### Page 1 of 45 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND

POLLUTION PREVENTION 

### MEMORANDUM

Date: March 17, 201 6

Subject: Aba mectin

. Petition for the Establishment of Permanent Tolerance s and Registra t ion

for Use on Sweet Corn and Soybeans. Summary of Analytical Chemistry and

Residue Data.

PC Code: 122804 DP Barcode: D 414022

Decision No.: 4 80190 Registration No s

. : 100

- 1350, 100

- 1351, 100

- 1408, and 100

- 1439

Petition No.: 3F 81 84 Regulatory Action: Section 3 Registration

Risk Assessment Type: NA Case No.: NA

T XR No.: N A CAS No.: 71751

- 41

- 2

MRID No.: See Below 40 CFR : 180. 449



### From: Nancy Dodd, Chemist

Risk Assessment Branch III ( RAB3) Health Effects Division ( HED; 7509P)

Through: Steve Funk, Senior Chemist

RAB3 / HED ( 7509P )

To: Venus Eagle/Jessica Rogala, RM #1 Registration Division (7505P)Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 2 of 45 Summary of Submitted Residue Chemistry Studies

O C S PP 860 Series

Guideline MRID

Number Title

860.1500 49071008 Carringer, S. (201 3) Abamectin 500 FS (A14006B) and Abamectin SC (A15368D)

– Magnitude of the Residues in or on Sweet Corn Resulting from Seed Treatment followed by Foliar Applications

- USA, 2011

. Final Report. Report Number:

TK0056923

. Morse Study Number: 67392. SGS Study Number: G

1112BK. Unpublished study prepared by Syngenta Crop Protection, LLC. 360 p.
860.1500/860.1520 49071010 Carringer, S. (201 3). Abamectin 500 FS (A14006B) and Abamectin SC (A15368D)

– Magnitude of the Residues in or on Soybean Resulting from Seed Treatment followed by Foliar Applications

– USA, 2011

. Report Number:

TK0040391

. Morse Study Number: 67391 . SGS Study Number: G

1110BK

. Unpublished study pre pared by Syngenta Crop Protection, LLC. 621 p.
860.1380 49071012 Rees , S. (2013) Stability of Abamectin Residues in Representative Crop Raw Agricultural and Processed Commodities Under Freezer Storage Conditions

. Final Report. Report Number: 69101 , Task Number: TK0167413 . Unpublished study prepared by Syngenta Crop Protection , LLC. 175 p.

860.1380 49071016 Kwiatkowski, A. (2007) Abamectin

- Storage Stability in Crops Stored Deep Frozen for up to Two Years

- Final Report. Repor t Number: T022438

- 04

- REG, Study Number: 05

- S504

. Unpublished study prepared by Syngenta Crop Protection, LLC. 71 p.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 3 of 45 Table of Contents

1.0 Executive Summary

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

2.0 Regulatory Recommendations

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

2.1 Data Deficiencies/Data Needs

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

2.2 Tolerance Considerations

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

2.2.1 Enforcement Analytical Method

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

2.2.2 Recommended Tolerances

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

2.2.3 Revisions to Petitioned

- For Tolerances

................................ ................................ .... 7

2.2.4 International Harmonization

................................ ................................ ..................... 7

2.3 Label Recommendations

................................ ................................ ................................ .. 8

3.0 Introduction

................................ ................................ ................................ ......................... 8

3.1 Chemical Identity

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

3.2 Physical/Chemical Characteristics

................................ ................................ ................. 10

3.3 Pesticide Use Pattern/Directions for Use (860.1200)

................................ ..................... 11

4.0 Metabolite/Degradate Residue Profile

................................ ................................ .............. 13

4.1 Nature of the Residue

................................ ................................ ................................ ..... 13

4.1.1 Summary of Plant Metabolism (860.1300)

................................ ............................. 14

4.1.2 Summary of Livestock Metabolism (860.1300)

................................ ..................... 14

4.1.3 Summary of Confined Rotational Crops (860.l850)

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

4.1.4. Summary of Metabolites and Degradates

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

4.2 Comparison of Metabolic Pathways

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

4.3 Residues of Concern Summary and Rationale

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

5.0 Residue Profile

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

5.1 Resi due Analytical Methods (860.1340)

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

5.1.1 Data Collection Methods

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

5.1.2 Multi

- Residue Methods (860.1360)

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

5.1.3 Tolerance Enforcement Methods

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

5.1.4 Submittal of Analytical Reference Standards (860.1650)

................................ ...... 18

5.2 Storage Stability (860.1380)

................................ ................................ .......................... 18

5.3 Residue Data

................................ ................................ ................................ .................. 19

5.3.1 Crop Field Trials (860.1500)

................................ ................................ .................. 19

5.3.2 Field Rotational Crops (860.1900)

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

5.3.3 Processed Food and Feed (860.1520)

................................ ................................ ..... 23Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 4 of 45 5.3.4 Meat, Milk, Poultry and Eggs (860.1480)

................................ .............................. 27

5.3.5. Food Handling (860.1460)

................................ ................................ ...................... 33

5.3.6. Water, Fish, and Irrigated Crops (860.1400)

................................ .......................... 33

5.4. Food Residue Profile

................................ ................................ ................................ ...... 33

6.0 Tolerance Derivation

................................ ................................ ................................ ........ 34

Appendix A. Field Trial Geographic Distribution

................................ ................................ ....... 36

Appendix B. International Residue Limits Tables

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

Appendix C. OECD MRL Calculation Procedure Inputs/Outputs

................................ .............. 40Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 5 of 45 1.0 Executive Summary

Syngenta Crop Protection LLC has submitted a petition to propose use of abamectin on soybeans

and sweet corn

. The petitioner proposes addition of the use s on soybeans and sweet corn to the

labels for Agri

- Flex ® Miticide/Insecticide, Agri

- Mek® SC Miticide/Insecticide, Epi

- MekTM SC Miticide/Insecticide, and Epi

- MekTM SCL Miticide/Insecticide.

The petitioner has proposed tolerance s for the combined residues of the insecticide a vermectin

B 1 

### (a mixture of avermectins containing greater than or equal to 80% avermectin B 1a 

### (5

- O

demethyl avermectin A 1 

### ) and less than or equal to 20% avermectin B 1b 

### (5

- O

- demethyl

- 25

- de(1

- methylpropyl)

- 25

- (1

- methylethyl) avermectin A 1 

### ) and its delta

- 8,9

- isomer in or on sweet corn commodities (forage, kernel plus cob with husk removed, and stover) and soybean commodities (forage, hay, and seed).

Tolerances are established under 40 CFR §180.449 for residues of abamectin (avermectin), including its metabolites and degradates, in or on various crop and livestock commodities at levels ranging from 0.005 ppm to 1.0 ppm. Compliance with the tolerance levels is to be

determined b y measuring only avermectin B 1 

### [a mixture of avermectins containing greater than or equal to 80% avermectin B 1a 

### (5

- O

- demethyl avermectin A 1 

### ) and less than or equal to 20%

avermectin B 1b 

### (5

- O

- demethyl

- 25

- de(1

- methylpropyl)

- 25

- (1

- methylethyl) avermectin A 1 

### ) ] and

its delta

- 8,9

- isomer.

Agri

- Flex ® Miticide/Insecticide, Agri

- Mek® SC Miticide/Insecticide, Epi

- MekTM SC Miticide/Insecticide, and Epi

- MekTM SCL Miticide/Insecticide are to be applied to sweet corn and soybeans as broadcast foliar sprays using ground or aerial equipment. A pplications can be

made with a retreatment interval of 7 days. The application rates are 0.018/ 0.019 lb ai/A/application ( 0.037/0.038 lb ai/A/season ) for sweet corn and 0.014/0.019 lb ai/A/application ( 0.028/0.038 lb ai/A/season ) for soybeans. The preharvest interval s are 7 days for sweet corn forage and ears

, either 7 or 14 days for sweet corn stover , and 28 days f or soybean seed

. The preharvest interval for soybean forage and hay is either 7 days or is restricted f rom feeding/grazing.

The residue chemistry database is adequate for tolerance assessment and for registration of the four formulations of abamectin on sweet corn and soybeans. Residues of concern in primary (treated) plants , rotational crops, and rumina nts are parent (avermectin B 1a 

### and B 1b 

### ) and the 8,9

- Z

isomers. The sweet corn and soybean field trials adequately reflect the proposed use pattern s

. The number of field trials and the geographic representation are adequate. An adequate method

was used for data collection. Adequate concurrent storage stability data are availab le to support

the field trials.

Field trial residues in sweet corn forage and stover and soybean forage and hay were small (low level) but quantifiable as combined residues ; these combined residues generally decreased with increasing PHI s . Combined residues in sweet corn kernel plus cob with husk removed and in soybean seed were all less than the limit of quantitation ( <LOQ ; <0.006 ppm).Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 6 of 45 No processed commodities are associa ted with sweet corn. The processed commodities for soybean are meal, hulls, refined oil, and aspirated grain fractions (AGF). A processing study on soybeans indicated that combined residues of avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z

avermectin B 1a 

### may concentrate in/on AGF (average processing factor of 59x), meal (1.1x), and hulls (1.2 x). A processing factor could not be calculated for refined oil because residues were below the LOQ in both the raw agricultural commodity ( RAC ) and processed commod it y; however , additional processing data are not required and a separate tolerance for refined oil is

not needed since the processing study was conducted at an exaggerated rate (~5x the proposed foliar rate).

A c onfined rotational crop study indicated t hat avermectin residues of significant toxicological concern are not expected to occur in rotational crops.

2.0 R egulatory R ecommendations

T here are no residue chemistry considerations that would preclude granting the requested registrations and establ ishing the recommended tolerance for abamectin on sweet corn and

so y beans. T he specific tolerance recommendations are discussed in Section 2.2 . There are no

recommended label m odifications

.

2.1 Data Deficiencies/Data Needs

There are no data deficienc i es.

2.2 Tolerance Considerations

2.2.1 Enforcement Analytical Method

Adequate enforcement methods for abamectin in plant and livestock commodities are available

in the Pesticide Analytical Manual, Volume II ( PAM II) . The methods have been validated for citrus and processed fractions (Method I), ginned cottonseed (Method IA), and bovine tissues and milk (Method II ). These methods determine residues in plant and livestock commodities at

the L OQs of 0.02 ppm for meat and meat byproducts and ≤0.01 ppm for other plant/livestock commodities. The limit of detection (LOD) of the methods for plant and livestock commodities is 0.001 ppm for each analyte, equivalent to 0.002 ppm for two analy te peaks (i.e., avermectin

B 1a 

### and its delta

- 8,9

- isomer in one peak and avermectin B 1b 

### and its delta

- 8,9

- isomer in the other peak).

2.2.2 Recommended Tolerances

The current tolerance expression in 40 CFR §180.449 is consistent with the S. Knizner memo dated 5/27/09.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 7 of 45 The petitioner must propose a tolerance of 0.40 ppm for grain, aspirated grain fractions and increase some of the established livestock tolerances, as indicated in Table 2.2.2 below.

