UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		23 October 2007

Subject:	Acetamiprid.  Petitions Requesting the Establishment of Permanent Tolerances (Associated with Section 3 Registration) for New Food/Feed Uses of the Insecticide on Berries (Crop Group 13), Bulb Vegetables (Crop Group 3), Edible Podded Legume Vegetables (Crop Subgroup 6A), Succulent Shelled Pea and Bean (Crop Subgroup 6B), and Strawberry and Other Low-growing Berries.  Summary of Analytical Chemistry and Residue Data.  Petition Numbers 6F7051 (Various Crops) and 6E7163 (Strawberry).

DP #	328216	Decision #	365869 & 373101

PC Code:	099050	MRIDs #	46785502, 46785503, 46785504, and 47013601

40CFR §180.	578

Chemical Class:	Neonicotinoid Insecticide

From:		William T. Drew, Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

Through:	Michael A. Doherty (PhD), Chemist

		Richard A. Loranger (PhD), Senior Scientist

		Registration Action Branch 2

		Health Effects Division (7509P)

To:		Daniel Rosenblatt/Barbara Madden, RM Team 05

		John Hebert, RM Team 07

		Insecticide Branch

		Registration Division (7505P)

This residue chemistry summary document was originally prepared under contract by Dynamac Corporation (2275 Research Boulevard, Suite 300; Rockville, MD 20850).  It has been reviewed by the Health Effects Division (HED), and revised to reflect current Office of Pesticide Programs (OPP) policies.  Executive Summary

	  SEQ CHAPTER \h \r 1 Acetamiprid, with CAS registry number 135410-20-7 and CAS name (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N '-cyano-N-methylethanimidamide, is a selective insecticide   SEQ CHAPTER \h \r 1 intended for use against various sucking/chewing insect pests that feed upon fruit and vegetable crops.  It is a member of the chloronicotinyl (neonicotinoid) class of insecticides, which function by binding to nicotinic acetylcholine receptors in the post-synaptic neurons of the insect’s central nervous system.  This binding results in the opening of ion pores, causing a subsequent overload of sodium ions in the neurons which leads to nervous system hyper-excitation, and eventual death of the insect.  Acetamiprid is currently registered for foliar application to cotton, leafy vegetables, cole (Brassica) vegetables, fruiting vegetables, tuberous and corm vegetables, citrus fruits, pome fruits, and grapes, and for seed treatment of canola and mustard seeds.  Applications for additional uses on cucurbit vegetables, stone fruits, and tree nuts (PP#4F6833) were reviewed by the Agency in 2004.

	  SEQ CHAPTER \h \r 1 The petitioner, Nippon Soda Company, Limited, has submitted an application for an amended Section 3 registration for the 70% active ingredient (ai) wettable powder (WP) formulation of acetamiprid (Assail® 70WP, EPA Registration #8033-23), and the 30% ai soluble granule formulation of acetamiprid (Assail® 30SG, EPA Registration #8033-36).  Based on the product label, the 30% soluble granule formulation is actually a water-dispersible granule (WDG) formulation.  The end-use products (EPs) are proposed for use on berries (including blueberries and caneberries), bulb vegetables, and edible podded and succulent shelled beans and peas as multiple foliar spray applications, using ground or aerial equipment, at maximum seasonal use rates of 0.3-0.6 pounds of ai per acre (lb ai/A) per season.  The proposed pre-harvest intervals (PHIs) are 1 day for berries, and 7 days for bulb and legume vegetables.

	Concurrently, Nisso America, Incorporated (representing Nippon Soda Company, which acquired the registrations for acetamiprid from Aventis CropScience), has proposed the establishment of permanent tolerances, under PP#6F7051, for residues of acetamiprid in or on the raw agricultural commodities (RACs) listed below.

Berries crop group (Group 13)	1.0 ppm

Bulb vegetables crop group (Group 3)	3.0 ppm

Edible podded legume vegetables (Subgroup 6A)	0.5 ppm

Succulent shelled peas and beans (Subgroup 6B)	0.5 ppm

	A separate petition (PP#6E7163) was submitted by the Interregional Research Project # 4 (IR-4) on behalf of the Agricultural Experiment Stations of MI, NC, and PA, requesting amended registrations of Nippon Soda Company’s 70% WP and 30% WDG EPs for use (in the US and Canada) on strawberries and other low-growing berries.  The EPs are proposed for multiple foliar spray applications at a maximum seasonal use rate of 0.26 lb ai/A per season, with a 1-day PHI.  IR-4 has proposed the establishment of permanent tolerances for combined (sic) residues of acetamiprid in or on the RACs listed below.

Strawberry	0.60 ppm

Bearberry	0.60 ppm

Bilberry	0.60 ppm

Blueberry, lowbush	0.60 ppm

Cloudberry	0.60 ppm

Cranberry	0.60 ppm

Lingonberry	0.60 ppm

Muntries	0.60 ppm

Partridgeberry	0.60 ppm

	  SEQ CHAPTER \h \r 1 Tolerances have been established under 40CFR §180.578[a][1] for residues of the insecticide acetamiprid, ranging from 0.01 to 20 ppm in/on cotton matrices, and various fruits and vegetables.  Tolerances for the combined residues of acetamiprid and N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-acetamidine have also been established under 40CFR §180.578[a][2] in livestock commodities (ruminants and poultry) ranging from 0.01 to 0.20 ppm.  Tolerances (0.01-1.20 ppm) are currently pending for residues of acetamiprid per se in/on cucurbit vegetables, stone fruits, prunes, plums, tree nuts, pistachios, and almond hulls (PP#4F6833).

	It was noted that all crops for which use is proposed under the current petitions, except edible podded legume vegetables and succulent shelled peas and beans, are affected by changes pending for the Crop Grouping Regulation.  The submitted data for the affected crops are evaluated in this document as recommended in the Reviewer’s Guide and Summary of HED ChemSAC Approvals for Amending Crop Groups/Subgroups (40CFR §180.41), and Commodity Definitions (40CFR §180.1[h]); see the HED Memorandum of 6/14/2006 by Bernard A. Schneider.

	  SEQ CHAPTER \h \r 1 HED has previously determined that the nature of the residue in plants and animals is adequately understood.  It was concluded that the tolerance expression should only include acetamiprid per se for plant commodities.

	  SEQ CHAPTER \h \r 1 There are no significant livestock feedstuffs associated with the proposed uses on berries, bulb vegetables, succulent legume vegetables, and strawberries.  Therefore, no livestock metabolism data, enforcement methods, storage stability data, nor feeding studies are required to support these petitions.

	  SEQ CHAPTER \h \r 1 Adequate residue analytical methods are available for the enforcement of established and proposed tolerances on plant commodities (GC/ECD and HPLC/UV).  The method limits of quantitation (LOQs) are 0.010 ppm for vegetables and non-citrus fruits, and 0.050 ppm for citrus fruits.  These methods have undergone successful petition method validation (PMV) trials.  Under PP#4F6833, Nisso America proposed that the LC/MS/MS method utilized for data collection (Method #KP-216R0 and its modification, Method #KP-216R1) replace the established GC/ECD tolerance enforcement method for the commodities proposed under PP#4F6833.  HED concluded that the method should undergo a successful independent laboratory validation (ILV), and possibly be submitted to ACB/BEAD for PMV as a condition of registration.  HED further noted that the LC/MS/MS method should analyze a minimum of two daughter ions specific to acetamiprid to be considered acceptable as both a tolerance enforcement and confirmatory method.  Method #KP-216R1 or a modified version of this method was used in the crop field trials associated with the subject petitions.

	Adequate multiresidue methods testing data have been submitted.  These data indicate that the multiresidue methods are not appropriate for determining residues of acetamiprid.

	Adequate storage stability data were previously submitted demonstrating that residues of acetamiprid are relatively stable under frozen storage conditions for intervals of up to 12 months in fortified samples of an oilseed (cotton seed), a leafy vegetable (head lettuce), a Brassica leafy vegetable (cabbage), a cucurbit vegetable (cucumber), and fruits (apple and orange), as well as the processed commodities of apple, cotton, and orange.  HED previously concluded that these data are sufficient to be representative of the current and proposed uses of acetamiprid.  In addition, adequate concurrent storage stability data were submitted in support of the proposed use on strawberry.

	  SEQ CHAPTER \h \r 1 Adequate crop field trial data have been submitted reflecting the proposed uses on green and bulb onions, edible podded and succulent shelled peas and beans, blueberries, and strawberries.  Adequate numbers of geographically representative field trials were conducted at roughly 1x the proposed maximum seasonal use rate for each crop except bulb onions.  The data indicate that the proposed tolerance on the bulb vegetable group (Group 3) is inappropriate, and should be replaced with individual tolerances on the crops in the pending green onion subgroup (Subgroup 3B) at 4.5 ppm, and on the crops in the pending bulb onion subgroup (Subgroup 3A) at 0.02 ppm.  Because a crop group tolerance is inappropriate, an additional two crop field trials for bulb onions would normally be needed to fulfill geographic representation requirements for the bulb onion subgroup.  However, since acetamiprid residues were less than the LOQ in all samples from the bulb onion field trials (except for one sample at 0.018 ppm), HED deems the additional bulb onion field trials to be unnecessary, and considers the residue data for bulb onions to be sufficient.  The proposed tolerance on the berries group (Group 13) is not supported by adequate data for caneberries; only one of the five caneberry field trials submitted was conducted utilizing the proposed use pattern for berries.  However, because residue levels from that blackberry field trial (average = 0.55 ppm) were substantially lower than the recommended tolerance on blueberries (1.6 ppm), HED recommends in favor of registration, with a tolerance established on the berries group (Group 13) at 1.6 ppm.  (Nisso America has recently submitted a magnitude of the residue study, involving three additional caneberry field trials, conducted strictly in adherence with the maximum proposed use pattern.  That caneberry field trial study, MRID #47224701, is currently under review by HED.)  The data indicate that the proposed tolerance of 0.5 ppm on edible podded legume vegetables (subgroup 6A) is too low, and the proposed tolerance of 0.5 ppm on succulent shelled beans and peas (subgroup 6B) is too high; revised tolerances of 0.60 ppm and 0.40 ppm, respectively, should be proposed.  The available field trial data for strawberry indicate that the proposed tolerances of 0.60 ppm on strawberries and associated low-growing berries (pending low-growing berries subgroup 13G) are appropriate, with the exception of the proposed tolerances on lowbush blueberry and lingonberry.  Lowbush blueberry and lingonberry are members of both pending subgroup 13B and pending subgroup 13G; therefore, the proposed tolerances on these crops should be based on the higher residues from blueberries (the representative commodity for pending subgroup 13B), and thus should be increased to 1.6 ppm.  Since lowbush blueberry is a member of the existing crop group 13, a separate tolerance is not necessary.  However, lingonberry is not in the existing crop group, so an individual tolerance of 1.6 ppm is necessary on that crop.

