### Page 1 of 51 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY AND
POLLUTION PREVENTION 

### MEMORANDUM

Date: March 17, 2016

Subject: Aba mectin

. Petition for the Establishment of Permanent Tolerance s and Registra t ion
for New Uses on Bean, Various Tropical Fruits, Onion, Green, Subgroup 3

- 07B; Fruit, Pome, Group 11

- 10; Fruit, Small Vine Climbing, except Fuzzy Kiwifruit, Subgroup 13

- 07F; Berry, Low Growing, Subgroup 13

- 07G; and Conversion of Existing Crop Groups to Vegetable, Fruiting, Group 8

- 10 (and A ddition of
Greenhouse

- grown T omato); Fruit, Citrus, Group 10

- 10; Frui t, Stone, Group 12

- 12; and Nut, Tree, Group 14

- 12. Summary of Analytical Chemistry and Residue Data.

PC Code: 122804 DP Barcode: D 4 24008
Decision No.: 495169 Registration No s

. : 100

- 1154

, 100

- 1351, 100

- 1408, and 100

- 1439
Petition No.: 4E8309 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: Chris tine Olinger, Branch Chief
Risk Assessment Branch III ( RAB3) Health Effects Division (HED; 7509P)

To: Barbara Madden/Sidney Jackson, R M # 5 Registration Division (7505P)Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 2 of 51 Summary of Submitted Residue Chemistry Studies

O C S PP 860 Series
Guideline MRID
Number Title

860.1500 49455901 Leonard, R. (2014) Abamectin: Magnitude of the Residue on Tomato (Greenhouse). Project Number: 05076, 05076/11/MIR03, 05076/11/WI14. Unpublished study prepared by Interregional Research Project No. 4, University of Florida, Texas AgriLife Research

. 229

p. 860.1500 49455902 Leonard, R. (2012) Abamectin: Magnitude of the Residue on Onion (Green). Project Number: A4068, A4068/09/MD18, A4068/09/FL55. Unpublished study prepared by University of Flo rida, Interregional Research Project No. 4, University of Maryland/LESREC. 172 p.

860.1500 49455903 Jolly, C. (2014) Abamectin: Magnitude of the Residue on Guava: Final Report. Project Number: 06435, 06435/99/BER03, 06435/99/FL51. Unpublished study prepared by Interregional Research Project No. 4, University of Flo rida, U.S. Dept. of Agriculture. 148

p. 860.1500 49455904 Jolly, C. (2014) Abamectin: Magnitude of the Residue on Bean (Lima): Final Report. Project Number: 07271, 07271/99/CIR03, 07271/99/CA58. Unpublished study prepared by Interregional Research Project No. 4, University of California Kearney Agricultural Center, University of Idaho. 186 p.

860.1500 49455905 Jolly, C. (2014) Abamectin: Magnitude of the Residue on Lychee: Final R eport. Project Number: 07831, 07831/01/NYR09, 07 83 1/01/FL19. Unpublished study prepared by Interregional Research Project No. 4, Cornell University, University of Florida. 137 p.

860.1500 49455906 Dorschner, K. (2013) Abamectin: Magnitude of the Residue on Papaya. Project Number: 04078, 04078/98/ABC06, 04078/98/FL15. Unpublished study prepared by Interregional Research Project No. 4, ABC Laboratories, Inc., University of Florida. 143 p.

860.1500 49455907 Jolly, C. (2014) Abamectin: Magnitude of the Residue on Pineapple. Project Number: 08439, 08439/02/HIR01, 08439/02/HI09. Unpublished study prepared by Interregional Research Project No. 4 and University of Hawaii. 258 p.

860.1500 49455908 Jolly, C. (2014) Abamectin: Magnitude of the Residue on Bea n (Snap): Final Report. Project Number: 05478, 05478/99/CIR02, 05478/99/FL33. Unpublished study prepared by Interregional Research Project No. 4, University of Florida, Cornell University. 226 p.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 3 of 51 Table of Contents

1.0 Executive Summary

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

2.0 Regulatory Recommendations

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

2.1 Data Deficiencies/Data Needs

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

2.2 Tolerance Considerations

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

2.2.1 Enforcement Analytical Method

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

2.2.2 Recommended Tolerances

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

2.2.3 Revisions to Petitioned

- For Tolerances

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

2.2.4 International Harmonization

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

2.3 Label Recommendations

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

3.0 Introduction

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

3.1 Chemical Identity

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

3.2 Physical/Chemical Characteristics

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

3.3 Pesticide Use Pattern/Directions for Use (860.1200)

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

4.0 Metabolite/Degradate Residue Profile

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

4.1 Nature of the Residue

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

4.1.1 Summary of Plant Metabolism (860.1300)

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

4.1.2 Summary of Livestock Metabolism (860.1300)

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

4.1.3 Summary of Confined Rotational Crops (860.l850)

................................ ............... 22

4.1.4. Summary of Metabolites and Degradates

................................ ............................... 22

4.2 Comparison of Metabolic Pathways

................................ ................................ .............. 22

4.3 Residues of Concern Summary and Rationale

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

5.0 Residue Profile

................................ ................................ ................................ .................. 24

5.1 Residue Analytical Methods (860.1340)

................................ ................................ ........ 24

5.1.1 Data Collection Methods

................................ ................................ ........................ 24

5.1.2 Multi

- Residue Methods (860.1360)

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

5.1.3 Tolerance Enforcement Methods

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

5.1.4 Submittal of Analytical Reference Standards (860.1650)

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

5.2 Storage Stability (860.1380)

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

5.3 Residue Data

................................ ................................ ................................ .................. 29

5.3.1 Crop Field Trials (860.1500)

................................ ................................ .................. 29

5.3.2 Field Rotational Crops (860.1900)

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

5.3.3 Processed Food and Feed (860.1520)

................................ ................................ ..... 37Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 4 of 51 5.3.4 Meat, Milk, Poultry and Eggs (860.1480)

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

5.3.5. Food Handling (860.1460)

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

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

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

5.4. Food Residue Profile

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

6.0 Tolerance Derivation

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

Appendix A. Field Trial Geographic Distribution

................................ ................................ ....... 43

Appendix B. International Residue Limits Tables

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

Appendix C. OECD MRL Calculation Procedure Inputs/Outputs

................................ .............. 47Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 5 of 51 1.0 Executive Summary

The petitioner, IR

- 4, on behalf of the A gricultural Experiment Stations of CA, HI, OR, SC, TN, FL, DE, and PR, requests establishment of tolerances for new uses on bean, papaya, star apple, black sapote, sapodilla, canistel, mamey sapote, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, acero la, lychee, longan, Spanish lime, rambutan, pulasan, pineapple; o nion, green, subgroup 3

- 07B; fruit, pome, group 11

- 10; f ruit, small vine climbing, except fuz zy kiwifruit, subgroup 13

- 07F; b erry, low growing, subgroup 13

- 07G; and convers ion of existing cro p groups

to v egetable, fruiting, group 8

- 10 (and a ddition of greenhouse

- grown tomato); fruit, citrus, group

10

- 10; fruit, stone, group 12

- 12; and n ut, tree, group 14

- 12. The labels affected by these changes are Agri

- Mek SC (EPA Reg. No. 100

- 1351); Epi

- Mek SC (EPA Reg. No 100

- 1408); Epi

- Mek 0.15 EC (EPA Reg. No. 100

- 1154); and Epi

- Mek SCL (EPA Reg. No. 100

- 1439).

The petitioner has proposed tolerance s for abamectin (avermectin), including its metabolites and degradates, in or on the specified commodities. Compliance with the tolerance levels specified is to be determined by measuring only 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

.

Tolerances are established under 40 CFR §18 0.449 for residues of abamectin , 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 specified is to be determined by measuring only avermectin B 1 

### [a mixture of avermectins containing greater than or equal to
80% averme ctin 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.

Epi

- Mek ® 0.15 EC Miticide/Insecticide (EPA R eg. N o . 100

- 1154) is proposed for u se on bean,
the g reen onion subgroup 3

- 07B

, the fruiting vegetable group 8

- 10, the citrus fruit g roup 10

- 10,
the small fruit vine c limbing, except fuzzy kiwifruit

, subgroup 13

- 07F; the lo w growing berry subgroup 13

- 07G, the p o me fruit group 11

- 10

, the stone fruit g roup 12

- 12, the tree nut group 14

- 12

, papaya, star apple, black sapote, s apodilla, canistel, mamey sapote, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, a cerola, lychee, longan, Spanish lime, rambutan, pulasan

, and pineapple

.

Agri

- Mek ® SC Miticide/Insecticide (EPA R eg . N o . 100

- 1351), Epi

- Mek TM SC Miticide/Insecticide (EPA R eg . N o . 100

- 1408)

, and Epi

- Mek TM SCL (EPA R eg . N o . 100

- 1439) are proposed f or u se on dry bean s , g reenhouse

- grown tomato, the f ru iting vegetable group 8

- 10, the citrus fruit group 10

- 10, the pome fruit group 11

- 10, the s mall fruit vine climbing, except fuzzy k iwifruit s ubgroup 13

- 07F ; the low growing berry subgroup 13

- 07G, the stone fruit group

12

- 12, and the tree nut g roup 14

- 12

.

Multiple broadcast foliar applications of the EC or SC formulations are made to control insects. Application rates range from 0.046 to 0.076 lb ai/A/season with PHIs ranging from 1 day to 16
weeks.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 6 of 51 T he residue chemistry database is adequate for toleranc e assessment and registration. Residues
of concern in primary (treated) plants , rotational crops, and ruminants are parent (avermectin B 1a 

### and B 1b 

### ) and the 8,9

- Z isomers. The crop field trials adequately reflect the proposed use
patterns. The number of trials and the geographic representation are adequate . Acceptable
method s w ere used for residue quantitation, and adequate storage stability data are available to support sample storage durations and conditions for all analytes. Residues were small but quantifiable in greenhouse

- grown tomato and papaya; residues ranged from not quantifiable to small but quantifiable in green onion, guava, and lychee. Residues were all <0.004 ppm in lima bean, snap bean, and pineapple. Residue decline studies on tomatoe s and green onions indicated
that residues decreased over time.

There are no processed commodities for green onion, guava, lima bean, lychee, papaya, and snap
bean.

The processed commodities for pineapple are process residue (also known as wet bran) an d juice. No processing study has been submitted for pineapple. Crop field trials were conducted at exaggerated application rates (in addition to the proposed label rate) and residues of abamectin were not detected. Therefore, processing studies for pinea pple are not needed, and tolerances for pineapple processed commodities are not required.

The processed commodities for tomato are paste and puree. Based on the results from the 5x rate field trials, th e average processing factors for abamectin residues were 0.52x in puree and 0.94x in paste. These data indicate that abamectin residues do not concentrat e in tomato processed fractions; therefore, separate tolerances are not required for tomato paste or puree.

A confined rotational crop study indicated th at avermectin residues of significant toxicological concern are not expected to occur in rotational crops.

2.0 R egulatory R ecommendations

Provided that the requested analytical reference standard s and revised Sections B and F are submitted, t here are n o residue chemistry considerations that would preclude the e stablishment of permanent tolerances and registration for new uses on bean, papaya, star apple, black sapote, sapodilla, canistel, mamey sapote, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, acerola, lychee, longan, Spanish lime, rambutan, pulasan, pi neapple, onion, green, subgroup 3

- 07B; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F; berry, low growing, subgroup 13

- 07G; f ruit, po me, group 11

- 10; and conversion of existing crop groups to vegetable, fruiting, group 8

- 10 (and additi on of greenhouse

- grown tomato); fruit, citrus, group 10

- 10; fruit, stone, group 12

- 12; and n ut, t ree , g roup 14

- 12.

The specific tolerance recommendations are discussed in Section 2.2 , and t he recommended
label modifications are discussed in Section 2.3.

2.1 Data Deficiencies/Data Needs

There are no data deficiencies

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



### Page 7 of 51 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

.

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.

The petitioner must submit a revised Section F with the correct commodity definition for subgroup 13

- 07F as shown in Table 2.2.2 .1 below.

Table 2.2.2

. 1. Tolerance Summary for Abamectin

. Established Commodity Established

Tolerance

(ppm) Proposed Commodity 1 Syngenta

Proposed

Tolerance

(ppm) HED

Recommended

Tolerance

(ppm) Comments ( correct commodity definition )

Vegetable, fruiting, group 8 0.020 Vegetable, fruiting, group 8

- 10 0.07 0.07 Includes greenhouse

- grown

tomatoes.
Citrus 0.02 Fruit, citrus, group

10

- 10 0.02 0.02 Retain established tolerances of 0.10 ppm on citrus, dried pulp and citrus,
oil. Grape 0.02 Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F 0.02 0.02 Grape is the representative commodity of the crop

group. Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F Strawberry 0.05 Berry, low growing, subgroup 13

- 07G 0.05 0.05 Strawberry is the representative commodity of the crop group. Fruit, stone, group

12 0.09 Fruit, stone, group

12

- 12 0.09 0.09

Apple

Pear 0.020
0.02 Fruit, pome, group

11

- 10 0.02 0.02 Apple and pear are the representative commodities of the crop group. Nut, tree, group 14
Pistachio 0.01

0.01 Nut, tree, group 14

- 12 0.01 0.01 Retain tolerance on almond hulls at 0.10 ppm.