Table 2.2.2 . Tolerance Summary for Abamectin

. Commodity Established

Tolerance

(ppm) Syngenta

Proposed

Tolerance

(ppm) HED

Recommended

Tolerance

(ppm) Comments ( correct commodity definition )

Cattle, fat 0.03 none 0.05
Cattle, meat 0.02 none 0.02 Cattle, meat byproducts 0.06 none 0.09 Corn, sweet, forage none 0.2 0.20 Corn, sweet, kernel plus cob

with husk removed none 0.01 0.01

Corn, sweet, stover none 0.5 0.50
Goat, fat 0.01 none 0.03
Goat, meat 0.02 none 0.02 Goat, meat byproducts 0.02 none 0.04 Grain, aspirated grain

fractions none none 0.40

Hog, fat 0.01 none 0.01
Hog, meat 0.02 none 0.02
Hog, meat byproducts 0.02 none 0.02
Horse, fat 0.01 none 0.03

Horse, meat 0.02 none 0.02 Horse, meat byproducts 0.02 none 0.04

Milk 0.005 none 0.015 Poultry, meat 0.02 none 0.02 Poultry, meat byproducts 0.02 none 0.02 Sheep, fat 0.01 none 0.03 Sheep, meat 0.02 none 0.02 Sheep, meat byproducts 0.02 none 0.04 Soybean, forage none 0.3 0.30 Soybean, hay none 1 1.0 Soybean, seed none 0.01 0.01



### 2.2.3 Revisions to Petitioned

- For Tolerances

The petitioner must propose a tolerance of 0.40 ppm for grain, aspirated grain fractions since residues in soybean seed (<0.006 ppm) concentrate 59x in aspirated grain fractions.

Since the proposed uses on sweet corn and soybeans include livestock feed it ems, higher tolerances are needed for the fat of cattle (0.05 ppm), meat byproducts of cattle (0.09 ppm), fat of goat, horse, and sheep (0.03 ppm), meat byproducts of goat, horse, and sheep (0.04 ppm), and milk (0.015 ppm).

2.2.4 International Harmoniza tion

The plant tolerance definitions are essentially the same for the US, Codex, and Canada , all including avermectin B 1a 

### , avermectin B 1b 

### , and the 8,9

- Z isomers

. There are no Codex orAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 8 of 45 Canadian maximum residue limits (MRLs) for abamectin on sweet corn or soybean commodities. Therefore, there are no harmonization issues at this time for plant commodities.

The livestock residue definitions are essentially the same for the US and Canada; the Codex residue definition includes only avermectin B 1a 

### and its 8,9

- Z isomer, whereas the US and Canada

include both avermectin B 1a 

### and avermectin B 1b 

### and their 8,9

- Z isomers. There are no Canadian

tolerances set on livestock commodities. There are some Codex maximum residue limits (MRLs) on livestock commodities, but fe wer than US tolerances . None of the Codex MRLs are

set at the same level as the US recommended tolerance levels

.

An International Residue Limits Status sheet is attached (Appendix B.)

2.3 Label Recommendations

None.

3.0 Introduction

Abamectin is an insecticide/miticide used to control mites, leaf miners, and other insects in commercially important crops. Avermectins are macrocyclic lactones produced as natural fermentation products of the soil bacterium Streptomyces avermitilis. Aba mectin is a mixture of

avermectin B 1 

### [a mixture of avermectins containing greater than or equal to 80% avermectin B 1a 

### (5

- O

- demethyl avermectin A 1 

### ) and less than or equal to 20% avermectin B 1b 

### (5

- O

- demethyl

- 25

- de(1

- methylpropyl)

- 25

- (1

- methylethyl) avermecti n A 1 

### )] and its delta

- 8,9

- isomer. Abamectin has limited plant systemic activity, but does exhibit some translaminar movement. Abamectin acts as an insecticide by interfering with the nervous system of the insect, causing the insect to become paralyzed. Available mechanistic data indicate a neurotoxic mechanism of action,

related to interference with GABA

- mediated neurotransmission.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 9 of 45 3.1 Chemical Identity

Table 3.1. Abamectin Nomenclature
Compound

Abamectin Chemical Structure

Common Names abamectin, avermectin B 1 Company experimental

name MK

- 0936

IUPAC name mixture of (10 E ,14 E ,16 E )

- (1 R ,4 S ,5 ' S ,6 S ,6 ' R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )

- 6 '

- [( S )

-

sec

- butyl]

- 21,24

- dihydroxy

- 5 ',11,13,22

- tetramethyl

- 2

- oxo

- (3,7,19

- trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa

- 10,14,16,22

- tetraene)

- 6

- spiro

- 2 '

- (5 ',6

'

- dihydro

- 2 ' H

- pyran)

- 12

- yl 2,6

- dideoxy

- 4

- O

- (2,6

- dideoxy

- 3

- O

- methyl

- α

- L

arabino

- hexopyranosyl)

- 3

- O

- methyl

- α

- L

- arabino

- hexopyranoside and (10 E ,14 E ,16 E )

- (1 R ,4 S ,5 ' S ,6 S ,6 ' R ,8 R ,12 S ,13 S ,20 R ,21 R ,24 S )

- 21,22

- dih ydroxy

- 6 '

- isopropyl

- 5 ',11,13,22

- tetramethyl

- 2

- oxo

- (3,7,19

- trioxatetracyclo[15.6.1.1 4,8 .0 20,24 ]pentacosa

- 10,14,16,22

- tetraene)

- 6

- spiro

- 2 '

- (5 ',6Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 10 of 45 Table 3.1. Abamectin Nomenclature

'

- dihydro

- 2 ' H

- pyran)

- 12

- yl 2,6

- dideoxy

- 4

- O

- (2,6

- dideoxy

- 3

- O

- methyl

- α

- L

arabino

- hexopyranosyl)

- 3

- O

- methyl

- α

- L

- arabino

- hexopyranoside

CAS n ame Avermectin B 1

CAS # Avermectin B 1 - 71751

- 41

- 2; Avermectin B 1a - 65195

- 55

- 3; Avermectin B 1b
- 65195

- 56

- 4

End

- use product s /EP s Agri

- Flex® Miticide/Insecticide, EPA Reg. No. 100

- 1350, contains 0.277 lb

abamectin and 1.27 lb thiamethoxam per gallon. Agri

- Mek® SC Miticide/Insecticide, EPA Reg. No. 100

- 1351, contains 0.7 lb abamectin per gallon. Epi

- MekTM SC Miticide/Insecticide, EPA Reg. No. 100

- 1408, contains 0.7 lb abamectin per gallon. Epi

- MekTM SCL Miticide/Insecticide, EP A Reg. No. 100

- 1439, contains 0.35 lb abamectin per gallon.



### 3.2 Physical/Chemical Characteristics

Avermectin is a crystalline powder with very low vapor pressure. It has very low water solubility but is soluble in organic solvents. Residues do not readily leach to groundwater due to their affinity for soil particles. Abamectin is stable to abiotic hydrolysis. Refer to Table 3.2 for the table of physical/chemical properties.

TABLE 3.2. Physico chemical Properties of the Technical Grade of Abamectin

Parameter Value Reference

Molecular weight 873.1 MRID 48758002

Melting point/range 161.8

- 169.4°C (with thermal decomposition)

pH 8

- 9 at 25°C

Density 1.18 x 10 3 kg/m 3 at 22°C

Water solubility at 25oC 1.21 μg/mL at pH 7.57

Solubility in organic solvents Acetone 72 g/L

Dichloromethane 470 g/L Ethyl acetate 160 g/L

Hexane 0.110 g/L

Methanol 13 g/L

Octanol 83 g/L

Toluene 23 g/L

Vapor pressure at 25oC <3.7 x 10

- 6 Pa

Dissociation constant (pK a ) no dissociation constant in aqueous solution

Octanol/water partition coefficient, Log P ow 4.4 at pH 7.2

UV/visible absorption spectrum Absorbance maxima

Neutral: 32,549 l/mol•cm at 245 nm 18,983 l/mol•cm at 255 nm

Acidic: 34,515 l/mol•cm at 245 nm 20,977 l/mol•cm at 255 nm

Basic: 29,551 l/mol•cm at 245 nmAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 11 of 45 3.3 Pesticide Use Pattern/ Directions for Use (860.1200)

IR

- 4 has submi tted a petition to add use s on sweet corn and soybeans to the following labels: Agri

- Flex ® Miticide/Insecticide, Agri

- Mek® SC Miticide/Insecticide, Epi

- MekTM SC Miticide/Insecticide, and Epi

- MekTM SCL Miticide/Insecticide.

Agri

- Flex ® Miticide/Insecticide (EPA Reg. No . 100

- 1350 ) is a suspension concentrate which contains 0.277 lb abamectin and 1.27 lb thiamethoxam per gallon. It contains 3.0% abamectin

and 13.9% thiamethoxam.

Agri

- Mek® SC Miticide/Insecticide (EPA Reg. No

. 100

- 1351 ) is a suspension concentrate

which contains 0. 7 lb abamectin per gallon. It contains 8.0% abamectin.

Epi

- MekTM SC Miticide/Insecticide (EPA Reg. No . 100

- 1408 ) is a suspension concentrate which contains 0.7 lb abamectin per gallon. It contains 8.0% abamectin.

Epi

- MekTM SCL Miticide/Insecticide (EPA Reg. No . 100

- 1439 is a suspension concentrate which contains 0.35 lb abamectin per gallon. It contains 4.2% abamectin.

Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C orn (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing,

T ype, and Equip. Formulation [EPA Reg.
No.] Applic

. Rate

(lb ai/A) Max. No. Applic.

per Season Max.

Seasonal Applic.

Rate (lb ai/A) PHI (days) Use Directions and

Limitations 1,2



### Corn (Sweet)

Postemergence;

Broadcast foliar

spray; Ground or

aerial equipment Agri

- Flex®

Miticide/

Insecticide [100

- 1350] 0.012

– 0.018 not stated 0.037 7 (forage or ears)

14 (stover) Apply to thoroughly cover the

crop to control spider mites

and insects. Apply when spider mites first appear. Repeat as needed to

maintain control. Do not apply more than 0.018 lb ai/A of Agri

- Flex® or more than 0.019 lb ai/A of any other foliar applied abamectin containing product or more than 0.086 lb ai/A of any other foliar applied thiamethoxam containing product per application. Do not apply more than 0.037 lb ai/A of Agri

- Flex® or more than 0.038 lb ai/A of any other foliar applied abamectin containing product or more than 0.172 lb ai/A of any other foliar applied thiamethoxam containing product per season.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 12 of 45 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C orn (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing,

T ype, and Equip. Formulation [EPA Reg.
No.] Applic

. Rate

(lb ai/A) Max. No. Applic.

per Season Max.

Seasonal Applic.

Rate (lb ai/A) PHI (days) Use Directions and

Limitations 1,2

Postemergence;

Broadcast foliar

spray; Ground or

aerial equipment Agri

- Mek®

SC M iticide/

Insecticide [100

- 1351]

Epi

- MekTM

SC Miticide/

Insecticide [100

- 1408]

Epi

- MekTM

SCL

Miticide/

Insecticide [100

- 1439] 0.0096

- 0.019 not stated 0.038 7 (forage,

ears, or stover) Apply to thoroughly cover the crop to control spider mites. Apply when spider mites first appear. Repeat as needed to

maintain control. Do not apply more than 0.019 lb ai/A of Agri

- Mek® SC/Epi

- MekTM SC/Epi

MekTM SCL or any other foliarly applied abamectin

c ontaining product per application. Do not apply more than 0.038 lb ai/A of Agri

- Mek® SC/ Epi

- MekTM SC/Epi

- MekTM SCL or any other foliarly applied abamectin

- containing product in a growing season.


### Soybeans

Postemergence;

Broadcast foliar

spray; Ground or

aerial equipment Agri

- Flex®

Miticide/

Insecticide [100

- 1350] 0.011

- 0.014 not stated 0.028 28 Apply to thoroughly cover the

crop to control spider mites

and insects. Apply when spider mites first appear. Repeat as needed to maintain

control. Do not appl y more than 0.014 lb ai/A of Agri

- Flex® or more than 0.019 lb ai/A of any other foliar applied abamectin containing product or more than 0.063 lb ai/A of any other foliar applied thiamethoxam containing product per application. Do not apply more than 0.028 lb ai/A of Agri

- Flex® or more than 0.038 lb ai/A of any other foliar applied abamectin containing product or more than 0.125 lb ai/A of any other foliar applied thiamethoxam containing product per season.