	The nature of the residue in rotational crops is adequately understood.  Acetamiprid was not detected in any matrix (mustard greens, radish, and grain crops) at any plant-back interval (PBI); the major metabolite detected was IM-1-4.  HED has previously determined that the residue of concern (ROC) in rotational crops is parent only, and that tolerances on rotational crops were not needed.  Rotational crop supporting storage stability data (required as a condition of registration for the original petition, PP#0F6082) have been submitted (MRID #46729102).

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry Deficiencies

	  SEQ CHAPTER \h \r 1 HED has examined the residue chemistry database for acetamiprid.  Pending submission of revised Sections B (see requirements under Directions for Use), and revised Sections F (see requirements under Proposed Tolerances), there are no residue chemistry issues that would preclude granting a registration for the requested uses of acetamiprid, or establishment of permanent tolerances for acetamiprid under 40CFR §180.578[a][1], as listed below.  SEQ CHAPTER \h \r 1

Vegetable, legume, edible podded, subgroup 6A	0.60 ppm

Pea and bean, succulent shelled, subgroup 6B	0.40 ppm

Berry, group 13	1.6 ppm

(Tolerances associated with pending low-growing berries subgroup 13G)

Bearberry	0.60 ppm

Bilberry	0.60 ppm

Cloudberry	0.60 ppm

Cranberry	0.60 ppm

Muntries	0.60 ppm

Partridgeberry	0.60 ppm

Strawberry	0.60 ppm

(Tolerances associated with pending bushberry subgroup 13B)

Bushberry subgroup 13B	1.6 ppm

Aronia berry	1.6 ppm

Buffalo currant	1.6 ppm

Chilean guava	1.6 ppm

European barberry	1.6 ppm

Highbush cranberry	1.6 ppm

Honeysuckle	1.6 ppm

Jostaberry	1.6 ppm

Juneberry	1.6 ppm

Lingonberry	1.6 ppm

Native currant	1.6 ppm

Salal	1.6 ppm

Sea buckthorn	1.6 ppm

(Tolerances associated with pending bulb onion subgroup 3A)

Onion, bulb	0.02 ppm

Fritillaria, bulb	0.02 ppm

Daylily, bulb	0.02 ppm

Garlic, bulb	0.02 ppm

Garlic, great headed, bulb	0.02 ppm

Garlic, Serpent, bulb	0.02 ppm

Lily, bulb	0.02 ppm

Onion, Chinese, bulb	0.02 ppm

Onion, Pearl	0.02 ppm

Onion, potato, bulb	0.02 ppm

Shallot, bulb	0.02 ppm

(Tolerances associated with pending green onion subgroup 3B)

Onion, green	4.5 ppm

Chive, fresh leaves	4.5 ppm

Chive, Chinese, fresh leaves	4.5 ppm

Elegans hosta	4.5 ppm

Fritillaria, leaves	4.5 ppm

Kurrat	4.5 ppm

Lady’s leek	4.5 ppm

Leek	4.5 ppm

Leek, wild	4.5 ppm

Onion, Beltsville bunching	4.5 ppm

Onion, fresh	4.5 ppm

Onion, macrostem	4.5 ppm

Onion, tree, tops	4.5 ppm

Onion, Welsh, tops	4.5 ppm

Shallot, fresh leaves	4.5 ppm

	HED notes that, until the Federal Register Notice amending the crop group and subgroup scheme is final for the bulb vegetable groups/subgroups, and the berry and small fruit groups/subgroups, all the new proposed commodities will have to be listed separately from the crop subgroup tolerances at the same level as the corresponding crop subgroup.

	860.1200 Directions for Use

	Because the field trial data submitted with these petitions did not reflect the use of surfactants in the application sprays, the label directions regarding use of surfactants should be amended to remove any statements specifying that surfactants be used in spray mixtures applied to berries, bulb vegetables, edible podded legume vegetables, succulent shelled beans and peas, or strawberries and other low-growing berries.

	860.1340 Residue Analytical Methods

	Additional method validation data reflecting fortification of green onions at 2.00 ppm would normally be needed to confirm that the method adequately recovers residues of acetamiprid at the anticipated levels in green onions (the highest level utilized in the field trials was 1.00 ppm).  However, since tolerances are already established on leafy vegetables (except Brassica) group 4 at 3.00 ppm, and on cotton gin byproducts at 20.0 ppm, further method validation will not be required.

	860.1550 Proposed Tolerances

	(1) The tolerance expression proposed by IR-4 should be revised to exclude the word “combined.”

	(2) The proposed tolerances should be revised to reflect the recommended tolerance levels, and correct commodity definitions as specified in Table 7; individual tolerances on the new members of each of the requested crop groups should be established as noted in Table 7.

	860.1500 Crop Field Trials

	Magnitude of the residue data (MRID #47224701), involving three additional caneberry field trials, have been submitted, reflecting applications according to the maximum proposed use pattern, and minimum PHI.  Two blackberry field trials and one raspberry field trial were conducted.  That caneberry field trial study is currently under review by HED.

	860.1850 Confined Accumulation in Rotational Crops

	HED recommends in favor of the conversion of conditional registration to unconditional registration for currently registered uses, in response to the submission of the following outstanding residue chemistry data pertaining to confined accumulation in rotational crops.

	The outstanding rotational crop supporting storage stability data (which were required as a condition of registration for the original petition, PP#0F6082) have been submitted (MRID #46729102).  The rotational crop storage stability data deficiency identified during HED’s review of PP#0F6082 has thus been resolved.

Background

	Nippon Soda Company, Limited, has submitted a petition for permanent tolerances (PP#6F7051), and requested amended registrations of the 70% WP formulation of acetamiprid (Assail® 70WP, EPA Registration #8033-23), and the 30% WDG formulation of acetamiprid (Assail® 30SG, EPA Registration #8033-36) on berries (including blueberries and caneberries), bulb vegetables, and edible podded and succulent shelled beans and peas.  Under a separate petition (PP#6E7163), IR-4 has proposed permanent tolerances, and requested amended registrations of the 70% WP and 30% WDG EPs for use (in the US and Canada) on strawberries and other low-growing berries.  Acetamiprid is currently registered for foliar application to cotton, leafy vegetables, Brassica vegetables, fruiting vegetables, tuberous and corm vegetables, citrus fruits, pome fruits, and grapes, and for seed treatment of canola and mustard seed.  The existing registrations were reviewed by HED under PP#0F6082 (D264154; Michael Doherty; 12/31/2001) and PP#3F6575 (D306191; William Drew; 11/3/2004).  Pending tolerances/uses on cucurbit vegetables, stone fruits, and tree nuts have also been reviewed by HED under PP#4F6833 (D303623; William Drew; 11/5/2004).

	The nomenclature of acetamiprid and its metabolites is summarized in Table 1 (below), and the physicochemical properties of acetamiprid are summarized in Table 2 (below).

Common Name	Acetamiprid

Molecular Formula	C10H11ClN4

Molecular Weight	222.68

Company Experimental Name	EXP-61842A, AEF124370, NI-25

IUPAC Name	  SEQ CHAPTER \h \r 1 (E)-N 1-[(6-chloro-3-pyridyl)methyl]-N 2-cyano-N 1-methylacetamidine

CAS Name	  SEQ CHAPTER \h \r 1 (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-N-methylethanimidamide

CAS Registry Number	135410-20-7

End-use Product (EP)	Assail® 70WP (70% WP; EPA Registration #8033-23) and

Assail® 30SG (30% WDG; EPA Registration #8033-36)

Chemical Structure of Acetamiprid Metabolite

  SEQ CHAPTER \h \r 1 N 1-[(6-chloro-3-pyridyl)methyl]-N 2-cyano-acetamidine

Chemical Structure of Acetamiprid Metabolite

IM-2-1-amide

  SEQ CHAPTER \h \r 1 N 2-aminocarbonyl-N 1-[(6-chloro-3-pyridyl)methyl]acetamidine

TABLE 2	Physicochemical Properties of Technical-Grade Acetamiprid.

Parameter	Value	Reference

Melting Point/Range ((C)	98.9	PP#6F7051

pH	6.08 (Aqueous solution at 20(C)

	Density (g/cm3)	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)	D264154; Michael Doherty; 12/31/2001

Dissociation Constant, pKa	0.7 (at 25(C)	PP#6F7051

Octanol/Water Partition Coefficient, Log KOW	0.8 (at 25(C)

	UV/Visible Absorption Spectrum	Not available

860.1200 Directions for Use

	Draft amended labels were submitted by Nippon Soda Company for acetamiprid, as Assail® 70WP (70% WP formulation), and Assail® 30SG (30% WDG formulation), for use on berries, bulb vegetables, and succulent legume vegetables.  Separate draft labels were submitted for the 70% WP and 30% WDG formulations by IR-4, for use on strawberries and other low-growing berries.  The proposed use directions for acetamiprid under PP#6F7051 and PP#6E7163 are presented in Table 3 (below).

Table 3	Summary of Directions for Use of Acetamiprid.

Application Type; Equipment	Formulation

[EPA Reg. Number]	Application Rate

(lb ai/A)	Maximum # of Uses per Season	Max. Seasonal Use Rate

(lb ai/A)	PHI

(Days)	Use Directions and Limitations

Berries (Group 13)

Including Blackberry, Blueberry, Currant, Elderberry, Gooseberry, Huckleberry, Loganberry, and Raspberry (Black and Red)

Foliar spray;

ground or aerial.	70% WP

[8033-23]	0.044-0.1	5	0.50	1	Application to be made in a minimum of 20 GPA using ground equipment, or 5 GPA using aerial equipment; a 7-day re-treatment interval (RTI) is specified.

