate s before deriving a tolerance level.

The OECD statistical calcula tion procedures recommend indivi dual tolerances of 10, 15, and 3 ppm for barley hay, straw, and grain, respec tively. The recommended tolerances for wheat forage, straw, hay, and grain are 15, 10, 30, 0.15 ppm based on the submitted data. A revised

Section F needs to be submitted to reflect the re commended tolerances. The petitioner needs to

submit a revised section F to revise the estab lished tolerance on wheat grain to 0.15 ppm. A summary of tolerance recommendations is pres ented in Table 16. Refer to Appendix I for

tolerance calculations.

The data from the wheat processing study indicate that residues of azoxystrobin concentrate in aspirated grain fractions (218x), bran (1.4x), an d germ (1.2x), but not in flour, middlings, and shorts (0.3x, 0.4x, 0.5x, respectively) following pr ocessing of the RAC (wheat grain) with quantifiable residues.

Based on the HAFT for wheat grain 0.133 ppm (see Table 13) and concentr ation factor of 218x for aspirated grain fractions, the maximum exp ected residues would be 29 ppm. The proposed tolerance of 460 ppm for aspirate d grain fractions is not appr opriate since the established tolerance on grain aspirated fract ions at 420 ppm is adequate. Th e maximum expected residue in wheat bran is 0.19 ppm (1.4x x 0.133 = 0.19). The established tolerance of wheat bran (0.20 ppm) needs to be removed from the 40 CFR with establishment of wheat grain tolerance at 0.2 ppm. Based on the HAFT for wheat grain of 0.133 ppm and the 1.2x concentration factor for germ, expected residues in wheat germ would be 0.16 ppm, which is cl ose to the recommended tolerance for wheat grain of 0.2 ppm; therefore, a tolerance for wheat germ is not needed.

The processing factors calculated for wheat were less than the maximum theoretical

concentration factors for wheat of 7.7x for br an, 1.4x for flour, and 8.3x for shorts (based on separation into components; OCSPP 860.1520, Table 3).

Adequate field rotational crop data are ava ilable to support the ex isting rotational crop restrictions on the propose d labels. Subsequent to the establ ishment of tolerances in/on oat and rye, rotational crop restrictions on oat and ry e should be removed. HED assumes that the rotational crop restrictions speci fied on the Quilt labels are due to use of propioconazole.

The residue definitions for plants and livestock are not harmonized with Codex; the US and the

Canadian residue definitions include both the predominant E isomer and the minor Z isomer

whereas the Codex includes only the E isomer.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 8 of 58 Codex maximum residue limits (MRLs) are esta blished for azoxystrobin on ginseng at 0.1 ppm and dry ginseng including red ginseng at 0.5 ppm. A proposed MRL ginseng, processed products at 0.5 ppm has been returned to JMPR for further consideration of the processing study.

Canadian MRLs have been established fo r residues of azoxystrobin including the ( Z )-isomer on ginseng roots at 0.5 ppm and at 0.03 ppm for barl ey, oats, rye, and wheat which are not in agreement with the US tolerances, except for ginse ng roots. Mexico adopts US tolerances and/or Codex MRLs for its export purposes. The Code x MRLs on barley grai n and wheat grain are estimated at 0.5 and 0.2 ppm, respectively and MRLs for oats and rye are extrapolated from the data on barley and wheat, respectively. The US tolerances on oat grain (1.5 ppm) and barley grain (3 ppm) could not be harmonized since the Codex MRLs are lower. Setting the US

tolerance to be consistent with the Codex MRLs mi ght lead to residues in excess of the tolerance, despite legal use of the pesticide in a ccordance with the registered label.

HED recommends increasing the US tolerances of ginseng to 0.5 ppm, and rye grain and wheat grain to 0.2 ppm to harmonize with the numerical portion of the Codex MRL. The US is not establishing a tolerance on ginseng ( fresh roots) since the dried ginse ng covers the fresh roots.

Analytical reference standards for azoxystrobin and its Z -isomer are currently available at the EPA National Pesticide Standards Repository.

Regulatory Recommendations and Residue Chemistry Deficiencies

HED has examined the residue chemistry databa se for azoxystrobin. Pending submission of a revised Section F (see requirements below), ther e are no residue chemistry issues that would preclude granting tolerances for combin ed residues of azoxystrobin and the Z -isomer in/on the following commodities as follows:

Ginseng................................................................0.50 ppm Oat, forage..............................................................5.0 ppm Oat, hay ..............................................................10.0 ppm Oat, straw .............................................................3.0 ppm Oat, grain ............................................................1.50 ppm Rye, forage ............................................................7.0 ppm Rye, straw ............................................................1.50 ppm Rye, grain ............................................................0.20 ppm Barley, hay ..........................................................10.0 ppm Barley, straw ........................................................15.0 ppm Barley, grain ..........................................................3.0 ppm Wheat, forage .......................................................15.0 ppm Wheat, straw .........................................................10.0 ppm Wheat, hay...........................................................30.0 ppm Wheat, grain..........................................................0.20 ppm Grain, aspirated grain fractions ....................................420 ppmAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 9 of 58 New poultry tolerances and increase of ruminant tolerances are not needed since the addition of oat and rye and increase of tolerances in/on barl ey and wheat does not a lter the dietary burdens

to livestock.

A human health risk assessment is forthcoming.

860.1550 Proposed Tolerances

 A revised Section F must be submitted reflect ing the recommended tolerances listed in

Table 16.

 A revised Section F must be submitted to revise the established tolerance on wheat grain to 0.20 ppm.

Note to PM: In conjunction with establishment of wheat grain tolerance at 0.2 ppm, the existing tolerance on wheat bran need to be removed from 40 CFR §180.507(a)(1).

The e-CFR includes the Z -isomer in the tolerance expression for livestock. The Z -isomer

should be removed from the tolera nce expression for livestock.

Background

The chemical structure and nomenclature of azoxystrobin and its Z -isomer, and the physicochemical properties of the technical grade of azoxystrobin ar e presented in Tables 1 and 2, respectively.

Table 1. Azoxystrobin Nomenclature.

Compound

Common name Azoxystrobin

Company experimental name ICIA 5504 (Zeneca), R 215504 (Syngenta)

IUPAC name methyl (2 E )-2-{2-[6-(2-cyanophenoxy)pyrimidin-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) 20% SC formulation (Azoxystrobin SC; Ortiva); Abound® Flowable Fungicide (EPA Reg. No. 100-1098), Quilt® Fu ngicide (EPA Reg. No. 100-1178), and Quilt Xcel® Fungicide (EPA Reg. No. 100-1324) N N

O O

CN OCH 3

O H 3 COAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 10 of 58 Table 1. Azoxystrobin Nomenclature.

Regulated metabolite, Z

isomer

Common name Azoxystrobin, Z -isomer

Company experimental name R230310

Chemical name methyl ( Z )-2-{2-[6-(2-cyanophenoxy)pyramidin-4-yloxy]phenyl}-3- methoxyacrylate

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)

Dissociation constant, pK

a Not dissociable

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

UV/visible absorption spectrum Not available



### 860.1200 Directions for Use

In support of the proposed import tolerance, Syngenta has submitted a draft label with English

translations for the 20% SC formulation of azoxystrobin (Azo xystrobin SC; Ortiva) reflecting established use patterns in Korea. A summary of the proposed use patterns for ginseng is presented in Table 3.

Syngenta has submitted proposed use directions (Section B) for the Abound Flowable Fungicide, EPA Reg. No. 100-1098; Quilt Fungicide, EPA Re g. No. 100-1178; and Quilt Xcel Fungicide, EPA Reg. No. 100-1178 on oats, rye, barley, an d wheat. A summary of proposed azoxystrobin N N

O O

CN

OCH 3 

### O H

3 

### COAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 11 of 58 end-use products is presented in Table 4. The pr oposed use directions for oats, rye, barley, and wheat are presented in Table 5.

Table 3. Summary of Directions for Use of Azoxystrobin on Ginseng.

Applic. Timing; Type; and Equip. Formulation Applic.

Rate 1 Max. No. Applic. per

Season Max. Seasonal Applic. Rate PHI (days) Use Directions and

Limitations

Ginseng

Foliar; Broadcast; Equipment not specified 20% SC 10 mL

formulated

product/

20 L water 4 Not specified:

Run-off spraying is

recommended 7 Applications are to be made at the beginning of

infestation after leaves are fully opened with a 10-day retreatment interval (RTI).

Use of surfactants or penetration stimulators is prohibited.

Table 4. Summary of Proposed Azoxystrobin End-Use Products

. Trade Name Reg. No. % ai of

formulation Formulation Type Target Crop Source

Abound®

Flowable Fungicide 100-1098 22.9% ai (2.08 lb ai/gal) SC Cereals (wheat, triticale, barley,

oats, and rye) Undated supplemental label

included in Section B

Quilt ® Fungicide 100-1178 7% azoxystrobin (0.62 lb ai/gal)

11.7% propiconazole (1.04 lb ai/gal) SE Cereals (wheat, triticale, barley,

oats, and rye) Undated supplemental label

included in Section B

Quilt Xcel® Fungicide 100-1324 13.5% azoxystrobin (1.18 lb ai/gal)

11.7% propiconazole (1.02 lb ai/gal) SE Cereals (wheat, triticale, barley,

oats, and rye) Undated supplemental label

included in Section BAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 12 of 58 Table 5. Summary of Directions for Use of Azoxystrobin.

Applic. Timing, Type, and Equip. Formulation [EPA Reg. No.] Applic. Rate

fl oz/A (lb ai/A) Max.

No. Applic.

per Season Max.

Seasonal Applic.

Rate

fl oz/A (lb ai/A) PHI (days) Use Directions and Limitations

Cereals (Wheat, Triticale)

Foliar Ground, aerial or chemigation 2.08 lb ai/gal SC [100-1098] 4.0-12 (0.07-0.20) 2 1 0.40 7-forage, hay Applications are to be made prior to disease development. Do not apply after Feekes 10.54. Do not apply more than 0.40 lbai/A/season of azoxystrobincontaining products. A crop oil concentrate adjuvant may be added at 1.0% v/v to optimize efficacy.

Foliar Ground, aerial or chemigation SE/MAI (0.62 lb ai/gal) [100-1178] 7-14 (0.03-0.07) 2 1 28 (0.14) 7-forage, hay Apply Quilt in the spring for suppression of early season diseases. Follow up with a second application for full season control. For high yields apply Quilt when flag leaf is 50% to full head emergence (Feekes 10.5). Applications may be made no closer than a 14-day interval. Do not apply after Feekes 10.54. Do not apply more than 0.40 lbai/A/season of azoxystrobincontaining products.

Foliar Ground, aerial or chemigation SE/MAI (1.18 lb ai/gal) [100-1324] 7-14 (0.06-0.13) 2 1 28 (0.26) 7-forage, hay Apply Quilt in the spring for suppression of early season diseases. Follow up with a second application for full season control. For high yields apply Quilt when flag leaf is 50% to full head emergence (Feekes 10.5). Applications may be made no closer than a 14-day interval. Do not apply after Feekes 10.54. Do not apply more than 0.40 lbai/A/season of azoxystrobincontaining products.

Cereals (Barley, Oat and Rye) 100-11 78, 100-1324 in cludes Triticale

Foliar Ground, aerial or chemigation 2.08 lb ai/gal SC [100-1098] 6-12 (0.10-0.20) 2 1 0.40 7-forage, hay Applications are to be made prior to disease development. Do not apply after Feekes 10.54.

Minimum volume for aerial applications is 5 gal/A.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 13 of 58 Table 5. Summary of Directions for Use of Azoxystrobin.

Applic. Timing, Type, and Equip. Formulation [EPA Reg. No.] Applic. Rate

fl oz/A (lb ai/A) Max.

No. Applic.

per Season Max.

Seasonal Applic.

Rate

fl oz/A (lb ai/A) PHI (days) Use Directions and Limitations

Foliar Ground, aerial or chemigation SE/MAI (0.62 lb ai/gal) [100-1178] 7-14 (0.03-0.07) 2 1 28 (0.14) 7-forage, hay Apply Quilt in the spring for suppression of early season diseases. Follow up with a second application for full season control. For high yields apply Quilt when flag leaf is 50% to full head emergence (Feekes 10.5). Applications may be made no closer than a 14-day interval. Do not apply after Feekes 10.54. Do not apply more than 0.40 lbai/A/season of azoxystrobincontaining products. An adjuvant may be added at

recommended rates.

Foliar Ground, aerial or chemigation SE/MAI (1.18 lb ai/gal) [100-1324] 7-14 (0.06-0.13) 2 1 28 (0.26) 7-forage, hay Apply Quilt in the spring for suppression of early season diseases. Follow up with a second application for full season control. For high yields apply Quilt when flag leaf is 50% to full head emergence (Feekes 10.5). Applications may be made no closer than a 14-day interval. Do not apply after Feekes 10.54. Do not apply more than 0.40 lbai/A/season of azoxystrobincontaining products.

1 For resistance management, no more than two sequential applications of Abound® Flowable Fungicide or other Group 11 fungicides should be made before alternating with a fungicide having a different mode of action (not in Group 11). Do not make more than two foliar applications of Abound® Flowable Fungicide or other Group 11 fungicide per season.

2 For resistance management, the supplemental labels for Quilt® Fungicide and Quilt Xcel® Fungicide do not
specify the maximum number of applications but 

### t he most recent accepted labels for both products dated 3/16/10 indicates that resistance management guidelines should be followed.



### Additional information was received: azoxys trobin content changed from 20% to 21.7%; application spray volume (3500 L/ha); product rate (1750 g (ml)/ha); and si ngle application rate (379.75 g/ha) (email communication Erin Malone, 10/09/12). Based on these information, the maximum seasonal application rate is 1519 g ai/ha (1.36 lb ai/A).

The proposed supplemental labels/Section B for the Abound ® 

### Flowable Fungicide, EPA Reg. No. 100-1098; Quilt ® 

### Fungicide, EPA Reg. No. 100-1178; and Quilt Xcel ® 

### Fungicide, EPAAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 14 of 58 Reg. No. 100-1324 specify that all applicable directions, restri ctions, and precautions on the EPA-registered label are to be followed and do not include rotational crop restrictions. The most recent accepted labels for Abound® Flowable Fungicide (EPA Reg. No. 100-1098, main label dated 8/10/12) and Quilt® Fungi cide (EPA Reg. No. 100- 1178) and Quilt Xcel® Fungicide (EPA Reg. No. 100-1324), ma in label dated 3/16/10 specify that the product should be integrated into an overall diseas e and pest management strategy.