Do not allow livestock to graze in treated areas or harvest treated soybean forage, straw or hay as feed for meat or dairy animals.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 13 of 45 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C orn (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing,

T ype, and Equip. Formulation [EPA Reg.
No.] Applic

. Rate

(lb ai/A) Max. No. Applic.

per Season Max.

Seasonal Applic.

Rate (lb ai/A) PHI (days) Use Directions and

Limitations 1,2

Do not feed treated soybean fodder or silage to meat or dairy animals.
Postemergence;

Broadcast foliar

spray; Ground or

aerial equipment Agri

- Mek®

SC Miticide/

Insecticide [100

- 1351]

Epi

- MekTM

SC Miticide/

Insecticide [100

- 1 408 ]

Epi

- MekTM

SC L

Miticide/

Insecticide [100

- 1 439 ] 0.0096

- 0.019 not stated 0.038 7 (forage or hay)

28 (seed) Apply to thoroughly cover the crop to control spider mites. Apply when spider mites first

appear. Repeat as needed to

maintain control. Do not apply more than 0.019 lb ai/A of Agri

- Mek® SC/Epi

- MekTM SC/ Epi

MekTM SCL or any other foliarly applied abamectin

containing product per application. Do not apply more than 0.038 lb ai/A of Agri

- Mek® SC/Epi

- MekTM SC/ Epi

MekTM SCL or any other foliarly applied abamectin

containing product in a growing season.

1 Restrictions that apply to all the above labels and all the above crops : Restricted Use Pesticide To avoid illegal residues, Agri

- Flex® / Agri

- Mek® SC / Epi

- MekTM SC / Epi

- MekTM SC m ust be mixed with a non

ionic activator type wetting, spreading and/or penetrating spray adjuvant. Do not use binder or sticker type adjuvants. Do not apply with aircr aft in NY state. Do not apply in less than 10 gal water /A by ground or 5 gal water/A by air. The retreatment interval is 7 days. For resistance management, do not make more than 2 sequential applications of Agri

- Flex® / Agri

- Mek® SC / Epi

MekTM SC / Epi

- MekTM S CL or any other foliar applied abamectin containing product.

2 Unless specifically restricted in the individual Crop Use Directions on the Agri

- Mek ® SC, Agri

- Flex ®

, Epi

- Mek TM SC, or Epi

- MekTM SC L labels, those products may be used in the same year abamectin is used as an at

plant seed treatment. Abamectin is registered as a seed treatment on the Avicta ® 500 FS label (EPA Reg. No. 100

- 1204) at rates of 0.20

- 0.25 mg ai/seed for corn and 0.10

- 0.15 mg ai/seed for soybean.



### Conclusion s

. The labels are adequate to allow evaluation of the residue data relative to the proposed use.

4.0 Metabolite/Degradate Residue Profile

4.1 Nature of the ResidueAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 14 of 45 4.1.1 Summary of Plant Metabolism (860.1300)

DP Barcode D 380523 , N. Dodd, 7/18/11



### No new plant metabolism data were submitted with this registration request. The qualitative

natu re of the abamectin residues in sweet corn and soybeans is adequately understood based on metabolism studies on cotton, citrus, and celery (PP#'s 5G3500, 5G3287, and 8F3649, respectively), as well as a report titled "Comparative Degradation of Avermectin B 1 

### a in Cotton Leaf, Citrus Fruit, Celery, and In Vitro " (PP#9F3703, S. Willett, 12/15/89). The available

studies indicate that the metaboli sm of abamectin in plants results in a complex mixture of residues. The majority of the terminal residue is composed of several unidentified polar degradates. The parent compound, its delta

- 8,9

- isomer, and the alpha 8

- OH degradate have been

identified in plants, with only the parent and its delta

- 8,9

- isomer each accounting for at least

10% of the total residue. The polar degradates generated on citrus (7

- day PHI) and in vitro (30 hour sample) have been tested for toxicity (in the developmental toxicity stu dy in CF

- 1 mice) and were found to be of no toxicological significance at the levels tested (TOX memos 7080 and 7081, W. Dykstra, 3/15/89; PP#8F3592, F. Boyd, 6/21/89; D203373, G. J. Herndon, 3/29/95).

As stated in The Pesticide Manual , Eleventh Edition, British Crop Protection Council (1997), abamectin has limited plant systemic activity, but does exhibit some translaminar movement. For the tolerance expression and risk assessment, the residues of concern in these crops are the parent compounds (avermect in B 1a 

### and B 1b 

### ) and their delta

- 8,9

- isomers (also known as 8,9

- Z

avermectin B 1a 

### and 8,9

- Z avermectin B 1b 

### ).

4.1.2 Summary of Livestock Metabolism (860.1300)

DP Barcode D 380523 , N. Dodd, 7/18/11 DP Barcode D357192, T. Morton, 1/27/09



### No new livestock metabolism data were submitted with this registration request.

The qualitative nature of abamectin residues in ruminants as a result of application to crops is adequately understood based on a goat metabolism st udy which was previously submitted (PP#7G3468, L. Cheng, 2/11/87; PP#9F3703, S. Willett, 12/15/89). The residues of concern in ruminants for the tolerance expression and risk assessment are the parent compounds (avermectin B 1a 

### and B 1b 

### ) and their delta

- 8,9

- isomers. An additional metabolite (24

- hydroxymethyl avermectin B 1a 

### ) was identified and is potentially of toxicological significance, but was not included in the tolerance expression because of its presence at low levels (PP#8F3592, F. Boyd, 6/21/89; DP#2 03373, G. J. Herndon, 3/29/95). If the tolerances for

residues in meat and milk need to be significantly raised at some future time due to registration of abamectin on additional feed items, the 24

- hydroxymethyl metabolite may need to be included

in the t olerance expression and appropriate enforcement methods developed.

The qualitative nature of the residue in ruminants from use of the cattle ear tag is adequately

understood based on sufficient non

- guideline data. The residues of concern are the parent

c ompounds ( avermectin B 1a 

### and B 1b 

### ) and their delta

- 8,9

- isomers

.

No poultry metabolism study has been submitted and none is required. Based on dietary burdenAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 15 of 45 calculations using Table 1 Feedstuffs (June 2008) , no secondary residues are expected to occur in poultry commodities. (Note: The tolerances for meat and meat by

- products of poultry and swine

were established for residues from use in food handling establishments.)

4.1.3 Summary of Confined Rotational Crops (860.l850)

DP Barcode D 380523 , N. Dodd, 7/ 18/11

DP Barcode D230333, G. Jeffrey Herndon, 1/10/97



### No confined rotational crop studies were submitted with this registration request. The qualitative nature of the residue in rotational crops is adequately defined. Review of the results of the previously submitted confined rotational crop study indicated that avermectin residues accumulated in some rotational crops at levels up to 10

- 12 ppb. However, the radioactivity was due to polar degradates that were of little toxicological concern as compared to the parent compound avermectin B 1 

### and/or the delta

- 8,9

- isomer (Memo, P. Mastradone, 4/24/88).

4.1.4. Summary of Metabolites and Degradates

4. 2 Comp arison of Metabolic Pathways

Metabolism studies on cottonseed , citrus, and celery indicate that the metabolism of abamectin in plants results in a complex mixture of residues. The majority of the terminal residue is composed of several unidentified polar degradates. The parent compound, its delta

- 8,9

- isomer, and the alpha 8

- OH degradate have been identified in plants, with only the parent and its delta

8,9

- isomer each accounting for at least 10% of the total residue. In citrus, the majority of the

resid ue remained in the peel but a small amount translocated into the pulp. For the tolerance assessment and risk assessment, the residues of concern in these crops are the parent compounds (avermectin B 1a 

### and B 1b 

### ) and their delta

- 8,9

- isomers (also known as 8, 9

- Z isomers).

The results of a confined rotational crop study indicated that avermectin residues accumulated in some rotational crops at levels up to 10

- 12 ppb; however, the radioactivity was due to polar degradates that were of little toxicological conce rn as compared to the parent compound

avermectin B 1 

### and/or the delta

- 8,9

- isomer. It is not likely that residues of concern will occur in rotational crops.

Based on the goat metabolism study, the residues of concern in ruminants for the tolerance expressi on and risk assessment are the parent compounds (avermectin B 1a 

### and B 1b 

### ) and their

delta

- 8,9

- isomers. T he 24

- hydroxy

- methyl metabolite is a minor metabolite in ruminants (goats).

A poultry metabolism study has not been conducted. Based on dietary burden calculations using Table 1 Feedstuffs (June 2008), no secondary residues are expected to occur in poultry commodities; therefore, no poultry metabolism study is required. (Note: The tolerances for meat and meat byproducts of poult ry and swine of 0.02 ppm were established for residues in food handling establishments.)

The qualitative nature of the residue in ruminants from use of the cattle ear tag is adequatelyAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 16 of 45 understood based on sufficient non

- guideline data. The residues of concern are the parent compounds ( avermectin B 1a 

### and B 1b 

### ) and their delta

- 8,9

- isomers

.

4.3 Residues of Concern Summary and Rationale

DP Barcode D402677, N. Dodd, 12/20/12



### As shown in Table 4.3 below, the residues of concern for primary crops, rotational crops, and ruminants for the tolerance expression and risk assessment are p arent (avermectin B 1a 

### and B 1b 

### )

and the delta

- 8,9

- isomers (also known as 8,9

- Z isomers)

.

Table 4.3. Summary of Metabolites and Degradates to be included in the Risk Assessment

and Tolerance Expression

Matrix Residues included in Risk

Assessment Residues included in Tolerance Expression

Plants Primary Crop Parent (avermectin B 1a and

B 1b ) and the delta

- 8,9

- isomers (also known as 8,9

- Z isomers) Parent (avermectin B 1a and

B 1b ) and the delta

- 8,9

- isomers (also known as 8,9

- Z isomers)

Rotational Crop Parent (avermectin B 1a and

B 1b ) and the delta

- 8,9

- isomers (also known as 8,9

- Z isomers) Parent (avermectin B 1a and

B 1b ) and the delta

- 8,9

- isomers (also known as 8,9

- Z isomers)**

Livestock Ruminant* Parent (avermectin B 1a and

B 1b ) and the delta

- 8,9

- isomers (also known as 8,9

- Z isomers) Parent (avermectin B 1a and

B 1b ) and the delta

- 8,9

- isomers (also known as 8,9

- Z isomers)

Poultry Not applicable Not applicable

Drinking Water Parent (avermectin B 1a and

B 1b ) *** Not applicable

* Residues of concern in ruminants include both use on crops and use in cattle ear tags.

** No rotational crop tolerances have been established.

*** T he delta

- 8,9

- isomers (also known as 8,9

- Z isomers) are not included in the drinking water assessment because they were not identified in the fate studies. The major soil degradate included in the previous assessment (a mixture

of an 8

- alpha

- hydroxy and a ring opened aldehyde derivative) was not included in the current assessment based on an assumption of stability of parent until acceptable environmental fate data are submitted (D380524, G. Orrick, 1/31/11).