	30% WDG

[8033-36]	0.047-0.1

Bulb Vegetables (Group 3)

Including Onion (Dry Bulb and Green), Garlic, Elephant Garlic, Leek, Welsh Onion, and Shallot

Foliar spray;

ground or aerial.	70% WP

[8033-23]

30% WDG

[8033-36]	0.094-0.15	4	0.60	7	Application to be made in a minimum of 20 GPA using ground equipment, or 5 GPA using aerial equipment; a 7-day RTI is specified.

Edible Podded Legume Vegetables (Subgroup 6A) and Succulent Shelled Peas and Beans (Subgroup 6B)

Including Bean (Phaseolus spp.), including Runner Bean, Snap Bean, Wax Bean, Lima Bean (Green); Bean (Vigna spp.), including Asparagus Bean, Chinese Longbean, Moth Bean, Yardlong Bean, Blackeyed Pea, Cowpea, Southern Pea; Jackbean; Broad Bean (Succulent); Pea (Pisum spp.), including Dwarf Pea, Edible-Pod Pea, Snow Pea, Sugar Snap Pea, English Pea, Garden Pea, Green Pea; Soybean (Immature Seed); Sword Bean; and Pigeon Pea.

Foliar spray;

ground or aerial.	70% WP

[8033-23]

30% WDG

[8033-36]	0.044-0.1	3	0.30	7	Application to be made in a minimum of 20 GPA using ground equipment, or 5 GPA using aerial equipment; a 7-day RTI is specified.

Strawberries and Other Low-growing Berries

Including Bearberry, Bilberry, Blueberry (Lowbush), Cloudberry, Cranberry, Lingonberry, Muntries, and Partridgeberry.

Foliar spray;

ground or aerial.	70% WP

[8033-23]

30% WDG

[8033-36]	0.035-0.13	Not specified.	0.26	1	Application to be made in a minimum of 20 GPA using ground equipment, or 10 GPA using aerial equipment; a 7-day RTI is specified.

	Applications are to be initiated when insect populations reach recognized economic threshold levels.  Under Application Instructions, the labels state that use of spray adjuvants such as non-ionic or silicone surfactants, or methylated seed oils is recommended for row crops, and use of non-ionic surfactants, and methylated seed or horticultural oils is recommended for orchard and vineyard crops to enhance coverage and plant uptake, and possibly improve pest control.  The labels state that the 70% WP and 30% WDG may be tank mixed with other pesticide or spray products.  No specific tank mixes are recommended; therefore, compatibility of the mixture must first be established.  Under the established use directions for cotton, leafy vegetables, cole crops, and fruiting vegetables, both labels state that there are no rotational crop plant-back restrictions for this product.  A restricted entry interval (REI) of 12 hours is specified.   Conclusions:  The submitted use directions are sufficient to allow evaluation of the available residue data relative to the proposed uses.

	The available field trial data reflect the proposed use patterns for all of the submitted field trials except three blackberry field trials and a raspberry field trial for which the individual application rates, and/or PHIs exceeded those proposed.

	Because the field trial data submitted with this petition did not reflect the use of surfactants in the application sprays, the label directions regarding use of surfactants should be amended to remove any statements specifying that surfactants be used in spray mixtures applied to bushberries, bulb vegetables, edible podded legume vegetables, succulent shelled beans and peas, or strawberries and other low-growing berries.

860.1300 Nature of the Residue - Plants

	Residue Chemistry Memo   SEQ CHAPTER \h \r 1 D278652; Michael Doherty; 11/13/2001

	Residue Chemistry Memo   SEQ CHAPTER \h \r 1 D264154; Michael Doherty; 12/31/2001

	No plant metabolism studies were submitted with the subject petitions.  Plant metabolism studies with acetamiprid on apple, cabbage, carrot, cotton, and eggplant were submitted as part of the data package for the original acetamiprid petition (PP#0F6082; D264154; Michael Doherty; 12/31/2001), which adequately delineate the qualitative nature of the residue in plants.  It was found that in most plants, acetamiprid is demethylated at the N1 amine to form IM-2-1, which may then be further metabolized to form IM-0 and IC-0.  IM-0 is then metabolized to form the glucose conjugate IM-0-Glc.  HED determined that for both the tolerance expression and risk assessment purposes, the ROC in plants is acetamiprid per se.

860.1300 Nature of the Residue - Livestock

	There are no significant livestock feedstuffs associated with the proposed uses on berries, bulb vegetables, succulent legume vegetables, and strawberries.  Therefore, data requirements for livestock metabolism are not relevant to this tolerance petition.

860.1340 Residue Analytical Methods

	Residue Chemistry Memo   SEQ CHAPTER \h \r 1 D264154, Michael Doherty; 12/31/2001

	Residue Chemistry Memo D303623; William Drew; 11/05/2004

	  SEQ CHAPTER \h \r 1 Enforcement Methods:  In conjunction with the original petition (PP#0F6082), the petitioner submitted two analytical methods for the determination of acetamiprid in crop matrices.  The methods and their performance are summarized in Table 4 (below).  Adequate ILV data were submitted.  The citrus method was successfully radiovalidated for acetamiprid using samples from the metabolism study.  Because the methods include instructions for confirmation of residues of acetamiprid using HPLC/MS/MS determination, interference testing was not required.  The GC/ECD method for vegetables and non-citrus fruits has undergone successful PMV.

Table 4	Summary of Validated Analytical Methods for Acetamiprid.

Target 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 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

	Under PP#4F6833, Nisso America proposed that LC/MS/MS Method #KP216R0 be used as an enforcement method for the tolerances proposed under PP#4F6833.  Method #KP216R0, along with its modified version Method #KP-216R1, was used for data collection in the crop field trial and processing studies associated with that petition.  HED concluded that the method should undergo a successful ILV, and possibly be submitted to ACB/BEAD for PMV as a condition of registration.  HED further noted that the LC/MS/MS method should analyze a minimum of two daughter ions specific to acetamiprid to be considered acceptable as both a tolerance enforcement and confirmatory method.  Nisso America has recently submitted an ILV study (MRID #47185401); that study is currently under review by HED.

	  SEQ CHAPTER \h \r 1 Data Collection Methods:  Samples from the crop field trials submitted in conjunction with the subject petitions were analyzed for residues of acetamiprid using LC/MS/MS Method #KP-216R1, entitled Preliminary LC/MS/MS Analytical Method for Determination of ASSAIL® 70WP Insecticide (Acetamiprid) in Crop Matrices, or a modification of Method #KP-216R1.

	In conjunction with the field trial studies associated with the subject petitions, acceptable recoveries were obtained in method validation conducted prior to the analysis of field samples and/or concurrent method validation using blackberries, blueberries, green beans, green peas, lima beans, onions, peas in pod, and strawberries fortified with acetamiprid at the LOQ (0.010 ppm) and up to 1.00 ppm.  The fortification levels used in method validation and concurrent method validation were adequate to bracket the expected residue levels for all trials except one blackberry trial reflecting exaggerated-rate application, and one green onion trial, where residues were 1.77-2.15 ppm.

	Conclusions:  The available residue analytical method data are adequate to satisfy data requirements for the subject petitions.    SEQ CHAPTER \h \r 1 An acceptable GC/ECD method is available for the enforcement of the proposed tolerances on berries, legume vegetables, bulb vegetables, and strawberries, and the LC/MS/MS method used for data collection was adequately validated in conjunction with the crop field trials for all commodities except green onions.  Additional method validation data reflecting fortification of green onions at 2.00 ppm would normally be needed to confirm that the method adequately recovers residues of acetamiprid at the anticipated levels in green onions (the highest level utilized in the field trials was 1.00 ppm).  However, since tolerances are already established on leafy vegetables (except Brassica) group 4 at 3.00 ppm, and on cotton gin byproducts at 20.0 ppm, further method validation will not be required.

860.1360 Multiresidue Methods

	Residue Chemistry Memo   SEQ CHAPTER \h \r 1 D264154, Michael Doherty; 12/31/2001

	The petitioner submitted data concerning the recovery of residues of acetamiprid using FDA multiresidue method protocols (PAM Volume I) in conjunction with the original petition (PP#0F6082; D264154; Michael Doherty; 12/31/2001).  These data have been forwarded to FDA for evaluation.  Based on the results of the testing, the multiresidue methods are not appropriate for determining acetamiprid ROC.  BEAD is currently working on a multi-residue method for the neonicotinoids.

860.1380 Storage Stability

	DER for MRID #47013601 (Strawberry)

	Residue Chemistry Memo   SEQ CHAPTER \h \r 1 D264154, Michael Doherty; 12/31/2001

	Residue Chemistry Memo D303623; William Drew; 11/05/2004

	Nippon Soda Company did not conduct storage stability studies in conjunction with the field trial studies submitted under PP#6F7051.  Instead, storage stability data generated in conjunction with PP#0F6082 were referenced.  These data demonstrated that residues of acetamiprid are relatively stable under frozen storage conditions for intervals of up to 12 months in fortified samples of an oilseed (cotton seed), a leafy vegetable (head lettuce), a Brassica leafy vegetable (cabbage), a cucurbit vegetable (cucumber), and fruits (apple and orange), as well as the processed commodities of apple, cotton, and orange.  In reviewing PP#4F6833, HED concluded that these data are sufficient to be representative of the current and proposed uses of acetamiprid.

	In addition, the stability of acetamiprid during short-term storage at ambient temperatures was evaluated.  Samples of cotton seed, cotton gin byproducts, cotton seed oil, whole grapes, grape juice, raisins, whole oranges, whole tomatoes, and tomato paste spiked with acetamiprid at 0.100 and 0.250 ppm were stored at ambient temperatures for 7 days (15 days for raisins).  Under these conditions, residues of acetamiprid were stable in all commodities.

	IR-4 conducted a concurrent storage stability study with the analysis of the field trial samples in conjunction with the strawberry field trials submitted under PP#6E7163.  Although no 0-day data were provided, the data indicate that residues of acetamiprid are reasonably stable under frozen storage conditions in fortified samples of strawberries for intervals of up to approximately 5 months.