-- -- Papaya 0.40 0.40

-- -- Star apple 0.40 0.40

-- -- Black sapote 0.40 0.40Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 8 of 51 Table 2.2.2

. 1. Tolerance Summary for Abamectin

. Established Commodity Established

Tolerance

(ppm) Proposed Commodity 1 Syngenta

Proposed

Tolerance

(ppm) HED

Recommended

Tolerance

(ppm) Comments ( correct commodity definition )

-- -- Sapodilla 0.40 0.40

-- -- Canistel 0.40 0.40

-- -- Mamey sapote 0.40 0.40

-- -- Guava 0.015 0.015

-- -- Feijoa 0.015 0.015

-- -- Jaboticaba 0.015 0.015

-- -- Wax jambu 0.015 0.015

-- -- Starfruit 0.015 0.015

-- -- Passionfruit 0.015 0.015

-- -- Acerola 0.015 0.015

-- -- Lychee 0.01 0.01

--- -- Longan 0.01 0.01

-- -- Spanish lime 0.01 0.01

-- -- Rambutan 0.01 0.01

-- -- Pulasan 0.01 0.01

-- -- Pineapple 0.015 0.015 Bean, dry, seed 0.01 Bean 0.015 0.015

-- -- Onion, green, subgroup 3

- 07B 0.08 0.08



### The following established tolerances should be removed upon approval of the tolerances in Table

2.2.2.1.

Table 2.2.2.2. Established Tolerances to be Removed upon Establishment of Tolerances in Table 2.2.2.1. Commodity ppm Bean, dry, seed 0.01

Citrus 0.02 Apple 0.02

Pear 0.02 Fruit, stone, group 12 0.09 Nut, tree, group 14 0.01

Pistachio 0.01 Grape 0.02 Strawberry 005 Vegetable, fruiting, group 8 0.020



### 2.2.3 Revisions to Petitioned

- For Tolerances

The petitioner should submit a revised Section F to propose the correct commodity definition for subgroup 13

- 07F as shown in Table 2.2.2.1.

2.2.4 International Harmonization

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 Codex and CanadianAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 9 of 51 maximum residue limits (MRLs) for abamectin on peppers, tomatoes, citrus fruit, strawberries, apples, pears, almonds and walnuts. A n a dditional Canadian MRL is established on grapes.
Since some of these MRL levels are different than the recommended US tolerance levels, there are harmonization issues for plant commodities.

Because of limited feed items associated with this petition, the established livestock tole rances have not been reassessed for these IR

- 4 proposed uses.

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

2.3 Label Recommendations

860.1200 Directions for Use The petitioner needs to resolve the following inconsistencies: On the Epi

- Mek SCL label for greenhouse

- grown tomatoes, the maximum rate is given as 3.5 fl oz/A. Because Epi

- Mek SCL contains only 0.35 lb ai/gal, 3.5 fl oz is 0.0096 lb ai/A, not 0.019 lb a i/A as stated under Use Restrictions on page 29. (Other greenhouse

- grown tomato labels have the maximum single application rate of 0.19 lb ai/A.) Also, the Use Restrictions on pages 28

- 29 refer to Epi

- Mek SC rather than Epi

- Mek SCL.

3.0 Introduction

A bamectin 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. Abam ectin 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) avermectin 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. Av ailable 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 10 of 51 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

- dihydroxy

- 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 11 of 51 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/Insec ticide, EPA 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 nm



### 3.3 Pesticide Use Pattern/ Directions for Use (860.1200)

IR

- 4 has submi tted a petition to add new use s or make crop conversions which affect the following registered labels: Agri

- Mek® SC Miticide/Insecticide, Epi

- MekTM SCAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 12 of 51 Miticide/Insecticide, Epi

- Mek 0.15 EC Miticide/Insecticide , and Epi

- MekTM SCL
Miticide/Insecticide.

Epi

- Mek ® 0.15 EC Miticide/Insecticide (EPA Reg. No. 100

- 1154) is an emulsifiable concentrate
which contains 0.15 lb ai/gal. It contains 2.0% abamectin.

Agri

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

. 100

- 1351 ) and Epi

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

- 1408 ) are suspension concentrate s which contains 0.7 lb abamectin per gallon. They contain 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.

Epi

- Mek ® 0.15 EC Miticide/Insecticide (EPA R eg. N o . 100

- 1154) is pro posed for u se on bean, the g reen onion subgroup 3

- 07B , the fruiting vegetable group 8

- 10, the citrus fruit g roup 10

- 10,
the small fruit vine c limbing, except fuzzy kiwifruit, subgroup 13

- 07F; the low growing berry subgroup 13

- 07G, the p o me fruit group 11

- 1 0, the stone fruit g roup 12

- 12, the tree nut group 14

- 12, papaya, star apple, black sapote, s apodilla, canistel, mamey sapote, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, a cerola, lychee, longan, Spanish lime, rambutan, pulasan, and pine apple.

Agri

- Mek ® SC Miticide/Insecticide (EPA R eg . N o . 100

- 1351), Epi

- Mek TM SC Miticide/Insecticide (EPA R eg . N o . 100

- 1408)

, and Epi

- Mek TM SCL (EPA R eg . N o . 100

- 1439) are proposed f or u se on dry beans, g reenhouse

- grown tomato, the f ru iting vegetable group 8

- 10, the citrus fruit group 10

- 10, the pome fruit group 11

- 10, the s mall fruit vine climbing, except fuzzy k iwifruit s ubgroup 13

- 07F ; the low growing berry subgroup 13

- 07G, the stone fruit group

12

- 12, and the tree nut g roup 14

- 12

.

Multiple broadcast foliar applications of the EC or SC formulations are made to control insects. Application rates range from 0.046 to 0.076 lb ai/A/season with PHIs ranging from 1 day to 16
weeks.

### Page 13 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2



### Bean : ( Cicer arietinum (chickpea, garbanzo bean); Lupinus spp. (including sweet lupine, white sweet lupine, white lupine, and grain lupine); Phaseolus spp. (including kidney bean, lima bean, mung bean, navy bean, pinto bean, snap bean, and waxbean); Vicia faba (broad bean, fava bean); Vigna spp. (including asparagus bean, blackeyed pea and cowpea) Postemergence;
Broadcast f oliar spray;
Ground or a erial equipment

. Epi

- Mek ® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.0094

- 0.019 NS 0.056 7 Spray for thorough coverage of the crop canopy

. Apply in a minimum of 10 gal water per acre by ground or 5 GPA by air. Repeat as needed.
Observe a 6

- day RTI. Do not make more than 2 sequential applications of this or any
other abamectin

- containing product. For use on cowpeas that are grown only for dry seed.
Do not allow livestock to graze cowpea forage and do not harvest cowpea forage or hay for use as livestock feed.


### Bean s , Dry : ( Cicer arietinum (chickpea, garbanzo bean), Lupinus spp. (including sweet lupine, white sweet lupine, white lupine, and grain lupine),

Phaseolus spp. (including kidney bean, lima bean, mung bean, navy bean, pinto bean, snap bean, and waxbean), Vicia faba (broad bean, fava bean), and Vigna spp. (including adzuki bean, asparagus b ean, blackeyed pea, catjang, Chinese longbean, cowpea*, crowder pea, moth bean, mung bean, rice bean, southern pea, urd bean, and yardlong bean) Postemergence;
Broadcast f oliar spray;
Ground or aerial equipment Agri

- Mek ® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SC 0.7 lb ai/gal [100

- 1408]

Epi

- MekTM SCL 0.35 lb ai/gal [100

- 1439] 0.0096

- 0.019 NS 0.056 7 Spray for thorough coverage of the crop canopy. Apply in a minimum of 10 gal water per acre by ground or 5 GPA by air. Apply when adult leafminer flies or spider mites are first
observed. Repeat as needed.
Observe a 6

- day RTI. For use on cowpeas that are grown only for dry seed.
Do not allow livestock to graze cowpea forage and do not harvest cowpea forage or hay for use as livestock feed. For resistance management, do not make more than 2 sequential applications of Agri

- Mek ® SC or any other foliar

applied abamectin

- containing product. 

### Citrus Fruit Group 10

- 10 : (Australian desert lime; Australian finger

- lime; Australian round lime; Brown River finger lime; calamondin; citron; citrus hybrids; grapefruit; Japanese summer grapefruit; kumquat; lemon; lime; Mediterranean mandarin; mount white lime; New Guinea w ild lim e; orange, sour;Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 14 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2

orange, sweet; pummelo; Russell River lime; satsuma mandarin; sweet lime; tachibana orange; Tahiti lime; tangelo; tangerine ( mandarin); tangor; trifoliate orange; uniq fruit; cultivars, varieties, and/or hybrids of these) Apply in spring, summer, and/or fall;
Broadcast f oliar spray;
Ground or aerial equipment. Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.0059

- 0.023 3 0.047 7 Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. For aerial applications, apply in a mi nimum spray volume of
10 GPA. Do not apply with aircraft to citrus in CA.
Do not use in citrus nurseries
Observe a 30

- day RTI. Do not allow livestock to graze in treated orchards. Apply with horticultural spray oil (not a dormant oil) in the spray mixture. Apply in spring, summer, and/or fall;
Broadcast f oliar spray;
Ground or aerial equipment. Agri

- Mek ® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SC 0.7 lb ai/gal [100

- 1408]

Epi

- MekTM SCL 0.35 lb ai/gal [100

- 1439] 0.0055

- 0.023 3 0.047 7 Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. For aerial applications, apply in a minimum spray volume of

10 GPA.
Do not use in citrus nurseries.
Observe a 30

- day RTI. Do not allow livestock to graze in treated orchards.



### Fruiting Vegetable Group 8

- 10 , except Greenhouse

- Grown Tomato : ( African eggplant; bush tomato; bell pepper; cocona; currant tomato; eggplant; garden huckleberry; goji berry; groundcherry; martynia; naranjilla; okra; pea eggplant; pepino; nonbell pepper; roselle; scarlet eggp lant; j unberry; tomatillo; tomato; tree tomato; cultivars, varieties, and/or hybrids of these ) Postemergence; Broadc
ast f oliar spray;
Ground or aerial equipment. Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.0094

- 0.019 NS 0.056 7 Spray for thorough coverage of the crop canopy. Apply in a minimum of 20 gal water per acre by ground or 5 GPA by air. The RTI is 7 days. Repeat as necessary to maintain control. Do not use on fruiting vegetables grown for transplanting.

D o not make more than 2 sequential applications of Epi

- Mek ®
0.15 EC or any other foliar

- appli ed abamectin

- containingAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 15 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2

product. Postemergence; Broadc
ast f oliar spray;
Ground or aerial equipment. Agri

- Mek ® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SCL 0.35 lb ai/gal [100

- 1439]

Epi

- MekTM SC
0.7 lb ai/gal [100

- 1408] 0.0096

- 0.019 NS 0.056 7 Spray for thorough coverage of the crop canopy. Apply in a minimum of 20 gal water per acre by ground or 5 GPA by air. The RTI is 7 days. Repeat as necessary to maintain control. Do not use on fruiting vegetables grown for transplanting. For resistance management, do not make more than 2 sequential applications of Agri

- Mek ® SC or any other foliar

applied abamectin

- containing product.



### Greenhouse

- Grown Tomato es Postemergence;
Broadcast f oliar spray;
Ground equipment only Agri

- Mek ® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SC 0.7 lb ai/gal [100

- 1408] 0.0096

- 0.019 NS 0.056 1 For resistance management, do not make more than 2 sequential applications of Agri

- Mek ® SC or any other foliar

applied abamectin

- containing product. The RTI is 7 days. Repeat as necessary to maintain control. Do not use on plants being grown for transplanting. Apply in a minimum of 20 gal water per acre.

Postemergence;
Broadcast f oliar spray; Ground equipment only Epi

- Mek TM SCL 0.35 lb ai/gal [100

- 1439] 0.0048

- 0.0096 NS 0.056 1 For resistance management, do not make more than 2 sequential applications of Epi

- MekTM SC L or any other foliar

applied abamectin

- containing product. The RTI is 7 days. Repeat as necessary to maintain con trol. Do not use on plants being grown for transplanting. Apply in a minimum of 20 gal water per acre.