### 5.0 Residue Profile

5.1 Residue Analytical Methods (860.1340)Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 17 of 45 5.1 .1 Data Collection Methods

49071008.der ( sweet corn )

49071010.de 1 ( soybean field trials )

49071010.de2 ( soybean processing study )



### Sweet Corn and Soybean : Samples of sweet corn forage, K+CWHR, and stover and soybean forage, hay, and seed from the field trials and soybean processing study were analyzed for

residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### using a high performance liquid chromatography method with tandem mass spectrometric detection ( HP LC/MS/MS), Morse Analytical Method Meth

- 192/Revision #2. The LOQ ( determined as the lowest level of method validation, LLMV) was 0.002 ppm for each analyte in each sweet corn and soybean matrix, for a combined LOQ of 0.006 ppm. The method was adequate fo r data collection based on acceptable concurrent recovery data. The fortification levels used in concurrent method recovery were adequate to bracket expected residue levels. Concurrent recoveries were corrected for apparent residues in controls; residues in the treated samples were not corrected for apparent residues in controls.

Conclusions. An adequate HPLC/MS/MS data collection method was used to determine residues in sweet corn and soybean field trials and the soybean processing study. The method separately determined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b



### . The LOQ was 0.002 ppm for each analyte in each sweet corn and soybean matrix, for a combined LOQ of 0.006 ppm.

5.1.2 Multi

- Residue Methods (860.1360)

DP Barcode D 380523 , N. Dodd, 7/18/11



### The Pestrak database indicates that abamectin and its metabolites are not recovered or not likely to be recovered by FDA multiresidue methods. Therefore, the multiresidue methods cannot be

used to determine residues for diet ary exposure assessment and can not be used as the primary

enforcement method.

5.1 .3 Tolerance Enforcement Methods

DP Barcode D 380523 , N. Dodd, 7/18/11

DP Barcode D230333, G. Jeffrey Herndon, 1/10/97

DP Barcode D198491, Jerry Stokes, 2/2/94



### Adequate enforcement methods for abamectin in plant and livestock commodities are available

in the Pesticide Analytical Manual, Volume II ( PAM II) . The methods have been validated for citrus and processed fractions (Method I), ginned cottonseed (Method IA ), and bovine tissues and milk (Method II ). These methods determine residues in plant and livestock commodities at LOQs of 0.02 ppm for meat and meat byproducts and ≤0.01 ppm for other plant/livestock commodities. The limit of detection (LOD) of the meth ods for plant and livestock commodities is 0.001 ppm for each analyte, equivalent to 0.002 ppm for two analy te peaks (i.e., avermectin

B 1a 

### and its delta

- 8,9

- isomer in one peak and avermectin B 1b 

### and its delta

- 8,9

- isomer in the other peak).Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 18 of 45 5.1.4 Submittal of Analytical Reference Standards (860.1650)

Analytical reference standards are available at the EPA National Pesticide Standards Repository [Source: e

- mail from Gregory Verdin of the Analytical Chemistry Branch/Biological and

Econo mic Analysis Division ( ACB/BEAD)].

5.2 Storage Stability (860.1380)

490 71008 .der ( sweet corn field trials )

49071010.de1 ( soybean field trials )

49071010.de2 ( soybean processing study )

49071012.der (c orn and soybean storage stability )

49071016.der ( storage stability on various crops )



### Sweet corn field trial samples were stored frozen ( <0 °C at the field sites and

- 25 to

- 10 °C at the analytical laboratory) from collection to analysis for 242

- 357 days (8.0

- 11.7 months) for forage,

232

- 342 days (7.6

- 11.2 months) for K+CWHR, and 2 78

- 380 days (9.1

- 12.5 months) for stover. Samples were analyzed within 0

- 14 days of extraction.

Soybean field trial samples were stored frozen ( <0 °C at the field sites and

- 25 to

- 10 °C at the analytical laboratory) from collection to analysis for 299

- 3 50 days (9.8

– 11.5 months) for forage, 362

- 440 days (11.9

- 14.5 months) for hay, and 317

- 360 days (10.4

- 11.8 months) for seed. Samples were analyzed within 0

- 6 days of extraction.

Soybean seeds for processing were stored frozen after harvest for 2 days at the Richland, IA site and at ambient temperatures for 6 days at the Bagley, IA site, after which they were shipped frozen from the field sites to the processing facility, where they were stored frozen (<

- 10 °F)

until processing. Processing took place within 232

- 276 days ( 7.6

- 9.1 months) of harvest. Samples were stored frozen (generally <

- 10 °F at the processing facility and

- 25 to

- 10 °C at the analytical laboratory) from harvest/processing to analysis for 339

- 351 days (11.1

- 11.5 months)

for seed (RAC ), 93

- 119 days ( 3.1

- 3.9 months) for AGF, and 47

- 79 days ( 1.5

- 2.6 months) for the processed commodities. Samples were analyzed within 1

- 4 days of extraction.

Acceptable storage stability data are available demonstrating that residues of avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin B 1a 

### are stable under frozen storage conditions in/on cottonseed (avermectin B 1a 

### only) for 14 months; in/on celery, tomato, and strawberries for 24 months; in/on oranges, lemons, and grapefruits for 29 months; and in/on pears for 35 months (DP# 191433, G. J. Herndon, 5/19/94). In addition, acceptable storage stability data have been submitted demonstrating that residues of avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin

B 1a 

### are stable in/on corn grain and forage dur ing frozen storage for up to 6 months (refer to 49071012.der) and in/on tomato, bean, sunflower seed, and potato for up to 24 months (refer to

49071016.der )Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 19 of 45 TABLE 5 .2. Summary of Storage Conditions

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

Sweet corn,

forage <0 °C at field sites;

- 25 to

- 10 at analytical laboratory 242

- 357 days (8.0

- 11.7 months) Acceptable storage stability data are available demonstrating that residues of avermectin

B 1a , avermectin B 1b , and 8,9

- Z avermectin

B 1a are stable under frozen storage conditions in/on cottonseed (avermectin B 1a only) for 14 months; in/on celery, tomato, and strawberries for 24 months; in/on oranges, lemons, and grapefruits for 29 months; and

in/on pears for 35 months (DP# 191433, G. J. Herndon, 5/19/94).

In addition, acceptable storage stability data have been submitted demonstrating that

residues of avermectin B 1a , avermectin B 1b , and 8,9

- Z avermectin B 1a are stable in/on corn grain and forage during frozen storage for up to 6 months (refer to 49071012.der ) and in/on tomato, bean, sunflower seed, and potato for up to 24 months (refer to

49071016.der )

.

In addition, acceptable storage stability data

have be en submitted demonstrating that

residues of avermectin B 1a , avermectin B 1b , and 8,9

- Z avermectin B 1a are stable in corn and soybean meal and oil during frozen storage for up to 6 months (refer to 49071012.der)

. Sweet corn,

K+CWHR 232

- 342 days (7.6

- 11.2 m onths)

Sweet corn,

stover 278

- 380 days (9.1

- 12.5 months)

Soybean, forage Frozen at field sites;

- 25 to

- 10 at analytical laboratory 299

- 350 days (9.8

– 11.5 months)

Soybean, hay 362

- 440 days (11.9

- 14.5 months)

Soybean, seed 317

- 360 days (10.4

- 11.8 months)

Soybean seed for processing

(RAC) Frozen at field sites;

- 25 to

- 10 at analytical laboratory 339

- 351 ( 11.1

- 11.5)

AGF 93

- 119 ( 3.1

- 3.9)

Meal 51

- 79 (1.7

- 2.6)

Hulls 57

- 66 ( 1.9

- 2.2)

Refined oil 47

- 63 ( 1.5

- 2.1)

1 Interval from harvest or processing to analysis. Sweet corn s amples were analyzed within 0

- 14 days of extraction. S oybean

s amples were analyzed within 0

- 6 days of extraction. Samples of soybean seeds for pr ocessing and soybean processed

fractions were analyzed within 1

- 4 days of extraction.



### Conclusions

. Acceptable storage stability data are available demonstrating that residues of

avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin B 1a 

### are stable under frozen storage for at least 24 months in five different crop types: high water (celery and pear), high acid (orange, lemon, grapefruit, strawberry, and tomato), high protein (bean), high fat (sunflower seed), and high starch (potato). Th e available and submitted storage stability data are adequate to support the storage conditions and durations of samples of corn forage, K+CWHR, and stover from the

submitted sweet corn field trials, soybean forage, hay, and seed from the submitted soybean f ield

trial s, and soybean seed and processed commodities from the soybean processing study

.

5.3 Residue Data

5.3.1 Crop Field Trials (860.1500)

490 71008 .der ( sweet corn field trials )

49071010.de1 (s oybean field trials )



### Sweet Corn :Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 20 of 45 Syngenta Crop Protectio n, LLC has submitted field trial data for abamectin on sweet corn

. Twelve field trials were conducted in the United States during the 2011 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 1 (NY and PA; 2 trials), 2 (NC; 1 trial), 3 (FL; 1 trial), 5 (IA, KS, MN, WI; 5 trials), 10 (CA; 1 trial), 11 (OR; 1 trial), and 12 (OR; 1 trial).

Each trial consisted of one untreated plot and one treated plot reflecting a combination of seed treatment and two foliar applications of abamectin. A 4.17 lb ai/gal flowable concentrate for seed treatment (FS) formulation (Abamectin 500FS; A14006B) was applied to sweet corn seed before planting. The nominal seed treatment rate was 0.25 mg ai/seed, which is 1X the registered rate on the Avicta 500 FS label (EPA Reg. No. 100

- 1204). Application rates of

~0.013

- 0.041 lb ai/A for seed treatment were based on approximate seeding rates (23,478

- 79,746 seeds/A) and actual seed treatment rates (0.262

- 0.234 mg ai/seed) as reported for each field trial. Each treated plot received two foliar broadcast applications of a 0.70 lb ai/gal suspension concentrate (SC) formulation (Abamectin SC; A15368D) at 0.0184

- 0.0197 lb ai/A /application. The first applications were made 51

- 103 days after planting, and the second foliar applications were made at retreatment intervals (RTIs) of 6

- 8 days. All foliar applications were made using ground equipment in spray volumes of 2.5

- 31 gal/A. A nonionic surfactant (NIS) or crop oil concentrate (COC) was added to the f oliar spray mixture for each trial. Total application rates including seed treatment and foliar applications were 0.0504

- 0.0795 lb ai/A

. Samples of sweet corn forage, kernel + cob with husk removed (K+CWHR), and stover were harvested from all

trials at preharvest intervals ( PHI s) of 6

- 7 days. A dditional samples were collected at PHIs of 1

, 3, 10, and 14 days from two trials to assess residue decline

. Stover samples were allowed to dry

for 4

- 12 days prior to collection.

Following a combination of seed treatment with the 4.17 lb ai/gal FS formulation and two foliar broadcast applications of the 0.70 lb ai/gal SC formulation at total application rates of 0.0504

- 0.0795 lb ai/A, residues (and per trial averages) of avermectin B 1a

, 

### 8,9

- Z avermectin B 1a 

### , and

avermectin B 1b 

### , respectively, in sweet corn harvested at PHIs of 6

- 7 days were: 0.0089 0

- 0.111 (0.0106

- 0.0975 ), <0.002

- 0.002 (<0.002), and <0.002 (<0.002) ppm in/on forage ; <0.002 (<0.002) ppm for all analytes in/on K+CWHR ; and 0.0118

- 0.355 (0.0181

- 0.322 ), <0.002

- 0.00293 (<0.002

- 0.00259), and <0.002

- 0.0296 (<0.002

- 0.0168) ppm in/on stover. Combined residues (and per trial averages) of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b



### were <0. 0129

- <0.115 ppm (<0.0146

- <0.102 ppm) in/on forage, < 0.006 ppm (<0.006 ppm) in/on K+CWHR, and <0.0158

- 0.363 (<0.0221

- 0.329) ppm in/on stover.