For the Abound ® 

### Flowable Fungicide, the following plan tback intervals (PBIs) have been established: 12 months for buckwheat, millet, oats, and rye; and 0 days for all other crops with azoxystrobin registered uses.

For Quilt Xcel® Fungicide (EPA Reg. No. 100-1324), th e following PBIs have been established: 12 months for buckwheat, millet, oats, and rye; 75 da ys for alfalfa (if propiconazole rate does not exceed 0.22 lb ai/A/season); 0 days for bulb crop s, carrots, cereals (wheat, barley, triticale), celery (and other leaf petiole cr ops in subgroup 4B), corn (fie ld, seed, popcorn, and sweet), grasses grown for seed, mint, peanuts, rice, soyb eans, strawberries, sorghum, sugar beets, and wild rice; and 105 days for all other crops inte nded for food/feed. For Quilt® Fungicide (EPA Reg. No. 100-1178), the following PBIs have been es tablished: 45 days for oats, rye, and rice; 105 days for all other crops intended for food/f eed. Soybeans may be planted as a double crop following a cereal crop which has been treated w ith Quilt. Do not use hay, forage, and fodder from the soybean crop as an animal feed or bedding.

The registered labels for Quilt and Quilt Xcel recommend a minimum sp ray volume of 10 gal/A (non-trees) and 50 gal/A (tree cr ops) for ground equipment and mi nimum of 2 gal/A (non-trees) and 10 gal/A (trees) for aerial equipment. The labe l states that chemigation applications are to be made through sprinkler-type irrigation systems only.

Conclusions: For ginseng, the label dire ctions are adequate to allo w evaluation of the residue data relative to the proposed use.

The label directions are adequate to allow evalua tion of the residue data relative to the proposed uses for certain cereal grains. The submitted field trial data for oats and rye reflect the maximum proposed use rates, the minimum RTIs, and th e proposed PHIs for the Quilt and Quilt Xcel.

The submitted crop field trial data on oats, rye, barley, and wheat does not reflect the proposed use pattern of the Abound. The crop field trials were conducted using the Quilt Xcel with lower application rates than the Abound; residues were adjusted using the propo rtionality principle.

Subsequent to the establishment of tolerances in /on oat and rye, the rota tional crop restrictions on the registered labels for the Abound, Quilt an d Quilt Xcel Fungicides should be revised to remove the PBIs for oats and rye to 0-days. HED assumes that the rota tional crop restrictions specified on the Quilt labels ar e due to use of propioconazole.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 15 of 58 860.1300 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, 12/30/98, W. Wassell



### 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 metabolized in plants. The parent compound under goes cleavage of the ether linkage s between the phenylacrylate and pyrimidinyl rings and the cyanophenyl and pyr imidinyl rings, with subsequent oxidation, hydrolysis, and/or reduction of the primary metabo lites to form numerous secondary metabolites. Azoxystrobin is systemic. HED has determined th at the residues of concern in/on plants for tolerance expression and risk assessme nt purposes are azoxystrobin and its Z -isomer.

860.1300 Nature of the Residue - Livestock

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 livestock 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 Methods

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 tolerances for residues of azoxystrobin and its Z -isomer in crop commodities. The method has undergone method validation by the Analytical Chemtistry Branch (ACB)/Biological and Economic Analysis Division (BEAD). The method was revised 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 LOQ is 0.01 ppm for each analyte in crop commodities.

Data-collection methods

Samples from the submitted ginseng residue stud ies were analyzed for residues of azoxystrobin using gas liquid chromatography/electron capt ure detection (GLC/ECD ); the method number was not reported. In MRIDs 48601201 and 48601202, th e reported (LOQs; (determined as the LLMV) were 0.003 ppm for fresh ginseng and 0.007 ppm for all other commodities. In MRID 48601203, the LOQs (determined as the LLMV) we re 0.02 ppm for fresh ginseng and 0.04 ppmAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 16 of 58 for all other commodities. The method was adequate for data collection based on acceptable concurrent method recoveries, and the fortification levels used in concurrent method recovery were adequate to bracket expected residues.

Samples were extracted twice by blending with acetoni trile (ACN) or acetone and filtered. The combined filtrate was partitioned twice with dichloromethane. The dichloromethane extracts were evaporated to dryness, reconstituted in n- hexane:dichloromethane (8:2, v:v) or n-hexane, and purified by Florisil chromatography. Residue s were eluted with dichloromethane/ACN (50:50, v:v) or dichloromethane:ethyl acetate (90: 10, v:v), evaporated to dryness, reconstituted in acetone, and analyzed using GLC/ECD.

Samples of oats, rye, wheat, and barley commodities from the submitted crop field trials and processing studies (wheat onl y) were analyzed for resi dues of azoxystrobin and its Z -isomer using an acceptable UPLC/MS/MS method, Me thod RAM 305/03. The method was adequately validated in conjunction with the analysis of th e field trial and processing study samples. The LOQ (determined as the LLMV) was 0.01 ppm for each analyte; the limit of detection (LOD) was not reported.

Briefly, samples were extracted twice with ACN:water (90:10, v:v). After centrifugation, the combined extracts were cleaned up on a C18 solid phase extraction column. Residues were eluted with ethyl acetate:dichloromethane (55:45, v:v). The eluate wa s evaporated to dryness

and re-dissolved in ACN: water (50:50, v:v) for analysis by UPLC/MS/MS.

Conclusions: An adequate residue analytical method is available for tole rance enforcement in crop commodities. The GLC/ECD method used fo r determination of azoxystrobin in ginseng (fresh and dried root) and its processed commodities and the UPLC/MS/MS method, Method RAM 305/03, used for determination of azoxys trobin in oats, rye, wheat, and barley commodities including wheat processed commodities were adequate for data collection purposes based on acceptable concurre nt method recoveries.

860.1360 Multiresidue Methods

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



### Data have previously been submitted pertai ning to the multiresidue methods testing of azoxystrobin in conjunction with the grape pe tition (PP#5F4541). The data indicate that azoxystrobin could not be recovered through applic ation of the multiresidue protocols. These

data have been forwarded to FDA for inclusion in PAM I.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 17 of 58 860.1380 Storage Stability

DER References: 48601201.der (including MRID 4860102)

48601203.der 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 ava ilable indicating that azoxystrobin and its Z -isomer are reasonably stable under frozen conditions in/on fo rtified samples of diverse crops. In previous studies, residues were determined to be stable fo r 2 years in/on apple, banana, carrot, cucumber, grape, leaf lettuce, rape seed, peach, winter wheat straw, wheat forage, and wine. Over the 2- 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 tomat o, peanut, and pecan, but all recoveries were >70%; residues in these crops were stable (without de crease) for up to 6-8 months of storage.

Previous studies conducted on processed commodities demonstrated that fortified residues 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 1 year, and in soybean meal, corn grits, and orange oil, juice and pul p for at least two years.

Storage stability studies were conducted to suppo rt the MOR studies. Control samples of each commodity were fortified with azoxystrobin and placed in storage under the same frozen conditions as the treated samples for the same storage durations; no 0-da y data were provided.

The storage conditions and durations for sample s collected from the MOR studies submitted are presented below in Tables 6 and 7.

Table 6. Summary of Storage Conditions and Durations of Ginseng Samples from MOR studies.

Matrix Analyte Storage Temperature (°C) Actual Storage

Duration Interval of

Demonstrated Storage Stability 1

Ginseng, fresh root Azoxystrobin -20 8-169 days (0.3-5.6 months) Up to 169 days

Dried ginseng 10-171 days (0.3-5.6 months) Up to 171 days

Red ginseng 6-174 days (0.2-5.7 months) Up to 174 days

Dried ginseng extract (EtOH) 11-93 days (0.4-3.1 months) Up to 93 days

Dried ginseng extract (Water) 4-93 days (0.1-3.1 months)

Red ginseng extract (EtOH) 4-91 days (0.1-3.0 months) Up to 91 days

Red ginseng extract (Water) 5-87 days (0.2-2.9 months) Up to 87 days

1 Based on storage stability data.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 18 of 58 Table 7. Summary of Storage Conditions

. Matrix Analyte Storage Temperature (°C) Actual Storage Duration 1,2 Interval of Demonstrated Storage Stability 3

Magnitude of the Residue Studies

Rye, forage Azoxystrobin Frozen at field sites; -10 at preparation facility; -20 at analytical laboratory 59-113 days (1.9-3.7 months) Residues of azoxystrobin and

R230310 are stable at <-15  C for at least two years in/on corn grits, grain sorghum forage, wheat grain stored

frozen. R230310 54-112 days (1.8-3.7 months)

Rye, grain Azoxystrobin 31-61 days (1.0-2.0 months)

R230310 32-62 days (1.1-2.0 months)

Rye,

straw Azoxystrobin 28-62 days (0.9-2.0 months)

R230310 27-61 days (0.9-2.0 months)

Oat, forage Azoxystrobin Frozen at field sites; -10 at preparation facility; -20 at analytical laboratory 97-407 days (3.2-13.4 months) 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; and residues of azoxystrobin and R230310 are stable for up to 2 years in cucumbers, apples, grapes, peaches, peanuts, pecans, rapeseed, tomatoes, bananas, and wheat grain stored frozen. R230310 97-403 days (3.2-13.3 months)

Oat, hay Azoxystrobin 92-447 days (3.0-14.7 months)

R230310 92-445 days (3.0-14.6 months)

Oat, grain Azoxystrobin 37-359 days (1.2-11.8 months)

R230310 37-359 days (1.2-11.8 months)

Oat, Oat,

straw Azoxystrobin 51-373 days (1.7-12.3 months)

R230310 50-372 days (1.6-12.2 months)

Barley, hay Azoxystrobin Frozen at field sites; -10 at preparation facility; -20 at analytical laboratory 64-469 days (2.1-15.4 months)

R230310 63-468 days (2.1-15.4 months)

Barley, grain Azoxystrobin 45-412 days (1.5-13.6 months)

R230310 45-412 days (1.5-13.6 months)

Barley, hay Azoxystrobin Frozen at field sites; -10 at preparation facility; -20 at analytical laboratory 64-469 days (2.1-15.4 months)

R230310 63-468 days (2.1-15.4 months)

Barley, grain Azoxystrobin 45-412 days (1.5-13.6 months)

R230310 45-412 days (1.5-13.6 months)

Barley,

straw Azoxystrobin 46-399 days (1.5-13.1 months)

R230310 45-399 days (1.5-13.1 months)

Wheat, forage Azoxystrobin Frozen at field sites; -10 at preparation facility; -20 at analytical laboratory 53-392 days (1.7-12.9 months)

R230310 52-391 days (1.7-12.9 months)

Wheat, hay Azoxystrobin 76-404 days (2.5-13.3 months)

R230310 75-403 days (2.5-13.3 months)

Wheat, grain Azoxystrobin 40-452 days (1.3-14.9 months)

R230310 40-452 days (1.3-14.9 months)

Wheat,

straw Azoxystrobin 42-455 days (1.4-15.0 months)

R230310 41-454 days (1.3-14.9 months)

Wheat Processing Study

Wheat, grain (processin g study) Azoxystrobin Ambient at field sites; 10 °F at processor; -10 at preparation facility; -20 at analytical laboratory 181-447 days (6.0-14.7 months) 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; and residues of azoxystrobin and R230310 are stable for up to 2 years in cucumbers, apples, grapes, peaches, peanuts, pecans, rapeseed, tomatoes, bananas, and wheat grain stored frozen. R230310

Wheat,

AGF Azoxystrobin 55-62 days (1.8-2.0 months)

R230310

Wheat,

bran Azoxystrobin 49-56 days (1.6-1.8 months)

R230310 42-49 days (1.4-1.6 months)

Wheat,

flour Azoxystrobin 43-50 days (1.4-1.6 months)

R230310

Wheat, middlings Azoxystrobin 48-55 days (1.6-1.8 months)

R230310Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 19 of 58 Table 7. Summary of Storage Conditions

. Matrix Analyte Storage Temperature (°C) Actual Storage Duration 1,2 Interval of Demonstrated Storage Stability 3

Wheat,

shorts Azoxystrobin 49-56 days (1.6-1.8 months)

R230310

Wheat,

germ Azoxystrobin 43-50 days (1.4-1.6 months)

R230310

1 Interval from harvest to analysis; Extracts were stored 0-6 days prior to analysis.

2 Interval from harvest/processing to analysis. Extracts were st ored 0-1 days prior to analysis. Samples were processed within 398 days of harvest.

3 DP# 390152, 1/4/12, M. Negussie



### Conclusions : The available storage stability data for azoxystrobin on representative crops are adequate to support the storage durations and cond itions of samples of oats, rye, wheat, barley, and ginseng raw agricultural commodities and wheat processed commodities from the submitted crop field trials.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses releva nt to this guideline topic.

860.1460 Food Handling

There are no proposed uses releva nt to this guideline topic.

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 PP#8E7474; DP#s 362963 and 363046, 8/20/09, M. Negussie PP#1E7851; DP# 390152, 01/04/12, M. Negussie



### 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 bypr oducts (0.07 ppm) of cat tle, 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 established. No tolerances for eggs and poultry meat and meat byproducts have been established.

Previously, the maximum theoretical dietary bu rdens (MTDBs) of azoxystrobin were estimated to be 51.3 ppm (beef), 44.4 ppm (dairy cattle), 14.4 ppm (poultry), and 15 ppm (swine). (DP# 390152, M. Negussie, 01/04/12). There are es tablished tolerances fo r numerous livestock

feedstuffs. The additional livest ock feedstuffs associated with th is petition are grain, forage, hay, and straw of oats and rye. The established to lerances for hay and straw of wheat and hay of barley will increase based on the submitted data, but were not included in the current dietary

burden estimate since those tolerances will not affect the total estimated dietary burden. The proposed commodities are fed to beef and dairy cattle , but are not fed to poultry or swine, except oat and rye grain which are fed to poultry. The previously esti mated dietary burden will not beAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 20 of 58 affected since the recommended tolerances and th e percents of the diets are much lower for oat and rye commodities.

Table 8. 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

TOTAL 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 potato waste CC 15 10 8 5.3

Canola meal PC 88 10 1.0 0.114

TOTAL BURDEN -- -- 100 -- 44.4

Poultry

Sorghum 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 8.8

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 con centrate; PC: Protein concentrate.