### Green Onion S ubgroup 3

- 07B : ( chive, fresh leaves; chive, Chinese, fresh leaves; Elegans hosta; fritillaria, leaves; kurrat; lady's leek; leek; leek, wild; onion, Beltsville bunching; onion, fresh; onion, green; onion, macrostem; onion, tree, tops; onion, Welsh, tops; shallot, fresh leaves; cultivars, varieties, and/or hybrids of these) Postemergence; Broadc
ast f oliar spray;
Ground or aerial equipment E pi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.0094

- 0.019 NS 0.076 7 Spray for thorough coverage. Apply in a minimum of 20 gal water per acre with ground equipment and in a minimum of 5 GPA with aircraft. Apply with a non

- ionic activator type wetting, spreadi ng,Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 16 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2

and/or penetrating adjuvant. Do not use binder or sticker type adjuvants. Do not make more than 2 sequential applications of this or any
abamectin

- containing product.
Observe a 7

- day RTI. Do not apply with aircraft in NY state or CA.


### Guava 1
: ( g uava, feijoa, jaboticaba, wax jambu, s tarfruit, passionfruit, and a cerola) Spring, summer, and/or fall;
Broadcast f oliar spray; Ground equipment only. Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.012

- 0.023 3 0.070 7 Apply when mites first appear. Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 5 GPA
with an electro

- static sprayer. Apply with horticultural spray oil (not a dormant oi l).
Observe a 14

- day RTI. 

### Low Growing Berry Subgroup 13

- 07G : (bearberry; bilberry; blueberry, lowbush; cloudberry; cranberry; lingonberry; muntries; partridgeberry; strawberry; cultivars, varieties, and/or hybrids of these) Postemergence;
Broadcast f oliar spray; Ground equipment only Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154]

Agri

- Mek® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SC 0.7 lb ai/gal [100

- 1408] 0.019 NS 0.075 3 Spray for thorough coverage. Make 2 applications 7

- 10 days apart when mites first appear. Wait at least 21 days after the second application before repeating application. Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 10 GPA
with a n electro

- static sprayer. Do not use in strawberry nurseries.

Postemergence;
Broadcast f oliar spray; Ground equipment only Epi

- Mek TM SCL 0.35 lb ai/gal [100

- 1439] 0.019 NS 0.075 3 Make 2 applications 7

- 10 days apart when mites first appear. Wait at least 21 days after the second application before repeating application. Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 10 GPAAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 17 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2

with a n electro

- static sprayer. Do not use in strawberry nurseries. 

### Lychee 1 

### : ( longan, Spanish lime, rambutan, and p ulasan) Spring, summer, and/or fall;
Broadcast f oliar spray; Ground equipment only. Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.012

- 0.023 2 0.046 14 Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 5 GPA
with an electro

- static sprayer. Apply with horticultural spray oi l (not a dormant oil).
Observe a 30

- day RTI. 

### Papaya 1 

### : (papaya, s tar apple, black s apote, s apodilla , c anistel, and mamey s apote) Spring, summer, and/or fall;
Broadcast f oliar spray; Ground equipment only. Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.012

- 0.023 3 0.070 3 Apply when mites first appear. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 5 GPA
with an electro

- static sprayer. Apply with a horti cultural spray oil (not a dormant oil).
Observe a 14

- day RTI. Do not apply to mango. 

### Pineapple

Broadcast f oliar spray; Ground equipment only. Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.012

- 0.023 2 0.047 16
weeks Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 5 GPA
with an electro

- static sprayer.
Observe a 7

- day RTI. 

### Pome Fruit Group 11

- 10 : (apple; azarole; crabapple; loquat; mayhaw; medlar; pear; pear, Asian; quince; quince, Chinese; quince, Japanese; tejocote; cultivars, varieties, and/or hybrids of these) Postemergence;
Broadcast f oliar spray; Ground equipment only Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.012

- 0.023 2 0.047 28 Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 40 gal water per acre. For best results, apply with a horticultural spray oil (not a dormant oil).
Observe a 21

- day RTI.
Do not allow livestock to graze in treated orchards.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 18 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2

Postemergence;
Broadcast f oliar spray ; Ground equipment only Agri

- Mek ® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SCL 0.35 lb ai/gal [100

- 1439]

Epi

- MekTM SC 0.7 lb ai/gal [100

- 1408] 0.011

- 0.023 2 0.047 28 Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 40 gal water per acre.
Observe a 21

- day RTI. Do not allow livestock to graze in treated orchards.



### Small Fruit Vine Climbing, Except Fuzzy Kiwifruit Subgroup 13

- 07 F : (Amur river grape; gooseberry; grape; kiwifruit, hardy; maypop; schisandra berry; cultivars, varieties, and/or hybrids of these) Postemergence;
Broadcast f oliar spray; Ground equipment only Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.0094

- 0.019 2 0.038 28 Spray for thorough coverage. Repeat application if needed.
Observe a 21

- day RTI. Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 5 GPA
with an electro

- static sprayer. Do not allow livestock to graze in treated vineyards. Postemergence;
Broadcast f oliar spray; Ground equipme nt only Agri

- Mek ® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SC 0.7 lb ai/gal [100

- 1408]

Epi

- MekTM SCL 0.35 lb ai/gal 0.0096

- 0.019 2 0.038 28 Spray for thorough coverage. Repeat application if needed.
Observe a 21

- day RTI. Apply in a minimum of 50 gal water per acre with conventional ground equipment or in a minimum of 5 GPA
with an electro

- static sprayer. Do not allow livestock to graze in treated vineyards.



### Stone fruit Group 12

- 12 : (apricot; apricot, Japanese; capulin; cherry, black; cherry, Nanking; cherry, sweet; cherry, tart; Jujube, Chinese; nectarine; peach; plum; plum, American; plum, beach; plum, Canada; plum, cherry; plum, Chickasaw; plum, Damson; plum, Japanese; plum, Klamath; plum, prune; plumcot; sloe; cultivars, varieties, and/or hybrids of these )Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 19 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2

Broadcast f oliar spray; Ground equipment only Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.012

- 0.023 2 0.047 21 Apply when mites first appear. Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 40 gal water per acre. Always apply with a nonionic surfactant or horticultural spray oil (not a dormant oil).
Observe a 21

- day RTI. Do not allow livestock to graze in treated orchards.

Broadcast f oliar sprays; Ground equipment only Epi

- Mek TM SC 0.7 lb ai/gal [100

- 1408]

Agri

- Mek® SC 0.7 lb ai/gal [100

- 1351]

Epi

- MekTM SCL 0.35 lb ai/gal [100

- 1439] 0.011

- 0.023 2 0.047 21 Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 40 gal water per acre.
Observe a 21

- day RTI. Do not allow livestock to graze in treated orchards.



### Tree Nut Group 14

- 12 : (African nut

- tree; almond; beechnut; Brazil nut; Brazilian pine; bunya; bur oak; butternut; Cajou nut; candlenut; cashew; chestnut; chinquapin; coconut; coquito nut; dika nut; ginkgo; Guiana chestnut; hazelnut (filbert); heartnut; hickory nut; Japanese horse

- chestnut; macadamia nut; mongongo nut; monkey

- pot; monkey puzzle nut; Okari nut; Pachira nut; peach palm nut; pecan; pequi; Pili nut; pine nut; pistac hio; Sapucaia nut; tropical almond; walnut, black; walnut, English; yellowhorn; cultivars, varieties, and/or hybrids of these)

Broadcast f oliar sprays; Ground equipment only Epi

- Mek® 0.15 EC 0.15 lb ai/gal [100

- 1154] 0.012

- 0.023 2 0.047 21 Apply when mites first appear. Spray for thorough coverage. Always use with a horticultural spray oil (not a dormant oil). Apply by ground in dilute or concentrate sprays. Apply in a minimum of 40 gal water per acre.
Observe a 21

- day RTI.
Do not allow l ivestock to graze in treated groves/orchards.

Broadcast f oliar sprays; Ground equipment only Agri

- Mek ® SC 0.7 lb ai/gal [100

- 1351] 0.011

- 0.023 2 0.047 21 Spray for thorough coverage. Apply by ground in dilute or concentrate sprays. Apply in a minimum of 40 gal water per acre.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 20 of 51 Table 3.3 . Summary of Proposed Directions for Use of Abamectin on C or n (Field, Pop, Seed, and Sweet) and Soybean

.

Applic. Timing, Type, 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 2

Epi

- MekTM SC 0.7 lb ai/gal [100

- 1408]

Epi

- MekTM SCL 0.35 lb ai/gal [100

- 1439] Observe a 21

- day RTI. Do not allow livestock to graze in treated groves/orchards.

1 The c ommodity definitions for guava, lychee, and papaya a re stated in the EPA “Reviewer’s Guide” (Bernard Schneider, June 14, 2006).

2 Restrictions: Epi

- Mek® 0.15 EC/Agri

- Mek® SC/Epi

- Mek TM SC/ Epi

- Mek TM SCL are Restricted Use Pesticide s. To avoid illegal residues

, Agri

- Mek® SC/ Epi

- Mek TM SC/Epi

- Mek TM SC L must be mixed with a non

- ionic activator type wetting, spreading and/or penetrating spray adjuvant or horticultural oil (not a dormant oil). Do not use binder or sticker type adjuvants. Do not apply Epi

- Mek® 0.15 EC/Agri

- Mek® SC/Epi

- Mek TM SC/Epi

- Mek TM SC L with aircraft in NY state. Do not apply Epi

- Mek® 0.15 EC/Agri

- Mek® SC/Epi

- Mek TM SC/Epi

- Mek TM SC L through any type of irrigation system.

### Page 21 of 51 Conclusion s

. The petitioner needs to resolve the following inconsistencies: On the Epi

- Mek
SCL label f or greenhouse

- grow n tomatoes, the maximum rate is given as 3.5 fl oz/A. Because Epi

- Mek SCL contains only 0.35 lb ai/gal, 3.5 fl oz is 0.0096 lb ai/A, not 0.019 lb ai/A as stated
under Use Restrictions on page 29. (Other greenhouse

- grown tomato labels have the maximum single application rate of 0.19 lb ai/A.) Also, the U se R estrictions on pages 28

- 29 refer to Epi

Mek SC rather than Epi

- Mek SCL.

Provided the inconsistencies noted above are resolved, t he labels are adequate to allow
evalu ation of the residue data relative to the proposed use.

4.0 Metabolite/Degradate Residue Profile

4.1 Nature of the Residue

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 plants 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 "Com parative 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 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 leas t 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 study in CF

- 1 mice) and were found to be of no toxicological significance at the le vels 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 act ivity, but does exhibit some translaminar movement. For the tolerance expression and risk assessment, the residues of concern in plants are the parent compounds (avermectin 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 study which was previously submitted (PP#7G3468, L. Cheng, 2/11/87; PP#9F3703, S. Willett, 12/15/89). The res idues of concern in ruminants for the tolerance expression and risk assessment are the parent compoundsAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 22 of 51 (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 t oxicological significance, but was not included in the tolerance expression because of its presence at low levels (PP#8F3592, F. Boyd, 6/21/89; DP#203373, G. J. Herndon, 3/29/95). If the tolerances for
residues in meat and milk need to be significantly ra ised at some future time due to registration of abamectin on additional feed items, the 24

- hydroxymethyl metabolite may need to be included in the tolerance expression and appropriate enforcement methods developed.

No poultry metabolism study has been submitted and none is required. Based on dietary burden 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 D2303 33, 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 confine d 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 Comparison 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 t he 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 residue remained in the peel but a small amount translocated into t he 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 concern 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 expression and risk assessment are the parent compounds (avermectin B 1 a 

### and B 1b 

### ) and their
delta

- 8,9

- isomers. T he 24

- hydroxy

- methyl metabolite is a minor metabolite in ruminants (goats).Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 23 of 51 A poultry metabolism study has not been conducted. Based on dietary burden calculations using Table 1 Feedstuffs (June 2008), no secon dary residues are expected to occur in poultry commodities; therefore, no poultry metabolism study is required. (Note: The tolerances for meat and meat byproducts of poultry and swine of 0.02 ppm were established for residues in food handling establishments.)

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 ) and structurally similar degradates *** 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.

*** The structurally similar degradates included in the drinking water assessment are NOA 44811 1 , NOA 448112, NOA 426289, NOA 44549 5, NOA 457464, and NOA 457465 (D412861, G. Orrick, 5/15/14 ; re fer to D412861 for

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



### Page 24 of 51 5.0 Residue Profile

5.1 Residue Analytical Methods (860.1340)

5.1 .1 Data Collection Methods 49455901.der (greenhouse

- grown tomato) 49455902.der (green onion) 49455903.der (guava) 49455904.der (lima bean)
49455905.der (lychee) 49455906.der (papaya) 49455907.der (pineapple) 49455908.der (snap bean)



### Greenhouse

- grown t omatoes : Samples in the current study were analyzed using a working
method based on the reference Method M

- 073

, entitled “M

- 073: HPLC

- Fluorescence Method f or the Quantitation of Avermectin B1 and 8,9

- Z Avermectin B1 in/on Fruits and Vegetables”.
Method M

- 073 is a reverse

- phase high performance liquid chromatography with f luorescence detection (HPLC

- FD). R esidues of a v ermectin B 1a 

### /8,9

- Z avermectin B 1a 

### ( as a single analyte/ peak ) and avermectin B 1b 

### ( as a separate analyte/ peak ) were determined . Acceptable
method validation and concurrent recoveries were reported for tomato samples at fortification
levels of 0.002 and 0.02 mg/kg (ppm), thus validating the method. The limit of quantitation (LOQ) was 0.002 ppm per analyte for tomatoes

.