	The storage durations and conditions of samples from the submitted crop field trials are presented in Table 5 (below).

Table 5	Summary of Storage Conditions and Durations of Samples from Crop Field Trial Studies.

Matrix	Storage Temperature (°C)	Actual Storage Duration 1 (Days) [Months]	Interval of Demonstrated Storage Stability  (Days) [Months] 2

PP#6F7051

Blueberry	-29 to -12	169-229 [5.6-7.5]	[12]

Blackberry

174-245 [5.7-8.1]

	Raspberry

168  [5.5]

	Green Bean (Succulent Podded Bean)	-29 to -12	77-217 [2.5-7.1]

	Pea in Pod (Succulent Podded Pea)

6-233 [0.2-7.7]

	Lima bean (Succulent Shelled Bean)

48-254 [1.6-8.4]

	Green pea (Succulent Shelled Pea)

105-189 [3.5-6.2]

	Bulb Onion	“Frozen”	124-236 [4.1-7.8]

	Green Onion

77-173 [2.5-5.7]

	PP#6E7163

Strawberry	-25 to -15	9-109 [0.3-3.6]	148 [4.9]

1. Actual storage duration from collection to analysis.

2. Residues of acetamiprid were relatively stable under frozen storage conditions in various crops for intervals of up 	to 12 months (refer to D264154; Michael Doherty; 12/31/2001).

	Conclusions:  The available storage stability data for acetamiprid on representative crops, and the submitted concurrent storage stability data for strawberry are adequate to support the submitted berry, succulent legume vegetable, bulb vegetable, and strawberry crop field trials.

860.1400 Water, Fish, and Irrigated Crops

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

860.1460 Food Handling

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

860.1480 Meat, Milk, Poultry, and Eggs

	There are no significant livestock feedstuffs associated with this petition; therefore, the potential for residues in ruminant and poultry commodities does not need to be addressed.

860.1500 Crop Field Trials

	DER for MRID #46785502 (Berries)

	DER for MRID #46785503 (Bulb Vegetables)

	DER for MRID #46785504 (Edible Podded and Succulent Shelled Peas and Beans)

	DER for MRID #47013601 (Strawberry)

Table 6	Summary of Residue Data from Crop Field Trials with Acetamiprid.

Commodity	Total Use Rate

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

	n	Min.	Max.	HAFT2	Median	Mean	Std. Dev.

BULB VEGETABLES (GROUP 3)

up to 4 applications  at ≤0.15 lb ai/A; 0.60 lb ai/A total application rate; 7-day PHI.

Bulb Onion	0.588-0.603	6-7	12	<0.010	0.018	0.014	0.010	0.011	0.002

Green Onion	0.593-0.601	7	6	0.038	2.149	1.960	0.384	0.798	0.921

EDIBLE PODDED LEGUME VEGETABLES (SUBGROUP 6A)

SUCCULENT SHELLED PEAS AND BEANS (SUBGROUP 6B)

Proposed use pattern = up to 3 applications at ≤0.10 lb ai/A; 0.30 lb ai/A total application rate; 7-day PHI.

Succulent Podded Bean	0.299-0.317	7	12	<0.010	0.190	0.179	0.010	0.040 0.065

Succulent podded pea	0.305-0.309	7-8	6	0.071	0.282	0.272	0.133	0.162 0.090

Succulent Shelled Bean	0.301-0.307	7	12	0.019	0.190	0.178	0.060	0.077 0.058

Succulent Shelled Pea	0.303-0.308	7-8	12	<0.010	0.032	0.030	0.019	0.020 0.009

BERRIES (GROUP 13)

 up to 5 applications at ≤0.10 lb ai/A; 0.50 lb ai/A total application rate; 1-day PHI.

Blueberry	0.504-0.533	1	12	0.080	0.692	0.617	0.368	0.353	0.199

Blackberry [5 apps]	0.514	1	2	0.543	0.547	0.545	0.545	0.545	NA

Blackberry [5 apps]	0.505-0.507	7-8	4	0.221	0.383	0.302	0.302	0.302 0.071

Blackberry [2 apps]	0.537	2	2	2.26	2.71	2.49	2.49	2.49	NA

Raspberry [3 apps]	0.506	1	2	0.736	0.822	0.779	0.779	0.779	NA

STRAWBERRY AND OTHER LOW-GROWING BERRIES

Proposed use pattern = multiple applications at ≤0.13 lb ai/A; 0.26 lb ai/A total application rate; 1-day PHI.

Strawberry	0.252-0.265	1	20	0.03	0.25	0.24	0.10	0.12	0.08

1. For statistical calculations, the validated LOQ (0.010 ppm) was used for residues reported as <LOQ or below the 	validated LOQ.

2. HAFT = Highest Average Field Trial.

	Bulb Vegetables (Crop Group 3):  Nippon Soda Company   SEQ CHAPTER \h \r 1 has submitted field trial data on bulb and green onion, the representative commodities of the bulb vegetables group (Group 3).  Six field trials were conducted on bulb onion in Zones 1 (PA; 1 trial), 6 (TX; 1 trial), 8 (TX; 1 trial), 10 (CA; 2 trials) and 11 (WA; 1 trial); and three trials were conducted on green onion in Zones 5 (WI; 1 trial), 6 (TX; 1 trial) and 10 (CA; 1 trial) during the 2004 growing season.

	At each trial location, four foliar broadcast applications of the 70% WP formulation were made at 6- to 9-day RTIs, at a nominal rate of 0.148 lb ai/A per application, for total seasonal use rates of 0.588-0.603 lb ai/A (roughly 1x the proposed maximum seasonal application rate).  Applications were made using ground equipment, in spray volumes of 20-34 gallons per acre (GPA), without any adjuvant.  Samples of mature bulb onions or green onions were harvested 6-7 days after the last application (DALA).

	Samples of onions were analyzed for acetamiprid residues using LC/MS/MS Method #KP-216R1.  The validated method LOQ was 0.010 ppm.  The method is adequate for data collection, based on acceptable method validation and concurrent method recovery data.  It was noted that the fortification levels used in method validation and concurrent method validation did not encompass the maximum residues found in green onion.  Adequate storage stability data are available to support the sample storage conditions and durations.

	The results of the bulb vegetable field trials are presented in Table 6 (above).  Maximum residues of acetamiprid were 0.018 and 2.149 ppm in bulb onions and green onions, respectively, harvested 6-7 days following the last of four foliar broadcast applications at total seasonal use rates of 0.588-0.603 lb ai/A.

	Conclusions:  The submitted bulb vegetable field trial data are adequate to satisfy data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for bulb onion and green onion as the representative crops of the bulb vegetable group, and the use pattern of the field trials adequately reflects the use pattern proposed for bulb vegetables.

	No residue decline studies were included in the onion field trials.  Residue decline studies on cotton, head lettuce, oranges, pears, and peppers were submitted in conjunction with PP#0F6082 (D264154; Michael Doherty; 12/31/2001).  These studies indicated that residues of acetamiprid did not increase in the subject crops with increasing harvest intervals.  Therefore, residue decline data will not be required to support the bulb vegetable field trials.

	Because maximum residues in green onion exceeded maximum residues in bulb onion by significantly more than 5x, HED has determined that a crop group tolerance on bulb vegetables is inappropriate.  The petitioner should propose separate tolerances on the new subgroups of bulb vegetables, the bulb onion subgroup 3A, and the green onion subgroup 3B.  No additional field trials are required to support a tolerance on the green onion subgroup.  Because a crop group tolerance is inappropriate, an additional two crop field trials for bulb onions would normally be needed to fulfill geographic representation requirements for the bulb onion subgroup.  However, since acetamiprid residues were less than the LOQ in all samples from the bulb onion field trials (except for one sample at 0.018 ppm), HED deems the additional bulb onion field trials to be unnecessary, and considers the residue data for bulb onions to be sufficient.

	The available field trial data will support tolerances for residues of acetamiprid in crops belonging to the pending bulb onion subgroup 3A at 0.02 ppm, and in crops belonging to the pending green onion subgroup 3B at 4.5 ppm; the tolerance calculations for green onions are presented in Appendix 2.

	Edible Podded Legume Vegetables (Crop Subgroup 6A), and Succulent Shelled Pea and Bean (Crop Subgroup 6B):  Nippon Soda Company   SEQ CHAPTER \h \r 1 has submitted field trial data on succulent edible podded beans and peas (green beans and peas in pod), and succulent shelled beans and peas (lima beans and green peas), the representative commodities of the edible podded legume vegetables subgroup (Subgroup 6A), and the succulent shelled peas and beans subgroup (Subgroup 6B), respectively.  Six field trials were conducted on succulent podded beans in Zones 1 (PA; 1 trial), 2 (GA; 1 trial), 3 (FL; 1 trial), 5 (MI and WI; 2 trials), and 11 (OR; 1 trial); three trials were conducted on succulent podded peas in Zones 1 (NJ; 1 trial), 8 (TX; 1 trial), and 10 (CA; 1 trial); six trials were conducted on succulent shelled beans in Zones 2 (GA; 3 trials), 3 (FL; 1 trial), 5 (WI; 1 trial), and 10 (CA; 1 trial); and six trials were conducted on succulent shelled peas in Zones 1 (PA; 1 trial), 5 (MI, MN, and WI; 3 trials), 11 (OR; 1 trial), and 12 (WA; 1 trial) during the 2004 and 2005 growing seasons.

	At each trial location, three foliar broadcast applications of the 70% WP formulation were made at 6- to 8-day RTIs (10 and 4 days for one succulent podded pea trial), at a nominal rate of 0.101 lb ai/A per application, for total seasonal use rates of 0.299-0.317 lb ai/A (roughly 1x the proposed maximum seasonal application rate).  Applications were made using ground equipment, in spray volumes of 11-31 GPA, without any adjuvant.  Samples of mature green peas, green beans, peas in pod, and lima beans were harvested 7-8 DALA.