2 OPPTS 860.1000 Table 1 Feedstuffs (June 2008).

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

Comments 1) Alfalfa hay is chosen because it is the mo st widely used hay for cattle across the US. 2) Normally alfalfa hay will be given over al falfa forage mainly because many production animals are in confined spaces and not grazing in pastures. 3) Canola and cottonseed meals are listed in diets, but co uld be replaced with soybean meal and not affect the proposed diets and total dietary burdens. 4) Rice grain could replace the barley grain for swine, bu t would not affect the tota l estimated dietary burden.



### A poultry feeding study conducted at 60 ppm yiel ded no quantifiable azoxystrobin residues in eggs or tissues. This represents a 4X exagge ration of the calculated di etary burden for poultry.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 21 of 58 Conclusions . The addition of oats and rye and the in crease of tolerances for some barley and wheat commodities do not alter the dietary burde ns of azoxystrobin to ruminants, and the existing tolerances for ruminant commodities will not be exceeded with the proposed uses on oats and rye.

The proposed uses of azoxystrobin addressed inthis document do not alter the Agency’s previous conclusion that there is no reasonable expectation of finite residues in poultry commodities [Category 3 of 40 CFR §180.6(a)]. No tolerances are needed for poultry tissues or

eggs.

860.1500 Crop Field Trials

Ginseng
DER References: 48601201.der.doc (includes review of MRID 4860102) 48601203.der.doc (2008 trials) DP# 225494, 5/1/96, B. Schneider



### Syngenta has submitted residue data for azoxystrobi n on ginseng. Two trials were conducted in Korea during the 2008 growing season (MRID 48601203) , and two consecutive-year trials (2009 and 2010) were conducted in Korea during the 2009-2010 growing s easons (MRIDs 48601201 and 48601202). The results from these trials are di scussed below, and the residue data for dried ginseng are summarized in Table 9 (refer to the DERs for resi due data for fresh ginseng, red ginseng, and ginseng extracts).

Table 9. Summary of Residue Data from Gi nseng Crop Field Trials with Azoxystrobin.

Commodity Plot 1 Total App.

Rate

lb ai/A (g ai/ha) PHI Residue Levels (ppm) 2

n Sample

Min. Sample

Max. LAFT 3 HAFT 3 Median Mean Std.

Dev.

Ginseng (proposed use = 10 mL formula ted product/20 L water, 7-day PHI)

MRID 48601203

Ginseng,

dried root 2008 trials 1.98 (2,222) 7 2 0.10 0.14 0.12 0.13 0.13 0.13 N/A

MRIDs 48601201 and 48601202

Ginseng,

dried root 1a (2009 trials) 1.21-1.29 (1,355-1,450) 7 2 0.034 0.049 0.034 0.048 0.041 0.041 N/A

1b (2009-2010 trials) 2.43-2.58 (2,724-2,894) 7 2 0.060 0.179 0.063 0.177 0.120 0.120 N/A

1 The 2008 trials and Plot 1a received four foliar applica tions in year 1; plot 1b received four additional foliar applications in year 2 according to the same use pattern. The total seasonal application rate for Plot 2b was 1.221- 1.288 lb ai/A (1,369-1,444 g ai/ha).

2 Except for sample min/max, values reflect per trial av erages; n = no. of field tria ls. N/A = Not applicable.

3 LAFT = lowest average field trial; HAFT = highest average field trial.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 22 of 58 MRID 48601203 (2008 trials)

Syngenta has submitted field trial data for azoxy strobin on ginseng. Two ginseng field trials were conducted in the Republic of Korea in the Gangwon and Gyunggi provinces during the 2008 growing season.

Each trial consisted of one untre ated plot and one treated plot of 6-year-old ginseng. Each treated plot received four fo liar applications of a 20% SC formulation of azoxystrobin (Azoxystrobin SC; Ortiva) at a rate of 0.496 lb ai/A/application (556 g ai/ha/appl ication), for a

total seasonal rate of 1.983 lb ai/A (2,222 g ai/ha). Appli cations were made at 10-day retreatment interval (RTIs) using ground equipm ent in spray volumes of 594 gal/A (5,556 L/ha). Adjuvants were not added to the spray mixture fo r any of the applications. Samples of ginseng

root were harvested from all tria ls at a 7-day PHI. The harves ted fresh root was divided into three portions, with one sample reserved for analysis of fr esh root, and the remaining two samples reserved for production of dried ginseng and red ginseng

Samples were analyzed for residues of azoxystr obin using an adequately validated GLC/ECD method. The reported LOQs (determined as th e LLMV) were 0.02 ppm for fresh ginseng root and 0.04 ppm for dried ginseng, red ginseng, and the dried/red ginseng extracts. Adequate storage stability data are available to support sa mple storage intervals and conditions. Refer to Table 6 for sample storage conditions and durations.

The field trial results for dried ginseng are pres ented in Table 9 (refer to the DERs for residue data for fresh ginseng, red ginse ng, and ginseng extracts). Followi ng four foliar applications of the 20% SC formulation of azoxystrobin at a tota l rate of 1.983 lb ai/A (2,222 g ai/ha), residues (and per trial averages) of azoxystrobin were 0.10-0.14 (0.12-0.13) ppm in dried ginseng harvested at a 7-day PHI.

Residue decline data were not submitted; how ever, none are required because ginseng needs

three or fewer total trials.

MRIDs 48601201 and 48601202 (2009 and 2010 trials)

Syngenta has submitted field trial data for azoxy strobin on ginseng. Two consecutive-year field trials were conducted in the Republic of Ko rea in the Chungbuk and Chungnam provinces during the 2009-2010 growing seasons.

Each trial consisted of on e untreated plot and one treated plot of 4-year-o ld ginseng. The treated plot was subdivided into plot 1a and plot 1b. Each subplot receive d four foliar applications of a 20% SC formulation of azoxystrobin (Azoxys trobin SC; Ortiva) at a rate of 0.300-0.327 lb ai/A/application (336-366 g ai/h a/application), for a total se asonal rate of 1.209-1.294 lb ai/A (1,355-1,450 g ai/ha). Applications were made at 10-day RTIs using ground equipment in spray volumes of 359-392 gal/A (3,360-3,666 L/ha). Adjuva nts were not added to the spray mixture for any of the applications. Sample s of ginseng root were harvested from plot 1a at a 7-day PHI.

Plot 1b received four additional fo liar applications in year 2 (305- to 314-day RTI from year 1 applications) using the same use pattern as the previous year for a total seasonal rate of 1.221-Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 23 of 58 1.288 lb ai/A (1,369-1,444 g ai/ha). The overall to tal rate for plot 1b was 2.430-2.582 lb ai/A (2,724-2,894 g ai/ha). Samples of ginseng root were harvested from plot 1b at a 7-day PHI.

Harvested fresh root collected at the 7-day PHI from both subplots was divided into three portions, with one sample reserved for analysis of fresh root, and the remaining two samples reserved for production of drie d ginseng and red ginseng.

Samples were analyzed for residues of azoxystr obin using an adequately validated GLC/ECD method. The reported LOQs (determined as the LLMV) were 0.003 ppm for fresh root and 0.007 ppm for dried ginseng, red ginseng, and the dr ied/red ginseng extracts. Adequate storage stability data are available to support sample st orage intervals and conditions. Refer to Table 6 for sample storage conditions and durations.

The field trial results for dried ginseng are pres ented in Table 9 (refer to the DERs for residue data for fresh ginseng, red ginseng, and ginseng extracts). Following f our foliar applications (year 1) of the 20% SC formulation of azoxystr obin at a total rate of 1.209-1.294 lb ai/A (1,355- 1,450 g ai/ha), residues (and per trial averages) of azoxystrob in were 0.034-0.049 (0.034-0.048) ppm in dried ginseng harvested at a 7-day PHI.

Following four additional applications in year 2 for a total rate of 2.430-2.582 lb ai/A (2,724- 2,894 g ai/ha), residues (and per trial averages) of azoxystrob in were 0.021-0.026 (0.022-0.025) ppm in fresh root and 0.060-0.179 (0 .063-0.177) ppm in dried ginseng harvested at a 7-day PHI.

In the Chungbuk trial, there was a proportional (~2x) increase in residues of azoxystrobin in fresh ginseng root, dried ginseng, and red gi nseng following eight ap plications over 2 consecutive years when compared to residues fo llowing four applications over 1 year. Residues in the dried/red ginseng extracts were 2.7-4.5x hi gher in the 2-year samples. In the Chungnam trial; residues of azoxystrobin were comparable in 1- and 2-year fresh ginseng root (average residues of 0.026 and 0.025 ppm, respectively); ho wever, residues in dried ginseng were 3.7x higher, and residues in red ginse ng increased proportionally (~2x). Residues in the dried ginseng extracts were ~2x higher, and residues in th e red ginseng extracts we re ~5-7x higher.

Residue decline data were not submitted; how ever, none are required because ginseng needs

three or fewer total trials.

Conclusions : The submitted ginseng crop field trial data are acceptable. The number and

locations of the field trials are ad equate to reflect use in Korea, a major exporter of ginseng to the US. The Agency considers the RAC of ginseng to be the dried root, defined as “ginseng” for tolerance purposes (refer to DP# 225494).

The study results indicated that average resi dues of azoxystrobin were 0.034-0.13 ppm in samples of dried ginseng from the 1-year plot s (four trials) and 0.063-0.177 ppm in samples from the 2-year plots (two trials). Comparison of th e 1- and 2-year results in the consecutive-year study indicated that residues were ~2-3.7x hi gher in samples harvested following eight applications over 2 consecutive years when compar ed to residues following four applications over 1 year. Because HED believes that consecu tive-year harvests are likely to be commonAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 24 of 58 cultural practice for ginseng in Korea, the 2-year data were included in the tolerance calculation for ginseng.

Samples from the submitted studies we re not analyzed for residues of the Z -isomer; therefore, the petitioner proposed a worst-case metabolic f actor of 0.09x, determined from the existing root crop data reflecting analysis fo r residues of azoxystrobin and the Z -isomer. The results of the

available field trial data on root and tuber vegetables (c arrot, radish, sugar beet, and potato DP# D260134, M. J. Nelson, 09/06/2000) indi cate that residues of the Z -isomer were all below the LOQ (0.01 ppm). The proposed factor is adequate to estimate the expected residues. This factor was applied to the residue results for dried gins eng for calculation of the recommended tolerance level for ginseng.

The submitted data for ginseng dried root are sufficient for establishing an import tolerance for ginseng resulting from use of azoxystrobin in Kor ea. Based on the submitted data, reflecting 1- and 2-year applications and ex trapolation of residues of azoxystrobin to account for the Z

isomer, the recommended tolerance for ginseng is 0.4 ppm. The tole rance calculations are presented in Appendix I.

Oats

DER Reference: 48681702.der.doc



### Syngenta has submitted field trial data for azoxy strobin on oats. Twelve field trials were conducted in the United States during the 2009- 2010 growing seasons in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (PA; 1 trial), 2 (SC; 1 tr ial), 5 (ND, MN, and IA; 6 trials), 6 (TX; 1 trial), 7 (SD and ND; 2 trials), and 8 (CO; 1 trial).

Two trial pairs or sets (tri als C12-9086 and C12-9087, and tr ials C13-9083, C13-9088, and C13- 9091) were each conducted by the same principal field i nvestigator (PFI). All trials reflected use of different tank mixes for all applications. Trial C13-9091 was conducted in a different NAFTA Zone; thus, HED concludes that th is trial may be counted as a separate trial for purposes of 860.1500 data requirements. Careful examination of th e field trial records for the remaining trials indicates that the only difference between trials C12-9086 and C12-9087 was a >20-mile separation between trial locati ons, and the only differences be tween trials C12-9083 and C12- 9088 were 5- to 11-day off-set in application da tes and a >25% difference in spray volume (~20 gal/A vs. 2 gal/A). HED has concluded that the differences between trials C12-9086 and C12- 9087 are insufficient to classify them as separate trials; therefore, these trials cons titute a single trial with replicate samples for purposes of 860.1500 data requirements. Trials C13-9083 and C13-9088 would not normally satisfy the ChemSAC criteria for differentiation of field trials; however, because of the apprecia ble differences in spray volumes (~20 vs. ~2 gal/A) and the

variation in residue results be tween the two trials, HED concludes that these trials may be counted as separate trials. The adjustment in tr ial numbers results in a total of 11 field trials,

with five trials conducted in NAFTA Zone 5.

Each trial consisted of one untreated plot and tw o treated plots; separate plots were established for the harvest of forage and hay and for the harv est of grain and straw. At each trial location, the treated plots received two foliar broadcast ap plications of a multiple active ingredient (MAI) suspo-emulsion (SE) formulation (Quilt XcelTM) containing 1.18 lb ai/gal azoxystrobin and 1.02Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 25 of 58 lb ai/gal propiconazole. Appli cations were targeted at growth stage 5 (BBCH 30), and 7 days prior to harvest for the forage and hay plots, and at 14 days prior to Feekes 10.54 (BBCH 71), and Feekes 10.54 for grain and straw plots. BBCH 71 is described as the watery ripe stage, where first grains have reached half their final size. This stage is prior to the milk stage. Each treated plot received two applic ations of azoxystrobin at 0.122 8-0.1366 lb ai/A/application, for a

total seasonal rate of 0.2494-0.2696 lb ai/A. Applications were made at 11- to 17-day RTIs using ground equipment in spray volumes of 1.97-31.39 gal/A. A nonionic surfactant (NIS) was added to the spray mixtures for all applications in eleven trials, and a crop oil concentrate (COC) was added to the spray mixtures in one trial. Sa mples of forage and hay were harvested from all trials at PHIs of 7 and 14 days; grain and straw were harvested at maturity (PHIs of 25-48 days). Additional forage and hay samples were harvested at PHIs of 0, 3, 7, and 21 days from one trial (in ND) to assess residue decline; additional grain and straw samples were collected 14 and 7 days prior to, and 7 days after, maturity. The petitioner noted that no 0-day decline samples were collected for hay and that the 3-day samples we re actually collected at a 5-day PHI. Hay samples were dried to approximately 10-20% moisture content; drying intervals were not reported.

Samples were analyzed for re sidues of azoxystrobin and its Z -isomer (R230310) using an UPLC/MS/MS, Method RAM 305/03. The LOQ dete rmined as the lowest level of method validation, LLMV was 0.01 ppm for each analyte. The method was adequate for data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to brack et expected residue levels.

