Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 2 of 141 Table of Contents

BACKGRO UND

................................ ................................ ................................ ................................ ........................... 4

EXECUTIVE SUMMARY

................................ ................................ ................................ ................................ ........... 4

REGULATORY RECOMMEND ATIONS

................................ ................................ ................................ ................... 5

P RE

- R E GISTRATION D ATA N EEDS

................................ ................................ ................................ ............................. 5

C ONDITION

- OF

- R EGISTRATION D ATA N EEDS

................................ ................................ ................................ ............ 5

T OLERANCE C ONSIDERATIONS

................................ ................................ ................................ ................................ .. 5

Analytic al Method

................................ ................................ ................................ ................................ ................ 5

Livestock Commodity Method

................................ ................................ ................................ ............................ 6

R ECOMMENDED T OLERANCES

................................ ................................ ................................ ................................ ... 6

I NTERNATIONAL H ARMONIZATION

................................ ................................ ................................ ............................ 9

R EVISI ONS TO P ETITIONED

- F OR T OLERANCES

................................ ................................ ................................ ........ 12

R ESIDUE P ROFILE

................................ ................................ ................................ ................................ .................... 12

RESIDUE CHEMISTRY GU IDELINES

................................ ................................ ................................ .................... 15

D IRECTIONS FOR U SE (860.1200)

................................ ................................ ................................ ............................ 15

N A TURE OF THE R ESIDUE (860.1300)

................................ ................................ ................................ ...................... 16

Plants

................................ ................................ ................................ ................................ ................................ .. 16

Tomato

................................ ................................ ................................ ................................ .......................... 17

Lettuce

................................ ................................ ................................ ................................ ........................... 20

Succulent Peas

................................ ................................ ................................ ................................ ............... 21

Rice

................................ ................................ ................................ ................................ ............................... 23

Livestock Metabolism

................................ ................................ ................................ ................................ ........ 26

Poultry Metabolism (Laying Hens)

................................ ................................ ................................ ............... 28

Lactating Goat Metabolism

................................ ................................ ................................ ........................... 31

R ESIDUE A NALYTICAL M ETHODS (860.1340)

................................ ................................ ................................ ......... 37

Enforcement method in plant matrices

................................ ................................ ................................ ............... 37

Data generation methods in plants

................................ ................................ ................................ ..................... 38

Enforcement method in animal matrices

................................ ................................ ................................ ............ 38

Data generation methods for animal matrices

................................ ................................ ................................ .... 39

Radiovalidation of enforcement methods for plants and animal matrices

................................ ......................... 39

M ULTIRESIDUE M ETHODS (860.1360)

................................ ................................ ................................ ..................... 40

S TORAGE S TABILITY (860.1380)

................................ ................................ ................................ ............................. 40

W ATER

, F ISH

, AND I RRIGATED C ROPS (860.1400)

................................ ................................ ................................ ... 41

F OOD H ANDLING (860.1460)

................................ ................................ ................................ ................................ ... 41

M EAT

, M ILK

, P OULTRY

, AND E GGS (860.1480)

................................ ................................ ................................ ...... 41

Poultry

................................ ................................ ................................ ................................ ................................ 41

Cattle

................................ ................................ ................................ ................................ ................................ .. 44

M AXIMUM R EASONABLY B ALANCE D D IETS (MRBD S )

................................ ................................ ........................... 47

P OTENTIAL R ESIDUE L EVELS IN M ILK

, E GGS

, AND T ISSUES

................................ ................................ .................... 50

C ROP F IELD T RIALS (860.1500)

................................ ................................ ................................ .............................. 53

R OOT AND T UBER V EGETABLES

, C ROP G ROUP 1

................................ ................................ ................................ .... 54

L EAVES OF R OOT AND T UBER V EGETABLE

, C ROP G ROUP 2

................................ ................................ .................... 56

B ULB V EGETABLES

, C ROP G ROUP 3

................................ ................................ ................................ ........................ 56

L EAFY V EGETABLES (E XCEPT B RASSICA V EGETABLES ), C ROP G ROUP 4

................................ ................................ . 56

B RASSICA (C OLE ) L EAFY V EGETABLES

, C ROP G ROUP 5

................................ ................................ .......................... 59

L EGUME V EGETABLES (S UCCULENT OR D RIED ), C ROP G ROUP 6

................................ ................................ ............ 60

F OLIAGE OF L EGUME V EGETABLE

, C ROP G ROUP 7

................................ ................................ ................................ . 61

F RUITING V EGETABLE

, C ROP G ROUP 8

................................ ................................ ................................ ................... 61

C UCURBIT V EGETABLE

, C ROP G ROUP 9

................................ ................................ ................................ .................. 63

C ITRUS F RUIT

, C ROP G ROUP 10

................................ ................................ ................................ .............................. 64

P OME F RUIT

, C ROP G ROUP 11

................................ ................................ ................................ ................................ . 65Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 3 of 141 S TONE F RUIT

, C ROP G ROUP 12

................................ ................................ ................................ ................................ 67

B ERRIES G ROUP

, C ROP G ROUP 13

................................ ................................ ................................ ........................... 69

T REE N UTS

, C ROP G ROUP 14

................................ ................................ ................................ ................................ ... 70

C EREAL G RAIN

, C ROP G ROUP 15

................................ ................................ ................................ ............................ 70

F ORA GE

, F ODDER AND S TRAW OF C EREAL G RAIN

, C ROP G ROUP 16

................................ ................................ ....... 72

O ILSEED

, C ROP G ROUP 20

................................ ................................ ................................ ................................ ....... 73

P ROCESSED F OOD AND F EED (860.1520)

................................ ................................ ................................ ................. 75

C ONFINED A CCUMULATION IN R OTATIONAL C ROPS (F IELD ; 860.1850)

................................ ................................ .. 83

F IELD A CCUMULATION IN R OTATIONAL C ROPS (F IELD ; 860.1900)

................................ ................................ ......... 85

TOLERANCE DERIVATION

................................ ................................ ................................ ................................ .... 86

BIBLIOGRAPHY

................................ ................................ ................................ ................................ ....................... 88

860.1300 N ATURE OF T HE RESIDUE

- PLANTS

, LIVESTOCK

................................ ................................ ........................ 88

860.1340 R ESIDUE ANALYTICAL ME THOD

................................ ................................ ................................ ............... 88

860.1360 M ULTIRESIDUE METHOD

................................ ................................ ................................ .......................... 89

860.1380 S TORAGE STABILITY DAT A

................................ ................................ ................................ ....................... 90

860.1480 M EAT / MILK / POULTRY / EGGS

................................ ................................ ................................ .................... 90

860.1500 C ROP FIELD TRIALS

................................ ................................ ................................ ................................ .. 90

860.1520 P ROCESSED FOOD / FEED

................................ ................................ ................................ .......................... 100

860.1850 C ROP R OTATION S TUDIES

................................ ................................ ................................ ...................... 102

N ON

- G UIDELINE S TUDIES

................................ ................................ ................................ ................................ ..... 102

APPENDIX 1. TOLERAN CE SUMMARY FOR SULFO XAFLOR

................................ ................................ ...... 104

APPENDIX 2. FIELD T RIAL GEOGRAPHIC DIST RIBUTION.

................................ ................................ ......... 108

APPENDIX 3. SUMMARY TABLE OF NAFTA AND E UROPEAN FIELD TRIAL DATA

.............................. 109

APPENDIX 4. FIELD T RIAL DATA AND OECD M RL CALCULATOR OUTPUT

................................ .......... 113

APPENDIX 5. INDIVID UAL MRLS FOR REPRESENTATIVE COMMO DITIES AND CROP GROU P MRLS

................................ ................................ ................................ ................................ ................................ ................... 136

APPENDIX 6. STRUCTU RES OF IMPORTANT MET ABOLITES AND DEGRADA TES FOUND IN

METABOL ISM STUDIES, CONFINE D ROTATIONAL CROP ST UDY, CROP FIELD TRIA LS, LIVESTOCK

FEEDING STUDIES, AND ENVIRONMENTAL FATE S TUDIES.

................................ ................................ ..... 140Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 4 of 141 Background

Sulfoxaflor { N

- [methyloxido[1

- [6

- (trifluoromethyl)

- 3

- pyridinyl]ethyl]

- γ 4



### - sulfanylidene]

cyanamide } is the first member of the sulfoximine class of insecticides. It controls insects via a

unique interaction with the insect nicotinic acetylcholine receptor. It is current ly proposed for

foliar applications only

. The petitioner

, DowAgroScience, LLC , is requesting registration of the

new insecticide sulfoxaflor

, on 39 crops/crop groups and establishment of permanent tolerances

for residues in/on those crops/crop groups

. Th ese are the first uses for this new insecticide. The

data were evaluated under a joint review agreement between Canada’s Pest Managemen t

Regulatory Agency (PMRA), Australia’s Pesticides and V eterinary M edicines A uthority

( AP VMA ) and the USEPA

.

This document summarizes information contained in a large number of residue chemistry Tier 2

summaries that were prepared by PMRA and HED . Those Tier 2 summaries are contained in 4

separate monographs that are referenced throughout this document. The fir st monograph,

s ulfoxaflor (XDE

- 208, GF

- 2032 / GF

- 2372) , OECD Joint Review Project, Section B7 : R esidue

data , contains Tier 2 summaries relating to metabolism in plants and livestock , livestock feeding

studies, storage stability of residues, crop field trials, and processing studies. This monograph

was prepared by PMRA and USEPA . The monograph for the analytical methods, sulfoxaflor

( XDE

- 208, GF

- 2032 / GF

- 2372), OECD Joint Review Project, Section B5: Methods of Analysis

was prepared by PMRA

. The t h ird monograph, prepared by USEPA, contains field trial Tier 2

summaries and is titled Sulfoxaf l or OECD Joint Review Project, Section B.7: Residue Data.

The final monograph

, prepared by PMRA

, contains processing study Tier 2 summaries and is

titled sulfoxaflo r OECD Joint Review Project, Section B.7.7: Effects of Industrial Processing

and/or Household Preparation.

Two formulations are proposed for registration: GF

- 2032 which is a suspension concentrate

containing 2 lbs of a

. i

. per gallon (21.8%) and GF

- 2372 which is a water dispensable granule

(WDG) containing 50% a

. i

. by weight

.

Executive Summary

Acceptable data were submitted depicting me tabolism in crops and livestock; analytical

methods; storage stability ; and residues in target crops, rotational crops, processed foods/feeds,

and livestock commodities. The data are adequate to support tolerance evaluation /enforcement

and human health risk assessment.

The global review team has determined the residue definition for tolerance enforcement and risk

assessment to be the parent compound, sulfoxaflor, only for both plant and livestock

commodities. Adequate analytical methods , utilizing solvent extraction and liquid

chromatography with tandem mass spectro metry (LC/MS/MS) techniques are availabl e to

enforce tolerances in crops and livestock. Field trials and feeding studies with sulfoxaflor

indicate that tolerances are needed for both crops and livestock. Tolerance levels recommended

by the USEPA are summarized in Table 1. These tolerances hav e been harmonized, to the extent

possible, with those recommended by our global review partners and the Joint Meeting on

Pesticide Residues (JMPR) at their 2011 meeting.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 5 of 141 R egulatory R ecommendations

Provided the submitted Section F and product labels are re vised as noted below, there are no

residue chemistry issues that would preclude granting the requested Section 3 registration for

sulfoxaflor and for the recommended tolerances on the proposed commodities as listed in Table

1 below . The tolerance expressi on for plant and livestock commodities is provided below, in the

Recommended Tolerances section of this document.

The sulfoxaflor labels should limit application to soybean forage to two applications

, as

supported by the available residue data

.

Pre

- Registration Data Needs

The registrant needs to submit a revised Section F in which the recommended tolerances listed in

Table 1 are proposed.

Condition

- of

- Registration Data Needs

No residue chemistry conditional registration data needs are associated with this tolerance

petition.

Tolerance Considerations

Analytical Method

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B5: Methods of Analysis



### Plant Methods

- Residues of Sulfloxaflor and its metabolites in crops were determined using

Dow analytical Methods 091031 or 091116. Enforcement Method for the Determination of

Sulfoxaflor (XDE

- 208) and its Main Metabolites in Agricultural Commodities using Offline

Solid

- Phase Extraction and Liquid Chromatography with Tand em Mass Spectrometry Detection.

This method is applicable for the quantitative determination of residues of sulfoxaflor and its

metabolites, X11719474, N

- ((methyl)oxido){1

- [6

- (trifluoromethyl)pyridine

- 3

- yl]ethyl}

- λ4

- sulfanylidene)urea

, and X11721061, 1

- [6

- (trifluoromethyl)pyridin

- 3

- yl]ethanol, in agricultural

commodities and its processed products. The method was validated over the concentration range

of 0.010

- 5.0 mg/kg with a validated limit of quantitation of 0.010 mg/kg for all matrices

involved in thi s registration action. The registrant submitted acceptable radio validation data and

an acceptable independent laboratory validation (ILV). The Dow AgroSciences Study Number

091188 will be forwarded to FDA for inclusion in PAM II. The method can also be obtained

from the Analytical Chemistry Branch of the Biological and Economic Analysis Division

(ACB/BEAD).

The FDA Multi

- Residue Method was reported by the registrant as unsuitable for analysis of

sulfoxaflor and/or its metabolites. HED notes that t here are similarities between the German

DFG S19 method and the proposed enforcement method (Method 091116). It is expected that

labs would obtain satisfactory results for sulfoxaflor residues using the DFG S19 method

.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 6 of 141 Livestock Commodity Method

Residues of sulfoxaflor and the metabolites X11719474 and X11721061 were determined in

bovine and poultry matrices using analytical methods CEMS

- 4567, CEMS

- 4568

, and 091188.

This method is applicable for the quantitative determination of residues of sulfoxaflor and its

major metabolites (X11719474 and X11721061) in ruminant and poultry tissues. The method

was validated over the concentration range of 0.010

- 1.0 mg/kg for all matrices with a validated

limit of quantitation of 0.010 mg/kg. The registrant submitted an acceptable ILV. Methods

CEMS

- 4567, CEMS

- 4568, and Dow AgroSciences Study Number 091188 will be forwarded to

FDA for inclusion in PAM II. The method can also be obtained from ACB/BEAD.

The generally good agreement between the results from the metabolism study and the proposed

enforcement methods (Method 091116 for plant commodities s and 091188 for livestock

commodities ) demonstrates successful radio validation of the analytical method and provides

assurance that the enforcement methods are capable of extr acting bioincurred residues of interest

from plant and animal commodities.

Recommended Tolerances

HED recommends that 40 CFR be amended by establishing tolerances for the plant and livestock

commodities listed in the T able 1 . As the residue definitions for plant and animal commodities

are the same , HED recommends that the same entr y be used for both types of commodities. T he

tolerances should be defined as follows:

Tolerances are established for residues of the insectici de sulfoxaflor , including its metabolites

and degradates, in or on the commodities in the table below. Compliance with the tolerance

levels specified below is to be determined by measuring only sulfoxaflor ( N

- [methyloxido[1

- [6

- (trifluoromethyl)

- 3

- pyridiny l]ethyl]

- γ 4



### - sulfanylidene]cyanamide )

.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 7 of 141 Table 1 . Tolerance Summary for Sulfoxaflor. 1



### Commodity Proposed

Tolerance

(ppm) HED

Recommended

Tolerance (ppm) Comments (correct commodity

definition)

Almond, hulls 4 .0 6.0

Barley, grain 0.15 0.4 0

Barley, hay 0.8 1.0

Barley, straw 1.5 2.0 Tolerance is higher than the HAFT,

but lower than the maximum

residue. Since the CODEX Global

MRL recommended by JMPR is 2.0

ppm

, this value would be

harmonized.

Bean, dry seed 0.2 5 0.2 0

Bean, succulent 0.7 4 .0

Beet, sugar, dried pulp

-- 0.07

Beet, sugar, molasse s 0.03 0.25

Berry, low growing, subgroup 13

-

07G 0.06 0.7 0

Cauliflower 0.08 0.08 Individual tolerance is being set

because it exceeds a 5x factor.

Citrus, dried pulp 0.9 3.6

Cotton, hulls 0.4 0.35

Cotton, gin byproducts 8 .0 6.0

C ottonseed subgroup 20C 0. 2 0.2 0

Fruit, citrus, group 10

- 10 0.6 0.7 0

Fruit, p ome, group 11

- 10 0.4 0.50

Fruit, small, vine climbing,

subgroup 13

- 07F, except fuzzy

kiwi fruit 1.3 2.0

Fruit, stone, group 12 0.6 3.0

Grain, aspirated fractions

-- 20 .0

Grape, raisin 5.0 6.0 The calculated tolerance was 5.4

ppm; however, HED recommends

for a 6.0 ppm tolerance in order to

harmonize with pending CODEX

Global MRL

. Leaf y greens , subgroup 4A 5 .0 6.0

Leaf y petiole, subgroup 4B 1 .0 2.0

Nuts, tree, g roup 14 0.02 0.015

Onion, bulb, subgroup 3

- 07A 0.01 0.01

Onion, green, subgroup 3

- 07B 0.6 0.7 0

Pistachio 0.02 0.015 Pistachio requires a separate

tolerance. Data for tree nuts are

translated to pistachio.

Rapeseed, meal 0.5 0.5 0

R apeseed subgroup 20A 0.3 0. 4 0

Soybean, seed 0.2 0. 2 0

Tomato, paste 1. 6 2.6

Tomato, puree 0. 7 1.2

Vegetable , brassica , lea fy, group

5, except cauliflower 1.0 (5A)

1.6 (5B) 2.0Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 8 of 141 Table 1 . Tolerance Summary for Sulfoxaflor. 1



### Commodity Proposed

Tolerance

(ppm) HED

Recommended

Tolerance (ppm) Comments (correct commodity

definition)

Vegetable, c ucurbit, g roup 9 0.3 (except

squash) 0.4 0 Squash is included in HED’s

recommended tolerance.

Vegetable, fruitin g, group 8

- 10 1.2 0. 7 The calculated tolerance was 0.9

ppm; however, HED recommends

for a 0.7 ppm tolerance in order to

harmonize with CODEX.

Vegetable, l eaves of r oot and t uber,

g roup 2 4 .0 3.0 Base d on sugar beet and radish top

data

Vegetabl e, legume, foliage, group

7 -- 3.0

Vegetable, root and tuber, g roup 1 0.01 0.05

Watercress

-- 6.0 Translated from subgroup 4A data,

not a member of subgroup 4A.

Wheat, forage 0.8 1.0 Tolerance is higher than the HAFT,

but lower than the maximum

residue.

Wheat, grain 0.0 7 0.08

Wheat hay 1.1 1.5

Wheat, straw 2 .0 2.0

Livestock Commodities

Cattle, meat 0.1 0.15

Cattle, fat 0.04 0.10

Cattle, kidney 0.2

-- See Cattle meat byproducts

Cattle, meat byproducts 0.25 0.40

Milk 0.08 0.15

Sheep, meat 0.1 0.15

Sheep, fat 0.04 0.10

Sheep, kidney 0.2

-- See Sheep meat byproducts

Sheep, meat byproducts (except

kidney) 0.3

-- See Sheep meat byproducts

Sheep, meat byproducts

-- 0.40

Hog, meat 0.01 0.01

Hog, fat 0.01 0.01

Hog, meat byproducts 0.04 0.01

Poultry, meat 0.01 0.01

Poultry, fat 0.01 0.01

Poultry, meat byproducts 0.03 0.01

Poultry, eggs 0.01 0.01

Horse, meat 0.1 0.15

Horse, fat 0.04 0.10

Horse, kidney 0.2

-- See Horse, meat byproducts

Horse, meat byproducts (except

kidney) 0.3

-- See Horse, meat byproducts

Horse, meat byproducts

-- 0.40

Goat, meat 0.1 0.15

Goat, fat 0.04 0.10

Goat, kidney 0.2

-- See Goat meat byproducts

Goat, meat byproducts (except 0.3

-- See Goat meat byproductsSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 9 of 141 Table 1 . Tolerance Summary for Sulfoxaflor. 1



### Commodity Proposed

Tolerance

(ppm) HED

Recommended

Tolerance (ppm) Comments (correct commodity

definition)

kidney)

Goat, meat byproducts

-- 0.40

1. A complete list of the tolerances proposed by the petitioner is included in Appendix 1

. All the proposed tolerances

were not presented here in order to simplify the tolerance table and to reduce confusion. The petitioner proposed

tolerances for many individual commodities and also proposed different tolerances for these same commodities as part

of a crop group.



### HED is recom mending, for harmonization purposes (with PMRA) , t olerances at the LOQ level

(0.01 ppm) for sulfoxaflor in poultry meat, fat and eggs, and swine meat, fat , and byproducts.

International Harmonization

Sulfoxaflor is a new active ingredient and no maximum residue limits ( MRLs ) have yet bee n

established by Canada, Mexico, or Australia

. CODEX MRLs have been proposed by the 2011

JMPR

, see Table 2 below. The table shows the MRLs based on a Regional approach and a

Global approach. The global partners in this joint review agreed to use global field trial data

from other growing areas, in many cases from other continents to set MRLs. Therefore, the

Agency is attempting to harmonize with the global MRLs.

T he three countries participating in the joint re view, th e U.S., Canada, and Australia

, have all

agreed to use the Organization for Economic Co

- operation and Development ( OECD ) tolerance

calculation procedures to derive recommended tolerances/MRLs

. As a result, for all

commodities, the highest average field tri al data from each field site were entered into the

calculator. If one field site had data reflecting a second formulation or used different adjuvants,

only the highest average residue value from the site was entered into the calculator. In general,

for cr op groups, the field trial data for the representative commodities were entered into the

calculator and the highest recommended tolerance was selected for the entire crop group. In

addition, the three countries are in agreement with respect to the residue s of concern for

tolerance enforcement. The residue of concern in plant and livestock commodities is parent

sulfoxaflor only

.

The tolerance calculated using the OECD tolerance calculation procedures for wheat straw is

higher than the highest average field trial value for wheat straw (HAFT) , but lower than the

maximum residue observed in the wheat field trials

. Since the CODEX Global MRL

recommended by JMPR for wheat straw is 2.0 ppm

, this value would be harmonized. In its

evaluation

, JMPR grouped bel l and non

- bell pepper data into one file, while EPA evaluate s bell

and non

- bell peppers separately

. The 0.7 ppm MRL recommended by JMPR is adequate since

no pepper field trial residue exceeded this value. For Leafy Vegetables, harmonization with

JMPR wou ld result in individual commodity tolerance listings rather than a crop group tolerance

of 2.0 ppm (see Table 2) . This harmonization issue was discussed with Registration Division risk

managers and it was decided to follow the crop

- group approach

.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 10 of 141 Table 2. CODEX MRLs have been proposed by the 2011 JMPR and are pending approval by CCPR.

Crop/Crop Group JMPR Recommendations Joint review OECD

calculator recommended

tolerance EPA Recommended

tolerance†

Current Practice

(Regional Method) Global Dataset

Method

MRL (mg/kg) MRL (mg/kg) MRL (mg/kg) MRL (mg/kg)

Carrot No MRL a 0.05 0.05 0.05

Dry Bean No MRL a 0.2 0.2 0.2

Common Bean No MRL a 4 4.0 4.0

Citrus Fruit 0.9 0.7 0.7 0.7

Pome Fruit 0.4 0.5 0.5 0.5

Stone Fruit 3 3 3.0 3.0

Tree Nuts 0.015 0.015 0.015 0.015

Fruiting Vegetables, Cucurbit 0.5 0.4 0.4 0.4

Fruiting Vegetables, other than

cucurbits (except sweet corn

and mushroom) 1.5 0.7 0.9 0. 7*

Leafy Vegetables 6 6 6 6

Root and Tuber Vegetables b 0.03 0.05 0.05 0.05

Barley 0.6 0.4 0.4 0.4

Barley straw and fodder, dry 3 2 2.0 2.0

Broccoli 3 2 2.0 2.0

Cabbages, Head 0.4 0.5 2.0 2.0 **

Cauliflower 0.04 0.07 2.0 2.0 **

Celery 1.5 1.5 2.0 2.0 **

Cotton seed 0.4 0.2 0.2 0.2

Garlic 0.01 0.01

-- -- Grapes 2 2 2.0 2.0

Dried Grape 6 6 5.4 6.0

Okra 1.5 0.7 0.9 0.9

Onion, bulb 0.01 0.01 0.01 0.01

Spring onion 0.7 0.7 0.7 0.7

Dried chili pepper 15 7

-- --

Pistachio nut 0.015 0.015 0.015 0.015

Rape seed 0.15 0.4 0.4 0.4

Soya bean fodder 3 2 2.0 2.0

Soya bean (immature seed) 0.3 0.2 0.2 0.2Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 11 of 141 Crop/Crop Group JMPR Recommendations Joint review OECD

calculator recommended

tolerance EPA Recommended

tolerance†

Current Practice

(Regional Method) Global Dataset

Method

MRL (mg/kg) MRL (mg/kg) MRL (mg/kg) MRL (mg/kg)

Strawberry 0.5 0.7 0.7 0.7

Triticale 0.2 0.15 1 0.0 8 0. 08

Watercress 6 6 6 6

Wheat 0.2 0.15 1 0.0 8 0. 08

Wheat straw and fodder, dry 3 2 2.0 2.0

Livestock Commodities

Mammals , meat 0.3

NA 0.15 ppm for the meat of

cattle, goat, horse, and

sheep

Mammals

, offal 0.6 0.40 ppm for the meat

byproducts of cattle,

goat, horse, and sheep,

0.10 ppm for the fat of

cattle, goat, horse, and

sheep,

M ilk 0.2 0.15

Poultry

, meat 0.1 Tolerances are being

recommended at the

LOQ level (0.01 ppm)

for poultry meat, fat and

eggs,

Poultry

, offal 0.3 0. 0 1 ppm tolerance for

poultry byproducts.

E ggs 0.1 0.01

† Where there were differences between the JMPR global recommended MRL and the OECD calculator result, EPA defaulted to the JMP R global value for the

purpose of harmonization, unless otherwise noted.

a No recommendation due to insufficient number of trials.



### * JMPR grouped the bell and non

- bell pepper while EPA evaluated bell and non

- bell peppers. 0.7 ppm is adequate since no residue exceeded this value.



### ** In order to harmonize with JMPR, we would not be able to set a crop group tolerance

. JMPR recommended that CCPR accept the MRLs based on the Global Dataset Method. MRLs based on current practice (Regional Data set Method) were

provided in the event that CCPR does not accept the Global Dataset Method.

1. JMPR reviewer reevaluated this to be 0.08 ppm.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 12 of 141 The majority of the recommended MRLs are expected to be harmonized between Canada, and

the U.S

. It is not yet known what tolerances will be established by Australia. In the cases where

MRL s are not being harmonized, it is because of policy differences in the way the two countries

establish MRLs. Canada does not establish MRLs for animal feed items, whereas the U.S. does.

On the other hand, the U.S. generally does not establish MRLs for li vestock commodities when

there is no reasonable expectation of finite residues , whereas Canada establishes LOQ tolerances

in these situations (e.g., sulfoxaflor residues in swine)

.

The calculated tolerance for crop group 8 was 0.9 ppm; however, HED recommends for a 0.7

ppm tolerance in order to harmonize with pending global CODEX MRL

. This is due to JMPR

c ombining all the bell pepper and non

- bell pepper data vs. the US approach of evaluating the bell

and non

- bell pepper se parately.

Revisions to Petitioned

- For Tolerances

M any of the proposed tolerances are different from th ose recommended by HED . The reason for

the differences is that the registrant determined the proposed tolerances using the NAFTA

(North American Free

- Trade Agreement) tolerance calculator. In addition, the registrant

proposed tolerances for some crops as both an individual crop and as members of a crop group.

As stated above, the three countries participating in this joint review all agreed to use the OECD

calculat ion procedures to determine the recommended MRLs . The registrant should submit a

revised Section F in which the proposed tolerances are the same as those recommended by HED.

Residue Profile

Table 3

. Sulfoxaflor Nomenclature

Compound Chemical Structure



### Common name Sulfoxaflor

Company experimental names XDE

- 208

IUPAC name 1

- (6

- trifluoromethylpyridin

- 3

- yl)ethyl](methyl)

- oxido

- λ 6



### - sulfanylidenecyanamide

CAS name cyanamide, N

- [methyloxido[1

- [6

- (trifluoromethyl)

- 3

- pyridinyl]ethyl] λ 4



### - sulfanylidene]

Molecular formula C 10 

### H 10 

### F 3 

### N 3 

### OS

CAS registry number 946578

- 00

- 3

End

- use products (EP) GF

- 2032 SC, Transform WGSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 13 of 141 Figure 1. Structural formula



## N C F

3 

## S

O N C N 1

2

Sulfoxaflor isomers

Sulfoxaflor has two chiral centers (indicated by 1 and 2 in the structure above) and therefore

contains a pair of diastereomers, designated A and B below, each of which is comprised of two

enantiomers. Commercially available sulfoxaflor is considered to be present as an approximate

1:1 mixture of the diastereomers. Diastereomers A (X11546257) and B (X11546258) have

different HPLC retention times and are readily separated by conventional (non chiral) HPLC

columns. Thus, two p eaks for the test material are observed in the HPLC chromatograms; HPLC

percentages of the two peaks are added together to calculate the total amount of sulfoxaflor.

Figure 2. Sulfoxaflor isomers

The interconversion rate of the diastereoisomers is strongly pH dependent, with interconversionSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 14 of 141 equilibrium being reached in less than 1 hour, 3 days, and more than 100 days at pH 9, 7, and 5,

respectively (186, Ma, 2010). At equilibrium, the diastereoiso mer ratio is approximately 50:50,

except at pH 5, where it is 70:30 (A:B).

Additionally, both ( E )

- and ( Z )

- isomers (involving the S=N double bond and the cyano group)

exist, but they are thought to rapidly interconvert at ambient temperatures (A. Wood,

Co mpendium of Common Pesticide Names).

Figure 3. ( E )

- and ( Z

)

- isomer Interconversion

N C F 3 S

N

O C N

N C F 3 S

N

O

C

N



### E

- Sulfoxaflor Z

- Sulfoxaflor

Table 4

. Physical Chemical Properties

Parameter Value

Melting point/range 112.9 oC

pH (24 oC) 5.82 (1.00% w/w aqueous solution)

Density ( Technical grade @ 19.7 oC) 1.5378 g/cm 3

Water solubility ( 20 ° C) 99.7% pure active ingredient

pH 5 1380 mg/L

pH 7 570 mg/L

pH 9 550 mg/L

Unbuffered 670 mg/L

Solvent solubility (g/L at 20 ° C) t echnical grade material

Methanol 93.1

Acetone 217

p

- Xylene 0.743

1,2

- dichloroethane 39.6

ethyl acetate 95.2

n

- heptane 0.000242

n

- octanol 1.66

Vapor Pressure ( pure active ingredient ) 2.5 x 10

- 6 Pa (1.9 x 10

- 8 mm Hg) at 25°C

1.4 x 10

- 6 Pa (1.1 x 10

- 8 mm Hg) at 20°C.

Dissociation constant (pK

a ) NA

Octanol/water partition coefficient Log(K OW )

Unbuffered NA

pH 5 lo gK O / W = 0.806

pH 7 lo gK O / W = 0.802

pH 9 lo gK O / W = 0.799

UV/visible absorption spectrum wavelength max absorption: 192, 211, and

260 nm

N/A = not availableSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 15 of 141 Residue Chemistry Guidelines

Directions fo r Use (860.1200)

Sulfoxaflor products are intended to be used as an insecticide i n a wide variety of crops as well

as turf grass and ornamentals. Sulfoxaflor is generally applied 1

- 4 times with retreatment

intervals ranging from 5

- to 14

- day s , depending on crop, pest, and country/region. The

recommended application rate s for agricultural crops range from 0.016

– 0.133 lb ai/A. A

summary of the use directions is provided in Table 5

.

These end

- use products may be applied through a variety of application methods including

aerial, chemigation, ground

- boom sprayer

, and air blast sprayer

. The two proposed labels allow

the use of adjuvants.

Rotational C rops/ G reenhou se Uses

- The proposed 30

- day plant back interval is considered

adequate, and HED notes that there are only a few commodities that are not proposed for

registration (e.g., corn, peanut, pasture grass es ) that could be rotational crop options.

Limited data were submitted for sulfoxaflor residues in greenhouse tomatoes. No greenhouse

uses were requested with this submission. If greenhouse uses are requested in the future,

additional data would be required.

Table 5 . Summary of Proposed Directions fo r Use of Sulfo xa flor.

Applic. Timing,

Type, and Equip. Formulation Applic.

Rate

(lb ai/A) Max. No.

Applic.

per

Season Max. Seasonal

Applic. Rate

(lb ai/A)

[g ai/ha] PHI

(days) Use Directions and

Limitations

Barley/Triticale/Wheat

Ground, air blast

, aerial,

and chemigation. SC/WDG 0.01 2

- 0.043 2 0.09 [ 101 ] 7

(forage/fodder

/hay)

14

(grain/straw) 14

- day retreatment

interval.

Brassica (Cole) Leafy Vegetables

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

– 0.09 4 0.266 [ 298 ] 3 7

- day retreatment interval.

Bulb Vegetables (Crop Group 3

- 07)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.09 3 0.266 [ 298 ] 7 7

- day retreatment interval.

Canola (Rapeseed) Subgroup 20A

Ground, air blast , aerial,

and chemigation. SC/WDG 0.012

- 0.043 2 0.09 [ 101 ] 14 14

- day retreatment

interval.

Citrus (Crop Group 10)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

- 0.133 4 0.266 [ 298 ] 1 7

- day retreatment interval.

Cotton

Ground, air blast , aerial,

and chemigation. SC/WDG 0.012

- 0.09 4 0.266 [ 298 ] 14 5

- day retreatment interval.

Cucurbit Vegetables (Crop Group 9)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

- 0.09 4 0.266 [ 298 ] 1 7

- day retreatment interval.

Fruiting Vegetables (Crop Group 8)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.022

- 0.09 4 0.266 [ 298 ] 1 7

- day retreatment interval.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 16 of 141 Table 5 . Summary of Proposed Directions fo r Use of Sulfo xa flor.

Applic. Timing,

Type, and Equip. Formulation Applic.

Rate

(lb ai/A) Max. No.

Applic.

per

Season Max. Seasonal

Applic. Rate

(lb ai/A)

[g ai/ha] PHI

(days) Use Directions and

Limitations

Leafy Vegetables (except Brassica) Crop Group 4

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

- 0.09 4 0.266 [ 298 ] 3 7

- day retreatment interval.

Leaves of Root and Tuber Vegetables (Crop Group 2)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

- 0.09 4 0.266 [ 298 ] 7 7

- day retreatment interval.

Pome Fruits (Crop Group 11)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

- 0.09 4 0.266 (298) 7 7

- day retreatment interval.

Root and Tuber Vegetables (Crop Group 1)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

–

0.09 4 0.266 [ 298 ] 7 7

- day retreatment interval.

Small Fruit Vine Climbing

, except Fuzzy Kiwifruit (Subgroup 13

- 07F)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.043

–

0.09 4 0.266 [ 298 ] 7 7

- day retreatment interval.

Low Growing Berry (Subgroup 13

- 07G)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.043

–

0.09 4 0.266 [ 298 ] 1 7

- day retreatment interval.

Soybean

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

–

0.09 4 * 0.266 [ 298 ] 7 (grain

, forage , and

hay) 7

- day retreatment interval.

Stone Fruit (Crop Group 12)

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

–

0.133 4 0.266 [ 298 ] 7 7

- day retreatment interval.

Succulent, Edible Podded , and Dry Beans

Ground, air blast , aerial,

and chemigation. SC/WDG 0.023

–

0.09 4 0.266 [ 298 ] 7 7

- day retreatment interval.

Tree Nuts

Ground, air blast , aerial,

and chemigation. SC/WDG 0.02 2

–

0.133 4 0.266 [ 298 ] 7 7

- day retreatment interval.

Turf grass / Ornamentals

Ground and chemigation.

Aerial for ornamentals

only. SC/WDG 0.043

–

0.133 Not

specified 0.266 [ 298 ] NA 7

- day retreatment interval.

Greenhouse use.

*The residue data support two applications for soybean forage.



### Conclusions : The proposed use directions are sufficient to allow evaluation of the metabolism

and residue studies. The labels must be revised to reflect that only two applications can be made

to soybean forage, which corresponds to the residue data for th is com modity

.

That use pattern for the submitted field trials are in accord with the proposed critical good

agricultural practice (cGAP), which is 400 g a.i./ha for most commodities, higher than the use

rates proposed for the US.

Nature of the Residue (860.1300)

S ulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B7 : Residue data

ROCKS Decision Memo Reference



### Plants

The metabolism of sulfoxaflor was investigated in four different plants, i.e., tomato, lettuce,Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 17 of 141 succulent pea, and rice. For each metabolism study, foliar and soil application were studied

separately, although only foliar uses are being proposed.

Tomato

14 

### C

- Sulfoxaflor was applied to tomatoes (commercial variety 9557) by foliar and soil

application

. For the foliar application , 4 treatments at 213, 202, 129, and 74 g a.i./ha were

applied at 30, 18, and 17 day re

- treatment intervals, respectively, for a to tal rate of 618 g a.i./ha.

I mmature plants were collected 14 days after the first application, and 14 days after the second

application. Ripe tomatoes, displaying a red color

- break, were harvested at 1

- , 7

- , and 14

- day

PHIs. Mature vines were collected 14 day after the last application.

Immature plants collected 14 d ays after the first and second foliar applications contained 0.578

and 0.799 ppm of total radioactive residues ( TRRs ) , respectively (Table 6) . Ripe tomatoes

harvested at 1

- , 7

- , and 14

- day PHIs contained 0.038, 0.033, and 0.030 ppm of TRRs,

respectively, and mature vines collected at a 14

- day PHI contained 1.344 ppm TRRs. Over 84 %

of the TRRs were extractable. The major residues in all tomatoes matrices were sulfoxaflor

(12.8

- 33.3 % TRR; 0.009

- 0.384 ppm) and X11719474 (15.5

- 27.3 % TRR; 0.006

- 0.208 ppm).

Immature plants collected 14 days after the first foliar application, ripe tomatoes, and mature

vines also contained the glucose plus malonyl conjugate of X11721061 (8.9

- 13.3 % TRR; 0.004

- 0.120 p pm).

Immature plants collected 14 days after the first soil application contained 0.836 ppm of TRRs.

Ripe tomatoes harvested at 14

- , 21

- , and 28

- day PHIs contained 0.023, 0.026, and 0.029 ppm of

TRRs, respectively, and mature vines collected at a 28

- day PHI contained 2.790 ppm of TRRs.

Over 91 % of the TRRs were extractable. In all tomato matrices except vines, the major residue

(>10% TRR) was sulfoxaflor (11.5

- 17.2 % TRR; 0.003

- 0.109 ppm) and in all matrices

X11719474 (16.0

- 73.1 % TRR, 0.016

- 0.445 ppm) w as a major residue. The glucose conjugate of

X11721061 was also observed (1.4

- 4.3 % TRR; <0.001

- 0.038 ppm) in all matrices. The glucose

plus malonyl conjugate was observed in all matrices (3.5

- 9.7 % TRR; <0.001

- 0.157 ppm) except

for ripe tomatoes at the 21

- day PHI where it was not detected. X11721061 was only observed in

mature vines (2.3 % TRR; 0.064 ppm). P ost

- extracted solids from vines indicated incorporation

of radioactivity into lignin (8.1% TRR, 0.226 ppm). Table 6 summarizes the reported results for

foliar applications to tomatoes.

For the soil application , 2 treatments at 249 and 211 g a.i./ha were applied, for a total rate of 460

g a.i./ha, with a 28

- day retreatment interval. Soil treatments were made by application of the test

substance with a p ipet into four shallow furrows on each side of the plant that were back

- filled

once the solution was absorbed. Tomato plants were collected 14 days after the first application.

Ripe tomatoes were collected at 14, 21, and 28 days after the second treatment. Mature vines

were collected 28 days after the last application.

After two soil applications, the primary residue in the mature fruit (14

- 28 day PHIs) was

metabolite X11719474, at 59

- 73% of the TRR, while parent was present at 12

- 17% TRR. Minor

metabol ites in ripe tomatoes were the glucose and the glucose plus malonyl conjugates of

X11721061, both at about 4% TRR. No free X11721061 was found in any matrix except for

mature vines (2% TRR). Similar residue distributions were noted for immature plants an dSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 18 of 1 41 mature vines, but with higher total residue levels, and lower relative levels of X11719474.

Overall, similar results were obtained from foliar and soil application methods. Table 7

summarizes the reported results for soil applications to tomatoes.

T he metabolism of sulfoxaflor in tomatoes proceeds through oxidation of the cyano

- carbon to

X11719474, and the loss of the sulphur side

- chain to produce X11721061. X11721061 is then

conjugated with glucose, which in turn may become conjugated with malonic acid. Metabolism

continues through natural incorporation of the radiolabeled carbon into natural plant constituents,

such as lignin

.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 19 of 141 Table 6

. Characterization and Identification of Radioactive Residues in Plant Matrices Following Foliar Application of Radiolabeled Sulfoxaflor at 618 g a.i./ha.

