UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  11 August 2009

SUBJECT:	Clothianidin; Petitions for Tolerances and Uses on Berries
Subgroup 13-07H, Brassica Vegetables, Cotton, Cucurbit Vegetables, Figs,
Fruiting Vegetables, Leafy Vegetables, Peaches, Pomegranates, Soybeans,
Tuberous and Corm Vegetables, and Tree Nuts.  Summary of Analytical
Chemistry and Residue Data.

PC Code:  044309	DP Barcodes:  D355896, D360842, and D362499

Decision Nos.:	397135, 401868, and 405608	Registration Nos.:  59639-150,
59639-151, 59639-152

Petition Nos.:	8F7395, 8E7460 and 9F7530	Regulatory Action:  Section 3
Registrations

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  210880-92-5

MRID No.:  See MRID Summary Table	40 CFR:  180.586

		              									Ver.Apr.08

FROM:	Michael A. Doherty, Ph.D., Chemist

		Risk Assessment Branch II

		  SEQ CHAPTER \h \r 1 Health Effects Division (7509P)

THROUGH:	Richard A. Loranger, Ph.D., Senior Scientist

		Risk Assessment Branch II

		  SEQ CHAPTER \h \r 1 Health Effects Division (7509P)

TO:		Kable Davis/Venus Eagle (Team 01)

		Insecticide/Rodenticide Branch

		Registration Division (7505P)  SEQ CHAPTER \h \r 1

		Barbara Madden

		Risk Integration, Minor Use & Emergency Response Branch

		Registration Division (7505P)  SEQ CHAPTER \h \r 1

MRID Summary Table

MRID No.	Study Type	Comments

47471601	860.1500 Almond	New DER; 47471601.der.doc

47471602	860.1500 Peppers	New DER; 47471602.der.doc

47471603	860.1500 Cabbage	New DER; 47471603.der.doc

47471604	860.1500 Cantaloupe	New DER; 47471604.der.doc

47471605	860.1500 Cauliflower	New DER; 47471605.der.doc

47471606	860.1500 Celery	New DER; 47471606.der.doc

47471607	860.1500/1520 Cotton	New DERs; 47471607.de1.doc and
47471607.de2.doc

47471608	860.1500 Cucumber	New DER; 47471608.der.doc

47471609	860.1500 Head Lettuce	New DER; 47471609.der.doc

47471610	860.1500 Leaf Lettuce	New DER; 47471610.der.doc

47471611	860.1500 Mustard Greens	New DER; 47471611.der.doc

47471612	860.1500 Pecans	New DER; 47471612.der.doc

47471613	860.1500/1520 Soybean	New DERs; 47471613.de1.doc and
47471613.de2.doc

47471614	860.1500 Spinach	New DER; 47471614.der.doc

47471615	860.1500 Summer Squash	New DER; 47471615.der.doc

47471616	860.1500/1520 Tomato	New DERs; 47471616.de1.doc and
47471616.de2.doc

47578101	860.1500 Peach	One new DER for both peach submissions;
47578101.der.doc

47578102	860.1500 Peach

	47578103	860.1500 Cranberry	New DER; 47578103.der.doc

47666901	860.1500 Fig	New DER; 47666901.der.doc

47666902	860.1500 Pomegranate	New DER; 47666902.der.doc

  SEQ CHAPTER \h \r 1 This document was originally prepared under
contract by Dynamac Corporation (1910 Sedwick Road, Building 100, Suite
B; Durham, NC 27713).   The document has been reviewed by the Health
Effects Division (HED) and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

Clothianidin,
(E)-N-[(2-Chloro-5-thiazolyl)methyl]-N’-methyl-N”-nitroguanidine, is
a broad spectrum, systemic neonicotinoid insecticide (Group 4A
insecticide).  It is currently registered to Bayer CropScience for seed
treatment uses on canola (rapeseed), cotton, corn, sorghum, and sugar
beet, and to Valent USA Corporation for seed treatment uses and for
direct soil or foliar applications to grapes, pome fruits, potatoes and
tobacco.  Permanent tolerances are established for residues of
clothianidin per se in or on plant commodities at 0.01-1.0 ppm and in
milk at 0.01 ppm [40 CFR §180.586(a)], and time-limited tolerances are
established for clothianidin residues in sugar beet roots and tops at
0.02 ppm [40 CFR §180.586(b)].  Tolerances are also established for the
indirect residues of clothianidin at 0.02 ppm in nongrass livestock
feeds; forage, fodder, and straw of cereal grains; forage, fodder, and
hay of grasses; and soybean forage and hay [40 CFR §180.586(d)].

Valent has submitted petitions (PP#s 8F7395 and 9F7530) proposing new
uses for clothianidin formulated as a 50% water-dispersible granule
(WDG; Arena® 50 WDG, EPA Reg. No. 59639-152) and a 2.13 lb/gal flowable
concentrate (FlC; V-1070 2.13 SC, EPA Reg. No 59639-150) for the control
of various insects on the following crops/crop groups:  Brassica leafy
vegetables, cotton, cucurbit vegetables, figs, fruiting vegetables,
leafy vegetables, pomegranates, soybeans and tree nuts.  The proposed
uses for both formulations on vegetable crops are for either a single
soil application at up to 0.2 lb ai/A, or repeated foliar applications
at 0.05-0.067 lb ai/A, with a maximum of 0.2 lb ai/A/season.  The
proposed uses for cotton and soybeans are for repeated foliar
applications at 0.05-0.067 lb ai/A with a maximum of 0.2 lb ai/A/season.
The proposed uses on figs and pomegranates are for repeated foliar
applications at 0.06-0.09 lb ai/A with a maximum of 0.2 lb ai/A/season,
and the proposed use on tree nuts is for repeated foliar applications at
0.05-0.10 lb ai/A with a maximum of 0.2 lb ai/A/season.  The minimum
retreatment intervals (RTIs) for the foliar applications are 7 days for
cotton and soybeans, 10 days for vegetables and tree nuts, and 14 days
for figs and pomegranates.  The minimum preharvest intervals (PHIs) are
7 days for the various vegetable crops, figs and pomegranates and 21
days for cotton, soybeans and tree nuts.  Applications can only be made
using ground equipment, and can include the use of an adjuvant.  Valent
is also proposing to amend the use directions for its 5 lb/gal FlC
formulation (V-10170 5 FS, EPA Reg. No. 59639-151) to include uses on
potato seed pieces and soybean seeds.  In conjunction with these uses,
Valent is proposing the following permanent tolerances for clothianidin:

Almond hull 	1.5 ppm

Brassica (Cole) vegetables, Crop Group 5	3.0 ppm

Cotton, seed	0.25 ppm

Cotton, gin trash	4.5 ppm

Cotton, meal	0.25 ppm

Cotton, hulls	0.25 ppm

Cotton, refined oil	0.01 ppm

Cucurbits vegetables, Crop Group 9	0.05 ppm

Fig	0.05 ppm

Fruiting vegetables, Crop Group 8	0.25 ppm

Leafy vegetables, Crop Group 4	3.5 ppm

Pomegranate	0.20 ppm

Soybean, seed	0.03 ppm

Soybean, hull	0.35 ppm

Soybean, meal	0.07 ppm

Soybean, oil	0.01 ppm

Tomato, paste	0.08 ppm

Tomato, puree	0.07 ppm

Tree nuts, Crop Group 14	0.01 ppm

In addition, Interregional Research Project No. 4 (IR-4) has submitted a
separate petition (PP#8E7460) proposing new uses for Valent’s 50% WDG
and 2.13 lb/gal FlC formulations on peaches and members of the
low-growing berry (except strawberry) Subgroup 13-07H.  The proposed use
on peaches is for repeated foliar applications at 0.05-0.10 lb ai/A,
with a minimum RTI of 10 days and a maximum of 0.2 lb ai/A/season.  For
low-growing berries, the proposed uses are for either a single soil
application at up to 0.2 lb ai/A, or repeated foliar applications at
0.05-0.066 lb ai/A, with a minimum RTI of 7 days and a maximum of 0.2 lb
ai/A/season.  The minimum PHIs are 7 days for peaches and 21 days for
low-growing berries.  IR-4 is also proposing that the existing uses on
potatoes on the 50% WDG and 2.13 lb/gal FlC labels be extended to cover
all members of the tuberous and corm vegetables Subgroup 1C.  In
conjunction with these uses, IR-4 has proposed the following tolerances
for clothianidin:

Crop Subgroup 13-07H	0.01 ppm

Peach	0.70 ppm

Vegetables, tuberous and corm, crop subgroup1C	0.05 ppm

  SEQ CHAPTER \h \r 1 The nature of the residue in plants has been
adequately delineated based on the acceptable corn, sugar beet, apple,
and tomato metabolism studies.  Parent compound is the only residue of
concern in primary crops for both tolerance setting and risk assessment
purposes, except in leafy vegetables and root crops.  In these crops,
the residues of concern also include thiazolylmethylguanidine (TMG) for
purposes of risk assessment.  The nature of the residue in livestock is
also understood based on the acceptable goat and hen metabolism studies.
 For risk assessment, the residues of concern in ruminants include
parent and the metabolites TZU, TZG, TZNG, and ATMG-Pyruvate, and the
residues of concern in poultry include parent and the metabolites TZU,
TZG, TZNG, and ATG-Acetate.  However, only parent needs to be included
in the tolerance expression for animal commodities.

  SEQ CHAPTER \h \r 1 Adequate LC/MS/MS methods are available for
enforcing tolerances for clothianidin residues in plant commodities
(Bayer Methods 00552, 00552-M001, and 109240-1) and livestock
commodities (Bayer Method 00624).  The validated limit of quantitation
(LOQ) for clothianidin in plant commodities is 0.010 ppm, except in
wheat straw (0.020 ppm), while the validated LOQs are 0.010 ppm in milk,
and 0.020 ppm in livestock tissues.

