Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 3 of 33 Summary of Submitted Residue Chemistry Studies

OPPTS 860 Series

Guideline MRID

Number Title

860.1500 48590101 48590101 Samoil, K. (2011) Acetamiprid: Magnitude of the Residue on Asparagus. Project Number: 09939, 09939/08/MIR04. Unpublished study prepared by Interregional Research Project No. 4. 162 p.

48590102 48590102 Samoil , K. (2011) Acetamiprid: Magnitude of the Residue on Mustard Greens.

Project Number: 09271, 09271/09/CAR05. Unpublished study prepared by Interregional Research Project No. 4, University of Arkansas and U.S. Dept. of Agriculture, Agr. Res. Serv. 147 p

. 48590103 48590103 Samoil, K. (2011) Acetamiprid: Magnitude of the Residue on Sweet Corn.

Project Number: 10216, 10216/09/CAR01. Unpublished study prepared by Interregional Research Project No. 4, University of California and University of Florida. 232 p.

48590104 48590104 Lonsbary, S. (2010) Acetamiprid: Magnitude of the Residue on Sweet Corn:

Final Report. Project Number: AAFC06/034R, AAFC06/034R/297. Unpublished study prepared by University of California, Davis. 398 p.



## Background

The Agenc y has received a petition from the Interregional Research Project No. 4 (IR

- 4) to register the insecticide acetamiprid { (1 E )

- N

- [(6

- chloro

- 3

- pyridinyl)methyl]

- N '

- cyano

- N

methylethanimidamide } for post

- emergen t foliar use on asparagus; B rassica leafy greens, subgroup 5B, and turnip greens; and sweet corn. In addition, IR

- 4 is proposing to update crop group definitions for established tolerances for vegetable, fruiting, group 8

- 10; fruit, citrus, group

10

- 10; and fruit, pome, group 11

- 10

. The end

- use produc ts under consideration for the new uses are the 70% wettable powder (WP) formulation, Assail® 70 WP Insecticide (EPA Reg. No.

8033

- 23), and the 30% water soluble granule (SG) formulation, Assail® 30 SG Insecticide (EPA Reg. No. 8033

- 36).

Acetamiprid is registered for use on a number of crops, and permanent tolerances have been established (40 CFR § 180.578) ranging from 0.01 ppm to 50 ppm in plant commodities and from 0.010 ppm to 0.20 ppm in livestock commodities. The residue definition f or risk assessment and tolerance enforcement is the parent compound for plant commodities, and combined residues of the parent compound and Metabolite IM

- 2

- 1 for livestock commodities (plus Metabolite IM

- 2

- 1

- amide in ruminant muscle for risk assessment pur poses only). Acceptable analytical methods are available to enforce tolerances for residues of acetamiprid in plant and livestock commodities.



## Executive Summary

The petitioner is proposing to use acetamiprid as post

- emergence foliar applications to asparagus, brassica leafy vegetables and turnip greens, and sweet corn. Maximum seasonal rates and preharvest interv als (PHIs), respectively, are: 0.2 pounds active ingredient per acre ( lb ai/A ) and 1 day for asparagus, 0.375 lb ai/A and 3 days for B rassi ca leafy vegetables and turnip greens, and 0.21 lb ai/A and 7 days (following two applications) or 1 day (following four applications) for sweet corn.

To support the proposed uses, the petitioner has submitted studies depicting residues of acetamiprid i n/on asparagus, mustard greens, and sweet corn kernel + cob with husks removedAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 4 of 33 

### (K+CWHR), forage, and stover. The asparagus and mustard greens field trials were conducted in the U.S. and reflect application of the 70% WP formulation . The asparagus field t rials were

conducted with and without a non

- ionic surfactant (NIS), whereas all mustard greens field trials

included an NIS . Sweet corn field trials were conducted in the U.S. with the 30% SG formulation applied as both two and four applications with an N IS and in Canada with the 70% WP formulation applied as four applications without an adjuvant. Applications were made in accordance with the proposed labeling a t all trials, except that the Canadian sweet corn field trials reflected a significantly longer PHI for stover (38

- 89 days). Stover samples from the Canadian trials were allowed to dry before harvest, while samples from the U.S. trials were harvested at the target PHI s and dried after harvest in a dr y er or at ambient temperatures in the

field or t est facility

.

The residue data are supported by appropriate analytical method and storage stability data.

T he submitted crop field trial data for asparagus and mustard greens are adequate to support the proposed uses and are sufficient for establishing tolerances at 0.80 ppm in asparagus
, and 15

ppm in B rassica leafy greens, subgroup 5B, and turnip greens. Residues (and per trial averages) of acetamiprid were 0.11

- 0.43 (0.12

- 0.41) ppm in/on asparagus and 0.20

- 10 (0.30

- 9.2) ppm in/on mustard greens

.

HED has concluded that insufficient data have been submitted to support the use on sweet corn. Although there is evidence to support residue equivalency for the 70% WP formulation and the

30% SG formulation and the combination of trials conducted with the se two formulations provide for an adequate number of trials with sufficient geographic variation, it is not possible to

combine the two sets due to the significant differences in the stover PHIs between the U.S. and

Canadian trials. These differences are reflected in the residue data for stover. In the U.S. trials, residues (and per trial averages) of acetamiprid were <0.01 (<0.01) in K+CWHR , 0.39

- 10 (0.41

- 9

. 1) in forage , and 0.12

- 21 (0.19

- 20) ppm in stover . In the Canadian trials, residues (and per tri al averages) were <0.01 (<0.01) in K+CWHR , 0.23

- 1.1 (0.43

- 0.82) in forage , and <0.01

- 0.35 (0.011

- 0.285) ppm in stover

. Furthermore, although the use patterns were similar between the U.S. and Canadian trials for K+CWHR and forage (four applications, 1

- to 2

- day PHI), the U.S. trials performed with the 30% SG formulation included an adjuvant, whereas the Canadian trials using the 70% WP formulation did not include an adjuvant. Additional crop field trial data are required to support the proposed uses.



## R egulatory Recommendations

The available residue chemistry data for acetamiprid are sufficient for purposes of assessing risk

and establis hing tolerances in asparagus, B rassica leafy greens, subgroup 5B and turnip greens

. T he labels for the 7 0% WP and 30% SG formulation s should be modified to prohibit the harvest of turnip root s for food/feed purposes

, and to specify use of a n NIS as adjuvant for applications to asparagus, brassica leafy greens, and turnip s

. Furthermore, it was noted that the draft label for the 30% SG formulation includes the following error in the “Site” column: “Pome Fruit (within Crop Group 11)” instead of “Pome Fruit (within Crop Group 11

- 10 )”. This error should be

corrected on the label.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 5 of 33 

### There are no residue chemistry consideratio ns which would preclude granting registration of the

70% WP and 30% SG formulations for use on asparagus
, Brassica leafy greens, subgroup 5B and turnip greens. It is noted that all of the submitted field trials for asparagus and mustard greens used the 70 % WP formulation. The registrant is requesting the use of both the 70% WP

and the 30% SG formulation. Normally, consistent with OCSPP and OECD Crop Field Trial Guidance, a dditional bridging data would be required to support the use of the 30% SG

formulat ion. However, during a previous assessment, a similar situation was encou ntered and the registrant provided additional information on the SG formulation. As a result, HED

concluded that such data were not necessary, agreeing that due to high water solubi lity both products are likely to produce a solution of acetamiprid (D369474, 12/1/09)

. Therefore bridging data to support the use of the 30% SG formulation on these commodities are not required.

With the establishment of a tolerance in B rassica

, leafy greens, subgroup 5B, the established

tolerance in vegetable, B rassica , leafy, group 5, should be removed, and a new tolerance should

be established in B rassica , head and stem, subgroup 5A, at 1.2 ppm. No additional data are required to support this tolerance, as adequate residue data were previously submitted and

reviewed (D 264154, 12/31/01, M. Doherty )

. This petition requests a revised use pattern for subgroup 5B commodities, specifically a shorter PHI; therefore, a higher U.S. tolerance of 15

ppm is required.

The available residue chemistry data for acetamiprid are insufficient for assessing risk and establishing tolerances for use of the 30% SG and 70% WP formulations on sweet corn. Until the requested sweet corn field trial data have been su bmitted, this use should be removed from

both labels. Tolerances in sweet corn K+CWHR, forage, and stover will not be established until the outstanding data have been received. The registrant has been made aware of this data gap and will be submitting ad ditional field trial data at a later date.

The proposed use of acetamiprid on sweet corn will result in a significant increase in the maximum reasonable dietary burden for ruminants as a result of dietary contributions from sweet corn forage and cannery waste. Based on the data currently available, the tolerance in milk should be increased from 0.10 to 0.30 ppm, and the tolerances in the fat, meat, and meat byproducts of cattle, goat, horse, and sheep should be increased as follow s : from 0.10 to 0.20

p pm in fat; from 0.10 to 0.30 ppm in meat; and from 0.20 to 0.70 ppm in meat byproducts. HED recommends that the tolerances not be revised at this time, but be re

- evaluated when the outstanding data for sweet corn have been submitted and reviewed.

The established tolerances in vegetable, fruiting, group 8; fruit, citrus, group 10; and fruit, pome, group 11, can be updated to the current crop group definitions ( with no accompanying data ) to vegetable, fruiting, group 8

- 10; fruit, citrus, group 10

- 10; and fruit, pome, group 11

- 10.