Green o nion : Green onion samples were analyzed for residues of abamectin ( i.e.

, avermectin

B 1a 

### / 8,9

- Z avermectin B 1a 

### and avermectin B 1b 

### ) usi ng analytical Method M

- 073 (“HPLC

Fluorescence Method for the Quantitation of Avermectin B 1 

### and 8

- 9

- Z Avermectin B 1 

### in/on Fruits and Vegetables” ), without modification. The lowest level of method validation ( LLMV ) was 0.002 ppm for each analyte ; therefore, the limit of quanti t ation (LOQ) will be set at 0.002 ppm for each analyte. The method was validated prior to sample analysis by spiking control green onion samples with 0.002, 0.020, and 0.100 ppm avermectin B 1a 

### and 8,9

- Z avermectin B 1a 

### , and 0. 002 and 0.010 ppm avermectin B 1b 

### . There were two method validation recoveries that were low due to sample spillage which were not included in statistical calculations. The remaining method validation recoveries were all within the acceptable 70

- 120% range. Accuracy of the method was confirmed by spiking control samples with 0.002

- 0.100 ppm avermectin B 1a 

### , avermectin B 1b 

### and 8,9

- Z avermectin B 1a 

### and determining recoveries concurrently with analysis of treated sample sets. There were also 2 low concurrent rec overies attributed to sample spillage that were not included in statistical calculations. For the remaining samples, with the exception of one low recovery (60% in sample spiked with 0.020 ppm avermectin B 1a 

### ), all recoveries were within the acceptable 70

- 1 20% range. Given that the majority of method validation and concurrent recoveries were within the acceptable range, Method M

- 073 is adequate for the determination of residues in green onions in this study.

Guava : Samples were analyzed for residues of ave rmectin B 1a 

### / 8,9

- Z avermectin B 1a 

### and
avermectin B 1b 

### using a high performance liquid chromatography (HPLC) method with fluorescence detection adapted from Merck Method No. M

- 073. Acceptable method validation and concurrent recoveries were reported for samp les fortified with avermectin B 1a 

### and 8,9

- Z
avermectin B 1a 

### at 0.002

- 0.1 ppm and with avermectin B 1b 

### at 0.002

- 0.008 ppm, thus validatingAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 25 of 51 the method. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.002 ppm fo r each analyte; the combined LOQ was 0.004 ppm. The fortification levels used in concurrent method recovery were adequate to bracket expected
residue levels. Concurrent recoveries and residues in treated samples were not corrected for apparent residues i n controls.

Lima b ean : Lima bean samples were analyzed for residues of avermectin B 1a 

### , avermectin B 1b 

### , 8,9

- Z avermectin B 1a 

### , and 8,9

- Z avermectin B 1b 

### using a high performance liquid chromatography (HPLC) method with fluorescence detection adapted from Merck Method No. 936

- 95

- 2. The
method determines residues of avermectin B 1 a 

### + 8,9

- Z avermectin B 1 a 

### as a single analyte and
residues of avermectin B 1b 

### + 8,9

- Z avermectin B 1b 

### as a single analyte. Acceptable concurrent recoveries were reported for samples f ortified with avermectin B 1a 

### at 0.002

- 0.1 ppm and with 8,9

- Z avermectin B 1a 

### at 0.002 ppm, thus validating the method. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.002 ppm for each analyte;
the combined L OQ was 0.004 ppm. 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.

Lychee : Lychee samples were analyzed for residues of avermectin B 1a 

### and 8,9

- Z avermectin B 1a 

### using a high performance liquid chromatography (HPLC) method with fluorescence detection adapted from Merck Method No. M

- 073. The method determines residues of avermectin B 1a 

### + 8,9

- Z avermectin B 1a 

### as a single analyte; avermectin B 1b 

### was not monitored during this study except during method validation. Acceptable method validation and concurrent recoveries were reported for sampl es fortified with avermectin B 1a 

### and 8,9

- Z avermectin B 1a 

### at 0.002

- 0.1 ppm
and with avermectin B 1b 

### at 0.002 ppm, thus validating the method. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.002 ppm. The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels. Concurrent recoveries and residues in treated samples were not corrected for apparent residues in controls

.

Papaya : Papaya samples were analyzed for residues of avermectin B 1a 

### , avermectin B 1b 

### , 8,9

- Z
avermectin B 1a 

### , and 8,9

- Z avermectin B 1b 

### using a high performance liquid chromatography (HPLC) method with fluorescence detection adapted from Merck Method No. M

- 073. The
method determines residues of avermectin B 1a 

### + 8,9

- Z avermectin B 1a 

### as a single analyte and
residues of avermectin B 1b 

### + 8,9

- Z avermectin B 1b 

### as a single analyte. Acceptable method validation and concurrent recoveries were reported for samples fortified with avermectin B 1a 

### and 8,9

- Z avermectin B 1a 

### at 0.002

- 0.3 ppm and with avermectin B 1b 

### at 0.002 ppm, thus validating the
method. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.002 ppm for each an alyte; the combined LOQ was 0.004 ppm. The fortification levels used in method validation and concurrent method recovery were adequate to bracket expected residue levels (within an order of magnitude)

. Concurrent recoveries and residues in treated sample s were not corrected for apparent residues i n controls.

Pineapple : Pineapple samples were analyzed for residues of avermectin B 1a 

### / 8,9

- Z avermectin B 1a 

### and avermectin B 1b 

### using a high performance liquid chromatography (HPLC) method withAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 26 of 51 fluorescence detection adapted from Merck Method No. M

- 073. Acceptable method validation and concurrent recoveries were reported for samples fortified with avermectin B 1a 

### and 8,9

- Z
avermectin B 1a 

### at 0.002

- 0.02 ppm and with avermectin B 1b 

### at 0.002 ppm, thu s validating the
method. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.002 ppm for each analyte; the combined LOQ was 0.004 ppm. The fortification
levels used in method validation and concurrent method r ecovery were adequate to bracket expected residue levels. Concurrent recoveries and residues in treated samples were not corrected for apparent residues in controls.

Snap bean : Samples were analyzed for residues of avermectin B 1a 

### , avermectin B 1b 

### , 8,9

- Z
avermectin B 1a 

### , and 8,9

- Z avermectin B 1b 

### using a high performance liquid chromatography (HPLC) method with fluorescence detection adapted from Merck Method No. 936

- 95

- 2. The
method determines residues of avermectin B 1 a 

### + 8,9

- Z avermectin B 1 a 

### as a single analyte and
residues of avermectin B 1b 

### + 8,9

- Z avermectin B 1b 

### as a single analyte. Acceptable method validation and concurrent recoveries were reported for samples fortified with avermectin B 1a 

### and 8,9

- Z avermectin B 1a 

### at 0.002

- 0.1 ppm and with avermectin B 1b 

### at 0.002

- 0.008 ppm, thus validating the method. The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.002 ppm for each analyte ; the combined LOQ was 0.004 ppm . 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 residu es in controls.

5.1.2 Multir esidue 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 p rimary
enforcement method.

5.1 .3 Tolerance Enforcement Methods

DP Barcode D 414022, N. Dodd, 5/15/14



### 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 by products 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

.

5.1.4 Submittal of Analytical Reference Standards (860.1650)

A nalytical referenc e 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)].Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 27 of 51 5.2 Storage Stability (860.1380)

49455901.der (greenhouse

- grown tomato) 49455902.der (green onion) 49455903.der (guava) 49455904.der (lima bean) 49455905.der (lychee) 49455906.der (papaya) 49455907.der (pineapple) 49455908.der (snap bean)



### Storage stability data : As shown in Table 5.2.1, a cceptable 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, pear, and tomato), high ac id (orange, lemon, grapefruit, and strawberry), high protein (bean), high fat (sunflower seed), and high starch (potato) (DP# 191433, G. J. Herndon, 5/19/94; D414022, N. Dodd, 5/15/14).

As shown in Table 5.2.2, c oncurrent storage stability data were pro vided for greenhouse

- grown

tomato (MRID 49455901) and for guava (MRID 49455903). The s torage stability data 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 tomato fru it for 716 days and in/on guava for 1013 days (33.3 months)

.

Summary of Storag e Conditions of Treated Samples :

Greenhouse

- grown tomato: All greenhouse

- grown tomato samples were maintained frozen at the testing facility, during shipping to the laboratory, and were stored frozen (

- 20°C) until analysis. The maximum storage interval for samples between harvest and extraction was 768 days

. Samples were analyzed within 5 days of extraction.

Green onion : Green onion samples from the submitted crop field trials were stored frozen (≤

- 10 o 

### C) from harvest to residue extraction for up to 274 days (~9 months). Samples were analyzed for residues within 2 days of extraction.

Guava : Samples were placed in frozen storage at the field sites within ~1 hour of harvest and were shipped frozen within 38

- 45 days of harvest to the analytical laboratory, where the samples were stored frozen (~ <

- 20 °C) prior to preparation and analysis . T he maximum storage interval for samples be tween harvest and extraction was 1068 days (35.1 months )

. Samples were analyzed within 0

- 2 days of extraction.

Lima b ean : S amples were maintained frozen at the testing facilit ies , during shipping, and at the analytical laboratory until analysis . Samples were stored for a maximum of 434 days (14.3
months ) from harvest to extraction. Samples were analyzed within 2 days of extraction.

Lychee : All samples were maintained frozen at the testing facilit ies , during shipping, and at the analytical laboratory (~

- 21°C) until analysis. The maximum storage interval for samples
be tween harvest and extraction was 102 days (3.4 months ). Samples were analyzed on the day
of extraction

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



### Page 28 of 51 Papaya : All samples were maintained frozen at the testing facilit ies , during shipping, and were
stored frozen at the analytical laboratory (~

- 20 °C) until analysis. The maximum storage interval for samples be tween harvest and extraction was 337 days (11.1 months ). Samples were analyzed within 3 days of extraction.

Pineapple : All samples were placed in coolers at the testing facilit ies and were transported on the day of harvest to the analytical laboratory where they were stored frozen until analysis. The maximum storage int erval for samples be tween harvest and extraction was 142 days (4.7
months ). Samples were analyzed within 1 day of extraction

.

Snap b ean : All samples were maintained frozen at the testing facilities , during shipping, and
were stored frozen at the analyti cal laboratory until analysis. The maximum storage interval for samples be tween harvest and extraction was 351 days (11.5 months ). Samples were analyzed within 2 days of extraction.

TABLE 5.2.1. Summary of Storage Conditions.

Matrix Analyte Storag e Temperature (°C) Actual Storage
Duration 1 Interval of Demonstrated Storage Stability (months)
Green onions A vermectin B 1a ≤

- 10 274 days (~ 9 months) 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, pear, and tomato), high acid (orange, lemon, grapefruit, and strawberry), high protein (bean), high fat (sunflower seed), and high starch (potato) ( DP # 191433, 5/19/94, G.J. Herndon; and DP# 414022, 5/15/14, N. Dodd ). A vermectin B 1b 8,9

- Z A vermectin

B 1a Lima bean A vermectin B 1a / 8,9

- Z A vermectin

B 1a Frozen 69

- 434 days (2.3

- 14.3 months)

A vermectin B 1b / 8,9

- Z A vermectin

B 1 b Lychee A vermectin B 1a ~ - 21 ± 7 97

- 102 days (3.2

- 3.4 months) 8,9

- Z A vermectin

B 1a A vermectin B 1b Papaya A vermectin B 1a ~ - 20 98

- 337 days (3.2

- 11.1 months) 8,9

- Z A vermectin

B 1a A vermectin B 1b Pineapple A vermectin B 1a <0 7

- 142 days (0.2

- 4.7 months) 8,9

- Z A vermectin

B 1a A vermectin B 1b Snap bean A vermectin B 1a Frozen 272

- 351 days (8.9

- 11.5 months) 8,9

- Z A vermectin

B 1a A vermectin B 1b

1 Storage interval between sample harvest and extraction. Samples were analyzed within 0

- 3 days of extraction

.

Table 5.2.2 . Summary of Storage Conditions.

Matrix Analyte Storage Temperature (°C) Actual Storage

Duration 1 Interval of Demonstrated Storage Stability 2

(days)

Guava Avermectin B 1a ~ <

- 20 1056

- 1068 days (34.7

- 35.1 months) 1013 days (33.3 months) (MRID 49455903) 8,9

- Z Avermectin B 1aAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 29 of 51 Table 5.2.2 . Summary of Storage Conditions.