In the field trials and processing studies submitted by Valent, residues
of clothianidin were determined using adequate LC/MS/MS methods (Morse
Method #Meth-164, and Valent Method RM-39C-1), Method #Meth-164 has been
previously proposed for enforcing tolerances.  This method was also used
to determine residues of TMG in leafy vegetables, Brassica vegetables,
and cotton gin byproducts (gin trash).  The validated LOQ for each
analyte was 0.01 ppm in each matrix tested.

In the cranberry and peach field trials submitted by IR-4, residues of
clothianidin were determined using an adequate LC/MS/MS method, which is
a slightly modified version of Bayer Method 00552.  The lowest level of
method validation (LLMV) was 0.01 ppm for cranberries and 0.02 ppm for
peaches, and the statistically calculated LOQs were 0.004 ppm for
cranberries and 0.011-0.017 ppm for peaches.  Both LC/MS/MS methods were
adequately validated both prior to and in conjunction with the analysis
of the field trial and processing study samples.

 stable at ≤-20°C for at least 2 months in almond hulls and tomato
paste, 4 months in pecan nutmeats, soybean seeds, and cottonseed meal
and refined oil, 5 months in cottonseeds and cranberries, ~7-8 months in
cucumbers, tomatoes, lettuce and cauliflower, and 16 months in peaches.
The data also indicate that the metabolite TMG is stable at ≤-20°C
for at least 6.6 months in cauliflower and 8 months in lettuce.  The
available storage stability data adequately support the storage
conditions and durations for samples from the submitted field trials and
processing studies.

Adequate field trial data were submitted by Valent supporting the use of
repeated foliar applications of the WDG and FlC formulations on the
proposed crops and crop groups.  An adequate number of tests were
conducted on the required representative crops in the appropriate
geographic regions.  Clothianidin (WDG or FlC) was applied at ~1x the
proposed maximum seasonal rate and the appropriate commodities were
collected from each test around the proposed PHIs.  However, with the
exceptions of the tests on figs, pomegranates, and tree nuts, the single
application rate used in the field trials (0.1 lb ai/A/application) was
1.5x higher than the proposed maximum single rate (0.067 lb ai/A).  As
the minimum RTIs are 7-14 days and the residue decline tests indicate
that clothianidin residues declined substantially within 7 days of
application, the final application of clothianidin is likely to
contribute the majority of the residues at harvest.  Therefore, the
submitted data using the 1.5x single application rate are likely to
slightly overestimate clothianidin residues in/on crop commodities
following repeated foliar applications.

The available residue data for each crop were generated using either the
WDG or FlC formulation of clothianidin.  Although no side-by-side tests
were conducted comparing residues resulting from the WDG and FlC
formulations on the same crop, the available data will support the use
of both formulations on crops with PHIs > 7 days since the use
directions for the two formulations are identical.  For crops with a PHI
of 7 days, side-by-side trials should be submitted to show the impact of
the formulations on residue levels.  Furthermore, only limited data were
provided supporting the proposed soil applications of the WDG and FlC
formulations on the various vegetable crops and, with the exceptions of
the fig and pomegranate field trials, none of the foliar applications on
the other crops included the use of an adjuvant, which is allowed on the
label.  Given these variables, HED is requesting that a comprehensive
set of bridging studies be conducted and that the design of those
studies be discussed with HED prior to their initiation.

With regards to the proposed use of the 5 lb/gal FlC formulation as a
seed-piece treatment for potatoes and a soybean seed treatment, adequate
residue data are available to support this use on potatoes, and the
residue data from the available soybean field trials, which used foliar
applications, will cover the proposed seed treatment use as the foliar
application has a higher use rate and a shorter PHI.  In addition, the
proposed labels prohibit subsequent foliar applications to soybean seeds
treated with clothianidin; therefore, soybeans would not receive both a
seed treatment and foliar applications.  No data were submitted with
these petitions to support the use on tuberous and corm vegetables.
This use is supported by previously submitted and reviewed studies.

As requested by the Agency, adequate data were also submitted by Valent
depicting residues of TMG in/on all leafy vegetables, Brassica
vegetables, and cotton gin trash.  For each crop, the ratio of
clothianidin:TMG residues was relatively consistent.  Considering only
samples having quantifiable residues of both analytes, residues of
clothianidin were 6x-23x higher than TMG residues in leafy vegetable
crops, with clothianidin residues averaging 17x higher in celery and
~12x higher in head and leaf lettuce and spinach.  In mustard greens,
clothianidin residues were 1.2-9.9x higher than the associated TMG
residues, and averaged 4x higher.  For cotton gin trash, residues of
clothianidin were 8-22x higher than the associated TMG residues, and
averaged 15x higher.

Adequate field trial data were also submitted by IR-4 supporting the use
of clothianidin (50% WDG) on peaches and low-growing berries (except
strawberry).  An adequate number of tests were conducted on peaches and
cranberries using the 50% WDG formulation in the appropriate geographic
regions at ~1x the maximum seasonal rate.  Samples were collected at the
proposed PHIs and analyzed for clothianidin using an adequate LC/MS/MS
method.  Although no field trial data were submitted supporting the use
of the FlC formulation on these crops, the available residue data for
the WDG formulation on berries will be translated to support the FlC
formulation as the proposed PHIs for the foliar applications are >7 days
(21 days proposed) for these crops.  However, bridging data are needed
to support use of the FlC product on peaches with a 7-day PHI.

Adequate residue data are also available on potatoes to support amending
the current uses for potatoes on the labels of the 50% WDG and 2.13
lb/gal FlC formulation to include all members of the tuberous and corm
vegetable (Subgroup 1C).

Adequate processing studies are available on cotton, soybean and tomato.
 Separate tolerances are not required for tomato puree and cotton hulls,
meal and refined oil as processing reduced clothianidin residues in
these commodities.  A separate tolerance is also not required for tomato
paste.  Although residues concentrated slightly in tomato paste (1.2x),
the maximum expected residues in paste (0.043 ppm) are well below the
recommended tolerance for fruiting vegetables (0.2 ppm).  Separate
tolerances are also not required for any soybean processed fractions.
Although processing factors could not be calculated for soybean
processed fractions, the data indicate that quantifiable residues of
clothianidin are unlikely to occur in soybean meal, hulls, and refined
oil following applications at the 1x rate, because clothianidin residues
were <LOQ (<0.01 ppm) in/on seeds, meal, and refined oil, and ≤0.015
ppm in hulls following applications at a 5x exaggerated rate.  In
addition, given the low levels of residues detected in soybean hulls,
quantifiable residues of clothianidin are also unlikely to occur in
soybean aspirated grain fractions (AGF) following a 1x application.

Adequate livestock feeding studies are available for clothianidin, and
tolerances for clothianidin residues in animal commodities were recently
assessed in conjunction with petitions for uses on grapes, potatoes,
sorghum and cotton.  As the proposed uses will not increase the dietary
exposure of livestock to clothianidin residues, reassessment of animal
tolerances is not required for these petitions.

Adequate confined and limited field rotational crop studies are
available for clothianidin.  The metabolism of clothianidin in
rotational crops is similar to the metabolism in primary crops, and HED
has concluded that parent, TZNG and MNG are the residues of concern in
rotational crops for purposes of risk assessment.  However, only parent
needs to be included in the tolerance expression.  The available field
rotational crop studies support the existing tolerances for rotational
crops, and these data will also support Valent’s proposed uses on
field and vegetable crops provided that the labels are amended to
include the rotational crop restrictions supported by the available
residue data.

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

While several deficiencies related to the field trial residue data were
noted in the subject petitions, none of these deficiencies would
preclude establishing permanent tolerances for clothianidin residues on
the proposed crops or crop groups.  The following deficiencies were
noted in the field trial data:

	•	Although the proposed labels allow for the use of spray adjuvants,
only the fig and pomegranate field trials included the use of any
adjuvants in the spray mix.  HED is requesting bridging data to support
the use of spray adjuvants for all other commodities except soybeans and
tree nuts excluding almonds.

	•	No residue data were submitted on soybean forage and hay following
the proposed foliar applications.

	•	Only limited residue data were provided on the WDG formulation
comparing repeated foliar applications on vegetables crops with the
proposed single soil application.  Only 1 or 2 soil application tests
were conducted on each vegetable crop, and none of the soil applications
were applied at the proposed minimum PHI (7 days).  Of the 13 available
soil application tests, the soil application was made at planting in 8
tests, at 21 days prior to harvest in 4 tests, and a 1 month prior to
harvest in 1 test.  Although the soil treatment tests do suggest that
clothianidin residues at ≥21 days following a single soil application
at 0.2 lb ai/A are likely to be less than or equal to the residues
resulting from repeated foliar applications totaling 0.2 lb ai/A,
insufficient data are available to make this determination.  Based on
the submitted soil application data, HED also assumes that the desired
PHI for soil applications is 21 days rather than the currently specified
7-day PHI.  More comprehensive bridging data are requested.

The following label amendments and field trial data are required:

	•	Label directions for Valent’s 50% WDG and 2.13 lb/gal FlC
formulations should be amended to include rotational crop restrictions
(see conclusions under Directions for Use).

	•	Label directions for Valent’s 50% WDG and 2.13 lb/gal FlC
formulations should be revised to remove the soil application for
vegetable crops.

	•	Label directions for both the seed treatment and foliar application
uses on soybeans should be amended to prohibit the grazing or feeding
for soybean forage and hay to livestock.

	•	Label directions for all crops except fig, pomegranate, soybeans
and tree nuts (excluding almonds) should be revised to prohibit the use
of adjuvants.  If the petitioner wants to allow the use of adjuvants,
side-by-side trials should be conducted.  HED recommends that the
petitioner consult with the Agency prior to conducting any such trials.