Compound Immature plant, 14

days after 1 st

treatment Immature plant, 14 days

after 2 nd treatment Ripe tomato, 1 days PHI Ripe tomato, 7 days PHI Ripe tomato, 14 days

PHI Vines, 14 days PHI

TRRs = 0.578 ppm TRRs = 0.799 ppm TRRs = 0.038 ppm TRRs = 0.033 ppm TRRs = 0.030 ppm TRRs = 1.344 ppm

% TRR ppm % TRR ppm % TRR ppm % TRR ppm % TRR ppm % TRR ppm

Sulfoxaflor 12.8 0.074 25.2 0.201 31.6 0.012 27.3 0.009 33.3 0.010 28.6 0.384

X11719474 16.1 0.093 17.5 0.140 23.7 0.009 27.3 0.009 20.0 0.006 15.5 0.208

Glucose conjugate of

X11721061 3.5 0.020 4.1 0.033 2.6 0.001 9.1 0.003 3.3 0.001 3.8 0.051

Glucose plus malonyl

conjugate of

X11721061 10.9 0.063 8.6 0.069 10.5 0.004 12.1 0.004 13.3 0.004 8.9 0.120

X11721061 3.1 0.018 2.5 0.020 nd nd nd nd nd nd 2.2 0.030

Total identified 46.4 0.268 58.0 0.463 68.4 0.026 75.8 0.025 70.0 0.021 59.0 0.793

Total characterized 43.1 0.249 30.0 0.240 15.8 0.006 15.2 0.005 26.7 0.008 32.5 0.437

Total extractable 89.5 0.517 88.0 0.703 84.2 0.032 90.9 0.03 96.7 0.029 91.5 1.230

Unextractable (PES) 1 10.0 0.058 18.4 0.147 5.3 0.002 6.1 0.002 6.7 0.002 8.2 0.110

Accountability 2 99.5 106 89.5 97.0 103 99.7

1 Residues remaining after various solvent extractions. 2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis) * 100.

Table 7

. Characterization and Identification of Radioactive Residues in Plant Matrices Following Soil Application of Radiolabeled Sulfoxaflor at 460 g a.i./ha.

Compound Immature plant, 14 days after

treatment Ripe tomato, 14 days PHI Ripe tomato, 21 days PHI Ripe tomato, 28 days PHI Vines, 28 days PHI

TRRs = 0.836 ppm TRRs = 0.023 ppm TRRs = 0.026 ppm TRRs = 0.029 ppm TRRs = 2.790 ppm

% TRR ppm % TRR ppm % TRR ppm % TRR ppm % TRR ppm

Sulfoxaflor 13.0 0.109 13.0 0.003 11.5 0.003 17.2 0.005 3.6 0.100

X11719474 27.5 0.230 69.5 0.016 73.1 0.019 58.6 0.017 16.0 0.445

Glucose conjugate of

X11721061 3.7 0.031 4.3 <0.001 3.9 0.001 3.5 0.001 1.4 0.038

Glucose plus malonyl

conjugate of

X11721061 9.7 0.081 4.3 <0.001 nd nd 3.5 0.001 5.6 0.157

X11721061 nd nd n d nd nd nd nd nd 2.3 0.064

Total identified 54.0 0.451 91.3 0.021 88.5 0.023 82.8 0.024 28.8 0.804

Total characterized 37.8 0.316 21.7 0.005 11.6 0.003 17.2 0.005 68.2 1.903

Total extractable 91.8 0.767 113 0.026 100 0.026 100 0.029 97.0 2.707

Unextractable (PES) 1 18.8 0.157 4.4 0.001 3.9 0.001 6.9 0.002 0.5 0.014

Accountability 2 111 117 104 107 97.5

1 Residues remaining after various solvent extractions, except for mature vines where residues remaining are after bound residu e determination. 2 Accountability = (Total extractable + Total

unextractable)/(TRRs from combustion analysis) * 100Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 20 of 141 Lettuce

Two studies , one with foliar application and the second using soil application, were

conducted to investigate the nature of residue in lettuce

. Lettuce plants were grown outside

using standard agricultural practices. The 14C

- sulfoxaflor was applied to lettuce (Envy) by

foliar application consisting of 3 applications at 195, 199, and 205 g a.i./ha at 21

- day

retreatment intervals using a hand

- held sprayer, for a total rate of 599 g a.i./ha. The first

application occurred 28 days after transplanting. Immature plants were collected 14 days

after the first and second applications. Mature lettuce was harvested at a 7

- day PHI.

Following thr ee foliar applications of sulfoxaflor, major residues include sulfoxaflor (17%

TRR), and metabolite X11719474 (27

- 31% TRR). The glucose conjugate of X11721061 (3

- 5% TRR) and the glucose plus malonyl conjugate of X11721061 (6% TRR) were found at

lower leve ls. Very low levels of free X11721061, X11579457, and X11519540 (each < 1%

TRR) were also reported. Table 8 summarizes the metabolites identified and their

concentrations in lettuce samples that were treated with sulfoxaflor using foliar applications.

T able 8 . Summary of Characterization and Identification of Radioactive Residues in Lettuce Plants

Following Foliar Application of Radiolabeled Sulfoxaflor at 599 g a.i./ha.

Compound Immature Lettuce, 14 d after 1 st treatment Mature Lettuce, 7 day PHI

TRRs = 0.182 ppm TRRs = 4.393 ppm

% TRR p pm % TRR ppm

Sulfoxaflor 17.0 0.031 16.6 0.730

X11719474 26.9 0.049 30.9 1.355

Glucose conjugate of

X11721061 5.0 0.009 2.7 0.119

Glucose plus malonyl

conjugate of X11721061 6.0 0.011 5.5 0.241

X11721061 <0.6 <0.001 0.9 0.041

X11579457 <0.6 <0.001 0.2 0.009

X11519540 N d N d 0.6 0.028

Others 25.8 0.047 28.1 1.232

Total identified 56.0 0.102 57.3 2.523

Total characterized 34.6 0.063 42.5 1.869

Total extractable (Table

6.1.1/1

- 5) 90.7 0.165 100 4.392

Unextractable (PES) 1 9.3 0.017 0.05 0.002

Accountability 2 100 100

1

. Residues remaining after various solvent extractions.

2

. Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis) * 100. nd: not detected



### For the soil treatments , 2 applications at 238 and 216 g a.i./ha were made , for a total rate of

454 g a.i./ha. The first application occurred 5 days after transplanting, and the second

application was 28 days after the first. Soil treatments were made by application of the test

substance with a pipet into four shallow furrows on each side of the plant that were back

filled once the solution was absorbed. Immature lettuce was collected 14 days after the first

application. Mature lettuce was collected 14 days after the second application.

For soil application of sulfoxaflor, X11719474 was the only major metabolite in lettuce,

comprising 49

- 60% of the TRR. Glucose and glucose plus malonyl conjugates of

X11721061 were found at ≤4% TRR. Sulfoxaflor, X11721061, X11579457, and X11519540Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 21 of 141 were each present at ≤1% TRR. Table 9 summ arizes the metabolites identified and their

concentrations in lettuce samples that were treated with sulfoxaflor using soil applications.

Table 9

. Summary of Characterization and Identification of Radioactive Residues in Lettuce Plants

Following Soil Application of Radiolabeled Sulfoxaflor at 454 g a.i./ha.

Compound Immature Lettuce, 14 days after 1st

treatment Mature Lettuce, 14 days after

last treatment

TRRs = 0.135 ppm TRRs = 1.411 ppm

% TRR ppm % TRR ppm

Sulfoxaflor nd nd 1.0 0.014

X11719474 60.0 0.081 49.0 0.691

Glucose conjugate of X11721061 4.4 0.006 1.3 0.018

Glucose plus malonyl conjugate of X11721061 3.0 0.004 3.8 0.054

X11721061 0.7 <0.001 1.0 0.014

X11579457 nd nd 0.2 0.003

X11519540 nd nd 0.1 0.002

Others 18.5 0.025 26.5 0.374

Total identified 68.2 0.092 56.4 0.796

Total characterized 23.7 0.032 43.4 0.613

Total extractable (Table 6.1.1/1

- 5) 91.9 0.124 99.9 1.409

Unextractable (PES) 1 8.2 0.011 0.07 0.001

Accountability 1 100 99.9



### 1. Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis) * 100.nd: not detected

.



### Succulent Peas

Two studies were conducted to investigate the nature of residue in succulent peas: one with

three foliar applications of radiolabeled sulfoxaflor to pea plants and a separate study

consisting of two soil applications of radiolabeled sulfoxaflor near growing pea plants. Pea

plants were grown outside using standard agricultural practices. The 14C

- sulfoxaflor was

app lied to pea ( Sugar Ann) via foliar application consisting of three treatments at 197, 201,

and 203 g a.i./ha at 14

- and 28

- day retreatment intervals using a hand

- held sprayer, for a total

rate of 601 g a.i./ha. The first application occurred 41 days after planting. Immature plants

were collected 14 days after the first and second applications. Mature pods and vines were

harvested at a 14

- day PHI.

Following three foliar applications of sulfoxaflor, significant residues of parent sulfoxaflor

(59

- 71% TRR), and X11719474 (12

- 13% TRR) were found in mature pea pods and vines.

The glucose conjugate of X11721061 (7

- 10% TRR) and the glucose plus malonyl conjugate

of X11721061 (1

- 3% TRR) were found at lower levels, and free X11711061 was only found

at 1% TRR in mature pea matrices. The i mmature pea plants demonstrated lower overall

residue levels, together with relatively more of the glucose conjugate of X11721061 than

found in the mature pea plants. Table 10 summarizes the metabolites identified and their

concentrations in pea plants th at were treated with sulfoxaflor using foliar applications.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 22 of 141 Table 10 : Summary of Characterization and Identification of Radioactive Residues in Pea

Plants Following Foliar Application of Radiolabeled Sulfoxaflor at 601 g a.i./ha.

Compound Immature Plants, 14

days after 1 st treatment Immature Plants, 14

days after 2 nd

treatment Mature Pea Pods,

14 days after last

treatment Mature Pea Vines,

14 days after last

treatment

TRRs = 0.348 ppm TRRs = 0.592 ppm TRRs = 1.046 ppm TRRs = 5.478 ppm

% TRR ppm % TRR ppm % TRR ppm % TRR ppm

Sulfoxaflor 34.5 0.120 30.4 0.180 59.4 0.621 71.2 3.898

X11719474 30.5 0.106 31.9 0.189 13.3 0.139 11.7 0.639

Glucose conjugate of

X11721061 22.1 0.077 18.1 0.107 10.1 0.106 6.7 0.365

Glucose plus malonyl

conjugate of

X11721061 0.6 0.002 0.9 0.005 2.9 0.030 1.2 0.067

X11721061 nd nd 1.5 0.009 0.8 0.008 1.4 0.078

Total identified 87.6 0.305 82.8 0.490 86.4 0.904 92.1 5.047

Total characterized 11.5 0.037 10.0 0.059 4.9 0.051 9.3 0.507

Total extractable 99.1 0.342 92.7 0.549 91.3 0.955 101 5.554

Unextractable (PES) 1 0.9 0.003 1.7 0.010 1.5 0.016 1.7 0.092

Accountability 2 99.1 94.4 92.8 103

1 Residues remaining after various solvent extractions



### . 2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis) * 100.



### For the soil application, 2 treatments at 212 and 222 g a.i./ha were applied, for a total rate of

434 g a.i./ha. The first application occurred 55 days after planting, and the second

application was 28 days after the first. Soil treatments were made by application of the test

substance with a pipet into four shallow furrows on each side of the plant that were back

filled once the solution was absorbed. Immature pea plants were collected 14 days after the

first application. Mature pods and vines were collected 14 days after the second soil

application.

For soil application of sulfoxaflor, the primary residue in mature pods and vines was

metabolite X11719474 (88

- 90% TRR). Parent sulfoxaflor (nd

- 5% TRR) and the glucose

conju gate of X11721061 (2

- 8% TRR) were minor metabolites in the mature pea plants. Soil

treatments resulted in significantly lower overall residue levels in pea plants than foliar

applications. Table 1 1 summarizes the metabolites identified and their concentr ations in

lettuce samples that were treated with sulfoxaflor using soil applications.

Table 1 1 : Summary of Characterization and Identification of Radioactive Residues in

Pea Plant Matrices Following Soil Application of Radiolabeled Sulfoxaflor at 434 g

a.i./ha.

Compound Immature Plants, 14

days after 1st treatment Mature Pea Pods, 14

days after last

treatment Mature Pea Vines, 14

days after last

treatment

TRRs = 0.036 ppm TRRs = 0.042 ppm TRRs = 0.146 ppm

% TRR ppm % TRR ppm % TRR ppm

Sulfoxaflor 13.9 0.005 4.8 0.002 nd nd

X11719474 83.3 0.030 88.1 0.037 89.7 0.131

Glucose conjugate of

X11721061 11.1 0.004 2.4 0.001 7.5 0.011

Glucose plus malonyl

conjugate of

X11721061 nd nd nd nd nd ndSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 23 of 141 Table 1 1 : Summary of Characterization and Identification of Radioactive Residues in

Pea Plant Matrices Following Soil Application of Radiolabeled Sulfoxaflor at 434 g

a.i./ha.

Compound Immature Plants, 14

days after 1st treatment Mature Pea Pods, 14

days after last

treatment Mature Pea Vines, 14

days after last

treatment

TRRs = 0.036 ppm TRRs = 0.042 ppm TRRs = 0.146 ppm

% TRR ppm % TRR ppm % TRR ppm

X11721061 nd nd nd nd nd nd

Total identified 108 0.039 95.2 0.040 97.3 0.142

Total characterized 8.3 0.003 11.9 0.005 4.8 0.007

Total extractable 117 0.042 107 0.045 102 0.149

Unextractable (PES) 2.8 0.001 2.4 0.001 1.4 0.002

Accountability 1 119 110 103

1 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis) * 100.



### Rice

Two studies were conducted to investigate the nature of residue in rice: one with three foliar

applications of radiolabeled sulfoxaflor to rice plants and a separate study consisting of one

soil application of radiolabeled sulfoxaflor near growing rice plants. Rice plants were grown

outside using standard agricultural practices. The 14C

- sulfoxaflor was applied to rice plants

( Japonica) by foliar application consisting of 3 treatments at 227, 205, and 145 g a.i./ha at 49

-

and 28

- day retreatment intervals using a hand

- held sprayer, for a total rate of 578 g a.i./ha.

The first application occurred 41 days after planting. Immat ure plants were collected 14 days

after the first application. Grain and straw were separated, and mature grain was separated

into white rice and hulls.

Following three foliar applications of sulfoxaflor, parent sulfoxaflor was the major

metabolite in ma ture rice matrices (33

- 44% TRR). Metabolite X11719474 was found at

lower levels (7

- 10% TRR), as was the glucose conjugate of X11721061 (5

- 11% TRR). Free

X11721061 (2

- 4% TRR) was also found in the mature rice matrices. The immature rice

plants contained mostly parent sulfoxaflor (74% TRR) and correspondingly lower levels of

metabolites. The glucose plus malonyl conjugate of X11721061 was only detected in mature

rice straw (3% TRR). Table 1 2 summarizes the metabolites identified and their

concentrations in rice plants that were treated with sulfoxaflor using foliar applications.

Table 1 2 : Summary of Characterization and Identification of Radioactive Residues in Rice

Matrices Following Foliar Application of Radiolabeled Sulfoxaflor at 578 g a.i./ha.

Compound Immature plant, 14

days after treatment Mature Straw Mature Hulls Mature White

Rice

TRRs = 2.841 ppm TRRs = 5.627 ppm TRRs = 3.669 ppm TRRs = 0.243

ppm

% TRR ppm % TRR ppm % TRR ppm %

TRR ppm

Sulfoxaflor 73.7 2.095 43.9 2.472 33.4 1.226 35.4 0.086

X11719474 7.4 0.210 9.7 0.547 7.3 0.267 8.6 0.021

Glucose conjugate

of X11721061 2.1 0.059 5.4 0.301 7.0 0.256 11.1 0.027

Glucose plus

malonyl conjugate

of X11721061 nd nd 2.9 0.164 nd nd nd ndSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 24 of 141 Table 1 2 : Summary of Characterization and Identification of Radioactive Residues in Rice

Matrices Following Foliar Application of Radiolabeled Sulfoxaflor at 578 g a.i./ha.

Compound Immature plant, 14

days after treatment Mature Straw Mature Hulls Mature White

Rice

TRRs = 2.841 ppm TRRs = 5.627 ppm TRRs = 3.669 ppm TRRs = 0.243

ppm

% TRR ppm % TRR ppm % TRR ppm %

TRR ppm

X11721061 5.7 0.161 4.1 0.231 2.0 0.075 2.1 0.005

Total identified 88.9 2.525 66.0 3.715 49.7 1.824 57.2 0.139

Total characterized 11.9 0.338 33.6 1.892 39.4 1.444 41.6 0.101

Total extractable 101 2.863 99.7 5.607 89.1 3.268 98.8 0.240

Unextractable

(PES) 1 8.7 0.246 2.5 0.143 1.6 0.058 10.7 0.026

Accountability 2 109 102 90.7 110

1 Residues remaining after various solvent extractions



### . 2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis) * 100.



### For the soil application, 1 treatment at 474 g a.i./ha was applied at transplant. Soil treatment

was made by application of the test subst ance with a pipet into holes. Once the solution was

absorbed, rice plants at the 3

- 4 leaf stage were placed into the holes. Following this, the

plants were flooded. Immature rice plants were collected 14 and 28 days after the soil

application. Mature rice was collected 138 day s after the soil application. Grain and straw

were separated, and mature grain was separated into white rice and hulls.

After one soil application of sulfoxaflor, the major residue in the mature rice matrices was

metabolite X11719474 (31

- 40% TRR). No other metabolites were reported in white rice

grain, and relatively low levels of metabolite X11721061 (5

- 6% TRR) and its glucose

conjugate (5

- 6% TRR) oc curred in mature rice hulls and straw. Similar residue distributions

were reported in immature rice plants, although higher overall residue levels were obtained.

Additionally, low levels of the metabolite X11821639 (≤1% TRR) was reported in immature

rice plants. Table 1 3 summarizes the metabolites identified and their concentrations in rice

samples that were treated with sulfoxaflor using soil applications.

Table 1 3

. Summary of Characterization and Identification of Radioactive Residues in Rice

Matric es Following Soil Application of Radiolabeled Sulfoxaflor at 474 g a.i./ha.

Compound Immature plant, 14

days after treatment Mature Straw Mature Hulls Mature White

Rice

TRRs = 12.51 ppm TRRs = 1.794 ppm TRRs = 0.489 ppm TRRs = 0.049

ppm

% TRR ppm % TRR ppm % TRR ppm %

TRR ppm

Sulfoxaflor 3.7 0.463 nd nd nd nd nd nd

X11719474 55.5 6.948 31.1 0.558 40.3 0.197 36.7 0.018

Glucose conjugate

of X11721061 5.5 0.687 5.5 0.098 4.9 0.024 nd nd

Glucose plus

malonyl conjugate

of X11721061 1.8 0.221 nd nd nd nd nd nd

X11721061 1.8 0.229 6.3 0.113 5.3 0.026 <2.0 <0.001

Total identified 68.3 8.548 42.9 0.769 50.5 0.247 38.8 0.019

Total characterized 20.8 2.597 44.9 0.805 39.9 0.195 46.9 0.023

Total extractable 89.1 11.145 87.7 1.574 90.4 0.442 85.7 0.042Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 25 of 141 Table 1 3

. Summary of Characterization and Identification of Radioactive Residues in Rice

Matric es Following Soil Application of Radiolabeled Sulfoxaflor at 474 g a.i./ha.

Compound Immature plant, 14

days after treatment Mature Straw Mature Hulls Mature White

Rice

TRRs = 12.51 ppm TRRs = 1.794 ppm TRRs = 0.489 ppm TRRs = 0.049

ppm

% TRR ppm % TRR ppm % TRR ppm %

TRR ppm

Unextractable

(PES) 1 11.5 1.435 12.7 0.227 4.1 0.020 16.3 0.008

Accountability 2 101 100 94.5 102

1 Residues remaining after various solvent extractions, except for mature straw and hulls where residues

r emaining reflect the bound residue determination.

2 Accountability = (Total extractable + Total unextractable)/(TRRs from combustion analysis) * 100.



### Conclusions : Metabolism of sulfoxaflor was similar in all four crops: oxidation of the

cyano

- carbon bond to form X11719474 and loss of th e sulfur side chain to form X11721061.

X117211061 is then conjugated with glucose, which may then be conjugated with malonic

acid. Metabolism continues through natural incorporation of the radiolabeled carbon into

natural plant constituents, such as lign in and starch. A very minor pathway (<1%) included

degradation of the X11719474 urea side chain to form X1159540 and X11479457, which are

further reduced to give X11721061. The primary difference noted between the foliar and soil

metabolism studies was t hat parent sulfoxaflor was the predominant residue found from

foliar applications, while X11719474 was the major residue found in soil application

metabolism studies. Figure 4 p resents the proposed metabolic profile of sulfoxaflor in plants.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 26 of 141 Figure 4 . Proposed metabolic pathway of sulfoxaflor in plants.

Livestock Metabolism

M etabolism of sulfoxaflor ( XDE

- 208 ) , and the plant and soil metabolite X11719474, have

been studied in both ruminants and poultry. T he animals were orally dosed at levels

equivalent to 12

- 14 mg/kg dry feed in the diet for periods of either 5 (goats) or 7 (hens)

consecutive days wit h radiol abeled test materials. The anticipated dietary burdens for

sulfoxaflor are 2.3 ppm for dairy cows and 0.056 ppm for hens. 

### N S

N O

N O

F

F F

X11719474

N O H

F

F F



### X11721061

Natural incorporation glucose conjugate (X11863595)

and

glucose plus malonyl conjugate

(X11889781) N S

N O N F

F F

XDE-208Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 27 of 141 For goats dosed with XDE

- 208, residue levels were highest in liver, kidney, muscl e, and

milk, and lower in fat. Total residue levels in the eggs and edible tissues from hens dosed

with XDE

- 208 were lower than the levels observed in the ruminant. Residues in milk and

eggs appeared to have reached a plateau during dosing. The livestock metabolism studies

suggest rapid absorption and el imination of the 14 

### C

- XDE

- 208. The p arent and/or metabolites

were not observed to accumulate in fatty tissues. The majority of the residue in milk, eggs,

and edible tissues consisted of the parent compound , generally >80% of the residue except in

liver. Approximately 60% of the ruminant liver residue was identified as XDE

- 208 while

18% was identified as X11596066 (68% of the hen liver residue was identified as XDE

- 208

while 1 4 % was identified as X11596066 , which is consistent with the rat metabolism study ).

X11719540 was detected at low levels in most of the edible samples (<2% of the TRR in the

ruminant or ca. 8 % of the TRR in the hens) and X11721061 was detected in the ruminant

liver (3.3% of the TRR). No other component was detected at levels greater than 10 % of the

total radioactive residue level. The metabolic pathway is qualitatively similar in rats.

Figure 5 . The metabolic pathway of XDE

- 208 in animals is shown below.

N S

N O N F

F F



### XDE

- 208

N S O

O F

F

F



### X11519540

N O H

F

F F



### X11721061Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 28 of 141 N F

F

F



### X11596066

Since X11719474 was observed as a plant metabolite, yet was not detected in either the

ruminant or poultry metabolism studies , separate animal metabolism studies were conducted

with 14 

### C

- X 11719474. Residues of X11719474, like XDE

- 208, also did not accumulate in

fatty tissues, with almost 35% of the administered dose recovered in the goat urine and 4% in

the feces . No metabolism of X11719474 was obse rved in animals, with generally greater

than 90% of the residue in edible samples identified as X11719474. The major residue in

animals fed with parent 14 

### C

- XDE

- 208 or 14 

### C

- X11719474 was found to be the unchanged

XDE

- 208 or X11719474 (not from the parent) . X11596066 was found at trace levels onl y in

liver.

Poultry Metabolism (Laying Hens)

Laying hens were dosed with 12.2 mg/kg dry feed (10.9 mg/kg fresh feed) of 14C

- XDE

- 208.

The XDE

- 208 dietary burden for poultry was estimated, by the registrant, to be 0.7 mg/kg

(there was one very high canola sample, assessed as an outlier, among other f actors). HED

estimates the dietary burden to be 0.056 ppm for the parent and 0.01 ppm for the X11719474

metabolite.

The majority of the recovered radioactivity was eliminated in the excreta and cage rinse,

accounting for 37.1% and 5.5 % of the administer ed dose, respectively. The tissue with the

lowest residue was fat (0.011 % dose, 0.025 ppm). Skin with subcutaneous fat contained

0.036 ppm (0.047 % dose), leg muscle 0.059 ppm (0.14 % dose), breast muscle 0.062 ppm

(0.13 % dose), and liver 0.139 ppm (0.06 5 % dose). The TRRs in excreta appear to have

reached a peak at day 5 (5.378 ppm, 12.5 % dose). Low levels of radioactivity were detected

in eggs, which peaked at day 6. A total of 0.14% of the administered dose was recovered in

the eggs. The total recover y of radioactivity in the study was 43.1% of the administered dose.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 29 of 141 Table 14 . Distribution of the Radioactive Residue in Laying Hens Matrices Dosed with 14 

### C

sulfoxaflor (normalized).

Metabolite

Fraction Muscle

Leg Muscle

Breast Liver Skin and

Subcutaneous

Fat Fat Excreta (Day 6)

TRR=0.059 ppm TRR=0.062 ppm TRR=0.139 ppm TRR=0.036 ppm TRR= 0.025 ppm TRR=4.425 ppm

%

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm

Hexane

Extract nx nx nx nx n x nx 13.9 0.005 48.0 0.012 nx nx

ACN/H 2 O

Extract 98.3 0.058 95.2 0.059 110 0.153 86.1 0.031 60.0 0.015 128 5.672

Sulfoxaflor 94.9 0.056 90.3 0.056 67.6 0.094 83.3 0.030 92.0 0.023 125 5.530

X11519540 1.7 0.001 3.2 0.002 3.6 0.005 nd nd 8.0 0.002 nd nd

X11596066 nd nd nd nd 14.4 0.020 nd nd nd nd nd nd

Unidentified

Peaks 3.4 0.002 6.5 0.004 13.0 0.018 16.7 0.006 4.0 <0.001 nd nd

Post

Extraction

Solids (PES) 1.7 <0.001 1.6 0.001 7.2 0.010 2.8 0.001 4.0 <0.001 2.2 0.097



### nx: not extracted; nd: not detectable

LAYING HENS (DOSED WITH 14C

- X11719474)

The target dose rate was 10 mg/kg feed based on the average feed consumption during the

acclimation period, however, the hens consumed less than expected, resulting in an actual

dose of 11.8 mg/kg for the 14C

- X11719 474 dosed animals. The dose rate was equivalent to

13.3 mg/kg dry feed, ca. a 1300X feed rate when compared to the estimated dietary burden

(0.01 mg/kg in feed).

The majority of the recovered dose, 92%, was excreted with 94% of the dose was recovered

from the 14C

- X11719474 dosed animals . Blood and the remaining carcasses were not

evaluated. Overall, absorption and elimination of the 14C

- X11719474 was rapid

.

For egg, muscle, liver, skin with fat, and fat, the extractable TRRs were >94%. Over 7 days

of do sing, 93% of the applied dose was eliminated in feces and 0.27 % in cage washes.

In eggs, the TRRs plateau at 0.275 ppm by day 4. The major residue in eggs on day 6 was

X11719474 (101 % TRR, 0.281ppm). The TRRs in muscle were 0.243 and 0.258 ppm in leg

an d breast, respectively, and the major residue was X11719474 (98.5

- 101% TRR; 0.245

- 0.254 ppm). The major residue was also X11719474 in liver (96.2 % TRR; 0.277 ppm), in

skin plus subcutaneous fat (104% TRR; 0.099 ppm), and in fat (86.5% TRR; 0.032 ppm).

Re sidue levels are summarized in Tables 15 and 1 6.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 30 of 141 Table 15 : Summary of Characterization and Identification of Radioactive Residues in Hen

Matrices when Dosed with 14 

### C

- X11719474

.

Compound Muscle

Leg Muscle

Breast Liver Skin with Subcutaneous

Fat Fat

TRR=0.243

ppm TRR=0.258 ppm TRR=0.288 ppm TRR=0.095 ppm TRR=0.037 ppm

%

TRR ppm %

TRR ppm % TRR ppm % TRR ppm % TRR

ppm

X11719474 101 0.245 98.5 0.254 96.2 0.277 104 0.099 86.5 0.032

Unidentified

- - 1.6 0.004 3.8 0.011

- - 13.5 0.005

Total Identified 101 0.245 98.5 0.254 96.2 0.277 104 0.099 86.5 0.032

Total

Characterized - - 1.6 0.004 3.8 0.011 2.1 0.002 8.1 0.003

Total Extracted 101 0.245 98.5 0.254 96.2 0.277 106 0.101 94.6 0.035

Unextractable

PES 1.2 0.003 1.6 0.004 0.4 0.001 2.1 0.002 5.4 0.002

Accountability 102 100 96.5 108 100



### Table 16 : Summary of Charact erization and Identification of

Radioactive Residues in Eggs from Laying Hens when Dosed with

14 

### C

- X11719474

.

Compound Egg

(Day 1) Egg

(Day 6) Egg

(Day 7)

TRR=0. 151 ppm TRR=0.278 ppm TRR=0.274 ppm

% TRR ppm % TRR ppm % TRR ppm

X11719474 101 0.153 101 0.281 103 0.283

Unidentified

- - 0.7 0.002

- -

Total Identified 101 0.153 101 0.281 103 0.283

Total

Characterized 1

- 0.7 0.002

- -

Total Extracted 101 0.153 98.9 0.275 103 0.282

Unextractable PES 2.7 0.004 1.4 0.004 1.5 0.004

Accountability 104 100 104



### Figure 6

. Proposed Metabolic Profile of X11719474 in Laying Hens

N S

N O

F

3 C N H

2

O



## Not Metabolized N S

N O

F

3 C N H

2

O



## Not MetabolizedSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 31 of 141 Lactating Goat Metabolism

14C

- Sulfoxaflor was administered orally to one lactating goat (LaMancha) at a nominal dose

level of 10 mg/kg bw/day for 5 days following a 12 day acclimation period. The actual dose

administered, based on food consumption during the study period, was 12.2 ppm. The

estimated dairy cow dietary burden is 2.27 ppm f or sulfoxaflor and1.4 ppm for the

X11719474 metabolite.

Milk and urine were collected twice a day, and feces were collected daily just prior to dose

administration. Sacrifice occurred 6 hours after administration of the last dose. Muscle (loin

and flank), liver, kidney, fat (subcutaneous, omental, renal), and the gastrointestinal tract

with contents were collected. The TRR levels were determined in milk and urine by LSC, in

fat by heat solubilization followed by LSC, and in tissues and feces by oxidative c ombustion.

For milk, muscle, liver, kidney, and fat, the extractable TRRs were ≥96 %. Over 5 days of

dosing, 41.0 % of the applied dose was eliminated in urine and 13.3 % in feces.

In milk, the TRRs had peaked at 0.224 ppm by day 4. The major residue in milk on day 4

was sulfoxaflor (94.2 % TRR; 0.211 ppm). The TRRs in muscle were 0.197 and 0.205 ppm

in loin and flank, respectively, and the major residue was sulfoxaflor (96.1

- 97.0 % TRR;

0.191

- 0.197 ppm). For liver, the TRR was 0.518 ppm, and the major residues were

sulfoxaflor (60.4 % TRR; 0.313 ppm), and X11596066 (18.3 % TRR; 0.095 ppm). The TRRs

in kidney and fat were 0.435 ppm and 0.074

- 0.088 ppm, respectively, and the major resi due

was also sulfoxaflor in kidney (89.0 % TRR; 0.387 ppm) and fat (94.3

- 97.3 % TRR; 0.070

- 0.083 ppm).

The major residue in all goat matrices was sulfoxaflor (60.4

- 97.3 % TRR, 0.070

- 0.387 ppm).

Muscle had no other identifiable radioactive residues. The m etabolite X11519540 was

identified in milk (~ 1% TRR, 0.002 ppm), liver (1.7 % TRR, 0.009 ppm), kidney (1.2%

TRR, 0.005 ppm), and fat (<1.1

- 1.4 % TRRs, <0.001 ppm). Metabolites X11721061 (3.3%

TRR, 0.017 ppm) and X11596066 (18.3% TRR, 0.095 ppm) were only identified in liver.

The applied TRRs were rapidly eliminated (41.0% in urine and 13.3% in feces) and did not

accumulate in fat tissues.

Half of the administered 14C

- dose (54%

- dose) was eliminated in the urine and feces (41%

and 13% of dose, respectively) . It was noted in the study report that some urine from day 5

was lost when the animal was being transported for sacrifice. In milk, 3.69% of the dose was

recovered, and in edible tissues (muscle, kidney, liver, and fat) 1.34% of the dose was

recovered. T he TRR levels in urine, feces, and milk appeared to reach a plateau by days 3

- 4.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 32 of 141 Figure 7 . Pharmacokinetics of 14C XDE

- 208 in the Milk of Lactating Goats

Urine and Feces: In urine, sulfoxaflor was pre sent at 49 % of the TRR (0.509 ppm) within

12 hours of the first dose, and increased to levels of 78

- 87 % of the TRRs (6.0

- 7.5 ppm) over

the 5 days of dosing. Three unidentified metabolites that were more polar than the parent

(0.7

- 33 % TRRs, 0.017

- 0.840 p pm) as well as X11721061 (0.9

- 14.0 % TRR, 0.070

- 0.350

ppm) were also eliminated in urine. Analysis of feces from day 3 showed that 114 % of the

TRR (1.080 ppm) was identified as sulfoxaflor and ~ 6 % of the TRR (0.055 ppm) was an

unidentified metabolite th at was more polar than parent. Milk TRR with Time

0.00 0.05 0.10 0.15 0.20 0.25 0.30 0.35

1 2 3 4 5 6

Time (days after dosing)TRR (mg/kg)Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 33 of 141 Table 17

. Summary of Characterization and Identification o 

### f Radioactive Residue s in Goat Matrices when Dosed with 14 

### C

- sulfoxoflor.

Compound Milk

(Day

- 4 am) Milk

(day

- 5 pm) Muscle

Loin Muscle

Flank Liver Kidney Fat

Subcutaneous Fat

Omental Fat

Renal

TRR=0.224 ppm TRR=0.199 ppm TRR=0.197 ppm TRR=0.205 ppm TRR=0.518 ppm TRR=0.435 ppm TRR=0.088 ppm TRR=0.074 ppm TRR=0.074 ppm

%

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm %

TRR ppm

Sulfoxaflor 94.2 0.211 94.0 0.187 97.0 0.191 96.1 0.197 60.4 0.313 89.0 0.387 94.3 0.083 97.3 0.072 94.6 0.070

X11721061

- - - - - - - - 3.3 0.017

- - - - - - - -

X11519540 0.9 0.002 1.0 0.002

- - - - 1.7 0.009 1.2 0.005 <1.1 <0.001

- - 1.4 <0.001

31.6 min. RT

- - - - - - - - 1.2 0.006 1.8 0.008 2.8 0.003 2.0 0.002 2.7 0.002

X11596066

- - - - - - - - 18.3 0.095

- - - - - - - -

Total Identified 95.1 0.213 95.0 0.189 97.0 0.191 96.1 0.197 83.8 0.434 90.1 0.392 95.5 0.084 97.3 0.072 96.0 0.071

Total

Characterized 7.1 0.016 7.0 0.014 0.5 0.001 0.5 0.001 25.9 0.134 5.1 0.030 4.6 0.004 4.1 0.003 2.7 0.002

Total Extracted 96.0 0.215 96.0 0.191 97.5 0.192 96.6 0.198 109.7 0.568 97.0 0.422 100 0.088 101.4 0.075 98.7 0.073

Unextractable PES

- - - - 2.5 0.005 2.0 0.004 8.1 0.042 2.8 0.012 1.1 0.001 <1.4 <0.001 <1.4 <0.001

Accountability 96.0 96.0 100 98.5 118 99.8 101 103 100

- not detectedSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 34 of 141 Lactating Goat (dosed with 14C

- X11719474)

14C

- X11719474 was administered orally to one lactating goat (LaMancha) at a nominal

dose level of 10 mg/kg bw/day for 5 days following a 12 day acclimation period. The

actual dose administered, based on food consumption during the study period, was 11.4

mg/kg bw/day. The estimated dairy cow dietary burden for the X11719474 metabolite is

1.4 ppm.

Milk samples were collected twice a day, urine was collected twice a day, and feces were

collected daily just before dose administration. Sacrifice occurred ~6 hours after

administration of the last dose. Muscle (loin and flank), liver, kidney, fat (subcutaneous,

omental, renal), and the gastrointestinal tract with contents were collected. The TRR

levels were determined in milk and urine by LSC, in fat by heat solubilization followed

by LSC, and in tissues and feces by oxidative combustion.

For milk, muscle, liver, kidney, and fat, the extractable TRRs were >83 %. Over 5 days

of dosing, 34.8 % of the applied dose was eliminated in urine and 4.4 % in feces.

In milk, the TRRs had peaked at 0.145

- 0.173 ppm by days 3

- 4. The major residue in milk

on days 3

- 4 was X11719474 (90.1

- 97.9 % TRR; 0.141

- 0.165 ppm). The TRRs in muscle

were 0.131 and 0.123 ppm in loin and flank, respectively, and the major residue was

X11719474 (104

- 109 % TRR; 0.134

- 0.136 ppm). For liver, the TRR wa s 0.226 ppm, and

the major residue was X11719474 (107 % TRR; 0.242 ppm). The TRRs in kidney and fat

were 0.327 ppm and 0.014

- 0.038 ppm, respectively, and the major residue was also

X11719474 in kidney (108 % TRR; 0.352 ppm) and fat (71.4

- 94.7 % TRR; 0.010

- 0.036

ppm).

X11719474 was not metabolized in the lactating goat. The major residue in all goat

matrices was X11719474 (~71

- 108 % TRR, 0.010

- 0.352 ppm). There were no other

identifiable residues. The applied TRRs were rapidly eliminated (34.8 % in urine and 4.4

% in feces) and did not accumulate in fat tissues.

The overall recovery of the administered dose was ~59 %. A majority of the recovered

administered 14C

- dose (39.18%

- dose) was eliminated in the urine and feces (34.76 %

and 4.42% of dose, respectively). In milk, 1.14%

- dose was recovered, and in edible

tissues (muscle, kidney, liver, and fat) 0.65 %

- dose was recovered. The TRR levels in

urine and milk had reached a plateau by about days 3

- 4, and levels in feces had not

reached a plateau by day 5.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 35 of 141 Table 18

. Summary of Characterization and Identification o 

### f Radioactive

Residue s in Goat M ilk when Dosed with 14 

### C

- X11719474

.

Compound Milk

(day

- 3 am) Milk

(day

- 4 pm) Milk

(day 4 am) Milk

(day 5 pm)

TRR=0. 173 ppm TRR=0.162 ppm TRR=0.145 ppm TRR=0.151 ppm

% TRR ppm % TRR ppm % TRR ppm %

TRR ppm

X11719474 95.4 0.165 90.1 0.146 97.9 0.142 93.4 0.141

Total Identified 95.4 0.165 90.1 0.146 97.9 0.142 93.4 0.141

Total Characterized 2.3 0.004 3.7 0.006 4.8 0.007 4.0 0.006

Accountability 97.7 93.8 103 97.4Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 36 of 141 Table 19

. Summary of Characterization and Identification o 

### f Radioactive Residue s in Goat Tissues when Dosed with 14 

### C

- X11719474

.

Compound Muscle

Loin Muscle

Flank Liver Kidney Fat

Subcutaneous Fat

Omental Fat

Renal

TRR=0.131 ppm TRR=0.123 ppm TRR=0.226 ppm TRR=0.327 ppm TRR=0.038 ppm TRR=0.014 ppm TRR=0.018 ppm

% TRR ppm % TRR ppm % TRR ppm % TRR ppm % TRR ppm % TRR ppm % TRR ppm

X11719474 104 0.136 109 0.134 107 0.242 108 0.352 94.7 0.036 71.4 0.010 72.2 0.013

Total Identified 104 0.136 109 0.134 107 0.242 108 0.352 94.7 0.036 71.4 0.010 72.2 0.013

Total

Characterized - - - - - - - - 2.6 0.001 14.3 0.002 11.1 0.002

Total Extracted 106 0.139 109 0.134 107 0.242 108 0.352 97.4 0.037 85.7 0.012 83.3 0.015

Unextractable PES 3.1 0.004 4.1 0.005 2.7 0.006 1.2 0.004 2.6 0.001 7.1 <0.001 5.6 <0.00

1

Accountability 109 113 110 109 100 92.9 88.9Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 37 of 141 Residue Analytical Methods (860.1340)

S ulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B5: Methods of Analysis



### The enforcement and data collection methods are identical except for the solid

- phase extraction

( SPE ) step. The enforcement method involves off

- line SPE while the data collection method

made use of on

- line SPE.