## Pre

- Registration Data Needs

Asparagus; Brassica leafy vegetables, group 5 and subgroup s 5 A and 5B ; and turnip greens The petitioner should submit a revised Section F, specifying the recommended tolerances in Table 1, below.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 6 of 3 3 

### Sweet corn Five additional crop field trials should be conducted in the U.S. with the 30% SG formulation and an adjuvant in Zones 1 (1 trial), 5 ( 3 trials), and 12 (1 trial) to provide a full set of field trial

data for this formulation. Each trial sho uld include an additional side

- by

- side treated plot reflecting application of the 70% WP formulation with an adjuvant. Although the available data suggest that residues are similar following application according to the four

- application/1

- day PHI use patt ern and the two

- application/7

- day PHI use pattern, HED recommends that each use pattern be represented in at least two of the required trials. The registrant has been made aware of these issues and intends to complete the required trials during the 2012 g rowing season.

When the outstanding data for sweet corn have been submitted and reviewed, the established

tolerances in milk and the fat, meat, and meat byproducts of cattle, goat, horse, and sheep should

be re

- evaluated.



## Tolerance Considerations

Ana lytical Method

Approved tolerance enforcement methods for crops are available for acetamiprid, including gas chromatography with electroconductivity detection (GC/ECD) for vegetables and non

- citrus

fruits ; high performance liquid chromatography with ultra violet detection (HPLC/UV) for citrus fruits only ; and high performance liquid chromatography with tandem mass spectrometry detection (LC/MS/MS; Method #KP

- 216R0 and its modification Method #KP

- 216R1) for vegetables and non

- citrus fruits. The GC/ECD and HPLC/UV methods have undergone acceptable petition method validation (PMV) trials

. Following the submission of acceptable independent laboratory validation (ILV) data

, and the addition of a second daughter ion specific to acetamiprid to be monitored for an alysis of acetamiprid, the LC/MS/MS method was previously determined to be suitable for tolerance enforcement. The GC/ECD and LC/MS/MS methods use methanol extraction followed by partitioning into dichloromethane, and Florisil/silica gel column cleanup

. The HPLC/UV method uses acetonitrile (ACN) extraction, partitioning into hexane and dichloromethane, and Florisil/C18 cleanup. The limit of quantitation (LOQ) for vegetables and non

- citrus fruits is 0.01 ppm. The LOQ for citrus fruits is 0.05 ppm. An a pproved HPLC/UV tolerance enforcement method for livestock matrices is available. The LOQ is 0.01 ppm for meat, fat, milk, and eggs, and 0.05 ppm for liver and kidney.



## Recommended Tolerances

Table 1. Tolerance Summary for Acetamiprid.

Commodity Established/Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments ( Correct

Commodity Definition )

Asparagus 0.8 0.80

Brassica , leafy greens, subgroup 5B 15 15

Turnip greens 15 15 Turnip, greens

Vegetable, brassica, leafy, group 5 1.20 None With the establishment of the separate 5B tolerance, theAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 7 of 33 Table 1. Tolerance Summary for Acetamiprid.

Commodity Established/Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments ( Correct

Commodity Definition )

group 5 tolerance should be

removed.

Brassica , head and stem, subgroup

5A -- 1.2 Using the existing group 5 tolerance and available data, this separate 5A tolerance can

be established without

addi tional data.

Corn, sweet, kernel plus cob with

husks removed 0.01 To be determined Insufficient data are available to support the proposed

use/tolerances for sweet corn

at this time. Corn, sweet, forage 10

Corn, sweet, stover 30

V egetable, fruiting, group 8 0.20 None

F ruit, citrus, group 10 0.50 None

F ruit, pome, group 11 1.0 None

Vegetable, fruiting, group 8

- 10 0.20 0.20

Fruit, citrus, group 10

- 10 0.50 0.50

Fruit, pome, group 11

- 10 1.0 1.0



## International Harmonization

There are currently no established Codex, Canadian, or Mexican maximum residue limits (MRLs) for acetamiprid on asparagus and no established Codex MRLs on any B rassica vegetables ; therefore, there are no issues of harmonization. Canadian MRLs are establis hed for residues of acetamiprid at 1.2 ppm in/on Chinese cabbage ( Bok choy), cabbages, broccoli raab, collards, kale, mustard greens, mustard spinach, and rape greens. With the establishment of separate tolerances in leafy greens, subgroup 5B, and Brassica head and stem, subgroup 5A, the

Canadian MRLs for Bok choy Chinese cabbages

, b roccoli raab, collards, kale, mustard greens, mustard spinach, and rape greens will no longer be ha rmonized with U.S. tolerances. This petition requests a revised use p attern for subgroup 5B commodities, specifically a shorter PHI; therefore, a higher U.S. t olerance of 15 ppm is required. (Subgroup 5B includes b ok choy Chinese cabbage

, b roccoli raab, collards, kale, mustard greens, mustard spinach, and rape

greens .)



## Revisions to Petitioned

- For Tolerances

No revisions relative to the petitioned

- for tolerances are necessary for a sparagus; B rassica leafy

green s , subgroup 5 B ; or turnip greens. I n keeping with HED conventions for tolerance rounding and significant figures , the proposed tolerance for asparagus was changed from 0.8 ppm to 0.80

ppm

.

With the establishment of a tolerance in B rassica leafy greens, subgroup 5B, the established

tolerance in vegetable, B rassica , leafy, group 5, should be removed, and a n ew tolerance should

be established in B rassica , head and stem, subgroup 5A, at 1.2 ppm.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 8 of 33 

### Insufficient data are available to support the proposed tolerances in corn, sweet, kernel plus cob with husks removed; corn, sweet, forage; and corn, sweet, stover. Until the outstanding field trial data are received, no tolerances will be established.

No revisions are necessary relative to the petitioned

- for tolerances updating the cr op group definitions for vegetable, fruiting, group 8

- 10; fruit, citrus, group 10

- 10; and fruit, pome, group

11

- 10. The existing tolerances for the old crop group definitions should be removed.



## Residue Profile

Table 2. Acetamiprid Nom enclature.

Chemical Structure

Common Name Acetamiprid

Molecular Formula C 10 H 11 ClN 4 Molecular Weight 222.68

Company Experimental Name EXP

- 61842A, AEF124370, NI

- 25

IUPAC Name ( E )

- N 1

- [(6

- chloro

- 3

- pyridyl)methyl]

- N 2

- cyano

- N 1

- methylacetamidine

CAS Name (1 E )

- N

- [(6

- chloro

- 3

- pyridinyl)methyl]

- N'

- cyano

- N

- methylethanimidamide

CAS Registry Number 135410

- 20

- 7

End

- use Products (EPs) Assail® 70 WP Insecticide (EPA Reg. No. 8033

- 23) Assail® 30 SG Insecticide; EPA Reg. No. 8033

- 36)

Chemical Structure of Acetamiprid Metabolite

IM

- 2

- 1

N 1

- [(6

- chloro

- 3

- pyridyl )methyl]

- N 2

- cyano

- acetamidine

Chemical Structure of Acetamiprid Metabolite

IM

- 2

- 1

- amide (also referred to as IM

- 2

- 2)

N 2

- aminocarbonyl

- N 1

- [(6

- chloro

- 3

- pyridyl)methyl]acetamidine

Table 3. Physicochemical Properties of Technical

- Grade Acetamiprid.

Parameter Value Reference

Melting Point/Range ( C) 98.9 DP Barcode D328216, W. Drew, 

### N N

H Cl

C H 3



### N

O N H 2 

### N N

H C

l

C H 3



### N C N N N

C H 3 

### C

l

C H 3



### N C NAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 9 of 33 Table 3. Physicochemical Properties of Technical

- Grade Acetamiprid.

Parameter Value Reference

pH 6.08 (Aqueous solution at 20 C) 10/23/2007

Density (g/cm 3 ) 1.33 (at 20 C)

Water Solubility (g/L) 4.25 (at 25 C)

Solvent Solubility (at 25 C) Acetone >20 g/100 g

Methanol >20 g/100 g

Ethanol >20 g/100 g

Dichloromethane >20 g/100 g

Chloroform >20 g/100 g

Acetonitrile >20 g/100 g Tetrahydrofuran >20 g/100 g

Benzene 2.44 g/100 g Xylene 4.01 g/100 g

n

- Hexane 6.54 ppm

Carbon disulfide 507 ppm

Vapor Pressure (mm Hg) 7.5 x 10 - 9 (at 25 C) DP Barcode D 264154, M. Doherty;

12/31/2001

Dissociation Constant, pK

a 0.7 (at 25 C) DP Barcode D328216, W. Drew,

10/23/2007 Octanol/Water Partition Coefficient, Log K OW 0.8 (at 25 C)

UV/Visible Absorption Spectrum Not available



### The residue chemistry database for acetamiprid is complete and acceptable for supporting recommended tolerance levels and conducting human health risk assessments. The available metabolism data and information regarding physicochemical properties do not indicate that there are any special concerns with this chemical in terms of bioaccumulation, exposure, or other risk

assessment considerations.