	•	To support the use of clothianidin (WDG or FlC) as a soil
application on vegetable crops, bridging studies are required on
selected vegetable crops to compare residues resulting from soil vs.
foliar applications.  Additional field trials are required on leaf
lettuce, mustard greens, peppers, and cucumbers (3 tests for each crop).
 In each test, clothianidin (WDG or FlC) should be applied separately to
side-by-side plots as either a single soil application at 0.2 lb ai/A,
or as three foliar applications at 0.067 lb ai/A/application at a RTI of
7 days, for a total of 0.2 lb ai/A/season.  Samples of each commodity
should be harvested at 21 DAT for the soil application and at 7 DAT for
the foliar applications.  The foliar applications should also include
the use of spray adjuvants in each test.  If residues resulting from the
soil application are greater than those coming from the foliar use, a
full set of trials reflecting residues from soil applications will be
required.

	•	The available field trial data reflect the use of the WDG
formulation on leafy vegetables, Brassica vegetables, fruiting
vegetables, cucurbit vegetables, peaches, low-growing berries (except
strawberry), tree nuts, cotton, and soybeans; and of the FlC formulation
on figs and pomegranates.  Of these, translation between formulations
for the foliar uses on cotton, berries, soybean, and tree nuts is
appropriate since the PHI for these uses is greater than one week.  For
the other uses, side-by-side trials should be conducted to demonstrate
equivalency of formulations, with respect to residue levels, if
registrations for both formulations are desired.  Due to these
formulation issues and the adjuvant issues noted above, HED recommends
that the petitioner consult with the Agency prior to initiating any
side-by-side residue trials.

	•	A revised Section F should be submitted amending the proposed
tolerances to reflect the recommendations made by HED.

Although additional field trial data are being requested, sufficient
data are available to support permanent tolerances on the requested
commodities.  HED recommends establishing permanent tolerances for
residues of clothianidin as detailed in Table 8.  Note that HED is
currently evaluating other petitions for clothiandidin requesting
registration of seed-treatment uses.  The tolerance expression for
clothianidin should be revised to be as follows:

Tolerances are established for residues of the insecticide clothianidin,
including its metabolites and degradates, in or on the commodities in
the table below as a result of the application of clothianidin.
Compliance with the tolerance levels specified below is to be determined
by measuring only clothianidin
[(E)-N-[(2-Chloro-5-thiazolyl)methyl]-N’-methyl-N”-nitroguanidine]
in or on the commodity.

Human health risk assessments for clothianidin are forthcoming.

Background

Clothianidin is a broad spectrum, systemic insecticide belonging to both
the chloronicotinyl (neonicotinoid) and nitroguanidine classes of
chemicals.  It is also a major metabolite of thiamethoxam.  Clothianidin
acts by binding with the nicotinic acetylcholine receptor sites in
insects (Group 4A insecticide), interfering with neural transmission of
stimuli and eventually inhibiting reproduction of the insect.
Clothianidin Technical Insecticide was first registered in the U.S.
during 2003 by Takeda with Bayer CropScience (Bayer) acting as their
Agent.  Bayer currently has six end-use products containing clothianidin
that are registered only for seed treatment uses on corn, canola,
cotton, rapeseed, and sorghum.  Clothianidin end-use products with
direct foliar and/or soil uses on grapes, pome fruits, potatoes and
tobacco were originally registered to Arvesta (now known as Arysta).
However, these products/uses have been transferred to Valent, which is
now the Agent for Sumitomo Chemical Co. which owns the current
registration for Technical Clothianidin.

Permanent tolerances are established for residues of clothianidin in/on
a variety of plant commodities at levels ranging from 0.01 ppm in/on a
number of crops to 1.0 ppm in/on pome fruits [40 CFR §180.586(a)].
Tolerances for clothianidin have also been established in milk at 0.01
ppm.  Time-limited tolerances have been established at 0.02 ppm in/on
sugar beet roots and tops [40 CFR §180.586(b)]; these tolerances are
set to expire on 12/31/09.  In addition, tolerances for indirect or
inadvertent residues have been established for clothianidin at 0.02 ppm
in/on non-grass animal feeds, the forage, fodder and straw of cereal
grains, grass forage, fodder and hay, and soybean forage and hay [40 CFR
§180.586(d)].

Valent has submitted petitions (PP#s 8F7395 and 9F7530) proposing new
uses for its 50% WDG and 2.13 lb/gal FlC formulations on Brassica leafy
vegetables, cotton, cucurbit vegetables, figs, fruiting vegetables,
leafy vegetables, pomegranates, soybeans and tree nuts.  Valent is also
proposing to amend the use directions for its 5 lb/gal FlC formulation
to include a seed treatment use on potato seed pieces and soybean seeds.
 In addition, IR-4 has submitted a separate petition (PP#8E7460)
proposing new uses for Valent’s 50% WDG and 2.13 lb/gal FlC
formulations on peaches and members of the low-growing berries subgroup,
except strawberry (Subgroup 13-07H).  IR-4 is also proposing that the
current use directions for potatoes on the labels for the 50% WDG and
2.13 lb/gal FlC be amended to cover all tuberous and corm vegetables
(Subgroup 1C).  The chemical structure and nomenclature of clothianidin
and its metabolite, TMG, are listed in Table 1, and the physicochemical
properties of technical grade clothianidin are listed in Table 2.

Table 1.	Clothianidin Nomenclature.

Parent Compound

Common name	Clothianidin

Company experimental name	TI-435, V-10066

IUPAC name
(E)-1-(2-Chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

CAS name
(E)-N-[(2-Chloro-5-thiazolyl)methyl]-N’-methyl-N”-nitroguanidine

CAS registry number	210880-92-5 (formerly 205510-53-8)

Molecular wt.	249.68

End-use product (EP)	50% WDG (Arena® 50 WDG; EPA Reg. No. 59639-152)

2.13 lb/gal FlC (V-10170 2.13 SC; EPA Reg. No. 59639-150)

5 lb/gal FlC (V-10170 5 FS; EPA Reg. No. 59639-151)

Metabolite

Common name	Thiazolylmethylguanidine

Company experimental name	TMG

IUPAC name	N-(2-chlorothiazol-5-yl)-N´-methylguanidine

CAS Name	N-(2-chlorothiazol-5-yl)-N´-methylguanidine

CAS registry number	635283-91-9

Molecular wt.	204.68

Table 2.	Physicochemical Properties of Clothianidin.

Parameter	Value	Reference

Melting point (ºC)	176.8	D335355, W. Drew, 10/16/07

pH at 23ºC	6.24 (1% solution/suspension)

	Density (g/cm3)	1.61 (PAI), 1.59 (TGAI)

	Water solubility (g/L at 20ºC)	0.327

	Solvent solubility (g/L at 25ºC)	Acetone	15.2	Dichloromethane	1.32

Ethyl acetate	2.03	Heptane 	<0.00104

Methanol	6.26	Octanol	0.938

Xylene	0.0128

	Vapor pressure (Pa at 20ºC)	1.3 x 10 -10

	Dissociation constant, pKa at 20ºC	11.09

	Octanol/water partition coefficient, Log(KOW) at 25ºC	0.7

	UV/visible absorption spectrum (Maximum, nm)	265.5 (acidic or neutral)

246.0 (basic)

	PAI = Purified Active Ingredient; TGAI = technical grade active
ingredient.

860.1200  Directions for Use

There are currently three end-use products containing clothianidin that
are registered to Valent for use on food/feed crops in the U.S.  These
products are a 50% WDG (Arena® 50 WDG; EPA Reg. No. 59639-152), a 2.13
lb/gal FlC (V-10170 2.13 SC; EPA Reg. No. 59639-150) and a 5 lb/gal FlC
(V-10170 5 FS; EPA Reg. No. 59639-151).  The 50% WDG and the 2.13 lb/gal
FlC are currently approved for use on grapes, pome fruits and potatoes
as foliar or soil (grape and potato) applications at rates totaling 0.2
lb ai/A/season.  The 5 lb/gal FlC is currently approved for use as a
seed treatment on canola, rapeseed, corn (all types), sorghum, and sugar
beets.

Valent has proposed amending the use directions for the 50% WDG and the
2.13 lb/gal FlC to include uses on the following crops or crop groups:
Brassica leafy vegetables, cotton, cucurbit vegetables, figs, fruiting
vegetables (except cucurbits), leafy vegetables (except Brassica),
pomegranates, soybeans and tree nuts.  New seed treatment uses on
potatoes and soybeans are also being proposed for the 5 lb/gal FlC
formulation.  Example labels for these formulations were provided, and
the proposed use directions are summarized below in Table 3.

In a separate petition, IR-4 has proposed amending the use directions
for the 50% WDG and the 2.13 lb/gal FlC to include foliar applications
to peaches and foliar or soil applications to cranberries and other
members of the low-growing berry subgroup, except strawberry (Subgroup
13-07H).  Example labels including directions for these proposed uses
were provided and are summarized below.  In addition, IR-4 has proposed
amending the current use directions for potatoes on the labels for the
50% WDG and 2.13 lb/gal FlC to cover all members of the tuberous and
corm vegetable (Subgroup 1C).

Table 3.	Summary of Directions for Use of Clothianidin.

Applic. Timing, Type, and Equip.1	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations 2

Brassica Vegetables, Leafy Vegetables, Cucurbit Vegetables, and Fruiting
Vegetables

Soil application at planting or post-planting 3; ground equipment	50%
WDG [59639-152] 2.13 lb/gal FlC

[59639-150]	0.2	1	0.2	7	The minimum RTI for foliar applications is 10
days.

A minimum application volume is not specified.

Broadcast foliar applications as pest populations begin to build; ground
equipment

0.05-0.067	NS	0.2	7

	Cotton

Broadcast foliar applications as pest populations reach threshold
levels; ground equipment 	50% WDG [59639-152] 2.13 lbs/gal FlC

[59639-150]	0.05-0.067	NS	0.2	21	The minimum RTI is 7 days.

A minimum application volume is not specified.

Low Growing Berries, except Strawberry (Subgroup 13-07H)

Single post-bloom soil application as pest populations reach threshold
levels; ground equipment	50% WDG [59639-152] 2.13 lbs/gal FlC

[59639-150]	0.2	1	0.2	21	The minimum RTI is 7 days for foliar
applications.

A minimum application volume is not specified.