	Samples of succulent beans and peas were analyzed for residues of acetamiprid using LC/MS/MS Method #KP-216R1.  The validated method LOQ was 0.010 ppm.  The method is adequate for data collection, based on acceptable method validation and concurrent method recovery data.  Samples were stored frozen for up to 8.4 months prior to analysis; adequate storage stability data are available to support the sample storage conditions and durations.

	The results of the edible podded and succulent shelled bean and pea field trials are presented in Table 6 (above).  Following three foliar broadcast applications of the 70% WP formulation of acetamiprid at total seasonal use rates of 0.299-0.317 lb ai/A, maximum residues of acetamiprid were 0.190 and 0.282 ppm in succulent podded beans and peas, respectively, harvested 7-8 DALA.  Maximum residues of acetamiprid were 0.190 and 0.032 ppm in succulent shelled beans and peas, respectively, harvested 7-8 DALA.

	Conclusions:  The submitted field trial data for the edible podded legume vegetables subgroup (Subgroup 6A), and succulent shelled peas and beans subgroup (Subgroup 6B) are adequate to satisfy data requirements.  The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for the representative crops of Subgroups 6A and 6B, and the use pattern of the field trials adequately reflects the use pattern proposed for succulent legume vegetables.

	No residue decline studies were included in the bean and pea field trials.  Residue decline studies on cotton, head lettuce, oranges, pears, and peppers were submitted in conjunction with PP#0F6082 (D264154; Michael Doherty; 12/31/2001).  These studies indicated that residues of acetamiprid did not increase in the subject crops with increasing harvest intervals.  Therefore, residue decline data will not be required to support the succulent podded or shelled bean and pea field trials.

	Although maximum residues in succulent shelled beans exceeded residues in succulent shelled peas by 5.9x, in consideration of the relatively low residues in shelled beans and peas overall, HED has determined that a crop subgroup tolerance on Subgroup 6B is appropriate.

	The available field trial data will support tolerances for residues of acetamiprid in the edible podded legume vegetables subgroup (Subgroup 6A) at 0.60 ppm, and in the succulent shelled peas and beans subgroup (Subgroup 6B) at 0.40 ppm; the tolerance calculations for edible podded peas and succulent shelled beans are presented in Appendix 2.

	Berries (Crop Group 13):  Nippon Soda Company   SEQ CHAPTER \h \r 1 has submitted field trial data on blueberries, blackberries, and raspberries, the representative commodities of the berries group (Group 13).  Six field trials were conducted on blueberries in Zones 1 (PA; 1 trial), 2 (GA; 2 trials), 5 (MI and WI; 2 trials), and 12 (OR; 1 trial); four trials were conducted on blackberries in Zones 2 (GA; 1 trial) and 12 (OR; 3 trials); and one trial was conducted on raspberries in Zone 12 (OR) during the 2004 growing season.

	At each trial location (except one blackberry and one raspberry trial conducted in OR), five foliar broadcast applications of the 70% WP formulation were made at 6- to 8-day RTIs, at a nominal rate of 0.101 lb ai/A per application (roughly 1x the proposed maximum single application rate), for total seasonal use rates of 0.504-0.533 lb ai/A (roughly 1x the proposed maximum seasonal application rate).  At one blackberry trial in OR, plants received one application at 0.434 lb ai/A (roughly 4x the proposed maximum single application rate), and a second application at 0.103 lb ai/A.  At the raspberry trial in OR, plants received two applications at 0.196-0.206 lb ai/A per application (roughly 2x the proposed maximum single application rate), and a third application at 0.104 lb ai/A.  Total rates for these two trials approximated rates at the trials utilizing five applications.  Applications were made using ground equipment, in spray volumes of 46-108 GPA, without any adjuvant.  Samples of mature blueberries, blackberries, and raspberries were harvested 1 DALA, except at three OR sites where mature blackberries were harvested at sampling intervals of 2 days (following two applications), and 7 or 8 days (following five applications).

	Samples of blueberries, blackberries, and raspberries were analyzed for acetamiprid residues using LC/MS/MS Method #KP-216R1.  The validated method LOQ was 0.010 ppm.  The method is adequate for data collection, based on acceptable method validation and concurrent method recovery data.  Samples were stored frozen for up to 8.1 months prior to analysis; adequate storage stability data are available to support the sample storage conditions and durations.

	The results of the berry field trials are presented in Table 6 (above).  Following application of the 70% WP formulation of acetamiprid at total seasonal use rates of 0.504-0.533 lb ai/A, maximum residues of acetamiprid were 0.692 ppm in blueberries harvested 1 day following the last of five foliar broadcast applications.  Maximum residues of acetamiprid were 0.547 ppm in blackberries harvested 1 day following the last of five applications (1 trial).  In blackberries  harvested 7-8 days following five applications (2 trials), residues of acetamiprid were 0.221-0.383 ppm, and residues were much higher (2.256 and 2.713 ppm) in blackberries harvested 2 days following the last of two applications (with the first application made at roughly a 4x exaggerated rate; 1 trial).  Maximum residues of acetamiprid were 0.822 ppm in raspberries harvested 1 day following the last of three applications (with the first two applications made at roughly a 2x exaggerated rate).

	No residue decline studies were included in the berry field trials.  Residue decline studies on cotton, head lettuce, oranges, pears, and peppers were submitted in conjunction with PP#0F6082 (D264154; Michael Doherty; 12/31/2001).  These studies indicated that residues of acetamiprid did not increase in the subject crops with increasing harvest intervals.  Therefore, residue decline data will not be required to support the berry field trials.

	Conclusions:  The submitted field trial data for the berries group (Group 13) are not adequate to satisfy data requirements.  Although the number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for the representative crops of the berries group, only one of the five caneberry field trials reflects the use pattern proposed for berries.  All of the blueberry field trials were conducted in accordance with the proposed use pattern for berries.  However, only one of the caneberry field trials (the blackberry trial in Tift, GA) adhered to the proposed use pattern; the other four caneberry trials utilized exaggerated individual application rates and/or longer PHIs.  The available blueberry field trial data will support a tolerance of 1.6 ppm; the tolerance calculations for blueberries are presented in Appendix 2.  The data also support the establishment of 1.6 ppm tolerances on lingonberries and the 11 additional crops (specified as members of the pending bushberries subgroup 13B) in Table 7.

	In the administrative materials accompanying PP#6F7051, the petitioner acknowledged the lack of sufficient caneberry data, and requested that conditional registration and tolerances be granted on the berries group 13, pending completion of two additional caneberry trials.  Nisso America has recently submitted a magnitude of the residue study, involving three additional caneberry field trials, conducted strictly in adherence with the maximum proposed use pattern.  That caneberry field trial study (MRID #47224701) is currently under review by HED.

	Because residue levels from the blackberry field trial that conformed to the proposed berry use pattern (average = 0.55 ppm) were substantially lower than the recommended tolerance for blueberries (1.6 ppm), HED recommends in favor of registration, with a tolerance established on the berries group (Group 13) at 1.6 ppm.

	Strawberry:  IR-4 has submitted field trial data for acetamiprid on strawberries.  Ten trials were conducted on strawberries in the US and Canada.  Seven trials were conducted in the US in Zones 2 (NJ; 1 trial), 3 (FL; 1 trial), 5 (WI; 1 trial), 10 (CA; 3 trials), and 12 (OR; 1 trial); and three trials were conducted in Canada in Zones 1 (NB; 1 trial), 5 (ON; 1 trial) and 5B (QC; 1 trial) during the 2004 growing season.

	At each trial location, two foliar broadcast applications of the 70% WP formulation were made at 6- to 9-day RTIs, at a nominal rate of 0.130 lb ai/A per application, for total seasonal use rates of 0.252-0.265 lb ai/A (roughly 1x the proposed maximum seasonal application rate).  Applications were made using ground equipment, in spray volumes of 23-51 GPA, without any adjuvant.  Mature samples of strawberries were harvested 1 DALA.  Additional samples from a single CA trial were collected 3, 5 and 9 DALA to evaluate residue decline.

	Samples of strawberries were analyzed for acetamiprid residues using a modification of LC/MS/MS Method #KP-216R1.  The validated method LOQ was 0.010 ppm.  The method is adequate for data collection, based on acceptable method validation and concurrent method recovery data.  Samples were stored frozen for up to 3.6 months prior to analysis; adequate concurrent storage stability data are available to support the sample storage conditions and durations.

	The results of the strawberry field trials are presented in Table 6 (above).  Maximum residues of acetamiprid were 0.25 ppm in strawberries harvested 1 day following the last of two foliar broadcast applications at total seasonal use rates of 0.252-0.265 lb ai/A.

	The results of the residue decline study demonstrate that residues of acetamiprid steadily declined in strawberries harvested with longer sampling intervals.

	Conclusions:  The submitted residue data for strawberries are adequate to fulfill data requirements. The number and locations of the field trials are in accordance with OPPTS Guideline 860.1500 for strawberries, and the use pattern of the field trials adequately reflects the use pattern proposed for strawberries.

	The available strawberry field trial data may be used to support use of acetamiprid on bearberries, bilberries, cloudberries, cranberries, muntries, and partridgeberries in addition to strawberries; these crops are members of the pending low-growing berries subgroup (subgroup 13G).  The data will support tolerances on strawberries, bearberries, bilberries, cloudberries, cranberries, muntries, and partridgeberries at 0.60 ppm; the tolerance calculations for strawberries are presented in Appendix 2.  It was noted that the tolerance on lowbush blueberries, which was also proposed by IR-4 in connection with this use, will be covered by the recommended tolerance on the berries group (Group 13).  A separate tolerance of 1.6 ppm is needed on lingonberry, which is a member of both proposed subgroups 13B and 13G.

860.1520 Processed Food and Feed

	HED does not require residue data for any processed commodities associated with berries, bulb vegetables, edible podded legume vegetables, succulent shelled beans and peas, or strawberries.  Therefore, data requirements for processed food and feed are not relevant to this tolerance petition.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference Standards

	An analytical standard for acetamiprid is currently available in the National Pesticide Standards Repository (personal communication with Dallas Wright, ACB, 2/21/2007).

860.1850 Confined Accumulation in Rotational Crops

	Residue Chemistry Memo   SEQ CHAPTER \h \r 1 D264154, Michael Doherty; 12/31/2001

	  SEQ CHAPTER \h \r 1 No new confined rotational crop data were submitted with this petition.