Samples were shipped from the field sites to a sample preparation facility, where they were homogenized prior to shipment to the analytical laboratory. Samp les were stored frozen (<-10 °C at the preparation facility and <-20 °C at the analytical laboratory) from collection to analysis for 97-407 days (3.2-13.4 months) for forage , 92-447 days (3.0-14.7 months) for hay, 37-359 days (1.2-11.8 months) for grai n, and 50-373 days (1.6-12.3 months ) for straw. All samples were analyzed within 0-11 days of extraction. Ad equate storage stability data are available to support the sample storage durations and conditions of samples from the submitted field trials.

Following two foliar broadcast applications of th e 1.18 lb ai/gal SE formulation of azoxystrobin at 0.2494-0.2650 lb ai/A, residues of azoxystrob in, R230310, and combined residues (and per trial averages), respectively, in/on fo rage were: 0.106-2.21 (0 .109-1.98), <0.01-0.124 (<0.01- 0.112), and <0.116-2.33 (<0.119-2.09) ppm at the 7-day PHI and 0.0417-1.02 (0.0513-0.970), <0.01-0.0734 (<0.01-0.0679), and <0.0517-1.09 (<0.0613- 1.04) ppm at the 14-day PHI; corresponding residues in/on hay were: 0.147-3.38 (0.200-3.16), <0.01-0.220 (<0.0120-0.198), and <0.157-3.59 (<0.212-3.36) ppm at the 7- day PHI and 0.126-2.34 (0.139-1.77), <0.01-0.181 (<0.01-0.123), and <0.136-2.52 (<0.149-1.89) ppm at th e 14-day PHI. In/on grain and straw harvested at PHIs of 25-48 days followi ng two applications at 0.2532-0.2696 lb ai/A, corresponding residues (and per trial averages) were : 0.0115-0.636 (0.0127-0.374), <0.01-0.121 (<0.01-0.0709), and <0.0215-0.751 (<0.0227-0.444) ppm in/on grain, and 0.0429-0.934 (0.0487- 0.880), <0.01-0.146 (<0.01-0.131), and <0.0529- 1.08 (<0.0587-1.01) ppm in/on straw.

The residue decline results were variable for all crop matrices. The data indicate that combined residues of azoxystrobin and R 230310 in/on oat forage and hay ge nerally declined through theAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 26 of 58 14-day PHI but increased at the 21-day PHI. Co mbined residues in/on oat grain increased from the 11- to the 18-day PHI, then decreased at the 25-day target PHI and the 32-day PHI.

Combined residues in straw decreased from the 11- to the 18-day PHI, were highest at the target 25-day PHI, and decreased at the 32-day PHI.

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

Commodity Analyte Total App.

Rate (lb ai/A) PHI Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

Forage Azoxystrobin 0.2494-

0.2650 7 11 0.106 2.21 0.109 1.98 0.781 0.784 0.566

R230310 11 <0.01 0.124 <0.01 0.112 0.0312 0.0438 0.0345

Combined 11 <0.116 2.33 <0.119 2.09 0.815 0.826 0.597

Combined 3 11 0.179 3.59 0.183 3.22 1.26 1.27 0.92

Azoxystrobin 14 11 0.0417 1.02 0. 0513 0.970 0.262 0.391 0.314

R230310 11 <0.01 0.0734 <0.01 0.0679 0.0126 0.0297 0.0249

Combined 11 <0.0517 1.09 <0.0613 1.04 0.272 0.421 0.338

Hay Azoxystrobin 7 11 0.147 3.38 0.200 3.16 1.06 1.48 1.19

R230310 11 <0.01 0.220 <0.0120 0.198 0.0577 0.0930 0.0724

Combined 11 <0.157 3.59 <0.212 3.36 1.19 1.58 1.26

Combined 3 11 0.242 5.53 0.326 5.17 1.83 2.43 1.94

Azoxystrobin 14 11 0.126 2.34 0. 139 1.77 0.576 0.718 0.496

R230310 11 <0.01 0.181 <0.01 0.123 0.0435 0.0567 0.0402

Combined 11 <0.136 2.52 <0.149 1.89 0.619 0.774 0.534

Grain Azoxystrobin 0.2532-

0.2696 25-48 11 0.0115 0.636 0.0127 0.374 0.0521 0.120 0.134

R230310 11 <0.01 0.121 <0.01 0.0709 0.0106 0.0238 0.0229

Combined 11 <0.0215 0.751 <0.0227 0.444 0.0626 0.144 0.157

Combined 3 11 0.033 1.16 0.035 0.684 0.096 0.221 0.241

Straw Azoxystrobin 25-48 11 0.0429 0.934 0.0487 0.880 0.197 0.387 0.332

R230310 11 <0.01 0.146 <0.01 0.131 0.0189 0.0457 0.0438

Combined 11 <0.0529 1.08 <0.0587 1.01 0.215 0.432 0.373

Combined 3 11 0.082 1.66 0.129 1.56 0.564 0.721 0.556

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For ca lculation of median, mean, and standard deviation, the LOQ (0.01 ppm) wa s used for any results reported as <LOQ in Table C.3. N/A = Not applicable.

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

3 Adjusted combined residues.



### Rye

DER Reference: 48681701.der.doc



### Syngenta has submitted field trial data for azoxystr obin on rye. Four field trials were conducted in the United States during the 2009 growing season in the NAFTA Growing Zones 2 (SC; 1 trial), 5 (IA; 1 trial), and 7 (ND and NE; 2 trials). The petitioner indicated that a fifth trial, conducted in Zone 5 (IA), was not included in the study because it was conducted with annual ryegrass instead of cereal grain rye.

Each trial consisted of one untreated plot and tw o treated plots; separate plots were established for the harvest of forage and for the harvest of gr ain and straw. At each trial location, the treated plots received two foliar broadcast applicati ons of a MAI SE formulation (Quilt XcelTM) containing 1.18 lb ai/gal azoxystr obin and 1.02 lb ai/gal propic onazole. Applications wereAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 27 of 58 targeted at Feekes growth stage 5 (BBCH 30), and 7 days prior to harvest for the forage plots, and at 14 days prior to Feekes 10.54 (BBCH 71), and Feekes 10.54 (BBCH 71) for grain and straw plots. BBCH 71 is described as the watery ripe stage, where first grains have reached half

their final size. This stage is prior to the milk stage. Each treated plot received two applications of azoxystrobin at 0.1278-0.1330 lb ai/A/application, for a total seasonal rate of 0.2563-0.2646 lb ai/A. Applications were made at 13- to 16- day RTIs using ground equipment in spray volumes of 2.01-23.37 gal/A. A NIS was added to the spray mi xtures for all applica tions in three trials, and a COC was added to the spray mixtures in one trial. Samples of forage were harvested from all trials at PHIs of 6-8 and 13-15 days; grain an d straw were harvested at maturity (PHIs of 34- 50 days). Additional forage samples were harvested at PHIs of 0, 3, 7, and 21 days from one trial (in IA) to assess residue decline; additiona l grain and straw samples were collected 14 and 7 days prior to, and 7 da ys after, maturity.

Samples were analyzed for re sidues of azoxystrobin and its Z -isomer using an UPLC/MS/MS, Method RAM 305/03. The LOQ; determined as the LLMV was 0.01 ppm for each analyte. The method was adequate for data collection based on acceptable concurrent recovery data. The

fortification levels used in concurrent method recovery were adequate to bracket expected

residue levels.

Samples were shipped from the field sites to a sample preparation facility, where they were homogenized prior to shipment to the analytical laboratory. Samp les were stored frozen (<-10 °C at the preparation facility and <-20 °C at the analytical laboratory) from collection to analysis for 54-113 days (1.8-3.7 months) for forage, 31- 62 days (1.0-2.0 months) for grain, and 27-62 days (0.9-2.0 months) for straw. All samples we re analyzed within 0-5 days of extraction. Adequate storage stability data are availabl e to support the sample storage durations and conditions of samples from the submitted field trials.

Following two foliar broadcast applications of th e 1.18 lb ai/gal SE formulation of azoxystrobin at a total rate of 0.2571-0.2617 lb ai/A, residue s (and per trial averag es) of azoxystrobin, R230310, and combined residues, respectively, in/on forage were: 1.03-1.54 (1.05-1.52), 0.0305- 0.0955 (0.0359-0.0955), and 1.06-1.59 (1.08-1.58) ppm at the 6- to 8-day PHI; and 0.396-0.628 (0.418-0.590), 0.0176-0.0301 (0.0183-0.0299), and 0.414-0.658 (0.437-0.619) ppm at the 13- to 15-day PHI. In/on grain and straw harvested at PHIs of 34-50 days following two applications at 0.2563-0.2646 lb ai/A, corresponding residues (and per trial aver ages) were: <0.01-0.0159 (<0.01-0.0151), <0.01, and <0.02-<0.0259 (<0.02- <0.0251) ppm in/on grain, and 0.0911-0.495 (0.0952-0.382), <0.01-0.0363 (<0.01-0.0315), a nd <0.101-0.531 (<0.105-0.414) ppm in/on

straw.

The residue decline data indica te that combined residues of azoxystrobin and R230310 in/on rye forage increased from the 0- to the 3-day PHI, a nd then decreased thereafter. Combined residues in/on straw generally decreased with increasing PHI; residues in/on grain were <LOQ at all sampling intervals; therefore, residu e decline could not be assessed.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 28 of 58 Table 11. Summary of Residue Data from Rye Crop Field Trials with Azoxystrobin.

Commodity Analyte Total App.

Rate (lb ai/A) PHI Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

Forage Azoxystrobin 0.2571-

0.2617 6-8 4 1.03 1.54 1.05 1.52 1.25 1.27 0.227

R230310 4 0.0305 0.0955 0.0359 0.0955 0.0532 0.0595 0.0257

Combined 4 1.06 1.59 1.08 1.58 1.32 1.32 0.249

Combined 3 4 1.63 2.45 1.66 2.43 2.02 2.04 0.384

Azoxystrobin 13-15 4 0.396 0.628 0.418 0.590 0.486 0.495 0.0794

R230310 4 0.0176 0.0301 0.0183 0.0299 0.0245 0.0243 0.0063

Combined 4 0.414 0.658 0.437 0.619 0.510 0.519 0.0853

Grain Azoxystrobin 0.2563-

0.2646 34-50 4 <0.01 0.0159 <0.01 0.0151 0.0100 0.0113 0.0026

R230310 4 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

Combined 4 <0.02 <0.0259 <0.02 <0.0251 0.0200 0.0213 0.0026

Combined 3 4 0.031 0.040 0.031 0.039 0.031 0.033 0.004

Straw Azoxystrobin 34-50 4 0.0911 0.495 0.0952 0.382 0.158 0.198 0.126

R230310 4 <0.01 0.0363 <0.01 0.0315 0.0198 0.0203 0.0091

Combined 4 <0.101 0.531 <0.105 0.414 0.178 0.219 0.135

Combined 3 4 0.156 0.818 0.162 0.638 0.273 0.336 0.208

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For ca lculation of median, mean, and standard deviation, the LOQ (0.01 ppm) wa s used for any results reported as <LOQ in Table C.3. N/A = Not applicable.

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

3 Adjusted combined residues.



### Conclusions . Although the number of field trials is te chnically inadequate, HED concludes that the available data are sufficient to support regi stration of azoxystrobin on oats and rye because

the field trials conducted cover all zones requested. The field trials reflect the proposed use patterns for Quilt® Fungicide (EPA Reg. No. 100-1178 and Quilt Xcel® Fungicide (EPA Reg. No. 100-1324). Samples were analyzed for residues of azoxystrobin and its Z- isomer using acceptable methods, and the studies are supported by adequate storage stability data.

The submitted crop field trial data on oats and rye does not reflect the proposed use pattern of the Abound® Flowable Fungicide (EPA Reg. No. 100- 1098). The crop field trials were conducted using the Quilt Xcel® Fungicide (EPA Reg. No. 100-1324) w ith two foliar applications at 0.13 lb ai/A/application for a total seasonal application rate of 0.26 lb ai/A. The Abound can be applied up to two foliar applications at 0.20 lb ai/A/application for a to tal seasonal application rate of 0.40 lb ai/A. Therefore, the average residues are adjusted using the proportionality principle (average residues ar e multiplied by 1.54 = 0.40/0.26).

Based on the available data, the proposed tolerances for oat and rye commodities must be revised to reflect the appropriate tolerance levels es timated using the OECD statistical calculation procedures. HED recommends tolerances to be established at of 5, 10, 3, and 1.5 ppm for oat forage, hay, straw, and grain re spectively. The recommended tolerances for rye forage, straw, and grain are 7, 1.5, and 0.1, respectively. The proposed tolerances by the petitioner do not reflect the proposed highest application rate. A re vised Section F needs to be submitted to reflect the recommended tolerances. A summary of to lerance recommendations is presented in Table 16. Refer to Appendix I for the tolerance calculations.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 29 of 58 Barley

DER Reference: 48681702.der.doc



### Syngenta has submitted field trial data for azoxy strobin on barley. Nine field trials were conducted in the United States during the 2009- 2010 growing seasons in the NAFTA Growing Zones 2 (VA; 1 trial), 5 (ND and MN; 2 trials), 7 (SD, ND and NE; 3 trials), 9 (CO; 1 trial), 10 (CA; 1 trial), and 11 (ID; 1 trial).

Each trial consisted of one untreated plot and tw o treated plots; separate plots were established for the harvest of hay and for the harvest of grai n and straw. At each trial location, the treated plots received two foliar broadcast applicati ons of a MAI SE formulation (Quilt XcelTM) containing 1.18 lb ai/gal azoxystr obin and 1.02 lb ai/gal propic onazole. Applications were targeted at Feekes growth stage 5 (BBCH 30), and 7 days prior to harvest for the hay plots, and at 14 days prior to Feekes 10.54 (BBCH 71), and F eekes 10.54 for grain and straw plots. Each treated plot received two applic ations of azoxystrobin at 0.125 5-0.1341 lb ai/A/application, for a

total seasonal rate of 0.2532-0.2674 lb ai/A. Applications were made at 12- to 15-day RTIs using ground equipment in spray volumes of 1.95-30.75 gal/A. A NIS was added to the spray mixtures for all applications in eight trials, a nd a COC was added to the spray mixtures in one trial. Samples of hay were harvested from all trials at PHIs of 7 and 14 days; grain and straw samples were harvested at maturity (PHIs of 16-49 days). Additional hay samples were harvested at PHIs of 0, 3, 7, and 21 days from one trial (in ND) to a ssess residue decline; additional grain and straw samples were collected 14 and 7 days prior to, and 7 days after, maturity. Hay samples were dried to approximate ly 10-20% moisture cont ent; drying intervals were not reported.