Post-bloom broadcast foliar applications as pest populations reach
threshold levels; ground equipment

0.066	NS

21

	Fig

Post-bloom broadcast foliar applications as pest populations reach
threshold levels; ground equipment 	50% WDG [59639-152] 2.13 lbs/gal FlC

[59639-150]	0.06-0.09	2	0.2	7	The minimum RTI is 14 days.

Apply in a minimum of 100 gal/A.

Do not allow livestock to graze on cover crops from treated orchards.

Pomegranate

Post-bloom broadcast foliar applications as pest populations reach
threshold levels; ground equipment 	50% WDG [59639-152] 2.13 lbs/gal FlC

[59639-150]	0.06-0.09	2	0.2	7	The minimum RTI is 14 days.

Apply in a minimum of 100 gal/A.

Do not allow livestock to graze on cover crops from treated orchards.

Peach

Post-bloom broadcast foliar applications as pest populations reach
threshold levels; ground equipment 	50% WDG [59639-152] 2.13 lbs/gal FlC

[59639-150]	0.05-0.1	NS	0.2	7	The minimum RTI is 10 days.

A minimum application volume is not specified.

Do not allow livestock to graze on cover crops from treated orchards.

Potato/ Tuber and Corm Vegetables, Subgroup 1C 4

Seed-piece treatment; spray	5 lb/gal FlC

[59639-151]

2.13 lb/gal FlC

[59639-150]	0.01 lb ai/ 100 lb seed pieces

(0.2 lb ai/A) 5	1	0.2	NA	Do not use treated seed pieces for food, feed,
or fodder.

Do not apply any subsequent application of clothianidin following seed
piece treatment.

In-furrow soil application at planting, or side-dress or broadcast soil
application at ground-crack during hilling; ground equipment	50% WDG
[59639-152] 2.13 lbs/gal FlC

[59639-150]	0.12-0.19	1	0.2	NA	The minimum RTI for foliar applications
is 7 days.

A minimum application volume is not specified.

Broadcast foliar applications as pest populations reach threshold
levels; ground equipment

0.03-0.05	3	0.2	14

	Soybean

Seed Treatment, commercial seed treatment equipment	5 lb/gal FlC

[59639-151]	0.05 lb ai/

100 lb seed

(0.05 lb ai/A) 6	1	0.05	NA	Do not use treated seed for feed, food or oil
processing.

Broadcast foliar applications as pest populations reach threshold
levels; ground equipment 	50% WDG [59639-152] 2.13 lb/gal FlC

[59639-150]	0.05-0.067	NS	0.2	21	The minimum RTI for foliar applications
is 7 days.

A minimum application volume is not specified.

Do not apply foliar applications following a seed treatment with
clothianidin

Tree Nuts

Broadcast foliar or chemigation applications at post bloom; ground
equipment 	50% WDG [59639-152] 2.13 lb/gal FlC

[59639-150]	0.05-0.10	NS	0.2	21	The minimum RTI is 10 days.

A minimum application volume is not specified.

Do not allow livestock to graze on cover crops from treated orchards.

1	Do not apply by air.  Applications are allowed through the following
types of irrigations systems:  micro (spaghetti tubes), drip, and
overhead sprinklers (center pivot, solid set, hand move or moving wheel
systems).  Do not apply through any irrigation system connected to the
public water system.  Applications may include use of a spray adjuvant.

2	A 12-hour restricted entry interval is specified.  Do not apply to
vegetable, fruit or tree nut crops during pre-bloom, bloom or when bees
are actively foraging.   For all crops, do not apply a foliar
application of clothianidin following a soil application; and do not
apply more than 0.2 lb ai/A of clothianidin per season.

3	Soil applications can be made as either a narrow band centered on the
plant row, an in-furrow spray at planting on or below the seed, a
side-dress application to both sides of the row, a post-seeding drench
or transplant water drench, or by chemigation into the root zone through
drip, trickle, or micro-sprinkler systems.

4	The uses of the 50% WDG and 2.13 lb/gal FlC formulations on potatoes
were previously approved under PP#4F6869 (DP# D303164, W. Drew, 2/1/06).

5	The use rate per acre for the potato seed piece treatment is based on
a planting rate of 2,000 lb of seed pieces/acre.

6	The worst-case use rate per acre for the soybean seed treatment
assumes a high planting density (200,000 plants/A) and use of larger
seeds (2,000 seed/lb), which would require 100 lb of seed/A.  A more
typical planting density of 160,000 seed/A using average sized seed
(3,000 seed/lb) would result in a use rate of 0.026 lb ai/A.

NA = Not applicable.

NS = not specified.

Conclusions.  The use directions are adequate to allow for evaluation of
the submitted field trial data.  The field trial data submitted by
Valent adequately support the proposed use of the 50% WDG formulation
for broadcast foliar applications to low-growing berries (except
strawberry), peach, cotton, soybeans, leafy vegetables, Brassica
vegetables, fruiting vegetables, cucurbit vegetables, and tree nuts and
the use of the 2.13 lb/gal FlC on figs and pomegranates.  As the
proposed use directions are identical for the 50% WDG and 2.13 lb/gal
formulations, and the PHIs for the foliar applications are >7 days, the
residue data for the WDG or FlC formulations will also support the use
of either the FlC or WDG formulations (per pending OECD residue
chemistry guidelines) on low-growing berries, tree nuts, cotton, and
soybean.  However, insufficient residue data are available to translate
between formulations for the other requested uses or to evaluate
residues resulting from the single soil application of the WDG or FlC on
the various vegetable crop groups.

With regards to Valent’s proposed amendments to the use directions for
the 5 lb/gal FlC formulation, the inclusion of a treatment for potato
seed pieces is acceptable as this use is identical to the previously
approved use of the 2.13 lb/gal FlC formulation on potato seed pieces
(DP# D303164, W. Drew, 2/1/06).  The proposed seed treatment use on
soybeans for the 5 lb/gal FlC is also acceptable.  Although no field
trial data were submitted supporting the soybean seed treatment use,
residues resulting from the foliar application of clothianidin to
soybeans will cover any residues resulting from the seed treatment as
the foliar application rates (0.2 lb ai/A/season) are substantially
higher than the seed treatment rate (0.05 lb ai/A).  Considering that
clothianidin residues were detectable in only one sample of soybean
seeds (0.016 ppm) following two late-season foliar applications and that
the harvest interval is much longer for the seed treatment, quantifiable
residues are unlikely to occur in mature soybeans following a seed
treatment.  In addition, label directions for the soybean foliar
applications prohibit applications to plants grown from
clothianidin-treated seed.  HED notes that the labels directions for
soybeans for both the seed treatment use and the foliar application use
should be amended to prohibit the grazing or feeding of soybean forage
or hay to livestock as no residue data were submitted on soybean forage
and hay.

The peach and cranberry field trial data submitted by IR-4 will
adequately support the proposed uses for the WDG and FlC formulations on
peaches and low-growing berries, except strawberry (Subgroup 13-07H).
In addition, IR-4’s proposal to include all members of the tuberous
and corm vegetables subgroup (Subgroup 1C) under the use directions for
potatoes on the labels for the 50% WDG and 2.13 lb/gal FlC formulations
is acceptable, as adequate data are available supporting this use on
potatoes, which are the representative crop for Subgroup 1C.

Based on the available data, the following label amendments are
required:

	•	Use directions for soil applications to Brassica vegetables, leafy
vegetables, fruiting vegetables and cucurbit vegetables on labels for
the 50% WDG and 2.13 lb/gal FlC formulations should be removed from the
label.  Data are insufficient to support this use at this time.

	•	Label directions for both the proposed seed treatment and foliar
applications uses on soybeans should be amended to prohibit the grazing
or feeding for soybean forage and hay to livestock.

	•	Label directions for all uses except figs, pomegranates, tree nuts
(excluding almonds), and soybeans should be amended to prohibit the use
of spray adjuvants.

	•	The labels should be amended to include rotational crop
restrictions.  The available data support allowing for immediate
replanting of corn, sorghum, rapeseed, canola, sugar beets and all crops
listed on the label, except soybeans.  Other cereal grains, soybeans,
dried beans and peas may be replanted 30 days following the last
application, and all other crops not listed on the label may be
replanted 1 year after application.

860.1300 Nature of the Residue - Plants

  SEQ CHAPTER \h \r 1 MARC Memo, D282449, Y. Donovan, 4/25/03

DP#D282446, Y. Donovan, 5/1/03

Adequate plant metabolism studies are available reflecting the
application of [14C]-clothianidin as a seed treatment to corn and sugar
beets, as foliar applications to apples, and as soil and foliar
applications to tomatoes.  Based on these metabolism studies, the
Metabolism Assessment Review Committee (MARC) concluded that the nature
of the residue has been adequately delineated, and that parent only is
the residue of concern to be used in risk assessment and the tolerance
expression for most primary crops.  However, the MARC also determined
that future uses on root crops and/or leafy vegetables will require
analysis of TMG along with parent in field trial samples.  The metabolic
profiles in the tested primary crops were similar in that the highest
level residue was the parent, clothianidin, with the exception of mature
sugar beet tops.  The clothianidin risk assessment team has determined
that TMG should be a residue of concern in root and leafy vegetable
crops.