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

(days)

Avermectin B 1b
Tomato fruit Avermectin B 1a <

- 20 768 days (25.2 months) 716 days (23.5 months) (MRID 49455901) Avermectin B 1b 8,9

- Z avermectin B 1a

1 Storage interval between sample harvest and extraction. Samples were analyzed within 0

- 5 days of extraction.

2 Freezer storage stability data were generated concurrently with guava and tomato greenhouse trials.



### 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

, pear , and tomato ), high acid (oran ge, lemon, grapefruit, and strawberry ) , high protein (bean), high fat (sunflower seed), and high starch (potato) (DP# 191433, G. J. Herndon, 5/19/94; D414022, N. Dodd, 5/15/14).

Concurrent storage stability data were provided for greenhouse

- grown tomato and for guava

, which demonstrat e that residues of avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin B 1a 

### are stable under frozen storage conditions in/on tomato fruit for 716 days and in/on guava for 1013 days (33.3 months)

.

The available and submitted storage stability data are adequate to support the storage conditions
and durations of all field trial samples.

5.3 Residue Data

5.3.1

. Crop Field Trials (860.1500) 49455901.der (greenhouse

- grown tomato)
4945590 2 .der (green o nion) 49455903.der (guava) 49455904.der (lima bean) 49455905.der (lychee) 49455906.der (papaya) 49455907.der (pineapple) 49455908.der (snap bean)



### As shown in Table s 5.3.1

. 1 and 5.3.1

. 2 , a greenhouse residue trial was conducted on tomatoes, and field trials were conducted on green onion, guava, lima bean, lychee, papaya, pineapple, and snap bean.

As discussed in Section 5.1, two data collection methods were used: Merck Method No. M

- 07 3 (or a modification) for greenhouse

- grown tomatoes, green onion, lychee, and papaya, and a method adapted from M930

- 95

- 2 for lima bean and snap bean.

Method M

- 073

, entitled “M

- 073: HPLC

- Fluorescence Method for the Quantitation of Avermectin B1 and 8,9

- Z Avermectin B1 in/on Fruits and Vegetables

, ” is a reverse

- phase high performance liquid chromatography method with fluorescence detection (HPLC

- FD) . The
method determine s residues of a v ermectin B 1a 

### /8,9

- Z avermectin B 1a 

### as a single analyte andAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 30 of 51 a vermectin B 1b 

### /8,9

- Z avermectin B 1b 

### as a single analyte. The limit of quantitation (LOQ) was

0.002 ppm per analyte for tomatoes , green onions , guava, lychee, papaya, and pineapple. Based on adequate recoveries (generally 70

- 120%), the method is adequate for data co llection.

Merck Method No. 936

- 95

- 2 is a high performance liquid chromatography (HPLC) method with
fluorescence detection

. The method determines residues of avermectin B 1 a 

### + 8,9

- Z avermectin

B 1 a 

### as a single analyte and residues of avermectin B 1b 

### + 8,9

- Z avermectin B 1b 

### as a single analyte.
The limit of quantitation (LOQ; determined as the lowest level of method validation, LLMV) was 0.002 ppm for each analyte; the combined LOQ was 0.004 ppm. Based on adequate
recoveries (generally 70

- 120%), the method is adequate for data collection.

As discussed in Section 5.2, the available storage stability data are adequate to support the storage conditions and intervals of samples from the greenhouse and field trials.

Greenhouse

- grown Tomatoes

Four greenhouse brid ging trials for abamectin on tomatoes were conducted in the United States encompassing North American Free Trade Agreement (NAFTA) Growing Regions 3 (1 trial), 5A (1 trial), 6 (1 trial) and 10 (1 trial) during the 2011

- 2012 growing season s

.

At each trial location, two plots were treated. In the first plot, abamectin formulated as Agri

Mek 0.15 EC was applied as 3 foliar directed applications at a rate of 0.0197

- 0.0214 lb ai/A (22

- 24 g a i /ha) with re

- treatment intervals (RTIs) of 6 to 8 days for a total ra te of 0.0593

- 0.0626 lb ai/A (66

- 70 g ai/ha). In the second plot, abamectin formulated as Agri

- Mek SC was applied as 3 foliar directed applications at a rate of 0.0199

- 0.0210 lb ai/A (22

- 24 g ai/ha) with re

- treatment intervals (RTIs) of 6 to 8 days for a total rate of 0.059 7

- 0.0625 lb ai/A (67

- 70 g ai/ha). A non

ionic surfactant was added to the spray mixture for all applications. Mature tomatoes were collected at pre

- harvest intervals (PHIs) of 1 and 3 days. At one of the trial sites, samples were
collected at different time intervals (PHIs of 0, 1, 3 and 7 days) to assess the residue decline. Both large fruit and small fruit tomato varieties were used in this study.

In greenhouse

- grown tomato samples collected at a PHI of 1 day f ollowing a total application of
0.0597

- 0 .0625 lbs ai/A (67

- 70 g ai/ha) with Agri

- Mek SC

, total combined residues of avermectin

B 1a 

### , avermectin B 1b 

### and 8,9

- Z

- avermectin B 1a 

### for individual samples (and per

- trial averages) ranged from 0.00663 ppm to 0.02706 ppm (0.00684 to 0.02476 ppm ). A decline study indicates
that the level of abamectin residues in tomatoes decreases with time.

I n greenhouse

- grown tomato samples collected at a PHI of 1 day f ollowing a total application of
0.0593

- 0.0626 lbs ai/A (66

- 70 g ai/ha) with Agri

- Mek 0.15EC

, total comb ined residues of
avermectin B 1a 

### , avermectin B 1b 

### and 8,9

- Z

- avermectin B 1a 

### for individual samples (and per

- trial averages) ranged from 0.00519 ppm to 0.044 91 ppm (0.00587 to 0.04120 ppm).

Green Onion

Five field trials were condu cted on green onions in the US and Canada during the 2009 growing season in Zones 2 (1 in MD), 3 (1 in FL), 5 (1 in ON), 5B (1 in QC) and 10 (1 in CA). Agri

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



### Page 31 of 51 Mek ® 

### 0.15 EC was applied to green onions as four foliar broadcast applications at rates of 20.7

– 23.2 g ai/ha (0.018

- 0.021 lb ai/A) at each trial site , for total rates of 88.5

– 91 .5 g a i/ha / season ( 0.079

– 0.082 lb ai/A/season). A non

- ionic surfactant was included in the spray mixture for all applications. The re

- treatment interval (RTI) was 6

- 14 days, and mature green onion samples
were harvested at 6

- 8 day PHIs at all trial sites. Additional samples were harvested at one trial site at PHIs of 0, 3, and 11 days to determine residue decline behavior. There was one treated plot and one untreated co ntrol plot at each trial site.

In green onions harvested at PHIs of 6

- 8 days f ollowing four broadcast foliar applications of Agri

- Mek ® 

### 0.15 EC with a nonionic surfactant at a total rate of 88.5

– 91.5 g ai/ha/season (0.079

– 0.082 lb ai/A/season), t otal combined residues (and per

- trial averages) of avermectin B 1a 

### / 8,9

- Z
avermectin B 1a 

### and avermectin B 1b 

### ranged from <0.004

- <0.004 8 ppm ( <0.004

- <0.0046 ppm )

. R esidue decline data from one trial site showed that total residues of abamectin decreased with increasing PHI.

Guava

T he Interregional Research Project Number 4 (IR

- 4) has submitted field trial data for abamectin

on guava

. Three field trial s were conducted in the United States during the 1999 growing season
in the North American Free Trade A greement (NAFTA) Growing Zone 3 (FL).

Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received three foliar directed applications of a 0.15 lb ai/gal emulsifiable concentrate (EC)
formulation of abamectin (Agrimek 0.15 EC) at 0.024

- 0.025 lb ai/A/application for a total
seasonal rate of 0.073

- 0.074 lb ai/A/season. Applications were made at retreatment intervals (RTIs) of 13

- 14 days using ground equipment in spray volumes of 171

- 181 gal/A. A
hort icultural oil spray adjuvant was used. Guavas were harvested at a preharvest interval (PHI) of 8 days.

In guava harvested 8 days following the last of three foliar directed applications of a 0.15 lb ai/gal EC formulation of abamectin at a total applica tion rate of 0.073

- 0.074 lb ai/A, residues (and per

- trial averages) of abamectin (determined as the sum of avermectin B 1a 

### / 8,9

- Z avermectin

B 1a

, 

### and avermectin B 1b 

### ) were <0.004

- 0.0059 ppm (<0.004

- <0.0050 ppm ). Residue decline was
not evaluated.

Lima Bea n

The Interregional Research Project Number 4 (IR

- 4) has submitted field trial data for abamectin

on lima bean. Seven field trial s were conducted in the United States during the 1999 and 2000 growing season s in the North American Free Trade A greement (NAFTA) Growing Zones 2 (GA and SC; 3 trials), 5 (OH and WI; 2 trials), 10 (CA; 1 trial), and 11 (ID; 1 trial).

Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received three foliar dire cted or broadcast applications of a 0.15 lb ai/gal emulsifiable concentrate (EC) formulation of abamectin (Agrimek 0.15 EC) at 0.0174

- 0.0198 lb ai/A/application for a total seasonal rate of 0.0551

- 0.0566 lb ai/A, except in the SC trial, where aAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 32 of 51 fourth appl ication was made due to an error for a total rate of 0.0751 lb ai/A. Applications were made at retreatment intervals (RTIs) of 5

- 8 days using ground equipment, in spray volumes of 4

- 7 gal/A. No spray adjuvants were used. Lima beans were harvested at a p reharvest interval (PHI) of 6

- 8 days.

In lima bean harvested 6

- 8 days following the last of three foliar directed or broadcast applications of a 0.15 lb ai/gal EC formulation of abamectin at a total application rate of 0.0551

- 0.0566 lb ai/A (0.0751 lb a i/A for the SC trial), residues of abamectin (determined as the sum of
avermectin B 1a 

### /8,9

- Z avermectin B 1a 

### and avermectin B 1b 

### /8,9

- Z avermectin B 1b 

### ) were below the LOQ (<0.004 ppm) in/on all samples. Residue decline was not evaluated.

Lychee

The Interregional Research Project Number 4 (IR

- 4) has submitted field trial data for abamectin

on lychee. Three field trial s were conducted in the United States during the 2001 growing
season in the North American Free Trade A greement (NAFTA) Growing Zon e 3 (FL).

Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received two foliar directed applications of a 0.15 lb ai/gal emulsifiable concentrate (EC) formulation of abamectin (Agrimek 0.15 EC) at 0.024

- 0.025 lb ai/A/application for a total
seasonal rate of 0.048

- 0.050 lb ai/A/season. Applications were made at retreatment intervals (RTIs) of 14

- 15 days using ground equipment in spray volumes of 167

- 184 gal/A. A nonionic surfactant (NIS) was added to the spray mixture for all applications. Lychees were harvested at a preharvest interval (PHI) of 8

- 13 days.

In lychees harvested 8

- 13 days following the last of two foliar directed applications of a 0.15 lb ai/gal EC formulation of abamectin at a t otal application rate of 0.048

- 0.050 lb ai/A, residues (and per

- trial averages) of abamectin (determined as avermectin B 1a/ 

### 8,9

- Z avermectin B 1a 

### ) were
<0.002

- 0.0034 ppm (<0.002

- <0.0027 ppm ) . Residues of avermectin B 1b 

### were not monitored in this study. Residue decline was not evaluated.

Papaya

The Interregional Research Project Number 4 (IR

- 4) has submitted field trial data for abamectin

on papaya

. Three field trial s were conducted in the United States during the 1 998 gr owing
season in the North American Free Trade A greement (NAFTA) Growing Zone 3 (FL).

Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received three foliar broadcast applications of a 0.15 l b ai/gal emulsifiable concentrate (EC) formulation of abamectin (Agrimek 0.15 EC) at 0. 0246

- 0.0272 lb ai/A/application for a total
seasonal rate of 0. 0738

- 0.0816 lb ai/A. Applications were made at retreatment intervals (RTIs)
of 13

- 15 days using ground eq uipment in spray volumes of ~151

- 201 gal/A. A horticultural oil spray adjuvant was used. Papayas were harvested at a preharvest interval (PHI) of 3

- 5 days.

In papaya harvested 3

- 5 days following the last of three foliar broadcast applications of a 0.1 5 lb ai/gal EC formulation of abamectin at a total application rate of 0. 074

- 0.082 lb ai/A, residuesAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 33 of 51 (and per

- trial averages) of abamectin ( determined as the sum of avermectin B 1a 

### /8,9

- Z avermectin

B 1a 

### and avermectin B 1b 

### /8,9

- Z avermectin B 1b 

### ) were < 0.00 47

- 0 .1 64 ppm ( < 0.00 51

- 0.1 31 ppm )

. Residue decline was not evaluated.