## Residue Chemistry Guidelines

Directions for Use (860.1200)

Table 4. Summary of Proposed Directions for Use of Acetamiprid. 1

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

Asparagus

Post

- emergence, Broadcast, Aerial (≥5 gal/A) or ground, (≥20 gal/A) Assail®

70 WP [8033

- 23] 0.05

- 0.1 2 0.2 1 Minimum RTI = 10 days

Assail®

30 SG [8033

- 36] 0.047

- 0.1

Head and Stem Cole Crops (Crop Subgroup 5A): Broccoli, Chinese broccoli (gai lon), Brussels sprouts, Cabbage, Chinese Cabbage (bok choy, napa), Chinese

mustard cabbage (gai choy), Cavalo broccolo, Cauliflower, Kohlrabi
No change from established use pattern for Cole Crops (within Group 5) 3Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 10 of 33 Table 4. Summary of Proposed Directions for Use of Acetamiprid. 1

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

Leafy Cole Crops (Crop Subgroup 5B) and Turnip Greens: Broccoli raab (rapini), Collards, Kale, Mizuna, Mustard greens, Mustard spinach, Rape greens, Turnip greens

Post

- emergence, Broadcast, Aerial (≥5 gal/A) or ground, (≥30 gal/A) Assail®

70 WP [8033

- 23] 0.035

- 0.1 4 0.375 3 Minimum RTI = 7 days

Assail®

30SG [8033

- 36] 0.038

- 0.1

Sweet corn

Post

- emergence, Broadcast, Aerial (≥5 gal/A) or ground, (≥20 gal/A) Assail®

70 WP [8033

- 23]

Assail®

30 SG [8033

- 36] 0.075

- 0.1 2 0.21 7 Minimum RTI = 14 days

0.04

- 0.054 4 1 Minimum RTI = 7 days (if applied in a rotation or

tank mixture with another insecticide)

Fruiting Vegetables (within Crop Group 8

- 10): Eggplant (including A frican, pea, scarlet), Cocona, Garden huckleberry, Goji berry, Groundcherry, Martynia, Naranjilla, Okra, Pepino, Pepper (bell, nonbell), Roselle, Sunberry, Tomato (including bush, currant, tree), Tomatillo & Cultivars, varieties and/or hybrids of these

No change from established use pattern for Fruiting Vegetables (within Crop Group 8) 3

Citrus (within Crop Group 10

- 10): Calamondin, Citron, Citrus Hybrids, Grapefruit, Japanese summer grapefruit, Kumquat, Lemon, Lime (including Australian desert, Australian finger, Australian round, Brown River finger, Mount White, Russell River, sweet, Tahiti, New Guinea Wild), Mandarin (Mediterranean, Satsuma), Orange (sweet, sour, tac hibana, trifoliate),

Pummelo, Tangelo, Tangor, Uniq fruit & Cultivars, varieties and/or hybrids of these

No change from established use pattern for Citrus (within Crop Group 10) 3

Pome Fruit (within Crop Group 11

- 10): Apple, Azarole, Crabapple, Loquat, Ma y haw, Hook, Medlar, Pear (including Asian), Quince (including Chinese,

Japanese), Tejocote & Cultivars, varieties, and/or hybrids of these.

No change from established use pattern for Pome Fruit (within Crop group 11) 3

1 From draft labels dated 8/25/11 for Assail® 70 WP and 8/24/11 for Assail® 30 SG

2 RTI = Re

- treatment interval

3 Refer to accept ed labels dated 6/29/11 for both Assail® 70 WP and Assail® 30 SG.



### Adjuvant use : The draft labels for the 70% WP and 30% SG formulations state that an adjuvant,

such as a non

- ionic or silicone surfactant or methylated seed oil, is recommended on certain row crops. For the control of whiteflies on row crops, an adjuvant is recommended for vegetables (except legumes) and cotton . The draft labels for the 70% WP and 30% SG formulations also state that an adjuvant, such as a NIS , methylated seed oil, or horticultural oil, is recommended for use on orchard and vine crops, except on grapes. With regard to adjuvant use, the labels s tate “Please see specific crop use directions.” The specific crop use directions for asparagus do not mention the use of an adjuvant. For leafy cole crops (subgroup 5B), the specific use directions recommend the use of an adjuvant (type not specified) for control of whiteflies.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 11 of 33 

### It was note d that the use on the draft label for cabbage, Chinese bok choy, which is a member of subgroup 5B

, will be covered under subgroup 5A with the established use pattern for cole ( B rassica ) crops.

Conclusions . The labe ls are adequate to allow evaluation of the residue data relative to the proposed uses on asparagus; B rassica leafy greens , subgroup 5B, and turnip greens; and sweet

corn.

The asparagus and mustard greens field trials were conducted in the U.S. and refle ct application

of the 70% WP formulation with and without a n NIS for asparagus

, and with an NIS for mustard

greens . Sweet corn field trials were conducted in the U.S. with the 30% SG formulation applied as both two and four applications with an NIS

, and in Canada with the 70% WP applied as four applications without an adjuvant. Applications were made in accordance with the proposed labeling a t all trials, except that the Canadian sweet corn field trials reflected a significantly longer PHI for stove r (38

- 89 days).

HED has concluded that insufficient data have been submitted to support the use of either the 70% WP or the 30% SG formulation on sweet corn. Until the requested crop field trial data have been submitted, use on sweet corn should be remov ed from both labels.

In support of the proposed use on turnip greens, the label(s) should be revised to prohibit the harvest of turnip root for food/feed purposes because use on turnip root is not supported by

residue data or an established tolerance.

In support of the proposed use on B rassica leafy greens, subgroup 5B, the label(s) should be revised to include Chinese Bok Choy with the subgroup 5B commodities. Chinese Bok Choy is currently misplaced on the labels with subgroup 5A commodities.

T he labels should specify use of an NIS as adjuvant for the asparagus, B rassica leafy greens and turnip greens uses because other adjuvant types were not tested.

It was note d that the draft label for the 30% SG formulation includes the following error in th e “Site” column: “Pome Fruit (within Crop Group 11)” instead of “Pome Fruit (within Crop Group 11

- 10 )”. This error should be corrected on the label.



## Nature of the Residue (860.1300/1850)

Plants: Residue Chemistry Memo DP# 264154, 12/31/2001, M. Doher ty (PP#0F6082)

MARC Decision Memo, DP# 278652, 11/13/2001, M. Doherty

Livestock: Residue Chemistry Memo DP# 264154, 12/31/2001, M. Doherty (PP#0F6082)

MARC Decision Memo, DP# 278652, 11/13/2001, M. Doherty

Rotational: Residue Chemistry Memo DP# 328216, 10/23/2007, W. Drew (PP#6F7051 and PP#6E7163)

Residue Chemistry Memo DP# 264154, 12/31/2001, M. Doherty (PP#0F6082)



### Radiolabeled metabolism studies are available for carrot, cabbage, cotton, apple, eggplant, lactating goat, laying hen, and rat. In plan ts, there appears to be little translocation of acetamiprid following foliar application. In cabbage, there was uptake and translocation ofAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 12 of 33 

### acetamiprid to the above

- ground portions of the plant following a soil application. Due to the rapid dissipation of acetamiprid in the field, root uptake is not considered to be a likely source of residues in plants. Parent acetamiprid is the predominant residue (>90% TRR) in three of the

five metabolism studies. Confined rotational crop studies showed no residues of acetamiprid at

the 30

- day plant

- back interval.

Acetamiprid and metabolite IM

- 2

- 1 are the major residues in all ruminant tissues except muscle,

where IM

- 2

- 1

- amide accounts for nearly 50% of the TRR. IM

- 2

- 1

- amide was not found in any

other ruminant tissue . Metabolite IM

- 2

- 1 is the major residue in poultry tissues and eggs (50

- 80% TRR). IM

- 2

- 5 is also a major residue in eggs (~20% TRR). Parent acetamiprid was not detected in poultry tissues or eggs. The metabolism of acetamiprid in lactating goat was si milar to the profile observed in laying hen and rat. The initial transformation appears to be demethylation of the parent compound. The most abundant metabolite identified (both sexes) resulted from the removal of the cyanoacetamide group from demethylat ed parent. This removal (and direct removal of the group from the parent) resulted in cyanoacetamide metabolites.

Conclusions . The nature of the residue for acetamiprid is considered to be adequately understood for target crops, rotational crops, and livestock. The residue definitions for tolerance expression and risk assessment are summarized in Table 5.

Table 5. Risk Assessment and Tolerance Enforcement Residue Definitions for Acetamiprid.

Matrix Residues included in Risk Assessment Residues inc luded in Tolerance Expression

Plants Primary Crop Acetamiprid Acetamiprid

Rotational Crop Not applicable None at this time

Livestock Ruminant Acetamiprid + IM

- 2

- 1+ IM

- 2

- 1

- amide (ruminant muscle only) Acetamiprid and IM

- 2

- 1

Poultry Acetamiprid and IM

- 2

- 1 Acetamiprid and IM

- 2

- 1

Drinking Water Acetamiprid Not Applicable



## Residue Analytical Methods (860.1340)

Residue Chemistry Memo DP#s 342549 & 355773, 11/05/2008, W. Drew Residue Chemistry Memo DP# 328216, 10/23/2007, W. Drew (PP#6F7051 and PP#6E7163) Residue Chemistry Memo DP# 303623, 11/05/2004, W. Drew (PP#4F6833) Residue Chemistry Memo DP# 264154, 12/31/2001, M. Doherty (PP#0F6082)



### Enforcement methods : Adequate residue analytical methods (GC/ECD and HPLC/UV) are available for the enforcement of established tolerances on plant commodities. The method LOQs are 0.01 ppm for vegetables and non

- citrus fruits (GC/ECD), and 0.05 ppm for citrus fruits (HPLC/U V). These methods have undergone successful PMV trials. Under PP#4F6833, Nisso America proposed that the LC/MS/MS method utilized for data collection and confirmatory analysis (Method #KP

- 216R0 or its modification, Method #KP

- 216R1) be designated an

alte rnative to the established GC/ECD tolerance enforcement method. With submission of acceptable ILV data and the ability to analyze two daughter ions specific to acetamiprid, the

LC/MS/MS method was determined to be suitable for tolerance enforcement and co nfirmatoryAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 13 of 33 

### analysis of vegetables and non

- citrus fruits (DP#s 342549 & 355773). A summary of the available methods is presented in Table 6

.