High performance liquid chromatographic ( HPLC ) methods with positive

- ion electro spray (ESI)

tandem mass spectrometry (LC/MS/MS) were developed for data collection and enforcement of

sulfoxaflor residues and the two metabolites X11719474 and X11721061. Method 091116 was

developed for plant commodities, and Method 091188 was developed for a nimal commodities.

Successful validation of both methods was reported by the registrant and by an independent

laboratory. Additionally, successful radiovalidation was reported for both methods. The lowest

level of method validation (LLMV) was 0.01 mg/kg for sulfoxaflor, X11719474, and

X11721061 in all matrices. The limit of detection (LOD) was reported as 0.003 mg/kg for all

three analytes in all matrices.

Enforcement method in plant matrices

A brief description of Method 091116 follows. Residues of sulfoxaflor and its metabolites were

extracted from the sample matrices by homogenizing and shaking with an acetonitrile/water

(80:20 v/v) solution. One hundred and twenty

- five micro liters of a glycerin/methanol (10:90

v/v) solution containing 0.10 μg/mL of a stable

- isotope internal standard mixture were added to a

500

- μL aliquot of the extraction solution which was then concentrated to remove the organic

solvent. The sample was reconstituted with 500 μL of 0.01 N sodium hydroxide solution and

heated at 50 °C for 30 minutes to hydrolyze base

- labile conjugates. The mixture was then

acidified with 125 μL of a 0.25% formic acid solution followed by the addition of 250 μL of a 10

mg/mL glucosidase from Aspergillus Niger solution. The sample was then incubat ed at 50 °C

for 90 minutes to hydrolyze glucosidase

- labile conjugates. The solution was purified using a

reverse

- phase polymeric solid

- phase extraction (SPE) cartridge. After elution from the SPE

cartridge with an acetonitrile/water (80:20 v/v) solution c ontaining 0.1% formic acid, the sample

was then analyzed by LC/MS/MS. A C18 type column (reverse phase) was used, employing

gradient elution using two mobile phases, i.e., acetonitrile containing 0.01% formic acid and

water containing 0.01% formic acid.

The quantitative determination was carried out with internal and external standardization. The

internal standards were a mixture of stable

- isotopes (D3

- sulfoxaflor; D3

- sulfoxaflor urea; D3

- sulfoxaflor alcohol). The external standards were a mixture of sul foxaflor (MW = 277),

X11719474 (MW = 295), and X11721061 (MW = 191).

LC/MS/MS affords a highly

- specific method for both the quantitation and confirmation of

residue identity by retention time matching in conjunction with monitoring the MS/MS ion

transit ions for each analyte as follows: sulfoxaflor at m/z 278.09/174.00 for quantitation and m/z

278.09/154.00 for confirmation; X11719474 at m/z 296.00/174.00 for quantitation and m/z

296.00/104.90 for confirmation for all matrices except orange, lemon and soy bean, in which ionSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 38 of 141 transition m/z 296.00/104.10 was used for confirmation; and X11721061 at m/z 191.87/129.90

for quantitation and m/z 191.87/78.00 for confirmation.

V alidation data for the LC/MS/MS analytical Method 091116 for the determination of residu es

of sulfoxaflor, X11719474, and X11721061 was submitted for: the acidic crops/processed

commodity (whole orange and lemon fruits; orange juice), dry crops (wheat grain and straw; dry

bean grain), wet crops (potato tuber; peach whole fruit; grape), and o ily crops (soybean seed;

almond nutmeat; canola seed)

.

An independent laboratory validation (ILV) of Method 091116 was conducted . A ll the

recoveries were within acceptable ranges and demonstrate a successful independent laboratory

validation of Method 091116.

Data generation methods in plants

A data generation method for plants was developed for determining residues of sulfoxaflor,

X11719474, and X11721061 in/on acidic crops (whole orange fruit, whole lemon fruit, and

orange juice), dry crops (wheat g rain, wheat straw, and dry bean grain), wet crops (potato tuber,

peach whole fruit, and grape), and oily crops (soybean seed, almond nutmeat, and canola seed).

Briefly, residues of sulfoxaflor and its metabolites were extracted from the sample matrices by

homogenizing and shaking with an acetonitrile/water (80:20 v/v) solution. Fifty micro liters of a

glycerin/methanol (10:90 v/v) solution containing 0.10 μg/mL of a stable

- isotope internal

standard mixture were added to a 200

- μL aliquot of the extraction s olution which was then

concentrated to remove the organic solvent. The sample was reconstituted with 200 μL of 0.01 N

sodium hydroxide solution and heated at 50°C for 30 minutes to hydrolyze base

- labile

conjugates. The mixture was then acidified with 50 μ L of a 0.25% formic acid solution followed

by the addition of 100 μL of a 10 mg/mL glucosidase from Aspergillus Niger solution. The

sample was then incubated at 50 °C for 90 minutes to hydrolyze glucosidase

- labile conjugates.

The solution was purified usin g an on

- line reverse

- phase polymeric solid

- phase extraction (SPE)

cartridge and then analyzed by liquid chromatography with positive

- ion electro spray tandem

mass spectrometry (LC/MS/MS). A C18 type column (reverse phase) was used, employing

gradient elut ion using two mobile phases, i.e., acetonitrile containing 0.01% formic acid and

water containing 0.01% formic acid. The method is similar to the proposed enforcement

method, except that the SPE is on

- line for data gathering.

T he data generating method h as been adequately validated on a diverse set of crops. A second

plant method validation report for the data generating method was submitted.

Enforcement m ethod in a nimal matrices

LC/MS/MS method 091188 was submitted for determining residues of sulfo xaflor , X11719474,

and X11721061 in animal matrices (bovine cream, milk, muscle, liver, kidney, and fat; and in

poultry eggs, muscle, liver, and fat), along with validation data.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 39 of 141 This method separately determines residues of sulfoxaflor, X11719474, and X 11721061 in

animal matrices (milk, eggs, and bovine/poultry tissues).

For each matrix, samples are homogenized and residues are extracted one time from 1.0 g

samples with an acetonitrile/water (80:20) solution. Following centrifugation, the resulting

extract is centrifuged, evaporated, and reconstituted in 0.01 N hydrochlori c acid. The sample is

then cleaned

- up using an SPE column. The SPE column is washed with 0.01 N hydrochloric acid

and the residues are eluted with acetonitrile/water/formic acid (80/20/0.1). After adding the

internal standard (see below), and reconstitutin g in acetonitrile/water/formic acid (80/20/0.1),

residues are analyzed by HPLC with positive

- ion electro spray (ESI) tandem mass spectrometry

(LC/MS/MS). A Phenomenex Synergi Hydro RP (reverse phase) column is used, employing

gradient elution using two mobile phases, i.e., acetonitrile containing 0.01% formic acid and

water containing 0.01% formic acid.

The quantitative determination was carried out with internal and external standardization. The

internal standards were a mixture of stable

- isotopes (D 3

- sulfoxaflor; D3

- sulfoxaflor urea; D3

- sulfoxaflor alcohol). The external standards were a mixture of sulfoxaflor, X11719474, and

X11721061.

Data generation methods for animal matrices

Ruminants and Poultry

- A data generation method for poultry commodit ies was submitted. This

method separately determines residues of sulfoxaflor, X11719474, and X11721061 in poultry

tissues (fat, muscle, and liver) and eggs.

For each matrix, residues are homogenized and extracted one time from 1.0 g samples with an

aceton itrile/water (80:20) solution. Following centrifugation, the resulting extract is cleaned up

by on

- line SPE. The SPE cartridge is washed with water, and the residues are eluted with

acetonitrile/water/formic acid (80/20/0.1) onto a reverse phase analytical column. Residues are

analyzed by LC/MS/MS. The mobile phase is acetontrile and water, each containing 0.10 %

formic acid

, using gradient elution

. The quantitative determination was carried out with internal

and external standardization. The internal stand ards were a mixture of stable

- isotopes (D3

- sulfoxaflor; D3

- sulfoxaflor urea; D3

- sulfoxaflor alcohol). The external standards were a mixture

of sulfoxaflor (MW = 277), X11719474 (MW = 295), and X11721061. (MW = 191).

The LC/MS/MS method developed for deter mining residues of sulfoxaflor, X11719474, and

X11721061 in ruminant and poultry tissues , including eggs and milk, has a validated LOQ of

0.01 ppm for each analyte in each matrix. Recoveries were within the generally recognized

acceptable range (70

- 120 ) ex cept for two cream samples.

Radiovalidation of enforcement methods for plants and animal matrices

Data were submitted for the radiovalidation of the proposed enforcement methods 091116 and

091188 for plant and animal commodities, respectively, where samp les from the tomato pea,

lettuce, rice, and ruminant metabolism studies were analyzed for sulfoxaflor, X11719474, and

X1 1721061 by the two methods

.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 40 of 141 Conclusions : The generally good agreement between the results from the metabolism study and

the proposed en forcement methods (Method 091116 for plants and 091188 for animals)

demonstrates successful radiovalidation of the analytical method and provides assurance that the

enforcement methods are capable of extracting bioincurred residues of interest from plant and

animal commodities. It is also noted that the same acetonitrile/water (80:20) mixture was used

for extr action in the plant and animal metabolism studies , and is used in the proposed

enforcement methods

.

Multiresidue Methods (860.1360)

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B5: Methods of Analysis



### The FDA Multi

- Residue Method Test guidelines , as described in the Pesticide Analytical

Manual (PAM)

, are not applicable for the analysis of sulfo xaflor, due to low recoveries.

Sulfoxaflor only slightly fluoresced and is not suitable for Protocol A. Sulfoxaflor is not

recovered through fluorisil and is not suitable for analysis using Protocol D, E, or F. Sulfoxaflor

analysis using Protocol C has low recoveries.

Note: There are similarities between the German DFG S19 method and the proposed

enforcement method (Method 091116). It is expected that labs using this method would obtain

satisfactory results for sulfoxaflor residues using this method.

Storage Stability (860.1380)

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B7



### Dow AgroSciences, LLC has submitted the results of a 24

- month storage stability study with

sulfoxaflor in orange whole fruit, peach whole fruit, wheat grain, and soybean seed. The crops

selected for frozen storage stability of residues represent the four European Union commodity

categories ( high acid content, high water content, dry, and high fat content). Untreated samples

of each commodity were homogenized and spiked separately ( different samples for the parent

and the two metabolites) with sulfoxaflor and metabolites X11719474 and X11721061 at 0.10

ppm. Samples were placed in frozen storage at ca.

- 20oC and analyzed at storage intervals of 0,

30, 60, 182, 288, 375, 548, and 680 days.

Samples were analyzed for residues of sulfoxaflor and its metabolite s X11719474 and

X11721061 using a liquid chromatographic system with tandem mass spectrometers

(LC/MS/MS), Dow AgroSciences Methods 091116 (all storage intervals except 12

- , 18

- and 22

- month period s ) and 091031 (12

- , 18

- and 22

- month periods). The limit o f quantitation (LOQ)

for each analyte was 0.010 ppm.

Conclusions : The submitted storage stability results indicate that residues of sulfoxaflor,

X11719474, and X11721061 are stable in frozen storage for at least 680 days in plant matrices

and at least 9 weeks in livestock commodities. These intervals are adequate to cover the sample

storage intervals in the plant magnitude of the residue studies and the animal feeding studies.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 41 of 141 Water, Fish, and Irrigated Crops (860.1400)

The proposed uses are not direc tly relevant to this guideline topic. However, application of

sulfoxaflor could result in residues in surface water bodies. Sulfoxaflor is soluble in water ( 570

mg/L at 20 0 

### C ) and is r elative ly stab le to biodegradation in aquatic systems , i.e., it is stable to

hydrolysis

, and aqueous photolysis is not a major route of degradation

. These properties indicate

that sulfoxaflor might end up in fish tissues. However, i n the aerobic soil system, sulfoxaflor

degrades rather quickly to its major degradate X

- 4 74 (90 th 

### percentile t1⁄2= 0.4 days, range of <0.1

to 0.6 days). In eight US and EU soils, sulfoxaflor r esidues were at nondetectable levels within

one day in one soil, 3

- 4 days in five soils, and 7

- 14 days in two soils. The log K O/W 

### for

sulfoxaflor is 0.802 at pH 7

, which suggests that sulfoxaflor will not partition into fat tissue

. In

addition, the livestock metabolism and feeding studies all confirm that sulfoxaflor residues do

not partition into the fat and do not bioaccumulate in livestock tissue

. It is for these reasons that

sulfoxaflor residues in fish are not expected.

Catfish are bottom feeders and residues in catfish serve as a marker for pesticide residues. The

USDA Pesticide Data Program (PDP) does not have information for sulfoxaflor residu es in

catfish since it is a new chemical.

Food Handling (860.1460)

There are no proposed uses for which this guideline topic is relevant.

Meat, Milk, Poultry, and Eggs (860.1480)

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B7

ROCKS Reference List



### Sulfoxaflor is being proposed for use on numerous commodities that are significant livestock

feed stuffs , including the following: almond hulls, carrot cu lls; citrus pulp, dried; potato culls and

processed waste; sugar beet, molasses; soybean seed, forage, hay, meal, and hulls; wet apple

pomace; wheat grain, forage, hay, and straw; barley grain, forage, hay, and straw; aspirated grain

fractions; canola meal ; and cotton seed, meal, hulls, and gin byproducts. T here is the potential

for transfer of residues to livestock commodities, and the registrant conducted both dairy cattle

and poultry (laying hen) feeding studies.

Poultry

Sixty Lohman laying hens (12 hens/dosing and control group) were administered gelatin

capsules containing su l foxaflor, X11719474, and X11721061 for 29 or 30 con secutive days

. The

two m etabolites were included with parent compound in order to account for the formation of

these compoun ds in the treated RACs and associated commodities used as livestock feed items.

The target and actual dosing rates were as follows in Table 20

.

Table 20 . Dosing rates used in the poultry feeding study.

Target Dose (ppm) Actual Dose (ppm)a

Sulfoxaflor X11719474 X11721061 Sulfoxaflor X11719474 X11721061Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 42 of 141 0.14 0.01 0.0225 0.145 0.0103 0.023

0.70 0.04 0.09 0.757 0.043 0.097

2.1 0.12 0.27 2.096 0.120 0.269

10.5 0.60 1.35 10.70 0.611 1.375

a Based on actual feed consumption.

Eggs were collected daily during the dosing period and analyzed for sulfoxaflor and its two

metabolites. On day 29 after the first dose, the hens were sacrificed and liver, fat, muscle (leg

and breast) , and overlaying skin together with any associated fat were collected for analysis.

Additionally, thirty

- six separate laying hens were administered sulfoxaflor at 10.5 mg/kg for 28

consecutive days in order to investigate the depuration of sulfoxaflor and its metabolite in eggs

and tissues. The depuration per iod was 21 days. Eggs were collected and analyzed at 10 time

intervals during the depuration period, while other tissue samples were analyzed four time s

during depuration.

Tissue and egg samples were analyzed using LC/MS/MS M ethod 091188 (LOQ of 0.01 mg/kg

and LOD of 0.003 mg/kg). Adequate concurrent storage stability data were submitted with the

feeding study to support the storage conditions and durations of all samples.

Table 2 1 summarizes the concentration of sulfoxaflor and its metabolites in egg s and poultry

tissues at the four dosing levels administered. In eggs, quantifiable residues of sulfoxaflor were

observed at all dose levels except the lowest dose level. Residues of metabolite X11719474

were below the LOQ in eggs at all dose levels exce pt the highest dose level . R esidues of the

metabolite X11721061 were below the LOQ in eggs at all dose levels and sampling intervals.

Residues of sulfoxaflor and metabolite X11719474 in eggs reached a plateau within 10 days of

dosing. Residues levels of sulfoxaflor

, after reaching a plateau

, ranged from <0.01 to 0.594 ppm

and were dependent on dose level. Residues levels of X11719474 ranged from 0.012

- 0.022 ppm

at the high dose level.

Quantifiable residues of sulfoxaflor transferred into liver at al l dose levels and into muscle and

fat at dose levels of 0.757 ppm and higher. In general residues were highest in liver and lowest

in fat. Residues of sulfoxaflor ranged from 0.012 to 1.193 ppm in liver, from 0.025 to 0.659 ppm

in muscle, and from 0.011 to 0.184 ppm in fat. Quantifiable residues of metabolite X11719474

were observed in liver (0.021

- 0.026 ppm) and muscle (0.013

- 0.023 ppm) at the highest dose

level only. Quantifiable residues of metabolite X11721061 were observed only in liver at the

two highest dose levels, ranging from 0.016 to 0.088 ppm.

Depuration data at the high dose level demonstrates that residues levels declined in eggs and all

tissues following dosing cessation. In eggs, sulfoxaflor residues fell by approximately an order

of magnitude after 6 days of depuration. Similar large residue reductions were observed in other

poultry tissues. All residues were below the LOQ of 0.01 ppm following 21 days of depuration.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 43 of 141 Table 2 1

. Summary of Residue Data for Eggs and Tissues from the Poultry Feeding Study

with Sulfoxaflor, X11719474 and X11721061.

Analyte/

Matrix Dose Level

(ppm) Residues (ppm) a



### n Minimum Maximum Median Mean Std. D ev.

Sulfoxaflor

Eggs 0.145 24 <0.01 <0.01 0.01 0.01 NA

0.757 24 0.020 0.059 0.031 0.031 0.007

2.096 24 0.055 0.099 0.081 0.080 0.011

10.7 48 0.220 0.594 0.423 0.424 0.075

Muscle 0.145 3 <0.01 <0.01 0.01 0.01 NA

0.757 3 0.025 0.042 0.035 0.034 0.009

2.096 3 0.073 0.109 0.086 0.089 0.018

10.7 3 0.442 0.659 0.448 0.516 0.124

Liver 0.145 3 0.012 0.028 0.015 0.018 0.009

0.757 3 0.052 0.150 0.110 0.104 0.049

2.096 3 0.153 0.232 0.171 0.185 0.041

10.7 3 1.111 1.193 1.118 1.141 0.045

Fat 0.145 3 <0.01 <0.01 0.01 0.01 NA

0.757 3 0.011 0.013 0.012 0.012 0.001

2.096 3 0.028 0.048 0.033 0.036 0.010

10.7 3 0.153 0.184 0.164 0.167 0.016

X11719474

Eggs b 0.0103 24 <0.01 <0.01 0.01 0.01 NA

0.043 24 < 0.01 <0.01 0.01 0.01 NA

0.120 24 <0.01 <0.01 0.01 0.01 NA

0.611 48 0.012 0.022 0.015 0.016 0.002

Muscle 0.0103 3 <0.01 <0.01 0.01 0.01 NA

0.043 3 <0.01 <0.01 0.01 0.01 NA

0.120 3 <0.01 <0.01 0.01 0.01 NA

0.611 3 0.013 0.023 0.018 0.018 0.005

Liver 0.0103 3 <0.01 <0.01 0.01 0.01 NA

0.043 3 <0.01 <0.01 0.01 0.01 NA

0.120 3 <0.01 <0.01 0.01 0.01 NA

0.611 3 0.021 0.026 0.026 0.024 0.003

Fat 0.0103 3 <0.01 <0.01 0.01 0.01 NA

0.043 3 <0.01 <0.01 <0.01 <0.01 NA

0.120 3 <0.01 < 0.01 <0.01 <0.01 NA

0.611 3 <0.01 <0.01 <0.01 <0.01 NA

X11721061

Eggs 0.023 24 <0.01 <0.01 0.01 0.01 NA

0.097 24 <0.01 <0.01 0.01 0.01 NA

0.269 24 <0.01 <0.01 0.01 0.01 NASulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 44 of 141 Table 2 1

. Summary of Residue Data for Eggs and Tissues from the Poultry Feeding Study

with Sulfoxaflor, X11719474 and X11721061.

Analyte/

Matrix Dose Level

(ppm) Residues (ppm) a



### n Minimum Maximum Median Mean Std. D ev.

1.375 48 <0.01 <0.01 0.01 0.01 NA

Muscle 0.023 3 <0.01 <0.01 0.01 0.01 NA

0.097 3 <0.01 <0.01 0.01 0.01 NA

0.269 3 <0.01 <0.01 0.01 0.01 NA

1.375 3 <0.01 <0.01 0.01 0.01 NA

Liver 0.023 3 <0.01 <0.01 0.01 0.01 NA

0.097 3 <0.01 <0.01 0.01 0.01 NA

0.269 3 <0.01 0.020 0.016 0.015 0.005

1.375 3 0.065 0.088 0.066 0.073 0.013

Fat 0.023 3 <0.01 <0.01 0.01 0.01 NA

0.097 3 <0.01 <0.01 0.01 0.01 NA

0.269 3 <0.01 <0.01 0.01 0.01 NA

1.375 3 <0.01 0.011 0.010 0.010 0.001

NA = Not applicable. a The LOQ (0.01 ppm) was used for all residues reported as < LOQ in all calculations (mean, median, etc.). b Egg residues

are from samples collected from Study Days 10

- 27 or 28; residues were considered to have reached a plateau.



### Cattle

Nineteen lactating Friesian/Holstein dairy cows (Bos taurus; four cows/treatment group, four

treatment groups, and three control cows) were administered gelatin capsules containing

sulfoxaflor , X11719474, and X11721061 for 29 or 30 consecutive days. The m etabolites were

included with parent compound in order to account for the formation of these compounds in the

treated raw agricultural commodities and associated livestock feed items , i.e., they are significant

plant metabolites

. The target and actual dos ing rates were as follows in Table 22

.

Table 22 . Dosing rates used in the bovine feeding study.

Target Dose (ppm) Actual Dose (ppm)a

Sulfoxaflor X11719474 X11721061 Sulfoxaflor X11719474 X11721061

0.5 0.05 0.2 0.45 0.045 0.180

2.5 0.25 1.0 2.37 0.237 0.949

7.5 0.75 3.0 6.75 0.675 2.70

37.5 3.75 15.0 35.19 3.52 14.08

a Based on actual feed consumption.



### Milk was collected twice daily during the dosing period. The milk was kept separate and

analyzed. On D ay s 22 and 26, aliquots of milk were mechanically separated into cream and

skim milk fractions and analyzed. In a dditional, twelve cows were administered sulfoxaflor at

37.5 mg/kg for 28 consecutive days in order to investigate the depuration of sulfoxaflor and its

metabolite in milk and cow tissues over a 21

- day period

. Milk samples were collected and

analyzed at 10 intervals during the depuration period, while other tissue samples were analyzed

at four intervals during depuration. Cows from the four treat ment groups and the control groupSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 45 of 14 1 were sacrificed within 1

- 7 hours of receiving the final dose; cows from the depuration study

were sacrificed 3, 7, 14, and 21 days post

- dosing. The following tissue samples were collected

immediately after slaughter: mus cle (including hind leg or flank, loin, and diaphragm), liver

( sub sampled from several areas), kidney ( sub sampled from at least three areas of each kidney),

and fat (including mesenteric, subcutaneous, and renal). The samples were kept separate and

anal yzed/reported for each individual cow.

Tissue and milk samples were analyzed for residue by LC/MS/MS using M ethod 091188.

Adequate concurrent storage stability data were submitted with the feeding study to support the

storage conditions and durations of all samples.

Residues of sulfoxaflor and its major metabolites in milk and cow tissues are summarized in

Table 23 . Residues of sulfoxaflor transferred into milk, skim milk, and cream at all the dose

levels. Residues of metabolite X11719474 transferred into milk only at the two highe st dose

levels and into skim milk and cream at the highest dose level. Residues of metabolite

X11721061 were below the LOQ in milk, skim milk, and cream at all dose levels and sampling

intervals. Residues of sulfoxaflor and metabolite X11719474 reached a plateau in milk within 8

days of dosing. There was no evidence of preferential transfer of residues to skim milk or cream

from Study Days 22 and 26 . I n general, re sidues of sulfoxaflor were slightly lower in cream than

skin milk at all dose levels. For example, at the 2.37 ppm feeding level on day 26, residues of

sulfoxaflor in skim milk ranged from 0.067

– 0.114 ppm, while sulfoxaflor residues in cream

ranged from 0 .042

- 0.080 ppm.

In tissues, residues of sulfoxaflor transferred into muscle, fat, liver, and kidney at all dose levels.

Residues of metabolite X11719474 transferred into liver and kidney only at the two highest dose

levels, and transferred into muscle an d fat at the highest dose level only. Quantifiable residues of

metabolite X11721061 were observed only at the highest dose level in mu scle, fat, liver, and

kidney. Residues were generally highest in liver and kidney and lowest in fat. At the 6.75

- ppm

su lfoxaflor dose level, residues of metabolite X11719474 were 0.012

- 0.015 ppm in liver and

0.014

- 0.022 ppm in kidney . A t the highest dose level, respective residues of metabolites

X11719474 and X11721061 were 0.053

- 0.087 and <0.01

- 0.020 ppm in liver, 0.069

- 0.101 and

<0.01

- 0.273 ppm in kidney, 0.031

- 0.050 and <0.01

- 0.011 ppm in muscle, and <0.01

- 0.026 and

0.01

- 0.025 ppm in fat. The maximum X11721061 residue level of 0.273 ppm in kidney in the

highest dose group was observed from only one cow

, and the residue from this cow exceeded the

residues observed for the remaining three cows by >10x.

The depuration data generated at the highest dose level (35. 2 ppm sulfoxaflor) showed that

residues of sulfoxaflor and metabolites decreased rapidly in milk and tissues f ollowing dosing

cessation. All residues were below the LOQ in milk and tissues following 13

- 14 days of

depuration, except for residues of sulfoxaflor at 0.029 ppm in kidney in a single cow after 21

days of depuration.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 46 of 141 Table 23. Summary of Sulfoxaflor , X11719474, and X11721061 Residue Data for Whole

Milk and Tissue ( n = # of i ndividual samples)

Analyte/

Matrix Dose Level

(mg/kg) Residues (mg/kg)a

n Minimum Maximum Median Mean Std. Dev.

Sulfoxaflor

Milk b 0.45 28 0.013 0.038 0.024 0.024 0.006

2.37 25 0.056 0.123 0.090 0.088 0.017

6.75 28 0.181 0.288 0.243 0.242 0.026

35.19 64 0.895 1.679 1.253 1.274 0.210

Muscle 0.45 4 0.017 0.026 0.020 0.021 0.004

2.37 3 0.086 0.155 0.105 0.115 0.036

6.75 4 0.242 0.311 0.271 0.274 0.035

35.19 4 1.262 1.691 1.453 1.465 0.221

Fat 0.45 4 <0.01 0.014 0.013 0.012 0.002

2.37 3 0.032 0.057 0.039 0.043 0.013

6.75 4 0.091 0.139 0.099 0.107 0.022

35.19 4 0.449 0.915 0.592 0.637 0.212

Liver 0.45 4 0.043 0.061 0.057 0.054 0.009

2.37 3 0.238 0.375 0.283 0.299 0.070

6.75 4 0.604 0.758 0.744 0.713 0.073

35.19 4 3.196 4.030 3.766 3.689 0.364

Kidney 0.45 4 0.026 0.040 0.034 0.034 0.006

2.37 3 0.140 0.210 0.184 0.178 0.035

6.75 4 0.433 0.566 0.461 0.480 0.059

35.19 4 1.931 2.442 2.282 2.234 0.218

X11719474

Milk b 0.045 28 <0.01 <0.01 0.01 0.01 NA

0.237 25 <0.01 <0.01 0.01 0.01 NA

0.675 28 <0.01 0.015 0.010 0.011 0.001

3.52 64 0.026 0.057 0.035 0.038 0.009

Muscle 0.045 4 <0.01 <0.01 0.01 0.01 NA

0.237 3 <0.01 <0.01 0.01 0.01 NA

0.675 4 <0.01 <0.01 0.01 0.01 NA

3.52 4 0.031 0.050 0.041 0.041 0.008

Fat 0.045 4 <0.01 <0.01 0.01 0.01 NA

0.237 3 <0.01 <0.01 0.01 0.01 NA

0.675 4 <0.01 <0.01 0.01 0.01 NA

3.52 4 <0.01 0.026 0.010 0.014 0.008

Liver 0.045 4 <0.01 <0.01 0.01 0.01 NA

0.237 3 <0.01 <0.01 0.01 0.01 NA

0.675 4 0.012 0.015 0.014 0.014 0.001

3.52 4 0.053 0.087 0.069 0.069 0.014Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 47 of 141 Table 23. Summary of Sulfoxaflor , X11719474, and X11721061 Residue Data for Whole

Milk and Tissue ( n = # of i ndividual samples)

Analyte/

Matrix Dose Level

(mg/kg) Residues (mg/kg)a

n Minimum Maximum Median Mean Std. Dev.

Kidney 0.045 4 <0.01 <0.01 0.01 0.01 NA

0.237 3 <0.01 0.010 0.010 0.010 <0.001

0.675 4 0.014 0.022 0.020 0.019 0.003

3.52 4 0.069 0.101 0.093 0.089 0.015

X11721061

Milk 0.180 28 <0.01 <0.01 0.01 0.01 NA

0.949 25 <0.01 <0.01 0.01 0.01 NA

2.70 28 <0.01 <0.01 0.01 0.01 NA

14.08 64 <0.01 <0.01 0.01 0.01 NA

Muscle 0.180 4 <0.01 <0.01 0.01 0.01 NA

0.949 3 <0.01 <0.01 0.01 0.01 NA

2.70 4 <0.01 <0.01 0.01 0.01 NA

14.08 4 <0.01 0.011 0.010 0.010 0.001

Fat 0.180 4 <0.01 <0.01 0.01 0.01 NA

0.949 3 <0.01 <0.01 0.01 0.01 NA

2.70 4 <0.01 <0.01 0.01 0.01 NA

14.08 4 0.01 0.025 0.015 0.016 0.007

Liver 0.180 4 <0.01 <0.01 0.01 0.01 NA

0.949 3 <0.01 <0.01 0.01 0.01 NA

2.70 4 <0.01 <0.01 0.01 0.01 NA

14.08 4 <0.01 0.020 0.012 0.014 0.005

Kidney 0.180 4 <0.01 <0.01 0.01 0.01 NA

0.949 3 <0.01 <0.01 0.01 0.01 NA

2.70 4 <0.01 <0.01 0.01 0.01 NA

14.08 4 <0.010 0.273c 0.020 0.081 0.128

a The LOQ (0.01 ppm) was used for all residues reported as <LOQ in all calculations (mean, median, etc.). NA = Not applicable

. b Milk

residues are from samples collected from Study Days 8

- 28 or 29, including samples from the depuration group; residues were considered to

have reached a plateau during this time. c Residue for one cow in this group (0.273 ppm) w as >10x higher tha n those for the other cows:

0.025, 0.015, and <0.01 ppm.



### Maximum Reasonably Balanced Diets (MRBDs)

M RBD s for beef cattle, dairy cattle, swine, and poultry were calculated according to HED’s

guidance document: “Revisions of Table 1 Feedstuffs (OCSPP Guideline 860.1000 ; June

2008 )

, ” This document provides guidance for constructing balanced diets that take into account

the nutritional needs of livestock animals

. In addition

, the OECD guidance for animal diets was

also consulted. Cattle, swine, and pou ltry require adequate amounts of protein, carbohydrate, and

roughage in their diets. The diets that have been constructed ensure that these nutritional needs

are met. The diets can be considered to be MRBD s because for each of the three food groups

given , the commodities with the highest residue contributions were used to construct the diets.

As a result, the diets are high

- end, conservative estimates of the residue levels to which theSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 48 of 141 livestock animals will be exposed. Tables 24 through 2 7 , provide the dietary burdens for beef

cattle, dairy cattle, swine, and poultry, respectively. In the following tables, R represents

roughage, CC represents carbohydrate concentrate, and PC represents protein concentrate. The

contribution of a particular feed item to the diet is determined with the following equations:

Contribution = ([ highest r esidue or STMR /% DM] X % diet) for beef and dairy cattle; and

contribution = ([ highest residue or STMR ] X % diet) for poultry and swine. For processed feed

items, the concentration factor times the highest field trial or STMR value was used

.

Table 24

. Ca lculation of Dietary Burdens of Sulfoxaflor Residues to Beef Cattle.

Feedstuff Type 1 % Dry

Matter % of Diet

( max ever

used ) Highest Residue

or STMR 1

(ppm) Dietary Contribution

(ppm) 3

Beef Cattle

Barley, grain (STMR) CC 88 50 0. 055 0.03

Grain, aspirated fractions

(STMR ) (soybean) CC 85 5 1.24

(0.013 x 95) 0.07

Wheat, grain (STMR) CC 89 5

(20) 0.01 5 0.0008

Wheat, milled bypdts

(STMR) CC 88 2 0 0.01 5 0.00 3

CC 80%

Barley, straw (HR) R 89 10 2.0 2 0.25

Wheat, straw (HR)

( 500 WDG form .) R 88 5

( 10 ) 1.64 0.09

R 15%

Canola, meal (STMR) PC 88 5 0.08

(0.04 3 x 1.9) 0.005

PC 5%

TOTAL BURDEN

-- -- 100

-- 0.45

1 STMR (supervised trial median residue) values are obtained from the Tolerance/MRL spreadsheet which only included

independent field trials. The highest values observed are from the Tier II reviews.

2 One residue value was 2.2 ppm, it was reanalyzed as 1 .8 ppm.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 49 of 141 Table 25

. Calculation of Dietary Burdens of Sulfoxaflor Residues to Dairy Cattle

.

Feedstuff Type 1 % Dry

Matter 2 % Diet

( max ever

used ) Highest Residue

or STMR (ppm) Dietary Contribution

(ppm) 3

Dairy Cattle

Apple pomace, wet (STMR) CC 40 10 0.077

(0.07 x 1.1) 0.02

Barley, grain (STMR) CC 88 35

(45) 0.055 0.022

45%

Barley, straw (HR) R 89 5

(20) 2.0 2 0.11

Soybean, forage/silage (HR) R 35 20 1.73 0.99

Wheat, forage (HR) R 25 20 1.4 1.12

45%

Canola, meal (STMR) PC 88 10 0.08

(0.043 x 1.9) 0. 009

10%

TOTAL BURDEN

-- -- 100

-- 2.27

Table 26

. Calculation of Dietary Burdens of Sulfoxaflor Residues to Poultry

.

Feedstuff Type 1 % Dry

Matter % Diet

( max ever

used ) Highest Residue

or STMR

(ppm) Dietary Contribution

(ppm) 3

Poultry

Barley, grain (STMR) CC 75 0.055 0.04

75

Canola, meal (STMR) PC 15 0.08

(0.043 x 1.9) 0.0 12

Cotton meal (STMR) PC 10

(20) 0.02

(0.022 x 0.8) 0.002

25

TOTAL BURDEN

-- -- 100

-- 0.05 4Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 50 of 141 Table 2 7

. Calculation of Dietary Burdens of Sulfoxaflor Residues to Swine

.

Feedstuff Type 1 % Dry

Matter % Diet

( max ever

used ) Highest Residue

or STMR

(ppm) Dietary Contribution

(ppm) 3

Swine

Barley, grain (STMR) CC 20 0.055 0.01 1

Wheat, milled bypdts

(STMR) CC 50 0.01 5 0.00 7

85

Canola, meal (STMR) PC 15 0.08

(0.043 x 1.9) 0.0 12

15

TOTAL BURDEN

-- -- 100

-- 0.0 30



### Potential Residue Levels in Milk, Eggs, and Tissues

The results of the feeding study and the MRBDs calculated above were used to determine the

appropriate tolerance levels for livestock commodities. The registrant performed the feeding

studies at 0.25 X

, 1 X , 3 X , and 1 5 X the MRBDs that the registrant calculated. As stated above,

the feeding levels turned out to be approximately 0.1 X

, 1. 0 X

, 3.0X, and 15.5X the MRBD level

that HED calculated for dairy cattle, and 0.2X

, 0.8X

, 2.1X, and 1 1 x the MRBD level tha t HED

calculated for poultry. As stated in the Nature of the Residue section of this summary document,

the residues of concern in livestock commodities for both tolerance enforcement and risk

assessment is parent sulfoxaflor

.

Comparison of these dieta ry burden estimates to residue levels observed in the lactating cattle

and laying hen feeding studies ( Figures 8 and 9 ), result in anticipated residues shown in Tables

28 (cattle and swine) and 29 (poultry). Based on conservative assumptions, which are

ap propriate for deriving tolerance levels in livestock commodities, quantifiable residues in

commodities from cattle, horses, goats, and sheep may occur. For swine and poultry, residues

are expected to be less than the LOQ.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 51 of 141 Figure 8 . Lactating Cattle Fee ding Study

- Maximum Residues

.

Table 28 . Summary of Maximum Residues from the Dairy Cattle Feeding Study and Anticipated Residues.

Dose Level, ppm Milk Muscle Fat Liver Kidney

0.45 0.013 0.017 0.01 0.043 0.026

2.37 0.056 0.086 0.032 0.238 0.14

6.75 0.181 0.242 0.091 0.604 0.433

35.19 0.895 1.262 0.449 3.196 1.931

Slope 0.0255 0.0359 0.0128 0.0908 0.0552

r 2 0.9999 1.0000 0.9998 0.9999 0.9990

Livestock Dietary Burden , ppm Anticipated Residues

Beef Cattle 0.45

--- 0.016 0.006 0.041 0.025

Dairy Cattle 2.27 0.058 0.081 0.029 0.206 0.125

Swine 0.0 30

--- 0.001 0.000 0.003 0.002 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5

0 5 10 15 20 25 30 35 40Sulfoxaflor Residue, ppm

Dose Level, ppm Milk

Muscle

Fat

Liver

KidneySulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 52 of 141 Figure 9 . Laying Hen Feeding Study

- Maximum Residues.

Table 29 . Summary of Maximum Residues from the Laying Hen Feeding Study and Anticipated Residues.

Dose Level, ppm Eggs Muscle Fat Liver

0.145 0.01 0.01 0.028 0.01

0.757 0.059 0.042 0.15 0.013

2.096 0.099 0.109 0.232 0.048

10.7 0.594 0.659 1.193 0.184

Slope 0.0553 0.0612 0.1119 0.0174

r 2 0.9984 0.9991 0.9970 0.9947

Livestock Dietary Burden , ppm Anticipated Residues

Poultry 0.054 0. 003 0.0 03 0.0 06 0.0 01



### The results of these calculations indicate that tolerances will be needed for most livestock

commodities. HED is recommending in favor of the following tolerances: 0. 15 ppm for the

meat of cattle, goat, horse, and sheep, 0. 10 ppm for the fat of cattle, goat, horse, and sheep

, 0. 40

ppm for the meat byproducts of cattle, goat, horse, and sheep, and 0. 15 ppm for milk. HED

recommends that t olerances be set at the LOQ (0.01 ppm) for all hog commodities.

Tolerances are recommended at the LOQ level (0.01 ppm) for poultry meat, fat , byproducts, and

eggs

. 0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4

0 2 4 6 8 10 12Sulfoxaflor Residue, ppm

Dose Level, ppm Eggs

Muscle

Liver

FatSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 53 of 141 Conclusions : The cattle and poultry feeding studies are adequate and can be used to determine

the appropriate tolerance levels for livestock commodities.

Based on the MRBD s that were constructed and the results of the feeding studies, tolerances will

be needed for some livestock commodities. See Table 1 for a list of the recommended livestock

commod ity tolerances and the correct commodity definitions.

Crop Field Trials (860.1500)

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B7



### Five hundred and eighty

- three supervised sulfoxaflor residue trials were conducted i n Australia,

the Europe an Union (NZ/SZ)

, NAFTA areas , and Brazil using foliar application of SC

formulations, as summarized below. A table summarizing the residue data is included in

Appendix 3.

Analytical Method Residues of sulfoxaflor and its metabolit es were determined by

LC/MS/MS. The data gathering method for plants was used for sample analysis. Unless stated

otherwise, i n all trials

, untreated control plots gave residues <LOQ. The validated limit of

quantitation (LOQ) was 0.010 ppm for each analyt e in the RACs ; and the reported limits of

detection s (LODs) were 0.005 ppm (Australia and New Zealand study) or 0.003 ppm (EU and

US studies). Due to instrument availability at the Australian test site, the analytical method was

modified to suit laboratory equipment. Specifically, a fter extracting samples with

acetonitrile/water (80:20) solution, a 500 μ L aliquot of the extract was removed instead of a 200

μ L aliquot, as per the method. All the reagents were adjusted by a 2.5X factor. In additi on, t he

on

- line solid

- pha se extraction using a HySphere C18HD SPE cartridge cleanup was replaced by

off line solid

- phase using 30 mg/1 mL HLB column.

Adjuvants All the sulfoxaflor field trials were conducted using adjuvants; such as an

organosilicone surfactant, a fatty

- acid type surfactant (NIS), or a crop oil concentrate

. In

addition for celery and oranges

, side

- by

- side testing of adjuvants was conducted. For celery,

three of the FL trials included side

- by

- side plots to compare residues following applications

made with a non

- ionic surfactant (NIS) or a organosilicone surfactant (OSS)

. Residues of

sulfoxaflor in/on celery harvested at a 3

- day PHI were 0.058

- 0.170 ppm (mean 0.105 ppm)

following applications made without an additive, 0.064

- 0.212 ppm (mean 0.147 ppm) following

applications made with an organosilicone surfactant ( OSS ) , and 0.076

- 0.147 ppm (mean 0.124

ppm) following applications made with a NIS. For oranges, three of the CA trials included side

by

- side plots to conduct a test to compar e residues following applications made with no

adjuvant, with a non

- ionic surfactant ( NIS ) , and with a crop oil concentrate (COC)

. Residues of

sulfoxaflor in/on oranges harvested at a 1

- day PHI were 0.096

- 0.162 ppm (mean 0.115 ppm)

following applications with an NIS and 0.062

- 0.136 ppm (mean 0.103 ppm) following

applications made with a COC. Residues of sulfoxaflor in/on oranges h arvested at a 7

- day PHI

were 0.038

- 0.116 ppm (mean 0.089 ppm) following applications with an NIS and 0.043

-

0.144 ppm (mean 0.072 ppm) following applications made with a COC.