Pineapple

The Interregional Research Project Number 4 (IR

- 4) has submitted field trial data for abamectin

on pineapple

. Eight field trial s were conducted in the United States during the 2002 growing
season in the North American Free Trade A greement (NAFTA) Growing Zone 13 (HI).

Each trial consisted of one untreated plot and one or two treated plots. At each trial location, one treated plot received two foliar broadcast applications of a 0.15 lb ai/gal emulsifiable concentrate (EC) formulation of abamectin (Agrimek 0.15 EC) at 0.0232

- 0.0239 lb ai/A/application, for a
total seasonal rate of 0.0465

- 0.0475 lb ai/A/season (T reatment #2; T rt 02). At three trials, a second plot received two f oliar broadcast applications at 0.115

- 0.119 lb ai/A per application for a
total seasonal rate of 0.231

- 0.238 lb ai/A (Trt 03). Applications were made at retreatment intervals (RTIs) of 7 days using ground equipment in spray volumes of 148

- 153 gal/A. No

a djuvants were used. Pineapple was harvested at preharvest intervals (PHIs) of 78

- 112 days.

In pineapple harvested 78

- 112 days following the last of two foliar broadcast applications of a 0.15 lb ai/gal EC formulation of abamectin at a total application rate of 0.0465

- 0.0475 or 0.231

- 0.238 lb ai/A, residues of abamectin (determined as the sum of avermectin B 1a / 

### 8 ,9

- Z avermectin

B 1a 

### and avermectin B 1b 

### ) were below the LOQ (<0.004 ppm) in/on all samples . Residue decline

was not evaluated.

Snap Bean

The In terregional Research Project Number 4 (IR

- 4) has submitted field trial data for abamectin

on snap bean

. Seven field trial s were conducted in the United States during the 1999 gr owing
season in the North American Free Trade A greement (NAFTA) Growing Zones 1 (NY; 1 trial), 2 (GA; 2 trials), 3 (FL; 1 trial), 5 (WI and OH; 2 trials), and 11 (WA; 1 trial). The above trial
count reflects HED’s determination that two trials conducted at the same location s were replicate
trials.

Each trial consisted of one untreated plot and one treated plot. At each trial location, the treated plot received three foliar directed or broadcast applications of a 0.15 lb ai/gal emulsifiable concentrate (EC) formulation of abamectin (Agrimek 0.15 EC) , except as follow: two applications were made at one GA trial (GA*20) due to early pod maturity, and four and five applications were made at the FL and OH trials, respectively, due to late maturation of the crop. Applications were made at 0.017 1

- 0.020 1 lb ai/A/application, for total seasonal rates of 0. 0548

- 0.059 4 lb ai/A following three applications, and 0.0378, 0.0770, and 0.0944 lb ai/A following two, four, and five applications , respectively . Applications were made at retreatment intervals (RTIs) of 5

- 8 days using ground equipment in spray volumes of 4

- 5 gal/A. No spray adjuvants
were used. Snap beans were harvested at a preharvest interval (PHI) of 5

- 7 days.

In snap bean s harvested 5

- 7 days following the last of two to five foliar directed or broadcastAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 34 of 51 applications of a 0.15 lb ai/gal EC formulation of abamectin at total application rates of 0.0378

- 0.0944 lb ai/A, residues of abamectin ( determined as the sum of avermectin B 1a 

### /8,9

- Z
avermectin B 1a 

### and avermectin B 1b 

### /8,9

- Z aver mectin B 1b 

### ) were below the LOQ (<0.004 ppm) in/on all samples . Residue decline was not evaluated.

Table 5.3.1

. 1. Summary of Residues from Field Trials with Abamectin.

Crop Matrix Total Application

Rate (lbs ai/A) PHI (days) n 1 Abamectin Residues 2 (ppm)

Min. 3 Max. 3 LAFT 4 HAFT 4 Median 4 Mean 4 SD 4

GREENHOUSE

- GROWN TOMATO Proposed Use = 0.056 lb ai/acre total application rate, 1

- day PHI Agri

- Mek SC

Tomato fruit 0.0597

- 0.0625 1 4 0.00663 0.02706 0.00684 0.02476 0.01540 0.01560 0.007

3 4 0.00562 0.01971 0.00621 0.01699 0.01306 0.01233 0.004 Agri

- Mek 0.15EC

Tomato fruit 0.0593

- 0.0626 1 4 0.00519 0.04491 0.00587 0.04120 0.01285 0.01819 0.014

3 4 0.00566 0.03372 0.00573 0.03248 0.01088 0.01499 0.010
GREEN ONION Proposed Use = 0.076 lb ai/acre total application rate, 7

- day PHI

Green onion 0.079

– 0.082 6

- 8 5 <0.004 <0.0048 <0.004 <0.0046 <0.004 <0.004 0.00025

GUAVA Proposed Use = 0.070 lb ai/acre total application rate, 7

- day PHI

Guava 0.073

- 0.074 8 3 <0.004 <0.0059 <0.004 < 0.0050 0.0040 0.0043 0.0005

LIMA BEAN Proposed Use = 0.056 lb ai/acre total application rate, 7

- day PHI

Lima bean 0.0551

- 0.0566 6 6

- 8 7 <0.004 <0.004 <0.004 <0.004 0.004 0.004 N/A 5

LYCHEE Proposed Use = 0.046 lb ai/acre total application rate, 14

- day PHI
Lychee 0.048

- 0.050 8

- 13 3 <0.002 0.0034 <0.002 <0.0027 0.0024 0.0024 0.0004

PAPAYA Proposed Use = 0.070 lb ai/acre total application rate, 3

- day PHI

Papaya 0.074

- 0.082 3

- 5 3 <0.0047 0.164 <0.005

1 0.131 0.123 0.0863 0.0705

PINEAPPLE Proposed Use = 0.047 lb ai/acre total application rate, 16

- week PHI
Pineapple 0.0465

- 0.0475 78

- 112 8 <0.004 <0.004 <0.004 <0.004 0.004 0.004 N/A 5

0.231

- 0.238 98

- 108 3 <0.004 <0.004 <0.004 <0.004 0.004 0.004 N/A 5

SNAP BEAN Proposed Use = 0.056 lb ai/acre total application rate, 7

- day PHI
Snap bean 0.0378

- 0.0944 7 5

- 7 7 <0.004 <0.004 <0.004 <0.004 0.004 0.004 N/A 5

1 n = number of trials.

2 Combined residues of abamectin:
Greenhouse

- grown tomato , green onion, guava, and pineapple : Combined residues of avermectin B 1a / 8,9

- Z avermectin B 1a and
avermectin B 1b Papaya, l ima bean and snap bean : Combined residues of avermectin B 1a /8,9

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

- Z
avermectin B 1b

. Lychee: Combined residues of avermectin B 1a / 8,9

- Z avermectin B 1a . The B 1 b residue component was not monitored in this study.

3 Values based on total number of samples.

4 Values based on per

- trial averages. LAFT = lowest average field trial, HAFT = highest average field trial, SD = standard
deviati on. For computation of the LAFT, HAFT, median, mean, and standard deviation, values < LOQ are assumed to be at the LOQ (0.002 ppm for greenhouse

- grown tomatoes and lychee; 0.004 ppm for green onion, guava, lima bean, papaya, pineapple, and snap bean).

5 N /A = not applicable.

6 The lima bean trials included one SC trial at 0.0751 lb ai/A.

7 The snap bean trials targeted three applications, but the data reflect two to five applications; the number of applications depended on the rate of crop maturation.



### Conclusions

. Adequate field trial data have been submitted for greenhouse

- grown tomato, green onion, lima bean, lychee, papaya, pineapple and snap bean. The studies adequately reflect the proposed use patterns. The number of trials and the geographic re presentation are adequate.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 35 of 51 An acceptable method was used for residue quantitation, and adequate storage stability data are available to support sample storage durations and conditions for all analytes.

5.3.2 New Uses and Crop Group Updates

Except fo r new data on greenhouse

- grown tomatoes considered in the crop group tolerance (discussed in Section 5.3.1 above), n o additional data have been submitted for the following proposed new uses and crop group conversions.

Berry, low growing, subgroup 13

- 07G

A tolerance is established for strawberry. The petitioner is proposing a new use on the “Berry, low growing, subgroup 13

- 07G.” Strawberry is the only representative crop of the subgroup 13

- 07G. A dequate field trial data are available reflecting use of E C and SC formulation s on strawberry (D401832, N. Dodd, 12/19/12 )

. T he data on strawberry are adequate to establish a
tolerance on the Berry, low growing, subgroup 13

- 07G.

Fruit, citrus, group 10

- 10

A tolerance is established for “ Citrus.” The petitioner is proposing a crop group conversion to the “Fruit, citrus, group 10

- 10.” The representative crops for the Fruit, citrus, group 10

- 10 are orange or tangerine/mandarin, lemon or lime, and grapefruit. Adequate field trial data are
available refl ecting use of EC and SC formulation s on orange, lemon, and grapefruit (D364734, N. Dodd, 1/21/10). The data on orange, lemon, and grapefruit are adequate to establish a tolerance on the Fruit, citrus, group 10

- 10. Fruit, pome, group 11

- 10

Tolerances are established for apple and pear. The petitioner is proposing a new use on the “Fruit, pome, group 11

- 10 .” T he representative crops for group 11

- 10 are apple and pear. Adequate field trial data are available reflecting use of EC and SC formulations on app le and pear (D364734, N. Dodd, 1/21/10). The data on apple and pear are adequate to establish a tolerance on the Fruit, pome, group 11

- 10.

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F

A tolerance is established for “grape.” The petitioner is proposing a new use on the “Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F.” The representative crop for subgroup

13

- 07F is grape. Adequate field trial data are available reflecting use of EC and SC formulations

on grap es (D364734, N. Dodd, 1/21/10). The data on grapes are adequate to establish a tolerance on the Fruit, pome, group 11

- 10.

Fruit, stone, group 12

- 12

A t olerance is established for the “Fruit, stone, group 12.” The petitioner is proposing a crop conversi on to the “Fruit, stone, group 12

- 12 .” T he representative crops for group 12

- 12 areAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 36 of 51 sweet cherry or tart cherry, peach, and plum or prune plum . Adequate field trial data are available reflecting use of the EC formulation on sweet and tart cherries, peaches, plums /prune plums (D 254546, N. Dodd, 4/26/00; D316756, N. Dodd, 8/21/08 ). E C data on stone fruit ha ve been used to register SC formulations ; refer to D379892 ( N. Dodd, 9/28/10 ) , which recommends
translation of EC data to SC for plums/prunes and v arious other crops . The data on sweet and tart cherries, peaches, plums/prune plums are adequate to establish a tolerance on the Fruit,

stone, group 12

- 12

.

Nut, tree, group 14

- 12

Tolerances are established on the “Nut, tree, group 14” and “pistachio.” The petitioner is proposing a crop group conversion to the “Nut, tree, group 14

- 12.” The representative crops for group 14

- 12 are almond and pecan. Adequate field trial data are av ailable reflecting use of the
EC formulation on almond (D163057, G. J. Herndon, 11/26/91; D214699, G.J. Herndon, 10/30/95) and pecan (D316756, N. Dodd, 8/21/08 )

. EC data on tree nuts have been used to register SC formulations; refer to D379892 (N. Dodd, 9/28/10), which recommends translation
of EC data to SC for almonds and various other crops. The data on almond and pecan are adequate to establish a tolerance on the Nut, tree, group 14

- 12.

Vegetable, fruiting, group 8

- 10

A tolerance is established for “Vegetable, fruiting, group 8 ”

. The petitioner is proposing a crop group conversion to the “Vegetable, fruiting, group 8

- 10.” The representative crops for group 8

- 10 are tomato, standard size, and one cultivar of small tomato; bell pepper and one cultivar of small nonbell pepper. Adequate field trial data are available reflecting use of EC and SC
formulations on tomato

, bell pepper, and chili pepper (D364734, N. Dodd, 1/21/10). The residue
data include both regular size and small tomatoes ( D194897, M. Peters, 5/17/94; D364734, N. Dodd, 1/21/10)

. The field trial data on tomato, bell pepper, and chili pepper are adequate to establish a tolerance on the Vegetable, fruiting, group 8. The tolerance will set high enough to cover residue data on greenhouse

- grown tomatoes, discussed in Section 5.3.1 above.

Conclusion: Adequate data have previously been submitted to support the new uses/crop group
conversions for the B erry, low growing, subgroup 13

- 07G ; the Fruit, citrus, group 10

- 10 ; the Fruit, pome, group 11

- 10 ; Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F ; Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F ; Fruit, stone, group 12

- 12 ; Nut, tree, group 14

- 12 ; and the Vegetable, fruiting, group 8

- 10. Except for new data on greenhouse

- grown tomatoes considered in the crop group tolerance (discussed in Section 5.3.1 above) , n o additional data were submitted and none are required.