Table 5. Table 6. Summary of Validated Analytical Methods for Acetamiprid.

T arget Matrices Method Description LOQ (ppm) Method Validation

Fortification Levels (ppm) Recovery

Range (%)

Vegetables and

Non

- Citrus Fruits Methanol extraction, residues partitioned into

dichloromethane, Florisil/silica gel column cleanup, and LC/MS/MS determination. 0.010 0.010, 0.020 72

- 80

Vegetables and

Non

- Citrus Fruits Methanol extraction, residues partitioned into

dichloromethane, Florisil/silica gel column cleanup, and GC/ECD determination. 0.010 0.010, 0.050 68

- 112

Citrus Fruits Acetonitrile extraction, co

- extractives partitioned

into hexane, residues partitioned into dichloromethane, Florisil/C18 column cleanup,

and HPLC/UV determination. 0.050 0.050, 0.250 77

- 100



### An approved HPLC/UV tolerance enforcement method for livestock matrices is available. The LOQ is 0.01 ppm for meat, fat, milk, and eggs, and 0.05 ppm for liver and kidney.

Data collection methods : Samples of asparagus, mustard greens, and sweet corn c ommodities from the U.S. field trials were analyzed for residues of acetamiprid using an LC/MS/MS method based on the LC/MS/MS tolerance enforcement method (Method KP

- 216R1). Samples of sweet corn matrices from the Canada field trials were analyzed for re sidues of acetamiprid using an LC/MS/MS method based on the GC/ECD enforcement method. The LOQ was 0.01 ppm (determined as the lowest level of method validation, LLMV) for residues of acetamiprid in/on

all matrices

.

For asparagus, mustard greens, and swe et corn commodities from the U.S. field trials, samples

were extracted with methanol / water (1:1, v:v), then vacuum filtered. The extract was brought to

volume with methanol / water (1:1, v:v or 1:3 , v:v), and an aliquot was applied to a Waters Oasis

HLB sol id phase extraction (SPE) column or Strata

- X SPE column. Residues were eluted with ACN. The resulting eluate was adjusted to volume with water and diluted as needed with

ACN / water ( 1:1 , v:v) or evaporated to near dryness under nitrogen and diluted with ACN / water ( 1:1 , v:v), then filtered for LC/MS/MS analysis.

For sweet corn commodities from the Canadian field trials, samples were extracted with methanol, then vacuum filtered. The extract was combined with 5% sodium chloride and partitioned with hexane followed by methylene chloride (2x). The methylene chloride phases were dried through anhydrous sodium sulfate and combined. The combined extracts were

evapor ated to dryness, redissolved in 20% acetone/hexane, and applied to a Supelclean LC

Florisil SPE column; residues were eluted with 50% acetone/hexane. The resulting eluate was evaporated to near dryness and adjusted to volume with 50% methanol/water, then filtered for LC/MS/MS analysis.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 14 of 33 

### Conclusions . The methods used in the submitted asparagus, mustard green, and sweet corn crop field trials are essentially identical to establishe d tolerance enforcement methods; these methods

are therefore suitable for dat a collection. In addition, acceptable method validation and concurrent recovery data were submitted with all studies, and the fortification levels used in method validation and concurrent recovery were adequate to bracket expected residue levels in

all cr op matrices. Concurrent recoveries and residues in treated samples were not corrected for residues in controls in any of the submitted studies.



## Multiresidue Methods (860.1360)

Residue Chemistry Memo DP# 264154, 12/31/2001, M. Doherty (PP#0F6082)



### D ata c oncerning the recovery of residues of acetamiprid using FDA multiresidue method protocols (PAM Volume I) were submitted in conjunction with the original acetamiprid petition (PP#0F6082). Based on the results of the testing, the multiresidue methods are no t appropriate for determining acetamiprid residues of concern. The Biological and Economic Analysis Division (BEAD) is currently working on a multi

- residue method for the neonicotinoids.



## Storage Stability (860.1380)

Concurrent storage stability studies were conducted with the crop field trial studies on asparagus, mustard greens, and sweet corn (U.S. trials). The data demonstrate that residues of acetamiprid were stable during frozen storage in/on samples of asparagus for intervals of up to 426 days (14 .2 months) , mustard greens for up to 394 days (13.0 months) , and sweet corn K+CWHR, forage, and stover for up to 384

- 391 days (12.6

- 12.9 months) . N o 0

- day data were provided for any study . These data are acceptable to support the storage conditions and d urations of samples from the submitted field trials; however, storage stability studies should always include a 0

- day sampling interval to establish the residue levels present at the time samples are placed into storage [see OCSPP 860.1380(d)(6)(i)].

The storage durations and conditions of samples from the asparagus, mustard green, and sweet corn crop field trials are presented in Table 7.

Table 7 . Summary of Storage Conditions and Durations of Samples from Crop Field Trial Studies.

Matrix Storage

Temperature (°C) Actual Storage Duration Interval of Demonstrated Storage Stability

Asparagus

- 20 70

- 473 days (2.3

- 15.6 months) Up to 426 days (14.0 months) in/on asparagus

Mustard greens 160

- 382 days (5.3

- 12.6 months) Up to 394 days (13.0 months) in/on mustard

greens

Sweet corn, K+CWHR 144

- 363 days (4 .7

- 11.9 months) Up to 384

- 391 days (12.6

- 12.9 months) in/on sweet corn K+CWHR, forage, and stover Sweet corn, forage 168

- 360 days (5 .5

- 11.8 months)

Sweet corn, stover 142

- 377 days (4.7

- 12.4 months)



### Conclusions . The submitted concurrent storage stability data for asparagus, mustard greens, and sweet corn commodities are adequate to support the submitted crop field trials. The data indicate that there are no storage stability issues, and no corrections for decline on storage are needed.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 15 of 33 

## Water, Fish, and Irrigated Crops (860.1400)

This guideline topic is not relevant to the proposed uses.



## Food Handling (860.1460)

This guideline topic is not relevant to the proposed uses.



## Meat, Milk, Poultry, and Eggs (860.1480)

Residue Chemistry Memo DP# 264154, 12/31/01, M. Doherty DER Reference: 44988601.der, 12/14/01, H. Bietlot



### There are ruminant feedstuffs (forage, stover, and cannery waste) associated with the proposed use of acetamiprid on s weet corn. T he re are no significant livestock feedstuffs associated with

the proposed uses on asparagus; B rassica leafy greens, subgroup 5B ; and turnip greens.

Although additional crop field trial data are required for sweet corn to support the proposed use, the maximum reasonable dietary burdens of acetamiprid to ruminants, based on the addition of sweet corn forage and cannery waste

, are calculated herein for informational purposes (Table 8).

With the addition of sweet corn feedstuffs, the dietary bu rdens are 1.132 ppm for beef cattle and 12.777 ppm for dairy cattle. The current livestock tolerances are based on a maximum theoretical dietary burden of 4.5 ppm.

Table 8

. Calculation of Dietary Burdens of Acetamiprid Residues to Cattle.

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 Established

Tolerance or HR 3
(ppm) Dietary Contribution

(ppm) 4

Beef Cattle

Cotton gin byproducts R 90 5 20.0 1.111

R not registered R

-- 10

-- -- Potato processed waste CC 15 30 0.01 0.020

CC not registered CC

-- 50

-- --
Canola meal PC 88 5 0.01 0.001

TOTAL BURDEN

-- -- 100

-- 1.132

Dairy Cattle

Sweet corn forage R 48 45 10.0 9.375

Sweet corn cannery

waste CC 30 10 10.0 3.333

CC not registered CC

-- 3 5

-- -- Cotton, undelinted seed P C 88 10 0.60 0.068Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 16 of 33 Table 8

. Calculation of Dietary Burdens of Acetamiprid Residues to Cattle.

Feedstuff Type 1 % Dry

Matter 2 % Diet 2 Established

Tolerance or HR 3
(ppm) Dietary Contribution

(ppm) 4

TOTAL BURDEN

-- -- 100

-- 12.777

1 R = Roughage; CC = carbohydrate concentrate; PC = protein concentrate.

2 OCSPP 860.1000 Supplement (June 2008)

3 HR = Highest residue. HR used for sweet corn forage (and cannery waste); established tolerances used for remaining commodities.

4 Contribution = [tolerance or HR/% DM] X % diet



### In the cattle feeding study (refer to 44988601.der), the dietary feeding levels were 6, 18, and 60 ppm. Based on the data for sweet corn forage that are currently available, these correspond to 0.47x, 1.4x, and 4.7x the maximum reasonable dietary burden t o dairy cattle.