In the residue decline trials, combined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and

avermectin B 1b 

### generally decreased with increasing PHIs in/on sweet corn forage and stover

. Residues of all analytes were below the LOQ (<0.002 ppm) in/on all samples of K+CWHR; therefore, residue decline could not be evaluated.

An acceptable method was used for residue quantitation, and adequate storage stability data are

a vailable to support sample storage intervals and conditions for all analytes.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 21 of 45 TABLE 5.3.1

. Summary of Residue Data from Sweet Corn Crop Field Trials with Abamectin.

Commodity Analyte Total Rate (lb ai/A ) PHI (days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. L AFT 2 HAFT 2 Median Mean Std.

Dev.

SWEET CORN Proposed Use = max 0.038 lb ai/acre/season total application rate, min 7

- day PHI for forage, ears and stover

Sweet corn, forage Combined

Residues 3 0.0504

- 0.0795 6

- 7 12 <0.0129 <0.115 <0.0146 < 0.102 0.063 0.056 0.029

Sweet corn,

K+CWHR Combined

Residues 3 0.0504

- 0.0795 6

- 7 12 <0.006 <0.006 <0.006 <0.006 0.006 0.006 N/A

Sweet corn,

stover Combined

Residues 3 0.0504

- 0.0795 6

- 7 12 <0.0158 0.363 <0.0221 0.329 0.065 0.101 0.094

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. For calculation of median, mean, and standard deviation, the LOQ (0.002 ppm) was used for any results reported as <LOQ in Table C.3 . N/A = Not applicable.

2 LAFT = low est average field trial; HAFT = highest average field trial.

3 Combined residues of avermectin B 1a , 8,9

- Z a vermectin B 1a , and a vermectin B 1b

.



### Conclusion s

. Adequate field trials were submitted for abamectin on sweet corn. Following a

combination of seed treatment with the 4.17 lb ai/gal FS formulation and two foliar broadcast applications of the 0.70 lb ai/gal SC formulation at total application rates of 0.0504

- 0.0795 lb

ai/A ( approximately 1x the maximum registered seed treatment rate plus 1x the maximum proposed seasonal foliar application rate), c ombined residues (and per trial averages) of

avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### were <0.0129

- <0.115 ppm (<0.0146

- <0.102 ppm) in/on forage, <0.006 ppm (<0.006 ppm) in/on K+CWHR, and < 0.0158

- 0.363 (<0.0221

- 0.329) ppm in/on stover. C ombined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### generally decreased with increasing PHIs in/on sweet corn forage and stover

. Residues of all analytes were below the LOQ (<0.002 ppm) in/on all samples of K+CWHR; therefore, residue decline could not be evaluated.

The studies adequately reflect the proposed use patterns. The number of trials and the geographic representation are adequate. The residue data are adequately supported by the storage stability studies. The analytical methods are adequate for the analysis of the residues of concern. The residue data adequately address the residues of concern.

S oybeans :

Syngenta Crop Protection, LLC has submitted field trial data for abamectin on soybeans

. Twenty field trials were conducted in the United States during the 2011 growing season in the North American Free Trade Agreement (NAFTA) Growing Zones 2 (VA and NC; 2 trials), 4 (AR, LA, MO ; 3 trial s ), and 5 (IA, IL, MO, MN, ND, WI; 1 5 trials)

. Refer to Appendix A for the geographic distribution table.

Each trial consisted of one untreated plot and one treated plot reflecting a combination of seed treatment and two foliar applications of abamectin. A 4.17 lb ai/gal flowable concentrate for seed treatment (FS) formulation (Abamectin 500FS; A14006B) was applied to soybean seed before planting. The nominal seed treatment rate was 0.15 mg ai/seed, which is 1X the registered rate on the Avicta 500 FS label (EPA Re g. No. 100

- 1204). Seed treatment rates of

~0.0402

- 0.0884 lb ai/A were based on approximate seeding rates (124,069

- 260,282 seed/A) and actual seed treatment rates (0.135

- 0.158 mg ai/seed) as reported for each field trial. Each treatedAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 22 of 45 plot received two fo liar broadcast applications of a 0.70 lb ai/gal suspension concentrate (SC) formulation (Abamectin SC; A15368D) at 0.0181

- 0.0199 lb ai/A/application , except for the forage plot of Trial

- 10 (MN), where the second foliar application was made at 0.0223 lb ai /A

. The first foliar applications were made to forage and hay plots 25

- 80 days after planting and to seed plots 75

- 117 days after planting; the second foliar applications were made at retreatment intervals (RTIs) of 6

- 9 days. All foliar applications were made using ground equipment in spray

volumes of 2.5

- 35 gal/A. A nonionic surfactant (NIS) or crop oil concentrate (COC) was added to the foliar spray mixture for each trial. Total application rates including seed treatment and foliar applications were 0 .077

- 0.127 lb ai/A. The highest combined application rates occurred at

Trial

- 01 (VA), where the seed treatment rate was 0.0884 lb ai/A for both plots. Excluding this trial, the maximum combined application rate was 0.102 lb ai/A.

Samples of soybean f orage and hay were harvested from all trials at preharvest intervals ( PHI s)

of 6

- 8 day s, and samples of seed were harvested from all trials at PHIs of 27

- 29 day s. A dditional forage and hay samples were collected at PHIs of 1

, 3, 10, and 14 days , and addit ional seed samples were collected at PHIs of 20/21, 23/24, 31/32, and 34/35 days from two trials to assess residue decline. Hay samples were allowed to dry for 2

- 10 days prior to collection.

Residues f ollowing a combination of seed treatment with the 4. 17 lb ai/gal FS formulation and two foliar broadcast applications of the 0.70 lb ai/gal SC formulation at total application rates of

0.077

- 0.127 lb ai/A are shown in Table 5.3.2 below. C ombined residues (and per trial averages)

of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### were <0.0121

- 0.165 ( <0.0138

- <0.158 ) ppm in/on forage

, <0.0420

- 0.741 ( <0.0448

- 0.607 ) ppm in/on hay , and <0.006 (<0.006) ppm in/on seed

. The highest residues in hay were observed in the trial which received the highest sec ond foliar application (Trial

- 10).

In the residue decline trials, combined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and

avermectin B 1b 

### generally decreased with increasing PHIs in/on soybean forage and hay

. In one trial, however, residues in/o n hay increased from the 1

- to the 3

- day PHI and declined thereafter. Residues of all analytes were below the LOQ (<0.002 ppm) in/on all samples of seed; therefore,

residue decline could not be evaluated.

An acceptable method was used for residue quantit ation, and adequate storage stability data are available to support sample storage intervals and conditions for all analytes.

TABLE 5.3.2

. Summary of Residue Data from Soybean Crop Field Trials with Abamectin.

Com

modity Analyte Total

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

n Sample

Min. Sample

Max. L AFT 2 HAFT 2 Median Mean Std.

Dev.

SOYBEA N Proposed Use = max 0.038 lb ai/acre/season total application rate ; min 7

- day PHI for forage and hay;

28

- day PHI for seed

Forage Combined

Residues 3 0.0776

- 0.127 6

- 8 20 < 0.012 0 0.165 < 0.0138 < 0.158 0.03 7 0.0 59 0.047

Hay Combined

Residues 3 0.0776

- 0.127 6

- 8 20 < 0.0420 0.741 < 0.0448 0.607 0.200 0.240 0.17 4

Seed Combined

Residues 3 0.0770

- 0.127 27

- 29 20 < 0.00 6 < 0.00 6 < 0.00 6 < 0.00 6 < 0.00 6 < 0.00 6 N/A

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials. N/A = Not Applicable

.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 23 of 45 2 LAFT = lowest average field trial; HAFT = highest average field trial.

3 Combined residues of avermectin B 1a , 8,9

- Z a vermectin B 1a , and a ver mectin B 1b

.



### Conclusion s

. Adequate field trials were submitted for abamectin on soybeans. Following a

combination of seed treatment with the 4.17 lb ai/gal FS formulation and two foliar broadcast applications of the 0.70 lb ai/gal SC formulation at tota l application rates of 0.077

- 0.127 lb ai/A ( approximately 1x the maximum registered seed treatment rate plus 1x the maximum proposed seasonal foliar application rate) , c ombined residues (and per trial averages) of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### were <0.0121

- 0.165 ( <0.0138

- <0.158 ) ppm in/on forage

, <0.0420

- 0.741 ( <0.0448

- 0.607 ) ppm in/on hay , and <0.006 (<0.006) ppm in/on seed

. The highest residues in hay were observed in the trial which received the highest second foliar applicati on (Trial

- 10). C ombined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and

avermectin B 1b 

### generally decreased with increasing PHIs in/on soybean forage and hay. In one trial, however, residues in/on hay increased from the 1

- to the 3

- day PHI and decl ined thereafter. Residues of all analytes were below the LOQ (<0.002 ppm) in/on all samples of seed; therefore,

residue decline could not be evaluated.

The studies adequately reflect the proposed use patterns. The number of trials and the geographic rep resentation are adequate. The residue data are adequately supported by the storage stability studies. The analytical methods are adequate for the analysis of the residues of concern. The residue data adequately address the residues of concern.

5.3.2 Field Rotational Crops (860.1900 )

DP Barcode D380523, N. Dodd, 7/18/11 DP Barcode D230333, G. Jeffrey Herndon, 1/10/97



### No field rotational crop studies were submitted with this registration request. Review of the results of the confined rotational crop study indicated that field rotational crop studies are not required (PP#7F3500, PP#8F3592, and PP#5E4566, DP#s 230333, 230352, and 230880, G. Herndon, 1/10/97).

5.3.3 Processed Food and Feed (860.1520)

No pr ocessed commodities are associated with sweet corn. The processed commodities for soybeans are meal, hulls, refined oil, and aspirated grain fractions (AGF).

Syngenta CropScience, LLC has submitted a processing study with abamectin on soybean. Two trials were conducted during the 2011 growing season in Richland, IA and Bagley, IA reflecting a combination of seed treatment and two foliar applications of abamectin. A 4.17 lb ai/gal flowable concentrate for seed treatment (FS) formula tion (Abamectin 500FS; A14006B) was applied to soybean seed before planting. Application rates of ~ 0.0 413

- 0.0455 lb ai/A for seed

treatment were based on approximate seeding rates and actual seed treatment rates. Each treated plot received two foliar bro adcast applications of a 0.70 lb ai/gal suspension concentrate (SC) formulation (Abamectin SC; A15368D) at exaggerated rates of 0.0938

- 0.0949 lb ai/A/application (~5x the application rate used in the corresponding field trials). T he first applications wer e made 96

- 81 days after planting, and the second foliar applications were madeAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 24 of 45 at retreatment intervals (RTIs) of 6 days. A nonionic surfactant (NIS) or crop oil concentrate (COC) was added to the foliar spray mixture for each trial. Total application rates including seed

treatment were 0. 231

- 0.234 lb ai/A. Soybean seed was harvested at commercial maturity at preharvest intervals (PHIs) of 27

- 37 day s and processed into aspirated grain fractions (AGF), meal, hulls, and refined

- bleached deodorized oil us ing simulated commercial procedures.

Following a combination of seed treatment with the 4.17 lb ai/gal FS formulation and two foliar broadcast applications of the 0.70 lb ai/gal SC formulation at total application rates of 0.231

- 0.234 lb ai/A, residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### were below the LOQ in/on all samples of soybean seed and refined oil from both trials and in all samples of processed commodities from the Richland, IA trial except AGF, in which average residues of

avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### , and combined residues of the three analytes, respectively, were 0.193, 0.00332, 0.00256, and 0.198 ppm. In the Bagley, IA trial,

residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### , respectively, were: 0.496, 0.00456, 0.00635, ppm in/on AGF; <0.00233, <0.002, and <0.002 ppm in meal; and 0.00292, <0.002, and <0.002 ppm in hulls. Combined residues of the three analytes were 0.507, <0.00633, and < 0.00692 ppm in/on AGF, meal, and hulls, respectively.

