Document ID: EPA-HQ-OPP-2007-0105-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-28T05:00Z

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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 percentile should be selected as the tolerance value.  Using the
rounding procedure as outlined in the guidance, the 95% UCL on the 95th
percentile and the point estimate of the 99th percentile round to the
value 0.60 ppm (Figure 2-10).  The 0.60 ppm value is the recommended
tolerance level for acetamiprid on strawberry.  

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

	Residues of Acetamiprid (ppm)

	0.23

	0.24

	0.22

	0.24

	0.11

	0.11

	0.22

	0.25

	0.06

	0.06

	0.09

	0.09

	0.04

	0.04

	0.10

	0.13

	0.05

	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 

?

3

+ 

? 

California Method

Distribution-Free

EU Method II

Normality Test 

Shapiro-Francia 

Approximate 

rounded? (Y or N)==>

Would you like the above values 

Log Normal

EU Method I

Normal

EU Method I

Y

p-value > 0.05 : Do not reject lognormality assumption

0.9493

1.6

UPLMedian95th

0.45

0.60

(--)

(2.5)

(1.2)

0.90

0.60

0.40

(--)

(0.70)

(0.50)

0.45

0.40

0.35

99.9th Percentile

99th Percentile

95th Percentile

0.16

average:

0.13

median;

0.28

max:

0.07

min:

6

n:

MRID 46785504

MRID Citation:

Nippon Soda Co.

Submitter:

3 at 0.101 lb ai/A/application

App. Rate:

7-8 Days

PHI:

Edible Podded Pea

Crop:

Acetamiprid

Chemical:

EPA

Regulator:

N

C

N

3

H

C

Cl

3

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C

N

N

N

N

H

Cl

C

H

3

N

C

N

N

N

H

Cl

C

H

3

N

O

N

H

2