The use of surfactant s was included in all the field trial data, and is conside red to be fully

evaluated.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 54 of 141 WDG formulation

– In the side

- by

- side trial s with the SC formulation in lettuce, plums, radish,

soybeans and wheat , residues of sulfoxaflor and its metabolites were generally similar to those

following application of the SC formu lation. The use of the WDG formulation is considered to

have been fully evaluated.

Greenhouse Uses

. Limited data were submitted for sulfoxaflor residues in greenhouse

tomatoes. No greenhouse uses were requested with this submission . If greenhouse uses are

requested in the future, add itional data would be required.

R oot and T uber V egetables , C rop G roup 1

Carrots



### Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on carrots from 12 field

trials conducted in Europe and NAFTA areas during 2008 and 2009: 8 trials were conducted in

Europe (4 trials in the EU

- Northern Zone, Germany, Hungary, Poland, and the United Kingdom;

and 4 trials in the EU

- Southern Zone, France, Greece, Italy, and Spain); and 4 trials were

conducted in the US (1 trial each in Zone 3 (FL ), 5 (MI), 6 (TX) and 10 (CA)).

Following four foliar broadcast applications of sulfoxaflor to carrots at a total rate of 0.357

- 0.376

lb a.i./A (401

- 423 g a.i./ha) , residues of sulfoxaflor were 0.311

- 2.283 ppm in/ carrot tops and

< 0.01

- 0.032 ppm in/on roots harvested at a 7

- day PHI. Residues of metabolites X11719474 and

X11721061 were 0.026

- 0.167 and <0.01

- 1.043 ppm, respectively in/on tops and <0.01

- 0.054 and

<0.01 ppm, respectively, in/on roots at a 7

- day PHI.

Conclusions : Th e field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. Tha t use pattern is in

accord with the proposed critical good agricultural practice (cGAP).

Pot atoes

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on potatoes (tubers) from 18

field trials conducted during the 2008 and 2010 seasons in Europe and NAFTA areas : 8 trials

were conducted in Europe (4 trials in the EU

- Northern Zone, France, Germany, Poland, and the

UK; and 4 trials in the EU

- Southern Zone, France, Greece, Italy, and Spain), and 10 trials were

conducted in the US and Canada (2 trials in Zone 1 (PA and VA), 1 trial in Zone 2 (GA), 2 trials

in Zone 5 (MI), 1 trial in Zon e 9 (CO), 1 trial in Zone 10 (CA), 2 trials in Zone 11 (ID) and 1

trial in Zone 14 (MB)).

Following four foliar directed or broadcast applications of sulfoxaflor at a total rate of 0.355

- 0.374 lb a.i./A (399

- 420 g a.i./ha)

, residues of sulfoxaflor were below the LOQ (<0.01 ppm)

in/on potato tubers harvested at a ~7

- day PHI. Residues of metabolites X11719474 and

X11721061 were <0.01

- 0.022 ppm and <0.01 ppm, respectively

.

Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 55 of 141 Radish (SC/WDG formulations)

Dow Agr oSciences, LLC submitted field trial data for sulfoxaflor in/on radish (roots and tops)

from six field trials conducted in NAFTA areas during the 2010 season (1 trial in Zone 1 (PA), 2

trials in Zone 3 (FL), 1 trial in Zone 5 (MI), a nd two trials in Zone 1 0 (CA)).

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.360

- 0.363 lb a.i./A

(404

- 407 g a.i./ha), residues of sulfoxaflor were <0.01

- 0.013 ppm in/on radish roots and 0.183

-

0.506 ppm in/on radish tops harvested at a 7

- day PHI. Respective residues of metabolites

X11719474 and X11721061 were <0.01

- 0.078 and <0.01 ppm in/on radish roots, and 0.032

-

0.418 and 0.032

- 0.407 ppm in/on radish tops.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor, X117 19474, and

X11721061 were <0.01

- 0.016, <0.01

- 0.075, and <0.01 ppm, respectively, in/on radish roots, and

0.242

- 0.465, 0.062

- 0.783, and 0.141

- 0.374 ppm, respectively, in/on radish tops.

Conclusions : The field trials are acceptable and adequately reflect r esidues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

In the side

- by

- side trial with the WDG formulation, residues of sulfoxaflor and metabolites w ere

generally similar to those following application of the SC formulation.

Sugar beet

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on sugar beets (roots and

tops) from 13 trials conducted during the 2008 season in Europe and the US: 8 trials were

conducted in Europe (4 trials in the EU

- Northern Zone, France, Germany, Hungary and the UK;

and 4 trials in the EU

- Southern Zone, France, Greece, Italy, and Spain) and 5 trials were

conducted in the NAFTA : Zone 5 (MI), 7 (NE), 9 (CO), 10 (CA), and 11 (ID)).

Following four foliar broadcast applications of sulfoxaflor to sugar beets at a total rate of 0.351

- 0.374 lb a.i./A (394

- 420 g a.i./ha) , residues of sulfoxaflor were 0.141

- 1.685 ppm in/on tops and

<0.01

- 0.025 ppm in/on roots harvested at a 7

- day PHI. Residues of metabolites X11719474 and

X11721061, respectively, were 0.029

- 0.217 and 0.053

- 0.346 ppm in/on tops and <0.01

- 0.028

and <0.01

- 0.012 ppm in/on roots . We note that the petitioner did not report results for three

samples of tops harvested from three EU trials at the 7

- day PHI (1 sample) and 14

- day PHI (2

samples) because residues were below the LOQ. Based on the residue results for the treated and

control samples from the 7

- day PHI, it appeared that control and treated samples h ad been

exchanged in the field; for the 14

- day PHI samples it was assumed, based on the no n

quantifiable residues, that control samples had been collected in error.

Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 56 of 141 Leaves of Root and Tuber Vegetable , C rop Group 2

See summaries of the carrot, radish, and sugar beet trials in Root and Tuber Vegetables, above

Bulb Vegetables , C rop Group 3

Onion , bulb

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on bulb onion (whole onion

bulb with stalk/stems removed) from six field trials conducted during 2008

- 2009 in t he US

(NAFTA) in Zones 1 (VA; 1 trial), 6 (OK; 1 trial), 8 (TX; 1 trial), 10 (CA; 2 trials), and 11 (ID;

1 trial)

.

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.357

- 0.365 lb a.i./A

(400

- 409 g a.i./ha)

, residues of sulfox aflor and metabolites X11719474 and X11721061 were

below the LOQ (0.01 ppm) in/on bulb onions harvested at a 7

- day PHI.

Conclusions: T he field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxafl or per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

Onion, green

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on green onions (immature

bulbs with stalk/stem) from six field trials conduc ted during 2009 in the US (NAFTA areas ) in

Zones 1 (PA, 1 trial), 2 (GA, 1 trial), 5 (MI, 1 trial), 6 (OK, 1 trial), 10 (CA, 1 trial), and 12 (OR,

1 trial).

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.360

- 0.366 lb a.i./A

(404

- 410 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 0.440 ppm in/on green onions harvested

at a ~7

- day PHI. Residues of metabolites X11719474 and X11721061 were 0.011

- 0.332 ppm

and <0.01

- 0.088 ppm, respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

Leafy Vegetables (Except Brassica Vegetables) , C r op Group 4

Celery

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on celery (trimmed leaf

stalk) from six field trials conducted during 2009 in the US (NAFTA areas ) : 1 trial in Zone 3

(FL), 1 trial in Zone 5 (MI), and 4 trials in Zone 10 (CA). We note that the raw agricultural

commodity (RAC) for celery is defined in Table 1 (OCSPP 860.1000) and by OECD as the

untrimmed leaf stalk (petiole). However, the removal of excessive leaves in the field is

consistent with agricultural practic es and the study protocol. Further, the petiole itself is

generally considered to be the edible portion.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 57 of 141 Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.360

- 0.361 lb a.i./A

(404

- 405 g a.i./ha)

, residues of sulfoxaflor w ere 0.058

- 0.804 ppm in/on celery (trimmed stalks)

harvested at a ca. 3

- day PHI. Residues of metabolites X11719474 and X11721061 were 0.022

- 0.097 ppm and <0.01

- 0.165 ppm, respectively

.

In the tank

- mix additive comparison test, following application with no adjuvant or with an OSS

(Kinetic® at 0.05% v/v) or NIS (X

- 77 Spreader® at 0.25% v/v) adjuvant, residues were

generally similar but slightly higher when either type of adjuvant was used . Residues of

sulfoxaflor in/on celery harvested at a 3

- day PHI were 0.058

- 0.170 ppm (mean 0.105 ppm)

following applications made without an additive, 0.064

- 0.212 ppm (mean 0.147 ppm) following

applications made with an OSS, and 0.076

- 0.147 ppm (mean 0.1 24 ppm) following applications

made with an NIS. Residues of metabolite X11719474 (and mean) were 0.036

- 0.058 ppm

(0.044 ppm), 0.059

- 0.097 ppm (0.070 ppm), and 0.044

- 0.094 ppm (0.064 ppm) following

applications made without an adjuvant, with an OSS, and w ith an NIS, respectively. Residues of

metabolite X11721061 (and mean) were <0.01 ppm, <0.01 to 0.013 ppm (0.011 ppm), and

<0.01

- 0.015 ppm (0.011 ppm), following applications made without an adjuvant, with an OSS,

and with an NIS.

Conclusions: The fi eld trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. Use of an OSS or NIS adjuvant appear s to resu lt in

a modest increase in residue levels . The one Swiss chard sample was not combined with the

celery data, because it is not a representative crop. The sulfoxaflor residues on that sample were

within the range of the celery data.

Head Lettuce

Dow AgroSc iences, LLC submitted field trial data for sulfoxaflor in/on head lettuce (heads with

wrapper leaves) from 14 field trials conducted during 2008, 2009, and 2010 in Australia, Europe,

and NAFTA area s

. The raw agricultural commodity (RAC) for head lettuce i s defined in Table 1

of OCSPP 860.1000 as fresh head lettuce, with wrapper leaves. Based on the study reports

and/or the accompanying protocols, lettuce heads with wrapper leaves were collected for all

trials addressed herein. Residue data for lettuce wi thout wrapper leaves were not submitted.

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.328

- 0.388 lb a.i./A

(369

- 436 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 0.528 ppm in/on head lettuce harvested at

a ~3

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.08 ppm and

<0.01

- 0.136 ppm, respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Leaf Lettuce (SC/WDG formulations)

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on leaf lettuce (leaves) from

18 field trials conducted during 2008, 2009, and 2010 in Australia, Europe, and the US (NAFTA

areas ) : 4 trials were conducted in Australia (1 trial each in Queensland, New South Wales,Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 58 of 141 Victoria, and South Australia); 6 trials were conducted in Europe (2 trials in the EU

- Northern

(Germany and the United Kingdom) and 2 trials in the EU

- Southern Zone (Greece and Spain));

and 8 trials were conducted in the NAFTA (1 trial each in Zone 1 (VA), 2 (GA), and 3 (FL), and

5 trials in Zone 10 (CA)).

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.342

- 0.377 lb a.i./A

(384

- 424 g a.i./ha)

, residues of sulfoxaflor were 0.05

- 3.07 ppm in/on leaf lettuce harvested at a

~3

- day PHI. Residues of metabolites X11719474 and X11721061 were 0.016

- 0.155 ppm and

0.03

- 0.31 ppm, resp ectively

.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor, X11719474, and

X11721061 were 0.379

- 0.885, 0.035

- 0.164, and 0.031

- 0.056 ppm, respectively.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor and metabolites

w ere generally similar to those following application of the SC formulation

.

Spinach

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on spinach and Swiss chard

(also known as silver beet ) from eight field trials conducted during the 200 8

- 2010 seasons in

Australia and the US (NAFTA areas ): 2 trials were conducted in Australia (1 trial each in

Victoria and South Australia), and 6 trials were conducted in the US (1 trial each in NAFTA

Zone 1 (VA), 2 (GA), 6 (OK), and 9 (CO), and 2 trials i n NAFTA Zone 10 (CA)). Seven trials

were conducted on spinach, and one trial was conducted on Swiss chard. The Swiss chard

sample was not included in the evaluation of the spinach data and associated tolerance/MRL

evaluation, because in the US crop group scheme, it is more like celery than spinach.

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.3 60

- 0.372 lb a.i./A

( 405

- 418 g a.i./ha) , r esidues of sulfoxaflor were 0.039

- 3.256 ppm in/on spinach harvested at a 3

- day PHI. R esidues of metabolites X11719474 and X11721061 were 0.057

- 0.282 ppm and

0.019

- 0.153 ppm, respectively.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Watercress

Re si d ue chemistry field trial data were not submitted for watercress. Data from leafy

lettuce /spinach are translated to support use on watercress.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 59 of 141 Brassica (Co le) Leafy Vegetables , C rop Group 5

B roccoli

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on broccoli (head and stem)

from 15 field trials conducted during 2008, 2009, and 2010 in Australia, Europe, and the US

(NAFTA areas ) . Two tri als were conducted in Australia (Queensland and Victoria); 7 trials were

conducted in Europe (3 trials in the EU

- Northern Zone, Germany and the UK; and 4 trials in the

EU

- Southern Zone, France, Greece, and Spain); and 6 trials were conducted in the US (1 t rial in

Zone 6 (OK), 4 trials in Zone 10 (CA), and 1 trial in Zone 12 (OR)).

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.347

- 0.379 lb a.i./A

(390

- 426 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 1.60 ppm in/on broccoli (head and stem)

harvested at a 3

- day PHI; residues of metabolites X11719474 and X11721061 were <0.01

- 0.051

ppm and <0.01

- 0.090 ppm, respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be expected

f ollowing application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

Cabbage

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on cabbage (heads with

wrapper leaves) from 14 field trials conducted during 2008

- 2009 in Australia, Europe, and the

US (NAFTA areas ) : 2 trials were conducted in Australia (in South Australia and New South

Wales); 6 trials were conducted in Europe (4 trials in the EU

- Northern Zone, in France,

Germany, Hungary, and United Kingdom; and 2 trials in the EU

- Southern Zone, in France and

Greece); and 6 trials were conducted in the US (one each in Zone 1 (PA), 2 (GA), 3 (FL), 5 (MI),

6 (TX), and 10 (CA)).

Following four foliar broadcast applications of sulf oxaflor at a total rate of 0.341

- 0.383 lb a.i./A

(383

- 430 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 0.400 ppm in/on cabbage heads with

wrapper leaves harvested at a ~3

- day PHI; residues of metabolites X11719474 and X11721061

were <0.01

- 0.06 ppm and <0 .01

- 0.044 ppm, respectively.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Cauliflower

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on cauliflower from 10 field

trials conducted during 2008, 2009, and 2010 in Australia and Europe. Two trials were

conducted in Australia (Victoria and New South Wales ); and 8 trials were conducted in Europe

(3 trials in the EU

- Northern Zone, Germany and the UK; and 5 trials in the EU

- Southern Zone,

France, Greece, and Italy).

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.320

- 0.373 lb a.i./A

(360

- 419 g a.i./ha) , r esidues of sulfoxaflor were <0.01

- 0.07 ppm in/on cauliflower harvested at aSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 60 of 141 ~3

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.03 ppm and

<0.01

- 0.02 ppm, respectively

.

Conclusions: The field trials a re acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Mustard Greens

Dow AgroSciences, LLC submitted field tria l data for sulfoxaflor in/on mustard greens (leaves)

from eight field trials conducted during 2010 in the US (NAFTA areas ) in Zones 2 (GA; 2 trials),

3 (FL; 1 trial), 4 (MO; 1 trial), 5 (MI; 1 trial), 6 (OK; 1 trial) and 10 (CA; 2 trials).

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.354

- 0.367 lb a.i./A

(397

- 411 g a.i./ha) , r esidues of sulfoxaflor were 0.278

- 1.17 ppm in/on mustard greens harvested

at a 2

- to 4

- day PHI. Residues of metabolites X11719474 a nd X11721061 were 0.036

- 0.890

ppm and 0.061

- 0.897 ppm, respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That us e

pattern is in accord with the proposed cGAP.

Legume Vegetables (Succulent or Dried) , C rop Group 6

Note: For soybean seed, see the Oilseeds Group (Group 20), below

.

Dried shelled beans

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on dried shelled beans from

six field trials conducted during 2008 and 2010. Four trials were conducted in Brazil, and two

trials were conducted in Europe (1 trial each in the EU Northern and Southern Zones, in

Germany and Spain). ( Although the study report ( MRID 47832219 ) also contains data from five

trials on dry beans conducted in the EU, t hese trials did not include the target PHI of 7 days and

are not included herein. )

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.350

- 0.365 lb a.i./A

(393

- 411 g a.i./ha)

, residues of sulfoxaflor were 0.020

- 0.112 ppm in/on dried beans harvested at

a 7

- day PHI. Residues of metabolites X11719474 and X11721 061 were < 0.010

- 0.022 ppm and

< 0.010

- 0.196 ppm, respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

patte rn is in accord with the proposed cGAP.

Succulent edible

- podded beans

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on succulent edible

- podded

beans from six field trials conducted during 2008 and 2010 in the Northern and Southern Zo nesSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 61 of 141 of Europe. Three trials each were conducted in the Northern Zone (Germany, Hungary, and

Poland) and the Southern Zone (Greece, Italy, and Spain).

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.352

- 0.372 lb a.i./A

(3 95

- 419 g a.i./ha) , r esidues of sulfoxaflor were 0.024

- 2.019 ppm in/on edible

- podded beans

harvested at a 7

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.010

- 0.155 ppm and <0.010

- 0.228 ppm, respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP

.

Foliage of Legume Vegetable , C rop Grou p 7

Soybeans (SC/WDG formulations)

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on soybeans (forage and

hay) from 19 trials conducted during the 2008

- 2009 seasons in Brazil and the US: 4 trials were

conducted in Brazil, and 15 tria ls were conducted in the US (2 trials in NAFTA Zone 2 (GA), 2

trials in Zone 4 (AR and MS), and 11 trials in Zone 5 (IA, IL, IN, MI, MO, NE, and OH)).

Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.178

- 0.183 lb a.i./A

(200

- 205 g a.i./ha)

, residues of sulfoxaflor in/on forage harvested at a ~7

- day PHI were 0.013

- 1.734 ppm. Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.357

- 0.371 lb a.i./A (400

- 416 g a.i./ha), residues of sulfoxaflor were 0. 057

- 1.378 ppm in/on hay.

Residues of metabolites X11719474 and X11721061 were, respectively, <0.01

- 0.264 and 0.112

- 1.018 ppm in/on forage, 0.050

- 3.131 and 0.085

- 3.379 ppm in/on hay

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor and metabolites

w ere generally similar to those following application of the SC formulation; neither formulation

yielded consistently higher residues of sulfoxaflor for any matrix.

Fruiting Vegetable , C rop Group 8

Tomatoes

Dow AgroSciences, LLC submitted field trial da ta for sulfoxaflor in/on tomatoes (whole fruit)

from 44 trials conducted during the 2008

- 2010 seasons in Australia, Brazil, Europe, and the US:

6 trials were conducted in Australia (1 trial each in Western Australia and New South Wales, and

2 trials each in Queensland and Victoria); 4 trials were conducted in Brazil; 22 trials were

conducted in Europe (10 trials in the EU

- Northern Zone, Bulgaria, France, Germany, Hungary,

and Poland; and 12 trials in the EU

- Southern Zone, France, Greece, Italy, and Spain); and 12

trials were conducted in the US (1 trial each in NAFTA Zone 1 (VA), 2 (GA), 5 (MI), 2 trials in

Zone 3 (FL), and 7 trials in Zone 10 (CA)). Four of the EU trials were conducted on tomatoesSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 62 of 141 grown indoors (mid

- large size). Of the remaining trials, 10 reflected application to varieties that

produce small tomatoes, and 30 reflected application to varieties that produce mid

- size to large

tomatoes.

Following four foliar broadcast or directed applications of sulfoxaflor at a total rate of 0.317

-

0.383 lb a.i./A (356

- 430 g a.i./ha), r esidues of sulfoxaflor were <0.01

- 0.762 ppm in/on tomatoes

(whole fruit) harvested at a 1

- day PHI. Residues of metabolites X11719474 and X11721061

were <0.01

- 0.019 and <0.01

- 0.026 ppm, respectively, in/on tomatoes.

Residues of sulfoxaflor and metabolites were generally similar in the mid

- large tomatoes, small

tomatoes, and tomatoes grown indoors. Following harvest at a 1

- day PHI, residues of

sulfoxaflor, X11719474, and X11721061 were <0.01

- 0.762, <0.01

- 0.017, and <0 .01

- 0.013 ppm,

respectively, in/on mid

- sized/ large tomatoes; 0.020

- 0.451, <0.01

- 0.011, and <0.01

- 0.011 ppm,

respectively, in/on small tomatoes; and 0.049

- 0.378, <0.01

- 0.019, and <0.01

- 0.026 ppm,

respectively, in/on tomatoes grown indoors.

Conclusions: The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP. Residues of sulfoxaflor and metabolite s were similar in mid

size/ large tomatoes, small tomatoes, and tomatoes grown indoors. The mode of application

(directed versus broadcast) does not appear to significantly affect residues levels.

Cucumber

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on cucumber from 18 field

trials conducted during 2008, 2009, and 2010 in Europe, and NAFTA area s . Tw elve trials were

conducted in Europe (5 trials in the EU

- Northern Zone, Germany, Hungary, and Poland; and 7

trials in the EU

- Southern Z one, France, Greece, Italy, and Spain); and 6 trials were conducted in

the US (2 trials in Zone 2 (GA), 1 trial in Zone 3 (FL), 2 trials in Zone 5 (MI), and 1 trial in and

Zone 6 (OK)). Note: The cucumber Tier II review included the Australian zucchini t rials;

however, the zucchini samples were not included in the evaluation of the cucumber data and

associated tolerance/MRL evaluation, because in the US crop group scheme, it is more like

squash than cucumber.

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.3 55

- 0.374 lb a.i./A

(3 99

- 420 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 0.172 ppm in/on cucumber harvested at a

1

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.030 ppm and

<0.01

- 0.013 ppm, respectively

.

Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

Peppers

Do w AgroSciences, LLC submitted field trial data for sulfoxaflor in/on peppers (bell/capsicum,

non

- bell/ chili’s ) from 20 field trials conducted during the 2008

- 2010 seasons in Australia,

Europe, and the US (NAFTA areas ): 6 trials were conducted in Australia (3 trials in Queensland,Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 63 of 141 2 trials in Victoria, and 1 trial in Western Australia), 6 trials were conducted in Europe (EU

Southern Zone, France, Greece, Italy, and Spain), and 8 trials were conducted in the US (2 trials

in Zone 2 (GA), 2 trials in Zone 3 ( FL), 1 trial in Zone 5 (MI), 1 trial in Zone 8 (TX), and two

trials in Zone 10 (CA)). An additional US trial conducted in Zone 6 (TX) was lost due to a wind

storm. The trials included 12 bell pepper and 8 non

- bell pepper trials.

Following four foliar d irected or broadcast applications of sulfoxaflor at a total rate of 0.321

- 0.428 lb a.i./A (361

- 481 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 0.46 ppm in/on peppers

harvested at a 1

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

-

0 .038 ppm and <0.01

- 0.06 ppm, respectively

. Respective residues in/on non

- bell and bell

peppers at a 1

- day PHI were: 0.017

- 0.46 and <0.01

- 0.284 ppm for sulfoxaflor, <0.01

- 0.038 and

<0.01

- 0.019 ppm for X11719474, and <0.01

- 0.06 and <0.01

- 0.026 ppm for X117 21061.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. Residues of sulfoxaflor and metabolites

X11719474 and X11721061 were generally higher in non

- bell peppers than in bell peppers.

Cucurbit Vegetable , C rop Group 9

Melon

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on melon (whole f ruit) from

16 field trials conducted during 2008, 2009, and 2010 in Brazil, Europe, and the US: 4 trials

were conducted in Brazil; 6 trials were conducted in Europe (all in the EU

- Southern Zone in

France, Greece, Italy, and Spain); and 6 trials were condu cted in the US (1 trial each in Zones 2

(GA), 5 (MI), and 6 (TX), and 3 trials in Zone 10 (CA)).

It was noted that samples were harvested at a 0

- day PHI in the EU trials associated with study

CEMS

- 3965, even though a 1

- day PHI was specified in the study protocol. For trials from this

study, the 1

- day PHI samples from the two decline trials (CEMS

- 3965A, Greece; and CEMS

3965B, Spain) were included in data summary calculations, while the 0

- day data from the

remaining two trials were used.

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.356

- 0.375 lb a.i./A

(400

- 421 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 0.304 ppm in/on melons harvested at a

~1

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.012 ppm and

<0.01

- 0.015 ppm , respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Squash

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on squash (fruit) from six

trials conducted in the US (NAFTA areas ) during the 2008 and 2009 seasons (1 trial each in

NAFTA Zone 1 (VA), 2 (GA), 5 (MI), and 10 (CA), and 2 trials in NAFTA Zone 3 (FL). ThreeSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 64 of 141 trials each were conducted on summer and winter squash. Note: The cucumber Tier II review

included the Australian zucchini trials; however, since in the US crop group scheme the zucchini

samples are mor e like squash than cucumber

, there were included in the evaluation of the squash

tolerance/MRL.

Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.357

- 0.364 lb a.i./A

(400

- 408 g a.i./ha) , r esidues of sulfoxaflor were <0.01

- 0. 021 ppm in/on squash (fruit) harvested

at a 1

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.020 ppm and

<0.01 ppm, respectively. R esidues of sulfoxaflor were higher in winter squash (<0.01

- 0.021

ppm) and below the LOQ in summer sq uash, and residues of metabolite X11719474 were higher

in summer squash (<0.01

- 0.020 ppm) and below the LOQ in winter squash. Residues of

sulfoxaflor on zucchini ranged from 0.025

– 0.1 ppm.

Conclusions : The field trials are acceptable and adequately refl ect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

Citrus Fruit, C rop Group 10

Grapefruit

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on grapefruit from eight

field trials conducted during 2010 in the US in NAFTA Zones 3 (FL; 5 trials), 6 (TX; 1 trial),

and 10 (CA; 2 trials).

Following two foliar broadcast application s of sulfoxaflor at a total rate of 0.360 lb a.i./A (404 g

a.i./ha) , r esidues of sulfoxaflor were <0.01

- 0.186 ppm in/on grapefruit harvested at a 1

- day PHI.

Residues of metabolites X11719474 and X11721061 were each <0.01 ppm.

In treated grapefruit peel samples at a 1

- day PHI, residues of sulfoxaflor ranged from 0.0449 to

0.8815 ppm, while residues in the pulp were all below the LOQ (<0.01 ppm). Residues of the

metabolite X11719474 were not detected in any grapefruit pulp or peel sample. Residues of the

metabolite X11721061 were below the LOQ (<0.01 ppm) in all grapefru it pulp samples at a 1

- day PHI.

Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

Residues appear to be associated with the surface of the fruit at the 1

- day PHI.

Lemon

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on lemons from six field

trials conducted during 2009

- 2010 in the US (NAFTA areas ) in Zones 3 (FL; 1 trial) and 10

(CA; 5 trials).Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 65 of 141 Following two foliar broadcast applications of sulfoxafl or at a total rate of 0.360 lb a.i./A (404 g

a.i./ha)

, residues of sulfoxaflor were 0.025

- 0.317 ppm in/on lemons harvested at a 1

- day PHI;

residues of metabolites X11719474 and X11721061 were each <0.01 ppm.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Orange

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on orange (whole fruit)

from 26 field trials conducted during the 2008

- 2010 seasons in Australia, Brazil, and the USA

(NAFTA areas ) . Ten trials were conducted in Australia (5 trials in Queensland, 2 trials each in

South Australia and New South Wales, and 1 trial in Victoria), 4 trials were conducted in Brazil,

and 12 trials were conducted in the US (8 trials in NAFTA Zone 3 (FL), 3 trials in Zone 10 (CA),

and 1 trial in Zone 6 (TX)).

Following two or four foliar broadcast applications of sulfoxaflor at a total rate of 0.263

- 0.368 lb

a.i./A (296

- 413 g a.i./ha) , r esidues of sulfoxaflor were 0.037

- 0.46 ppm in/on oranges harvested at

a 1

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.014 ppm and

≤0.01 ppm, respectively.

In the tank

- mix additive comparison test, residues were similar in/on oranges f ollowing

applications made with an NIS (X

- 77 Spreader® at 0.05% v/v) or with a COC (Citrus Oil 354®

at 1% v/v) adjuvant. Residues of sulfoxaflor in/on oranges harvested at a 1

- day PHI were

0.096

- 0.162 ppm (mean 0.115 ppm) following applications with an NIS and 0.062

- 0.136 ppm

(mean 0.103 ppm) following applications made with a COC. Residues of sulfoxaflor in/on

oranges harvested at a 7

- day PHI were 0.038

- 0.116 ppm (mean 0.089 ppm) following

applications with an NIS and 0.043

- 0.144 ppm (mean 0.072 ppm) following applications made

with a COC. Residues of metabolites X11719474 and X11721061 in/on oranges harvested at 1

and 7 days were below the LOQ (<0.01 ppm) following applicati ons m ade with an NIS or a

COC.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP

. Use of a non

- ionic surfactant versus a crop oil

concentrate appears to have no affect on residue levels of sulfoxaflor and its primary metabolites

in/on oranges. The use of two or four applications did not appear to significantly impact residue

levels.

Pome Fruit, C rop Group 11

Apples

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on apples (whole fruit) from

22 trials conducted in Australia and New Zealand, Europe, and the US (NAFTA areas ): 6 trials

were conducted in Australia and New Zealand during the 2008

- 2009 season (1 trial each in

South Australia and New South Wales, and 2 trials each on the North and South Islands of NewSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 66 of 141 Zealand), 4 trials were conducted in Europe during the 2008 s eason (2 trials in the EU

- Northern

Zone, Germany and Poland; and 2 trials in the EU

- Southern Zone, Spain and Greece), and 12

trials were conducted in the US during the 2008 and 2010 seasons (3 trials in Zone 1 (PA), 1 trial

in Zone 2 (GA), 2 trials in Zone 5 (MI), 1 trial in Zone 9 (UT), 1 trial in Zone 10 (CA), and 4

trials in Zone 11 (ID, OR, WA)).

Following two or four foliar broadcast applications of sulfoxaflor at a total rate of 0.289

- 0.374 lb

a.i./A (325

- 420 g a.i./ha) in Australian/New Zealand, EU, and US trials , r esidues of sulfoxaflor

were <0.010

- 0.297 ppm in/on apples (whole fruit) harvested at a 7

- day PHI. Residues of

metabolites X11719474 and X11721061 were <0.010

- 0.013 ppm and <0.010

- 0.011 ppm,

respectively, in/on apples. In the Australia/Ne w Zealand trials, r esidues of all analytes were

similar following application of sulfoxaflor at the target seasonal rate, made in either two or four

applications.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. The use of two or four applications did not appear

to signi ficantly impact residue levels.

Pears

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on pears (whole fruit) from

14 trials conducted during the 2008

- 2010 seasons in Australia, Europe, and NAFTA area s : 2

trials were conducted in Australia (1 trial each in Victoria and South Australia), 6 t rials were

conducted in Europe (3 trials in the EU

- Northern Zone, Germany and Hungary; and 3 trials in

the EU

- Southern Zone, Greece, Spain, and Italy), and 6 trials were conducted in the US (1 trial

in NAFTA Zone 1 (PA), 2 trials in Zone 10 (CA), and 3 tri als in Zone 11 (OR and WA)).

Following two or four foliar directed or broadcast applications of sulfoxaflor at a total rate of

0.279

- 0.379 lb a.i./A (314

- 426 g a.i./ha) , r esidues of sulfoxaflor were 0.044

- 0.267 ppm in/on

pears (whole fruit) harvested at a ~7

- day PHI. Residues of metabolites X11719474 and

X11721061 were <0.01

- 0.01 and <0.01

- 0.02 ppm, respectively. Maximum residues in the

Australia trials reflecting applications at ~83% of the target rate were 0.25 ppm following two

applications and 0. 18 ppm following four applications. The petitioner noted that the warmer and

drier conditions experienced at this site may have contributed to higher residues than would have

been o bserved in an “average” season.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. Residues of all analytes were similar following

application o f sulfoxaflor as two or four applications at the same total rate; however, we note that

the highest residues of sulfoxaflor were observed in the US trial reflecting a concentrated spray

volume (Trial 04, WA).Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 67 of 141 Stone Fruit, C rop Group 12

Apr i cots

Dow Agro Sciences, LLC submitted field trial data for sulfoxaflor in/on apricots from two field

trials conducted during 2008 and 2009 in Shepparton, Victoria, Australia and Hast ings, Hawkes

Bay, New Zealand.

Following two or four foliar directed applications of su lfoxaflor at a total rate of 0.337

- 0.345 lb

a.i./A (~379

- 388 g a.i./ha) , r esidues of sulfoxaflor and metabolite X11721061 were 0.13

- 0.45

ppm and <0.010

- 0.04 ppm respectively in/on apricots harvested at a 7

- day PHI. Residues of

metabolite X11719474 were no t detected above the LOQ.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. The use of two applications appeared to have

increased the residue levels, when compared to making four applications with the same

maximum seasonal use rate.

Cherry

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on cherry from 14 field

trials conducted during 2008, 2009, and 2010 in Australia and New Zealand, Europe, and the US

(NAFTA areas ) : 1 trial each was conducted in Australia (New South Wal es) and New Zealand

(North Island); 6 trials were conducted in Europe (3 trials in the Northern Zone, Germany and

Hungary; and 3 trials in the Southern Zone, France, Greece, and Spain); and 6 trials were

conducted in the US (1 trial in Zone 1 (PA); 4 trial s in Zone 5 (MI), and 1 trial in Zone 10 (CA)).

Eight trials were conducted on sweet cherries and six trials were conducted on tart cherries.

Following two or four foliar broadcast applications of sulfoxaflor at a total rate of 0.337

- 0.365 lb

a.i./A (3 79

- 410 g a.i./ha)

, residues of sulfoxaflor were 0.26

- 1.6 ppm in/on cherries harvested at a

~7

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.029 ppm and

<0.01

- 0.06 ppm, respectively

.

Conclusions: The field trials are acceptable a nd adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. The use of two or four applications did not appear

to significantly impac t residue levels.

Nectarines

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on nectarines (pitted fruit)

from five trials conducted in Australia (Victoria, 2 trials; New South Wales, 1 trial; and Western

Australia, 1 trial) and New Zealand (North Island, 1 trial) conducted during the 2008

- 2009

seasons.

Following two or four foliar broadcast applications of sulfoxaflor at a total rate of 0.341

- 0.351 lb

a.i./A (383

- 394 g a.i./ha) , r esidues of sulfoxaflor were 0.074

- 0.247 ppm in/on nec tarinesSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 68 of 141 harvested at a 7

- day PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.013 ppm and <0.01

- 0.021 ppm, respectively

.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following appli cation of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. R esidues of all analytes were similar following

application of sulfoxaflor as two or four applications.

Peach

Dow AgroSciences, LLC submit ted field trial data for sulfoxaflor in/on peaches (pitted fruit)

from 20 trials conducted during the 2008

- 2010 seasons in Australia, New Zealand, Europe, and

the US (NAFTA areas ) : 7 trials were conducted in Australia (3 trials in Victoria, 2 trials in Ne w South Wales, and 1 trial each in Western Australia and Queensland), 1 trial was conducted in

New Zealand (North Island); 6 trials were conducted in Europe (2 trials in the EU

- Northern Zone

(Germany and Hungary); and 4 trials in the EU

- Southern Zone (Fran ce, Greece, Italy, and

Spain)); and 6 trials were conducted in the US (1 trial each in Zone 1 (PA), 5 (MI), 6 (TX), and

10 (CA), and 2 trials in Zone 2 (GA)).

Following two or four foliar directed or broadcast applications of sulfoxaflor at a total rate of

0.338

- 0.373 lb a.i./A (380

- 419 g a.i./ha) , r esidues of sulfoxaflor were <0.01

- 0.636 ppm in/on

peaches (pitted fruit) harvested at a ~7

- day PHI. Residues of m etabolites X11719474 and

X11721061 were <0.01

- 0.011 and <0.01

- 0.029 ppm, respectively.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. Residues of all analytes were similar following

application of sulfoxaflor as two or four applications.

Plums (SC/WDG formulations)

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on plums (pitted fruit) from

seven field trials conducted during 2009

- 2010 in Australia and the US (NAFTA areas ) : 1 trial

was conducted in Australia (New South Wales), and 6 trials were c onducted in the US (1 trial

each in NAFTA Zones 5 (MI) and 12 (OR), and 4 trials in Zone 10 (CA)).

Following two foliar directed or broadcast applications of sulfoxaflor at a total rate of 0.342

- 0.370 lb a.i./A (384

- 415 g a.i./ha) , r esidues of sulfoxaflor were 0.021

- 0.221 ppm in/on plums

harvested at a 7

- day PHI. Residues of metabolites X11719474 and X11721061 were both <0.01

- 0.012 ppm

.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor and metabolites

were generall y similar to those following application of the SC formulation; slightly higher

residues of sulfoxaflor were observed in four of six trials with the WDG formulation, and

slightly lower or comparable residues were observed in the remaining two trials. In s amples

harvested at a 7

- day PHI, residues of sulfoxaflor, X11719474, and X11721061 were 0.014

- 0.362, <0.01

- 0.016, and <0.01 ppm, respectively.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 69 of 141 Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following app lication of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor and metabolites

were generally similar to those following ap plication of the SC formulation; slightly higher

residues of sulfoxaflor were observed in four of six trials with the WDG formulation, and

slightly lower or comparable residues were observed in the remaining two trials.

Berries Group, C rop Group 13

Grape

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on grapes (fruit) from 33

field trials conducted during 2008, 2009 and 2010 in Australia, New Zealand, Europe, and the

USA (NAFTA) . Ten trials were conducted in Australia (1 trial each i n New South Wales and

Western Australia; 2 trials in Victoria; and 3 trials each in South Australia and Queensland); 2

trials were conducted in New Zealand (North Island); 12 trials were conducted in Europe (6 trials

in the EU

- Northern Zone, France, German y, and Hungary, and 6 trials in the EU

- Southern Zone,

France, Greece, Italy, and Spain); and 9 trials were conducted in the US (2 trials in Zone 1 (PA);

5 trials in Zone 10 (CA), and 1 trial each in Zones 11 (WA) and 12 (OR)).

Following four foliar broa dcast applications of sulfoxaflor at a total rate of 0.276

- 0.390 lb a.i./A

(310

- 438 g a.i./ha)

, residues of sulfoxaflor were 0.01

- 1.9 ppm in/on grapes harvested at a ~7

- day

PHI. Residues of metabolites X11719474 and X11721061 were <0.01

- 0.18 ppm and <0.01

- 0.08

ppm, respectively

.

Conclusions : The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Strawberry

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on strawberries from 13

trials conducted during the 2008 and 2009 seasons in Australia, New Zealand, and the US

(NAFTA): 4 trials were conducted in Australia and New Zealand (1 trial each in South

Australia, Victoria and Queensland, and 1 trial on the North Island of New Zealand), and 9 trials

were conducted in the NAFTA (1 trial each in NAFTA Zone 1 (PA), 2 (GA), 3 (FL), 5 (MI), and

12 (OR), and 4 trials in NAFTA Zone 10 (CA)).

Followi ng four foliar broadcast or directed applications of sulfoxaflor at a total rate of 0.339

- 0.369 lb a.i./A (381

- 414 g a.i./ha) , r esidues of sulfoxaflor were 0.02

- 0.50 ppm in/on strawberries

harvested at a 1

- day PHI. Residues of metabolites X11719474 and X1 1721061 were each <0.01

- 0.04 ppm in/on strawberries.

Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 70 of 141 T ree N ut s , C rop G roup 14

Almonds

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on almonds (nutmeat and

hulls) from six field trials conducted during 2008 in NAFTA Zone 10 (CA; 6 trials).

Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.355

- 0.367 lb a.i./A

(398

- 411 g a.i./ha) , r esidues of sulfoxaflor ranged from <LOQ (0.010 ppm) to 0.013 ppm in/on

almond nutmeat and from 1.04 to 3.12 ppm in/on almond hulls harvested at 7

- da y PHI. Residues

of metabolites X11719474 and X11721061 were 0.0272

- 0.099 ppm and 0.0434

- 0.152 ppm,

respectively, in/on almond hulls harvested at 7

- day PHI. Residues of metabolites X11719474

and X11721061 were not detected above the LOQ in almond nutmeat samples.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP. In almond hulls, residues of sulfoxaflor tend to

decline with increasing PHI; residues of the metabolites remained relatively constant during the

investigated r ange of PHIs (21 days maximum).