If the residues observed at the three dosing levels are adjusted to a 1x feeding level for dairy cattle (see Table 9 ), maximum expected combined residues of acetamiprid and IM

- 2

- 1 would be

0.28 ppm in milk, 0.61 ppm in kidney, 0. 56 ppm i n liver

, 0.15 ppm in fat , and 0.24 ppm in

muscle.

Table 9

. Summary of Data from Cattle Feeding Study with Acetamiprid.

Matrix Maximum combined residues of acetamiprid and IM

- 2

- 1 at each dosing

level 1 Residues adjusted to 1x feeding level for dairy cattle

6 18 60 0.5x 1.4 x 4.7 x
Milk (Days 4

- 27 ) 0.081 0.366 1.3 0.17 0.26 0.28

Fat <0.072 0.153 0.714 <0.15 0.11 0.15

Kidney <0.25 <0.86 2.54 <0.53 <0.61 0.54

Liver <0.15 0.64 2.65 <0.32 0.46 0.56

Muscle <0.050 0.289 1.11 <0.11 0.21 0.24

1 The LOQ s were 0.01 ppm for milk, fat, and muscle and 0.05 ppm for kidney and liver



### Conclusions. The proposed use of acetamiprid on sweet corn will result in a significant increase in the maximum reasonable dietary burden to ruminants as a result of dietary contr ibutions from sweet corn forage and cannery waste. When the results of the dairy cattle feeding study are adjusted for the increased dietary burden, the maximum expected combined residues of acetamiprid and IM

- 2

- 1 increase in milk and all tissues.

Based on the data currently available, the tolerance in milk should be increased from 0.10 to 0.30 ppm, and the tolerances in the fat, meat, and meat byproducts of cattle, goat, horse, and sheep should be increased from 0.10 to 0.20 ppm in fat; from 0.10 to 0.30 ppm in meat; and from 0.20 to 0.70 ppm in meat byproducts. T he tolerances should not be revised at this time, but be re

evaluated when the outstanding data for sweet corn have been submitted and reviewed.

Because sweet corn commodities are not significant feedstuffs for poultry or swine, no changes

are needed to the established tolerances in eggs, n or in poultry or hog tissues.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 17 of 33 

## Crop Field Trials (860.1500)

DER References: 48590101.der (Asparagus)

48590102.der (Mustard greens) 48590103.der (Sweet corn, U.S. trials) 48590104.der (Sweet corn, Canada trials).



### Asparagus

IR

- 4 has submitted field trial data for acetamiprid on asparagus

. During the 2008

- 2009 growing

season, 8 U.S. field trials w ere conducted in the following North American Free Trade Agreement (NAFTA) Growing Zones: 2 (MD; 1 trial); 5 (MI; 2 trials); 10 (CA; 3 trials); and 11 (ID and WA; 2 trials). The 2 MI trials and 2 of the CA trials were conducted by the same Field

Research Dire ctors (FRDs) at the same trial locations and used the same variety of asparagus. Careful examination of the field trial records indicates that the only differences between the two trials were use of different tank mixes for all applications

, and a 7

- day ( CA trials) or 21

- day (MI trials) offset in application dates. HED has concluded that the differences between these CA trials are insufficient to classify them as separate trials; therefore, this pair of trials constitutes a single trial with replicate sam ples for purposes of OCSPP 860.1500 data requirements. In the case of the MI trials, HED has concluded that while not ideal, the 21

- day offset in application dates is sufficiently different to be classified as independent field trials. The adjustment in trial numbers results in a total of seven field trials, with two trials total conducted in NAFTA Zone

10.

Each trial consisted of one untreated plot and one treated plot. T he treated plots received two foliar broadcast applications of a 70% WP f ormulation of acetamiprid (Assail® 70 WP) at 0.099

- 0.103 lb ai/A/application for a total seasonal rate of 0.200

- 0.204 lb ai/A (~1x the maximum proposed seasonal application rate) . Applications were made at 10

- to 14

- day retreatment intervals (RTIs) using ground equipment in spray volumes of 20

- 36 gal/A. In five of eight trials,

an NIS was added to each spray mixture (second application only at one of the trials); an adjuvant was not added to the spray mixtures at the remaining trial sites. Samples of asp aragus were harvested at maturity at a PHI of 1 day. In one CA trial, additional samples were harvested at PHIs of 0, 4, 8, and 11 days to assess residue decline.

Samples were analyzed for residues of acetamiprid using an adequate LC/MS/MS method , and

th e study is supported by acceptable storage stability data (see Table 7).

The results of the asparagus field trials are presented in Table 10

. Following two foliar broadcast applications of the 70% WP formulation of acetamiprid at a total rate of 0.200

- 0. 204 lb ai/A, residues of acetamiprid (and per trial averages) were 0.11

- 0.43 (0.12

- 0.41) ppm in/on asparagus spears at a 1

- day PHI.

When residues are compared for trials conducted with and without an adjuvant, residues were generally higher following appl ications made with an NIS (0.21

- 0.43 ppm; average 0.28 ppm) than following applications made without an adjuvant (0.11

- 0.26 ppm; average 0.18 ppm).Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 18 of 33 

### In the residue decline trial, residues of acetamiprid declined with increasing PHI.

Table 10. Summary of Residue Data from Asparagus Crop Field Trials with Acetamiprid.

Commodity Total

Applic. Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

ASPARAGUS (proposed use = 0.2 lb ai/A total application rate, 1

- day PHI)

Asparagus 0.200

- 0.204 1 7 0.11 0.43 0.12 0.41 0.2 6 0.25 0.09

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials.

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



### Conclusions . The submitted residue data for asparagus are acceptable. An acceptable method was used for residue quantitation, and the study is supported by adequate storage stabili ty data. The study reflects the maximum proposed use pattern for the 70% WP formulation for

asparagus . O wing to the designation of one pair of residu e trials as a single trial with replicate samples, geographic representation is inadequate from NAFTA Zon e 10 per OCSPP 860.1500 (refer to Appendix I ). However, given the requested PHI of 1 day, the maximum anticipated residues are going to be driven by application parameters and not meteorological or cultural practices. Furthermore, the available residue data is tightly grouped around the mean, with a small observed standard deviation. Therefore, it is highly unlikely that additional residue data from Zone 10 would have a significant impact on the recommended tolerance. Consequently HED is not requesting additional field trials for asparagus.

It is noted that a ll of the submitted field trials used the 70% WP formulation. The registrant is requesting the use of both the 70% WP and the 30% SG formulation. Normally, consistent with OCSPP and OECD Crop Field Trial Guidance, a dditional bridging data would be required to support the use of the 30% SG formulation. However, during a previous assessment, a similar situation was encountered and the registrant provided addit ional information on the SG formulation. As a result, HED concluded that such data were not necessary, agreeing that due to high water solubility both products are likely to produce a solution of acetamiprid (D369474, 12/1/09)

. Therefore bridging data to support the use of the 30% SG formulation on asparagus are not required. The data are sufficient for establishing tolerances on asparagus associated with the requested registration of the 70% WP and 30% SG formulation s.

Mustard greens

IR

- 4 has submit ted field trial data for acetamiprid on mustard greens

. During the 2009 growing

season, 8 U.S. field trials w ere conducted in the U .S. in the following North American Free

Trade Agreement (NAFTA) Growing Zones: 2 (GA, NC, and SC; 3 trials); 4 (AR; 1 trial); 5 (OH; 1 trial); 6 (TX; 1 trial); and 10 (CA; 2 trials). The 2 CA trials were conducted by the same

FRD at the same trial locations. Examination of the field trial records indicates that there were sufficient differences between the trials, inclu ding use of different tank mixes for all applications

, a 60

- day offset in initiation

, different crop varieties

, and different spray equipment.

Each trial consisted of one untreated plot and one treated plot. T he treated plots received four

foliar broad cast or directed applications of a 70% WP formulation of acetamiprid (Assail® 70Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 19 of 33 

### WP) at 0.074

- 0.080 lb ai/A for the first application and at 0.097

- 0.104 lb ai/A for subsequent applications, for a total seasonal rate of 0.374

- 0.384 lb ai/A (~1x the maximum proposed seasonal application rate) . A fifth application was made at the GA trial at 0.101 lb ai/A because the crop was not mature after four applications; the total seasonal rate for this trial was 0.476 lb ai/A. Applications were made at 6

- to 8

- day RT Is u sing ground equipment in spray volumes of

27

- 47 gal/A. An NIS was added to each spray mixture. Samples of mustard greens were harvested at maturity at PHIs of 2

- 4 days.

Samples were analyzed for residues of acetamiprid using an adequate LC/MS/MS met hod, and the study is supported by acceptable storage stability data (see Table 7).

The results of the mustard greens field trials are presented in Table 1 1

. Following four or five foliar broadcast or directed applications of the 70% WP formulation of acetamiprid at a total rate

of 0.374

- 0.476 lb ai/A, residues of acetamiprid (and per trial averages) were 0.20

- 10 (0.30

- 9.2) ppm in/on mustard greens at PHIs of 2

- 4 days. Residues at the GA trial that received five applications were well within the range of residues at the remaining trials.

No residue decline data were included in the submission ; however, no additional data are required because sufficient residue decline data are available for acetamiprid, indicating that residues do not increase with increasing harvest intervals (refer to DP# 264154, 12/31/01, M. Doherty and others ).