Samples were analyzed for re sidues of azoxystrobin and its Z -isomer using an UPLC/MS/MS, Method RAM 305/03. The LOQ; determined as the LLMV was 0.01 ppm for each analyte. The method was adequate for data collection based on acceptable concurrent recovery data. The

fortification levels used in concurrent method recovery were adequate to bracket expected

residue levels.

Samples were shipped from the field sites to a sample preparation facility, where they were homogenized prior to shipment to the analytical laboratory. Samp les were stored frozen (<-10 °C at the preparation facility and <-20 °C at the analytical laboratory) from collection to analysis for 63-469 days (2.1-15.4 months) for hay, 45-41 2 days (1.5-13.6 months) for grain, and 45-399 days (1.5-13.1 months) for straw. All samples were analyzed within 0-1 day of extraction. Adequate storage stability data are available to support the storage durations and conditions of samples from the submitted field trials.

Following two foliar broadcast applications of th e 1.18 lb ai/gal SE formulation of azoxystrobin at 0.2532-0.2674 lb ai/A, residues (and per tr ial averages) of az oxystrobin, R230310, and combined residues, respectively, in /on hay were: 0.448-3.77 (0.451-3.62), 0.0139-0.391 (0.0181-0.343), and 0.462-4.16 (0.469-3.96) ppm at the 7-day PHI; and 0.145-2.93 (0.150-2.73), <0.01-0.342 (<0.0107-0.342), and 0.156-3.27 (0.160-3.07) pp m at the 14-day PHI. In/on grain and straw harvested at PHIs of 16-49 days fo llowing two applications at 0.2560-0.2649 lb ai/A, corresponding residues (and pe r trial averages) were: <0.01-1.07 (<0.01-0.974), <0.01-0.116 (<0.01-0.112), and <0.02-1.19 (<0.02-1.09) ppm in/on grain; and 0.0835-3.83 (0.0896-3.49),Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 30 of 58 <0.01-0.463 (<0.01-0.379), and 0.0945-4.29 (0.101-3.87) ppm in/on straw.

The residue decline data indi cate that combined residues of azoxystrobin and R230310 in/on barley hay and straw generally de creased with increasing PHI. Re sidues in/on grain were near or below the LOQ at all sampling intervals; therefor e, residue decline could not be assessed.

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

Commodity Analyte Total App.

Rate (lb ai/A) PHI Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAF

T 2 Median Mean Std.

Dev.

Hay Azoxystrobin 0.2532-

0.2674 7 9 0.448 3.77 0.451 3.62 0.834 1.49 1.20

R230310 9 0.0139 0.391 0.0181 0.343 0.0702 0.0976 0.100

Combined 9 0.462 4.16 0.469 3.96 0.904 1.59 1.28

Combined 3 9 0.711 6.41 0.722 6.10 1.39 2.44 1.98

Azoxystrobin 14 9 0.145 2.93 0. 150 2.73 0.337 0.856 0.878

R230310 9 <0.01 0.342 <0.0107 0.342 0.0343 0.0713 0.105

Combined 9 0.156 3.27 0.160 3.07 0.371 0.926 0.973

Grain Azoxystrobin 0.2560-

0.2649 16-49 9 <0.01 1.07 <0.01 0.974 0.0366 0.183 0.314

R230310 9 <0.01 0.116 <0.01 0.112 0.0100 0.0273 0.0341

Combined 9 <0.02 1.19 <0.02 1.09 0.0466 0.210 0.350

Combined 3 9 0.031 1.83 0.031 1.68 0.072 0.323 0.539

Straw Azoxystrobin 16-49 9 0.0835 3.83 0.0896 3.49 0.356 1.24 1.44

R230310 9 <0.01 0.463 <0.01 0.379 0.0295 0.131 0.157

Combined 9 0.0945 4.29 0.101 3.87 0.377 1.37 1.59

Combined 3 9 0.146 6.61 0.156 5.96 0.581 2.11 2.45

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For ca lculation of median, mean, and standard deviation, the LOQ (0.01 ppm) was used for any results repor ted as <LOQ in Table C.3.

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

3 Adjusted combined residues.



### Wheat

DER Reference: 48681704.der.doc Residue chemistry memo DP# 230634, 4/30/1997, L. Kutney (PP# 6F4762)



### Syngenta has submitted field trial data for azoxy strobin on wheat. Fiftee n field trials were conducted in the United States during the 2008- 2010 growing seasons in the NAFTA Growing Zones 2 (VA; 1 trial), 4 (LA; 1 trial), 5 (ND and IA; 3 trials), 6 (TX; 1 trial), 7 (SD and ND; 4 trials), 8 (TX and CO; 4 tria ls), and 11 (ID; 1 trial).

Three trial pairs or sets (trials C13-9 033, C13-9038, and C13-9040, trials C16-9037 and C16- 9039, and trials W39-9042 and W39-9043) were each conducted by the same principal field investigator (PFI). All trials reflected use of different tank mixes for all applications. Trial C13- 9033 was conducted in a different NAFTA Zone; t hus, HED concludes that this trial may be counted as a separate trial for purposes of 860.1500 data requirements. Examination of the field

trial records indicates that ther e were sufficient differences in the parameters for each remaining pair of trials, including differences in wheat vari ety, dates of initial application (>30 days; trials

C13-9038 and C13-9040 and trials C16-9037 and C 16-9039 only), adjuvant use (COC vs NIS; trials C16-9037 and C16-9039 only), >20-mile se paration in trial location (trials W39-9042 andAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 31 of 58 W39-9043 only), irrigation use (furrow vs none ; trials W39-9042 and W39-9043 only), and a >25% difference in spray volume (~20 gal/A vs. 2 gal/A; trials C13-9038 and C13-9040 only), that each trial constitutes a separate tr ial for purposes of 860.1500 data requirements.

Each trial consisted of one untreated plot and tw o treated plots; separate plots were established for the harvest of forage and hay and for the harv est of grain and straw. At each trial location, the treated plots received two foliar broadcast applications of a MAI SE formulation (Quilt XcelTM) containing 1.18 lb ai/gal azoxystrobin and 1.02 lb ai/gal propiconazole. Applications were targeted at Feekes growth stage 5 (BBCH 30) , and 7 days prior to harvest for the forage and hay plots, and at 14 days prio r to Feekes 10.54 (BBCH 71), and F eekes 10.54 for grain and straw plots. Each treated plot received two a pplications of azoxystrobin at 0.1195-0.1358 lb ai/A/application, for a to tal seasonal rate of 0.247 5-0.2669 lb ai/A. Applications were made at 13- to 16-day RTIs using ground equipment in spray volumes of 2.00-24.16 gal/A; applications were made at a 7-day RTI to treated plot 3 (gra in and straw) at the C 12-9035 trial site. A NIS was added to the spray mixtures for all applicati ons in eleven trials, and a COC was added to the spray mixtures in four trials. Samples of forage and hay were harvested from all trials (with the exception of trial C12-9035) at PHIs of 7 and 14-20 days; grain and straw were harvested at maturity (PHIs of 24-64 days). Additional forage and hay samples were harvested at PHIs of 0, 3, 7, and 21 days from two trials (in IA and TX) to assess residue decline; additional grain and straw samples were collected 14 and 7 days prior to, and 7 days after, maturity. Hay samples were dried to approximately 10-20% moisture content; drying interv als were not reported.

Samples were analyzed for re sidues of azoxystrobin and its Z -isomer using an UPLC/MS/MS, Method RAM 305/03. The LOQ; determined as the LLMV was 0.01 ppm for each analyte. The method was adequate for data collection based on acceptable concurrent recovery data. The

fortification levels used in concurrent method recovery were adequate to bracket expected

residue levels.

Samples were shipped from the field sites to a sample preparation facility, where they were homogenized prior to shipment to the analytical laboratory. Samp les were stored frozen (<-10 °C at the preparation facility and <-20 °C at the analytical laboratory) from collection to analysis for 52-392 days (1.7-12.9 months) for forage , 75-404 days (2.5-13.3 months) for hay, 40-452 days (1.3-14.9 months) for grai n, and 41-455 days (1.3-15.0 months ) for straw. All samples were analyzed within 0-6 days of extraction. Ad equate storage stability data are available to support the sample storage durations and conditions of samples from the submitted field trials.

Following two foliar broadcast applications of th e 1.18 lb ai/gal SE formulation of azoxystrobin at 0.2534-0.2668 lb ai/A, residues (and per tr ial averages) of az oxystrobin, R230310, and combined residues, respectively, in/on forage were: 0.0825-6.17 (0.0898-5.91), <0.01-0.207 (<0.01-0.175), and <0.0925-6.25 (<0.0998-5.99) ppm at the 7-day PHI and 0.0289-1.65 (0.0307- 1.62), <0.01-0.0962 (<0.01-0.0870), and <0.0389-1.75 (<0.0407-1.71) ppm at the 14-20-day PHI; corresponding residues in/on hay were: 0.171-15.6 (0.194-14.7), <0.01-0.333 (<0.01- 0.271), and <0.181-15.8 (<0.204-14.8) ppm at the 7-day PHI and 0.0767-3.14 (0.0816-2.73), <0.01-0.160 (<0.01-0.138), and <0.0867-3.30 (<0.0916-2.87) ppm at the 14-20-day PHI. In/on grain and straw harvested at PHIs of 24-64 da ys following two applications at 0.2475-0.2669 lb ai/A, corresponding residues (and per trial averages) were: <0.01-0.0795 (<0.01-0.0764), <0.01,Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 32 of 58 and <0.02-<0.0895 (<0.02-<0.0864) ppm in/ on grain, and 0.0369-4.03 (0.0377-4.00), <0.01- 0.372 (<0.01-0.358), and <0.0469-4.37 (< 0.0447-4.36) ppm in/on straw.

The residue decline results were variable for all crop matrices. The data from both decline trials indicate that combined residues of azoxystr obin and R230310 in/on wheat forage and hay decreased with increasing PHI. In one decline tr ial, residues in/on grai n were below the LOQ at all sampling intervals; therefore, residue decl ine could not be assesse d and residues in straw increased from the 25-day PHI to th e highest at the 39-day target PH I, and then decreased at the 46-day PHI. In the second d ecline trial, combined residue s in/on wheat grain and straw decreased from the 10- to the 17-day PHI, increased at the 24-day target PHI, and then decreased at the 30-day PHI.

Table 13. Summary of Residue Data from Wheat Crop Field Trials with Azoxystrobin.

Commodity Analyte Total App.

Rate (lb ai/A) PHI Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

Forage Azoxystrobin 0.2534-

0.2668 7 15 0.0825 6.17 0.0898 5.91 0.799 1.67 1.85

R230310 15 <0.01 0.207 <0.01 0.175 0.0500 0.0597 0.0532

Combined 15 <0.0925 6.25 <0.0998 5.99 0.842 1.73 1.89

Combined 3 15 0.142 9.62 0.154 9.225 1.30 2.66 2.91

Azoxystrobin 14-20 15 0.0289 1.65 0.0307 1.62 0.258 0.457 0.495

R230310 15 <0.01 0.0962 <0.01 0.0870 0.0161 0.0266 0.0235

Combined 15 <0.0389 1.75 <0.0407 1.71 0.274 0.483 0.518

Hay Azoxystrobin 7 15 0.171 15.6 0.194 14.7 1.28 2.79 3.82

R230310 15 <0.01 0.333 <0.01 0.271 0.0835 0.103 0.0911

Combined 15 <0.181 15.8 <0.204 14.8 1.36 2.89 3.87

Combined 3 0.279 24.3 0.314 22.8 2.09 4.45 5.96

Azoxystrobin 14-20 15 0.0767 3.14 0.0816 2.73 0.534 0.858 0.888

R230310 15 <0.01 0.160 <0.01 0.138 0.0297 0.0519 0.0467

Combined 15 <0.0867 3.30 <0.0916 2.87 0.564 0.909 0.930

Grain Azoxystrobin 0.2475-

0.2669 24-64 15 <0.01 0.0795 <0.01 0.0764 0.0107 0.0176 0.0170

R230310 15 <0.01 <0.01 <0.01 <0.01 0.01 0.01 N/A

Combined 15 <0.02 <0.0895 <0.02 <0.0864 0.0207 0.0276 0.0170

Combined 3 15 0.031 0.138 0.031 0.133 0.032 0.042 0.026

Straw Azoxystrobin 24-64 15 0.0369 4.03 0.0377 4.00 0.546 0.991 1.14

R230310 15 <0.01 0.372 <0.01 0.358 0.0646 0.107 0.115

Combined 15 <0.0469 4.37 <0.0447 4.36 0.610 1.10 1.25

Combined 3 15 0.072 6.73 0.069 6.71 0.939 1.69 1.92

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For ca lculation of median, mean, and standard deviation, the LOQ (0.01 ppm) wa s used for any results reported as <LOQ in Table C.3. N/A = Not applicable.

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

3 Adjusted combined residues.



### Conclusions . The submitted barley and wheat field tr ial studies are acceptable, provided Section F is revised. The field trials reflect the propos ed use patterns for Quilt® Fungicide (EPA Reg. No. 100-1178 and Quilt Xcel® Fungicide (EPA Reg. No. 100-1324). Samples were analyzed for residues of azoxystrobin and its Z -isomer using acceptable methods, and the studies are supported by adequate storage stab ility data. The number and locati ons of the field trials are in

accordance with OPPTS 860.1500.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 33 of 58 The submitted wheat and barley data to change the PHI of forage and hay from 14-30 days to 7- days; and replace the 45-day PHI w ith growth stage restriction for grain and straw is acceptable. The existing wheat tolerances we re established using the Abound® Flowable Fungicide with up to two foliar applications at 0.20 lb ai/A/applica tion for a total seasonal application rate of 0.40 lb ai/A. Tolerances for barley are established based on translation of residue data from wheat. HED notes that the field trials on barley a nd wheat were submitted with the Quilt Xcel® Fungicide with lower applicati on rates (0.13 lb ai/A/application for a total seasonal application rate of 0.26 lb ai/A). The residue levels were adjusted using the proporti onality principle before deriving a tolerance level to reflect the proposed highest application rate.