Pecans

Dow AgroSciences, LLC submitted field trial data for s ulfoxaflor in/on pecans (nutmeat) from

six field trials conducted during 2009 in the US (NAFTA areas ) in Zones 2 (GA, 3 trials), 4 (AR,

1 trial), 6 (OK, 1 trial), and 8 (TX, 1 trial).

Following two foliar broadcast applications of sulfoxaflor at a total r ate of 0.360

- 0.363 lb a.i./A

(404

- 407 g a.i./ha)

, residues of sulfoxaflor and the metabolites X11719474 and X11721061 were

below the LOQ (0.01 ppm) in/on all samples of pecan nutmeat harvested at a 7

- day PHI.

Conclusions : The field trials are acceptab le and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Cereal Grain, Crop Group 15

Barley

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on barley (hay, grain, straw,

and forage) from 27 field trials conducted during 2008, 2009, and 2010 in Australia and New

Zealand, Europe, and the US (NAFTA areas ): 6 trials were conducted in Australia and New

Zealand ( 1 trial each in Queensland and South Australia, 2 trials in New South Wales, and 1 trial

each in on the North and South Islands of New Zealand); 15 trials were conducted in Europe (7

trials in the EU

- Northern Zone, Germany, Poland, UK; and 8 trials in the EU

- Southern Zone,

France, Italy, Spain, and Greece); and 6 trials were conducted in the US (1 trial in Zone 2 (GA),

1 trial in Zone 5 (MI), 2 trials in Zone 7 (NE and SD), one trial in Zone 9 (ID), and 1 trial in

Zone 11 (ID)).Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 71 of 141 Each field trial included o ne untreated plot and one or two treated plots in which sulfoxaflor,

formulated as a 240 g ai/L suspension concentrate (SC), was applied to barley as two foliar

broadcast applications at a target rate of 0.043

- 0.045 lb a.i./A/application, for a total seaso nal

rate of 0.086

- 0.090 lb ai/A (96

- 100 g a.i./ha); separate plots were established for hay and for

grain and straw in the EU and US trials . In addition, three separate plots were established in two

EU trials (Germany and Spain) to examine reverse decline in grain and straw; at these plots,

applications were made earlier in the season to plants at earlier growth stages. Four Australian

and two New Zealand trials included one or two additional treatment plots which received a

single application or two appl ications at ~0.021 lb ai/A/application (~24 g a.i./ha/application);

results from these plots are not included herein. Applications were made at ~14

- day retreatment

intervals (RTIs) using ground equipment in spray volumes of 10.2

- 46.3 gal/A (95

- 433 L/ha). A

commercial adjuvant (non

- ionic/organosilicone surfactant) was added to the spray mixture at

recommended rates for all applications. Single control and duplicate treated samples of hay were

harvested at target preharvest intervals (PHIs) of 7 days for h ay and 14 days for grain and straw.

In addition, forage samples were harvested at a target PHI of 7 days from two Australian and one

New Zealand trial . B arley forage is not considered to be a significant livestock feed item in the

US and Canada (OCSPP 860 .1000, Table 1).

Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.083

- 0.096 lb a.i./A

(94

- 108 g a.i./ha)

, residues of sulfoxaflor were <0.010

- 0.643 ppm in/on hay harvested at a ~7

- day PHI, and <0.01

- 0.37 and <0.01

- 2.2 ppm in/on grain and straw, respectively, harvested at a

~14

- day PHI. Residues of metabolites X11719474 and X11721061 were, respectively, <0.010

-

0.072 and 0.010

- 0.522 ppm in/on hay, <0.010

- 0.018 and <0.010

- 0.050 ppm in/on grain, and

<0.010

- 0.105 ppm and <0.01 0

- 0.190 ppm in/on straw.

Conclusions: The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP

.

Wheat (SC/WDG formulations)

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on wheat (forage, hay,

grain, and straw) from 38 trials conducted during the 2008

- 2009 season in Australia, New

Zealand, Brazil, Europe, the USA and Canada: 7 trials were conducted in Australia and New

Zealand (1 trial each in South Australia, Western Australia, and New South Wales, 2 trials in

Victoria, and 1 trial each on the North and South Islands of New Zealand), 4 trials were

conducted in Brazil, 16 tr ials were conducted in Europe (7 trials in the EU

- Northern Zone,

France, Germany, Poland and the United Kingdom; and 9 trials in the EU

- Southern Zone,

France, Greece, Italy, and Spain), and 11 trials were conducted in the US and Canada (1 trial

each in NAF TA Zone 2 (GA), 4 (AR), 5A (ON), 6 (TX), and 8 (TX), and 2 trials each in Zone 5

(MI and NE), 7 (ND and SD), and 14 (MB and SK)).

Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.084

- 0.098 lb a.i./A

(94

- 110 g a.i./ha)

, resi dues of sulfoxaflor were <0.01

- 0.067 in/on grain

. Residues of metabolites

X11719474 and X11721061 were, respectively, <0.01 and <0.01

- 0.021 ppm in/on grain

.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 72 of 141 In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor and metabolites

were generally similar to those following application of the SC formulation in/on all wheat

matrices. R esidues following application of the WDG formulation fell w ithin the range of

residues observed for the SC formulation, except for sulfoxaflor in straw, in which maximum

residues were slightly higher for the WDG formulation ; overall, n either formulation yielded

consistently higher residues of sulfoxaflor for any m atrix ; . Residues of sulfoxaflor, X11719474,

and X11721061 were 0.041

- 0.221, <0.01

- 0.025, and 0.039

- 0.323 ppm, respectively, in/on

forage; 0.101

- 0.167, 0.012

- 0.037, and 0.123

- 0.329 ppm, respectively, in/on hay; <0.01

- 0.063,

<0.01, and <0.01

- 0.016 ppm, resp ectively, in/on grain; and 0.060

- 1.641, 0.021

- 0.055, and 0.026

- 0.184 ppm, respectively, in/on straw.

Conclusions : The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use patte rn used in the study. That use

pattern is in accord with the proposed cGAP. In the side

- by

- side trials with the WDG

formulation, residues of sulfoxaflor and metabolites were generally similar to those following

application of the SC formulation. Neither formulation yielded consistently higher residues of

sulfoxaflor for any matrix.

Forage, Fodder and Straw of Cereal Grain, Crop Group 16

Barley

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on barley (hay, grain, straw,

and forage) from 27 field trials conducted during 2008, 2009, and 2010 in Australia and New

Zealand, Europe, and the NAFTA area as described above.

Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.083

- 0.096 lb a.i./A

(94

- 108 g a.i./ha)

, residues of sulfoxaflor were <0.010

- 0.643 ppm in/on hay harvested at a ~7

- day PHI, and <0.01

- 2.2 ppm in/on straw, harvested at a ~14

- day PHI. Residues of metabolites

X11719474 and X11721061 were, respectively, <0.010

- 0.072 a nd 0.010

- 0.522 ppm in/on hay,

a nd <0.010

- 0.105 ppm and <0.010

- 0.190 ppm in/on straw.

Conclusions: The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the s tudy. That use pattern is in

accord with the proposed cGAP.

Wheat (SC/WDG formulations)

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on wheat (forage, hay,

grain, and straw) from 38 trials conducted during the 2008

- 2009 season in A ustralia, New

Zealand, Bra zil, Europe, the USA and Canada as described above.

Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.084

- 0.098 lb a.i./A

(94

- 110 g a.i./ha)

, residues of sulfoxaflor were <0.01

- 1.4 and 0.024

- 1.024 pp m in/on forage and

hay, respectively, harvested at a ~7

- day PHI, and 0.030

- 1.562 ppm in/on straw, harvested at a

~14

- day PHI. Residues of metabolites X11719474 and X11721061 were, respectively, <0.01

-

0.079 and 0.015

- 0.359 ppm in/on forage, and <0.01

- 0.364 ppm in/on hay, and <0.01

- 0.064 and

0.016

- 0.203 ppm in/on straw. Residues of metabolites X11719474 and X11721061 were,Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 73 of 141 respectively, <0.01

- 0.079 and 0.015

- 0.359 ppm in/on forage, <0.01

- 0.127 and <0.01

- 0.364 ppm

in/on hay, <0.01 and <0.01

- 0.064 and 0.016

- 0.203 ppm in/on straw.

Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor and metabolites

were generally similar to those following application of the SC formulation. Neither formulation

yielded consistently higher residues of sulfoxaflor for any matri x.

O ilseed, Crop Group 20

Canola

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on canola/oil seed rape from

21 field trials conducted in Australia, Europe, and the US and Canada (NAFTA): 4 trials were

conducted during 2008

- 2009 in Australia (1 trial each in Victoria, Western Australia, New South

Wales, and South Australia); 8 trials were conducted in Europe in 2008

- 2009 and 2010 ( 5 trials

in EU

- Northern Zone

, and 3 trials in EU

- Southern Zone) ; and 9 trials were conducted during

200 8 in the US and Canada (1 trial in Zone 2 (GA), 3 trials in Zone 5 (MI and NE), 2 trials in

Zone 11 (ID and WA), and 3 trials in Zone 14 (MB, SK, and AB).

Following two foliar broadcast applications of sulfoxaflor at a total rate of 0.078

- 0.099 lb a.i./A

(88.1

- 110.8 g a.i./ha) , r esidues of sulfoxaflor were <0.01

- 0.224 ppm in/on canola seed harvested

at a ~14

- day PHI; residues of metabolites X11719474 and X11721061 were, respectively,

<0.01

- 0.097 and <0.01

- 0.04 ppm. In forage and stubble harvested at a ~14

- day PHI, residues of

sulfoxaflor were 0.03

- 1.5 and 0.02

- 1.1 ppm, respectively; respective residues of X11719474 and

X11721061 were 0.01

- 0.13 and 0.01

- 0.11 ppm in/on forage, and 0.03

- 0.11 and 0.02

- 0.10 ppm

in/on stubble.

Conclusions : The fiel d trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in the study. That use

pattern is in accord with the proposed cGAP.

Cotton

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on cotton seed and gin

byproducts from 22 field trials conducted during 2008, 2009, and 2010 in Australia, Brazil,

Europe and the US (NAFTA areas ). Four trials were conducted in Australia (2 trials each in

New South Wales and Queensland); 4 trials were conducted in Brazil; 8 trials were conducted in

Europe (Southern Zone, Greece and Spain); and 6 trials were conducted in the US (1 trial each in

Zones 2 (GA), 4 (AR), 6 (OK), and 10 (CA), and 2 trials in Zone 8 (TX)).

The Brazi l trials included one additional treatment plot (Treatment 3) reflecting a use pattern not

sought in Australia, Canada, or USA. These plots received two early

- season applications (made

pre

- boll formation) at a 14

- day RTI and two late

- season applications ( starting at boll opening) at

a 14

- day RTI; samples of cotton seed only were harvested at a target 14

- day PHI. Data forSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 74 of 141 Treatment 3 are in the Tier II review ; however, these results were not included in data summary

calculations.

Following four foliar br oadcast applications of sulfoxaflor at a total rate of 0.346

- 0.375 lb a.i./A

(389

- 422 g a.i./ha)

, r esidues of sulfoxaflor were 0.037

- 4.20 ppm in/on cotton gin by

- products

and < 0.01

- 0.182 ppm in/on undelinted seed harvested at a ~14

- day PHI. Residues of metabolite

X11719474 and X11721061 were, respectively, <0.01

- 0.250 and <0.01

- 0.570 ppm in/on gin by

products , and <0.01

- 0.020 and <0.01

- 0.046 ppm in/on seed.

In the Brazil t rials reflecting split season applications at a total rate of 0.344

- 0.362 lb a.i./A (387

- 407 g a.i./ha), residues in cotton seed were generally lower than were observed in the standard

trials. Residues of sulfoxaflor were <0.01

- 0.020 ppm at a 14

- day PHI, while residues of

metabolites X11719474 and X11721061 were below the LOQ (<0.01 ppm).

Conclusions : The field trials are acceptable and adequately reflect residues that may be

expected following application of sulfoxaflor per the use pattern used in th e study. That use

pattern is in accord with the proposed cGAP.

Soybean (SC/WDG formulations)

Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on soybeans (forage, hay,

and seed) from 19 trials conducted during the 2008

- 2009 seasons in Brazil and the US: 4 trials

were conducted in Brazil, and 15 trials were conducted in the US (2 trials in NAFTA Zone 2

(GA), 2 trials in Zone 4 (AR and MS), and 11 trials in Zone 5 (IA, IL, IN, MI, MO, NE, and

OH)).

Following two foliar broadcast applic ations of sulfoxaflor at a total rate of 0.178

- 0.183 lb a.i./A

(200

- 205 g a.i./ha)

, residues of sulfoxaflor in/on forage harvested at a ~7

- day PHI were 0.013

- 1.734 ppm. Following four foliar broadcast applications of sulfoxaflor at a total rate of 0.357

-

0 .371 lb a.i./A (400

- 416 g a.i./ha), residues of sulfoxaflor were 0.057

- 1.378 ppm in/on hay and

<0.01

- 0.214 ppm in/on seed harvested at a ~7

- day PHI. Residues of metabolites X11719474 and

X11721061 were, respectively, <0.01

- 0.264 and 0.112

- 1.018 ppm in/on forage, 0.050

- 3.131 and

0.085

- 3.379 ppm in/on hay, and <0.01 and <0.01

- 0.032 ppm in/on seed.

The petitioner noted that residues in the 13

- day PHI seed were higher than expected and

attributed this to the weather conditions, noting that leaching of residues through the pod or

breaking of pods due to rain and snow may have resulted in increased exposure of the seed.

Conclusions : The field trials are acceptable and adequately reflect residues that may be expected

following application of sulfoxaflor per the use pattern used in the study. That use pattern is in

accord with the proposed cGAP. The submitted residue data support two applications to soybean

forage.

In the side

- by

- side trials with the WDG formulation, residues of sulfoxaflor and metaboli tes

were generally similar to those following application of the SC formulation; neither formulation

yielded consistently higher residues of sulfoxaflor for any matrix.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 75 of 141 Processed Food and Feed (860.1520)

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B7 : Residue data



### T he effect of household processing and hydrolysis on aqueous samples containing 14C

sulfoxaflor, 14C

- X11719474, and 14C

- X11721061 was also studied. Radiolabeled compounds

were added at a concentration of 1 mg/L to vials of citric acid buffer prepared at a target pHs of

4, 5, and 6. The pH 4, 5, and 6 vials were subjected to hydrolysis at temperatures of 90, 100, and

120oC, respectively, for at least 20 minutes. S ulfoxaflor and X11721061 were stable to

hydrolysis during this testing . The compound X11719474 was stable to hydrolysis at pH 4 and

90 oC for 20 minutes, but was degraded to some extent with increased pH and temperature, with

formation of on e degradate, X11579457, accounting for approximately 3.8% and 11.6% of the

total radioactivity when boiled at 100°C for 60 minutes (pH 5) and steamed at 120°C for 20

minutes (pH 6), respectively. Typical food processing such as baking, boiling and canning are

unlikely to significantly affect the nature and magnitude of sulfoxaflor residues.

Table 30 : Identification of Radioactivity in Hydrolyzed Buffered Water*.

Analyte 14 C

- sulfoxaflor 14 C

- X11719474 14 C

- X11721061

pH 4 pH 5 pH 6 pH 4 pH 5 pH 6 pH 4 pH 5 pH 6

Sulfoxaflor 99.6 100.0 100.4

- - - - - -

X11719474

- - - 99.0 96.9 89.1

- - -

X11721061

- - - - - - 100.0 99.9 99.7

X11579457

- - - 0.4 3.8 11.6**

- - - Accountability 99.6 100.0 100.4 99.4 100.7 100.7 100.0 99.9 99.7

*Only the pH is reported in this table. **Confirmed by LC/MS/MS.



### Processing studies were conducted on apple, barley, cabbage, canola, carrot, cherry, cotton,

grapes, head lettuce, leaf lettuce, onions, oranges, potato, soybean, strawberry, sugar beet,

tomato, and wheat. The results are summarized in Table 31

.

Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Apple Apple Fruit

RAC

(prior to

processing)

*

0.716

(802.2) 7 0.343 0.030 (0.009)

-- -- --

Washed

apples 0.246 0.018 0.010 0.7x 0.6x 1.0x

Apple sauce 0.202 0.020 (0.009) 0.6x 0.7x NC

Juice 0.128 (0.009) (0.005) 0.4x 0.3x NC

Wet

pomace 0.365 0.034 0.016 1.1x 1.1x 1.6x

Dry pomace 1.431 0.143 0.051 4.2x 4.8x 5.1xSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 76 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Canned

apples (0.0098) ND (0.003) 0.03x 0.3x NC

Dried

apples 0.118 (0.009) 0.018 0.3x 0.3x 1.8x

* Note : Apple fruit RAC samples analyzed after collection had similar residues (0.362 ppm, 0.028 ppm, and

0.009 ppm) to RAC samples analyzed prior to processing.

Barley Grain prior

to

processing *

0.277

(311.7) 16 0.174 0.014 0.055

-- -- --

Pearl barley 0.130 0.012 0.037 0.7x 0.9x 0.7x

Pot barley 0.152 0.013 0.055 0.9x 0.9x 1.0x

Bran 0.167 0.018 0.071 1.0x 1.3x 1.3x

Flour 0.132 0.010 0.016 0.8x 0.7x 0.3x

Cleaned

barley 0.165 0.019 0.062 0.9x 1.4x 1.1x

Brewing

malt 0.163 0.016 0.041 0.9x 1.1x 0.7x

Malt

sprouts 0.224 0.030 0.039 1.3x 2.1x 0.7x

Beer 0.029 0.011 0.013 0.2x 0.8x 0.2x

Spent grains 0.029 (0.003) 0.020 0.2x 0.7x 0.4x

Brewer’s

yeast 0.026 ND 0.012 0.1x 0.7x 0.2x

* Note: Barley RAC samples analyzed after collection had similar residues (0.16 ppm, 0.014 ppm, and 0.041 ppm) to RAC samples

analyzed prior to processing.

Cabbage Heads

(upon

collection

of field

samples) g

0.734

(824) 3 0.429 0.089 0.035

-- -- --

Heads prior

to

processing

(inc.

wrapper

leaves) 0.180 0.065 0.016

-- -- --

Inner leaves 0.014 0.025 ND 0.1x 0.4x 0.6xSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 77 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Outer

(wrapper)

leaves 0.322 0.126 0.030 1.8x 1.9x 1.9x

Cooked

head (0.009) (0.009) (0.003) 0.1x 0.2x 0.6x

Cooking

liquid (0.007) (0.007) (0.005) 0.1x 0.2x 0.6x

Sauerkraut 0.017 0.028 ND 0.1x 0.4x 0.6x

Sauerkraut

juice 0.013 0.024 ND 0.1x 0.4x 0.6x

* Note: These values are not used in calculation of the processing factor. The cabbage RAC was stored under “cool”

conditions prior to processing, and was not kept in frozen storage.

Oil seed

, rape/

Taurus Seeds prior

to

processing

0.264

(296.4) 14 0.033 (0.004) (0.006)

-- -- --

Cleaned

seeds 0.037 ND (0.007) 1.1x NC NC

Meal 0.063 (0.006) (0.009) 1.9x NC NC

Crude oil ND ND ND 0.3x NC NC

Refined oil ND ND ND 0.3x NC NC

Solvent

extracted

meal 0.072 (0.008) (0.009) 2.2x NC NC

NC = Not calculated because residues were not detected above the LOQ in the RAC and processed fraction.

Canola RAC samples analyzed after collection had similar residues (0.038 ppm, ND, and <LOQ) to RAC samples analyzed

prior to processing.

Carrot Carrot root

(RAC) 1.092

(1,224) 7 0.0101 ND ND

-- -- --

Washed and

peeled root (0.0082)

ND ND

ND ND

ND <1.0x NC NC

Cooked

carrot ND

ND ND

ND ND

ND <1.0x NC NC

Cooking

liquid 0.0130

(0.0085)

Avg. 0.012 ND

ND ND

ND 1.1x NC NC

Carrot juice 0.0234

0.0246

Avg. 0.0240 (0.0039)

(0.0048) ND

ND 2.4x NC NC

Canned

carrot ND

ND ND

ND ND

ND <1.0x NC NC

NC = Not calculated ; residues were below the LOQ (<0.01 ppm) in both RAC and processed fraction for metabolites.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 78 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Cherr y Whole

cherries *

(RAC)

(prior to

processing)

0.715

(803) 7 0.765 0.023 0.033

-- -- --

Washed

cherries 0.648 0.026 0.026 0.8x 1.1x 0.8 x

Canned

cherries 0.737 0.043 0.044 1.0x 1.9x 1.3 x

Juice 0.653 0.022 0.040 0.9x 1.0x 1.2 x

Jam 0.838 0.031 0.048 1.1x 1.3x 1.5 x

Dried

cherries 3.950 1.572 0.384 5.2x 68x 12 x

* Cherry fruit RAC samples analyzed after collection had similar residues (0.616 ppm, 0.035 ppm, and 0.039 ppm) to RAC

samples analyzed prior to processing.

Cotton Seed (RAC)

1.08

(1,21 3 ) 15 0.1001 ND 0.0469

-- -- --

Aspirated

seed

fractions 2.3197 0.1230 0.1703 23x 12x 4x

Delinted

seed 0.0983 ND 0.0455 1.0x NC 1.0x

Hulls 0.1846 (0.0074) 0.0457 1.8x NC 1.0x

Meal 0.0822 (0.0058) 0.0553 0.8x NC 1.2x

Meal press

cake 0.0781 ND 0.0471 0.8x NC 1.0x

Crude oil (0.0059) ND 0.258 <0.1x NC 5.5x

Refined oil ND ND ND <0.1x NC <0.2x

Control specimens were collected and analyzed. No residues were detected in the unfortified control samples except in

aspirated seed fractions, where detectable residues of 0.1728, 0.0165, and 0.0217 ppm for sulfoxaflor , X11719474, and

X11721061, respectively

, were observed. N C = Not calculated ; residues were below the LOQ in both the RAC and

processed fractions.

Grape/

Pinot Noir RAC

( prior to

processing )

0.739

( 830 ) 7 0. 2 43 0.0 54 0.018 -- -- --

Raisins 0. 85 6 0. 285 0.066 3.5 x 5.3 x 3.7 x

Juice 0. 164 0.0 43 (0.00 8 ) 0. 7 x 0. 8 x <0.6xSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 79 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Wine

bottled 0.1 71 0.056 0.010 0. 7 x 1.0x 0.6x

P omace 0. 237 0.0 78 0.0 30 1 .0 x 1 .4 x 1.7 x

Head

Lettuce Heads with

wrapper

leaves

(RAC; prior

to

processing )

0.7 48

(8 37

. 9 ) 3 0. 592 0. 100 0.106

-- -- --

Wrapper

leaves 0. 593 0. 132 0.229 1.0X 1.3X 2.2X

Unwashed

heads

without

wrapper

leaves 0. 354 0.0 86 0.059 0.6 X 0. 9X 0.6X

Washed

heads 0.1 46 0.025 0.016 0. 2X 0.3 X 0.2X

Washings 0. 04 5 (0.004) (0.006) 0.1X <0.1 X <0.1 X

Head lettuce RAC samples analyzed after collection had similar residues (0.507 ppm, 0.081 ppm, and 0.07 ppm) to RAC

samples analyzed prior to processing.

Leaf

Lettuce Unwashed

lettuce

(RAC; prior

to

processing) 0.7 28

(8 18 ) 3 0. 654 0. 243 0. 115

-- -- --

Washed

lettuce 0. 488 0. 210 0.129 0. 7 x 0. 9 x 1.1 x

Washings 0. 159 0. 026 ND 0.2 x 0.1 x <0.1x

Onion Whole

onion

(RAC)

1.09

( 1,2 2 5 ) 7 ND ND ND

-- -- --

Peeled

onion ND ND ND NC NC NC

Dried onion ND ND ND NC NC NC

Orange

(Valencia) Pulp RAC *

1.79

(2.00) 1 (0.0039) ND ND

-- -- --

Peel RAC * 0.3661 0.0143 (0.0065)

-- -- --

Whole

orange

RAC *

(peel +pulp) 0.0625 (0.0049) ( 0. 0036)

-- -- --Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 80 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Juice (0.004 2 ) ND ND <0.2X NC NC

Wet pulp 0.1567 (0.0062 ) (0.0085) 2.5X NC NC

Dried pulp 0.5159 0.0193 0.0225 8.3X >1.9X >2.3X

Peel 0.5714 0.0256 0.0156 9.1X >2.6X >1.6X

Oil ND ND ND <0.2X NC NC

Marmalade ND ND ND <0.2X NC NC

Canned

slices ND ND ND <0.2X NC NC

*Oranges were separated into peel and pulp prior to analysis . Processing factors were calculated using the whole

orange RAC (peel + pulp) residues, which were calculated by the study reviewer as the sum of the peel and pulp

residues, adjusted for the individual weights of the fractions

.

Potato

(Kuras) Potato

tubers *

(RAC)

1.05

( 1,176 ) 7 0. 012 0.0 43 (0.009)

-- -- --

Washed

potatoes 0. 014 0.0 59 ( 0.0 08) 1.2X 1.4X NC

Peeled

potatoes 0. 019 0.0 69 (0.009) 1 .6 X 1.6X NC

Peel 0. 022 0.109 0.013 1.8X 2.5X >1.3X

Potato

flakes 0. 030 0. 100 ( 0.0 08) 2.5X 2.3X NC

Micro

waved

potatoes 0.013 0. 042 ( 0.0 07) 1.1X 1.0X NC

Boiled

potatoes 0.012 0.042 (0.00 5 ) 1.0X 1.0X NC

Cooking

water (0.006) 0.021 ( 0.0 05) < 0. 8X 0. 5X NC

Potato chips 0.025 0.106 (0.005) 2.1X 2.5X NC

Dried

potatoes 0.043 0.184 0.017 3.6X 4.3X >1.7X

French fries 0.019 0.052 ND 1.6X 1.2X NC

*Unpeeled and unwashed; sampled just prior to processing.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 81 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Soybean Seed (RAC)

1.10

( 1, 23 6 ) 7 0.0 727 ND 0.0134

-- -- --

AGF 6.8871 * 0.3256 * 0.4296 * 95X 33x 32X

Meal 0.0 964 (0.0052) 0.0 246 1.3X NC 1.8X

Hulls 0. 1079 ND 0.0156 1.5X NC 1.2X

Pressed

cake 0. 0793 (0.00 34 ) 0.0157 1 .1X NC 1.2X

Expeller

crude oil 0. 0220 ND ( 0.0 067) 0.3X NC <0.7 X

Solvent

extracted

crude oil 0.0203 ND ND 0.3X NC <0.7 X

Refined oil ND ND ND <0.1 X NC <0.7 X

* Results are the mean of re

- analysis.

Strawberry Unwashed

strawberry

0.7 24

( 812 ) 1 0.2003 0.0 124 (0.00 84 )

-- -- --

Washed

strawberry 0. 1670

0.1859

[ 0.1765 ] (0.0076)

0.0143

[ 0.0122 ] (0.00 60 )

(0.0058)

[ 0.0059 ] 0.9 X 1.0X NC

Juice 0. 0498

0.0564

[ 0.0531 ] (0.0050)

(0.0048)

[ 0.0049 ] ND

ND 0. 3X <0.8 X NC

Canned

strawberry 0.1215

0.1180

[ 0.1198 ] 0.0113

(0.0097)

[ 0.0107 ] (0.00 71 )

(0.0072)

[ 0.0072 ] 0.6 X 0.9 X NC

Jam 0. 0830

0.0702

[ 0.0766 ] (0.00 76 )

(0.0068)

[ 0.0072 ] (0.00 44 )

(0.0038)

[ 0.0041 ] 0.4 X <0.8 X NC

Samples were analyzed in duplicate; average residues are bolded and reported in brackets. Residues <LOQ were assigned

a value of 0.01 ppm when averaged with a detectable residue.

Sugar beet Sugar beet

root (RAC;

( prior to

processing )

1.06

( 1,191 ) 7 0. 013 0.0 21 ND

-- -- --

Pulp ( 0. 005) ( 0.0 06) ND <0.8x <0.5x NC

Press water (0.006) ( 0.0 07) ND <0.8x <0.5x NC

Raw juice 0. 01 8 0.023 (0.006) 1.4x 1.1x NCSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 82 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Thin juice 0. 014 0.0 27 ND 1.1x 1.3x NC

Lime sludge (0.010) 0. 02 3 ND <0.8x 1.1x NC

Thick juice 0.061 0.126 ND 4.7x 6.0x NC

Raw sugar 0. 023 0.048 ND 1.8x 2.3x NC

White sugar (0.006) 0.011 ND <0.8x 0.5x NC

Molasses 0.135 0.281 ND 10x 13x NC

Dried pulp 0.039 0.044 ND 3.0x 2.1x NC

Tomato Tomato

RAC

0.7 19

(80 7

. 8 ) 1 0. 119 0.0 12 (0.009)

-- -- --

Fruit,

washed and

peeled 0. 141 0.01 4 0.01 3 1.2X 1.2X >1.3X

Juice 0. 117 0.0 15 (0.009) 1.0X 1.3X NC

Canned 0. 093 0.015 0.014 0. 8X 1 .3 X >1.4X

Ketchup 0. 250 0.0 29 0.01 7 2.1X 2.4X >1.7X

Puree 0.235 0. 022 0.0 16 2.0X 1 .8 X >1.6X

Paste 0.518 0.060 0.034 4.4X 5.0X >3.4X

Wheat Wheat

Grain

(RAC)

0. 444

( 499 ) 15 0.0650 0.0130 0.0276

-- -- --

Aspirated

Grain

Fraction 1.3817 0.2892 0.3625 21X 22X 13X

Total bran 0.0230 ND 0.0190 0.4X <0.8X 0.7X

Germ 0.0307 ND 0.0399 0.5X <0.8X 1.4X

Bran 0.0279 ND 0.0223 0.4X <0.8X 0.8X

Middlings 0.0109 ND ND 0.2X <0.8X <0.4X

Shorts 0.0132 ND ND 0.2X <0.8X <0.4XSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 83 of 141 Table 31

. Residue data from processing stud ies with Sulfoxaflor (XDE

- 208)

RAC Processed

Commodity Total Rate

lb a.i./A

(g a.i./ha) PHI a

(day) Residues (ppm) b,c ,d Processing Factor e

XDE

- 208 X117 1 9474 X11721061 XDE

- 208 X117 1 9474 X11721061

Whole meal

flour 0.0136 ND 0.0135 0.2X <0.8X 0.5X

Refined

white flour (0.0079) ND ND <0.2X <0.8X < 0.4X

Whole grain

bread (0.0091) ND (0.0064) <0.2X <0.8X <0.4X

White bread (0.0046) ND ND <0.2X <0.8X <0.4X

Gluten ND ND ND <0.2X <0.8X <0.4X

Gluten feed

meal (0.0073) ND ND <0.2X <0.8X <0.4X

Starch ND ND ND <0.2X <0.8X <0.4X

a PHI = Preharvest Interval. ND = Non Detectable where residues were below the limit of detection (<LOD). LOD = 0.003

ppm.

b Residue values in parenthesis are <LOQ but >LOD. The LOQ was 0.010 ppm and the LOD was 0.003 ppm.

c Control specimens were collected and anal yzed. No residues were detected for the unfortified control samples nor were any

analytical interferences present in any untreated control sample.

d Processing factors were calculated using the equation: Processing Factor = [Measured residue for analyte in the processed

fraction] / [Measured residue for analyte in the RAC prior to processing]. Residues <LOQ and ND were assigned a value of

0.01 ppm for calculation purposes.

e NC = Not calculated because residues were not detected above the LOQ in the RAC and p rocessed fraction.



### Conclusions

. T he processing studies that were submitted are acceptable , with the except ion of

one of the wheat processing studies for which a replacement study was submitted and is

summarized in Table 31

. They were performed in accordance with the OECD guidance and can

be used in the dietary risk assessment and for evaluating the tolerances/MRLs for processed

commodities

.

Confined Accumulation in Rotational Crops (Field; 860.1850)

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B7 : Residue data



### 14C

- sulfoxaflor was applied to bare sandy loam soil in California, at a nominal rate of 600 g

a.i./ha. Radishes (cherry belle), lettuce (but ter crunch), and wheat (summit) were planted after

aging for the following plant back intervals (PBIs) : 30, 120, and 365 days. Immature and mature

radishes, immature and mature lettuce, wheat forage, wheat hay (fresh cut and dry cut), and

mature wheat grain and st raw were harvested at each P BI.

The respective TRRs in immature radish tops, mature radish tops, and mature radish roots were

1.383, 1.259, and 0.156 ppm for 30 day PBI; 0.458, 0.500, and 0.088 ppm for the 120 day PBI;

and 1.785, 1.239, and 0.061 ppm for the 365 day PBI. X11719474 c omprised the major residue

in all radish matrices at all PBIs (46.8

- 88.5 % TRR; 0.071

- 0.993 ppm). Sulfoxaflor was not

detected in mature radish roots, but was found in immature and mature radish tops at all PBIs

(0.9

- 3.2 % TRR; 0.008

- 0.040 ppm). The glucos e conjugate of X11721061, the glucose plusSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 84 of 141 malonyl conjugate of X11721061, X11721061, X11579457, and X11519540 were found in

immature and mature radish tops at < 7.0 % TRR (<0.13 ppm) at all PBIs, expect for X11721061

which was not detected at the 120 day PBI.

The respective TRRs in immature and mature lettuce were 1.713 and 0.743 ppm for the 30 day

PBI; 0.584 and 0.505 ppm at the 120 day PBI; and 0.841 and 0.383 ppm for the 365 day PBI.

X11719474 comprised the major residue in immature and mature lettuce at all PBIs (47.7

- 68.8 %

TRR; 0.183

- 0.817 ppm). Sulfoxaflor was not detected in mature lettuce at the 120 day PBI, but

was found in all other lettuce samples (<~2 % TRR; ≤0.03 ppm). The glucose conjugate of

X11721061, the glucose plus malonyl conjugate of X11721061, X11721061, X11579457, and

X11519540 were found in immature and mature lettuce (<~7.5 % TRR; <0.08 ppm), except for

X11721061 was not detected in immature lettuce at the 120 day PBI.

The respective TRRs in wheat forage, hay, straw, and grain were 1.472, 1.255, 2.047, and 0.077

ppm for the 30 day PBI; 0.260, 2.634, 3.805, and 0.081 ppm for the 120 day PBI; and 0.218,

1.137, 0.708, and 0.019 ppm for the 365 day PBI. X11719474 comprised the major residue in all

matrices (39.5

- 68.4 % TRR; 0.013

- 1. 504 ppm). Sulfoxaflor was not detected in wheat grain at

any PBI, in hay at the 365 day PBI, and in forage at the 120 and 365 day PBIs. The glucose

conjugate of X11721061, the glucose plus malonyl conjugate of X11721061, X11721061,

X11579457, and X11519540 were found in all wheat matrices at all PBIs (~≤6 %; ≤0.20 ppm),

except in wheat grain where levels were not detected at any PBI and in 120 day wheat forage

where X11519540 was not detected. Sulfoxaflor was taken up as pectin, lignin, hemicellulose,

and c ellulose in samples of wheat forage, hay, and straw where further bound residue

determinations were conducted.

Conclusions . Metabolism of sulfoxaflor in rotated crops is understood and is similar to that of

primary crops. Furthermore, this confined crop rotation study shows that a field accumulation

study is needed to establish PBIs and possibly MRLs in rotated crops.

X11719474 is the predominant residue observed in rotational crops. However, field rotational

crop studies demonstrate that the maximum amount of X11719474 taken up by succeeding crops

is similar to the maximum amount present in primary crops after foliar treatments. As these

summed levels of X11719474 are still low relative to the amount of parent sulfoxaflor in most

primary crops, risk assessments based on parent sulfoxaflor will be protective for any

X11719474 residues taken up by rotational crops. An exception to the preceding generalization

regarding relative metabolite levels was noted for the root and tuber vegetables. However, fo r

these crops, the maximum residue levels are low (<0.04 ppm). Thus, a separate residue of

concern definition for rotational root and tuber vegetable crops was not considered necessary.

Also, because there are few potential rotational crops that are not proposed for primary crop

tolerances, concerns regarding rotational crop issues are low. Based on the above considerations

combined with its substantially lower toxicity relative to sulfoxaflor, X11719474 is excluded

from the residue definition. For tole rance enforcement, parent sulfoxaflor is considered an

adequate indicator of misuse for the proposed application methods. Should there ever be soil

directed applications of sulfoxaflor to primary crops, there is a potential for significant residues

of X11 719474 in rotated crops, requiring this decision to be revisited.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 85 of 141 Field Accumulation in Rotational Crops (Field; 860.1900)

Sulfoxaflor (XDE

- 208, GF

- 2032/GF

- 2372), OECD Joint Review Project, Section B7 : Residue data



### Dow AgroSciences, LLC submitted limit ed field rotational crop data for sulfoxa flor in/on a root

crop (radish roots and tops), leafy vegetable (mustard green leaves), cereal grain (sorghum

forage, stover, and grain), and grass (forage and hay) from two field trials conducted during

2008

- 2009 i n NAFTA Zone s 2 ( GA ) and 10 (CA) . Rotational crops were planted after a primary

crop of spinach (GA) or carrot (CA) in 2008, or leaf lettuce (both sites) in 2009. The plots

treated in 2008 were used for the targeted 180

- day plant back interval (PBI), and the plots treated

in 2009 were used for the remaining PBIs (30, 90, and 295 or 361 days).

Each field trial included two treated plots in which sulfoxaflor, formulated as a 240 g a.i./L

suspension concentrate (SC), was applied to the primary crop as four foliar broadcast

applications at a target rate of 0.09 lb a.i./A/application, for a total seasonal rate of 0.36 lb a

. i

. /A

. The applications were made at target 7

- day retreatment intervals (RTIs) using ground equipment

(spray boom) in spray volume s of 20.7

- 30.7 gal/A. A commercial adjuvant (organosilicone/non

ionic surfactant) was added to the spray mixture at recommended rates for all applications.

Spinach, carrots, and lettuce (primary crops) were harvested from each plot at a preharvest

interv al (PHI) of 3 days. Rotational crops of radish, mustard greens , sorghum, and grass were

planted at targeted PBIs of ~ 30, 90, 180, and 270

- 365 days

.

The petitioner noted that the spinach and carrots were treated in connection with magnitude of

the residue (MOR) studies; residue results for these crops are not reported herein. It was further

noted that lettuce from the GA plot had matured beyond bolting (i.e., beyond commercial

maturity) at harvest.

Single control and duplicate treated samples of rotation al crops were harvested at maturity at

each PBI. Samples of sorghum stover and grain were not collected from the CA trial at the 361

- day PBI because the crop failed to mature due to poor weather conditions.

In rotational crop commodities, residues of sul foxaflor were <0.01 in/on all commodities at all

PBIs, except for two samples showing trace residues ( between the LOQ and LOD ) and the 124

- day radish tops sample from the CA trial . In the radish tops sample , residues were 0.023 ppm;

the petitioner noted t hat apparent residues of 0.055 ppm sulfoxaflor were also observed in the

corresponding control sample.

Metabolite X11719474 was identified in most rotational crop commodities and was the major

residue component. In general, residues declined with increas ing PBI, except in grass hay.

Metabolite X11719474 was the only identified residue in radish roots, at <0.01

- 0.031 ppm at the

30

- day PBI and <0.01

- 0.011 ppm at the 90

- and 124

- 180

- day PBIs. Quantifiable residues of

metabolite X11719474 were observed at a ll PBIs in/on radish tops, mustard greens, and grass

hay: respective residues at the 30

- and 361

- day PBIs were 0.027

- 0.364 and 0.015

- 0.032 ppm for

radish tops; 0.040

- 0.292 and 0.013

- 0.020 ppm for mustard greens; and <0.01

- 0.030 and <0.01

- 0.033 ppm for gr ass hay. Quantifiable residues were observed at the 30

- , 90

- , and 180

- day PBIs

in sorghum and grass forage; respective residues at the three PBIs were 0.012

- 0.030, <0.01

-Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 86 of 141 0.022, and <0.01

- 0.044 ppm for sorghum forage, and 0.013

- 0.054, <0.01

- 0.038, and 0.01 4

- 0.024

ppm for grass forage.

Quantifiable residues of metabolite X11721061 were observed in/on: 30

- day radish tops (<0. 01

- 0.025 ppm); 30

- and 180

- day mustard greens (<0.01

- 0.027 and <0.01

- 0.014 ppm, respectively);

180

- day sorghum forage (<0.01

- 0.014 ppm ); and 90

- day grass forage (<0.01

- 0.012 ppm).

Residues were below the LOQ in/on all remaining rotated crop commodities.

The highest residues of soil metabolite X11519540 were observed in 180

- day radish tops at

<0.01

- 0.035 ppm; residues were <0.01 to ≤0.01 6 ppm in/on 30

- day radish tops, 30 and 180

- day

mustard greens, 90

- day grass forage, and 90

- and 180

- day grass hay. Residues were below the

LOQ in/on all remaining rotated crop commodities.