Table 11. Summary of Residue Data from Mustard Greens Crop Field Trials with Ac etamiprid.

Commodity Total

Applic. Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1

n Sample

Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

BRASSICA, LEAFY GREENS, SUBGROUP 5B and TURNIP GREENS (proposed use = 0.375 lb ai/A total application rate, 3

- day PHI)

Mustard greens 0.374

- 0.476 2

- 4 8 0.20 10 0.30 9.2 1.9 2.6 2.8

1 Except for sample min/max, values reflect per trial averages; n = no. of field trials.

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



### Conclusions

. The submitted residue data for mustard greens are acceptable. The study reflects the maximum proposed use pattern for the 70% WP formulation for B rassica leafy greens, subgroup 5B and turnip greens, and the number and location of the field t rials are in accordance with OCSPP 860.1500 for mustard greens (refer to Appendix I). An acceptable method was used for residue quantitation, and th e study is s upported by adequate storage stability data.

The submitted residue data are adequate to support use of both the 70% WP and 30% SG

formulation s of acetamiprid on B rassica leafy greens and turnip greens

. It is noted that all of the submitted field trials used the 70% WP formulation. The registrant is requesting the use of both

the 70% WP and the 30% SG formulation. However, during a previous assessment, a similar situation was encountered and the registrant provided additional information on the SG formulation. As a result, HED concluded that such d ata were not necessary, agreeing that due to high water solubility both products are likely to produce a solution of acetamiprid (D369474, 12/1/09)

. Therefore bridging data to support the use of the 30% SG formulation on B rassicaAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 20 of 33 

### leafy greens and turnip greens are not required. The data are sufficient for establishing

tolerances on B rassica leafy greens and turnip greens associated with the requested registration of the 70% WP and 30% SG formulations (see below).

Sweet corn

Se ven sweet corn field trials were conducted in the U.S. during the 2009 growing season, and five trials were conducted in Canada during the 2006 growing season. The use patterns were similar. In the U.S. trials, samples of K+CWHR, forage, and stover (drie d after harvest) were

harvested at a 1

- day PHI following four applications of the 30% SG formulation at a total rate of

~0.21 lb ai/A or at a ~7

- day PHI following two applications of the 30% SG formulation at a total

rate of ~0.21 lb ai/A. In the Canadian trials, samples of K+CWHR and forage were harvested at

a 1

- to 2

- day PHI following four applications of the 70% WP formulation at a total rate of ~0.21 lb ai/A, and stover was harvested at maturity (41

- to 89

- day PHIs). The application rates used in

the studies are equivalent to ~1x the maximum proposed seasonal application rate.

U.S. Trials

IR

- 4 has submitted field trial data for acetamiprid on sweet corn. During the 2009 growing

season, 7 U.S. field trials w ere conducted in the following North America n Free Trade Agreement (NAFTA) Growing Zones: 1 (NY; 1 trial); 2 (GA and SC; 2 trials); 3 (FL; 1 trial); 5A (WI; 1 trial); 10 (CA; 1 trial); and 11 (ID; 1 trial).

Each trial consisted of one untreated plot and two side

- by

- side treated plots. At each tria l location, one treated plot (plot 2) received four foliar broadcast or directed applications of a 30% SG formulation of acetamiprid ( Assail® 30 SG) at 0 .053

- 0.057 lb ai/A/application for a total

seasonal rate of 0.212

- 0.220 lb ai/A . A second plot (plot 3 ) received two foliar broadcast or directed applications of the same formulation at 0.094

- 0.109 lb ai/A/application for a total

seasonal rate of 0.195

- 0.214 lb ai/A. Applica tions were made at 4

- to 8

- da y RTIs (plot 2) or 12

- to 16

- day RTIs (plot 3) using ground equipment

, in spray volumes of 23

- 49 gal/A. An NIS was added to each spray mixture.

Samples of K+CWHR, forage, and stover were harvested from the side

- by

- side plots at PHIs of 1 day (plot 2) or 5

- 8 days (plot 3), except at the NY trial, where PHIs for stover were 28 and 35 days for plots 2 and 3, respectively. Stover was dried in a dr y er or allowed to dry at ambient temperatures in the field or at the test facility for 2

- 18 days after harvest to a moisture con tent of

15

- 20%, except at the NY trial, where stover was allowed to dry prior to harvest.

Samples were analyzed for residues of acetamiprid using an adequate LC/MS/MS method, and the study is supported by acceptable storage stability data (see Table 7).

The results of the sweet corn field trials are presented in Table 1 2 (below)

. In samples of sweet corn harvested 1 day following four foliar broadcast or directed applications of the 30% SG formulation of acetamiprid at a total rate of 0.212

- 0.220 lb ai /A, acetamiprid residues (and per trial averages) were <0.01 (<0.01) in K+CWHR , 0.42

- 8.1 (0.54

- 7.3) in forage , and 0.12

- 16 (0.19

- 15.5) ppm in stover. In samples of sweet corn harvested 5

- 8 days following two foliar broadcast or directed applications of th e 30% SG formulation of acetamiprid at a total rate ofAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 21 of 33 

### 0.195

- 0.214 lb ai/A, acetamiprid residues (and per trial averages) were <0.01 (<0.01) in

K+CWHR , 0.39

- 10 (0.41

- 9.1) in forage , and 0.21

- 21 (0.21

- 20) ppm in stover. Results for stover

from the NY trial s, dried before harvest and reflecting PHIs of 28 and 35 days, were within the range of residue results for samples from the remaining trials reflecting ~1 and ~7

- day PHIs and

post

- harvest drying.

Side

- by

- side comparison of residues in/on corn forage and stover harvested 1 day following four

foliar applications or 5

- 8 days following two foliar applications suggested that the use patterns yielded similar residues in both matrices, with neither use pattern yielding consistently higher or

lower residues ; how ever, the data summary indicates that overall residues were slightly higher in both forage and stover following two applications with a 5

- to 8

- day PHI.

No residue decline data were included in the submission; however, residue decline data

submitted wit h the Canada sweet corn field trials indicated that residues of acetamiprid generally declined with increasing PHI in sweet corn forage and stover.

Canada trials

IR

- 4 has submitted field trial data for acetamiprid on sweet corn. During the 2006 growing

season, 8 field trials w ere conducted in Canada in the following North American Free Trade Agreement (NAFTA) Growing Zones: 5 (ON; 4 trials); 5B (QC; 2 trials); 7A (AB; 1 trial); and 12 (BC; 1 trial). The two pairs of ON trials and the two QC trials were conducted by the same

FRDs at the same trial locations. Careful examination of the field trial records indicates that the only differences between the two trials in each pair were the use of different tank mixes for all application s, different crop varieties, and a 6

- to 7

- day offset in application dates (ON trials). HED has concluded that the differences between the trials are insufficient to classify them as separate trials; therefore, each trial pair constitutes a single trial w ith replicate samples for purposes of OCSPP 860.1500/PMRA Regulatory Directive 98

- 2 data requirements. The adjustment in trial numbers results in a total of five field trials, with two trials conducted in

NAFTA Zone 5 and one trial conducted in NAFTA Zone 5B.

Each trial consisted of one untreated plot and one treated plot. T he treated plots received four foliar broadcast applications of a 70% WP f ormulation of acetamiprid (Assail® 70 WP) at 0.052

- 0.056 lb ai/A/application (58.7

- 62.6 g ai/ha/application) for a total seasonal rate of 0.213

- 0.219 lb ai/A (238.5

- 245.4 g ai/ha) . Due to an oversight by field personnel, the first three applications

at the AB trial site were made at 0.074

- 0.077 lb ai/A (82.7

- 86.6 g ai/ha), which resulted in a total

seasonal rate of 0.281 lb ai/A (314.7 g ai/ha). Applications were made at 6

- to 8

- da y RTIs u sing ground equipment

, in spray volumes of 20.8

- 77.0 gal/A (194

- 720 L/ha). An adjuvant was not added to the spray mixtures at any of the trial sites. Samples of sweet corn K+ CWHR an d forage

were harvested at PHIs of 1

- 2 days; stover samples were harvested at maturity at PHIs of 38

- 89 days. To assess residue decline, i n one ON trial, additional samples were harvested at PHIs of 0, 3, and 7 days for K+CWHR and forage, and at 70 , 83, and 90 days (target PHI = 76 days) for

stover.

Samples were analyzed for residues of acetamiprid using an adequate LC/MS/MS method, and the study is supported by acceptable storage stability data (see Table 7).Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 22 of 33 

### The results of the sweet corn field trials are presented in Table 1 2 (below)

. Following four foliar broadcast applications of the 70% WP formulation of acetamiprid at a total rate of 0.213

- 0.281 lb ai/A (238.5

- 314.7 g ai/ha), acetamiprid residues (and per trial averages) were <0.01 (< 0.01) ppm

in/on K+CWHR and 0.23

- 1.1 (0.43

- 0.82) ppm in/on forage harvested at PHIs of 1

- 2 days, and

<0.01

- 0.35 (0.011

- 0.285) ppm in/on stover harvested at PHIs of 41

- 89 days. It was note d that the highest residues in stover (0.22 and 0.35 ppm) were observ ed in/on samples from the AB trial which received a total seasonal application rate of 0.281 lb ai/A (314.6 g ai/ha). Although this rate exceeded the target application rate by ~22%, residues in these samples were still included in the summary data calcul ations

.