	A confined rotational crop study was reviewed in conjunction with PP#0F6082 (D264154; Michael Doherty; 12/31/2001).  The study was classified as unacceptable because insufficient supporting storage stability data were submitted.  In the study, acetamiprid was not detected in any rotational crop matrix at any plant-back interval.  The major metabolite identified in rotational crops was IM-1-4, at 2.94-56.65% TRR (<0.001-0.040 ppm).  IM-1-4 was identified in the following crops at >10% TRR:  30-, 58- and 120-DAT mustard; 30-, 58-, 120-, and 365-DAT radish tops; 30- and 120-DAT radish root; 30-, 58-, 120-, and 365-DAT grain crop forage and fodder/straw; and 58-DAT sorghum grain.  Two other metabolites were identified in most rotational crops:  IM-0-Glc, at 1.11-15.23% TRR (<0.001-0.010 ppm), and IC-0, at 2.75-24.19% TRR (<0.001-0.014 ppm).  Metabolite IM-0 was identified in 30-DAT sorghum forage, and 58-DAT sorghum fodder at <10% TRR; this metabolite was not identified in any other rotational crop matrix.

	Based on the available rotational crop data, HED determined that the ROC in rotational crops is parent only, and that tolerances would not be needed on rotational crops.  The available rotational crop data are adequate to support the uses proposed in this petition.

	The outstanding rotational crop supporting storage stability data (which were required as a condition of registration in the original petition, PP#0F6082) have been submitted (MRID #46729102).  The Agency had requested data demonstrating stability of the metabolite profile in various rotational crop matrices for an interval of 11 months.  Storage stability of the acetamiprid metabolites, IM-1-4, IC-0, and IM-0-Gluc, was checked in mustard greens.  The levels of these metabolites, as determined at the time of the rotational crop study, were 0.017, 0.011, and 0.005 ppm, respectively.  After 7 months of frozen storage, the levels were 0.025, 0.009, and 0.003 ppm, respectively; ergo, this metabolite profile was relatively stable.

	While the interval of the metabolites in mustard greens was only 7 months, instead of the requested 11 months, HED considers the rotational crop supporting storage stability data to be adequate for the following reasons:

	(1) the metabolites found in the rotational crop study were IM-1-4, IC-0, IM-0, and IM-0-Gluc;

	(2) these metabolites have been determined to be of low toxicity (MARC decision document; D278652; Henri Bietlot, Michael Doherty, Pamela Hurley; 11/13/2001);

	(3) the storage stability of acetamiprid per se has been demonstrated in various commodities for an interval of 12 months.

	The rotational crop storage stability data deficiency identified during HED’s review of PP#0F6082 has thus been resolved.

860.1900 Field Accumulation in Rotational Crops

	  SEQ CHAPTER \h \r 1 No field rotational crop data have been submitted, and no rotational crop restrictions have been proposed.  The available confined rotational crop data indicate that no field rotational crop studies are required to support the proposed uses; neither rotational crop restrictions nor tolerances are needed.

860.1550 Proposed Tolerances

	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 Tolerances are currently established under 40CFR §180.578[a][1] for residues of the insecticide, acetamiprid, in or on crop matrices.  The tolerance expression proposed by Nippon Soda Company is consistent with 40CFR §180.578; however, the tolerance expression proposed by IR-4 should be revised to exclude the word “combined.”

	It was noted that all crops for which use is proposed under the current petitions, except edible podded legume vegetables, and succulent shelled peas and beans, are affected by changes pending for the Crop Grouping Regulation.  The submitted data for the affected crops are evaluated in this document, as recommended in the Reviewer’s Guide and Summary of HED ChemSAC Approvals for Amending Crop Group/Subgroups (40CFR §180.41) and Commodity Definitions (40CFR §180.1[h]) (HED Memorandum; Bernard Schneider; 6/14/2006).

	Adequate field trial data are available for green and bulb onions, edible podded vegetables, succulent shelled peas and beans, blueberries, and strawberries. The available field trial data will support tolerances for residues of acetamiprid on crops in the pending green onion subgroup 3B at 4.5 ppm, crops in the pending bulb onion subgroup 3A at 0.02 ppm, the edible podded legume vegetables subgroup 6A at 0.60 ppm, the succulent shelled peas and beans subgroup 6B at 0.40 ppm, the berries group 13 (and associated commodities) at 1.6 ppm, and strawberries (and associated commodities) at 0.60 ppm.  The recommended tolerances are listed in Table 7 (below).  The tolerance spreadsheet in the Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels on the green onion subgroup 3B, the edible podded legume vegetables subgroup 6A, the succulent shelled peas and beans subgroup 6B, the berries group 13, and strawberries.  The tolerance spreadsheet was not used to determine the tolerance level on bulb onion subgroup 3A because the vast majority of the treated samples bore residues below the LOQ.

	The data indicate that the proposed tolerance on the bulb vegetable group (Group 3) is inappropriate, and should be replaced with individual tolerances on crops in the pending green onion subgroup 3B (and associated new commodities) at 4.5 ppm, and crops in the pending bulb onion subgroup 3A (and associated new commodities) at 0.02 ppm.  The proposed tolerance on the berries group (Group 13) is not supported by adequate data for caneberries.  However, HED recommends that registration and tolerances be granted on the berries group 13, as Nisso America has recently submitted a magnitude of the residue study, involving three additional caneberry field trials, conducted strictly in adherence with the maximum proposed use pattern.  That caneberry field trial study (MRID #47224701) is currently under review by HED.  The data indicate that the proposed tolerance of 0.5 ppm on the edible podded legume vegetables subgroup 6A is too low, while the proposed tolerance of 0.5 ppm on the succulent shelled peas and beans subgroup 6B is too high; revised tolerances of 0.60 ppm and 0.40 ppm, respectively, should be proposed.  The available field trial data for strawberries indicate that the proposed tolerances of 0.60 ppm on strawberries and associated low-growing berries are appropriate; however, the proposed tolerance on lowbush blueberries will be covered under the berries group 13 tolerance of 1.6 ppm.  A separate tolerance of 1.6 ppm is needed on lingonberry.

	Tolerances on   SEQ CHAPTER \h \r 1 animal commodities are not required for this petition because there are no significant livestock feedstuffs associated with the proposed uses on berries, bulb vegetables, edible podded legume vegetables, succulent shelled beans and peas, nor strawberries.

	Tolerances on rotational crops are not needed.  Residues of acetamiprid were not detected in any rotational crop matrix (mustard, lettuce, radish, sorghum, or wheat) at any PBI (30, 58, 120, or 365 days).

	There are no Codex, Canadian, or Mexican maximum residue limits (MRLs) established for residues of acetamiprid on the crops associated with this petition.  An International Residue Limit Status (IRLS) sheet is appended to this document (following the references).

	The proposed tolerances should be revised to reflect the recommended tolerance levels and correct commodity definitions, as specified in Table 7; individual tolerances on the new members of each of the requested pending crop groups should be established as noted in Table 7 (below).

Table 7	Tolerance Summary for Acetamiprid.

Commodity	Proposed Tolerance (ppm)	Recommended

Tolerance (ppm)	Comments; Correct Commodity Definition*

Proposed Tolerances

Bulb vegetables crop group (Group 3)	3.0	Remove	Separate tolerances should be proposed for the individual crops in the pending green onion and bulb onion subgroups.

Edible podded legume vegetables (Subgroup 6A)	0.5	0.60	Vegetable, legume, edible podded, subgroup 6A

Succulent shelled peas and beans (Subgroup 6B)	0.5	0.40	Pea and bean, succulent shelled, subgroup 6B

Berries crop group (Group 13)	1.0	1.6	Berry, group 13

Bearberry	0.60	0.60	Tolerances on commodities included in the pending low-growing berries subgroup 13G.

Bilberry	0.60	0.60

	Blueberry, lowbush	0.60	Remove (not needed).	Lowbush blueberry is already a member of the berries group 13.

Cloudberry	0.60	0.60	Tolerances on commodities included in the pending low-growing berries subgroup 13G.

Cranberry	0.60	0.60

	Lingonberry	0.60	1.6	Lingonberry is a member of the pending bushberries subgroup 13B, for which a higher tolerance is recommended.

Muntries	0.60	0.60	Tolerances on commodities included in the pending low-growing berries subgroup 13G.

Partridgeberry	0.60	0.60

	Strawberry	0.60	0.60

	Tolerances That Need to be Proposed

Aronia berry	--	1.6	Tolerances on commodities included in the pending bushberries subgroup 13B, along with lingonberry.

Buffalo currant	--	1.6

	Chilean guava	--	1.6

	European barberry	--	1.6

	Highbush cranberry	--	1.6

	Honeysuckle, edible	--	1.6

	Jostaberry	--	1.6

	Juneberry	--	1.6

	Native currant	--	1.6

	Salal	--	1.6

	Sea buckthorn	--	1.6

	Tolerances That Need to be Proposed

Onion, bulb	--	0.02	Tolerances on commodities included in the pending bulb onion subgroup 3A.

Fritillaria, bulb	--	0.02

	Daylily, bulb	--	0.02

	Garlic, bulb	--	0.02

	Garlic, great headed, bulb	--	0.02

	Garlic, Serpent, bulb	--	0.02

	Lily, bulb	--	0.02

	Onion, Chinese, bulb	--	0.02

	Onion, Pearl	--	0.02

	Onion, potato, bulb	--	0.02

	Shallot, bulb	--	0.02

	Onion, green	--	4.5	Tolerances on commodities included in the pending green onion subgroup 3B.

Chive, fresh leaves	--	4.5

	Chive, Chinese, fresh leaves	--	4.5

	Elegans hosta	--	4.5

	Fritillaria, leaves	--	4.5

	Kurrat	--	4.5

	Lady’s leek	--	4.5

	Leek	--	4.5

	Leek, wild	--	4.5

	Onion, Beltsville bunching	--	4.5

	Onion, fresh	--	4.5

	Onion, macrostem	--	4.5

	Onion, tree, tops	--	4.5

	Onion, Welsh, tops	--	4.5

	Shallot, fresh leaves	--	4.5

	* Refer to HED Memorandum dated 6/14/2006 by Bernard Schneider for pending changes to crop groups, and 	commodity definitions.