5.3.3 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. Re view 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).Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 37 of 51 5.3.4 Processed Food and Feed (860.1520)

G reen O nion, G uava, Lima Bean, Lychee, Papaya, and Snap B ean

There are no processed commodities for green onion, guava, lima bean, lychee, papaya, and snap
bean.

Pineapple The processed commodities for pineapple are process residue (also known as wet bran) and juice. No processing study has been submitted for pineapple. However, the crop field trials were conducted at exaggerated application rates (in addition to the proposed label rate) and residues of abamectin were not detected. Therefore, processi ng studies for pineapple are not needed, and tolerances for pineapple processed commodities are not required.

Tomato

The processed commodities for tomato are paste and puree. A p rocessing stud y was previously
reviewed (MRID 47702806; D364734, N. Dodd, 1/21/10) . In two field trials conducted in Zone 10 during 2008, abamectin (0.7 lb ai/gal SC) was applied to two separate plots of tomatoes in each trial as three broadcast foliar applications at total rates of 0.057

- 0.05 8 lb ai/A (1x rate) or

0.28

- 0.29 lb ai/A (5x rate). All samples were harvested at a 7

- day PHI. T omato samples from
each field trial were processed within 6 days of harvest into puree and paste using simulated commercial procedures. All s amples were stor ed frozen ( at

- 20°C ) for up to 6 months prior to analysis, an interval which is supported by the available storage stability data.

Samples of whole tomatoes and each processed fraction were analyzed for total abamectin residues (avermectin B 1a 

### , 8,9

- Z aver mectin B 1a 

### , and avermectin B 1b 

### ) using the LC/MS/MS method (Morse Labs Method No. Meth

- 192, rev. 2). The validated LOQ is 0.002 ppm for each analyte. Although the LC/MS/MS method determines a ver mectin B 1a 

### and 8,9

- Z avermectin B 1a 

### separately, residues for these two analytes were reported as the combined B 1a 

### residues (B 1a 

### + 8,9

- Z B 1a 

### ).

P rocessing factors for the two 1x rate field trials could not be calculated because residues in tomatoes, paste, and puree were all <0.004 ppm.

In the two 5x rate field trials

, t he average processing factors were 0.52x for tomato puree and
0.94x for tomato paste.

The maximum theoretical concentration factor s are 5.5x for tomato paste and 1.4x for tomato puree (Table 2, OCSPP 860.1520).

Conclusions

. T here are no proce ssed commodities for green onion, guava, lima bean, lychee, papaya, and snap bean.

The processed commodities for pineapple are process residue (also known as wet bran) and juice. No processing study has been submitted for pineapple. Crop field trials were conducted atAbamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 38 of 51 exaggerated application rates (in addition to the proposed label rate) and residues of abamectin were not detected. Therefore, processing studies for pineapple is not needed, and tolerances for pineapple processed commodities are not requ ired.

The available tomato processing stud y is adequate. An acceptable method was used for quantitation of abamectin residues of concern and the sample storage conditions and durations are supported by adequate storage stability data. Based on the resul ts from the 5x rate field trials, th e average processing factors for total abamectin residues were 0.52x in puree and 0.94x in paste. These data indicate that abamectin residues do not concentrat e in tomato processed fractions; therefore, separate toleran ces are not required for tomato paste or puree.

5.3.5 Meat, Milk, Poultry and Eggs (860.1480)

T he established livestock tolerances were reassessed in D416280 (N. Dodd, 5/15/14); the discussion/calculations from D416280 are repeated below. T he only new livestock feed item associated with this petition (D414022) is pineapple process residue ( Table 1 Feedstuffs , June 2008). Pineapple process residues can be used in the beef and dairy cattle diets at 10% of the diet; this feedstuff is not used in poultry or swine diets. Because no processing study was conducted on pineapple to determine residues in pineapple process residue, the reviewer used the pineapple fruit residue level (median/mean levels of 0.004 ppm and 25% dry matter) to
determine tha t adding pineapple process residue to the previously calculated beef and dairy cattle
diets (D41 4022 , N. Dodd, 3 /1 7 /1 6 ) will not increase the dietary burden calculations. T he calculated residues in livestock commodities include residues from uses on propo sed/registered crops, from use in food handling establishments, and from beef and dairy cattle ear tags

.

5.3.6

. Food Handling (860.1460)

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

5.3.7

. Water, Fish, and Irrigated Crops (860.1 400)

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

5.4. Food Residue Profile

T he residue chemistry database is adequate for tolerance assessment and for registration.

Crop field trials : The crop field trials adequately reflect the proposed use patterns. The number of trials and the geographic representation are adequate

. Acceptable method s w ere used for residue quantitation, and adequate storage stability data are available to support sample storage
durations and conditions fo r all analytes. Residues were small but quantifiable in greenhouse

grown tomato and papaya ; residues ranged from not quantifiable to small but quantifiable in green onion, guava, and lychee . Residues were all <0.004 ppm in lima bean, snap bean, and pinea pple. Residue decline studies on tomatoes and green onions indicated that residues
decreased over time.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 39 of 51 Processing studies : T here are no processed commodities for green onion, guava, lima bean, lychee, papaya, and snap bean.

The processed commodities for pineapple are process residue (also known as wet bran) and juice. No processing study has been submitted for pineapple. Crop field trials were conducted at exaggerated application rates (in addition to the proposed label rate) and residues of abamec tin were not detected. Therefore, processing studies for pineapple are not needed, and tolerances for pineapple processed commodities are not required.

The processed commodities for tomato are paste and puree. Based on the results from the 5x rate
field trials, th e average processing factors for abamectin residues were 0.52x in puree and 0.94x in paste. These data indicate that abamectin residues do not concentrat e in tomato processed fractions; therefore, separate tolerances are not required for tomato paste or puree.

Storage Stability : 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, pear, and tomato), high acid (orange, lemon, grapefruit, and strawberry), high protein (bean), high fat (sunflower seed), and high starch (potato) (DP # 191433, G. J. Herndon, 5/19/94; D414022, N. Dodd, 5/15/14).

Concurrent storage stability data were provided for greenhouse

- grown tomato and for guava

, which demonstrat e that residues of avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin B 1a 

### are stabl e under frozen storage conditions in/on tomato fruit for 716 days and in/on guava for 1013 days (33.3 months)

.

The available and submitted storage stability data are adequate to support the storage conditions
and durations of all field trial and processi ng samples.

Meat, Milk, Poultry, and Eggs : T he established livestock tolerances were reassessed in D416280 (N. Dodd, 5/15/14). T he only new livestock feed item associated with this petition (D414022) is pineapple process residue

, which is only fed to beef and dairy cattle ( Table 1 Feedstuffs , June 2008)

. A dding pineapple process residue to the previously calculated beef and dairy cattle diets (D416280, N. Dodd, 5/15/14) will not increase the dietary burden calculations.

T he calcu lated residues in livestock commodities include residues from uses on proposed/registered crops, from use in food handling establishments, and from beef and dairy cattle ear tags. As determined in D416280 (N. Dodd, 515/14), h igher tolerances are needed fo r some livestock commodities; these changes have not yet been made.

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 poul try commodities; therefore, no poultry feeding studies are required.

Rotational Crops : A c onfined rotational crop study indicated that avermectin residues of significant toxicological concern are not expected to occur in rotational crops.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 40 of 51 6.0 Toleran ce Derivation

A tolerance on the Vegetable, fruiting, group 8

- 10 is to be established based on the existing
data/ established tolerance for the Vege table, fruiting, group 8 plus new data on greenhouse

grown tomatoes. The crop group tolerance is to be increased based o n the greenhouse

- grown

tomato residue data included in this petition.

A tolerance on Fruit, citrus, group 10

- 10 is to be established based on the existing
data/ established tolerance on citrus. No new data were provided.

A tolerance on Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13

- 07F is to be
established based on the existing data/ established tolerance on the representative crop, grape

. No new data were provided.

A tolerance on Berry, low growing, subgroup 13

- 07G is to be established based on the existing
data/ established tolerance on the representative crop, strawberry. No new data were provided.

A tolerance on the Fruit, pome, group 11

- 10 is to be established based on existing
data/ established tolerances on the representative crops, pear and apple. No new data were provided.

A tolerance on the Fruit, stone, group 12

- 12 is to be established based on the existing
d ata/ established tol erance on the Fruit, stone, group 12. No new data were provided.

A tolerance on the Nut, tree, group 14

- 12 is to be established based on the existing
data/ established tolerances for the Nut, tree, group 14 and pistachio. No new data were provided.

A to lerance on Bean is to be established based on the existing data/established tolerance for Bean, dry seed and new data on edible podded bean (i.e.

, snap bean) and succulent shelled bean (lima bean) submitted in this petition.

Tolerances on various tropical fruits are to be established based on residue day on papaya, guava, and lychee. Papaya, guava, and lychee serve as representative crops for other proposed tropical fruits as indicated in EPA’s “Reviewer’s Guide and Summary of HED ChemSAC Approvals for Amending Crop Groups/Subgroups [40 CFR 180.41] and Commodity Definitions [40 CFR 180.1(h)] ” (Bernard Schneider, June 14, 2006). According to that document, p apaya is the representative crop for papaya, black sapote, canistel, mamey sapote, mango, sapodilla, and

star apple. Guava is the representative crop for guava, feijoa, jaboticaba, wa x jambu, starfruit, passionfruit, and acerola. Lychee is the representative crop for lychee, longan, Spanish lime, rambutan, and pulasan. Although mango c an be covered by the papaya data, IR

- 4 is not requesting a mango tolerance and registration in this petition.Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 41 of 51 The Organization for Economic Cooperation and Development ( OECD ) tolerance calculation procedures were not used for lima bean, snap bean, and pineapple since all residues for those crops were <0.004 ppm.

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

- grown tomatoes (used to establish the tolerance for the Vegetable, fruiting, crop group 8

- 10) , green onions, guava, lychee, and papaya. 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.

G reenhouse

- grown Tomatoes (MRID 49455901)

The dataset used to establish tolerances for abamectin consisted of residue data on greenhouse

grown tomatoes representing an applicat ion rate of 0.06 lb ai/A/season with a 1

- day PHI (except for one higher value at a 3

- day PHI)

. The field trial application rates are approximately 1x the
maximum p roposed seasonal application rate. Except for the one 3

- day PHI, t he PHIs are within
25% of the minimum label PHI. The average residue values used to calculate the tolerances are provided below. Combined residues of avermectin B 1a 

### / 8,9

- Z avermectin B 1a 

### and avermectin B 1b 

### were quantifiable in all eight trials. Using the OECD tolerance calculation proce dures, the
recommended toleranc e is 0. 07 ppm for the com bined residues of avermectin B 1a 

### , 8,9

- Z
avermectin B 1a 

### , and avermectin B 1b 

### in greenhouse

- grown tomatoes ; this tolerance level will be used for the Vegetable, fruiting, crop group 8

- 10

.

Green Onions (MRID 49455902)

The dataset used to establish tolerances for abamectin consisted of field trial data on green onions representing an application rate of 0.079

– 0.082 lb ai/A/season with PHIs of 6

- 8 days. The field trial application rates are approximately 1x the maximum proposed seasonal application rate. T he PHIs are within 25% of the minimum label PHI. The average residue values used to calculate the tolerances are provided below. Combined residues of avermectin

B 1a 

### / 8,9

- Z avermectin B 1a 

### and avermectin B 1b 

### were quantifiable in one of five trials . Using the OECD tolerance calculation procedures, the recommended toleranc e is 0.0 1 ppm for the
combined residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### in green onions.

Guava (MRID 49455903

The dataset used to establish tolerances for abamectin consisted of field trial data on guava representing an application rate of 0.073

- 0.074 lb ai/A /season with an 8

- day PHI

. The field trial application rates are approximately 1x the maximum proposed seasonal application rate. T he PHI is within 25% of the minimum label PHI. The average residue values used to calculate the tolerances are provided below. Combined residues of avermectin B 1a 

### / 8,9

- Z
avermectin B 1a 

### and avermectin B 1b 

### were quantifiable in one of three trials . Using the OECD tolerance calculation procedures, the recommended toleranc e is 0.0 1 ppm for the combined
residues of avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### in g uava

.

Lychee (MRID 49455905)Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 42 of 51 The datas et used to establish tolerances for abamectin consisted of field trial data on lychee representing an application rate of 0.048

– 0.050 lb ai/A /season with PHIs of 8

- 13 day s. The field trial application rates are approximately 1x the maximum proposed seasonal application rate. Since the data set is small (n=3), the data are being used although t he PHI s are

not within 25% of the minimum label PHI of 14 days

. The average residu e values used to calculate the tolerances are provided below. Combined residues of avermectin B 1a 

### / 8 ,9

- Z
avermectin B 1a 

### were quantifiable in two o f three trials . Using the OECD tolerance calculation procedures, the recommended toleranc e is 0.0 1 ppm for th e combined residues of avermectin

B 1a 

### , 8,9

- Z avermectin B 1a 

### , and avermectin B 1b 

### in lychee

.