860.1300 Nature of the Residue - Livestock

  SEQ CHAPTER \h \r 1 MARC Memo, D282449, Yan Donovan, 4/25/03

DP# D282446, Yan Donovan, 5/1/03

The nature of clothianidin residues in livestock is understood based on
the adequate goat and hen metabolism studies.  In these studies, a goat
was dosed orally for 3 days with [14C]-clothianidin at levels equivalent
to roughly 200 ppm in the diet, and hens were dosed orally for 3 days
with [14C]-clothianidin at levels equivalent to 140 ppm in the diet.
For ruminants, the MARC concluded that the residues of concern include
parent, TZU, TZG, TZNG, and ATMG-Pyruvate and that these residues should
be included in risk assessments.  For poultry, the MARC concluded that
the residues of concern include parent, TZU, TZG, TZNG and ATG-Acetate
for risk assessment purposes.  However, for purposes of tolerances, the
MARC recommended that only parent needs to be included in the tolerance
expression for animal commodities.  The clothianidin risk assessment
team concurs with the previous findings of the MARC

860.1340 Residue Analytical Methods

DP# D303164, W. Drew, 2/1/06

Adequate LC/MS/MS methods are available for enforcing tolerances for
clothianidin residues in plant (Bayer Methods 00552 and 109240-1) and
animal (Bayer Method 00624) commodities.  The LOQ for clothianidin in
plant commodities is 0.01 ppm, except for wheat straw (0.02 ppm), and
the validated LOQs are 0.01 ppm in milk and 0.02 ppm in animal tissues.
All three of these methods were reviewed by BEAD’s Analytical
Chemistry Laboratory, approved for tolerance enforcement, and forwarded
to FDA for inclusion in PAM Volume II.

In conjunction with an earlier petition for uses on grapes and potatoes
(DP# D303164), another  LC/MS/MS method (Morse Method #Meth-164) was
also proposed for enforcing tolerances and collecting data on residues
of clothianidin and TMG in grape and potato commodities.  This method is
similar to Method 00552 and involves extraction of residues with
acetonitrile/water, cleanup using solid phase extraction (SPE)
cartridges, and the separate analysis of clothianidin and TMG by
LC/MS/MS.  The validated LOQ for each analyte is 0.02 ppm in all grape
and potato matrices, except for potato chips and raisins (with LOQs of
0.04 ppm).  The method was adequately validated in conjunction with the
field trials and processing studies and has undergone a successful
independent laboratory validation (ILV) trial.

In the current field trials and processing studies submitted by Valent,
the residue data were collected using two LC/MS/MS methods.  Except in
the fig and pomegranate field trials, residues were determined using a
slightly modified version of Morse Method #Meth-164.  The major
modifications to the method included: (1) changing the extraction
solvents from acetonitrile/water/guanidine-HCl (20:80:1 vol/vol/wt); (2)
elimination of the SPE column cleanup procedures for selected
commodities; and (3) changing the HPLC column and type of MS/MS detector
used for analysis.

For method Meth-164 (modified), residues were extracted from soybeans,
fruiting vegetables, Brassica vegetables and leafy vegetables with 0.1%
formic acid in water.  For soybean processed commodities and all cotton
commodities, residues were extracted with 20% acetonitrile:80%
water:0.1% formic acid.  Residues in cotton meal, hulls and gin trash
were also purified by elution through a Chem Elute LLE column.  Residues
of clothianidin and TMG (leafy vegetables, Brassica vegetables, and
cotton gin trash only) were then determined by LC/MS/MS using external
standards.  The m/z 250→169 ion transition is used for quantifying
clothianidin residues, and the m/z 205→132 ion transition is used for
quantifying TMG residues.  The validated LOQ is 0.01 ppm for each
analyte in each matrix, and the LODs were not reported.  This method was
further validated using side-by-side analysis of field trial samples
using Meth-164 (modified) and Meth-164 (original).  Recoveries were
nearly identical, despite the fact that Meth-164 (modified) does not use
any organic solvents during the extraction process.

Method Meth-164 was adequately validated both prior to and in
conjunction with the analysis of the field trial and processing study
samples.  For method validation, control samples were fortified with
clothianidin or TMG at 0.01 and ~3.0-5.0 ppm.  Adequate recoveries were
obtained for clothianidin from all matrices and for TMG from all
matrices tested (leafy vegetables, Brassica vegetables, and cotton gin
trash).  The fortification levels tested bracketed the observed residue
levels.  Apparent residues of TMG were <LOQ in control samples of each
matrix tested, and apparent residues of clothianidin were <LOQ in
control samples of each matrix, with the exception on one control sample
of cotton gin trash.

 The m/z 248→165 ion transition was used for quantifying clothianidin
residues.  The validated LOQ is 0.01 ppm for both figs and pomegranates,
and the LOD is 0.005 ppm.

Method RM-39C-1was adequately validated both prior to and in conjunction
with the analysis of the fig and pomegranate field trial samples.  For
validation, control samples were fortified with clothianidin at
0.01-0.10 ppm for figs and at 0.01-0.15 ppm for pomegranates.  Adequate
recoveries were obtained for clothianidin from crops, and the
fortification levels tested bracketed the observed residue levels.
Apparent residues of clothianidin were <LOQ in all control samples of
figs and pomegranates.

m/z 250→169 ion transition for quantifying residues.  The lowest level
of method validation (LLMV) was 0.01 ppm for cranberries and 0.02 ppm
for peaches.  The statistically calculated LOQs were 0.004 ppm for
cranberries and 0.011-0.017 ppm for peaches.

The method was adequately validated both prior to and in conjunction
with the analysis of the field trial samples.  For validation, control
samples were fortified with clothianidin at 0.01-1.0 ppm for cranberries
and at 0.02-5.0 ppm for peaches.  Adequate recoveries were obtained for
clothianidin from both cranberries and peaches, and the fortification
levels tested bracketed the observed residue levels.  Apparent residues
of clothianidin were <LOQ in all control samples of cranberry and peach.

Conclusions. Adequate LC/MS/MS methods are available for enforcing the
proposed tolerances, and the field trial and processing study data were
collected using adequate LC/MS/MS methods (Morse Method #Meth-164 -
modified, RM-39C-1, or Bayer Method 00552 - modified).

860.1360 Multiresidue Methods

DP# D282446, Yan Donovan, 5/1/03

Multiresidue method testing of clothianidin and its metabolites MNG,
TZG, TZNG, TZU, and ATMG-Pyr have been submitted.   Clothianidin and its
major metabolites are not adequately recovered using any of the
multiresidue methods.  These data were forwarded to the US FDA for
further evaluation.

860.1380 Storage Stability

47471601.der.doc (almond)	47471605.der.doc (cauliflower)
47471607.de2.doc (cotton)

47471608.der.doc (cucumber)	47471609.der.doc  (lettuce)	47471616.de2.doc
(tomato)

47471612.der.doc (pecan)	47471613.de1.doc (soybean)	47578101.der.doc
(peach) 47578103.der.doc (cranberry)

In conjunction with selected field trials and processing studies, Valent
generated data demonstrating the frozen storage stability of
clothianidin and TMG in a variety of crop commodities.  The stability of
clothianidin at ≤-20°C was determined in almond hulls, pecan
nutmeats, cauliflower, cucumbers, lettuce, cotton (seeds, meal, and
refined oil), soybeans, and tomato (fruit and paste), and the stability
of TMG at ≤-20°C was determined in lettuce and cauliflower.  For each
commodity, control samples were separately fortified with clothianidin
or TMG at approximately 0.01 and 3-5 ppm and stored under the same
conditions (≤-20°C) as the field trial and processing study samples.
The fortified stored samples were analyzed along with a control sample
and freshly fortified control samples of each commodity at the following
storage intervals:  ~60 and 120 days for soybean seeds, pecan nutmeats,
and cottonseed meal and refined oil; 75 and 150 days for cottonseeds;
89, 125 and 228 days for cucumber; 123 and 242 days for lettuce; 135 and
202 days for cauliflower; 33 and 69 days for almond hulls; 109 and 214
days for tomatoes; and 35 and 64 days for tomato paste.

When corrected for recoveries from freshly fortified samples, the
average recoveries of clothianidin from frozen stored samples were as
follows:  95% from almond hulls after 69 days; 94% from pecan nutmeats
after 120 days; 99% from cucumbers after 228 days; 99% from tomatoes
after 214 days; 93% from tomato paste after 64 days; 85% from soybean
seeds after 120 days; 96% from cottonseed after 150 days; 99% from
cottonseed meal after 120 days; 101% from cottonseed refined oil after
120 days; 96% from lettuce after 242 days; and 95% from cauliflower
after 202 days.  For TMG, corrected recoveries from frozen stored
samples were 100% from lettuce after 242 days and 94% from cauliflower
after 202 days.

≤-10ºC).  After 154 days (cranberry) or 485 days (peach), the stored
samples were analyzed along with control samples and freshly fortified
control samples.  The corrected recovery of clothianidin was 84% from
cranberries after 154 days and 93% from peaches after 485 days of frozen
storage.

The storage durations and conditions of samples from the crop field
trials and processing studies submitted to support these petitions are
presented in Table 4.

≤-20	26-125	242

(lettuce)

Celery

10-155

	Leaf lettuce

4-222

	Spinach

43-211

	Cauliflower	≤-20	16-163	202

(cauliflower)

Cabbage

29-174

	Mustard greens

22-114

	Tomato	≤-20	10-160	214

(tomato)

Bell pepper

14-64

	Non-Bell pepper

84-119

	Tomato paste

56	64

(tomato paste)

Tomato puree

56

	Cantaloupe	≤-20	101	228

(cucumber)

Cucumber

113

	Summer squash

225

	Almond nutmeats	≤-20	12-49	120

(pecan nutmeat)

Pecan nutmeats

58-113

	Almond hulls

12-52	69

(almond hulls)

Cottonseeds	≤-20	39-141	150

(cotton seed)

Cotton gin byproducts

106-172	242

(lettuce)

Cottonseed hulls

110	150

(cottonseeds)

Cottonseed meal

111	120

(cotton meal and oil)

Cotton refined oil

91

	Soybean seeds	≤-20	17-92	120

(soybean seeds)

Soybean hulls

22

	Soybean meal

20	120

(cotton meal and oil)

Soybean refined oil

17

	Figs	≤-20	103-131	485

(peach)

Pomegranate	≤-20	66-104	485

(peach)

Cranberry	≤-10	146-154	154

(cranberry)

Peach	≤-12	23-497	485

(peach)

1	The relevant commodity used to generate the supporting storage
stability data is listed in parentheses.

Conclusions.  The available storage stability data are adequate and
indicate that clothianidin is stable at ≤-20°C for at least 2 months
in almond hulls and tomato paste, 4 months in pecan nutmeats, soybean
seeds, and cottonseed meal and refined oil, 5 months in cottonseeds and
cranberries, ~7-8 months in cucumbers, tomatoes, lettuce and
cauliflower, and 16 months in peaches.  The data also indicate that the
metabolite TMG is stable at ≤-20°C for at least 6.6 months in
cauliflower and 8 months in lettuce.  The available storage stability
data adequately support the storage conditions and durations for samples
from the submitted field trials and processing studies.