The processing data indicate that combined residues of avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin B 1a 

### may concentrate in/on AGF (average processing factor of 59 x)

, meal (1.1x),

and hul ls (1.2 x). For all other matrices, p rocessing factors could not be calculated because residues were below the LOQ in both the RAC and processed commodities.

The observed processing factors are less than the theoretical concentration factor of 11.3x in soybean hulls, 2.2x in soybean meal, and 12x in soybean oil (based on separation into components; OCSPP 860.1520, Table 3).

### Page 25 of 45 TABLE 5.3 .3. Residue Data from Soybean Processing Study with Abamectin.

RAC Processed Commodity Total

Rate (lb ai/A) PHI (days) Residues 1 (ppm) [Average] Processing Factor 3

Avermectin B 1a 8,9

- Z

Avermectin B 1a Avermectin B 1b Combined

Residues 2 Avermectin

B 1a 8,9

- Z

Avermectin

B 1a Avermectin

B 1b Combined

Residues 2

Ri c h l a nd

, I A; 20 1 1 (TK0040391

- 19)

Soybean Seed (RAC) 0.231 27 <0.002

, <0.002

, < 0.002
[ <0.002 ] ND

, ND

, ND [ <0.002 ] ND

, ND

, ND [ <0.002 ] <0.006, <0.006,

<0.006
[ <0.006] -- -- -- --

AGF 0.196

, 0.189
[ 0.192] 0.00344,

0.00320
[ 0.00332] 0.00246

, 0.00266
[ 0.00256] 0.202, 0.195
[ 0.198] ≥ 96 ≥ 1.7 ≥ 1.3 ≥ 33

Meal <0.002

, ND [ < 0.002 ] ND

, ND [ <0.002 ] ND

, ND [ <0.002 ] <0.006, <0.006
[ <0.006] NC 4 NC NC NC

Hulls <0.002

, <0.002
[ <0.002 ] ND

, ND [ <0.002 ] ND

, ND [ <0.002 ] <0.006, <0.006
[ <0.006] NC NC NC NC

Refined oil ND

, ND [ <0.002 ] ND

, ND [ <0.002 ] ND

, ND [ <0.002 ] < 0.006, <0.006
[ <0.006] NC NC NC NC

Bagley, I A ; 2 0 1 1 ( TK0040391

- 20 )

Soybean Seed (RAC) 0.234 37 <0.002

, <0.002

, <0.002
[ <0.002 ] ND

, ND

, ND [ <0.002 ] ND

, ND

, ND [ <0.002 ] <0.006, <0.006,

<0.006
[ <0.006] -- -- -- --

AGF 0.498

, 0.494
[ 0.496] 0.00492,

0.00420
[ 0.00456] 0.00615

, 0.00655
[ 0.00635] 0.509, 0.505
[ 0.507] ≥ 248 ≥ 2.3 ≥ 3.2 ≥ 84.5

Meal ND

, 0.00265
[ <0.00232] ND, ND [ <0.002] ND, ND [ <0.002] <0.006,

<0.00665
[ 0.00632] 1.2 NC NC 1.1

Hulls 0.00281

, 0.00302
[ 0.00292] ND, ND [ < 0.002] ND, ND [ <0.002] <0.00681,

0.00702
[ 0.00692] 1.5 NC NC 1.2

Refined oil ND, ND [<0.002] ND, ND [<0.002] ND, ND [<0.002] <0.006, <0.006 [<0.006] NC NC NC NCAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 26 of 45 TABLE 5.3 .3. Residue Data from Soybean Processing Study with Abamectin.

RAC Processed Commodity Total

Rate (lb ai/A) PHI (days) Residues 1 (ppm) [Average] Processing Factor 3

Avermectin B 1a 8,9

- Z

Avermectin B 1a Avermectin B 1b Combined

Residues 2 Avermectin

B 1a 8,9

- Z

Avermectin

B 1a Avermectin

B 1b Combined

Residues 2

Average Processing Factors (for Trials TK0040391

- 19 and TK0040391

- 20)

Soybean Seed (RAC)

-- -- -- --

AGF 172 2.0 2.2 59

Meal 1.2 NC NC 1.1

Hulls 1.5 NC NC 1.2

Refined oil NC NC NC NC

1 The LOQ was 0.002 ppm for each analyte in each corn matrix; the LOD was not reported. < 0.002 ppm represents values <LOQ. ND = not detected (no observable chromatographic response) as reported by the petitioner. Average residues and combined residues were calculated by the study reviewer using the LOQ for values reported as <LOQ.

2 Combined residues of avermectin B 1a , avermectin B 1b , and 8,9

- Z avermectin B 1a

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

4 NC = Not calculated; residues were bel ow the LOQ in both the RAC and processed fraction.

### Page 27 of 45 Conclusions . No processed commodities are associated with sweet corn. The processed commodities for soybean are meal, hulls, refined oil, and aspirated grain fractions (AGF). A processing study on soybeans indicated that combined residues of avermectin B 1a 

### , averme ctin

B 1b 

### , and 8,9

- Z avermectin B 1a 

### may concentrate in/on AGF (average processing factor of 59 x)

, meal (1. 1 x), and hulls (1. 2 x). A processing factor could not be calculated for refined soybean oil because residues were below the LOQ in both the RAC and the processed commodit y ; however

, additional processing data are not required and a separate tolerance for refined oil is not needed since the processing study was conducted at an exaggerated rate (~5x the proposed foliar rate). Based on the average residues in soybean seed and the concentration factor of 1. 1 x for meal and

1. 2 x for hulls (i.e., 0.006 ppm x 1. 2 x = 0.00 72 ppm), no separate tolerances are needed for soybean meal and hulls since residues in those commodities will be less than the recommended tolerance of 0.01 ppm on soybean seed.

The residue data are adequately supported by the storage stability studies. The analytical method is adequate for the analysis of the residues of concern. The residue data adequately address the

residues of concern.

5.3.4 Meat, Milk, Poultry and Eggs (860.1480)

Livestock feed items are associated with the proposed uses on sweet corn and soybeans ( Table 1 Feedstuffs , June 2008)

. Because there are feed items associated with the proposed uses, t he

established livestock tolerances have been reassessed. Residues in livestock commodities

calculated below include residues from us es o n proposed/registered crops and from beef and dairy cattle ear tags.

Livestock Feeding Studies
RCB #1568, L. Cheng, 2/11/87



### No poultry feeding studies have been submitted or required. No additional ruminant feeding

studies have been submitted with this petition.

F eeding studies on lactating dairy cattle were reviewed in PP#7G3468 (RCB #1568, L. Cheng, 2/11/87; MRID #164157; Accession #265585) . Each feeding level included three treated

animals. A control group was also included.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 28 of 45 T able 5.3.4. a

. Abamectin Residues in Cow Milk from a 28

- Day Feeding Study

Day Avermectin B 1a 1 Levels (ppb) in Milk at 3 Dosing Levels

10 ppb 30 ppb 100 ppb

1 ND 2 ND ND

2 ND ND ND

- 1

3 ND ND ND

- 1

5 ND ND

- 1 ND

- 1

7 ND ND 1

- 2

14 ND ND 1

- 4

28 ND ND 1

1 Abamectin was fed. Avermectin B 1a was determined.

2 ND = not detectable down to the lower limit that adequate method recoveries were achieved (0.5 ppb).

T able 5.3.4. b . Abamectin Residues in Dairy Cattle Tissues from a 28

- Day Feeding Study

Dose (ppb) Avermectin B 1a 1 Levels in Various Tissues and Organs (ppb)

Liver Muscle Fat Kidney

10 3

- 4 1

- 2 2 1

- 2

30 5

- 8 2 4

- 6 2

100 18

- 20 2 10

- 14 4

- 5

1 Abamectin was fed. Avermectin B 1a was determined. The data were validated at 5 ppb avermectin B 1a

.

Table 5.3.4. c . Summary of Livestock Feeding Studies with Abamectin

. Commodity Feeding Level, ppm Residue in Tissue, ppm 1 Tissue

- to

- Feed Ratio

Milk 0.010 ND 2

-- 0.030 0.001 0.033

0.100 0.004 0.040

Muscle (cattle) 0.010 0.002 0.20

0.030 0.002 0.067

0.100 0.002 0.02 Fat (cattle) 2 0.010 0.002 0.20

0.030 0.006 0.20

0.100 0.014 0.14 Liver (cattle) 0.010 0.004 0.40

0.030 0.008 0.27

0.100 0.020 0.2 Kidney (cattle) 0.010 0.002 0.2

0.030 0.002 0.067

0.100 0.005 0.05

1 maximum residue

2 ND = not detectable.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 29 of 45 5.3.4.1 Dietary Burden

A summary of the livestock feeds considered in a more balanced diet (MDB) is presented in

Table 5.3.4.1.1., and the estimated dietary burden is presented in Table 5.3.4.1.2

.

Table 5.3.4.1.1 Feeds Considered in More Balanced Diet

Crop Commodity Type input %DM Max

%Diet % Diet Used

Beef Cattle

Cotton Hulls R 0.006 Median 90 10 10

Citrus Pulp, dried R 0.02 Median 91 10 0

Cotton Gin byproducts R 0.018 Median 90 5 0
Pineapple Process residue R 0.016 Median 25 10 0

Grain Aspirated grain fractions CC 0.4 Median 85 5 5

Potato Culls CC 0.0027 HR 20 30 0

Potato Process Waste CC 0.0027 Median 12 30 0

Cotton Meal PC 0.006 Median 89 5 5
Soybean Seed PC 0.006 Median 89 5 0
Dairy Cattle

Corn, sweet Stover R 0.329 HR 83 15 15

Corn, sweet Forage R 0.102 HR 48 45 30

Almond Hulls R 0.039 Median 90 10 0

Citrus Pulp, dried R 0.02 Median 91 10 0
Pineapple Process residue R 0.016 Median 25 10 0

Corn, sweet Cannery waste CC 0.063 Median 30 10 10

Apples Pomace, wet CC 0.02 Median 40 10 0

Potato Process Waste CC 0.0027 Median 12 10 0

Potato Culls CC 0.0027 HR 20 10 0

Cotton Undelinted seed PC 0.006 Median 88 10 10

Cotton Meal PC 0.006 Median 89 10 0
Soybean Seed PC 0.006 Median 89 10 0

Poultry

Cotton Meal PC 0.006 Median 89 20 20
Soybean Seed PC 0.006 Median 89 20 5

Swine

Cotton Meal PC 0.006 Median 89 15 15
Soybean Seed PC 0.006 Median 89 15 0Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 30 of 45 Table 5.3.4.1.2 More Balanced Diet (MBD)

Crop Commodity Type Residue %DM %Diet Dietary Contribution

ppm ppm input

Beef Cattle

Cotton Hulls R 0.006 Median 90 10 0.0007

Grain Aspirated grain fractions CC 0.4 Median 85 5 0.02

Cotton Meal PC 0.006 Median 89 5 0.0003

Untreated feed NA NA NA NA NA 80 0

Total NA NA NA NA NA 100 0.02
Dairy Cattle

Corn, sweet Stover R 0.329 HR 83 15 0.06
Corn, sweet Forage R 0.102 HR 48 30 0.06

Corn, sweet Cannery waste CC 0.063 Median 30 10 0.02

Cotton Undelinted seed PC 0.006 Median 88 10 0.0007

Untreated feed NA NA NA NA NA 35 0

Total NA NA NA NA NA 100 0.14

Poultry

Cotton Meal PC 0.006 Median 89 20 0.001
Soybean Seed PC 0.006 Median 89 5 0.0003

Untreated feed NA NA NA NA NA 75 0

Total NA NA NA NA NA 100 0.002

Swine

Cotton Meal PC 0.006 Median 89 15 0.0009

Untreated feed NA NA NA NA NA 85 0

Total NA NA NA NA NA 100 0.0009

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

2 Table 1 Feedstuffs (July 2008).

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

4 LOQ tolerance (i.e., <0.002 ppm x 3 analytes = <0.006 ppm).



### 5.3.4.2. E stimated Secondary Residues in Livestock

E stimated Secondary Residues in Livestock from Crops

Table 5.3.4.2.1 . Estimation of Secondary Residues in Cattle Commodities from Use of Abamectin on Crops Commodity Tissue

- to

- Feed Ratio 1 Dietary Burden (ppm) Expected Residue

Milk 0.040 0.14 0.00 5 6

Muscle 0.02 0.14 0.0028

Fat 0.14 0.14 0.020

Liver 0.2 0.14 0.028 Kidney 0.05 0.14 0.007

1 The 0.100 ppm feeding level is used because it is close st to the dietary burden of 0.14 ppm.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 31 of 45 Table 5.3.4.2.2 . Estimation of Secondary Residues in Swine Commodities from Use of Abamectin on Crops Commodity Tissue

- to

- Feed Ratio 1 Dietary Burden (ppm) Expected Residue

Muscle 0.02 0.00090 0.000018

Fat 0.14 0.00090 0.00013

Liver 0.2 0.00090 0.00018 Kidney 0.05 0.00090 0.000045

1 The 0.100 ppm feeding level

.