Papaya (MRID 49455906)

The dataset used to establish tolerances for abamectin consisted of field trial data on papaya representing an application rate of 0.074

- 0.082 lb ai/A with PHIs of 3

- 5 day s. The field trial application rates are approximately 1x the maximum proposed seasonal application rate

. Since the data set is small (n=3), the data are being used although t he PHI s are not within 25% of the
minimum label PHI of 3 days

. The average residue values used to calculate the tolerances are provided below. Combined residues of avermectin B 1a 

### / 8 ,9

- Z avermectin B 1a 

### and avermectin

B 1b 

### /8,9

- Z avermectin B 1b 

### were quantifiable in all three trials . Using th e OECD tolerance calculation procedures, the recommended toleranc e is 0. 4 ppm for the combined residues of
avermectin B 1a 

### , 8,9

- Z avermectin B 1a 

### , avermectin B 1b 

### , and 8,9

- Z avermectin B 1b 

### in papaya

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



### Page 43 of 51 Appendix A. Field Trial Geographic Distribution

Greenhouse

- grown Tomatoes (MRID 49455901)

Table A.1

. Trial Numbers and Geographical Locations for Greenhouse

- grown Tomatoes *.

Crop Region Total 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Tomatoes

- - 1

- 1 1

- - - 1

- - - - 4

* PMRA’s DIR2010

- 05 specifies zone requirements for national registration in/on greenhouse

- grown tomatoes ( i.e. 2 trial s in
each of zones 5 and 12 ). However, as the trials required to support the proposed use expansion are to be conducted in 4 separate greenhouses according to current Canadian greenhouse cultivation practices, the zones in which these will be conducted are not
relevant for this use. EPA has no geographic specifications for greenhouse

- grown tomatoes.



### Green Onion (MRID 49455902)

Table B.7.6.1.2

- 2. Trial Numbers and G eographical Locations. 1

Crop No.
Trials NAFTA Growing Zone Total 1 2 3 4 5 5B 6 7 8 9 10 11 12 13

Green onion Sub. 1 1 1 1 1 5
Req. 3

1 OCSPP 860.1500, Table 4.



### Guava (MRID 49455903)

Table A.3 . Trial Numbers and Geographical Locations for Guava

. Crop No.
Trials NAFTA Growing Zone Total 1 2 3 4 5 6 7 8 9 10 11 12

Guava Sub. 3 3
Req. 1 2

1 As per Table 1 of OCSPP 860.1500 for guava ; a minimum of two field trials with a minimum of eight samples is required.

G eographic distribution is not specified for crops requiring ≤3 trials.



### Lima Bean (MRID 49455904)

Table A.4. Trial Numbers and Geographical Locations for Lima Bean

. Crop No.
Trials NAFTA Growing Zone Total 1 2 3 4 5 6 7 8 9 10 11 12

Bean, lima,

green Sub. 3 2 1 1 7
Req. 1 4/3 1/1 2/1 1/1 8/6

1 As per Table 5 of OCSPP 860.1500 for lima beans; 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 44 of 51 Lychee (MRID 49455905)

Table A.5 . Trial Numbers and Geographical Locations for Lychee

. Crop No.
Trials NAFTA Growing Zone Total 1 2 3 4 5 6 7 8 9 10 11 12 13
Lychee Sub. 3 3
Req. 1 1

1 As per Table 1 of OCSPP 860.1500 for lychee, one crop field trial with a minimum of four samples is required. Geographic distribution is not specified for crops requiring ≤3 trials. Lychee is not included in Table 6 of OCSPP 860.1500, which reports regional distribution of crop production.



### Papaya (MRID 49455906)

Table A.6. Trial Numbers and Geographical Locations for Papaya

. Crop No.
Trials NAFTA Growing Zone Total 1 2 3 4 5 6 7 8 9 10 11 12 13

Papaya Sub. 3 3
Req. 1 3 or 2

1 As per Table 1 of OCSPP 860.1500 for papaya, three trials with a minimum of 6 samples or two trials with a minimum of 8 samples are required. Geographic distribution is not specified for crops requiring ≤3 trials. P er Table 6 of OCSPP 860.1500,
Zone 13 a ccounts for 96% of U.S. papaya production.



### Pineapple (MRID 49455907)

Table A.7 . Trial Numbers and Geographical Locations for Pineapple

. Crop No.
Trials NAFTA Growing Zone Total 1 2 3 4 5 6 7 8 9 10 11 12 13
Pineapple Sub. 8 8
Req. 1 8/6 8/6

1 A s per Table 5 of OCSPP 860.1500 for pineapple; 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

.


### Snap Bean (MRID 49455908)

Table A.8 . Trial Numbers and Geographical Locations for Snap Bean

. Crop No.
Trials NAFTA Growing Zone Total 1 2 3 4 5 6 7 8 9 10 11 12
Snap bean Sub. 1 2 1 2 1 7
Req. 1 1/1 1/1 1/1 3/2 1/0 1/1 8/6

1 As per Table 5 of OCSPP 860.1500 for snap beans; 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 45 of 51 Appendix B

. International Residue Limits T able s

Abamectin (122804; 10/23/2015) Summary of US and International Tolerances and Maximum Residue Limits Residue Definition :
US Canada Mexico 2 Codex

40 CFR §180.449 Compliance with the tolerance levels specified is to be determined by 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. avermectin B1 (a mixture of avermectins containing greater than or equal to 80% avermectin B1a (5

- O

- demethyl avermectin A1a) and less than or equal to 20% avermectin B1b (5

- O

- demethyl

- 25

- de(1

- methylpropyl)

- 25

- (1

- methylethyl) avermectin A1a)
and its delta

- 8,9

- isomer) Plant commodities:
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 (pp m) /Maximum Residue Limit (mg/kg)

US Canada Mexico 2 Codex

V e g e t a b l e , f r u i ti n g , g r oup 8

- 10 0.07

0.01 peppers, tomatoes 0.2 peppers chili,
dried 0.02 Peppers, sweet (including pimento or pimiento), tomato

F r u i t

, c i t r u s , g r oup 10

- 10 0.02 0.02 0.01 (*)

F r u i t

, s m a ll

, v i n e c li m b i n g , exce p t
f u z zy k i w ifr u i t

, s u bg r oup 13

- 07F 0.02 0.02 grapes

Berry, low growing, subgroup 13

- 07G 0.05 0.02 strawberries 0.02 strawberry

F r u i t

, s t one, g r oup 12

- 12 0.09

F r u i t , po m e, g r oup 11

- 10 0.02 0.02 apples, pears 0.02 apple, pear

N u t

, t r ee, g r o u p 14

- 12 0.01 0.005 almond nuts, black walnuts, English walnuts 0.01 (*) almonds,
walnuts Papa y a 0.40

S t ar ap p l e 0.40

B l ack sap o t e 0.40 Sapod i l l a 0.40

C an i s t el 0.40

Ma m ey sapo t e 0.40

G ua va 0.015

Fe i j oa 0.015

J abo t i c aba 0.015

Wax j a m bu 0.015

S t a r fr u i t 0.015

Pa s s i on f r u i t 0.015

A ce r o l a 0.015

L y chee 0.01

L on g an 0.01 Span i s h l i m e 0.01

R a m bu t an 0.01

Pu l a s an 0.01

P i nea p p l e 0.015

B ean 0.015

O n i on, g r een, s ub g r oup 3

- 0 7B 0.08 Completed: M. Negussie; 10/30/2015Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 46 of 51 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 47 of 51 A ppendix C

. OECD MRL Calculation Procedure Inputs/Outputs

Greenhouse

- grown Tomatoes
Abamectin
MRID 49455901

0.06 lb ai/A/season; 1

- day PHI

**Residues (mg/kg) n** 

0.00587 1

0.00684 1

0.01022 * 1

0.01216 1

0.01549 1

0.01864 1

0.02476 1

0.0412 1



### * 3

- day value was used; 1

- day PHI value was 0.01021 ppm.

**A bamectin** 

**G reenhouse** 

**- grown**  **Tomatoes**

**USA**
**0.06 lb ai/A/season; 1** 

**- day PHI** 

**Total number of data (n)** 8

**Percentage of censored data** 0%

**Number of non**

**- censored data**  8

**Lowest residue**  0.006
**Highest residue** 0.041

**Median residue** 0.014

**Mean** 0.017

**Standard deviation (SD)** 0.012
**Correction factor for censoring (CF)** 1.000

**Proposed MRL estimate**

**- Highest residue**  0.041

**- Mean + 4 SD**  0.063

**- CF x 3 Mean**  0.051

**Unrounded MRL** 0.063

**Rounded MRL 0.07** Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 48 of 51 Green Onion
Abamectin
MRID 49455902

0 .079

– 0.082 lb ai/A/season; 6

- 8 day PHI

**Residues (mg/kg) n** 

< 0.004 4

0.00456 1

**Abamectin**

**Green Onion**

**USA and Canada** 

0 **.079**

**– 0.082 lb ai/A/season;**  **6**

**- 8 day PHI** 

**Total number of data (n)** 5

**Percentage of censored data** 80%

**Number of non**

**- censored data**  1

**Lowest residue** 0.004
**Highest residue** 0.005

**Median residue** 0.004

**Mean** 0.004

**Standard deviation (SD)** 0.000
**Correction factor for censoring (CF)** 0.467

**Proposed MRL estimate**

**- Highest residue**  0.005

**- Mean + 4 SD**  0.005

**- CF x 3 Mean**  0.006

**Unrounded MRL** 0.006

**Rounded MRL 0.01** 

High uncertainty of MRL estimate.
[Small dataset and high level of censoring]Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 49 of 51 Guava
Abamectin
MRID 49455903

0.073

- 0.074 lb ai/A; 8

- day PHI

**Residues (mg/kg) n** 

< 0.004 2

0.005 1

**Abamectin**

**Guava**

**USA**

**0.073**

**- 0.074 lb ai/A;**  **8**

**- day PHI** 

**Total number of data (n)** 3

**Percentage of censored data** 67%

**Number of non**

**- censored data**  1

**Lowest residue** 0.004
**Highest residue** 0.005

**Median residue** 0.004

**Mean** 0.004

**Standard deviation (SD)** 0.001
**Correction factor for censoring (CF)** 0.556

**Proposed MRL estimate**

**- Highest residue**  0.005

**- Mean + 4 SD**  0.007

**- CF x 3 Mean**  0.007

**Unrounded MRL** 0.007

**Rounded MRL 0.01** 

High uncertainty of MRL estimate.
[Small dataset and high level of censoring]Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 50 of 51 Lychee
Abamectin
MRID 49455905

**0.048**

**– 0.050 lb ai/A; 8** 

**- 13 day PHI**  **Residues (mg/kg) n** 

< 0.002 1

0.0024 1

0.0027 1

**Abamectin**

**L ychee** 

**USA**

**0.048**

**– 0.050 lb ai/A; 8** 

**- 13 day PHI** 

**Total number of data (n)** 3

**Percentage of censored data** 33%

**Number of non**

**- censored data**  2

**Lowest residue** 0.002
**Highest residue** 0.003

**Median residue** 0.002

**Mean** 0.002

**Standard deviation (SD)**  0.000
**Correction factor for censoring (CF)** 0.778

**Proposed MRL estimate**

**- Highest residue**  0.003

**- Mean + 4 SD**  0.004

**- CF x 3 Mean**  0.006

**Unrounded MRL** 0.006

**Rounded MRL 0.01** 

High uncertainty of MRL estimate.

[Small dataset]Abamectin Summary of Analytical Chemistry and Residue Data Barcode D 414022



### Page 51 of 51 Papaya
Abamectin
MRID 49455906

0.074

- 0.082 lb ai/A; 3

- 5 day PHI

**Residues (mg/kg) n** 

0.0051 1

0.123 1

0.131 1

**Abamectin**

**Papaya**

**USA**

**0.074**

**- 0.082 lb ai/A;**  **3**

**- 5 day PHI** 

**Total number of data (n)** 3

**Percentage of censored data** 0%

**Number of non**

**- censored data**  3

**Lowest residue** 0.005
**Highest residue** 0.131

**Median residue** 0.123

**Mean** 0.086

**Standard deviation (SD)** 0.070
**Correction factor for censoring (CF)** 1.000

**Proposed MRL estimate**

**- Highest residue**  0.131

**- Mean + 4**  **SD** 0.368

**- CF x 3 Mean**  0.259

**Unrounded MRL** 0.368

**Rounded MRL 0.4** 

High uncertainty of MRL estimate.

[Small dataset]