860.1400 Water, Fish, and Irrigated Crops

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

860.1460 Food Handling

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

860.1480 Meat, Milk, Poultry, and Eggs

DP# D282446, Y. Donovan, 5/1/03

DP# D309473, W. Drew, 2/1/06

Adequate livestock feeding studies are available for clothianidin, and
tolerances for clothianidin residues in animal commodities were recently
assessed in conjunction with petitions for uses on grapes, potatoes,
sorghum and cotton (DP# D309473).  The maximum dietary burdens (MDB) of
livestock for clothianidin residues were calculated at that time to be
0.321 ppm for beef cattle, 0.287 ppm for dairy cattle, 0.020 ppm for
poultry, and 0.035 ppm for swine.  However, based on the most recent
changes in Agency guidance on calculating pesticide residues in maximum
reasonably balanced diets (MRBD) for livestock (ChemSAC memo, 6/30/08),
and the addition of the livestock feed items in this petition (soybean
seed and meal), the MRBD for livestock to clothianidin residues was
recalculated to be 0.291 ppm for beef cattle, 0.289 ppm for dairy
cattle, 0.013 ppm for poultry and 0.012 ppm for swine (Table 5).

As the proposed uses will not increase the dietary exposure of livestock
to clothianidin residues, reassessment of animal tolerances is not
required for these petitions.  The current 0.01 ppm tolerance for milk
is adequate and tolerances are not required for eggs or fat, meat, and
meat byproducts of cattle, goats, hogs, horses, sheep and poultry.

Table 5.   Calculation of Dietary Burdens for Clothianidin Residues to
Livestock.

Feedstuff	Dietary Component	% Dry Matter 1	% Diet 1	Residues  (ppm) 2
Dietary Contribution (ppm) 3

Beef Cattle

Field corn forage	R	40	10	0.10	0.025

Cotton gin byproducts	R	90	5	4.5	0.250

Sugar beet molasses	CC	75	10	0.05	0.007

Field corn grain	CC	88	70	0.01	0.008

Cottonseed meal	PC	89	5	0.02 4	0.001

TOTAL BURDEN	100

0.291

Dairy Cattle

Field corn forage	R	40	35	0.1	0.088

Almond, hulls	R	90	10	1.5	0.167

Sugar beet molasses	CC	75	10	0.05	0.007

Field corn grain	CC	88	35	0.01	0.004

Cottonseed	PC	88	10	0.20	0.023

TOTAL BURDEN	100

0.289

Poultry

Field corn grain	CC

75	0.01	0.008

Cottonseed meal	PC

20	0.02 4	0.004

Soybean seed	PC

5	0.02	0.001

TOTAL BURDEN	100

0.013

Swine

Field corn grain	CC

85	0.01	0.009

Cottonseed meal	PC

15	0.02 4	0.003

TOTAL BURDEN	100

0.012

1	Potential dietary burdens for livestock were determined using recent
Agency guidance on calculating the maximum reasonably balanced diets for
livestock (memo, 6/30/2008).

2	The tolerance level for the RAC was used for any associated processed
fractions unless otherwise indicated.

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

4	A residue level of 0.02 ppm was used for cottonseed meal, as the
cotton processing study indicated that residues are reduced in meal by
0.1x.

860.1500 Crop Field Trials

47471601.der.doc (almond)	47471602.der.doc (peppers)
47471603.der.doc(cabbage)

47471604.der.doc (cantaloupe)	47471605.der.doc (cauliflower)
47471606.der.doc (celery)

47471607.de1.doc  (cotton)	47471608.der.doc (cucumber)	47471609.der.doc
(head lettuce)

47471610.der.doc (leaf lettuce)	47471611.der.doc (mustard greens)
47471612.der.doc (pecans)

47471613.de1.doc  (soybean)	47471614.der.doc (spinach)	47471615.der.doc
(summer squash)

47471616.de1.doc (tomato)	47578101.der.doc (peach)	47578103.der.doc
(cranberry)

47666901.der.doc (fig)	47666902.der.doc (pomegranate)

Valent has submitted field trial data on celery, lettuce (head and
leaf), spinach, cauliflower, cabbage, mustard greens, tomatoes, peppers,
cucumbers, cantaloupes, squash, pecans, almonds, figs, pomegranates,
cotton and soybeans supporting the proposed uses of clothianidin (50%
WDG and 2.13 lb/gal FlC) on leafy vegetables, Brassica vegetables,
fruiting vegetables, cucurbit vegetables, tree nuts, figs, pomegranates,
cotton and soybeans.  In addition, IR-4 has submitted field trial data
on cranberries and peach  supporting the proposed uses of clothianidin
(50% WDG and 2.13 lb/gal FlC) on the low-growing berries, except
strawberry, Subgroup (13-07H) and peaches.    SEQ CHAPTER \h \r 1 The
results from these field trials are discussed below and the residue data
are summarized in Table 6.

Table 6.	Summary of Residue Data from Crop Field Trials with
Clothianidin (WDG/FlC). 1

Crop matrix	Analyte	Applic. type	Total Rate

(lb ai/A)	PHI (days)	Residue Levels (ppm) 2

	n	Min.	Max.	HAFT 3	Median	Mean	Std. Dev.

Leafy Vegetables, except Brassica (proposed use = 0.2 lb ai/A total
application rate, 7-day PHI)

Celery	Clothianidin	Broadcast foliar	0.198-0.206	7	12	0.023	0.941	0.924
0.435	0.453	0.363

	TMG

12	<0.01	0.090	0.086	0.027	0.034	0.027

	Clothianidin	Soil drench at planting	0.200	77	2	<0.01	<0.01	<0.01	0.01
0.01	NA

	TMG

2	<0.01	<0.01	<0.01	0.01	0.01	NA

Head lettuce, w/ wrapper leaves	Clothianidin	Broadcast foliar
0.197-0.204	7

	12	<0.010	0.589	0.527	0.250	0.274	0.214

	TMG

12	<0.010	0.044	0.040	0.021	0.024	0.015

Head lettuce, w/o wrapper leaves	Clothianidin

0.200	7	4	<0.010	0.024	0.019	0.012	0.014	0.007

	TMG

4	<0.010	<0.01	<0.01	0.01	0.01	NA

Head lettuce, w/ wrapper leaves	Clothianidin	Soil chemigation	0.200	32	2
0.042	0.044	0.043	0.043	0.043	NA

	TMG

2	<0.01	<0.01	<0.01	0.01	0.01	NA

Leaf lettuce	Clothianidin	Broadcast foliar	0.198-0.202	7	12	0.195	1.21
1.098	0.478	0.542	0.329

	TMG

12	0.015	0.078	0.077	0.046	0.047	0.020

	Clothianidin	Side-dress soil	0.203	21	2	0.043	0.046	0.045	0.045	0.045
NA

	TMG

2	<0.01	<0.01	<0.01	0.01	0.01	NA

Spinach	Clothianidin	Broadcast foliar	0.193-0.204	6-7	12	0.077	1.81	1.73
0.471	0.636	0.593

	TMG

12	0.022	0.122	0.119	0.042	0.051	0.033

	Clothianidin	Banded soil at planting	0.200	82	2	0.030	0.034	0.032	0.032
0.032	NA

	TMG

2	<0.01	<0.01	<0.01	0.01	0.01	NA

Brassica Leafy Vegetables (proposed use = 0.2 lb ai/A total application
rate, 7-day PHI)

Cabbage, w/ wrapper leaves 	Clothianidin	Broadcast foliar	0.198-0.204
6-7	12	0.013	0.413	0.367	0.025	0.125	0.158

	TMG

12	<0.01	0.013	0.012	0.010	0.010	0.001

Cabbage, w/o wrapper leaves	Clothianidin

4	<0.01	0.035	0.026	0.013	0.018	0.012

	TMG

4	<0.01	0.010	0.010	0.010	0.010	0.000

Cabbage, w/ wrapper leaves 	Clothianidin	Soil drench at planting	0.200
77	2	<0.01	<0.01	<0.01	0.01	0.01	NA

	TMG

2	<0.01	<0.01	<0.01	0.01	0.01	NA

Cauliflower	Clothianidin	Broadcast foliar	0.199-0.204	7	12	0.010	0.068
0.061	0.023	0.029	0.018

	TMG

12	<0.01	<0.01	<0.01	0.01	0.01	NA

	Clothianidin	Banded soil at planting	0.205	97	2	<0.01	<0.01	<0.01	0.01
0.01	NA

	TMG

2	<0.01	<0.01	<0.01	0.01	0.01	NA

Mustard greens	Clothianidin	Broadcast foliar	0.195-0.202	6-7

	10	0.129	1.440	1.310	0.283	0.475	0.462

	TMG

10	0.033	0.274	0.267	0.139	0.134	0.085

	Clothianidin	In-furrow at planting	0.199	54	2	<0.01	<0.01	<0.01	0.01
0.01	NA

	TMG

2	<0.01	<0.01	<0.01	0.01	0.01	NA

Fruiting Vegetables (proposed use = 0.2 lb ai/A total application rate,
7-day PHI)

Peppers	Clothianidin	Broadcast  foliar	0.197-0.203	7	18	<0.01	0.092
0.090	0.025	0.036	0.027

side-dress soil	0.200-0.202	21	4	<0.01	0.01	0.01	0.01	0.01	NA

Tomato	Clothianidin	Broadcast foliar	0.196-0.206	7	24	<0.01	0.042	0.036
0.018	0.019	0.009