### Residues in Meat, Fat, and Meat Byproducts from Use of Ear Tag s on Beef Cattle and Non

lactating Dairy Cattle

D357192, T. Morton, 1/27/09



### Quantifiable residues of abamectin (>0.005 ppm) were found in some liver, kidney, and fat samples from beef cattle/non

- lactating dairy cattle t reated with the cattle ear tag according to label directions (1x). Based on these data, the tolerances for cattle fat and cattle meat byproducts were increased to from 0.01 to 0.03 ppm and from 0.02 to 0.06 ppm, respectively. No change was required to the established toleranc e for ruminant meat as a result of the ear tag use.

Residues in Milk from Use of Ear Tags on Lactating Dairy Cattle

D410993, N. Dodd, 5/14/14



### Maximum residues of abamectin in milk from use of ear tags on lactating dairy cattle were 0.0046 ppm.

Comparison of Established Tolerances to Expected Residue s

The table below compares the total expected residues in livestock commodities to the established

tolerances.

Table 5.3.4.2.3 . Comparison of Expected Residues to Established Tolerances, and Tole rance Recommendations.

Commodity Expected Residue from Dietary

Burden (ppm) Expected

Residue from Cattle Ear Tag

Use 1 (ppm) Total Expected

Residue

(ppm) Established

Tolerance 3

(ppm) Recommended

Tolerance

(ppm) 4

Cattle, fat 0.020 0.018 + (0.0036) 0.042 0.03 0.05
Cattle, meat 0.00 2 8 <0.005 + (<0.001) 0.0088 0.02 0.02

Cattle, meat byproducts (L iver ) 0.0 2 8 0.043 + (0.0086) 0.080

0.06 0.0 9 Cattle, meat byproducts (Kidney) 0.0070 0.0 17 + (0.0034) 0.027

Milk 0.0064 0.0046 0.011 0.005 0.015
Goat, Horse, Sheep, fat 0.020 0.020 0.01 0.03 Goat, Horse, Sheep, meat 0.0028 0.0028 0.02 0.02 Goat, Horse, Sheep, meat byproducts;(Liver) 0.028 0.028

0.02 0.04 Goat, Horse, Sheep, meat byproducts (Kidney) 0.0070 0.0070

Hog, fat 0.00013 0.00013 0.01 0.01Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 32 of 45 Table 5.3.4.2.3 . Comparison of Expected Residues to Established Tolerances, and Tole rance Recommendations.

Commodity Expected Residue from Dietary

Burden (ppm) Expected

Residue from Cattle Ear Tag

Use 1 (ppm) Total Expected

Residue

(ppm) Established

Tolerance 3

(ppm) Recommended

Tolerance

(ppm) 4

Hog, meat 0.000018 0.000018 0.02 0.02 Hog, meat byproducts (Liver) 0.00018 0.00018 0.02 0.02

Hog, meat byproducts (Kidney) 0.000045 0.000045

Poultry, meat 0.00 5 0.00 0.02 5 0.02 Poultry, meat byproducts ( Liver) 0.00 5 0.00 0.02 5 0.02

1 Maximum residues of avermectin B 1a /8,9

- Z avermectin B 1a from D357192 ( T. Morton, 1/27/09 ) are reported in the

table

. The LOQ of 0.005 ppm in cattle muscle, fat, kidney, and liver for the method (an HPLC method with fluorescence detection; Method AATM

- R

- 53) was sup ported by acceptable method validation recoveries. Residues

of avermectin B 1b /8,9

- Z avermectin B 1b were not determined; they comprise ≤20% of the active ingredient. Residues

of a vermectin B 1b /8,9

- Z avermectin B 1b are included in the table (in parenthesis ) as 20% of the reported avermectin

B 1a /8,9

- Z avermectin B 1a residue and are included in the total.

2 The maximum residue of abamectin (total avermectin B 1a /8, 9

- Z isomer and avermectin B 1b /8,9

- Z isomer) in milk from the dairy cattle ear tag use (pending) is reported as 0.0046 ppm (D416280, N. Dodd, 5/1 5 /14 ).

3 Tolerances on cattle fat and meat byproducts are higher than other ruminant tolerances because they were raised upon establishment of the abamecti n ear tag use on beef cattle. The established tolerances for meat and meat by

products of poultry and swine were established at the LOQ of the enforcement method for residues in food handling

establishments. In connection with D310414 (N. Dodd, 12/1/04), the LOQs of the enforcement methods for the

combined residues of avermectin B 1a and 8,9

- Z

- avermectin B 1a (one peak on the chromatogram) and the combined

residues of avermectin B 1 b and 8,9

- Z

- avermectin B 1 b (one peak on the chromatogram) were determined to be 0.005 ppm for milk, 0.02 ppm for meat and meat byproducts, and ≤0.01 ppm for other food items in food handling

establishments.

4 Recommended changes are bolded.

5 No poultry metabolism or feeding stud ies ha ve been submitted. Based on dietary burden c alculations using Table 1 Feedstuffs (June 2008), no secondary residues are expected to occur in poultry commodities; therefore, no poultry metabolism or feeding studies are required

. The tolerances for meat and meat by

- products of poultry and swine were established for residues in food handling establishments and were set at the enforcement method LOQs.



### Conclusions. Because there are livestock feed items associated with the propos ed uses on sweet corn and soybeans , the established livestock tolerances have been reassessed. The calculated

residues in livestock commodities include residues from uses on proposed/registered crops, from use in food handling establishments, and from bee f and dairy cattle ear tags.

H igher tolerances are needed for the fat of cattle (0.05 ppm), meat byproducts of cattle (0.09 ppm), fat of goat, horse, and sheep (0.03 ppm), meat byproducts of goat, horse, and sheep (0.04 ppm) , and milk (0.015 ppm) . The es tablished tolerances on the remaining livestock commodities are adequate. Refer to Table 2.2.2 for all the recommended livestock tolerances.

No poultry feeding studies have been submitted or required. Based on dietary burden calculations using Table 1 F eedstuffs (June 2008), no secondary residues are expected to occur in poultry commodities; therefore, no poultry f eeding studies are required.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 33 of 45 5.3.5. Food Handling (860.1460)

There are no proposed uses that are relevant to this guideline topic.

5.3.6. Water, Fish, and Irrigated Crops (860.1400)

There are no proposed uses that are relevant to this guideline topic.

5.4. Food Residue Profile

The residue chemistry database is adequate for tolerance assessment and for registration of the

four formulations of abamectin on sweet corn and soybeans.

Crop field trials : The sweet corn and soybean field trials adequately reflect the proposed use

pattern s

. The number of trials and the geographic representation are adequate. Field trial

residues in sweet corn forage and stover and soybean forage and hay were small (low level) but quantifiable as combined residues ; these combined residues generally decreased with increasing

PHI s . Combined residues in sweet corn kernel plus cob with husk removed and in soybean seed were all <LOQ (<0.006 ppm).

Processing studies : No processed commodities are associated with sweet corn. The processed commodities for soybean are meal, hulls, refined oil, and aspirated grain fractions (AGF). A processing study on soybeans indic ated that combined residues of avermectin B 1a 

### , avermectin

B 1b 

### , and 8,9

- Z avermectin B 1a 

### may concentrate in/on AGF (average processing factor of 59 x)

, meal (1.1x), and hulls (1.2 x). A processing factor could not be calculated for refined oil because residues were below the LOQ in both the RAC and processed commodities ; however , additional processing data are not required and a separate tolerance for refined oil is not needed since the processing study was conducted at an exaggerated rate (~5x the prop osed foliar rate).

Storage S tability : Acceptable storage stability data are available demonstrating that residues of

avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin B 1a 

### are stable under frozen storage for at least 24 months in five different crop types: high water (celery and pear), high acid (orange, lemon, grapefruit, strawberry, and tomato), high protein (bean), high fat (sunflower seed), and high starch (potato). The available and submitted storage stability data are adequate to support

the st orage conditions and durations of samples from the residue studies.

Meat, Milk, Poultry, and Eggs : Because there are livestock feed items associated with the proposed uses on sweet corn and soybeans, the established livestock tolerances have been

reasses sed. The calculated residues in livestock commodities include residues from uses on proposed/registered crops and beef and dairy cattle ear tags. Higher tolerances are needed for

some livestock commodities.

No poultry feeding studies have been submitted or required. Based on dietary burden calculations using Table 1 Feedstuffs (June 2008)

, no secondary residues are expected to occur in poultry commodities; therefore, no poultry f eeding studies are required.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 34 of 45 Rotational Crops : A c onfined rotational crop study indicated that avermectin residues of significant toxicological concern are not expected to occur in rotational crops.

6.0 Tolerance Derivation

Based on residues <LOQ (< 0.006 ppm) in soybean seed and sweet corn kernel plus cob with husk removed, the proposed tolerances of 0.01 ppm for those commodities are adequate. Based on the average residues in soybean seed and the concentration factor of 1.1x for meal and 1.2x

for h ulls (i.e., 0.006 ppm x 1.2x = 0.0072 ppm), no separate tolerances are needed for soybean

meal and hulls since residues in those commodities will be less than the recommended tolerance of 0.01 ppm on soybean seed. Based on residues of <0.006 ppm in soybea n seed and a concentration factor of 59x in aspirated grain fractions, a tolerance is needed for grain, aspirated grain fractions at 0.40 ppm.

S ince livestock feed items are associated with sweet corn and soybean, the established livestock

tolerances ha ve been re

- evaluated . Higher tolerances are needed for the fat of cattle (0.05 ppm), meat byproducts of cattle (0.09 ppm), fat of goat, horse, and sheep (0.03 ppm), meat byproducts of goat, horse, and sheep (0.04 ppm), and milk (0.015 ppm). The establish ed tolerances on the remaining livestock commodities are adequate. Table 2.2.2 lists all the recommended livestock

tolerances.