In the residue decline trial, residues of acetamiprid generally declined with increasing PHI in sweet corn forage and stover. Residues in K+CWHR were below the LOQ at all harvest intervals; therefore, residue decline could not be assessed.

Tab le 12. Summary of Residue Data from Sweet Corn Crop Field Trials with Acetamiprid.

Com

modity No.

Apps. Total Applic.

Rate (lb ai/A) PHI

(days) Residue Levels (ppm) 1

n Sampl

e Min. Sample

Max. LAFT 2 HAFT 2 Median Mean Std.

Dev.

SWEET CORN (proposed use = 0.21 lb ai/A total application rate; 4 applications with a 1

- day PHI or 2 applications with a 7

- day PHI)

U.S. Trials (30% SG formulation)

K+CWHR 4 0.212

- 0.220 1 7 <0.01 <0.01 0.01 0.01 0.01 0.01 N/A

2 0.195

- 0.214 5

- 8 7 <0.01 <0.01 0.01 0.01 0.01 0.01 N/A

Forage 4 0.212

- 0.220 1 7 0.42 8.1 0.54 7.3 1.3 3.0 2.8

2 0.195

- 0.214 5

- 8 7 0.39 10 0.41 9.1 1.4 2.9 3.1

Stover 4 0.212

- 0.220 1 3 7 0.12 16 0.19 15.5 4.1 5.7 5.7

2 0.195

- 0.214 5

- 8 3 7 0.21 21 0.21 20 2.8 5.3 7.0

Canada Trials (70% WP formulation)

K+CWHR 4 0.213

- 0.281

(238.5

- 314.7) 1

- 2 5 <0.01 <0.01 0.01 0.01 0.01 0.01 N/A

Forage 4 5 0.23 1.1 0.43 0.82 0.61 0.60 0.15

Stover 4 0.213

- 0.219

(238.5

- 245.4) 41

- 89 5 <0.01 0. 35 0.011 0. 285 0.0 50 0.0 82 0.0 95

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

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

3 Including PHIs of 28 and 35 days for stover from plots 2 and 3 of the NY tr ail , respectively. Although the PHIs

from this trial differed by >25%, this data was included in the summary results because the residues were within the range of those in the other trials, and the use pattern was consistent with typical stover harvest

.



### Conclusions . The submitted residue data for sweet corn are acceptable. The study reflects the maximum proposed use patterns for sweet corn, and, if the U.S. and Canadian field trials are combined, the number and location of the field trials are in accor dance with OCSPP 860.1500 for sweet corn (refer to Appendix I ). A cceptable methods were used for residue quantitation,

and th e studies are su pported by adequate storage stability data.

In considering the available data, HED has concluded that insufficient data have been submitted to support the use on sweet corn. Although there is evidence to support residue equivalency for

the 70% WP formulation and the 30% SG formulation and the combination of trials conductedAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 23 of 33 

### with the se two formulations provide for an adequate number of trials with sufficient geographic variation, it is not possible to combine the two sets due to the significant differences in the stover

PHIs between the U.S. and Canadian trials. These differences are reflected in the residue data for stover. In the U.S. trials, residues (and per trial averages) of acetamiprid were <0.01 (<0.01) in K+CWHR, 0.39

- 10 (0.41

- 9.1) in forage, and 0.12

- 21 (0.19

- 20) ppm in stover. In the Canadian trials, residues (and per tri al averages) were <0.01 (<0.01) in K+CWHR, 0.23

- 1.1 (0.43

- 0.82) in forage, and <0.01

- 0.35 (0.011

- 0.285) ppm in stover. Furthermore, although the use patterns were similar between the U.S. and Canadian trials for K+CWHR and forage (four applications, 1

- to 2

- day PHI), the U.S. trials performed with the 30% SG formulation included an adjuvant, whereas the Canadian trials using the 70% WP formulation did not include an adjuvant. Additional crop field trial data are required to support the proposed uses.

B ased on the crop field trial study designs, the U.S. use pattern appears to be less restrictive for stover (1

- or 7

- day PHI in the U.S. vs. harvest at maturity in Canada); therefore, to support the proposed uses on sweet corn, five additional crop field tr ials must be conducted in the U.S. with

the 30% SG formulation and an adjuvant in Zones 1 (1 trial), 5 (3 trials), and 12 (1 trial) to provide a full set of field trial data for this formulation. Each trial should include an additional

side

- by

- side treate d plot reflecting application of the 70% WP formulation with an adjuvant. Although the available data suggest that residues are similar following application according to

the four

- application/1

- day PHI use pattern and the two

- application/7

- day PHI use pat tern, HED recommends that each use pattern be represented in at least two of the required trials.

HED concludes that the available data are insufficient for establishing tolerances associated with the requested registration at this time.



## Processed Fo od and Feed (860.1520)

There are no significant processed commodities associated with the proposed uses on asparagus;
B rassica leafy greens, subgroup 5B and turnip greens; or sweet corn

.



## Submittal of Analytical Reference Standards (860.1650)

Analytical standard s for acetamiprid and metabolites IM

- 2

- 1, and IM

- 2

- 2 are currently available in the EPA National Pesticide Standards Repository

, confirmed via personal communication

bet ween T. Cole, of BEAD’s A nalytical C hemistry B ranch (ACB) , and Versar, 11/30 /11

. Please

note that the acetamiprid metabolite IM

- 1

- 2 ha s expired ( 8/1/2009 ) and an updated certificate of analysis ( COA ) or a new standard for this compound should be sent in . The a nalytical reference

standard for metabolite IM

- 1

- 2 should be supplied and supplies replenished as requested by the Repository , or an updated COA should be supplied . The reference standards should be sent to

ACB , which is located at Fort Meade, to the attention of either Theresa Cole or Frederic Siegelman at the following addre ss:Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 24 of 33 

### USEPA National Pesticide Standards Repository/Analytical Chemistry Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755

- 5350

(Note that the mail will be returned if the extended zip code is not used.)



## Rotational Crops (Field; 860.1900)

Residue Chemistry Memo DP# 328216, 10/23/2007, W. Drew (PP#6F7051 and PP#6E7163)



### No field rotational crop data have been submitted, and no rotational crop restrictions are established on the subject labels . The available confined rotational crop data ind icate that no field rotational crop studies or label restrictions for rotational crops are required to support the proposed uses.



## Tolerance Derivation

Residue Chemistry Memo DP# 264154, 12/31/2001, M. Doherty (PP#0F6082)



### Tolerances are currently establi shed under 40 CFR §180.578(a)(1) for residues of the insecticide, acetamiprid, to be determined by measuring only acetamiprid, in or on crop matrices. The tolerance expression proposed by IR

- 4 in this petition is consistent with 40 CFR §180.578(a)(1).

Sw eet corn. HED has concluded that the available data for sweet corn are insufficient to establish tolerances at this time; therefore, the data were not entered into the OECD tolerance

calculat i o n procedure , and the proposed tolerances were not assessed.

U pdated crop group definitions . The established tolerances for vegetable, fruiting, group 8; fruit, citrus, group 10; and fruit, pome, group 11, can be updated to the current crop group definitions with no accompanying data to vegetable, fruiting, group 8

- 10 (at 0.20 ppm); fruit, citrus, group 10

- 10 (at 0.50 ppm); and fruit, pome, group 11

- 10 (at 1.0 ppm).

Livestock commodities . The available field corn residue data indicate that the established tolerances on milk and the fat, meat, and meat byproducts of cattle, goat, horse, and sheep may be too low once use on sweet corn has been registered. The established tolerances will be reassessed when the outstanding sweet corn field trial data have been received.

Asparagus ; B rassica, leafy greens, subgroup 5B ; and turnip greens. Sufficient field trial data have been submitted for asparagus and mustard greens for establishing tolerances associated with the requested registration of the 70% WP formulation and the 30% SG formulation. The

available field trial d ata will support the proposed tolerances of 0.80 ppm in asparagus and 15

ppm in B rassica leafy greens, subgroup 5B and turnip greens

. The OECD tolerance calculation procedure (March 2011 version) was utilized in determining the appropriate tolerance level s. Average values from the asparagus and mustard greens field trials were used.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 25 of 33 

### With the establishment of a tolerance in B rassica

, leafy greens, subgroup 5B, the established

tolerance in vegetable, B rassica , leafy, group 5 should be removed, and a new to lerance should

be established in B rassica , head and stem, subgroup 5A, at 1.2 ppm. No additional data are required to support this tolerance because adequate residue data were previously submitted and

reviewed under DP# 264154.

There are currently no established Codex, Canadian, or Mexican MRLs for acetamiprid on asparagus and no established Codex MRLs on any B rassica vegetables ; therefore, there are no

issues of harmonization. Canadian MRLs are established for residues of acetamiprid at 1.2 ppm

in/on Chinese cabbage (bok choy), cabbages, broccoli raab, collards, kale, mustard greens, mustard spinach, and rape greens. With the establishment of separate tolerances in B rassica leafy greens, subgroup 5B, and B rassica head and stem, subgroup 5A, the Canadian MRLs for Bok choy Chinese cabbages

, b roccoli raab, collards, kale, mustard greens, mustard spinach, and

rape greens will no longer be harmonized with U.S. tolerances. This petition requests a revised use pattern f

or subgroup 5B commodities, specifically a shorter PHI; therefore, a higher U.S. tolerance of 15 ppm is required. An International Residue Limit Status Sheet (IRLS) follows the

references in this document.