Quantifiable residues of soil metabolite X11579457 were observed in/on: 30

- , 90

- , and 180

- day

radish tops at <0.01

- 0.026, <0.01

- 0.013, and <0.01

- 0.019 ppm, respectively; 30

- and 90

- day

mustard greens at <0.01

- 0.024 and <0.01

- 0.010 ppm, respectively; 30

- , 90

- , and 180

- day

sorghum forage at <0.01

- 0.010, <0.01

- 0.011, and <0.01

- 0.024 ppm; 30

- and 90

- day grass forage

at <0.01

- 0.013 and <0.01

- 0.025 ppm, respectively; and 90

- , 180

- , and 361

- day grass hay at

<0.01

- 0.026, <0.01

- 0.027, and <0.01

- 0.011 ppm, respectively. In general residues tended to

decline with increasing PBI. Residues were below the LOQ in/on all remaining rotated crop

commodities.

Conclusions : The supervised residue trials on rotated crops are considered fully reliable. Based

on the study results, residues of sulfoxaflor are not expected to accumulate above the LOQ in

root, leafy vegetable, cereal grain, or grass commodities planted at PBIs of 30, 90, 180, or 295

- 361 days following four foliar broadcast applications of sulfoxaflor formulated as a 240 g/L SC,

at a total rat e of 0.360

- 0.363 lb a.i./A to primary crops.

The proposed 30

- day plant back interval is considered adequate, and HED notes that there are

only a few commodities that are not proposed for registration that could be rotational crop

options

.

Samples were an alyzed for sulfoxaflor and metabolites using an acceptable method . T he study is

supported by adequate storage stability data

. The method was adequately validated prior to and

in conjunction with the analysis of the field trial samples

. The validated limit of quantitation

(LOQ) was 0.010 ppm

, and the reported limit of detection (LOD) was 0.003 ppm for each

analyte in /on all matrices.

Tolerance Derivation

The OECD MRL calculat ion procedures were used to determine the MRLs for all commodities.

The three countries participating in this joint review, Australia, Canada, and the U. S ., all agreed

to use the OECD MRL c alculat ion procedures to determine recommended MRLs. The

procedures generate MRLs based on mean field trial values. As a result, the means of the two

samples taken at each trial site were used to arrive at the recommended MRLs. For crop groups,

the MRL was set at the highest MRL for a representative commodity of that group. TheSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 87 of 141 individual spreadsheets for the various commodities can b e found in A ppendix 4, while the

worksheets for crop groups can be found in Appendix 5

.

Appendix 1. Tolerance Summary for Sulfoxaflor

Appendix 2 . Field Trial Geographic Representation

Appendix 3 . Summary Table of NAFTA and European Field Trial Data

A ppendix 4 . Field Trial Data and OECD MRL Calculator Output

Appendix 5 . Individual MRLs for Representative Commodities and Crop Group MRLs

Appendix 6 . Chemical Structures of Important Metabolites Ident ified in Metabolism Studies and

Analyzed in Field T rials and Livestock Feeding StudiesSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 88 of 141 Bibliography

860.1300 Nature of the residue

- plants, livestock

47832032 Rotondaro, S.; Balcer, J.; Smith, K. (2010) A Nature of the Residue Study with Carbon 14

-

XR

- 208 Applied to Rice: (Amended Report). Project Number: 070034/OCR. Unpublished

study prepared by Dow AgroSciences, LLC, Research for Hire and ABC Laboratories, Inc.

166 p.

47832075 Hastings, M.; Rotondaro, S.; Baker, J. (2010) A Nature of the Residue Study with

[(Carbon 14)]

- XR

- 208 Applied to Peas. Pr oject Number: 070035/OCR, 070035.

Unpublished study prepared by Research for Hire, Dow AgroSciences, LLC and ABC

Laboratories, Inc. 144 p.

47832079 Liu, D.; Adelfinskaya, Y. (2010) A Nature of the Residue Study in the Laying Hen with

[Carbon 14]

- X1171947 4, a Metabolite of XDE

- 208. Project Number: 090078, 090078/OCR.

Unpublished study prepared by Dow AgroSciences, LLC and Southwest Bio

- Labs, Inc. 113

p.

47832080 Becker, J. (2010) A Nature of the Residue Study in the Ruminant with (Carbon 14)

- XDE

208. Pro ject Number: 080005. Unpublished study prepared by Southwest Bio

- Labs, Inc. 140

p.

47832084 Rotondaro, S. (2010) A Nature of the Residue Study in the Ruminant with [Carbon 14]

- X11719474, Metabolite of XDE 208. Project Number: 090066. Unpublished study p repared

by Southwest Bio

- Labs, Inc. 129 p.

47832225 Rotondaro, S. (2010) A Nature of the Residue Study with (carbon 14)

- XDE

- 208 Applied to

Tomatoes: Amended Report. Project Number: 070021, 22109/5051/1, R050708. Unpublished

study prepared by Dow AgroSci ences LLC and Research for Hire and ABC Laboratories,

Inc. 151 p.

47832226 Graper, L.; Smith, K. (2010) A Nature of the Residue Study with (carbon 14)

- XR

- 208

Applied to Lettuce. Project Number: 070033, 22109/5051/2, R050707. Unpublished study

prepared by Dow AgroSciences LLC and Research for Hire and ABC Laboratories, Inc. 148

p.

47832227 Rotondaro, S. ; Smith, K. (2009) A Nature of the Residue Study in the Laying Hen with

14C

- XDE

- 208. Project Number: 080006, 008/01027. Unpublished study prepared by Dow

AgroSciences LLC and Southwest Bio

- Labs, Inc. 115 p.



### 860.1340 Residue analytical method

47832030 Rodrigues, A. (2010) Residue Method Validation for the Determination of XDE

- 208 and its

Major Metabolites (X11719474 and X11721061) in Agricultural Commodit ies and Processed

Products using On

- Line Solid

- Phase Extraction and Liquid Chromatography with Tandem

Mass Spectrometry Detection. Project Number: 091031/OCR. Unpublished study prepared by

Dow AgroSciences Industrial Ltda. 88 p.

47832031 Rodrigues, A. (2010) Enforcement Method for the Determination of Sulfoxaflor (XDE

208) and its Main Metabolites in Agricultural Commodities using Offline Solid

- Phase

Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 89 of 141 Project Numb er: 091116/OCR. Unpublished study prepared by Dow AgroSciences

Industrial Ltda. 91 p.

47832148 Grotenhuis, A.; Wendelburg, B. (2010) Radiovalidation of Analytical Methods for the

Determination of the Residues of XDE

- 208 (Sulfoxaflor) in Agricultural Com modities

and Animal Tissues. Project Number: 101569, 101569/OCR. Unpublished study prepared

by Dow Agrosciences, LLC. 91 p.

47832259 Wendelburg, B. (2010) Method Validation Study for the Determination of Residues of XDE

208 and its Major Metabolites in B ovine and Poultry Tissues using Offline Solid

- Phase

Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection. Project

Number: 091188/OCR, 091188. Unpublished study prepared by Dow AgroSciences, LLC.

76 p.

47832260 Rawle, N. (2010) Lab oratory Validation of a Method for the Determination of XDE

- 208,

X11719474 and X11721061 in Bovine Milk, Skim Milk, Cream, Muscle, Liver Kidney

and Fat: Final Report. Project Number: /091149, CEMS/4567. Unpublished study prepared

by CEM Analytical Services , Ltd. 264 p.

47832261 Clements, B. (2010) Laboratory Validation of a Method for the Determination of XDE

- 208,

X11719474 and X11721061 in Hen Eggs, Muscle, Liver and Fat: Final Report. Project

Number: CEMR/4568, CEMS/4568. Unpublished study prepared by C EM Analytical

Services, Ltd. 164 p.

47832262 Merdian, H. (2010) XDE

- 208: Assessment, Development and Validation of Analytical

Methods for the Determination of XDE

- 208 in Plant Materials, Foodstuffs of Animal Origin,

Soil and Water. Project Number: 10109 5, P/1901/G. Unpublished study prepared by PTRL

Europe Gmbh. 109 p.

47832271 Seal, S. (2010) Independent Laboratory Validation Study for the Determination of Residues

of Sulfoxaflor (XDE

- 208) and its Major Metabolites in Bovine and Poultry Tissues Using

Offline Solid

- Phase Extraction and Liquid Chromatography with Tandem Mass

Spectrometric Detection. Project Number: 101098. Unpublished study prepared by Pyxant

Labs, Inc. 155

p.

47832272 Seal, S. (2010) Independent Laboratory Validation of Enforcement M ethod for the

Determination of Sulfoxaflor (XDE 208) and its Main Metabolites in Agricultural

Commodities using Offline Solid

- Phase Extraction and Liquid Chromatography with

Tandem Mass Spectrometric Detection. Project Number: 101097, 2136. Unpublished stu dy

prepared by Pyxant Labs, Inc. 107 p.

47832273 Rawle, N. (2010) Laboratory Validation of a Method for the Determination of XDE

- 208,

X11719474 and X11721061 in Dry Crops, Acidic Crops, Oily Crops and Crops with a High

Water Content: Final Report. Projec t Number: 091174, CEMS/4295. Unpublished study

prepared by CEM Analytical Services, Ltd. 164 p.



### 860.1360 Multiresidue method

47832263 Rockwell, D. (2010) PAM I Multiresidue Protocol Testing for XDE

- 208 in Oranges and

Soybean Seed. Project Number: 101094, 2121. Unpublished study prepared by Pyxant Labs,

Inc. 75 p.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 90 of 141 860.1380 Storage stability data

47832224 Rodrigues, A. (2010) Frozen Sto rage Stability of Sulfoxaflor (XDE

- 208) and its Main

Metabolites in Crops: Interim Report. Project Number: 090091. Unpublished study

prepared by Dow AgroSciences Industrial Ltda. 103 p.

48641601 Rodrigues, A. (2011) Frozen Storage Stability of Sulfoxaflo r (XDE

- 208) and its Main

Metabolites in Crops: Interim Report. Project Number: 090091/OCR. Unpublished

study prepared by Dow AgroSciences Industrial Ltda. 122p.

48288943 Rodrigues, A. (2010) Frozen Storage Stability of Sulfoxaflor (XDE

- 208) and its Main

Metabolites in Crops: Final Report. Project Number: 090091, 090091S1R1/OCR.

Unpublished study prepared by Dow AgroSciences Industrial Ltda. 111 p.



### 860.1480 Meat/milk/poultry/eggs

47832295 Rawle, N. (2010) XDE

- 208 Livestock Feeding Study: Magnitude of R esidue in Eggs,

Muscle, Liver and Fat of Laying Hens. Project Number: 090116, CEMS/4561. Unpublished

study prepared by CEM Analytical Services, Ltd. 492 p.

47832296 Rawle, N. (2010) XDE

- 208 Livestock Feeding Study: Magnitude of Residue in Milk,

Muscle, F at, Liver and Kidney of Lactating Dairy Cattle. Project Number: 090117,

CEMS/4554. Unpublished study prepared by CEM Analytical Services, Ltd. 667 p.



### 860.1500 Crop field trials

47832081 Becker, J. (2010) Residue of XDE

- 208 in, on Potato from the USA and Canada. Project

Number: 080010, ARA/08/15/03. Unpublished study prepared by Ag Research Associates.

211 p.

47832082 Becker, J. (2010) Residue of XDE

- 208 in/on Cotton from the USA. Projec t Number: 080027,

ARA/08/15/01. Unpublished study prepared by Dow Agrosciences, LLC and Ag Research

Associates. 324 p.

47832093 Becker, J. (2010) Residue of XDE

- 208 in and on Almonds from the USA. Project

Number: 080021, ARA/08/15/16. Unpublished study p repared by Ag Research

Associates and Dow AgroSciences Industrial Ltda. 315 p.

47832152 Litzow, D. (2010) Residues of XDE

- 208 in Zucchinis following Foliar Application of GF

2032 in Australia. Project Number: 080078, DOW/GLP/08/15/5/1a,

DOW/GLP/08/15/5/O CR. Unpublished study prepared by Agrisearch Analytical Pty, Ltd. and

Agrisearch Services Pty. Ltd. 107 p.

47832153 Litzow, D. (2010) Residues of XDE

- 208 in Citrus following Foliar Application of GF

- 2032 in

Australia. Project Number: 080079/OCR, DOW/GLP /08/15/6/1a, DOW/GLP/08/15/6.

Unpublished study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical Pty,

Ltd. 121 p.

47832154 Becker, J. (2010) Residue of XDE

- 208 in

- on Peach from the USA: Amended Report.

Project Number: 080019, ARA/08/1 5/15/OCR. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences Industrial, Ltda. 222 p.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 91 of 141 47832155 Becker, J. (2010) Residue of XDE

- 208 in

- on Apple from the USA: Amended Report.

Project Number: 080020/OCR, ARA/08/15/14. Unpublished stu dy prepared by Ag Research

Associates and Dow AgroSciences Industrial, Ltda. 227 p.

47832156 Becker, J. (2010) Residue of XDE

- 208 in and on Sugar Beet from the USA. Project

Number: 080011/OCR, ARA/08/15/06. Unpublished study prepared by Ag Research

Assoc iates and Dow AgroSciences Industrial, Ltda. 276 p.

47832157 Becker, J. (2010) Residue of XDE

- 208 in and on Leaf Lettuce from the USA. Project

Number: 080012, ARA/08/15/08, 080012/OCR. Unpublished study prepared by Ag

Research Associates and Dow AgroScie nces Industrial Ltda. 226 p.

47832158 Becker, J. (2010) Residue of XDE

- 208 in and on Spinach from the USA: Amended

Report. Project Number: 080013/OCR, ARA/08/15/09. Unpublished study prepared by

Dow AgroSciences Industrial, Ltda. and Ag Research Associat es. 219 p.

47832159 Becker, J. (2010) Residue of XDE

- 208 in and on Tomato from the USA. Project Number:

080014/OCR, ARA/08/15/10. Unpublished study prepared by Ag Research Associates and

Dow AgroSciences Industrial, Ltda. 223 p.

47832160 Becker, J. (2010) Residue of XDE

- 208 in and on Cucumber from the USA. Project

Number: 080015, ARA/08/15/11, ARA/08/15/11/OCR. Unpublished study prepared by

Ag Research Associates. 213 p.

47832161 Becker, J. (2010) Residue of XDE

- 208 in and on Squash from the USA. Project Number:

080016/OCR, ARA/08/15/12. Unpublished study prepared by Ag Research Associates and

Dow AgroSciences Industrial Ltda. 212 p.

47832162 Becker, J. (2010) Residue of XDE

- 208 in and on Broccoli from the USA. Project Number:

080017/OC R, ARA/08/15/02. Unpublished study prepared by Dow AgroSciences

Industrial, Ltda. and Ag Research Associates. 208 p.

47832163 Rawle, N. (2010) Residues of XDE

- 208 in Sugarbeet at Intervals and Harvest following

Multiple Applications of GF

- 2032

- Northern and Southern Europe

- 2008. Project Number:

080030/02/OCR, CEMR/3936. Unpublished study prepared by CEM Analytical Services,

Ltd. 334 p.

47832164 Rawle, N. (2010) Residues of XDE

- 208 in Carrots at Intervals and Harvest following Multiple

Applications o f FG

- 2032 Northern and Southern Europe

- 2008. Project Number:

080029/OCR, CEMS/3977. Unpublished study prepared by CEM Analytical Services, Ltd.

261 p.

47832165 Rawle, N. (2010) Residues of XDE

- 208 in Potatoes at Intervals and Harvest following

Multipl e Applications of GF

- 2032 Northern and Southern Europe

- 2008. Project Number:

080028/OCR, CEMS/3933. Unpublished study prepared by CEM Analytical Services, Ltd.

264 p.

47832166 Becker, J. (2010) Residues of XDE

- 208 in

- on Strawberry from the USA: Amende d Report.

Project Number: 080026/OCR, ARA/09/15/01. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial, Ltda. 233 p.

47832167 Litzow, D. (2010) Residues of XDE

- 208 in Grapes following Foliar Application of GF

2032 in Aus tralia. Project Number: 090108, DOW/GLP/09/14/1, DOW/GLP/09/14/OCR.

Unpublished study prepared by Agrisearch Analytical Pty, Ltd. and Agrisearch Services Pty.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 92 of 141 Ltd. 133 p.

47832168 Becker, J. (2010) Residue of XDE

- 208 in and on Canola from the USA and Can ada. Project

Number: 080024/OCR, ARA/08/15/19. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial, Ltda. 243 p.

47832169 Becker, J. (2010) Residue of XDE

- 208 in and on Orange from the USA. Project Number:

080018/OCR, ARA /08/15/13. Unpublished study prepared by Dow AgroSciences

Industrial, Ltda. and Ag Research Associates. 273 p.

47832170 Becker, J. (2010) Residue of XDE

- 208 in and on Wheat from the USA and Canada:

Amended Report. Project Number: 080022/OCR, ARA/08/15/04 . Unpublished study

prepared by Dow AgroSciences Industrial, Ltda. and Ag Research Associates. 467 p.

47832171 Becker, J. (2010) Residue of XDE

- 208 in

- on Soybeans from the USA: Amended Report.

Project Number: 080023/OCR, ARA/08/15/18. Unpublished study p repared by Dow

AgroSciences Industrial, Ltda. and Ag Research Associates. 427 p.

47832173 Rawle, N. (2010) Residues of XDE

- 208 in Leaf Lettuce at Intervals and Harvest following

Multiple Applications of GF 2032

- Northern and Southern Europe

- 2008. Project Number:

080032/04, CEMS/3939, CEMS/3939/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 207 p.

47832174 Rawle, N. (2010) Residues of XDE

- 208 in Head Lettuce at Intervals and Harvest fol lowing

Multiple Applications of GF 20332

- Northern and Southern Europe

- 2008. Project Number:

080032/02, CEMS/3942, CEMR/3942/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 204 p.

47832175 Rawle, N. (2010) Residues of XDE

- 208 in Brocc oli at Intervals and Harvest following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2008 and 2009. Project

Number: 080033/02/OCR, CEMS/3945. Unpublished study prepared by CEM Analytical

Services, Ltd. 262 p.

47832176 Rawie, N. (2010) Residues of XDE

- 208 in Cauliflower at Intervals and Harvest Following

Multiple Applications of Gf

- 2032

- Northern and Southern Europe

- 2008 AND 2009. Project

Number: 080033/04, CEMR/3947, CEMS/3947/OCR. Unpublished study prepared by CEM

Analytical Service s, Ltd. 265 p.

47832177 Rawle, N. (2010) Residues of XDE

- 208 in Head Cabbage at Intervals and Harvest following

Multiple Application of GF 2032

- Northern and Southern Europe

- 2008. Project Number:

080034/02/OCR, CEMS/3949. Unpublished study prepared b y CEM Analytical Services,

Ltd. 228 p.

47832178 Rawle, N. (2010) Residues of XDE

- 208 in Cherry Tomatoes at Intervals and Harvest

following Multiple Applications of GF

- 2032

- Northern and Southern Europe

- 2008. Project

Number: 080036/02, CEMS/3957. Unpub lished study prepared by CEM Analytical Services,

Ltd. 204 p.

47832179 Rawle, N. (2010) Residues of XDE

- 208 in Tomatoes and Intervals and Harvest following

Multiple Applications of FG 2032

- Northern and Southern Europe

- 2008. Project

Number: 80037/02/ OCR, CEMS/3953. Unpublished study prepared by CEM Analytical

Services, Ltd. 282 p.

47832180 Rawle, N. (2010) Residues of XDE

- 208 in Bell Peppers at Intervals and Harvest following

Multiple Applications of GF 2032

- Southern Europe

- 2008. Project Number :Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 93 of 141 080039/02/OCR, CEMS/3959. Unpublished study prepared by CEM Analytical Services,

Ltd. 231 p.

47832181 Rawle, N. (2010) Residues of XDE

- 208 in Cucumbers at Intervals and Harvest following

Multiple Applications of GF 2032

- Northern and Southern Europe

- 2008 and 2009.

Project Number: 080041/02, CEMS/3962, CEMR/3962/OCR. Unpublished study

prepared by CEM Analytical Services, Ltd. 287 p.

47832182 Rawle, N. (2010) Residues of XDE

- 208 in Apples at Intervals and Harvest following

Multiple Applications of G F

- 2032 Northern and Southern Europe

- 2008. Project Number:

080045/02/OCR, CEMS/3968. Unpublished study prepared by CEM Analytical Services,

Ltd. 208 p.

47832183 Rawle, N. (2010) Residues of XDE

- 208 in Pears at Intervals and Harvest following

Multiple A pplications of GF

- 2032 Northern and Southern Europe

- 2008. Project

Number: 80046/02/OCR, CEMS/3971. Unpublished study prepared by CEM Analytical

Services, Ltd. 219 p.

47832184 Rawle, N. (2010) Residues of XDE

- 208 in Peaches at Inervals and Harvest following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2008 and 2009. Project

Number: 080047/02/OCR, CEMS/4069. Unpublished study prepared by CEM Analytical

Service s, Ltd. 248 p.

47832185 Rawle, N. (2010) Residues of XDE

- 208 in Cherries at Intervals and Harvest following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2008 and 2009. Project

Number: 080048/02/OCR, CEMR/4072. Unpublished study prepar ed by CEM Analytical

Services, Ltd. 244 p.

47832186 Rawle, N. (2010) Residues of XDE

- 208 in Grapes at Intervals and Harvest following

Multiple Application of GF

- 2032 Northern and Southern Europe

- 2008. Project Number:

080053, CEMS/3972, CEMS/3972/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 281 p.

47832187 Rawle, N. (2010) Residues of XDE

- 208 in Cotton at Harvest Following Multiple

Applications of GF

- 2032

- Southern Europe

- 2008. Project Number: 080055/02,

CEMS/3931, CEMR/3931/OCR . Unpublished study prepared by CEM Analytical

Services, Ltd. 248 p.

47832188 Litzow, D. (2010) Residues of XDE

- 208 in Lettuce following Foliar Application of GF

2032 in Australia. Project Number: 080073, DOW/GLP/08/15/1/1,

DOW/GLP/08/15/1/OCR. Unpublish ed study prepared by Agrisearch Analytical Pty, Ltd.

and Agrisearch Services Pty., Ltd. 116 p.

47832189 Litzow, D. (2010) Residues of XDE

- 208 in Broccoli, Cabbage, Chinese Cabbage and

Brussels Sprouts following Foliar Application of GF

- 2032 in Australia. Project Number:

080074, DOW/GLP/08/15/2/1, DOW/GLP/08/15/2/OCR. Unpublished study prepared by

Agrisearch Services Pty, Ltd., and Agrisearch Analytical Pty, Ltd. 190 p.

47832190 Litzow, D. (2010) Residues of XDE

- 208 in Tomatoes following Foliar Applicatio n of

GF

- 2032 in Australia. Project Number: 080076, DOW/GLP//08/15/3. Unpublished study

prepared by Agrisearch Services Pty, Ltd., and Agrisearch Analytical Pty, Ltd. 136 p.

47832191 Litzow, D. (2010) Residues of XDE

- 208 in Apples following Foliar Applica tion of GF

- 2032

in Australia and New Zealand. Project Number: 080080, DOW/GLP/08/15/7/1,Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 94 of 141 DOW/GLP/08/15/7/OCR. Unpublished study prepared by Agrisearch Services Pty. Ltd., and

Agrisearch Analytical Pty, Ltd. 160 p.

47832192 Litzow, D. (2010) Residues of X DE

- 208 in Pears following Foliar Application of GF

- 2032

in Australia. Project Number: 080081, DOW/GLP/08/15/8/1, DOW/GLP/08/15/8/OCR.

Unpublished study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical

Pty Ltd. 123 p.

47832193 Litzow, D. (2010) Residues of XDE

- 208 in Nectarines following Foliar Application of

GF

- 2032 in Australia and New Zealand. Project Number: 080082,

DOW/GLP/08/15/10/1, DOW/GLP/08/15/10/OCR. Unpublished study prepared by

Agrisearch Services Pty., Ltd., and Agrisearch Analytical Pty, Ltd. 139 p.

47832194 Litzow, D. (2010) Residues of XDE

- 208 in Peaches following Foliar Application of GF

2032 in Australia and New Zealand. Project Number: 080083/OCR, DOW/GLP/08/15/11/1.

Unpublished study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical Pty,

Ltd. 138 p.

47832195 Litzow, D. (2010) Residues of XDE

- 208 in Cherries following Foliar Application of GF

2032 in Australia and New Zealand. Project Number: 080084/OCR, DOW/GLP/08/15/12/1.

Unpublished study prep ared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical Pty,

Ltd. 121 p.

47832196 Litzow, D. (2010) Residues of XDE

- 208 in Apricots following Foliar Application of GF

2032 in Australia and New Zealand. Project Number: 080085/OCR, DOW/GLP/08/15/1 3/1.

Unpublished study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical Pty,

Ltd. 124 p.

47832197 Litzow, D. (2010) Residues of XDE

- 208 in Grapes following Foliar Application of GF

- 2032

in Australia and New Zealand. Project Number: 08 0088/OCR, DOW/GLP/08/15/9/1.

Unpublished study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical Pty,

Ltd. 148 p.

47832198 Litzow, D. (2010) Residues of XDE

- 208 in Strawberries following Foliar Application of GF

2032 in Australia and New Zealand. Project Number: 080089/OCR, DOW/GLP/08/15/16/1.

Unpublished study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytic al Pty,

Ltd. 131 p.

47832199 Litzow, D. (2010) Residues of XDE

- 208 in Canola following Foliar Application of GF

2032 in Australia. Project Number: 08008B/OCR, DOW/GLP/08/15/19/1. Unpublished

study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical Pty, Ltd. 133 p.

47832201 Litzow, D. (2010) Residues of XDE

- 208 in Cotton Following Foliar Application of GF

2032 in Australia. Project Number: 080090/ANZ/2008, DOW/GLP/08/15/20/1.

Unpublished study prepared by Agrisearch Services Pty, Ltd. a nd Agrisearch Analytical Pty,

Ltd. 142 p.

47832202 Rampazzo, P. (2010) Residues of XDE

- 208 Insecticide in Citrus after Multiple Applications

of GF

- 2032 Formulation, Brazil, 2008. Project Number: 080093, GHB/P/1839. Unpublished

study prepared by Dow AgroS ciences Industrial Ltda. 431 p.

47832203 Rampazzo, P. (2010) Residues of XDE

- 208 Insecticide in Cotton after Multiple

Applications of GF

- 2032 Formulation, Brazil, 2008

- 2009. Project Number: 080095,

GHB/P/1842. Unpublished study prepared by Dow AgroScienc es Industrial Ltda. 316 p.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 95 of 141 47832219 Rawle, N. (2010) Residues of XDE

- 208 in Beans at Intervals and Harvest Following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2008 and 2009. Project

Number: 080113/02, CEMS/3975, CEMR/3975. Unpublis hed study prepared by CEM

Analytical Services, Ltd. 340 p.

47832220 Becker, J. (2010) Residue of XDE

- 208 in/on Carrot from the USA. Project Number: 080122,

ARA/08/15/05, GHB/P/1836. Unpublished study prepared by Ag Research Associates and

Dow AgroScience s Industrial Ltda. 281 p.

47832221 Becker, J. (2010) Residue of XDE

- 208 in/on Bulb Onion in the USA. Project Number:

080123, ARA/08/15/07, GHB/P/1840. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial Ltda. 211 p.

4783 2222 Rampazzp, P. (2010) Residues of XDE

- 208 Insecticide in Melon after Applications of GF

2032 Formulation, Brazil, 2008. Project Number: 080148, GHB/P/1848, 10001643.

Unpublished study prepared by Dow AgroSciences Industrial Ltda. 255 p.

47832223 Ramp azzo, P. (2010) Residues of XDE

- 208 Insecticide in Soybeans Commodities After

Multiple Applications of GF

- 2032 Formulation, Brazil, 2008

- 2009. Project Number: 080149,

GHB/P/1846, 10001643. Unpublished study prepared by Dow AgroSciences Industrial Ltda.

363 p.

47832228 Litzow, D. (2010) Residues of XDE

- 208 in Cereals Following Foliar Application of GF

2032 in Australia. Project Number: 090114, DOW/GLP/09/15/1, 10/0030. Unpublished

study prepared by Agrisearch Services Pty, Ltd. and Agrisearch Analytical Pt y, Ltd. 223 p.

47832229 Litzow, D. (2010) Residues of XDE

- 208 in Cereals Following Foliar Application of GF

2032 in New Zealand. Project Number: 080087, DOW/GLP/08/15/18/1. Unpublished

study prepared by Agrisearch Services Pty, Ltd. and Agrisearch Analyt ical Pty, Ltd. 258 p.

47832230 Litzow, D. (2010) Residues of XDE

- 208 in Cereals Following Foliar Application of GF

2032 in Australia. Project Number: 080086, DOW/GLP/08/15/17/1. Unpublished study

prepared by Agrisearch Services Pty, Ltd. and Agrisearch Analytical Pty, Ltd. 253 p.

47832231 Rawle, N. (2010) Residues of XDE

- 208 in Barley at Intervals and Harvest Following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2009. Project Number:

090031, CEMS/4365, CEMR/4365. Unpublished study prepared by CEM Analytical

Services, Ltd. 434 p.

47832232 Rawle, N. (2010) Residues of XDE

- 208 in Barley at Intervals and Harvest Following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2008. Project Number:

080050/02, CEMS/3923, CEMR /3923. Unpublished study prepared by CEM Analytical

Services, Ltd. 472 p.

47832233 Rampazzo, P. (2010) Residues of XDE

- 208 Insecticide in Dry Beans After Applications of

GF

- 2032 Formulation, Brazil, 2008. Project Number: 080150, GHB/P/1849. Unpublished

s tudy prepared by Dow AgroSciences Industrial Ltda. 282 p.

47832234 Becker, J. (2010) Residues of XDE

- 208 in and on Cabbage from the USA. Project

Number: 090022, ARA/09/15/08, GHB/P/1874. Unpublished study prepared by Ag

Research Associates and Dow AgroSc iences Industrial Ltda. 221 p.

47832235 Litzow, D. (2010) Residues of XDE

- 208 in Canola following Foliar Application of GF

2032 in Australia. Project Number: 090109, DOW/GLP/09/16/1, 10/0031. UnpublishedSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 96 of 141 study prepared by Agrisearch Services Pty, Ltd. an d Agrisearch Analytical Pty, Ltd. 139 p.

47832236 Rawle, N. (2010) Residues of XDE

- 208 in Oil Seed Rape at Intervals and Harvest Following

Multiple Applications of GF 2032

- Northern and Southern Europe

- 2008 and 2009. Project

Number: 080052/02, CEMS/39 28, CEMR/3928. Unpublished study prepared by CEM

Analytical Services, Ltd. 234 p.

47832237 Litzow, D. (2010) Residues of XDE

- 208 in Cauliflowers following Foliar Application

of GF

- 2032 in Australia. Project Number: 090104, DOW/GLP/09/10/1, 09/0901.

Unpub lished study prepared by Agrisearch Services Pty, Ltd. and Agrisearch Analytical

Pty, Ltd. 108 p.

47832238 Becker, J. (2010) Residues of XDE

- 208 in/on Green Onion from the USA. Project

Number: 090018, ARA/09/15/04, GHB/P/1871. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences Industrial Ltda. 205 p.

47832239 Becker, J. (2010) Residues of XDE

- 208 in/on Celery from the USA. Project Number:

090019, ARA/09/15/18, GHB/P/1872. Unpublished study prepared by Ag Research

Associates and Do w AgroSciences Industrial Ltda. 213 p.

47832240 Becker, J. (2010) Residues of XDE

- 208 in/on Muskmelon from the USA. Project

Number: 090021, ARA/09/15/12, GHB/P/1873. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences Industrial Ltda . 205 p.

47832241 Becker, J. (2010) Residues of XDE

- 208 in/on Pear from the USA. Project Number: 090026,

RA/09/15/14, GHB/P/1869. Unpublished study prepared by Ag Research Associates and

Dow AgroSciences Industrial Ltda. 204 p.

47832242 Becker, J. (201 0) Residues of XDE

- 208 in/on Plum from the USA. Project Number: 090028,

ARA/09/15/05, GHB/P/1866. Unpublished study prepared by Ag Research Associates and

Dow AgroSciences Industrial Ltda. 223 p.

47832243 Becker, J. (2010) Residues of XDE

- 208 in/on Pecan from the USA: Amended Report.

Project Number: 090029, ARA/09/15/13, GHB/P/1868. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences Industrial Ltda. 200 p.

47832244 Rawle, N. (2010) Residues of XDE

- 208 in Cotton at Intervals and Harvest Following

Multiple Applications of GF

- 2032 Southern Europe

- 2009. Project Number: 090032,

CEMS/4364, CEMR/4364. Unpublished study prepared by CEM Analytical Services, Ltd.

311 p.

47832245 Litzow, D . (2010) Residues of XDE

- 208 in Citrus following Foliar Application of GF

2032 in Australia. Project Number: 090035, DOW/GLP/09/11/1, 10/0033. Unpublished

study prepared by Agrisearch Services Pty, Ltd. and Agrisearch Analytical Pty, Ltd. 133 p.

47832246 Becker, J. (2010) Residues of XDE

- 208 in/on Head Lettuce from the USA. Project

Number: 090045, ARA/09/15/03, GHB/P/1862. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences Industrial Ltda. 194 p.

47832247 Becker, J. (2010) Magnitu de of Residues of XDE

- 208 in/on Wheat from the USA and

Canada

- Formulation Bridging Study: Amended Report. Project Number: 090076,

ARA/09/15/16, GHB/P/1870. Unpublished study prepared by Ag Research Associates

and Dow AgroSciences Industrial Ltda. 431 p.

47832248 Rampazzo, P. (2010) Residues of XDE

- 208 Insecticide in Wheat After Applications of

GF

- 2032 Formulation, Brazil, 2008. Project Number: 080152, GHB/P/1847, 10001643.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 97 of 141 Unpublished study prepared by Dow AgroSciences Industrial Ltda. 380 p.

47832249 Becker, J. (2010) Magnitude of Residues of XDE

- 208 in/on Soybean from the USA

- Formulation Bridging Study. Project Number: 090079, ARA/09/15/17, GHB/P/1875.

Unpublished study prepared by Ag Research Associates and Dow AgroSciences Industrial

Ltda. 347 p.

47832250 Rampazzo, P. (2010) Residues of XDE

- 208 Insecticide in Tomato after Applications of

GF

- 2032 Formulation, Brazil, 2009. Project Number: 090095, GHB/P/1850, 10001643.

Unpublished study prepared by Dow AgroSciences Industrial Ltda. 228 p.

47832251 Litzow, D. (2010) Residues of XDE

- 208 in Lettuce following Foliar Application of GF

2032 in Australia. Project Number: 090101, DOW/GLP/09/07/1, 09/0900. Unpublished

study prepared by Agrisearch Services Pty, Ltd. and Agrisearch Analytical Pty, Ltd. 122 p

.

47832252 Litzow, D. (2010) Residues of XDE

- 208 in Spinach following Foliar Application of GF

- 2032

in Australia. Project Number: 090102/ANZ/2009/OCR, DOW/GLP/09/08/1,

090102/ANZ/2009. Unpublished study prepared by Agrisearch Services Pty, Ltd. and

Agri search Analytical Pty, Ltd. 111 p.

47832253 Litzow, D. (2010) Residues of XDE

- 208 in Capsicums following Foliar Application of

GF

- 2032 in Australia. Project Number: 080077/ANZ/2008/OCR, DOW/GLP/08/15/4/1,

080077/ANZ/2008. Unpublished study prepared by Ag risearch Analytical Pty, Ltd. and

Agrisearch Services Pty, Ltd. 108 p.

47832254 Litzow, D. (2010) Residues of XDE

- 208 in Peaches following Foliar Application of GF

- 2032

in Australia. Project Number: 090106/ANZ/2009/OCR, DOW/GLP/09/12/1,

090106/ANZ/2009. Unpublished study prepared by Agrisearch Analytical Pty, Ltd. and

Agrisearch Services Pty, Ltd. 124 p.

47832290 Becker, J. (2010) Residue of XDE

- 208 in and on Grape from the USA. Project

Number: 080025, ARA/08/15/20. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial, Ltda. 251 p.

47832291 Litzow, D. (2010) Residues of XDE

- 208 in Nectarines and Plums following Foliar

Application of GF

- 2032 in Australia. Project Number: 090107, DOW/GLP/09/13/1.

Unpublished study prepared by Agrisearch Analytical Pty, Ltd. 105 p.

47832292 Rawle, N. (2010) Residues of XDE

- 208 in Outdoor Melons at Intervals and Harvest

Following Multiple Applications of GF

- 2032

- Southern Europe

- 2008. Project Number:

080041/02, CEMS/3965. Unpublished study prepared by CEM Analytical Services, Ltd.

280 p.

47832293 Rawle, N. (2010) Residues of XDE

- 208 in Wheat at I ntervals and Harvest Following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2008. Project Number:

080049/02, CEMS/3921. Unpublished study prepared by CEM Analytical Services, Ltd.

611 p.

47832294 Rawle, N. (2010) Residues of XDE

- 208 i n Wheat at Intervals and Harvest Following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2009. Project Number:

090030, CEMS/4363. Unpublished study prepared by CEM Analytical Services, Ltd. 551 p.

48288901 Schreier, T. (2010) Residues in/on a Root, Leafy Vegetable, Cereal, and Forage Grass asSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 98 of 141 Rotated Crops Following Treatment with XDE

- 208. Project Number: 090056,

ARA/09/15/06, ARA/09/15/06/OCR. Unpublished study prepared by Ag Research

Associates. 375 p.

48288902 Schreier, T. (2010) R esidues of XDE

- 208 in/on Apple from the USA. Project

Number: 090132, ARA/09/15/26, ARA/09/15/26/OCR. Unpublished study

prepared by Ag Research Associates. 138 p.

48288903 Rawle, N. (2010) Residues of XDE

- 208 in Barley at Intervals and Harvest Following

M ultiple Applications of GF

- 2032 Southern Europe

- 2010. Project Number: 101647,

CEMR/4741, 101647/OCR. Unpublished study prepared by CEM Analytical Services, Ltd.

231 p.

48288904 Schreier, T. (2010) Residues of XDE

- 208 in/on Barley from the USA. Project

Number: 090131, ARA/09/15/25, 090131/OCR. Unpublished study prepared by

Ag Research Associates. 168 p.

48288905 Rawle, N.; Jutsum, L. (2010) Residues of XDE

- 208 in Beans at Intervals and Harvest

Following Multiple Applications of GF

- 2032

- Northern and Southern Europe

- 2010.

Project Number: 101471, CEMR/4710/OCR. Unpublished study prepared by CEM

Analytical Services, Ltd. 266 p.

48288907 Rawle, N.; Jutsum, L. (2010) Residues of XDE

- 208 in Broccoli at Intervals and Harvest

Following Multiple Applicatio ns of GF

- 2032

- Northern and Southern Europe

- 2010. Project

Number: 101455, CEMR/4692/OCR, CEMR/4692/VERSION/2. Unpublished study prepared

by CEM Analytical Services, Ltd. 183 p.

48288908 Rawle, N. (2010) Residues of XDE

- 208 in Oil Seed Rape at Intervals and Harvest Following

Multiple Applications of GF 2032

- Northern Europe

- 2010. Project Number: 101630,

CEMR/4713, CEMS/4713/OCR. Unpublished study prepared by CEM Analytical Services,

Ltd. 234 p.

48288909 Rawle, N. (2010) Residues of XDE

- 208 in Cauliflower at Intervals and Harvest Following

Multiple Applications of GF 2032

- Northern and Southern Europe

- 2010. Project

Number: 101456, CEMR/4693, CEMS/4693/OCR. Unpublished study prepared by CEM

Analytical Services, Ltd. 204 p.

48288910 Schrei er, T. (2010) Residues of XDE

- 208 in and on Cherry from the USA. Project

Number: 090027, ARA/09/15/15, ARA/09/15/15/OCR. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences Industrial, Ltda. 204 p.

48288911 Rawle, N. (2010) Residues of XDE

- 208 in Cotton at Intervals and Harvest Following Multiple

Applications of GF

- 2032 Southern Europe

- 2010. Project Number: 101774, CEMR/4742,

CEMS/4742/OCR. Unpublished study prepared by CEM Analytical Services, Ltd. 215 p.

48288912 Rawle, N. (201 0) Residues of XDE

- 208 in Cucumbers at Intervals and Harvest Following

Multiple Applications of GF 2032

- Northern and Southern Europe

- 2010. Project Number:

101465, CEMR/4704, CEMS/4704/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 230 p.

48288913 Rawle, N. (2010) Residues of XDE

- 208 in Grapes at Intervals and Harvest Following

Multiple Applications of FG

- 2032 Northern and Southern Europe

- 2010. Project Number:

101454, CEMR/4715/VERSION/2, CEMS/4715/OCR. Unpublished study prepared b y CEM

Analytical Services, Ltd. 230 p.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 99 of 141 48288914 Schreier, T. (2010) Residues of XDE

- 208 in, on Grapefruit from the USA. Project

Number: 090024, ARA/09/15/19, ARA/09/15/19/OCR. Unpublished study prepared by

Ag Research Associates. 347 p.