A s shown in Appendix C, t he OECD tolerance calculation procedures were used for calculating

the recommended tolerance for sweet corn forage and stover and soybean forage and hay. The statistical goal of the tolerance calculation procedures is to produce an MRL proposal in the region of the 95 th 

### percentile of the underlying residues distribution.

Sweet Corn Forage and Stover (MRID 49 071008 )

The dataset s used to establish tolerance s for abamectin consisted of field trial data on sweet corn forage and stover representing application rates of 0.0 5 04

- 0.0795 l b ai/A abamectin with PHIs of

6

- 7 days. The field trial application rat es are approximately 1x the maximum registered seed treatment rate plus 1x the maximum proposed seasonal foliar application rate. The PHIs are within 25% of the minimum label PHI. The average residue values used to calculate the

tolerance s are provided b elow. Combined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and

avermectin B 1b 

### were quantifiable in/on samples from all twelve field trials. Using the OECD tolerance calculation procedures, the recommended tolerance s are 0. 2 ppm and 0.5 ppm for

comb ined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### in sweet corn forage and stover, respectively

.

Soybean Forage and Hay (MRID 49071010)

The dataset s used to establish tolerance s for abamectin consisted of field trial data on soybean forage and hay representing application rates of 0.0 776

- 0. 127 lb ai/A abamectin with PHIs of 6

- 8 days. The field trial application rates are approximately 1x the maximum registered seed treatment rate plus 1x the maximum proposed seasonal foliar a pplication rate. The PHIs are

within 25% of the minimum label PHI. The average residue values used to calculate theAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 35 of 45 tolerance s are provided below. Combined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and

avermectin B 1b 

### were quantifiable in/on samp les from all twe nty trials. Using the OECD tolerance calculation procedures, the recommended tolerance s are 0.3 ppm and 1 ppm for

combined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### in soybean forage and hay , respectively

.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 36 of 45 Appendix A. Field Trial Geographic Distribution

Sweet Corn

TABLE A .1.3. Trial Numbers and Geographical Locations

. NAFTA Growing Regions Sweet Corn

Submitted Requested 1

Canada U.S.

1 2

-- 2/2

1A

-- -- --

2 1

-- 1

3 1

-- 1

4

-- -- --

5 5

-- 5/3

5A

-- -- --

5B

-- -- --

6

-- -- --

7

-- -- --

7A

-- -- --

8

-- -- --

9

-- -- --

10 1

-- 1

11 1

-- 1

12 1

-- 1

13

-- -- --

14

-- -- --

15

-- -- --

16

-- -- --

17

-- -- --

18

-- -- --

19

-- -- --

20

-- -- --

21

-- -- --

Total 12 12 (9)

1 As per Table 5 of 860.1500 for sweet corn ; the second number reflects a 25% reduction in the number of field trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifiable residues.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 37 of 45 Soybeans

TABLE A .1.3. Trial Numbers and Geographical Locations

. NAFTA Growing Regions Soybean

Submitted Requested 1

Canada U.S.

1

-- -- --

1A

-- -- --

2 2

-- 2/2

3

-- -- --

4 3

-- 3/2

5 15

-- 15/11

5A

-- -- --

5B

-- -- --

6

-- -- --

7

-- -- --

7A

-- -- --

8

-- -- --

9

-- -- --

10

-- -- --

11

-- -- --

12

-- -- --

13

-- -- --

14

-- -- --
15

-- -- --

16

-- -- --

17

-- -- --

18

-- -- --
19

-- -- --

20

-- -- --

21

-- -- --

Total 20 20/15

1 As per Table 5 of 860.1500 for soybean. The second number reflects a 25% reduction in the number of field trials allowed for the crop as a representative commodity in support of a crop group/subgroup tolerance or when application results in no quantifiable residues.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 38 of 45 Appendix B . Internation al Residue Limits T able s

Plants : 

## Abamectin ( 122804 ; 9/19/ 20 13 )

Summary of US and International Tolerances and Maximum Residue Limits Residue Definition :
US Canada Mexico 2 

### Codex

40 CFR §180.449: avermectin B 1 [a mixture of avermectins containing greater than or equal to 80% avermectin B 1a (5

- O

- demethyl avermectin A 1 ) and less than or equal to 20% avermectin B 1b (5

- O

- demethyl

- 25

- de(1

- methylpropyl)

- 25

- (1

- methylethyl) avermectin A 1 )] and its

delta

- 8,9

- isome r avermectin B 1 (a mixture of avermectins containing greater than or equal to

80% avermectin B 1a (5

- O

demethyl avermectin A 1a ) and less than or equal to

20% avermectin B 1b (5

- O

demethyl

- 25

- de(1

- methylpropyl)

- 25

- ( 1

- methylethyl ) avermectin

A 1a ) and its delta

- 8,9

- isomer) Plants: sum of avermectin B1a, avermectin B1b,
8,9

- Z

- avermectin B1a and 8,9

- Z

avermectin B1b.

Animal

commodities:

sum of

avermectin B1a and 8,9

- Z

avermectin B1a.



### Commodity 1 

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

US Canada Mexico 2 

### Codex Corn, sweet, forage 0.2 0 Corn, sweet, kernel plus cob with

husk s removed 0.01

Corn, sweet, stover 0.5 0 Soybean, forage 0.3 0 Soybean, hay 1 .0 Soybean, seed 0.01 Completed: M. Negussie; 9/19/2013

1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant.

2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 39 of 45 Livestock : 

## Abamectin ( 122804 ; 9/19/ 20 13 )

Summary of US and International Tolerances and Maximum Residue Limits Residue Definition :
US Canada Mexico 2 

### Codex 3

40 CFR §180.449: avermectin B 1 [a mixture of avermectins containing greater than or equal to 80%

avermectin B 1a (5

- O

- demethyl

avermectin A 1 ) and less than or equal to 20% avermectin B 1b (5

- O

- demethyl

- 25

- de(1

- methylpropyl)

- 25

- (1

- methylethyl) avermectin A 1 )] and

its delta

- 8,9

- isomer avermectin B 1 (a mixture of avermectins containing greater than or equal to 80%

avermectin B 1a (5

- O

- demethyl

avermectin A 1a ) and less than or equal to 20% avermectin B 1b (5

- O

- demethyl

- 25

- de(1

- methylpropyl)

- 25

- ( 1

- methylethyl ) avermectin A 1a )

and its delta

- 8,9

- isomer) A nimal

commodities: sum

of avermectin B1a and 8,9

- Z

avermectin B1a.



### Commodity 1 

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

US Canada Mexico 2 

### Codex 3

Cattle, fat 0.05 0.1 4

Cattle, meat 0.02 0.01 (*)

Cattle, meat byproducts 0.09 0.05 4 cattle kidney

0.1 4 cattle liver
Goat, fat 0.03
Goat, meat 0.02 0.01 (*)

Goat, meat byproducts 0.04 0.1 goat edible

offal Hog, fat 0.01 Hog, meat 0.02 Hog, meat byproducts 0.02
Horse, fat 0.03
Horse, meat 0.02
Horse, meat byproducts 0.04

Milk 0.01 5 0.005 cattle milk 0.005 goat milk Poultry, meat 0.02 Poultry, meat byproducts 0.02 Sheep, fat 0.03 Sheep, meat 0.02 Sheep, meat byproducts 0.04 Completed: M. Negussie; 9/19/2013

1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant.

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

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

4 The MRL accom m odates external animal treatment.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 40 of 45 A ppendix C

. OECD MRL Calculation Procedure Inputs/Outputs

Sweet Corn Forage (MRID 49071008 )



### 0.0504

- 0.0795 lb ai/A, 6

- 7

- day PHI

**Residues (mg/kg) n** 

0.0146 1

0.0184 1

0.0242 1

0.0303 1

0.0556 1

0.062 1

0.0636 1

0.065 1

0.0673 1

0.0702 1

0.0995 1

0.102 1

**Abamectin**

**Sweet Corn F**  **orage**

**USA**

**0.0504**

**- 0.0795**  **lb ai/A, 6**

**- 7 day PHI** 

**Total number of data (n)** 12

**Percentage of censored data** 0%

**Number of non**

**- censored data**  12

**Lowest residue** 0.015

**Highest residue** 0.102

**Median residue** 0.063

**Mean** 0.056

**Standard deviation (SD)** 0.029

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

**Proposed MRL estimate**

**- Highest residue**  0.102

**- Mean + 4 SD**  0.172

**- CF x 3 Mean**  0.168

**Unrounded MRL** 0.172

**Rounded MRL 0.2** Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 41 of 45 Sweet Corn Stover (MRID 49071008 )



### 0.0504

- 0.0795 lb ai/A, 6

- 7

- day PHI

**Residues (mg/kg) n** 

0.0221 1

0.0248 1

0.0273 1

0.0467 1

0.0554 1

0.0592 1

0.0707 1

0.0818 1

0.125 1

0.138 1

0.235 1

0.329 1

**Abamectin**

**Sweet Corn S tover** 

**USA**

**0.0504**

**- 0.0795**  **lb ai/A, 6**

**- 7 day PHI** 

**Total number of data (n)** 12

**Percentage of censored data** 0%

**Number of non**

**- censored data**  12

**Lowest residue**  0.022

**Highest residue** 0.329

**Median residue** 0.065

**Mean** 0.101

**Standard deviation (SD)** 0.094

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

**Proposed MRL estimate**

**- Highest residue**  0.329

**- Mean + 4 SD**  0.478

**- CF x 3 Mean**  0.304

**Unrounded MRL** 0.478

**Rounded MRL 0.5** Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 42 of 45 Soybean Forage (MRID 49071010)

0.0776

- 0.127 lb ai/A, 6

- 8 day PHI

**Residues (mg/kg) n** 

0.0138 1

0.014 1

0.0172 1

0.0188 1

0.0192 1

0.0244 1

0.0247 1

0.0257 1

0.0337 1

0.0348 1

0.0391 1

0.0486 1

0.0599 1

0.0602 1

0.0965 1

0.0979 1

0.115 1

0.132 1

0.145 1

0.158 1Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 43 of 45 **Abamectin**

**Forage**

**USA**

**0.0776**

**- 0.127 lb a**  **i /A, 6** 

**- 8 day PHI** 

**Total number of data (n)** 20

**Percentage of censored data** 0%

**Number of non**

**- censored data**  20

**Lowest residue** 0.014

**Highest residue** 0.158

**Median residue** 0.037

**Mean** 0.059

**Standard deviation (SD)** 0.047

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

**Proposed MRL estimate**

**- Highest residue**  0.158

**- Mean + 4 SD**  0.249

**- CF x 3 Mean**  0.177

**Unrounded MRL** 0.249

**Rounded MRL 0.3** Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 44 of 45 Soybean Hay (MRID 49071010)

0.0776

- 0.127 lb ai/A, 6

- 8 day PHI

**Residues (mg/kg) n** 

0.0448 1

0.0449 1

0.0489 1

0.062 1

0.08 1

0.11 1

0.117 1

0.122 1

0.156 1

0.185 1

0.215 1

0.226 1

0.295 1

0.332 1

0.365 1

0.366 1

0.414 1

0.453 1

0.553 1

0.607 1Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 45 of 45 **Abamectin**

**Soybean Hay**

**USA**

**0.0776**

**- 0.127 lb ai**  **/A, 6**

**- 8 day PHI** 

**Total number of data (n)** 20

**Percentage of censored data** 0%

**Number of non**

**- censored data**  20

**Lowest residue** 0.045

**Highest residue** 0.607

**Median residue** 0.200

**Mean** 0.240

**Standard deviation (SD)** 0.174

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

**Proposed MRL estimate**

**- Highest residue**  0.607

**- Mean + 4 SD**  0.938

**- CF x 3 Mean**  0.719

**Unrounded MRL** 0.938

**Rounded MRL 1**