The proposed and recommended tolerances for acetamiprid as a result of the subject action are presented in Table 1

.

References

MARC Decision Memo, DP# 278652, 11/13/2001, M. Doherty DER Reference: 44988601.der, 12/14/01, H. Bietlot

R esidue Chemistry Memo DP# 264154, 12/31/2001, M. Doherty (PP# 0F6082) Residue Chemistry Memo DP# 303623, 11/05/2004, W. Drew (PP#4F6833) Residue Chemistry Memo DP# 328216, 10/23/2007, W. Drew (PP#6F7051 and PP#6E7163) Residue Chemistry Memo DP#s 342549 & 355773, 11/05/2008, W. DrewAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 26 of 33 

### A ttachment 1

. International Maximum Residue Limits

– Acetamiprid

.



## Acetamiprid (099050, Requested 14 November, 2011)

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

### Codex 3



### 40 CFR 180.578:

Plants and Livestock:

N 1

- [(6

- chloro

- 3

- pyridyl)methyl]

- N 2

- cyano

acetamidine Plants: ( E )

- N

- [(6

- chloro

- 3

- pyridinyl)methyl]

- N'

- cyano

- N

methylethanimidamide

Livestock:( E )

- N

- [(6

- chloro

- 3

- pyridinyl)methyl]

- N'

- cyano

- N

methylethanimidamide, including the metabolite ( E )

- N

- [(6

- chloro

- 3

- pyridinyl)methyl]

- N'

- cyanoethanimidamide None



### Commodity 1 

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

US Canada Mexico 2 

### Codex 3

Asparagus 0.8

Brassica , leafy greens, subgroup

5B 15 1.2 (bok choy) Chinese
cabbages, broccoli raab,
collards, kale, mustard greens,
mustard spinach, rape greens

Turnip greens 15

Corn, sweet, kernel plus cob with

husks removed 0.01

Corn, sweet, forage 10

Corn, sweet, stover 30

Vegetable, fruiting, group 8

- 10 0.20 0.2 bell peppers, eggplants,
groundcherries, non

- bell
peppers, pepinos, pepper
hybrids, tomatillos, tomatoes

0.4 tomato paste

Fruit, citrus, group 10

- 10 0.50 0.5 calamondins, citrus
citrons, citrus, hybrids,
grapefruits, kumquats, lemons,
limes, oranges, pummelos,
satsuma mandarins, tangerines

1.2 dried citrus fruit pulpAcetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 27 of 33 

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

### Codex 3

Fruit, pome, group 11

- 10 1.0 1.0 apples, Asian pears,
crabapples, loquats, mayhaws,
pears, quinces



### Completed: M. Negussie; 11/16/2011

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

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

3. * = absent at the LOQ ; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 28 of 33 

### Appendix I

. Field Trial Geographic Distribution

.

Table I .1. Trial Numbers and Geographical Locations for Asparagus

. NAFTA Growing Zones Asparagus

Submitted Requested 1

Canada U.S.

1

-- -- --
1A

-- -- --
2 1

-- 1/1

3

-- -- --
4

-- -- --
5 2

-- 2/2

5A

-- -- --
5B

-- -- --

6

-- -- --

7

-- -- --
7A

-- -- --
8

-- -- --
9

-- -- --
10 2 2

-- 3/2

11 2

-- 2/1

12

-- -- --
13

-- -- --
14

-- -- --
15

-- -- --
16

-- -- --
17

-- -- --
18

-- -- --
19

-- -- --
20

-- -- --
21

-- -- --

Total 7 2 8/6

1 As per Table 5 of OCSPP 860.1500 for asparagus; 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.

2 HED has concluded that two of the Zone 10 trials (CA35 and CA37) constitute a single trial with replicate samples for purposes of OCSPP 860.1500 data requirements.

T able I.2. Trial Numbers and Geographical Locations for Mustard Greens

. NAFTA Growing Zones Mustard Greens

Submitted Requested 1

Canada U.S.

1

-- -- --

1A

-- -- --

2 3 2

-- 2/1

3

-- -- 1/0Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 29 of 33 T able I.2. Trial Numbers and Geographical Locations for Mustard Greens

. NAFTA Growing Zones Mustard Greens

Submitted Requested 1

Canada U.S.

4 1

-- 1/1

5 1

-- 1/1

5A

-- -- --
5B

-- -- --

6 1

-- 1/1

7

-- -- --

7A

-- -- --

8

-- -- --

9

-- -- --

10 2

-- 2/1

11

-- -- --

12

-- -- --

13

-- -- --

14

-- -- --

15

-- -- --

16

-- -- --

17

-- -- --

18

-- -- --

19

-- -- --

20

-- -- --

21

-- -- --

Total 8 8/5

1 As per Table 5 of OCSPP 860.1500 for mustard greens; the first number reflects the field trials required if a tolerance is sought on the crop subgroup leafy Brassica greens; the second number reflects the number of field trials required if a tolerance is sought only on mustard gr eens.

2 The petitioner noted that one of the Zone 2 trials (GA*06) was located near the border of Zone 3.

T able I .3. Trial Numbers and Geographical Locations for Sweet Corn

. NAFTA Growing Zones Sweet Corn

Submitted Requested 1

Canada U.S. Canada U.S.

1

-- 1

-- 2/1

1A

-- -- -- --
2

-- 2

-- 1/1

3

-- 1

-- 1/1

4

-- -- -- --
5 2 2

-- 4 5/3

5A

-- 1

-- --
5B 1 2

-- 2

--

6

-- -- -- --

7

-- -- -- --
7A 1

-- 1

--
8

-- -- -- --Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 30 of 33 T able I .3. Trial Numbers and Geographical Locations for Sweet Corn

. NAFTA Growing Zones Sweet Corn

Submitted Requested 1

Canada U.S. Canada U.S.

9

-- -- -- --
10

-- 1

-- 1/1

11

-- 1

-- 1/1

12 1

-- 1 1/1

13

-- -- -- --
14

-- -- -- --
15

-- -- -- --
16

-- -- -- --
17

-- -- -- --
18

-- -- -- --
19

-- -- -- --
20

-- -- -- --
21

-- -- -- --

Total 5 7 8 12/9

1 As per Table 5 of OCSPP 860.1500 and Table 2 of PMRA Regulatory Directive 98

- 2 for sweet corn; the second number reflects a 25% reduction in the number of field trials allowed for the crop as a representative commodity in support of a cro p group/subgroup t olerance or when application results in no quantifiable residues.

2 HED has concluded that two pairs of the Zone 5 trials (131/132 and 133/134) and the two Zone 5B trials (136/137) each constitute a single trial with replicate samples for purposes of 86 0.1500 data requirements.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 31 of 33 

### Appendix II. Tolerance Assessment Calculations

.

T he OECD tolerance calculation procedure (March 2011 version), was used for calculating

recommended tolerances in asparagus; and B rassica leafy greens, subgroup 5B and turnip greens (based on data for mustard greens) . The statistical goal of the OECD tolerance calculation procedure is to produce a tolerance proposal in the region of the 95 th 

### percentile of the underlying

residues distributi on. The average residue values used to calculate the tolerances are provided in

Table I

- 1.

Table I I

- 1. Residue data used to calculate tolerance for acetamiprid in/on asparagus and mustard greens

. Regulator: EPA

Chemical: Acetamiprid

Crop: Asparagus Mustard greens

PHI: 1 Day 2

- 4 Days

App. Rate: 0. 20 lb ai/A 0. 375 lb ai/A

Submitter: IR

- 4 IR

- 4

MRID Citation: MRID 48590101 MRID 48590102

Acetamiprid (ppm)



### 0.21 9.2

0.21 2.65

0.405 1.55

0.12 2.15

0.27 1.2

0.26 0.30

0.26 1.7

-- 2.4



### Asparagus

The dataset used to establish a tolerance for acetamiprid on asparagus consisted of field trial data representing application rates of 0.200

- 0.204 lb ai/A acetamiprid with a 1

- day PHI. The field trial application rates and PHIs are within 25% o f the maximum label application rate and minimum label PHI, respectively. The average residue values used to calculate the tolerance are provided in Table I I

- 1. Residues of acetamiprid were quantifiable (LOQ = 0.01 ppm) in/o n all samples of asparagus

. U sing the OECD tolerance calculation procedure , the recommended tolerance is 0.80 ppm.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 32 of 33 

### Mustard greens

The dataset used to establish a tolerance for acetamiprid on B rassica leafy greens, subgroup 5B and turnip greens consisted of field trial data on mustard greens representing application rates of

0.374

- 0.476 lb ai/A acetamiprid with a 2

- to 4

- day PHI. The field trial application rates and PHIs are within 25% of the maximum label application rate (except for one field trial that received an extra app lication) and minimum label PHI, respectively. The average residue values used to calculate the tolerance are provided in Table I I

- 1. Residues of acetamiprid were quantifiable (LOQ = 0.01 ppm) in/o n all samples of mustard greens

. Using the OECD toleranc e calculation procedure , the recommended tolerance is 15 ppm.Acetamiprid Summary of Analytical Chemistry and Residue Data Barcode D394 779

Page 33 of 33