Chemigation	0.202	21	2	<0.01	<0.01	0.01	0.01	0.01	NA

Soil drench at planting	0.198	82	2	0.025	0.028	0.027	0.027	0.027	NA

Cucurbit Vegetables (proposed use = 0.2 lb ai/A total application rate,
7-day PHI)

Cantaloupe	Clothianidin	Broadcast foliar	0.200-0.204	7	12	<0.01	0.037
0.034	0.018	0.020	0.008

Banded soil at planting	0.207	92	2	<0.01	<0.01	0.01	0.01	0.01	NA

Cucumber	Clothianidin	Broadcast foliar	0.199-0.203	7	12	<0.01	0.017
0.016	0.011	0.012	0.002

Side-dress soil	0.207	21	2	0.014	0.015	0.015	0.015	0.015	NA

Summer Squash	Clothianidin	Broadcast foliar	0.195-0.209	7	10	<0.01	0.043
0.041	0.010	0.016	0.013

In-furrow at planting	0.206	73	2	<0.01	<0.01	0.01	0.01	0.01	NA

Peaches (proposed use = 0.2 lb ai/A total application rate, 7-day PHI)

Peach	Clothianidin	Foliar	0.19-0.21	6-7	32	0.023	0.997	0.819	0.065	0.117
0.192

Low-growing Berries, except Strawberry (proposed use = 0.2 lb ai/A total
application rate, 21-day PHI)

Cranberry	Clothianidin	Broadcast soil	0.197-0.213	21-22	10	<0.004	0.006
0.005	0.004	0.004	0.001

Broadcast foliar	0.199-0.217	21-22	10	<0.004	<0.004	0.004	0.004	0.004	NA

Tree Nuts (proposed use = 0.2 lb ai/A total application rate, 21-day
PHI)

Almond, hulls	Clothianidin	Broadcast foliar	0.194-0.207	21	10	0.04	0.93
0.86	0.23	0.40	0.39

Almond, nutmeats

	10	<0.01	0.01	0.01	0.01	0.01	NA

Pecan, nutmeats	Clothianidin	Broadcast foliar	0.199-0.203	21	10	<0.01
<0.01	0.01	0.01	0.01	NA

Figs (proposed use = 0.2 lb ai/A total application rate, 7-day PHI)

Figs	Clothianidin	Foliar	0.20	7	6	0.015	0.031	0.029	0.025	0.024	0.007

Pomegranates (proposed use = 0.2 lb ai/A total application rate, 7-day
PHI)

Pomegranates	Clothianidin	Foliar	0.20	7	6	0.021	0.077	0.075	0.058	0.053
0.022

Cotton (proposed use = 0.2 lb ai/A total application rate, 21-day PHI)

Cotton, undelinted seed	Clothianidin	Broadcast foliar	0.197-0.205	19-22
24	<0.01	0.091	0.080	0.018	0.033	0.028

Cotton, gin byproducts	Clothianidin

	19-22	12	0.490	2.48	2.31	1.18	1.35	0.672

	TMG

12	0.048	0.138	0.136	0.093	0.091	0.032

Soybean (proposed use = 0.2 lb ai/A total application rate, 21-day PHI)

Soybean, seed	Clothianidin	Broadcast foliar 	0.199-0.207	20-27 4	40
<0.01	0.016	0.013	0.010	0.010	0.001

1	The 50% WP formulation of clothianidin was used for application in the
field trials, with the exceptions of the fig and pomegranate field
trials which used the 2.13 lb/gal FlC formulation.

2	The method LOQ was 0.01 ppm for clothianidin and TMG in all matrices
except peach (LOQ =0.017 ppm) and cranberry (LOQ = 0.004 ppm).  For
residue values <LOQ, the LOQ value was used for all calculations.

3	HAFT = Highest average field trial result.

4	One soybean field trial had a PHI of 27 days, and all other PHIs were
20-21 days.

Leafy Vegetables, Except Brassica (Group 4)

Samples of celery were stored at ≤-20°C for up to 155 days prior to
extraction for analysis; these storage conditions and durations are
supported by the available storage stability data.

Residues of clothianidin and TMG were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for each analyte in/on celery; the LOD was not reported.

Following two foliar applications totaling ~0.2 lb ai/A (1x rate),
clothianidin residues were 0.023-0.941 ppm and the TMG residues were
<0.01-0.090 ppm in/on 12 samples of celery harvested at 7 DAT.  For
samples having quantifiable residues of TMG, clothianidin residues were
10-23x higher (avg. 17x) than the associated TMG residues.  Average
residues were 0.453 ppm for clothianidin and 0.034 ppm for TMG, and the
highest average field trial (HAFT) residues were 0.924 ppm for
clothianidin and 0.086 ppm for TMG.  For the one test using a soil
drench application at planting at ~0.2 lb ai/A (1x rate), clothianidin
and TMG residues were each <0.01 ppm in/on celery harvested at 77 DAT.
No residue decline tests were conducted for celery.

Head Lettuce. In six field trials conducted in the United States in
Zones 1, 3, and 10 during 2007, clothianidin (50% WDG) was applied to
head lettuce as two broadcast foliar applications during vegetative
development at rates of 0.097-0.102 lb ai/A/application (1.5x single
rate) and RTIs of 7 days, for a total of 0.197-0.204 lb ai/A (1x
seasonal rate).  At one of the field sites, clothianidin (50% WDG) was
also applied to a separate plot as a single soil application via
chemigation at 0.200 lb ai/A (1x rate) approximately one month prior to
harvest.  All foliar applications were made using ground equipment in
volumes of 23-40 gal/A, and the soil application was made using drip
irrigation equipment in 310 gal/A.  No adjuvants were used for any
applications.  Single control and duplicate treated samples of head
lettuce with wrapper leaves were harvested at commercial maturity, which
was at 7 DAT for the foliar applications and at 32 DAT for the soil
application.  At one site, samples were also harvested at 1, 4, 7, 10,
and 13 DAT to assess residue decline, and at two sites, samples without
wrapper leaves were also collected at 7 DAT.  Samples were stored at
≤-20°C for up to 125 days prior to extraction for analysis; these
storage conditions and durations are supported by the available storage
stability data.

Residues of clothianidin and TMG were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for each analyte in/on lettuce; the LOD was not reported.

Following two foliar applications totaling ~0.2 lb ai/A (1x rate),
clothianidin residues were <0.01-0.589 ppm and the TMG residues were
<0.01-0.044 ppm in/on 12 samples of head lettuce (w/ wrapper leaves)
harvested at 7 DAT.  For samples having quantifiable residues of TMG,
clothianidin residues were 7-18x higher (avg. 12x) than the associated
TMG residues.  Average residues were 0.274 ppm for clothianidin and
0.024 ppm for TMG, and the HAFT residues were 0.527 ppm for clothianidin
and 0.040 ppm for TMG.  For the four samples without wrapper leaves,
clothianidin residues were <0.01-0.024 ppm and TMG residues were <0.01
ppm.

In the residue decline test, clothianidin residues in/on head lettuce
decreased steadily from an average of 0.657 ppm at 1 DAT to 0.262 ppm by
13 DAT.  Residues of TMG also declined slowly over time from 0.044 ppm
at 1 DAT to 0.035 ppm at 13 DAT.

 – 0.110-0.197 ppm; and TMG - ≤0.011 ppm).

Leaf Lettuce. In six field trials conducted in the United States in
Zones 2, 3, and 10 during 2007, clothianidin (50% WDG) was applied to
leaf lettuce as two broadcast foliar applications during vegetative
development at rates of 0.097-0.102 lb ai/A/application (1.5x single
rate) and RTIs of 7 days, for a total of 0.198-0.202 lb ai/A (1x
seasonal rate).  At one of the field sites, clothianidin (50% WDG) was
also applied to a separate plot as a single side-dress soil application
at 0.203 lb ai/A (1x rate) at 21 days prior to harvest.  All
applications were made using ground equipment in volumes of 20-72 gal/A,
and no adjuvants were used.  Single control and duplicate treated
samples of leaf lettuce were harvested at commercial maturity, which was
at 7 DAT for the foliar applications and 21 DAT for the soil
application.  Samples of lettuce were stored at ≤-20°C for up to 222
days prior to extraction for analysis; these storage conditions and
durations are supported by the available storage stability data.

Residues of clothianidin and TMG were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for each analyte in/on lettuce; the LOD was not reported.

Following two foliar applications totaling ~0.2 lb ai/A (1x rate),
clothianidin residues were 0.195-1.21 ppm and TMG residues were
0.015-0.078 ppm in/on 12 samples of leaf lettuce harvested at 7 DAT.
Clothianidin residues were 6-18x higher (avg. 12x) than the associated
TMG residues.  Average residues were 0.542 ppm for clothianidin and
0.047 ppm for TMG, and the HAFT residues were 1.098 ppm for clothianidin
and 0.047 ppm for TMG.  In the single test using a soil application at
~0.2 lb ai/A (1x rate), clothianidin residues were 0.043-0.046 ppm and
TMG residues were <0.01 ppm in/on leaf lettuce at 21 DAT.  No residue
decline tests were conducted on leaf lettuce.

Spinach.  In six field trials conducted in the United States in Zones 1,
2, 6, 9, and 10 during 2007, clothianidin (50% WDG) was applied to
spinach as two broadcast foliar applications during vegetative
development at rates of 0.095-0.103 lb ai/A/application (1.5x single
rate) and RTIs of 6-7 days, for a total of 0.193-0.204 lb ai/A (1x
seasonal rate).  At one of the field sites, clothianidin (50% WDG) was
also applied to a separate plot as a single banded soil application at
planting at 0.199 lb ai/A (1x rate).  All applications were made using
ground or soil treatment equipment in volumes of 5-31 gal/A, and no
adjuvants were used.  Single control and duplicate treated samples of
spinach were harvested at commercial maturity, which was at 7 days DAT
for the foliar applications and 82 DAT for the soil application.
Samples of spinach were stored at ≤-20°C for up to 211 days prior to
extraction for analysis; these storage conditions and durations are
supported by the available storage stability data.

Residues of clothianidin and TMG were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for each analyte in/on spinach; the LOD was not reported.