References

	Acetamiprid.  Results of the HED Metabolism Assessment Review Committee Meeting Held on October 16, 2001.; D278652; Henri Bietlot, Michael Doherty, Pamela Hurley; 11/13/2001.

	0F6082.  Section 3 Registration for Use of Acetamiprid on Cotton, Leafy Vegetables, Cole Vegetables, Fruiting Vegetables, Citrus Fruits, Pome Fruits, Grapes, and Canola and Mustard Seed.  Summary of Analytical Methods and Residue Chemistry DERs.; D264154; Michael Doherty; 12/31/2001.

	Acetamiprid.  Tolerance Petition Requesting Section 3 Registration for Food Use of the Insecticide Acetamiprid on Tuberous and Corm Vegetables (Crop Subgroup 1C) and Non-Food Use on Tobacco.  Summary of Analytical Chemistry and Residue Data.  Petition Number 3F6575.; D  SEQ CHAPTER \h \r 1 306191; William Drew; 11/3/2004.

	Acetamiprid.  Tolerance Petition Requesting Section 3 Registration for Food Use of the Insecticide Acetamiprid on Cucurbit Vegetables (Crop Group 9), Stone Fruits (Crop Group 12), and Tree Nuts (Crop Group 14).  Summary of Analytical Chemistry and Residue Data.  Petition Number 4F6833.; D303623; William Drew; 11/5/2004.

	Reviewer's Guide and Summary of HED ChemSAC Approvals for Amending Crop Group/Subgroups (40CFR §180.41) and Commodity Definitions (40CFR §180.1 [h]).; Bernard Schneider; 6/14/2006.

  SEQ CHAPTER \h \r 1 Attachments:

Appendix 1 - International Residue Limit Status sheet

Appendix 2 - Tolerance Assessment Calculations

Appendix 1:  International Residue Limit Status sheet

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano- N1-methylacetamidine	Common Name:  Acetamiprid

	X Proposed tolerances

 Reevaluated tolerance

 Other	Date:  4/23/2007

Codex Status (Maximum Residue Limits)	US Tolerances

 √  No Codex proposal step 6 or above

  No Codex proposal step 6 or above for the crops requested	Petition Numbers:  6F7051 & 6E7163

DP Numbers:  328216 & 336255

Other Identifier:  PC Code 099050

Residue definition (step 8/CXL): N/A	Reviewer/Branch:  William T. Drew/RAB2

	Residue definition:  Acetamiprid per se

Crop(s)	MRL (mg/kg)	Crops	Tolerance (ppm)

PP#6F7051 (Nippon Soda Company, Limited)

Berries (Group 13)	1.0

Bulb vegetables (Group 3)	3.0

Edible podded legume vegetables (Subgroup 6A)	0.5

Succulent shelled peas and beans (Subgroup 6B)	0.5

PP#6E7163 (IR-4)

Strawberry	0.60

Bearberry	0.60

Bilberry	0.60

Blueberry, lowbush	0.60

Cloudberry	0.60

Cranberry	0.60

Lingonberry	0.60

Muntries	0.60

Partridgeberry 	0.60

Limits for Canada	Limits for Mexico

 No Limits

√  No Limits for the crops requested	 No Limits

√  No Limits for the crops requested

Residue definition:  (E)-N-[(6-chloro-3-pyridinyl)methyl]-N’-cyano-N-methylethanimidamide Residue definition:  Acetamiprid

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	Notes:  Steve Funk, 02/20/2007

Appendix 2:  Tolerance Assessment Calculations.

Bulb Vegetables (Group 3)

	The dataset used to support a tolerance for acetamiprid on bulb vegetables consisted of field trial data representing four foliar applications at ~0.148 lb ai/A per application, for total rates of 0.588-0.603 lb ai/A, with 6- to 7-day PHIs.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates, and PHIs, are within 25% of the maximum label application rate, and minimum label PHI, respectively.  The representative commodities of the bulb vegetable crop group are bulb onion and green onion; however the field trial data indicate that a crop group tolerance is not applicable because residues in green onion were >5x the residues in bulb onion.  Separate tolerances are needed on the bulb onion subgroup 3A and the green onion subgroup 3B.

	All six green onion field trial sample results had acetamiprid residues above the LOQ; therefore, MLE procedures were not needed to impute censored values.  For bulb onion, residue data were not entered into the spreadsheet because most of the residue values (10 of 12 samples) were below the LOQ.  Residue values used to calculate the tolerance are provided in Table 2-1.

	Green Onion:  The dataset was entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plot (Figure 2-1) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure 2-2) confirmed that the assumption of lognormality should not be rejected.

	Since the field trial data for acetamiprid on green onion represent a small dataset (less than 15 samples), and are reasonably lognormal, the upper bound estimate of the 95th percentile based on the median residue value was compared to the minimum of the 95% upper confidence limit (UCL) on the 95th percentile and the point estimate of the 99th percentile, and the minimum value was selected as the tolerance value.  Using the rounding procedure as outlined in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the upper bound estimate of the 95th percentile based on the median residue value rounds to 4.5 ppm (Figure 2-2).  Because this value was the minimum value, 4.5 ppm is the recommended tolerance level for acetamiprid on green onion subgroup 3A.

Table 2-1	Residue data used to calculate tolerance for acetamiprid on green onion.

Regulator:	EPA

Chemical:	Acetamiprid

Crop:	Green onion

PHI:	7 Days

App. Rate:	4 at 0.148 lb ai/A per application

Submitter:	Nippon Soda Co.

MRID Citation:	MRID #46785503

	Residues of Acetamiprid (ppm)

	0.038

	0.062

	1.771

	2.149

	0.340

	0.428

Figure 2-  SEQ Figure_II- \* ARABIC  1 	Lognormal probability plot of acetamiprid field trial data for green onion.

Figure 2-2	Tolerance spreadsheet summary of acetamiprid field trial data for green onion.

Edible Podded Legume Vegetables (Subgroup 6A)

	The dataset used to establish a tolerance for acetamiprid on edible podded legume vegetable consisted of field trial data representing three foliar applications at ~0.101 lb ai/A per application, for total rates of 0.299-0.317 lb ai/A, with 7- to 8-day PHIs.  The field trial application rates, and PHIs, are within 25% of the maximum label application rate, and minimum label PHI, respectively.  The representative commodities of the edible podded legume vegetable subgroup are succulent cultivars of edible podded bean and pea.

	All 6 succulent podded pea field trial sample results had acetamiprid residues above the LOQ; therefore, MLE procedures were not needed to impute censored values.  For succulent podded bean, residue data were not entered into the spreadsheet because most of the residue values (8 of 12 samples) were below the LOQ.  The residue values used to calculate the tolerance are provided in Table 2-2.

	Succulent Edible Podded Pea:  The dataset was entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plot (Figure 2-3) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure 2-4) confirmed that the assumption of lognormality should not be rejected.

	Since the field trial data for acetamiprid on succulent podded pea represent a small dataset (less than 15 samples), and are reasonably lognormal, the upper bound estimate of the 95th percentile based on the median residue value was compared to the minimum of the 95% UCL on the 95th percentile and the point estimate of the 99th percentile, and the minimum value was selected as the tolerance value.  Using the rounding procedure as outlined in the guidance, the point estimate of the 99th percentile rounds to the value 0.60 ppm (Figure 2-4).  Because this value was the minimum value, 0.60 ppm is the recommended tolerance level for acetamiprid on succulent edible podded pea.

Table 2-2	Residue data used to calculate tolerance for acetamiprid on succulent edible podded pea.

Regulator:	EPA

Chemical:	Acetamiprid

Crop:	Succulent podded pea

PHI:	7-8 Days

App. Rate:	3 at 0.101 lb ai/A per application

Submitter:	Nippon Soda Co.

MRID Citation:	MRID #46785504

	Residues of Acetamiprid (ppm)

	0.114

	0.151

	0.262

	0.282

	0.0707

	0.0920

Figure 2-3	Lognormal probability plot of acetamiprid field trial data for succulent edible podded pea.

Figure 2- 4	Tolerance spreadsheet summary of acetamiprid field trial data for succulent edible podded pea.

Succulent Shelled Pea and Bean (Subgroup 6B)

	The dataset used to establish a tolerance for acetamiprid on succulent shelled peas and beans consisted of field trial data representing three foliar applications at ~0.101 lb ai/A per application, for total rates of 0.301-0.308 lb ai/A, with 7- to 8-day PHIs.  The field trial application rates, and PHIs, are within 25% of the maximum label application rate, and minimum label PHI, respectively.  The representative commodities of the succulent shelled pea and bean subgroup are succulent shelled cultivars of bean and garden pea.

	All 12 succulent shelled bean field trial sample results had acetamiprid residues above the LOQ; therefore, MLE procedures were not needed to impute censored values.  For succulent shelled pea, residue data were not entered into the spreadsheet because >15% residue values (2 of 12 samples) were below the LOQ.  The residue values used to calculate the tolerance are provided in Table 2-3.

	Succulent Shelled Bean:  The dataset was entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plot (Figure 2-5) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure 2-6) confirmed that the assumption of lognormality should not be rejected.

	Since the field trial data for acetamiprid on succulent shelled bean represent a small dataset (less than 15 samples), and are reasonably lognormal, the upper bound estimate of the 95th percentile based on the median residue value was compared to the minimum of the 95% UCL on the 95th percentile and the point estimate of the 99th percentile, and the minimum value was selected as the tolerance value.  Using the rounding procedure as outlined in the guidance, the point estimate of the 99th percentile rounds to the value 0.40 ppm (Figure 2-6).  Because this value was the minimum value, 0.40 ppm is the recommended tolerance level for acetamiprid on succulent shelled bean.

Table 2-3	Residue data used to calculate tolerance for acetamiprid on succulent shelled bean.

Regulator:	EPA

Chemical:	Acetamiprid

Crop:	Succulent shelled bean

PHI:	7 Days

App. Rate:	3 at 0.101 lb ai/A per application

Submitter:	Nippon Soda Co.