The OECD tolerance calculati on procedure recommends individua l tolerances of 10, 15, and 3 ppm for barley hay, straw, and grain, respec tively. HED recommends tolerances to be established at 15, 30, 10, and 0.15 ppm on wheat fora ge, hay, straw, and grain, respectively. A

revised Section F needs to be submitted to refl ect the recommended tolerances. A summary of tolerance recommendations is presented in Ta ble 16. Refer to Appendix I for tolerance

calculations.

860.1520 Processed Food and Feed

Ginseng
DER References: 48601201.der.doc (includes review of MRID 4860102) 48601203.der.doc (2008 trials) DP# 225494, 5/1/96, B. Schneider



### Syngenta has submitted residue data for azoxystrobi n on ginseng. Two trials were conducted in Korea during the 2008 growing season (MRID 48601203) , and two consecutive-year trials (2009 and 2010) were conducted in Korea during the 2009-2010 growing s easons (MRIDs 48601201 and 48601202) ( refer to the DERs for detailed residue data).

Dried ginseng was produced by drying washed fresh ginseng root in a hot air drying machine at

60 °C until the water content was <14%.

Red ginseng was produced by steaming washed fr esh ginseng root by steaming for 3 hours at 98 °C. The steamed samples were dried in a hot air drying machine at 65 °C until the water content

was ~50-55%. The smaller roots were removed and further dried in the sunlight until the water

content was <14%.

Samples of dried or red ginseng were processed into dried/red gi nseng extracts by cutting each sample to about 1 cm in size and then extracti ng three times in a refluxing extractor with 70%

EtOH at 70 °C or with water at 85 °C for ~18 hour s. The solvents were evaporated to reach the

65 or 72 ° Brix.

The processed commodities were analyzed using a GLC/ECD method.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 34 of 58 The data from the ginseng field trial indicate that re sidues of azoxystrobin may concentrate in

ethanol extracts and water extracts of dried a nd red ginseng processed from dried ginseng and red ginseng bearing quantifiable residues.

The maximum expected residue of azoxystrobin in dried and red gins eng ethanol and water extracts were determined by multiplying the average processing factor (see Table 14) by the HAFT residue of dried ginseng (see Table 9) (1.8 x 0.193 = 0.35 pp m). Since this estimate is below the recommended tolerance for ginseng, a pr ocessed commodity tolerance is not needed. Furthermore, the Agency does not typically set tolerances on ginseng processed commodities. The petitioner needs to submit a revised secti on F to propose a tolerance on ginseng at 0.5 ppm.

Table 14. Summary of Processing Factors of Gi nseng Processed Commodities with Azoxystrobin

Crop Processed Commodity Total Rate (lb ai/A) PHI (days) Processing Factor 1
[Average] Average Processing

Factors HAFT 2 x PF (ppm)

Ginseng Dried ginseng (RAC)

1.21-2.58 7 -- 1.8 0.35

Dried ginseng

Ethanol Extract 1.0, 1.6, 3.4, 1.5, 2.2, 2.6 [2.1]

Dried ginseng

Water Extract 1.1, 1.6, 1.4, 0.8, 1.9, 1.3 [1.4]

Red ginseng (RAC) --

Red ginseng

Ethanol Extract 1.0, 1.5, 0.5, 1.9, 6.2, 3.3 [2.4]

Red ginseng Water

Extract 0.8, 1.5, 0.5, 1.3, 1.8, 2.0 [1.3]

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

. 2 The HAFT for dried ginseng equals 0.193 (0.177 x 1.09 = 0.193 it includes the metabolic factor of 0.09x); this value was used to estimate expected residues since tole rance is established on dried ginseng which covers red ginseng also (HAFT = 0.112).



### Wheat

DER Reference: 48681704.der1.doc



### Syngenta has submitted processing data for azoxy strobin on wheat. In two crop field trials conducted in LA and ND, wheat received two foliar broadcast applic ations of a MAI SE formulation (Quilt XcelTM) containing 1.18 lb ai/gal azoxystrobin and 1.02 lb ai/gal propiconazole. Applications we re targeted at 14 days prior to Feekes 10.54, and Feekes 10.54. Each treated plot received two applications of azo xystrobin at an exaggerate d rate (5x field rate) of 0.6383-0.6447 lb ai/A/application, for a total seasonal rate of 1.283 lb ai/A. Applications were made at 13- to 14-day RTIs using gr ound equipment in spray volumes of 5.29-20.04 gal/A. A NIS was added to the spray mixtures for both a pplications in one trial, and a COC was added to the spray mixtures at the second trial site. Wheat grain was harvested from the plots at a 30- to 55-day PHI and processed into AGF, bran, flour , germ, middlings, and shorts using simulated commercial procedures. Processing was conduc ted by GLP Technologies (Navasota, TX). Adequate descriptions were pr ovided of the proce ssing procedures, includi ng material balance

summaries.

Samples were analyzed for re sidues of azoxystrobin and its Z -isomer using an UPLC/MS/MS, Method RAM 305/03. The LOQ; determined as the LLMV was 0.01 ppm for each analyte. TheAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 35 of 58 method was adequate for data collection based on acceptable concurrent recovery data. The

fortification levels used in concurrent method recovery were adequate to bracket expected

residue levels.

Samples were shipped from the processor to a sa mple preparation facility, where they were homogenized prior to shipment to the analytical laboratory. Samp les were stored under ambient conditions (field sites) and frozen (<-10 °C at the preparation facili ty and <-20 °C at the analytical laboratory) from harvest/processing to analysis. Processing took place within 398 days of harvest. Sample analyses were co mpleted within 181-447 days (6.0-14.7 months) for grain (RAC) and 42-62 days (1.4-2.0 months) for th e processed commodities. All samples were analyzed within 0-1 days of extraction. Adequate storage stability data are available to support the sample storage durations and conditions of samples from the submitted wheat processing study.

Following two foliar broadcast applications of the 1.18 lb ai/gal SE formulation at 1.283 lb ai/A, average residues of azoxystrobin, R230310, and co mbined residues, respectively, were: 0.0525- 0.124, <0.01-0.0123, and <0.0625-0.136 ppm in/on wheat grain (RAC); 12.1-28.1, 0.942-2.82, and 13.0-30.9 ppm in AGF; 0.0887-0.129, 0.0150- 0.0163, and 0.104-0.145 ppm in bran; <0.01- 0.0273, <0.01, and <0.02-<0.0373 ppm in flour; 0.0115-0.0535, <0.01, and <0.0215-<0.0635 ppm in middlings; 0.0102-0.0814, <0.01, and < 0.0202-<0.0914 ppm in shorts; and 0.0851-0.114, <0.01-0.0134, and <0.0951-0.127 ppm in germ. The pr ocessing data indicate that combined residues may concentrate in AGF, bran, and ge rm (average processing factors of >218x, >1.4x, and <1.2x) but do not concentrate in flour, middli ngs, and shorts (average processing factors of <0.30x, <0.40x, and <0.50x, respectively).

The processing factors calculated in this st udy were less than the maximum theoretical

concentration factors for wheat of 7.7x for br an, 1.4x for flour, and 8.3x for shorts (based on separation into components; OCSPP 860.1520, Table 3).

Table 15. Residue Data from Wheat Processing Study with Azoxystrobin.

RAC Processed Commodity Total

Rate (lb ai/A) PHI Residues (ppm) 1 [Average] Processing Factor 2

Azoxystrobin R230310 Combined Azoxystrobin R230310 Combined

Cheneyville, LA; 2009 (E17-9032)

Wheat Grain (RAC) 1.283 30 0.129, 0.119 [0.124] 0.0136,

0.0109 [0.0123] 0.143,

0.130 [0.136] -- -- --

AGF 28.1 2.82 30.9 227x 230x 227x

Bran 0.129 0.0163 0.145 1.0x 1.3x 1.1x

Flour 0.0273 <0.01 <0.0373 0.22x <0.82x <0.27x

Middlings 0.0535 <0.01 <0.0635 0.43x <0.82x <0.47x

Shorts 0.0814 <0.01 <0.0914 0.66x <0.82x <0.67x

Germ 0.114 0.0134 0.127 0.92x 1.1x 0.94x

Carrington, ND; 2009 (C13-9038)

Wheat Grain (RAC) 1.283 55 0.0524, 0.0523,

0.0529 [0.0525] <0.01, <0.01,

<0.01 [<0.01] <0.0624, <0.0623,

<0.0629 [<0.0625] -- -- --Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 36 of 58 Table 15. Residue Data from Wheat Processing Study with Azoxystrobin.

RAC Processed Commodity Total

Rate (lb ai/A) PHI Residues (ppm) 1 [Average] Processing Factor 2

Azoxystrobin R230310 Combined Azoxystrobin R230310 Combined

AGF 12.1 0.942 13.0 230x >94x >209x

Bran 0.0887 0.0150 0.104 1.7x >1.5x >1.7x

Flour <0.01 ND <0.0200 <0.19x NC 3 <0.32x

Middlings 0.0115 <0.01 <0.0215 0.22x NC <0.34x

Shorts 0.0102 <0.01 <0.0202 0.19x NC <0.32x

Germ 0.0851 <0.01 <0.0951 1.6x NC <1.5x

Average 4

Wheat Grain (RAC) 1.283 30-

55 -- -- --

AGF 228x >162x >218x

Bran 1.4x >1.4x >1.4x

Flour <0.21x <0.91x <0.30x

Middlings 0.33x <0.91x <0.40x

Shorts 0.43x <0.91x <0.50x

Germ 1.3x <1.1x <1.2x

1 The LOQ was 0.01 ppm for all analytes in all matrices. Per tria l average residues were calculated by the study reviewer using the LOQ for all residues reported as <LOQ. ND = Not detected. Residues were not adjusted.

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

. 3 NC = Not calculated; residue s were below the LOQ in both RAC and processed fraction.

4 In the calculation of the average processing factor, a value of 1.0 was used when a processing fa ctor was not calculated due t o residues <LOQ in the processed fraction.



### Conclusions : The data from the wheat processing study i ndicate that residues of asoxystrobin concentrate in aspirated grain fractions (218x), bran (1.4x), and germ (1.2x), but not in flour, middlings, and shorts 0.3x, 0.4x, 0.5x, respectively following processing of the RAC (wheat grain) with quantifiable residues.

Based on the HAFT for wheat grain 0.133 ppm (see Table 13) and concentr ation factor of 218x for aspirated grain fractions, the maximum expect ed residues would be 29 ppm. An aspirated grain fractions tolerance was established previously at 420 ppm based on sorghum. The maximum expected residue in wheat bran is 0.19 ppm (1.4x x 0.133 = 0.19); the established tolerance of wheat bran (0.20 ppm) needs to be removed from the 40 CFR with establishment of wheat grain tolerance at 0.2 pp m. Based on the HAFT for wheat grain of 0.133 ppm and the 1.2x concentration factor for germ, expected re sidues in wheat germ would be 0.16 ppm, which

is close to the recommended to lerance for wheat grain of 0.2 pp m; therefore, a tolerance for wheat germ is not needed.

The data from the ginseng field trial indicate that re sidues of azoxystrobin may concentrate in

ethanol extracts and water extracts of dried a nd red ginseng processed from dried ginseng and red ginseng bearing quantifiable residues.

The maximum expected residue of azoxystrobin in dried and red gins eng ethanol and water extracts is 0.35 ppm. Since th is estimate is below the reco mmended tolerance for ginseng, a processed commodity tolerance is not needed. Furthermore, the Agency does not typically set tolerances on ginseng processed commodities. The petitioner needs to submit a revised section F to propose a tolerance on ginseng at 0.5 ppmAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 37 of 58 860.1650 Submittal of Analytic al Reference Standards

Analytical standards for azoxystrobin and its Z -isomer (R230310) are curre ntly available in the EPA National Pesticide Standards Repository (p ersonal communication between T. Cole, ACB, and Versar, 4/30/12). The standards w ill expire in 2014 and 2013, respectively.

860.1850 Confined Accumulation in Rotational Crops

PP#6F4762; DP#s 230634, 230635, 2306 36, and 230637, L. Kutney, 4/25/97 PP#9F6058; DP# 260134, 9/6/00, M. Nelson



### Adequate confined studies have previously be en presented in PP#6F4762 and re-evaluated in

PP#9F6058. Total radioactive residues, expressed as [ 14 

### C]azoxystrobin equivalents, accumulated at >0.01 ppm in the raw agricultura l commodities of lettuce, radishes, and wheat planted in sandy loam soil 30, 200, and 365 da ys 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 rotated crop co mmodities 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, azoxystrobin 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 c onjugated metabolites (compound 42 and the M, N, and O metabolites) of primary crop metabolites were iden tified, indicating that azoxystrobin is more extensively metabolized in rotational crops than in primary crops. HED

has concluded that the residues of concer n in rotational crops 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 6F7106 & 7F7198; DP# 334571 & 340016, W. Cutchin, 3/12/08



### Limited field rotational crop stud ies, reflecting applications ma de to the primary crop at a seasonal rate of 0.8 lb ai/A, were initially submitted in PP#6F4762. Subsequently, additional limited field rotational crop studies, with applicati ons made to the primary crop at seasonal rates 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 PBIs were appropriate to support a maximum seasonal application rate of 2.0 lb ai/A to rotated crops: 12 mont hs for buckwheat, millet, oats and rye; and 36 days for the leafy vegetables (except Brassica ) crop group; the Brassica leafy greens subgroup; the root vegeta bles subgroup; the tuberous and corm vegetable subgroup; and the leaves of root and tuber vegetables group. Crops with registered use may be planted immediately after the last treatment unless otherw ise specified. For crops not on the label, a 12-

month PBI must be observed unless otherwise specified.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 38 of 58 Conclusions: Because the proposed amended uses do not result in increased maximum seasonal application rates of azoxystrobin, no changes to the existing rotational crop restrictions are needed. Subsequent to the establishment of tolerances in/on oat and rye, rotational crop restrictions on oat and rye should be removed. HED assumes the rotati onal crop restrictions specified on the Quilt labels are due to use of propioconazole. Rotati onal crop data is not required on ginseng.