48288915 Schrei er, T. (2010) Residues of XDE

- 208 in/on Lemon from the USA. Project Number:

090025/OCR, ARA/09/15/20. Unpublished study prepared by Ag Research Associates

and Dow AgroSciences Industrial Ltda. 208 p.

48288916 Rawle, N. (2010) Residues of XDE

- 208 in Head Lettuce at Interval and Harvest Following

Multiple Applications of GF 2032

- Northern and Southern Europe

- 2010. Project Number:

101625, CEMR/4691, CEMS/4691/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 182 p.

48288917 Rawle, N. (201 0) Residues of XDE

- 208 in Leaf Lettuce at Intervals and Harvest Following

Multiple Applications of GF 2032

- Northern and Southern Europe

- 2010. Project Number:

101453, CEMR/4690, CEMS/4690/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 181 p.

48288918 Rawle, N. (2010) Residues of XDE

- 208 in Outdoor Melons at Intervals and Harvest

Following Multiple Applications of GF

- 2032

- Southern Europe

- 2010. Project Number:

101468, CEMR/4707, CEMS/4707/OCR. Unpublished study prepared by CEM

Analy tical Services, Ltd. 252 p.

48288919 Schreier, T. (2010) Residues of XDE

- 208 in/on Mustard Greens from the USA. Project

Number: 090129, ARA/09/15/23, 090129/OCR. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences, LLC. 138 p.

48288920 Schreier, T. (2010) Residues of XDE

- 208 in/on Orange from the USA. Project Number:

090127, ARA/09/15/21, 090127/OCR. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial Ltda. 200 p.

48288921 Rawle, N. (2010) Res idues of XDE

- 208 in Pears at Intervals and Harvest Following

Multiple Applications of GF

- 2032 Northern and Southern Europe

- 2010. Project Number:

101474, CEMR/4714, CEMS/4714/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 175 p.

482889 22 Schreier, T. (2010) Residues of XDE

- 208 in/on Pepper from the USA. Project Number:

090130, ARA/09/15/24, 090130/OCR. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial Ltda. 270 p.

48288923 Rawle, N. (2010) Residues of XDE

- 208 in Bell Peppers at Intervals and Harvest Following

Multiple Applications of GF 2032

- Southern Europe

- 2010. Project Number: 101628,

CEMR/4701, CEMS/4701/OCR. Unpublished study prepared by CEM Analytical Services,

Ltd. 183 p.

48288924 Litzow, D. (2010) Residues of XDE

- 208 in Chilis Following Foliar Application of GF

2032 in Australia. Project Number: 090103, DOW/GLP/09/09/1, DOW/GLP/09/09/OCR.

Unpublished study prepared by Agrisearch Services Pty. Ltd., and Agrisearch Analytical

Pty, Ltd. 118 p

.

48288925 Schreier, T. (2010) Residues of XDE

- 208 in/on Potato from the USA. Project Number:

101089, ARA/10/15/02, 101089/OCR. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial Ltda. 177 p.

48288926 Schreier, T. (201 0) Residues of XDE

- 208 in/on Radish from the USA. ProjectSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 100 of 141 Number: 090016, ARA/10/15/01, 090016/OCR. Unpublished study prepared by Ag

Research Associates and Dow AgroSciences, LLC. 154 p.

48288927 Rawle, N. (2010) Residues of XDE

- 208 in Tomatoes at Interv als and Harvest Following

Multiple Applications of GF

- 2032

- Northern and Southern Europe

- 2010. Project Number:

101460, CEMR/4695, CEMS/4695/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 225 p.

48288928 Rawle, N. (2010) Residues of XDE

- 208 in Cherry Tomatoes at Intervals and Harvest

Following Multiple Applications of GF

- 2032

- Northern and Southern Europe

- 2010. Project

Number: 101626, CEMR/4697, CEMS/4697/OCR. Unpublished study prepared by CEM

Analytical Services, Ltd. 191 p.

4828 8929 Rawle, N. (2010) Residues of XDE

- 208 in Indoor Tomatoes at Intervals and Harvest

Following Multiple Applications of GF

- 2032

- Europe

- 2010. Project Number: 101627,

CEMR/4699, CEMS/4699/OCR. Unpublished study prepared by CEM Analytical

Services, Ltd. 227 p.

48288930 Schreier, T. (2010) Residues of XDE

- 208 in/on Tomato from the USA. Project Number:

090128, ARA/09/15/22, 090128/OCR. Unpublished study prepared by Ag Research

Associates and Dow AgroSciences Industrial Ltda. 188 p.

48581201 Litzow, D. (2011) Residues of XDE

- 208 in Canola following Foliar Application of GF

- 2032

I n Australia. Project Number: 101784, DOWAUS/GLP/10/03, DOWAUS/GLP/10/03/1.

Unpublished study prepared by Agrisearch Services Pty., Ltd. and Agrisearch Analytical Pty,

Ltd. 133p.



### 860.1520 Processed food/feed

47832172 Rawle, N. (2010) Residues of XDE

- 208 in Sugarbeet and Process Fractions following

Multiple Applications of GF

- 2032 Southern Europe

- 2008. Project Number: 080030/03/OCR,

CEMS/3937. Unpublished study prepared by CEM Analytical Services, Ltd. 372 p.

47832204 Rawle, N. (2010) Residues of XDE

- 208 in Potatoes and Process Fractions Following

Multiple Applications of GF

- 2032 Northern Europe

- 2008. Project Numb er: 080096,

CEMS/3934, CEMR/3934. Unpublished study prepared by CEM Analytical Services, Ltd.

355 p.

47832205 Becker, J. (2010) Residue of XDE

- 208 in Carrot Processed Fractions: Amended Report.

Project Number: 080097, ARA/08/15/21. Unpublished study prep ared by Ag Research

Associates and University of Idaho, Cooperative Extension and Dow AgroSciences Industrial

Ltda. 212 p.

47832206 Becker, J. (2010) Residue of XDE

- 208 in Onion Processed Fractions. Project Number:

080099, ARA/08/15/22. Unpublished study prepared by Ag Research Associates and

University of Idaho, Cooperative Extension and Dow AgroSciences Industrial Ltda.

191 p.

47832207 Rawle, N. (2010) Residues of XDE

- 208 in Leaf Lettuce and Process Fractions Following

Multiple Applications of GF 2032

- Northern Europe

- 2008. Project Number: 080100/01,

CEMS/3940, CEMR/3940. Unpublished study prepared by CEM Analytical Services, Ltd.

165 p.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 101 of 141 47832208 Rawle, N. (2010) Residues of XDE

- 208 in Head Lettuce and Process Fractions Following

Multiple Applicat ions of GF 2032

- Northern Europe

- 2008. Project Number: 080100/02,

CEMS/3943, CEMR/3943. Unpublished study prepared by CEM Analytical Services, Ltd.

181 p.

47832209 Rawle, N. (2010) Residues of XDE

- 208 in Head Cabbage and Process Fractions Following

Mu ltiple Applications of GF 2032

- Northern Europe

- 2008. Project Number: 080101,

CEMR/3950, CEMS/3950. Unpublished study prepared by CEM Analytical Services, Ltd.

253 p.

47832210 Rawle, N. (2010) Residues of XDE

- 208 in Tomatoes and Process Fractions Foll owing

Multiple Applications of GF

- 2032 Southern Europe

- 2008. Project Number: 080102,

CEMS/3954, CEMR/3954. Unpublished study prepared by CEM Analytical Services, Ltd.

289 p.

47832211 Becker, J. (2010) Residue of XDE

- 208 in Orange Processed Fractions: Amended Report.

Project Number: 080103, ARA/08/15/23, GHB/P/1843. Unpublished study prepared by

Ag Research Associates and University of Idaho, Cooperative Extension and Dow

AgroSciences Industrial Ltda. 228 p.

47832212 Rawle, N. (2010) Residues of XDE

- 208 in Apples and Process Fractions Following

Multiple Applications of GF

- 2032 Northern Europe

- 2008. Project Number: 080104,

CEMR/3969, CEMS/3969. Unpublished study prepared by CEM Analytical Services, Ltd.

293 p.

47832 213 Rawle, N. (2010) Residues of XDE

- 208 in Cherries and Process Fractions Following

Multiple Applications of GF

- 2032 Northern Europe

- 2009. Project Number: 080105,

CEMR/4362, CEMS/4362. Unpublished study prepared by CEM Analytical Services, Ltd.

250 p.

47832214 Becker, J. (2010) Residue of XDE

- 208 in Wheat Processed Fractions. Project Number:

080106, ARA/08/15/24. Unpublished study prepared by Ag Research Associates and GLP

Technologies and Dow AgroSciences Industrial Ltda. 216 p.

47832215 Becker, J . (2010) Residue of XDE

- 208 in Soybean Processed Fractions: Amended Report.

Project Number: 080108, ARA/08/15/25. Unpublished study prepared by Ag Research

Associates and GLP Technologies and Dow AgroSciences Industrial Ltda. 212 p.

47832216 Rawle, N. (2 010) Residues of XDE

- 208 in Grapes and Process Fractions Following

Multiple Applications of GF

- 2032 Northern Europe

- 2008. Project Number: 080110,

CEMR/3973, CEMS/3973. Unpublished study prepared by CEM Analytical Services, Ltd.

246 p.

47832217 Becker, J. (2010) Residues of XDE

- 208 in Strawberry Processed Fractions. Project Number:

080111, ARA/09/15/02, GHB/P/1856. Unpublished study prepared by Ag Research

Associates and University of Idaho, Cooperative Extension and Dow AgroSciences

Industrial Ltda. 20 0 p.

47832218 Becker, J. (2010) Residues of XDE

- 208 in Cotton Processed Fractions. Project Number:

080112, ARA/08/15/26, GHB/P/1859. Unpublished study prepared by Ag Research

Associates and GLP Technologies and Dow AgroSciences Industrial Ltda. 207 p.

4 7832297 Rawle, N. (2010) Residues of XDE

- 208 in Barley grain and Process Fractions at Harvest

Following Multiple Applications of GF

- 2032

- 2008. Project Number: 080107, CEMS/3924.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 102 of 141 Unpublished study prepared by CEM Analytical Services, Ltd. 367 p.

4783229 8 Rawle, N. (2010) Residues of XDE

- 208 in Oil Seed Rape and Process Fractions Following

Multiple Applications of GF 2032

- 2008. Project Number: 080109, CEMR/3929.

Unpublished study prepared by CEM Analytical Services, Ltd. 253 p.

48288931 Schreier, T. (2010) Residues of XDE

- 208 in Wheat Processed Fractions. Project Number:

090133, ARA/09/15/27, 090133/OCR. Unpublished study prepared by Ag Research

Associates, GLP Technologies and Dow AgroSciences Industrial Ltda. 258 p.

Hydrolysis Study

– Household Pro cessing

47832083 Ma, M.; Adelfinskaya, Y. (2010) Processing Study to Determine the Nature of Residues of

(Carbon 14)

- XDE

- 208, (Carbon 14)

- X11719474 and (Carbon 14)

- X11721061 Following

Industrial or Household Preparation. Project Number: 080145. Unpublish ed study prepared

by Dow AgroSciences, LLC. 81 p.



### 860.1850 Crop Rotation Studies

47832311 Graper, L.; Smith, K.; Balcer, J. (2010) A Confined Rotational Crop Study with 14C

- XDE

208. Project Number: 070051. Unpublished study prepared by Dow AgroSciences, LLC and

Research for Hire and ABC Laboratories, Inc. 185 p.

48445804 DeBoer, G.; Robinson, A.; Adelfinskaya, Y. (2011) Uptake, Translocation and Metabolism

of Sulfoxaflor (XDE

- 208) in Three Plants: Cabbage, Pepper and Cotton. Project Number:

RSB/001. Unpublished study prepared by Dow AgroScience Discovery Research. 32 p.



### Non

- Guideline Studies

47832304 Brinkmeyer, R. (2010) XDE

- 208 MII Section 4 Residues . Project Number: MII/0004.

Unpublished study prepared by Dow AgroSciences, LLC. 1138 p.

47832307 Brinkmeyer, R. (2010) OECD XDE

- 208 Document N. Project Number: N/0001.

Unpublished study pre pared by Dow AgroSciences, LLC. 76 p.

47832310 The Inter

- conversion of the Diastereomers of XDE

- 208 and X11719474 in Soil, Water,

and Biological Solutions. Dow AgroSciences study ID 101081, 23 July 2010. GLP

unpublished. Ma, M., 2010

.

47832520 Brinkmeyer, R. (2010) GF

- 2372 MIII Section I Identity. Project Number: MIII/0013.

Unpublished study prepared by Dow AgroSciences LLC. 27 p.

47832523 Brinkmeyer, R. (2010) GF

- 2372 MIII Section 4 Residues. Project Nu mber: MIII/0016.

Unpublished study prepared by Dow AgroSciences LLC. 9 p.

47832524 Brinkmeyer, R. (2010) GF

- 2372 MIII Section 5 Fate. Project Number: MIII/0017.

Unpublished study prepared by Dow AgroSciences LLC. 11 p.

48165607 Brinkmeyer, R. (2010) GF

- 2032 MIII Section 1: Identity. Project Number: MIII/0007/OCR.

Unpublished study prepared by Dow AgroSciences, LLC. 28 p.

48165608 Brinkmeyer, R. (2010) GF

- 2032: MIII Section 2: Analytical Methods. Project Number:

MIII/0008/OCR. Unpublished study prepared by Dow AgroSciences, LLC. 9 p.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 103 of 141 48165610 Brinkmeyer, R. (2010) GF

- 2032 MIII Section 4: Residues. Project Number: MIII/0010.

Unpubl ished study prepared by Dow AgroScience, LLC. 9 p.

48288944 Johnston, J. (2010) Acute and Chronic Dietary Exposure and Risk Assessments for

Proposed Uses of Sulfoxaflor (Amended Report). Project Number: Sulfoxaflor/10/02,

000721/000/BOTO/1210 /0001, SULF OXAFLOR/10/02/A/OCR. Unpublished study

prepared by Exponent, Inc. 39 p.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 104 of 141 Appendix 1

. Tolerance Summary for Sulfoxaflor

Appendix 1 . Tolerance Summary for Sulfoxaflor.

Commodity

(as proposed) Proposed

Tolerance

(ppm) HED

- Recommended

Tolerance (ppm) Comments (correct commodity

definition)

Almond 0.02



### See Table 1 See Nut , tree

, g roup 14

Almond, hulls 4 .0

Apple 0.3 See Fruit , pome

, g roup 11

Apple, dried pomace 1.3 Tolerance for processed commodity

is not required; the residues are

covered by the RAC tolerance.

Barley, grain 0.15

Barley, hay 0.8

Barley, straw 1.5

Barley, malt sprouts 0.2 Tolerance for processed commodity

is not required; the residues are

covered by the RAC tolerance.

Beans, dry seed 0.2 5

Bean, succulent 0.7

Beet, sugar, root 0.03 See Root and tuber vegetables

, g roup

1

Beet, sugar, molasse s 0.03

Beet, sugar, raw sugar 0.04 Tolerance for processed commodity

is not required; the residues are

covered by the RAC tolerance.

Beet, sugar, thick juice 0.15 Tolerance for processed commodity

is not required; the residues are

covered by the RAC tolerance.

Beet, sugar, dried pulp 0.07 Tolerance for processed commodity

is not required; the residues are

covered by the RAC tolerance.

Beet, sugar, tops 3 .0 See R oot and t uber v egetables, g roup

2

Berry and small fruits,

Berry subgroup 13

- 07F 1.5 See Small Fruit Vine Climbing Crop

subgroup 13

- 07F

Berry and small fruits,

subgroup 13

- 07G 0.6 See B erry

, l ow growing

, subgroup

13

- 07G

Brassica Leafy Vegetables,

head and stem (except

cauliflower), subgroup 5A 1.0 See Vegetable, b rassica , leafy , g roup

5

, except cauliflower

Brassica Leafy Vegetables,

leafy greens, subgroup 5B 1.6 See Vegetable, b rassica , leafy , g roup

5

, except cauliflower

Berry, low growing,

subgroup 13

- 07G

Broccoli 0.45 See Vegetable, b rassica , leafy , g roup

5

, except cauliflower

Bulb vegetables, Onion,

bulb, subgroup 3

- 07A 0.01

Bulb Vegetables, Onion,

green, subgroup 3

- 07B 0.6

Cabbage 1 .0 See Vegetable, b rassica , leafy, g roupSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 105 of 141 Appendix 1 . Tolerance Summary for Sulfoxaflor.

Commodity

(as proposed) Proposed

Tolerance

(ppm) HED

- Recommended

Tolerance (ppm) Comments (correct commodity

definition)



### See Table 1. 5

Canola, seed 0.25 See Rapeseed s ubgroup 20A

Canola, meal 0.5 Rapeseed, meal is correct term.

Carrot, roots 0.05 See Vegetables, r oot and tuber, g roup

1

Carrot, tops 4 .0 See Leaves of Root and Tuber

Vegetables, Crop Group 2

Cauliflower 0.08 Individual tolerance is required as it

exceeds a 5x factor relative to other

crop group representative

commodities.

Celery 1 .0 See Leaf petiole (except Brassica ),

subgroup 4B

Cherry 2.5 See Fruit, stone,

Crop group 12

Cherry, dried cherry 15 .0

Citrus, dried pulp 0.9

Citrus, juice

-- Citrus, oil

-- Citrus, peel 1 .0

Cottonseed subgroup, 20C 0.2

Cotton, seed 0.2 See Cottonseed subgroup 20C

Cotton, hulls 0.4

Cotton, gin byproducts 8 .0

Cotton, aspirated grain

fractions 4.6 AGF tolerance not required for

cotton.

Cucumber 0.3 See Vegetable, c ucurbit , g roup 9

Cucurbit Vegetables (except

squash) , Group 9 0.3 Squash can be included in the crop

group tolerance

. See Vegetable,

c ucurbit , g roup 9

Fruit, citrus,

group 10 0.6 Fruit, citrus,

group 10

- 10

Fruit, Pome,

group 11 0.4 0 Fruit, Pome,

group 11

- 10

Fruiting Vegetables (except

cucurbits, plus okra)

, Group 8 1.2 See Vegetables, fruiting, group 8

- 10

Fruit, stone,

group 12 0.6 Fruit, stone,

group 12

Grain, aspirated fractions

-- Grape 1. 3 See Crop s ubgroup 13

- 07F

Grape, raisin 5.0

Grapefruit 0. 25 See Fruit, c itrus

, g roup 10

- 10

Leaf petiole, subgroup 4A 5 .0 S pinach requires a separate tolerance.

Leaf petiole, subgroup 4B 1 .0

Leaves of Root and Tuber

Vegetables, Crop Group 2 4 .0 Vegetables, leaves of root and tuber

vegetables, group 2 is correct term.

Lemon 0. 45 See Fruit, c itrus, g roup 10

- 10Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 106 of 141 Appendix 1 . Tolerance Summary for Sulfoxaflor.

Commodity

(as proposed) Proposed

Tolerance

(ppm) HED

- Recommended

Tolerance (ppm) Comments (correct commodity

definition)

Lettuce, head 2.5 

### See Table 1. See Leaf petiole, subgroup 4A

Lettuce, leaf 3.5 See Leaf petiole, subgroup 4A

Low growing berry

subgroup 13

- 07G 0.60 See Berry, low growing, subgroup

13

- 07G

Melon 0.3 See Vegetable, c ucurbit , g roup 9

Mustard greens 1.6 See Vegetable, b rassica , leafy, g roup

5

, except cauliflower

Nectarine, pitted fruit 0. 3 See Fruit, stone (except cherry),

group 12

Nuts, tree, Crop Group 14

-- Nut, tree, group 14

Oilseed Group, rapeseed

subgroup 20A 0.3

Oilseed Group, cottonseed

subgroup 20C 0.15

Onion, dry bulb 0.01 Onion, bulb, subgroup 3

- 07A

Onion, green 0.6 Onion, green, subgroup 3

- 07B

Orange 0.6 See Fruit, citrus, g roup 10

Peach, pitted fruit 0.6 See Fruit, stone, group 12, except

cherry

Pear 0.4 0 See Pome f ruit

,

g roup 11

- 10

Pecan 0.01 See Nuts

, tree,

g roup 14

Pepper, bell and non

- bell 1.2 See Vegetables, f ruiting g roup 8

- 10

Pistachio 0.02 Pistachio requires a separate

tolerance. It is not yet a member of

crop group 14.

Plum, pitted fruit 0.25 See Fruit, stone, group 12, except

cherry

Plum, prune, dried Not needed, covered by RAC

tolerance.

Potato 0.01 See Vegetables , r oot and t uber

, group

1

Potato, wet peel 0.02 Tolerance for processed commodities

are not required; the residues are

covered by the RAC tolerance. Potato, chips 0.02

Potato, dried 0.02

Potato, granules/ flakes 0.02

Radish, roots 0.03 See Vegetable, r oot and t uber , group

1

Radish, tops 0.7 See Leaves of r oot and t uber

v egetables , group 2

Rapeseed subgroup 20

- A 0.25

Root Vegetables

, subgroup

1 A 0.05 See Vegetable, r oot and t uber , group

1

Root Vegetables (except

sugar beet), crop subgroup

1 B 0.05 See Vegetable, r oot and t uber , group

1

Small Fruit Vine Climbing 1.3 Fruit, small, vine climbing, subgroupSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 107 of 141 Appendix 1 . Tolerance Summary for Sulfoxaflor.

Commodity

(as proposed) Proposed

Tolerance

(ppm) HED

- Recommended

Tolerance (ppm) Comments (correct commodity

definition)

subgroup (except fuzzy

kiwifruit), subgroup 13

- 07F



### See Table 1. 13

- 07F, except fuzzy kiwifruit

Soybean, seed 0.2

Soybean, hay 1.8 Covered by Crop group 7

Soybean, forage 1.9

Soybean, hulls 0.3 Tolerance for processed commodities

are not required; the residues are

covered by the RAC tolerance. Soybean, meal, toasted 0.3

Soybean, aspirated grain

fractions 18 .0 See Grain, aspirated fractions

Spinach 5 .0

Squash 0.03 See Vegetable

, c ucurbit

,

g roup 9

Strawberry, fruit 0.6 See Crop s ubgroup 13

- 07G

Tomato 0. 4 5

Tomato, puree 0. 7

Tomato, paste 1. 6

Tomato, catsup 0. 8 HED does not set tolerances for

ketchup (calculated as 1.3 ppm).

Tree Nuts (plus pistachio),

crop group 14 0.02 A separate tolerance is required for

pistachio. See Nut, tree, group 14

Tuberous and Corm

Vegetables, subgroup 1C 0.01 See Vegetable, r oot and t uber , group

1

Tuberous and Corm

Vegetables, subgroup 1D 0.01 See Vegetable, r oot and t uber , group

1

Vegetable , brassica , leafy

(except cauliflower),

Crop Group 5 -- Vegetable , brassica , leafy, group 5,

except cauliflower

Vegetables, Cucurbit, Crop

Group 9 -- Vegetables, cucurbit, group 9

Vegetables, fruiting, Croup

Group 8

- 10 -- Vegetables, fruiting, group 8

- 10,

except cucurbits

Vegetable, root and tuber,

Group 1 -- Vegetable, root and tuber,

group 1

Watercress

-- Translate subgroup 4A data.

Wheat, grain 0.0 7

Wheat, forage 0.8

Wheat hay 1.1

Wheat, straw 2 .0

Livestock Commodities

Tolerances of unchanged parent, sulfoxaflor were also proposed for milk at 0.08 ppm; fat of cattle, goat, horse and

sheep at 0.04 ppm; kidney of cattle, goat, horse and sheep at 0.2 ppm; meat of cattle, goat, horse and sheep at 0.1

ppm; meat byproducts of cattle, goat, horse and sheep at 0.25 ppm; fat and meat of hog at 0.01 ppm; meat

byproducts of hog at 0.04 ppm; egg at 0.01 ppm; fat and meat of poultry at 0.01 ppm; meat byproduct of poultry at

0.03 ppm.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 108 of 141 Appendix 2

. Field Trial Geographi c Distribution

.

Crop Country # of Trials

Human Foods

Carrot Root EU, USA 12

Sugar Beet Root EU, USA 13

Potato Tuber EU, USA/CAN 18

Radish Root USA 6

Onion USA 12

Celery USA 6

Lettuce (Head and Leaf) AUS, EU, USA 32

Spinach and Swiss Chard AUS, USA 8

Broccoli AUS, EU, USA 15

Cabbage AUS, EU, USA 14

Cauliflower AUS, EU 10

Mustard Green USA 8

Green Bean BRZ, EU 6

Shelled Dry Bean BRZ, EU 6

Soybean Seed AUS, USA 19

Pepper (Bell and Non

- bell) BRZ, EU, USA 20

Tomato AUS, BRZ, EU, USA 44

Cucumber EU, USA 18

Melon BRZ, EU, USA 16

Squash (Summer and Winter) and Zucchini AUS, USA 8

Grapefruit USA 8

Lemon USA 6

Orange AUS, BRZ, USA 26

Apple AUS/NZ, EU, USA 22

Pear AUS, EU, USA 14

Cherry AUS/NZ, EU, USA 14

Nectarine AUS/NZ 5

Peach and Apricot AUS/NZ, EU, USA 22

Plum AUS, USA 7

Grape AUS/NZ, EU, USA 33

Strawberry AUS/NZ, USA 13

Almond Nutmeat USA 6

Pecan USA 6

Canola (Rape Seed) AUS, EU, USA/CAN 21

Cotton Seed AUS, BRZ, EU, USA 22

Barley Grain AUS, EU, USA 25

Wheat Grain AUS/NZ, BRZ, EU, USA/CAN 36

Total 583

Livestock Feeds

Almond Hull USA 6

Cotton Gin Byproduct AUS, BRZ, EU, USA 21

Carrot Top USA 4

Radish Top USA 6

Sugar Beet Top EU, USA 13

Barley (Straw & Hay) AUS, EU, USA 27

Soybean (Forage & Hay) BRZ, USA 22

Wheat (Forage, Hay & Straw) AUS/NZ, BRZ, EU, USA/CAN 35Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 109 of 141 A ppendix 3 . Summary Table of NAFTA and European Field Trial Data

Table A 3 . Summary of Residues from the Crop Field Trials with Sulfoxaflor

(SC formulation unless otherwise specified)

. Crop Matrix Applic. Rate

lb ai/A

(g a.i./ha) PHI

(days) n Residues (ppm)

Min Max HAFT 1 Median Mean Std. Dev

C rop Group 1 (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )

Carrot roots 0.357

- 0.376

(401

- 423) 7 24 <0.01 0.032 0.031 0.010 0.015 0.008

Potato roots 0.35 5

- 0.374

(399

- 420 ) 6

- 8 36 <0.01 <0.01 0.01 0.01 0.01 NA

Radish roots

( WDG

formulation) 0.36 0

- 0.3 63

(40 4

- 4 07 ) 7 1 2 <0.01 0.0 13 0.01 2 0.010 0.011 0.00 1

0 .36 0

- 0.3 64

(40 4

- 4 07 ) 7 6 <0.01 0.016 0.014 0.010 0.011 0.002

Sugar beet roots 0.351

- 0.374

(39 4

- 4 20 ) 7 26 <0.01 0.025 0.02 3 0.010 0.011 0.00 3

C rop Group 2 (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )



### Carrot top s 0.360

- 0.366

(405

- 411) 7 8 0.311 2.283 2.069 0.515 0.857 0.764



### Radish tops

( WDG

formulation) 0.36 0

- 0.3 64

(40 4

- 4 07 ) 7 1 2 0.18 3 0.50 6 0.47 8 0.2 58 0. 297 0.10 8

0.3 6 0

- 0.3 64

(40 4

- 4 07 ) 7 6 0.242 0.465 0.441 0.398 0.370 0.099



### Sugar beet tops 0.351

- 0.374

(39 4

- 4 20 ) 7 25 0.14 1 1.68 5 1.6 15 0.71 6 0.744 0.452

C rop Group 3 (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )



### Dry Bulb Onion 0.357

- 0.365

(40 0

- 4 09 ) 7 12 <0.01 <0.01 0.01 0.01 0.01 NA



### Green Onion 0.360

- 0.366

(404

- 41 0 ) 7

- 8 12 <0.01 0.440 0.387 0.105 0.13 2 0.13 0

C rop Group 4 (proposed use = 0.266 lb ai/A total application rate, 3

- day PHI )



### Celery 0.360

- 0.361

(404

- 405) 2

- 3 24 0.058 0.804 0.771 0.143 0.229 0.235



### Head Lettuce 0.328

- 0.38 8

(36 9

- 43 6 ) 2

- 3 27 <0.01 0.528 0.494 0.040 0.148 0.177



### Leaf Lettuce

( WDG

formulation) 0.34 2

- 0.37 7

(384

- 424) 2

- 3 36 0.05 3.07 2.74 0.49 5 0.74 4 0.6 59

0.3 60

- 0.3 63

( 404

- 4 07 ) 3 6 0.379 0.885 0.806 0.577 0.595 0.189



### Spin ach 0.34 3

- 0.37 2

(385

- 418) 3 16 0.039 3.25 6 2.86 3 0.8 20 1.076 0.927

C rop Group 5 (proposed use = 0.266 lb ai/A total application rate, 3

- day PHI )



### Broccoli 0.347

- 0.379

(390

- 426) 3 29 <0.01 1.600 1.584 0.070 0.201 0.395



### Cauliflower 0.320

- 0.373

(360

- 419) 3

- 4 20 <0.01 0.07 0.055 0.014 0.020 0.014



### Cabbage 0.341

- 0.383

(383

- 430) 2

- 3 28 <0.01 0.400 0.377 0.058 0.092 0.103



### Mustard Greens 0.354

- 0.367

(397

- 411) 2

- 4 16 0.27 8 1.1 67 0.899 0.666 0.680 0.234Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 110 of 141 Table A 3 . Summary of Residues from the Crop Field Trials with Sulfoxaflor

(SC formulation unless otherwise specified)

. Crop Matrix Applic. Rate

lb ai/A

(g a.i./ha) PHI

(days) n Residues (ppm)

Min Max HAFT 1 Median Mean Std. Dev

C rop Group 6 Beans (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )

Succulent edible

podded bean 0. 35 2

- 0. 3 72

(393

- 411) 7 12 0. 02 4 2.019 1.938 0.104 0.422 0.716



### Dry s helled b ean 0.350

- 0.365

(393

- 411) 7 12 0.020 0.112 0.104 0.078 0.068 0.029

C rop Group 7 (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )

(Use the higher of the two for group 7)



### Soybean, Forage 0.178

- 0.183

(200

- 20 5 ) 7

- 8 38 0. 013 1.734 1.690 0.219 0.346 0.386



### Soybean, Hay 0.35 8

- 0.3 68

(40 1

- 41 4 ) 6

- 8 38 0.057 1.378 1.238 0.725 0.670 0.383

Crop Group 8 (proposed use = 0.266 lb ai/A total application rate, 1

- day PHI )



### Tomato 0.31 7

- 0.38 3

(356

- 430) 1 88 <0.01 0.762 0.60 2 0.051 0.09 1 0.123



### Pepper , bell 0.32 1

- 0. 364

(361

- 4 09 ) 1 24 <0.01 0. 284 0. 256 0.0 92 0. 106 0. 095



### Pepper , non

- bell 0.3 43

- 0.42 8

( 385

- 481) 1 15 0. 017 0. 46 0. 44 0.090 0. 156 0.14 5

C rop Group 9 (proposed use = 0.266 lb ai/A total application rate, 1

- day PHI )



### Cucumber (revised

from Tier II removing

Zucchini samples) 0.3 55

- 0.37 4

(3 99

- 420) 1 36 < 0.0 1 0.172 0.152 0.04 7 0.0 55 0.0 49



### Squash , summer

/Zucchini (revised

from Tier II adding

Zucchini samples)



### Squash , winter 0.357

- 0.36 7

(400

- 4 12 ) 1 10 < 0. 0 1 0.1 0 0.1 0 0.01 0 0.0 3 1 0.039

0.357

- 0.364

(400

- 408) 1 6 <0.01 0.021 0.01 8 0.011 0.013 0.00 4



### Melon 0.356

- 0.375

( 400

- 421) 0

- 2 e 31 <0.01 0.304 0.266 0.0 31 0.05 4 0.06 7

Crop Group 10 (proposed use = 0.266 lb ai/A total application rate, 1

- day PHI )



### Grapefruit 0.36 0 (404) 1 16 <0.01 0.186 0.130 0.014 0.041 0.056



### Lemons 0.360

(404) 1 12 0.025 0.31 7 0. 136 0.0 50 0.09 8 0.100



### Oranges 0.26 3

- 0.368

(296

- 413 ) 1 61 0.03 7 0.46 0.4 4 0.11 4 0.167 0.120

CROP Group 11 Pome Fruit (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )



### Apples 0.289

- 0.374

(325

- 420) 6

- 8 56 <0.01 0.297 0.266 0.070 0.086 0.057



### Pears 0. 279

- 0.3 79f

( 314

- 426) 7

- 8 32 0.04 4 0.26 7 0.26 1 0.14 2 0.14 6 0.063

C rop Group 12 (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )



### Apricot 0.337

- 0.345

(379

- 388) 7 8 0.13 0.45 0.39 0.16 0.21 0.12



### Cherry 0.33 7

- 0.36 5

( 379

- 410 ) 7 32 0.2 6 1. 60 1.4 9 0.820 0.8 24 0.3 79



### Nectarine 0.34 1

- 0.35 1 7 18 0.07 4 0.247 0.232 0.1 50 0.15 4 0.045Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 111 of 141 Table A 3 . Summary of Residues from the Crop Field Trials with Sulfoxaflor

(SC formulation unless otherwise specified)

. Crop Matrix Applic. Rate

lb ai/A

(g a.i./ha) PHI

(days) n Residues (ppm)

Min Max HAFT 1 Median Mean Std. Dev

(383

- 394)



### Peach 0.33 8

- 0.373

(380

- 419 ) 6

- 8 48 <0.01 0.63 6 0.54 1 0.12 1 0.16 4 0.1 18



### Plum

( WDG

formulation ) 0.34 2

- 0.37 0

(384

- 415) 7 1 4 0.02 1 0.22 1 0.212 0.04 9 0.0 74 0.06 4

0.3 58

- 0.366

(401

- 410) 7 12 0.01 4 0.362 0.358 0.07 6 0.115 0.117

C rop Group 15 (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )



### Barley Grain 0.083

- 0.095

(94

- 108) 12

- 17 50 < 0.010 0.37 0.32 0.048 0.0 60 0.0 60



### Barley Hay 0.086

- 0.096

(97

- 108) 6

- 8 f 40 < 0.010 0.643 0.642 0.213 0.2 49 0.174



### Barley Straw 0.083

- 0.095

(94

- 108) 12

- 17 52 < 0.010 2. 2 1. 46 0. 189 0.32 2 0.4 13



### Wheat Grain

( WDG

formulation ) 0.08 4

- 0.098

(9 4

- 110) 12

- 17 67 <0.01 0. 067 0. 059 0.013 0.0 19 0.0 13

0 .08 9

- 0.09 3

( 100

- 104 ) 14 6 <0.01 0.063 0.063 0.010 0.02 8 0.0 27



### Whea t Forage

( WDG

formulation ) 0.08 4

- 0.098

(9 4

- 110) 6

- 8 g 60 <0.01 1. 4 00 1. 4 00 0.10 8 0.1 87 0.2 25

0.08 4

- 0.098

(9 4

- 110) 7 6 0.041 0.221 0.197 0.09 5 0.111 0.073



### Wheat Hay

( WDG

formulation ) 0.08 4

- 0.09 6

(9 4

- 1 08 ) 6

- 8 60 0.024 1.02 4 0.848 0.2 46 0.29 2 0. 202

0.0 8 9

- 0.09 3

( 100

- 104 ) 7 6 0.101 0.167 0.159 0.150 0.139 0.030



### Wheat Straw

( WDG

formulation ) 0.08 4

- 0.09 7

(9 4

- 1 09 ) 12

- 17 g 6 9 0.030 1.56 2 1.4 8 9 0.2 50 0.40 0 0. 393

0 .08 8

- 0.09 3

( 99

- 1 04 ) 14 6 0.060 1.64 1 1.60 0 0.105 0.588 0.784

C rop Group s 1 3

- 07F & 1 3

- 07G (proposed use = 0.266 lb ai/A total application rate, 1

- day or 7

- day PHI )



### 13

- 07G

Strawberries 0.3 39

- 0.369

(381

- 414) 1 26 0.02 0.50 0.49 0.184 0.182 0.109



### 13

- 07F

Grape (all) 0.27 6

- 0.39 0

(310

- 43 8 ) 7

- 8 66 0.01 1.9 1. 6 0.133 0.26 8 0.3 36

Crop Group 14 Tree Nuts (proposed use = 0.266 lb ai/A total application rate, 7

- day PHI )



### Almond nutmeat 0.355

- 0.367 7 12 <0.01 0.013 0.123 <0.01 0.011 0.001



### Almons hulls 0.355

- 0.367 7 12 1.04 3.12 3.05 1.68 1.86 0.681



### Pecan nutmeat 0.360

- 0.363

(404

- 40 7 ) 7 12 <0.01 <0.01 <0.01 <0.01 <0.01 NA

CROP Group 20 (proposed use = 0.266 lb ai/A total application rate, 14

- day PHI )



### Cotton gin

byproducts

(14

- Day PHI) 0.34 6

- 0.37 5

(389

- 422) 14

- 15 42 0.037 4.20 4.0 3 0.476 0.869 1.1 2



### Cotton , seed 0.34 6

- 0.37 5 14

- 15 44 <0.01 0.18 2 0.176 0.019 0.03 7 0.038Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 112 of 141 Table A 3 . Summary of Residues from the Crop Field Trials with Sulfoxaflor

(SC formulation unless otherwise specified)

. Crop Matrix Applic. Rate

lb ai/A

(g a.i./ha) PHI

(days) n Residues (ppm)

Min Max HAFT 1 Median Mean Std. Dev



### (14

- Day PHI) (389

- 422)



### Canola , seed

(14

- Day PHI) 0.078

- 0.099

(88.1

- 110.8) 13

- 15 36 <0.01 0.224 0.215 0.04 2 0.054 0.046



### Canola , forage

(14

- Day PHI) 0.078

- 0.099

(88.1

- 110.8) 13

- 14 8 0.03 1.5 1.3 0.11 0.39 0.57



### Soybean, Seed 0.357

- 0.37 1

(40 0

- 416) 6

- 8 36 <0.01 0.214 0.199 0.010 0.026 0.044

1 HAFT = Highest Average Field Trial [Note: For OECD data with 1 sample per trial, this column may be

removed.] e Includes 0

- day PHI samples from t rials CEMS

- 3965C and CEMS

- 3965D and 1

- day PHI samples from

decline trials CEMS

- 3965A and CEMS

- 3965B

. f Including Australian trial 080544 , for which total rate s were

0.2 79

- 0.28 3 lb a.i./A (314

- 318 g a.i./ha)

, ~83 % of target application rate ; the application range for all other

applications was 0.341

- 0.379 lb a.i./A (383

- 426 g a.i./ha)

. NOTE: all concentrations for min, max, HAFT, median

and mean are reported in ppm (mg/kg). e Includes hay samples from US Trial 03 that were harvested at an 11

- day

PHI. f Includes hay samples from US Trial 03 that were harvested at an 11

- day PHI. g Includes samples from Trial

090760 that were harvested at a 23

- day PHI; forage includes samples from Trial 090761 that were harvested at a 14

- day PHI.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 113 of 141 A ppendix 4

. Field Trial Data and OECD MRL Calculator Output

The OECD tolerance/ MRL c alcula tion procedures generates tolerances/ MRLs that are based on

mean field trial values. As a result, the residue values in mg/kg listed in the tables in this

attachment are the means of the two samples taken at each trial site.

Root and Tuber Vegetables

Crop Carrots Radish Sugar Beet Potatoes

Region / Country EU; USA USA EU; USA Canada ; EU; US A

GAP 0.266 (298) 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data (n) 12 6 13 18

% of censored data 33% 50% 69% 100%

Number of non

- censored

data 8 3 4 0

Lowest residue 0.010 0.010 0.010 0.010

Highest residue 0.031 0.014 0.023 0.010

Median residue 0.011 0.011 0.010 0.010

Mean 0.015 0.011 0.011 0.010

Standard deviation (SD) 0.008 0.002 0.003 0.000

Correction factor for

censoring (CF) 0.778 0.667 0.538 0.333

- Highest residue 0.031 0.014 0.023 0.010

- Mean + 4 SD 0.045 0.017 0.025 0.010

- CF x 3 Mean 0.034 0.022 0.018 0.010

Unrounded MRL 0.045 0.022 0.025 0.010

Rounded MRL 0.05 0.03 0.03 0.01

High uncertainty of

MRL estimate due to

small dataset.