MRID Citation:	MRID 46785504

	Residues of Acetamiprid (ppm)

	0.0777

	0.0899

	0.0330

	0.0353

	0.0875

	0.131

	0.0381

	0.0423

	0.166

	0.190

	0.0189

	0.0201

Figure 2-5	Lognormal probability plot of acetamiprid field trial data for succulent shelled bean.

Figure 2-6	Tolerance spreadsheet summary of acetamiprid field trial data for succulent shelled bean.

Berry (Group 13)

	The dataset used to support a tolerance for acetamiprid on berries consisted of field trial data representing five foliar applications at ~0.101 lb ai/A per application, for total rates of 0.504-0.533 lb ai/A, with a 1-day PHI.  The field trial application rates, and PHIs, are within 25% of the maximum label application rate, and minimum label PHI, respectively.  The representative commodities of the berries crop group are blueberry and blackberry and/or raspberry.

	All 12 blueberry field trial sample results had acetamiprid residues above the LOQ; therefore, MLE procedures were not needed to impute censored values.  The available blackberry and raspberry trials which represent the seasonal use rate and PHI only include 2 samples for each crop; therefore, tolerance spreadsheets were not used for blackberry and raspberry.  The residue data for blueberry may be used to calculate a tolerance on the berry group 13.  The residue values used to calculate the tolerance are provided in Table 2-4.

	Blueberry:  The dataset was entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plot (Figure 2-7) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure 2-8) confirmed that the assumption of lognormality should not be rejected.

	Since the field trial data for acetamiprid on blueberry represent a small dataset (less than 15 samples), and are reasonably lognormal, the upper bound estimate of the 95th percentile based on the median residue value was compared to the minimum of the 95% UCL on the 95th percentile and the point estimate of the 99th percentile, and the minimum value was selected as the tolerance value.  Using the rounding procedure as outlined in the guidance, the point estimate of the 99th percentile rounds to the value 1.6 ppm (Figure 2-8).  Because this value was the minimum value, 1.6 ppm is the recommended tolerance level for acetamiprid on berry group 13.

Table 2-4	Residue data used to calculate tolerance for acetamiprid on blueberry.

Regulator:	EPA

Chemical:	Acetamiprid

Crop:	Blueberry

PHI:	1 Day

App. Rate:	5 at 0.101 lb ai/A per application

Submitter:	Nippon Soda Co.

MRID Citation:	MRID 46785502

	Residues of Acetamiprid (ppm)

	0.080

	0.095

	0.465

	0.485

	0.541

	0.692

	0.459

	0.527

	0.199

	0.201

	0.218

	0.276

Figure 2-7	Lognormal probability plot of acetamiprid field trial data for blueberry.

Figure 2-8	Tolerance spreadsheet summary of acetamiprid field trial data for blueberry.

Strawberry

	The dataset used to establish a tolerance for acetamiprid on strawberry consisted of field trial data representing two foliar applications at ~0.13 lb ai/A per application, for total rates of 0.252-0.265 lb ai/A, with a 1-day PHI.  As specified by the guidance, the field trial application rates, and PHIs, are within 25% of the maximum label application rate, and minimum label PHI, respectively.  The residue values used to calculate the tolerance are provided in Table 2-5.  All 20 strawberry field trial sample results had acetamiprid residues above the LOQ; therefore, MLE procedures were not needed to impute censored values.

	The dataset was entered into the tolerance spreadsheet. Visual inspection of the lognormal probability plot (Figure 2-9) provided in the spreadsheet indicates that the dataset is reasonably lognormal.  The result from the approximate Shapiro-Francia test statistic (Figure 2-10) confirmed that the assumption of lognormality should not be rejected.

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Table 2-5	Residue data used to calculate tolerance for acetamiprid on strawberry.

Regulator:	EPA/PMRA

Chemical:	Acetamiprid

Crop:	Strawberry

PHI:	1 Day

App. Rate:	2 at 0.13 lb ai/A per application

Submitter:	IR-4

MRID Citation:	MRID 47013601

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	0.22

	0.24

	0.11

	0.11

	0.22

	0.25

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	0.06

	0.09

	0.09

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	0.04

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	0.13

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	0.05

	0.03

	0.03

Figure 2- 9.  Lognormal probability plot of acetamiprid field trial data for strawberry.

Figure 2-10.   Tolerance spreadsheet summary of acetamiprid field trial data for strawberry.

Page   PAGE  2  of   NUMPAGES  39

Acetamiprid	Summary of Analytical Chemistry and Residue Data	DP #328216

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[Federal Register: April 3, 2006 (Volume 71, Number 63)]
[Notices]
[Page 16601-16603]
[DOCID:fr03ap06-83]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53557; File No. SR-BSE-2006-09]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Chapter VII, Section 1(g) Relating to the Exercise of Options
Contracts

March 28, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 15, 2006, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule

change as described in Items I and II below, which Items have been
prepared by the Exchange. The BSE filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section 19(b)(3)(A) of
the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders it
effective upon filing with the Commission.\5\ The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(B)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
    \5\ As required by Rule 19b-4(f)(6)(iii), 17 CFR 240.19b-
4(f)(6)(iii), the BSE submitted written notice of its intent to file
the proposed rule change, along with a brief description and text of
the proposed rule change, at least five business days prior to the
date of filing.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The BSE, pursuant to Section 19(b)(1) of the Act \6\ and Rule 19b-4
thereunder,\7\ proposes to amend the Rules of the Boston Options
Exchange (``BOX''), an options trading facility of the BSE, to amend
Chapter VII, Section 1(g) relating to the exercise of options contracts
and the deadline within which one may make a final decision to exercise
or not exercise an expiring option. The text of the proposed rule
change is available on the BSE's Web site at (http://bostonstock.com),

at the BSE's principal office, and at the Commission's Public Reference
Room.\8\
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    \6\ 15 U.S.C. 78s(b)(1).
    \7\ 17 CFR 240.19b-4.
    \8\ In its proposal, the Exchange indicated that no change is
being made to subsections .01 and .02 of the Supplementary Material
following Chapter VII, Section 1 of the BOX Rules. During a
telephone conversation on March 21, 2006, the Exchange clarified
that no change is to be made to subsections .03 through .05 of the
Supplementary Material following Chapter VII, Section 1 of the BOX
Rules. Telephone conversation between Bill Meehan, General Counsel,
BSE, and Johnna B. Dumler, Attorney, Division of Market Regulation
(``Division''), Commission, on March 21, 2006.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposal. The text of these
statements may be examined at the places specified in Item IV below.
The BSE has prepared summaries, set forth in Sections A, B, and C
below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The BSE proposes to amend Chapter VII, Section 1(g) of the BOX
Rules to clarify the amount of time that is set forth as the deadline
to make a final decision to exercise or not exercise an options
contract.
    On January 11, 2006, the BSE filed a proposed rule change, which
the Commission subsequently approved on an accelerated basis, relating
to the change in the closing time for trading options on individual
stocks from 4:02 p.m. Eastern Time (``ET'') to 4 p.m. ET.\9\ However,
that proposed rule change did not address a corresponding change to
Chapter VII, Section 1(g) of the BOX Rules relating to the time frame
within which to exercise or not exercise an options contract.
Therefore, the BSE now seeks to amend this rule text for purposes of
consistency with the new hours of trading in equity options on
individual stocks. The BSE proposes to change all references in Chapter
VII, Section 1(g) from 28 minutes to 30 minutes to reflect the two
minute change in the closing time for trading of options on individual
stocks.
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    \9\ See Securities Exchange Act Release No. 53245 (February 7,
2006), 71 FR 8010 (February 15, 2006) (approving SR-BSE-2006-02).
The BSE filed SR-BSE-2006-02 on January 11, 2006 and subsequently
filed a partial amendment on February 2, 2006, which requested the
implementation date for the new closing time be changed from
February 1, 2006, as originally proposed, to February 13, 2006.
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    According to the Exchange, the proposed rule change is based on
similar rule changes submitted by the Pacific Exchange, Inc., the
Philadelphia Stock Exchange, Inc. and the International Securities
Exchange, Inc.\10\
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    \10\ See Securities Exchange Act Release Nos. 53249 (February 7,
2006), 71 FR 8035 (February 15, 2006) (SR-PCX-2005-138); 53407
(March 3, 2006), 71 FR 12764 (March 13, 2006) (SR-Phlx-2006-12);
53439 (March 7, 2006), 71 FR 13643 (March 16, 2006) (SR-ISE-2006-
11). See also 53438 (March 7, 2006, 71 FR 13641 (March 16, 2006)
(SR-CBOE-2006-19).
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \11\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \12\ in particular, because it
is designed to foster cooperation and coordination with persons engaged
in facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.\13\
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
    \13\ The Exchange clarified that it is relying on the statutory
bases set forth above, as opposed to the factors enumerated in the
``Basis'' Section of Exhibit 1. Telephone conversation between Bill
Meehan, General Counsel, BSE, and Johnna B. Dumler, Attorney,
Division, Commission, on March 21, 2006.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The BSE has neither solicited nor received comments on the proposed
rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30-days after the
date on which it was filed, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) of the Act \14\ and Rule 19b-4(f)(6)
thereunder.\15\
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    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \16\ normally
does not become operative prior to 30-days after the date of filing.
However, Rule 19b-4(f)(6)(iii) permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The BSE has asked the Commission to
waive the 30-day operative delay. The Commission believes that waiving
the 30-day operative delay is consistent with the protection of
investors and the public interest because such waiver will allow the
BSE to immediately clarify its rule and conform it to the industry-wide
close of trading times now in effect. Accelerating the operative date
will facilitate efficient and effective market operation by offering
clarity and internal consistency with existing BSE rules. For these
reasons, the

Commission designates the proposed rule change as effective and
operative immediately upon filing with the Commission.\17\
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    \16\ Id.
    \17\ For the purposes only of waiving the 30-day operative date
of this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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    At any time within 60-days after the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-BSE-2006-09 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BSE-2006-09. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the BSE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-BSE-2006-09 and should be submitted on or before April
24, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-4755 Filed 3-31-06; 8:45 am]

BILLING CODE 8010-01-P