860.1550 Proposed Tolerances

DP# 225494, 5/1/96, B. Schneider



### The residues of concern in/on crop commodities for tolerance expression and risk assessment purposes are azoxystrobin and its Z -isomer. The tolerance expre ssion proposed by the petitioner for plants is appropriate, but need to be re vised for livestock commodities to remove the Z

isomer.

The submitted crop field trial data for ginseng are adequate for purposes of establishing an import tolerance. The OECD tolerance statis tical calculation procedur es (March 2011) were used in determining appropriate tolerance leve ls. For ginseng, because samples were not analyzed for the Z -isomer, a metabolic factor of 0.09x was applied to the results for azoxystrobin

to account for residues of the Z -isomer in the tolerance calculation. The proposed and recommended tolerances are presented in Table 16.

The proposed tolerance for ginseng extracts (red ginseng extract and gi nseng extract) at 0.5 ppm

needs to be revised. A revised Section F need s to be submitted to propose a tolerance of 0.50 ppm on ginseng.

The residue definitions for plants and livestock are not harmonized with Codex; the US and the

Canadian residue definitions include both the predominant E isomer and the minor Z isomer

whereas the Codex includ es only the E isomer.

Codex maximum residue limits (MRLs) are esta blished for azoxystrobin on ginseng at 0.1 ppm and dry ginseng including red ginseng at 0.5 ppm. A proposed MRL ginseng, processed products at 0.5 ppm has been returned to JMPR fo r further consideration of the processing study (Report of the 44 th 

### Session of the CCPR, April 2012, paragraph 59 and Appendix III).

Canadian MRLs have been established fo r residues of azoxystrobin including the ( Z )-isomer on ginseng roots at 0.5 ppm and at 0.03 ppm for barl ey, oats, rye, and wheat which are not in agreement with the US tolerances, except for ginse ng roots. Mexico adopts US tolerances and/or Codex MRLs for its export purposes. The Code x MRLs on barley grai n and wheat grain are estimated at 0.5 and 0.2 ppm, respectively and MRLs for oats and rye are extrapolated from the data on barley and wheat, respectively. The US tolerances on oat grain (1.5 ppm) and barley grain (3 ppm) could not be harmonized since the Codex MRLs are lower. Setting the US

tolerance to be consistent with the Codex MRLs mi ght lead to residues in excess of the tolerance, despite legal use of the pesticide in a ccordance with the registered label.

HED recommends increasing the US tolerances of ginseng to 0.5 ppm, and rye grain and wheat grain to 0.2 ppm to harmonize with the numerical portion of the Codex MRL. The US is notAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 39 of 58 establishing a tolerance on ginseng ( fresh roots) since the dried ginseng covers the fresh roots.

Ginseng

The Codex and US tolerances are based on field trials conducted in Kor ea at the maximum GAP with 4 foliar applications of azoxystrobin at 10 days interval at a ra te of 0.34–0.56 kg ai/ha (0.5 lb ai/A) with a PHI of 7 days. The maximum residue was 0.05 mg/kg. The Meeting estimated a maximum residue level of 0.1 mg/kg and an STMR of 0.025 mg/kg. Based on processing, 0.5 mg/kg for ginseng, processed products (dried, red, ethanol and water extracts) was estimated. The US tolerance for ginseng is recommended at 0.5 ppm based on the same data. The US tolerance was estimated using th e OECD calculation procedures and was adjusted upward from 0.4 ppm to 0.5 ppm to harmonize with Codex.

Oat and Rye

The Codex MRLs are based on field trials conducted in Europe. Trials on barley and wheat were conducted at the GAP rate (± 30%) of 0.25 kg ai/h a (0.223 lb ai/A), 2–3 ap plications, and a PHI of 35–42 days. The MRL for oats was extrapolated from the data on barley grain and MRL for rye from data on wheat grain which. The highe st residues were 0.28 and 0.14 ppm, respectively. The MRL was estimated at 0.5 ppm on oat gr ain and at 0.20 ppm on rye grain. The US tolerances on oats (1.5 ppm) and on rye (0.1 ppm) was based on field trial data conducted on oat and rye at 0.26 lb ai/A with PHIs of 25-48 and 34-50, respectively. The rye grain tolerance (0.1 ppm) was increased to 0.2 pp m to harmonize with Codex.

Table 16. Tolerance Su mmary for Azoxystrobin

Commodity Proposed Tolerance (ppm) Recommended Tolerance (ppm) Comments; Correct Commodity Definition

Ginseng Extract (Red Ginseng Extract and Ginseng Extract) 0.5 -- The US does not currently regulate any processed commodity of ginseng; therefore, this tolerance is not

needed.

Ginseng -- 0.50 Based on data for dried ginseng root/

to harmonize with Codex.

Oat, forage 4 5.0

Oat, hay 7 10.0

Oat, straw 3 3.0

Oat, grain 1 1.50

Rye, forage 4 7.0

Rye, straw 0.8 1.50

Rye, grain 0.07 0.20 To harmonize with Codex.

Barley, hay 7 10.0

Barley, straw 8 15.0

Barley, grain 2 3.0

Wheat, forage 10 15.0

Wheat, straw 6 10.0

Wheat, hay 20 30.0Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 40 of 58 Grain, aspirated fractions 460 (Established at 420) 420 The established tolerance of 420 ppm

is sufficient. Grain, aspirated grain fractions

Tolerance That Need To be Revised

Wheat, grain Not proposed (Established at 0.10) 0.20 Based on data/to harmonize with

Codex.

Livestock Commodities Requested To be Revised

Cattle, fat 0.3 Not Needed

Hog, fat 0.1

Hog, meat 0.02

Livestock Commodities Requested to be Established

Poultry, meat 0.01 Not Needed

Poultry, liver 0.2

Poultry, fat 0.01

Egg 0.1

Cattle, liver 0.5

Cattle, kidney 0.1

Hog, liver 0.2

Hog, kidney 0.03



### References

DP#s: 218318 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: 43678102-43678107, 43678193-43678195, 43678200-43678210 and 43694201-

43694206

DP#s: 230634, 230635, 230636, and 230637 Subject: PP#6F4762. Azoxystrobin. Permanen t 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: 235342 Subject: Azoxystrobin Method Va lidation of Method 243/04.

From: C. Stafford

To: E. Haeberer

Dated: 5/30/97Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 41 of 58 MRIDs: MRID 44915207

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 Stone 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 44613503

DP#: 251683 Subject: Azoxystrobin. Conclusions of the Metabolism 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, Tree 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#: 260134 Subject: PP#9F06058: Azoxystrobin. Evaluati on 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 Tuber Vegetables, Soybeans, and Wild Rice; Higher Tolerances for th e 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: 9/6/00

MRIDs: 44915206-44915232 and 44983101Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 42 of 58 DP#s: 283588 and 287062 Subject: PP#9F06058 and ID#s 000100-01098 and 000100-01093. Azoxystrobin. Condition-of-Registration Data, Incl uding 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 Crop Data.

From: N. Dodd

To: J. Bazuin/C. Giles-Parker

Dated: 2/6/03 MRIDs: 45640301, 45640302, 45640304-46560307, and 45738101

DP#: 298114 Subject: Azoxystrobin. Heritage Fungici de (EPA Reg. No. 100-1093. Condition-ofRegistration Data: Limited Field Rotational Crop Data. Petition Number

9F6058. From: L. Cheng

To: J. Bazuin/C. Giles-Parker

Dated: 12/20/05

MRIDs: 45872401

DP#s: 334571 and 340016 Subject: Azoxystrobin. Petitions for the Esta blishment of Permanent Tolerances for New/Amended Uses on Non-grass Animal Feeds (Crop Group 18), Sorghum, Wheat, Cotton and Wild Rice. PP#s 6F 7106 & 7F7198. Summary of Analytical Chemistry and Residue Data.

From: W. Cutchin To: S. Piper and T. Kish/J. Bazuin

Dated: 3/12/08 MRIDs: 46924301-46924303, 47096401-47096402

DP#s: 362963 and 3363046 Subject: Azoxystrobin . Section 3 Amendment to Reduce the Preharvest Interval for Barley Grain and Straw and to Add S eed Treatment Uses on Head and Stem

Brassica Vegetables (Subgroup 5A) and Sorghum , Grain. Summary of Analytical Chemistry and Residue Data. From: M. Negussie

To: T. Kish/B. Madden

Dated: 8/20/09

MRIDs: 47486501

Subject: Pesticide Residues in Food 2011. Report 2011. From: Joint FAO/WHO Meeting on Pesticide Residues To: Publication (h ttp://www.fao.org)

Dated: 2011

Attachments:

International Residue Limit Status sheet Appendix I - Tolerance A ssessment CalculationsAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 43 of 58 

## International Re sidue Limits Azoxystrobin (PC Code 128810; 08/22/12)

Summary of US and International Tolerances and Maximum Residue Limits Residue Definition :

US Canada Mexico 2 

### Codex 3

40 CFR 180.507: Plant: 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- cyanophenoxy)pyrimidin-4- yloxy)phenyl)-3 methoxyacrylate] ( α E)-methyl 2-[[6-(2- cyanophenoxy)-4- pyrimidinyl]oxy]- α - methoxymethylene)benzene

acetate, including the isomer (Z)- methyl 2-[[6-(2- cyanophenoxy)-4- pyrimidinyl]oxy]-- (methoxymethylene)benzen

eacetate Azoxystrobin.

The residue is fat

soluble.



### Commodity 1 

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

US Canada Mexico 2 

### Codex 3

Ginseng 0.50 0.5 ginseng roots 0.1Ginseng 0.5 Ginseng, dried including red ginseng 0.5 ginseng, processed products (proposed) Oat, forage 5.0 Oat, hay 10.0 Oat, straw 3.0 15 straw and fodder of cereal grains Oat, grain 1.50 0.03 0.5 Rye, forage 7.0 Rye, straw 1.50 15 straw and fodder of cereal grains Rye, grain 0.20 0.03 0.2 Barley, hay 10.0 Barley, straw 15.0 15 straw and fodder of cereal grains Barley, grain 3.0 0.03 0.5 Wheat, forage 15.0 Wheat, straw 10.0 15 straw and fodder of cereal grains Wheat, hay 30.0 Wheat, grain 0.20 0.03 0.2 Grain, aspirated grain

fractions* 420

Completed: M. Negussie; 08/31/2012

1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant. *The established tolerance should remain at 420 ppm.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.

3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated co mmodity, such as processing of treated stored wheat. (fat) = to be measured on theAzoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 44 of 58 fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.



### Appendix I. Tolerance Assessment Calculations.

Ginseng

The OECD tolerance statistical calculation procedures (March 2011 version) were used for calculating the recommended tolerances. Th e statistical goal of the OECD calculation procedures is to produce an MRL proposal in the region of the 95 th 

### percentile of the underlying

residues distribution.

The dataset used to establis h a tolerance for combined re sidues of azoxystrobin and its Z -isomer on ginseng consisted of field trial data represen ting application rates of 1.21-1.98 lb ai/A (four applications at 0.300-0.496 lb ai/A/a pplication) with a 7-day PHI. The dataset includes results for two trials reflecting 2-year consecutive-year applications. The field trial PHIs are within

25% of the minimum label PHI.

Based on the additional use pattern informati on submitted, the maximum label rate is 1.36 lb ai/A; the application rate of 1.98 lb ai/A for two of the four 1-year trials > 25% of the maximum label rate. The application rate of the other two trials (1.21-1.29 lb ai/A) ar e within 25% of the

maximum label rate. HED has concluded that inclusion of all data is appropriate for determination of a tolerance for ginseng.

Samples from the submitted field trials were analyzed for residues of azoxystrobin only. To

account for residues of the Z -isomer, the petitioner proposed a worst-case metabolic factor of 0.09x, determined from the existing root crop data reflecting analysis for residues of azoxystrobin and the Z -isomer. This factor was applied to the residue results for calculation of

the recommended tolerance level. Tolerance calc ulations reflecting data from the extrapolated results are presented in Table I-1.

The average residues values used to calculate th e tolerance are provided in Table I-1. Residues of azoxystrobin were quantifiable (LOQ = 0.003 or 0.02 ppm) in/on all sample s of dried ginseng.

Using the OECD tolerance calcula tion procedures and extrapolat ion of azoxystrobin residues to

account for residues of the Z -isomer, the recommended tolerance for combined residues of azoxystrobin and its Z -isomer in/on ginseng is 0.4 ppm. HED notes that the recommended

tolerance would be the sa me without extrapolation.

Oats, Rye, Wheat, and Barley

The dataset used to establis h tolerances for combined re sidues of azoxystrobin and its Z -isomer on oats, rye, barley, and wheat consisted of fiel d trial data representing application rates of 0.24- 0.26 lb ai/A with a 7-day PHI for forage and hay. The field trial applica tion rates and PHIs are within 25% of the maximum label application rate, except for the proposed uses for the Abound label. The recommended tolerances using the OECD statistical calculation procedures are adjusted using the proportionality principle. Th e residue values entered into the OECD tolerance spreadsheet are provided in Table I-1-5.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 45 of 58 Based on the available data and using the OECD statistical calculation procedures, the proposed tolerances for the proposed commoditi es of oats, rye, barley, and wh eat must be revised to reflect the appropriate tolerance levels estimated and commodity definition as listed in Table 16.

Table I-1. Residue data used to calculat e tolerance for azoxystrobin in/on ginseng.

Regulator: EPA

Chemical: Azoxystrobin

Crop: Ginseng

PHI: 7 Days

App. Rate: 1.21-1.98 lb ai/A

Submitter: Syngenta Crop Protection, Inc.

MRID Citation: MRIDs 48601201, 48601202, and 48601203

Combined Residues of Azoxystrobin and the

Z

-isomer Based on Extrapolation (ppm) 1 Residues of Azoxystrobin (ppm)

1-Year Data 

### 0.037 0.034

0.052 0.048

0.13 0.12

0.14 0.13

2-Year Data 

### 0.069 0.063

0.193 0.177

1 A 0.09x metabolic factor was applied to the Korean data and then added to reported residues for azoxystrobin per

se.Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 46 of 58 **Total number of data (n)** 6

**Percentage of censored data** 0%

**Number of non-censored data** 6

**Lowest residue** 0.037

**Highest residue** 0.193

**Median residue** 0.100

**Mean** 0.104

**Standard deviation (SD)** 0.061

**Correction factor for censoring (CF)** 1.000

**Proposed MRL estimate**

**- Highest residue** 0.193

**- Mean + 4 SD** 0.346

**- CF x 3 Mean** 0.311

**Unrounded MRL** 0.346

**Rounded MRL 0.4** 

High uncertainty of MRL estimate.