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.010 0.011 0.010 * 0.010 *

0.017 0.010 * 0.010 * 0.010 *

0.011 0.010 * 0.010 * 0.010 *

0.011 0.010 * 0.012 0.010 *

0.014 0.014 0.010 0.010 *

0.010 * 0.012 0.023 0.010 *

0.030 0.010 * 0.010 *

0.031 0.010 * 0.010 *

0.013 0.010 * 0.010 *

0.010 * 0.010 * 0.010 *

0.010 0.010 * 0.010 *

0.010 * 0.010 0.010 *

0.010 * 0.010 *

0.010 *

0.010 *

0.010 *

0.010 *Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 114 of 141 0.010 *

Leaves of Root and Tuber Vegetables: Crop Group 2

Crop Carrot Tops Sugar Beet Tops

Region / Country EU; US A EU; US

GAP 0.266 (298) 0.266 (298)

Total number of data (n) 4 13

Percentage of censored data 0% 0%

Number of non

- censored data 4 13

Lowest residue 0.338 0.152

Highest residue 2.069 1.615

Median residue 0.510 0.639

Mean 0.857 0.740

Standard deviation (SD) 0.815 0.444

Correction factor for censoring

(CF) 1.000 1.000

- Highest residue 2.069 1.615

- Mean + 4 SD 4.115 2.515

- CF x 3 Mean 2.570 2.221

Unrounded MRL 4.115 2.515

Rounded MRL 5 3

High uncertainty of

MRL estimate due to

small dataset.

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

2.069 0.843

0.338 0.853

0.587 0.905

0.432 1.607

0.745

0.370

0.530

0.639

0.555

0.388

0.421

1.615

0.152Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 115 of 141 Bulb Vegetables: Crop Group 3

- 07

Crop Dry Bulb Onion Green Onion

Region / Country US A US A

GAP 0.266 (298) 0.266 (298)

Total number of data (n) 6 6

Percentage of censored data 100% 17%

Number of non

- censored data 0 5

Lowest residue 0.010 0.010

Highest residue 0.010 0.387

Median residue 0.010 0.109

Mean 0.010 0.132

Standard deviation (SD) 0.000 0.133

Correction factor for censoring

(CF) 0.333 0.889

- Highest residue 0.010 0.387

- Mean + 4 SD 0.010 0.665

- CF x 3 Mean 0.010 0.351

Unrounded MRL 0.010 0.665

Rounded MRL 0.01 0.07

High uncertainty of MRL due

to small dataset and high level

of censoring. High uncertainty of MRL

due to small dataset.

Residues (mg/kg)

0.010 * 0.090

0.010 * 0.048

0.010 * 0.128

0.010 * 0.010 *

0.010 * 0.387

0.010 * 0.128Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 116 of 141 Leafy Vegetables Except Brassica : Crop Group 4

Crop Celery Head Lettuce Leaf Lettuce Spinach

Region / Country US A AUS; EU; US A AUS; EU; USA AUS; USA

GAP 0.266 (298) 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data 6 13 16 7

% of censored data 0% 8% 0% 0%

Number of non

- censored

data 6 12 6 7

Lowest residue 0.072 0.010 0.055 0.041

Highest residue 0.771 0.494 2.744 2.863

Median residue 0.185 0.065 0.587 1.038

Mean 0.344 0.160 0.783 1.145

Standard deviation (SD) 0.304 0.177 0.694 0.996

Correction factor for

censoring (CF) 1.000 0.949 1.000 1.000

- Highest residue 0.771 0.494 0.694 2.863

- Mean + 4 SD 1.561 0.869 1.000 5.128

- CF x 3 Mean 1.032 0.454 2.350 3.436

Unrounded MRL 1.561 0.869 3.557 5.128

Rounded MRL 2 0.9 4 6

High uncertainty of

MRL estimate due

to small dataset. High uncertainty

of MRL estimate

due to small

dataset.

Residues

(mg/kg) Residues

(mg/kg) Residues

(mg/kg) Residues

(mg/kg)

0.692 0.065 0.930 0.365

0.771 0.035 0.055 1.871

0.158 0.035 0.230 2.863

0.171 0.010 0.170 1.038

0.198 0.321 0.751 0.041

0.072 0.015 0.315 0.405

0.494 1.356 1.434

0.174 0.417

0.236 0.424

0.487 0.183

0.010 * 0.415

0.178 1.069

0.015 1.587

2.744

0.789

1.099Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 117 of 141 Brassica Leafy Vegetables: Crop Group 5

Crop Broccoli Cauliflower Cabbage Mustard Greens

Region / Country AUS; EU; USA AUS; EU AUS; EU; USA US A

GAP 0.266 (298) 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data (n) 15 10 14 7

Percentage of censored data 0% 30% 7% 0%

Number of non

- censored data 15 7 13 7

Lowest residue 0.010 0.010 0.010 0.286

Highest residue 1.584 0.055 0.377 0.899

Median residue 0.070 0.014 0.074 0.674

Mean 0.204 0.020 0.092 0.667

Standard deviation (SD) 0.395 0.014 0.098 0.226

Correction factor for censoring

(CF) 1.000 0.800 0.952 1.000

- Highest residue 1.584 0.055 0.377 0.899

- Mean + 4 SD 1.786 0.075 0.484 1.573

- CF x 3 Mean 0.612 0.047 0.262 2.002

Unrounded MRL 1.786 0.075 0.484 2.002

Rounded MRL 2 0.08 0.5 2

High uncertainty of

MRL estimate due

to small dataset.

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.065 0.010 * 0.150 0.817

0.070 0.055 0.010 0.603

0.073 0.021 0.377 0.674

0.281 0.012 0.081 0.495

0.164 0.014 0.034 0.896

1.584 0.022 0.016 0.286

0.074 0.029 0.066 0.899

0.057 0.014 0.019

0.036 0.010 * 0.097

0.010 0.010 * 0.040

0.393 0.097

0.060 0.010 *

0.117 0.185

0.050 0.101

0.029Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 1 18 of 141 Soybeans and Dried Shelled Peas and Beans: Crop Subgroup 6C

Crop Dried Shelled Bean Beans, succulent Soybean Seed

Region / Country Brazil; /EU Brazil; /EU Brazil; US A

GAP 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data (n) 6 6 20

Percentage of censored data 0% 0% 35%

Number of non

- censored data 6 6 13

Lowest residue 0.028 0.029 0.010

Highest residue 0.104 1.938 0.199

Median residue 0.077 0.096 0.013

Mean 0.022 0.422 0.029

Standard deviation (SD) 0.104 0.749 0.044

Correction factor for censoring (CF) 0.077 1.000 0.767

- Highest residue 0.104 1.938 0.199

- Mean + 4 SD 0.184 3.418 0.204

- CF x 3 Mean 0.205 1.267 0.067

Unrounded MRL 0.205 3.418 0.204

Rounded MRL 0.2 4 0.2

High uncertainty of MRL estimate

due to small dataset. High uncertainty of MRL

estimate due to small dataset. High uncertainty of MRL estimate

due to small dataset.

Residues

(mg/kg) Residues (mg/kg)

0.080 1.938 0.010 *

0.082 0.116 0.030

0.074 0.072 0.039

0.049 0.076 0.010 *

0.104 0.306 0.010

0.022 0.029 0.013

0.016

0.010 *

0.199

0.028

0.017

0.013

0.010 *

0.010 *

0.010 *

0.034

0.013

0.021

0.010 *

0.085Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 119 of 141 Foliage of Legume Vegetables: Crop Group 7

Crop Soybean Forage Soybean Hay

Region / Country Brazil; USA Brazil; USA

GAP 0.266 (298) 0.266 (298)

Total number of data 20 20

% of censored data 0% 0%

Number of non

- censored data 20 20

Lowest residue 0.016 0.016

Highest residue 1.690 1.238

Median residue 0.246 0.691

Mean 0.398 0.662

Standard deviation (SD) 0.415 0.383

Correction factor for censoring

(CF) 1.000 1.000

- Highest residue 1.690 1.238

- Mean + 4 SD 2.059 2.196

- CF x 3 Mean 1.194 1.986

Unrounded MRL 2.059 2.196

Rounded MRL 2 3

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.215 1.014

0.111 1.217

0.217 0.716

0.276 0.245

0.440 0.564

0.526 1.238

0.016 0.016

0.036 0.122

0.187 0.968

0.430 0.667

0.209 0.936

0.157 1.007

0.373 0.127

0.357 0.501

0.397 0.890

1.690 0.869

0.946 0.385

1.141 0.464

0.126 0.246

0.113 1.049Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 120 of 141 Fruiting Vegetables: Crop Group 8

- 09

Crop Tomatoes (Field) Bell Peppers Non

- Bell Peppers

Region / Country AUS; BRZ; EU; USA AUS; EU; USA AUS; EU; USA

GAP 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data (n) 44 12 8

Percentage of censored data 2% 0% 0%

Number of non

- censored data 43 12 8

Lowest residue 0.010 0.010 0.020

Highest residue 0.602 0.256 0.440

Median residue 0.054 0.052 0.086

Mean 0.092 0.096 0.173

Standard deviation (SD) 0.119 0.098 0.161

Correction factor for censoring (CF) 0.985 1.000 1.000

- Highest residue 0.602 0.256 0.440

- Mean + 4 SD 0.567 0.486 0.816

- CF x 3 Mean 0.272 0.288 0.520

Unrounded MRL 0.602 0.486 0.816

Rounded MRL 0.6 0.5 0.9

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.025 0.010 0.080

0.050 0.010 0.440

0.015 0.010 0.400

0.015 0.083 0.075

0.015 0.176 0.086

0.030 0.256 0.020

0.074 0.229 0.200

0.035 0.117 0.085

0.096 0.012

0.015 0.015

0.054 0.022

0.085 0.211

0.052

0.022

0.024

0.113

0.035

0.030

0.373

0.057

0.026

0.405

0.076

0.042

0.602

0.054Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 121 of 141 Fruiting Vegetables: Crop Group 8

- 09

Crop Tomatoes (Field) Bell Peppers Non

- Bell Peppers

Region / Country AUS; BRZ; EU; USA AUS; EU; USA AUS; EU; USA

0.047

0.231

0.313

0.150

0.063

0.095

0.010 *

0.030

0.010

0.026

0.150

0.082

0.058

0.061

0.094

0.085

0.077

0.047

Cucurbit Vegetables: Crop Group 9

Crop Cucumbers Squash/Zucchini Melon

(Whole Fruit)

Region / Country AUS; EU; USA US A BRZ; EU; USA

GAP 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data (n) 18 8 16

Percentage of censored data 0% 50% 0%

Number of non

- censored data 18 4 16

Lowest residue 0.010 0.010 0.010

Highest residue 0.152 0.100 0.266

Median residue 0.047 0.011 0.034

Mean 0.055 0.024 0.054

Standard deviation (SD) 0.039 0.031 0.066

Correction factor for censoring (CF) 1.000 0.667 1.000

- Highest residue 0.152 0.100 0.266

- Mean + 4 SD 0.211 0.149 0.317

- CF x 3 Mean 0.166 0.048 0.162

Unrounded MRL 0.211 0.149 0.317

Rounded MRL 0.3 0.15 0.4

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.084 0.010 * 0.043

0.029 0.010 * 0.014Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 122 of 141 Cucurbit Vegetables: Crop Group 9

Crop Cucumbers Squash/Zucchini Melon

(Whole Fruit)

Region / Country AUS; EU; USA US A BRZ; EU; USA

0.031 0.010 * 0.022

0.052 0.018 0.020

0.083 0.011 0.045

0.023 0.010 * 0.014

0.103 0.100 0.036

0.152 0.025 0.133

0.034 0.105

0.062 0.048

0.112 0.010

0.055 0.025

0.010 0.266

0.071 0.038

0.025 0.032

0.041 0.018

0.014

0.018Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 123 of 141 Citrus Fruits : Crop Group 10

Crop Grapefruit Lemon Orange

Region / Country US A US A AUS; BRZ; US A

GAP 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data (n) 8 5 30

Percentage of censored data 13% 0% 0%

Number of non

- censored data 7 5 30

Lowest residue 0.010 0.034 0.038

Highest residue 0.130 0.292 0.435

Median residue 0.014 0.051 0.122

Mean 0.041 0.112 0.174

Standard deviation (SD) 0.050 0.109 0.121

Correction factor for censoring (CF) 0.917 1.000 1.000

- Highest residue 0.130 0.292 0.435

- Mean + 4 SD 0.241 0.547 0.658

- CF x 3 Mean 0.113 0.335 0.522

Unrounded MRL 0.241 0.547 0.658

Rounded MRL 0.3 0.6 0.7

High uncertainty of MRL

estimate due to small

dataset.

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.011 0.136 0.410

0.013 0.051 0.370

0.011 0.292 0.325

0.010 * 0.034 0.085

0.016 0.045 0.150

0.130 0.145

0.024 0.155

0.112 0.430

0.340

0.435

0.280

0.099

0.096

0.283

0.121

0.132

0.098

0.102

0.136

0.123

0.112

0.112

0.074

0.098Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 124 of 141 Citrus Fruits : Crop Group 10

Crop Grapefruit Lemon Orange

Region / Country US A US A AUS; BRZ; US A

0.062

0.048

0.155

0.085

0.120

0.038

Pome Fruit: Crop Group 11

- 09

Crop Apples Pears

Region / Country AUS/NZ; EU; US A AUS; EU; USA

GAP 0.266 (298) 0.266 (298)

Total number of data (n) 22 14

Percentage of censored data 0% 0%

Number of non

- censored data 22 14

Lowest residues 0.011 0.052

Highest residue 0.266 0.261

Median residue 0.071 0.145

Mean 0.088 0.146

Standard deviation (SD) 0.060 0.065

Correction factor for censoring (CF) 1.000 1.000

- Highest residue 0.266 0.261

- Mean + 4 SD 0.327 0.406

- CF x 3 Mean 0.265 0.438

Unrounded MRL 0.327 0.438

Rounded MRL 0.4 0.5

Residues (mg/kg) Residues (mg/kg)

0.185 0.125

0.140 0.220

0.070 0.058

0.100 0.052

0.090 0.184

0.050 0.097

0.185 0.105

0.078 0.176

0.266 0.155

0.074 0.134

0.043 0.176

0.040 0.261Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 125 of 141 Pome Fruit: Crop Group 11

- 09

Crop Apples Pears

Region / Country AUS/NZ; EU; US A AUS; EU; USA

0.064 0.228

0.036 0.075

0.066

0.121

0.072

0.011

0.039

0.089

0.056

0.068

Stone Fruit: Crop Group 12

- 09

Crop Apricots Cherries Nectarines Peaches Plums

Region / Country A US/NZ AUS/NZ; EU;

USA AUZ;NZ AUS/NZ; EU; USA AUS; USA

GAP 0.266 (298) 0.266 (298) 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data

(n) 4 14 6 20 7

% of censored data 0% 0% 0% 0% 0%

Number of non

censored data 4 14 6 20 7

Lowest residue 0.135 0.345 0.131 0.015 0.022

Highest residue 0.390 1.491 0.232 0.541 0.358

Median residue 0.160 0.848 0.168 0.141 0.066

Mean 0.211 0.895 0.171 0.169 0.104

Standard deviation

(SD) 0.120 0.334 0.038 0.122 0.116

Correction factor for

censoring (CF) 1.000 1.000 1.000 1.000 1.000

- Highest residue 0.390 1.491 0.232 0.541 0.358

- Mean + 4 SD 0.690 2.230 0.323 0.658 0.568

- CF x 3 Mean 0.634 2.684 0.512 0.507 0.311

Unrounded MRL 0.690 2.684 0.512 0.658 0.568

Rounded MRL 0.7 3 0.6 0.7 0.6

High uncertainty of

MRL estimate due

to small dataset. High uncertainty of

MRL estimate due to

small dataset. High uncertainty

of MRL estimate

due to small

dataset.

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.390 0.345 0.131 0.220 0.022

0.160 1.290 0.178 0.272 0.358

0.135 1.491 0.136 0.150 0.091

0.160 0.898 0.157 0.142 0.066

0.770 0.232 0.015 0.053

0.541 0.190 0.100 0.031Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 126 of 141 Stone Fruit: Crop Group 12

- 09

Crop Apricots Cherries Nectarines Peaches Plums

Region / Country A US/NZ AUS/NZ; EU;

USA AUZ;NZ AUS/NZ; EU; USA AUS; USA

0.983 0.119 0.107

0.799 0.109

1.241 0.360

1.221 0.196

1.047 0.541

0.760 0.267

0.586 0.204

0.554 0.083

0.090

0.032

0.054

0.173

0.140

0.116

Grape: Crop Subgroup 13

- 07F/ Strawberries: Crop Subgroup 13

- 07G

Crop Grape Strawberry

Region / Country AUS/NZ; EU; USA AUS/NZ; USA

GAP 0.266 (298) 0.266 (298)

Total number of data (n) 33 12

Percentage of censored data 0% 0%

Number of non

- censored data 33 12

Lowest residues 0.010 0.020

Highest residue 1.550 0.490

Median residue 0.140 0.191

Mean 0.268 0.182

Standard deviation (SD) 0.331 0.115

Correction factor for censoring (CF) 1.000 1.000

- Highest residue 1.550 0.490

- Mean + 4 SD 1.591 0.641

- CF x 3 Mean 0.803 0.547

Unrounded MRL 1.591 0.641

Rounded MRL 2 0.7

Residues (mg/kg) Residues (mg/kg)

0.110 0.020

0.100 0.125

0.140 0.490

0.130 0.210Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 127 of 141 Grape: Crop Subgroup 13

- 07F/ Strawberries: Crop Subgroup 13

- 07G

Crop Grape Strawberry

Region / Country AUS/NZ; EU; USA AUS/NZ; USA

GAP 0.266 (298) 0.266 (298)

0.350 0.065

0.095 0.134

0.205 0.210

1.550 0.203

0.030 0.208

0.010 0.142

0.450 0.191

0.555 0.191

0.146

0.357

0.956

0.291

0.231

0.152

0.099

1.019

0.225

0.457

0.080

0.061

0.106

0.091

0.042

0.035

0.098

0.331

0.078

0.142

0.119Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 128 of 141 Tree Nuts: Crop Group 14

Crop Almond Nutmeat Almond Hulls Pecan Nutmeat

Region / Country US A US A US A

GAP 0.266 (298) 0.266 (298) 0.266 (298)

Total number of data (n) 6 6 6

Percentage of censored data 83% 0% 100%

Number of non

- censored data 1 6 0

Lowest residue 0.010 1.219 0.010

Highest residue 0.013 3.055 0.010

Median residue 0.010 1.595 0.010

Mean 0.010 1.864 0.010

Standard deviation (SD) 0.001 0.677 0.000

Correction factor for censoring

(CF) 0.444 1.000 0.333

- Highest residue 0.013 3.055 0.010

- Mean + 4 SD 0.014 4.570 0.010

- CF x 3 Mean 0.014 5.592 0.010

Unrounded MRL 0.014 5.592 0.010

Rounded MRL 0.015 6 0.01

High uncertainty of

MRL estimate due to

small dataset and

high level of

censoring. High

uncertainty of

MRL estimate

due to small

dataset. High uncertainty of

MRL estimate due to

small dataset and

high level of

censoring.

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.010 * 3.055 0.010 *

0.010 * 1.675 0.010 *

0.010 * 1.515 0.010 *

0.013 1.219 0.010 *

0.010 * 1.475 0.010 *

0.010 * 2.245 0.010 *Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 129 of 141 Wheat, and Barley Grain: Crop Group 15

Crop Wheat Grain Barley Grain

Region / Country AUS/NZ; BRZ; EU; Canada/USA AUS; EU; USA

GAP 0.09 (101) 0.09 (101)

Total number of data (n) 33 23

Percentage of censored data 27 0%

Number of non

- censored data 24 23

Lowest residue 0.010 0.010

Highest residue 0.063 0.320

Median residue

0.015 0.055

Mean 0.020 0.061

Standard deviation (SD) 0.013 0.062

Correction factor for censoring

(CF) 0.818 1.000

- Highest residue 0.063 0.320

- Mean + 4 SD 0.074 0.307

- CF x 3 Mean 0.049 0.183

Unrounded MRL 0.074 0.320

Rounded MRL 0.08 0.4

Residues (mg/kg) Residues (mg/kg)

0.015 0.055

0.035 0.320

0.04 0.025

0.01 0.105

0.01 * 0.075

0.015 0.010

0.01 * 0.016

0.02495 0.057

0.01 * 0.060

0.01 * 0.056

0.0225 0.043

0.027 0.015

0.018 0.079

0.01 * 0.058

0.02 0.020

0.0135 0.045

0.0315 0.043

0.0185 0.061

0.0125 0.044

0.056 0.026

0.012 0.033

0.011 0.088

0.01475 0.073Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 130 of 141 Wheat, and Barley Grain: Crop Group 15

Crop Wheat Grain Barley Grain

Region / Country AUS/NZ; BRZ; EU; Canada/USA AUS; EU; USA

GAP 0.09 (101) 0.09 (101)

0.01

0.01

0.0203

0.01 *

0.01 *

0.0122

0.01

0.01 *

0.05795

0.01 *Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 131 of 141 Cereal Grain Forage: Crop Group 16

Crop Wheat Forage Barley Forage

Region / Country AUS/NZ; BRZ; EU; Canada/USA NA

GAP 0.09 (101) NA

Total number of data (n) 29

Percentage of censored data 0%

Number of non

- censored data 29

Lowest residue 0.011

Highest residue 0.950

Median residue 0.095

Mean 0.146

Standard deviation (SD) 0.184

Correction factor for censoring (CF) 1.000

Highest residue 0.950

- Mean + 4 SD 0.880

- CF x 3 Mean 0.437

Unrounded MRL 0.950

Rounded MRL **1**

Residues (mg/kg) Residues (mg/kg)

0.950

0.095

0.389

0.118

0.112

0.051

0.016

0.226

0.186

0.371

0.033

0.066

0.174

0.150

0.020

0.103

0.035

0.070

0.294

0.065

0.024

0.092

0.052

0.099

0.086

0.011Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 132 of 141 Cereal Grain Forage: Crop Group 16

Crop Wheat Forage Barley Forage

Region / Country AUS/NZ; BRZ; EU; Canada/USA NA

GAP 0.09 (101) NA

0.105

0.197

0.042

Cereal Grain Hay: Crop Group 16

Crop Wheat Hay Barley Hay

Region / Country AUS/NZ; BRZ; EU; Canada ; USA AUS; EU; USA

GAP 0.09 (101) 0.09 (101)

Total number of data (n) 29 19

Percentage of censored data 0% 0%

Number of non

- censored data 29 19

Lowest residue 0.016 0.016

Highest residue 0.848 0.642

Median residue 0.214 0.254

Mean 0.276 0.258

Standard deviation (SD) 0.204 0.174

Correction factor for censoring (CF) 1.000 1.000

Highest residue 0.848 0.642

- Mean + 4 SD 1.092 0.953

- CF x 3 Mean 0.829 0.775

Unrounded MRL 1.092 0.953

Rounded MRL 1.5 **1**

Residues (mg/kg) Residues (mg/kg)

0.263 0.200

0.532 0.197

0.418 0.642

0.533 0.212

0.209 0.037

0.216 0.405

0.016 0.016

0.600 0.041

0.074 0.254

0.313 0.434

0.087 0.357

0.341 0.030

0.188 0.377

0.493 0.388

0.280 0.123Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 133 of 141 Cereal Grain Hay: Crop Group 16

Crop Wheat Hay Barley Hay

Region / Country AUS/NZ; BRZ; EU; Canada ; USA AUS; EU; USA

GAP 0.09 (101) 0.09 (101)

0.571 0.465

0.104 0.307

0.848 0.314

0.411 0.115

0.152

0.048

0.199

0.214

0.026

0.082

0.345

0.194

0.159

0.104

Cereal Grain Straw: Crop Group 16

Crop Wheat Straw Barley Straw

Region / Country AUS/NZ; BRZ; EU; Canada ; USA AUS; EU; USA

GAP 0.09 (101) 0.09 (101)

Total number of data (n) 34 22

Percentage of censored data 0% 0%

Number of non

- censored data 34 22

Lowest residue 0.016 0.016

Highest residue 1.599 1.455

Median residue 0.260 0.157

Mean 0.390 0.273

Standard deviation (SD) 0.408 0.325

Correction factor for censoring (CF) 1.000 1.000

Highest residue 1.599 1.455

- Mean + 4 SD 2.022 1.572

- CF x 3 Mean 1.170 0.819

Unrounded MRL 2.022 1.572

Rounded MRL 2 2

Residues (mg/kg) Residues (mg/kg)

0.285 0.215

1.400 1.455Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 134 of 141 Cereal Grain Straw: Crop Group 16

Crop Wheat Straw Barley Straw

Region / Country AUS/NZ; BRZ; EU; Canada ; USA AUS; EU; USA

GAP 0.09 (101) 0.09 (101)

0.410 0.030

0.055 0.240

0.295 0.100

0.460 0.090

0.016 0.016

1.061 0.216

0.084 0.128

0.052 0.584

0.218 0.530

0.107 0.375

0.346 0.051

0.491 0.073

0.234 0.106

0.179 0.121

0.616 0.319

0.507 0.524

0.321 0.186

0.209 0.024

0.319 0.044

0.815 0.587

0.623

0.310

0.063

0.113

0.222

0.114

0.043

0.169

1.341

0.071

1.599

0.115Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 135 of 141 Oilseed Crops: Crop Group 20

Crop Canola Cottonseed Cotton Gin Bypds

Region / Country AUS; EU; Canada;

USA AUS; BRZ; EU; USA AUS; BRZ; EU; USA

GAP 0.09(101) 0.266(298) 0.266(298)

Total number of data 20 22 21

% of censored data 0% 14% 0%

Number of non

censored data 20 19 21

Lowest residue 0.010 0.010 0.042

Highest residue 0.215 0.176 4.026

Median residue 0.043 0.022 0.486

Mean 0.053 0.037 0.869

Standard deviation

(SD) 0.044 0.038 1.126

Correction factor for

censoring (CF) 1.000 0.909 1.000

- Highest residue 0.215 0.176 4.026

- Mean + 4 SD 0.228 0.190 5.373

- CF x 3 Mean 0.158 0.101 2.608

Unrounded MRL 0.228 0.190 5.373

Rounded MRL **0.3** 0.2 6

Residues (mg/kg) Residues (mg/kg) Residues (mg/kg)

0.020 0.010 * 0.115

0.085 0.015 0.590

0.060 0.080 3.850

0.010 0.045 1.600

0.038 0.039 1.517

0. 027 0.010 * 0.514

0.057 0.014 0.351

0.072 0.042 0.926

0.043 0.080 0.413

0.215 0.011 0.355

0.076 0.070 0.486

0.051 0.010 * 0.234

0.033 0.027 1.400

0.035 0.013 0.893

0.010 0.031 0.188

0.017 0.043 0.577

0.047 0.041 0.042

0.072 0.010 0.048

0.042 0.015 0.073

0.042 0.016 0.061

0.017 4.026

0.176Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 136 of 141 A ppendix 5 . Individual MRLs for Representative Commodities and Crop Group MRLs

Sulfoxaflor : U.S. Recommended MRLs for Plant Commodities

Determined Using OECD MRL Calculator

Crop Group Representative Crops Maximum Individual

Residue Values

(ppm) Individual MRL

(ppm) Proposed

Crop Group MRL

Crop Group

1

(7

- Day PHI) Carrot (roots) 0.03 0.05

0.05 ppm for all crops of

Crop Group 1 Radish (roots) 0.02 0.03

Sugar beet (roots) 0.03 0.03

Potato (tubers) <0.01 0.01

Processed commodities:

Carrot juice

Potato flakes

Potato chips

Potato dried

Potato, peel, wet

Sugar beet , sugar, refined

Sugar beet

, molasses HAFT x PF =

0.031 x 2.4 = 0.07

0.01 x 2.5 = 0.025

0.01 x 2.1 = 0.025

0.01 x 3.6 = 0.036

0.01 x 1.8 = 0.0 18

0.023 x 0.8 = 0.0 2

0.023 x 10.0 = 0.23 NA

N R

N R

NR

NR

NR

0.25 N R = Not required , all less

than the crop group tolerance

. NA

- HED does not set

tolerance s for c arrot juice

.

Sugar beet , molasses at

0.25 ppm

Crop Group

2

(7

- Day PHI) Sugar beet tops (leaves) 1.69 3.0 3.0 ppm for all crops of

Crop Group 2

(representative crops are

turnips and beets) Radish tops 0.51 1.0

Crop

subg roup s

3

- 07 A

3

- 07B

(7

- Day PHI) Subgroup 3

- 07A

O nion , bulb subgroup <0.01 0.01 0. 01 ppm

for subg roup 3

- 07 A

Subgroup 3

- 07B

O nion , green subgroup 0.44 0.7 0.7 ppm

for subgroup 3

- 07B

Crop Group

4

(3

- Day PHI) Celery (4B) 0.80 2.0 6 .0 ppm for subgroup 4A

2.0 ppm for subgroup 4B

(translate 4A data for

Watercress) Head lettuce (4A) 0.53 0.9

Leaf lettuce (4A) 3.07 4.0

Spinach (4A) 3.26 6 .0

Crop Group

5

(3

- Day PHI) Broccoli 1.60 2.0

2.0 ppm

for all crops of Group 5 Cauliflower 0.07 0.08

Cabbage (w wrapper leaves) 0.40 0.5

Mustard Greens 1.17 2.0

Crop Group

6

(7

- DayPHI) Beans (succulent) 2.02 4.0 4.0 ppm Beans, succulent

Dry beans 0.11 0.2 0.2 ppm Beans, dry

Soybeans 0.21 4 0. 2 (0.3)* 0. 2 ppm Soybean, seed

(* 0.3 when the highest individual

value 0.214 ppm was used instead

of the average for one field trial)

Processed commodities:

Soybean hulls

Soybean meal

Soybean, oil, refined HAFT x PF =

0.013 x 1.5 = 0.02 (NR)

0.013 x 1.3 = 0.02 (NR)

0.013 x 0.1 = 0.001 (NR) NR = Not required, soybean

seed tolerance is 0.2 ppm.Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 137 of 141 Sulfoxaflor : U.S. Recommended MRLs for Plant Commodities

Determined Using OECD MRL Calculator

Crop Group Representative Crops Maximum Individual

Residue Values

(ppm) Individual MRL

(ppm) Proposed

Crop Group MRL

Crop Group

8

(1

- Day PHI) Tomato 0.76 0 .6 0.9 ppm for all crops of

Crop Group 8

- 09 Bell pepper 0.28 0 .5

Non

- bell pepper 0.46 0.9

Processed commodities:

Tomato p aste

Tomato puree HAFT x PF

0.602 x 4.4 = 2.6 ppm

0.602 x 2.0 = 1.2 ppm 2.6 ppm for tomato paste

1.2 ppm for tomato puree

Crop Group

9

(1

- Day PHI) Cucumber 0.17 0.3

0. 4 ppm for all crops of

Crop Group 9 Squash 0.02 0.15

Melon 0.30 0.4

Crop Group

10

(1

- Day PHI) Grapefruit <0.01 0.3

0.7 ppm for all crops of

Crop Group 10 Lemon 0.32 0.6

Oranges 0.46 0.7

Processed commodities:

Citrus, peel

Citrus, pulp, dried

Citrus, oil

Citrus juice HAFT x PF

0.435 x 9.13 = 4.0 ppm

0.435 x 8.3 = 3.6 ppm

0.435 x 0.2 = 0. 0 9 ppm

0.435 x 0.2 = 0. 0 9 ppm 4.0 ppm for Citrus, peel

3.6 ppm for Citrus, dried,

pulp

Citrus oil and c itrus juice

tolerance s are not required;

both are less than the crop

group tolerance.

Crop Group

11

(7

- Day PHI) Apple 0.30 0.4 0.5 ppm for all crops of Crop

Group 11

- 09

Apple juice tolerance is not

required; it is less than the

crop group tolerance. Pear 0.27 0.5

Processed commodities:

Apple, pomace, wet

Apple juice HAFT x PF

0.266 x 1.1 = 0.29 ppm (NR)

0.266 x 0.4 = 0

. 11 ppm (NR)

Crop Group

12

(7

- Day PHI) Apricot 0.45 0.7

3.0 ppm for all crops of Crop

Group 12

- 09

. Cherry 1.60 3.0

Nectarine 0.25 0.6

Peach 0.64 0.7

Plum 0.36 0.6

Processed commodities:

Cherry, dried

Prune HAFT x PF

1.49 x 5.2 = 7.7 ppm

0.358 x 5. 2 = 1. 9 ppm

(use PF from dried cherry) Tolerances are not set for

dried cherries.

Plum, dried tolerance is not

required; it is less than the

crop group tolerance.

Crop Group

13

- 07F Grape 1.9 2.0 2.0 ppm for all crops of Crop

Subgroup 13

- 07FSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 138 of 141 Sulfoxaflor : U.S. Recommended MRLs for Plant Commodities

Determined Using OECD MRL Calculator

Crop Group Representative Crops Maximum Individual

Residue Values

(ppm) Individual MRL

(ppm) Proposed

Crop Group MRL

(7

- Day PHI) Processed commodities:

Grape, raisin

Grape juice HAFT x PF

1.55 x 3.5 = 5.4 ppm

1.56 x 0.8 = 1.25 ppm (NR) 6.0 ppm for Grape, raisin in

order to harmonize with

proposed CODEX MRL

Crop Group

13

- 07 G

(1

- D ay PHI) Strawberry 0.50 0.7 0.7 ppm for all crops of Crop

Subgroup 13

- 07G

Crop Group

14

(7

- Day PHI) Almond 0.013 0.015 0.015 ppm for all crops of

Crop Group 14

- 11

(Pistachio requires a

tolerance, not yet a crop

group member.) Pecan <0.01 0.01

Crop Group

15

(Barley and

Wheat only)

(14

- Day PHI) Wheat 0.07 0.08 0.0 8 ppm for wheat, grain

Processed commodities:

Wheat, bran

Wheat, flour

Wheat, middlings

Wheat, shorts

Wheat, germ HAFT x PF

0.0 63 x 0.4 = 0.0 3

0.0 63 x 0.2 = 0.01

0.0 63 x 0.2 = 0.01

0.0 63 x 0.2 = 0.01

0.0 63 x 0.5 = 0.03 Wheat processed commodity

tolerances are not required,

they are all less than the

wheat, grain tolerance.

Barley 0.37 0.4 0.4 ppm for barley, grain

Processed commodities:

Barley, pearled

Barley, flour

Barley, bran HAFT x PF

0.32 x 0.7 = 0.22

0.32 x 0.8 = 0.26

0.32 x 1.0 = 0.32 Barley processed commodity

tolerances are not required;

they are all less than the 0.4

ppm barley grain tolerance.

Crop Group

20

(14

- Day PHI) Canola 0.2 24 0. 3 0. 4 ppm for all crops of Crop

Group 20 A (to harmonize

with CODEX)

0. 5 ppm for Canola meal

0.4 ppm for all crops of Crop

Group 20 C Processed commodities:

Canola meal

Canola, oil, refined HAFT x PF

0.2 15 x 1.9 = 0. 4 1

0.2 15 x 0.3 = 0.0 7

Cottonseed 0.18 0.2

Processed food

commodities:

C otton , oil, refined HAFT x PF

0.176 x 0.1 = 0.02 Not required, below the RAC

tolerance.

Livestock Feed Commodities

Crop Group

1 Sugar b eet

, d ried p ulp HAFT x PF = 0.023 x 3.0 = 0.02 0.07 ppm

Sugar beet molasses HAFT x PF = 0.023 x 10.0 = 0.23 0.25 ppm

Sugar beet, tops 1.62 3.0 3.0 ppm

Processed p otato w aste HAFT x PF = 0.0 1 x 4.0

= 0.04 Not required, less than the

RAC tolerance.

Crop Group 7 Vegetables, legume, foliage 1.4 3.0 3.0 ppm for Crop Group 7Sulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 139 of 14 1 Sulfoxaflor : U.S. Recommended MRLs for Plant Commodities

Determined Using OECD MRL Calculator

Crop Group Representative Crops Maximum Individual

Residue Values

(ppm) Individual MRL

(ppm) Proposed

Crop Group MRL

( hay )

Vegetables, legume, foliage,

vines/forage 1.73 2.0 Use the higher 3.0 for group

7

Crop Group

10 Citrus, pulp, dried HAFT x PF = 0.435 x 8.3 = 3.61 3.6 ppm

Crop Group

11 Wet apple pomace HAFT x PF = 0.266 x 1.1 = 0.29 Not required, Pome fruit

tolerance is 0.5 ppm.

Crop Group

14 Almond Hulls 3.12 ppm 6.0 6.0 ppm for almond hulls

Crop Group

15 and

Soybeans Aspirated Grain Fractions

Soybeans

Wheat 0.199 x 95 = 18.9

0.0 63 x 21 = 1. 3 2 18.9 ppm

1. 3 ppm 20.0 ppm for aspirated grain

fractions (AGF)

, ( rounded to

20.0 ppm ).

Soybean meal HAFT x PF = 0.013 x 1.3 = 0.02 Not required, soybean seed

tolerance is 0.2 ppm.

Soybean hulls HAFT x PF = 0.013 x 1.5 = 0.02 Not required, soybean seed

tolerance is 0.2 ppm.

Soybean forage 1.69 2.0 Covered by Crop Group 7 at

3.0 ppm Soybean hay 1.24 3.0

Wheat milled byproducts HAFT x PF = 0.0 63 x 0.2 = 0.0 1

(used wheat shorts PF = 0.2X) Not required, wheat grain

tolerance is 0.0 8 ppm.

Crop Group

16 Grain, Cereal, hay Barley

- 0.64

Wheat

- 1.02

(7

- Day PHI) Barley

- 1.0

Wheat

- 1.5 Barley, hay

- 1.0 ppm

Wheat, hay

- 1.5 ppm

Grain, Cereal, forage Barley

- NA

Wheat

- 1. 4

(HAFT = 0.95)

(7

- Day PHI) Barley

- NA

Wheat

- 1.0 Barley, forage

- NA

Wheat, forage

- 1.0 ppm

(tolerance is higher than the HAFT

, but lower than the maximum

residue)

Grain, Cereal, straw Barley

- 2.2

(HAFT = 1.45)

Wheat

- 1.56

(7

- Day PHI) Barley

- 2.0

Wheat

- 2.0 Barley, straw

- 2.0 ppm

(tolerance is higher than the HAFT,

but lower than the maximum

residue)

Wheat, straw

- 2.0 ppm

Crop Group

20

(14

- Day PHI) Cotton Gin Byproducts 4.20 ppm 6.0 6.0ppm for cotton gin bypd

Cotton meal HAFT x PF = 0. 176 x 0.8 = 0. 14 Not required, cottonseed

RAC tolerance is 0.2 ppm.

Cotton hulls 0.176 x 1.8 = 0.32 0.35 ppm for Cotton hulls,

other commodities are below

the RAC tolerance.

Rapeseed , meal 0.2 15 x 1.9 = 0. 4 1 ppm 0. 5 ppm for Rapeseed mealSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 140 of 141 A ppendix 6 . Structures of Important Metabolites and Degradates Found in Metabolism

Studies, Confined Rotational Crop Study, Crop Field Trials, Livestock Feeding Studies,

and Environmental Fate Studies

.

Table A. 6

. I dentification of Compounds from XDE

- 208 Metabolism Stud ies

Common name/code

ID No. Chemical name

(IUPAC) Chemical structure



### Sulfoxaflor

( XDE

- 208 ) [1

- (6

- trifluoromethylpyridin

- 3

- yl)ethyl](methyl)

- oxido

- λ 6



### - sulfanylidenecyanamide

X11719474 N

- (methyl)oxido){1

- [6

- (trifluoromethyl)pyridine

- 3

- yl]ethyl}

- λ 6



### - sulfanylidene)

urea N S

N O

N O

F

F F



### X11721061 1

- [6

- (trifluoromethyl)pyridin

- 3

- yl]ethanol

N O H

F

F

F



### X11863595,

Glucose

conjugate of

X11721061 1

- [6

- (trifluoromethyl)pyridine

- 3

- yl]ethyl D

- glucopyranoside



### X11889781,

Glucose plus

malonyl

conjugate of

X11721061 1

- [6

- (trifluoromethyl)pyridine

- 3

- yl]ethyl

- 6’

- O

- malonyl D

glucopyranoside

X11519540 5

- (1

- methanesulfonyl

ethyl)

- 2

- trifluoromethyl

pyridine O

N F

F F O O H

O H

O H

O H

O

N F

F F O O H

O H

O H O O O

O H

N S O

O F

F

FSulfoxaflor Summary of Analytical Chemistry and Residue Data Barcode 398756



### Page 141 of 141 Table A. 6

. I dentification of Compounds from XDE

- 208 Metabolism Stud ies

Common name/code

ID No. Chemical name

(IUPAC) Chemical structure



### X11821639 3

- [6

- tri

fluoromethyl)pyridin

- 3

- yl]butanoic acid

N F

F

F O H O



### Laying Hen 

### and Ruminant Metabolism Study

X11596066 1

- [6

- (trifluoromethyl)pyridin

3

- yl]ethane

N F

F F



### X11721061 1

- [6

-

(trifluoromethyl)pyridin

- 3

-

yl]ethanol

N O H

F

F

F



### C rop R otation Stud y

X11579457 5

- [1

- (S

methylsulfonimidoyl)ethyl]

- 2

- (trifluoromethyl)pyridine

Metabolite 1 Un known N S

N O H

C F

3

N S

N O O

C F

3 N



### + O