[Small dataset] **1.21-1.98 lb ai/A; 7-day PHI Azoxystrobin** 

**Ginseng (extrapolated; including 2-yr data)**

**Korea**Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 47 of 58 Table I-2. Residue data used to calcul ate tolerance for azoxystrobin in/on rye

Regulator: EPA EPA EPA

Chemical: Azoxystrobin Azoxystrobin Azoxystrobin

Crop: Rye, forage Rye, grain Rye, straw

PHI: 6-8 Days 34-50 Days 34-50 Days

App. Rate: 0.257-0.262 lb ai/A 0.256-0.265 lb ai/A 0.256-0.265 lb ai/A

Submitter: Syngenta Syngenta Syngenta

MRID Citation: MRID 48681701 MRID 48681701 MRID 48681701

Combined Residues of Azoxystrobin and the Z -isomer (ppm)

1.756 0.039 

### 0.280

2.295 0.031 

### 0.162

2.433 0.031 

### 0.266

1.663 0.031 

### 0.638

**Azoxystrobin**

**Rye, forage**

**E P**  **A**

**0.257**

**- 0**  **.262 lb ai/ A** 

**Total number of data (n)** 4

**Percentage of censored data** 0%

**Number of non- c**  **ensored data** 4

**Lowest residue** 1.663

**Highest residue** 2.433

**Median residue** 2.025

**Mean** 2.037

**Standard deviation (SD)** 0.384

**Correction factor for censoring (CF)** 1.000

**Proposed MRL estimate**

**- Highest residue** 2.433

**- Mean + 4 SD** 3.572

**- CF x 3 Mean** 6.110

**Unrounded MRL** 6.110

**Rounded MRL 7** 

High uncertainty of MRL estimate.

[Small dataset]Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 48 of 58 **Azoxystrobin**

**R ye, grain** 

**E P**  **A**

**0.256**

**- 0**  **.265 lb ai/ A** 

**Total number of data (n)** 4

**Percentage of censored data** 0%

**Number of non- c**  **ensored data** 4

**Lowest residue** 0.031

**Highest residue** 0.039

**Median residue** 0.031

**Mean** 0.033

**Standard deviation (SD)** 0.004

**Correction factor for censoring (CF)** 1.000

**Proposed MRL estimate**

**- Highest residue** 0.039

**- Mean + 4 SD** 0.048

**- CF x 3 Mean** 0.098

**Unrounded MRL** 0.098

**Rounded MRL 0**  **.1**

High uncertainty of MRL estimate.

[Small dataset]

**Azoxystrobin**

**R ye, straw** 

**E P**  **A**

**0.256**

**- 0**  **.265 lb a**  **i/ A** 

**Total number of data (n)** 4

**Percentage of censored data** 75%

**Number of non- c**  **ensored data** 1

**Lowest residue** 0.162

**Highest residue** 0.638

**Median residue** 0.273

**Mean** 0.336

**Standard deviation (SD)** 0.208

**Correction factor for censoring (CF)** 0.500

**Proposed MRL estimate**

**- Highest residue** 0.638Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 49 of 58 **- Mean + 4 SD** 1.167

**- CF x 3 Mean** 0.505

**Unrounded MRL** 1.167

**Rounded MRL 1**  **.5**

High uncertainty of MRL estimate.

[Small dataset and high level of censoring]

Table I-3. Residue data used to calcul ate tolerance for azoxystrobin in/on Oats

Regulator: EPA EPA EPA

Chemical: Azoxystrobin Azoxystrobin Azoxystrobin Azoxystrobin

Crop: Oats, forage Oats, hay Oats, grain Oats, straw

PHI: 7 Days 7 Days 25-48 Days 25-48 Days

App. Rate: 0.249-0.265 lb ai/A 0.249-0.265 lb ai/A 0.253-0.270 lb ai/A 0.253-0.270 lb ai/A

Submitter: Syngenta Syngenta Syngenta Syngenta

MRID

Citation: MRID 48681703 MRID 48681703 MRID 48681703 MRID 48681703

Combined Residues of Azoxystrobin and the Z -isomer (ppm)

0.821 1.445 0.684 1.200

3.219 5.174 0.111 1.261

0.416 0.691 0.057 0.249

0.323 0.434 0.059 0.148

0.183 0.326 0.088 0.129

1.910 5.082 0.328 1.295

2.187 3.542 0.090 0.564

1.374 2.033 0.209 0.331

1.255 5.067 0.035 0.130

0.724 1.078 0.096 1.064

1.586 1.833 0.675 1.555

**Azoxystrobin**

**Oats, forage**

**E P**  **A**

**0.249**

**- 0**  **.265 lb ai/ A** 

**Total number of data (n)** 11

**Percentage of censored data** 36%

**Number of non- c**  **ensored data** 7

**Lowest residue** 0.183

**Highest residue** 3.219

**Median residue** 1.255

**Mean** 1.272Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 50 of 58 **Standard deviation (SD)** 0.920

**Correction factor for censoring (CF)** 0.758

**Proposed MRL estimate**

**- Highest residue** 3.219

**- Mean + 4 SD** 4.953

**- CF x 3 Mean** 2.892

**Unrounded MRL** 4.953

**Rounded MRL 5** 

**Azoxystrobin**

**O ats, hay** 

**E P**  **A**

**0.249**

**- 0**  **.265 lb ai/ A** 

**Total number of data (n)** 11

**Percentage of censored data** 36%

**Number of non- c**  **ensored data** 7

**Lowest residue** 0.326

**Highest residue** 5.174

**Median residue** 1.833

**Mean** 2.428

**Standard deviation (SD)** 1.936

**Correction factor for censoring (CF)** 0.758

**Proposed MRL estimate**

**- Highest residue** 5.174

**- Mean + 4 SD** 10.173

**- CF x 3 Mean** 5.518

**Unrounded MRL** 10.173

**Rounded MRL 1**  **0**Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 51 of 58 **Azoxystrobin**

**Oats, grain**

**E P**  **A**

**0.253**

**- 0**  **.270 lb ai/ A** 

**Total number of data (n)** 11

**Percentage of censored data** 36%

**Number of non- c**  **ensored data** 7

**Lowest residue** 0.035

**Highest residue** 0.684

**Median residue** 0.096

**Mean** 0.221

**Standard deviation (SD)** 0.241

**Correction factor for censoring (CF)** 0.758

**Proposed MRL estimate**

**- Highest residue** 0.684

**- Mean + 4 SD** 1.186

**- CF x 3 Mean** 0.503

**Unrounded MRL** 1.186

**Rounded MRL 1**  **.5**

**Azoxystrobin**

**Oats, straw**

**E P**  **A**

**0.253**

**- 0**  **.270 lb ai/ A** 

**Total number of data (n)** 11

**Percentage of censored data** 36%

**Number of non- c**  **ensored data** 7

**Lowest residue** 0.129

**Highest residue** 1.555

**Median residue** 0.564

**Mean** 0.721

**Standard deviation (SD)** 0.556

**Correction factor for censoring (CF)** 0.758Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 52 of 58 **Proposed MRL estimate**

**- Highest residue** 1.555

**- Mean + 4 SD** 2.945

**- CF x 3 Mean** 1.638

**Unrounded MRL** 2.945

**Rounded MRL 3** 

Table I-4. Residue data used to calculat e tolerance for azoxystrobin in/on Barley.

Regulator: EPA EPA EPA

Chemical: Azoxystrobin Azoxystrobin Azoxystrobin

Crop: Barley, hay Barley, grain Barley, straw

PHI: 7 Days 16-49 Days 16-49 Days

App. Rate: 0.253-0.267 lb ai/A 0.256-0.265 lb ai/A 0.256-0.265 lb ai/A

Submitter: Syngenta Syngenta Syngenta

MRID Citation: MRID 48681702 MRID 48681702 MRID 48681702

Combined Residues of Azoxystrobin and the Z -isomer (ppm)

5.082 0.340 5.590

0.772 0.036 0.231

0.722 0.058 0.420

1.392 0.045 0.473

1.250 0.072 1.180

2.218 0.031 0.156

6.098 0.551 5.960

3.357 1.679 4.374

1.104 0.094 0.581

**Azoxystrobin**

**Barley, Hay**

**E P**  **A**

**0.253**

**- 0**  **.264lb ai/ A** 

**Total number of data (n)** 9

**Percentage of censored data** 33%

**Number of non- c**  **ensored data** 6

**Lowest residue** 0.722

**Highest residue** 6.098

**Median residue** 1.392Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 53 of 58 **Mean** 2.444

**Standard deviation (SD)** 1.978

**Correction factor for censoring (CF)** 0.778

**Proposed MRL estimate**

**- Highest residue** 6.098

**- Mean + 4 SD** 10.354

**- CF x 3 Mean** 5.703

**Unrounded MRL** 10.354

**Rounded MRL 1**  **0**

**Azoxystrobin**

**Barley, grain**

**E P**  **A**

**0.257**

**- 0**  **.262 lb ai/ A** 

**Total number of data (n)** 9

**Percentage of censored data** 44%

**Number of non- c**  **ensored data** 5

**Lowest residue** 0.031

**Highest residue** 1.679

**Median residue** 0.072

**Mean** 0.323

**Standard deviation (SD)** 0.539

**Correction factor for censoring (CF)** 0.704

**Proposed MRL estimate**

**- Highest residue** 1.679

**- Mean + 4 SD** 2.477

**- CF x 3 Mean** 0.682

**Unrounded MRL** 2.477

**Rounded MRL 3** Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 54 of 58 **Azoxystrobin**

**Barley, straw**

**E P**  **A**

**0.257**

**- 0**  **.262 lb ai/ A** 

**Total number of data (n)** 9

**Percentage of censored data** 44%

**Number of non- c**  **ensored data** 5

**Lowest residue** 0.156

**Highest residue** 5.960

**Median residue** 0.581

**Mean** 2.107

**Standard deviation (SD)** 2.453

**Correction factor for censoring (CF)** 0.704

**Proposed MRL estimate**

**- Highest residue** 5.960

**- Mean + 4 SD** 11.920

**- CF x 3 Mean** 4.448

**Unrounded MRL** 11.920

**Rounded MRL 1**  **5**Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 55 of 58 Table I-5. Residue data used to calculat e tolerance for azoxystrobin in/on Wheat.

Regulator: EPA EPA EPA

Chemical: Azoxystrobin Azoxystrobin Azoxystrobin Azoxystrobin

Crop: Wheat, forage Wheat, hay Wheat, grain Wheat, straw

PHI: 7 Days 7 Days 24-64 Days 24-64 Days

App. Rate: 0.253-0.267 lb ai/A 0.253-0.267 lb ai/A 0.248-0.267 lb ai/A 0.248-0.267 lb ai/A

Submitter: Syngenta Syngenta Syngenta Syngenta

MRID

Citation: MRID 48681704 MRID 48681704 MRID 48681704 MRID 48681704

Combined Residues of Azoxystrobin and the Z -isomer (ppm)

6.730 6.329 0.042 6.714

0.433 1.003 0.037 2.880

0.154 0.314 0.031 0.069

0.286 0.373 0.031 0.169

1.848 4.712 0.039 1.252

9.225 22.792 0.032 1.423

0.394 1.129 0.031 0.316

0.598 0.901 0.031 0.839

1.237 2.772 0.031 0.121

4.635 4.019 0.031 0.280

1.540 0.425 0.133 4.297

5.421 8.747 0.033 2.633

5.806 10.149 0.055 3.234

1.297 2.094 0.050 0.939

0.303 0.981 0.031 0.176

**Azoxystrobin**

**Wheat, forage**

**E P**  **A**

**0.253**

**- 0**  **.267 lb ai/ A** 

**Total number of data (n)** 15

**Percentage of censored data** 27%

**Number of non- c**  **ensored data** 11

**Lowest residue** 0.154

**Highest residue** 9.225

**Median residue** 1.297

**Mean** 2.660

**Standard deviation (SD)** 2.912

**Correction factor for censoring (CF)** 0.822

**Proposed MRL estimate**

**- Highest residue** 9.225Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 56 of 58 **- Mean + 4 SD** 14.307

**- CF x 3 Mean** 6.562

**Unrounded MRL** 14.307

**Rounded MRL 1**  **5**

**Azoxystrobin**

**Wheat, hay**

**E P**  **A**

**0.253**

**- 0**  **.267 lb ai/ A** 

**Total number of data (n)** 15

**Percentage of censored data** 27%

**Number of non- c**  **ensored data** 11

**Lowest residue** 0.314

**Highest residue** 22.792

**Median residue** 2.094

**Mean** 4.449

**Standard deviation (SD)** 5.958

**Correction factor for censoring (CF)** 0.822

**Proposed MRL estimate**

**- Highest residue** 22.792

**- Mean + 4 SD** 28.282

**- CF x 3 Mean** 10.975

**Unrounded MRL** 28.282

**Rounded MRL 3**  **0**

**Azoxystrobin**

**Wheat, grain**

**E P**  **A**

**0.248**

**- 0**  **.267 lb ai/ A** 

**Total number of data (n)** 15Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 57 of 58 **Percentage of censored data** 0%

**Number of non- c**  **ensored data** 15

**Lowest residue** 0.031

**Highest residue** 0.133

**Median residue** 0.032

**Mean** 0.042

**Standard deviation (SD)** 0.026

**Correction factor for censoring (CF)** 1.000

**Proposed MRL estimate**

**- Highest residue** 0.133

**- Mean + 4 SD** 0.147

**- CF x 3 Mean** 0.127

**Unrounded MRL** 0.147

**Rounded MRL 0**  **.15**

**Azoxystrobin**

**Wheat, straw**

**E P**  **A**

**0.248**

**- 0**  **.267 lb ai/ A** 

**Total number of data (n)** 15

**Percentage of censored data** 7%

**Number of non- c**  **ensored data** 14

**Lowest residue** 0.069

**Highest residue** 6.714

**Median residue** 0.939

**Mean** 1.690

**Standard deviation (SD)** 1.924

**Correction factor for censoring (CF)** 0.956

**Proposed MRL estimate**

**- Highest residue** 6.714

**- Mean + 4 SD** 9.387

**- CF x 3 Mean** 4.843

**Unrounded MRL** 9.387

**Rounded MRL 1**  **0**Azoxystrobin Summary of Analytical Chemistry and Residue Data DP#: 397692



### Page 58 of 58