Following two foliar applications totaling ~0.2 lb ai/A (1x rate),
clothianidin residues were 0.077-1.81 ppm and TMG residues were
0.022-0.122 ppm in/on 12 samples of spinach harvested at 6-7 DAT.  With
one exception, residues of clothianidin were 7-20x higher than TMG
residues.  Average residues were 0.636 ppm for clothianidin and 0.051
ppm for TMG, and the HAFT residues were 1.73 ppm for clothianidin and
0.119 ppm for TMG.  In the single test using the banded soil application
at planting at ~0.2 lb ai/A (1x rate), clothianidin residues were
0.030-0.034 ppm and TMG residues were <0.01 ppm in/on spinach harvested
at 82 DAT.  No residue decline tests were conducted on spinach.

Brassica (Cole) Leafy Vegetables (Group 5)

Cabbage. In six field trials conducted in the United States in Zones 1,
2, 3, 5, 6, and 10 during 2006, clothianidin (50% WDG) was applied to
cabbage as two broadcast foliar applications during vegetative
development at rates of 0.098-0.102 lb ai/A/application (1.5x single
rate) and RTIs of 7 days, for a total of 0.198-0.204 lb ai/A (1x
seasonal rate).  At one of the field sites, clothianidin (50% WDG) was
also applied to a separate plot as a single soil drench application at
transplanting at 0.200 lb ai/A (1x rate).  All applications were made
using ground equipment in volumes of 18-50 gal/A, and no adjuvants were
used.  Single control and duplicate treated samples of cabbage heads
(with wrapper leaves) were harvested from each test at commercial
maturity, which was at 6-7 DAT for the foliar applications and at 77 DAT
for the soil application.  In two of the foliar tests, samples of
cabbage without wrapper leaves were also collected at 7 DAT.  Samples of
cabbage were stored at ≤-20°C for up to 174 days prior to extraction
for analysis; these storage conditions and durations are supported by
the available storage stability data.

Residues of clothianidin and TMG were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for each analyte in/on cabbage; the LOD was not reported.

Following two foliar applications totaling ~0.2 lb ai/A (1x rate),
clothianidin residues were 0.013-0.413 ppm and the TMG residues were
<0.01-0.013 ppm in/on 12 samples of cabbages (w/ wrapper leaves)
harvested at 6-7 DAT.  Average residues were 0.125 ppm for clothianidin
and 0.01 ppm for TMG, and the HAFT residues were 0.367 ppm for
clothianidin and 0.012 ppm for TMG.  For the four samples without
wrapper leaves, clothianidin residues were <0.01-0.035 ppm and TMG
residues were <0.01 ppm.  In the single test using a soil drench
application at transplanting at 0.200 lb ai/A (1x rate), clothianidin
and TMG residues were each <0.01 ppm in/on the two cabbage samples
harvested at 77 DAT.  No residue decline tests were conducted on
cabbage.

≤-20°C for up to 163 days prior to extraction for analysis; these
storage conditions and durations are supported by the available storage
stability data.

Residues of clothianidin and TMG were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for each analyte in/on cauliflower; the LOD was not reported.

Following two foliar applications totaling ~ 0.2 lb ai/A (1x rate),
clothianidin residues were 0.01-0.068 ppm and TMG residues were <0.01
ppm in/on 12 samples of cauliflower harvested at 7 DAT.  For
clothianidin, the average residue was 0.029 ppm and the HAFT residue was
0.061 ppm.  In the one test using the at-planting soil application at
0.205 lb ai/A (1x rate), residues of both clothianidin and TMG were
<0.01 ppm at 97 DAT.

In the residue decline test, residues of clothianidin decreased from
0.054 ppm at 1 DAT to 0.022 ppm by 7 DAT, and then increased slightly to
0.028 ppm by 13 DAT.  Residues of TMG were <0.01 ppm at all intervals.

Mustard Greens.  In five field trials conducted in the United States in
Zones 2, 4, 5, 6, and 10 during 2006, clothianidin (50% WDG) was applied
to mustard greens during vegetative development as two broadcast foliar
applications at rates of 0.097-0.102 lb ai/A/application (1.5x single
rate) and RTIs of 7 days, for a total of 0.195-0.202 lb ai/A (1x
seasonal rate).  At one of the field sites, clothianidin (50% WDG) was
also applied to a separate plot as a single in-furrow application at
planting at 0.199 lb ai/A (1x rate).  All applications were made using
ground equipment in volumes of 7-30 gal/A, and no adjuvants were used.
Single control and duplicate treated samples of mustard green leaves
were harvested at normal commercial maturity, which was at 7 DAT for the
foliar applications and at 54 DAT for the soil application.  Samples of
mustard greens were stored at ≤-20°C for up to 114 days prior to
extraction for analysis; these storage conditions and durations are
supported by the available storage stability data.

Residues of clothianidin and TMG were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for each analyte in/on mustard greens; the LOD was not
reported.

Following two foliar applications totaling ~0.2 lb ai/A (1x rate),
clothianidin residues were 0.129-1.440 ppm and residues of TMG were
0.033-0.274 ppm in/on 10 samples of mustard greens harvested at 6-7 DAT.
 Clothianidin residues were 1.2-9.9x higher (avg. 4x) than the
associated TMG residues.  Average residues were 0.475 ppm for
clothianidin and 0.134 ppm for TMG, and the HAFT residues were 1.31 ppm
for clothianidin and 0.267 ppm for TMG.  In the single test using an
in-furrow application at planting at 0.199 lb ai/A (1x rate),
clothianidin and TMG residues were each <0.01 ppm in/on mustard greens
harvested at 54 DAT.  No residue decline tests were conducted on mustard
greens.

Legume Vegetables (Group 6)

Soybean.  In 20 field trials conducted in the United States in Zones 2,
4 and 5 during 2007, clothianidin (50% WDG) was applied to soybeans as
two broadcast foliar applications during pod/seed development at rates
of 0.096-0.105 lb ai/A/application (1.5x single rate) with a 7-day RTI,
for a total of 0.199-0.207 lb ai/A (1x seasonal rate).  Applications
were made using ground equipment in volumes of 10-25 gal/A, and no
adjuvants were used.  Soybeans were harvested at commercial maturity,
20-21 DAT, except in one test where soybeans were harvested at 27 DAT
due to wet weather.  At two sites, soybean seeds were also harvested at
11-12, 16, 21, 25-26, and 30-31 DAT to assess residue decline.  Samples
of soybean forage and hay were not collected.  Samples of soybean seeds
were stored at <-20°C for up to 92 days prior to extraction for
analysis; these storage conditions and durations are supported by the
available storage stability data.

Residues of clothianidin in/on soybean seeds were determined using an
adequate LC/MS/MS method (Morse Method #164, modified).  The validated
LOQ is 0.01 ppm for soybeans; the LOD was not reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A (1x
rate), clothianidin residues in/on soybean seeds at 20-27 DAT were <LOQ
(<0.01 ppm) in/on 39 samples and 0.016 ppm in/on one sample.  The
average residues in/on soybean seeds were 0.01 ppm and the HAFT residues
were 0.013 ppm.

In one of the residue decline tests, average residues of clothianidin
in/on soybean seeds decreased from 0.029 ppm at 11 DAT to <0.01 ppm by
16 DAT.  Residues in/on seed in the second decline trial were ≤0.011
ppm at all intervals (12-30 DAT).  No field trial data were submitted
supporting the proposed seed treatment use of the 5 lb/gal FlC
formulation on soybeans.

Fruiting Vegetables, Except Cucurbits (Group 8)

≤-20°C for up to 119 days prior to extraction for analysis; these
storage conditions and durations are supported by the available storage
stability data.

Residues of clothianidin in/on pepper were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for pepper; the LOD was not reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A,
clothianidin residues were <0.01-0.092 ppm in/on 18 samples of peppers
harvested at 7 DAT.  The average clothianidin residue was 0.036 ppm
in/on peppers and the HAFT residue was 0.090 ppm.  Following a single
the soil treatment (side-dress or chemigation), residues were <0.01 ppm
in/on all four pepper samples harvested at 21 DAT.  The average residue
in/on peppers from foliar applications at the same trial sites was 0.054
ppm.

Tomato.  In 12 field trials conducted in the United States in Zones 1,
2, 3, 5, and 10 during 2007, clothianidin (50% WDG) was applied to
tomatoes as two broadcast foliar applications during fruit development
at rates of 0.097-0.104 lb ai/A/application (1.5x single rate) and RTIs
of 6-8 days, for a total of 0.196-0.206 lb ai/A (1x seasonal rate).  At
two of the test sites, clothianidin (50% WDG) was also applied to a
separate plot as either a single soil drench application at
transplanting at 0.198 lb ai/A (1x rate), or as a single soil
application at 0.202 lb ai/A (1x rate) by chemigation (drip irrigation)
during fruit development.  Applications were made using ground or
irrigation equipment in volumes of 17-208 gal/A, and no adjuvants were
used.  Single control and duplicate treated samples of tomatoes were
harvested at commercial maturity, at 7 DAT for the foliar applications,
21 DAT for the chemigation application, and 82 DAT for the soil drench
application.  In one of the foliar application tests, samples were also
harvested at 1, 4, 7, 10, and 13 DAT to assess residue decline.  Samples
of tomatoes were stored at <-20°C for up to 160 days prior to
extraction for analysis; these storage conditions and durations are
supported by the available storage stability data.

Residues of clothianidin in/on tomatoes were determined using an
adequate LC/MS/MS method (Morse Method #164, modified).  The validated
LOQ is 0.01 ppm for tomatoes; the LOD was not reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A (1x
rate), clothianidin residues were <0.01-0.042 ppm in/on 24 samples of
tomatoes harvested at 7 DAT.  The average residue was 0.019 ppm and the
HAFT residue was 0.036 ppm.  In the residue decline test using the
foliar applications, residues in/on tomatoes decreased from an average
of 0.015 ppm at 1 DAT, 0.012 ppm at 7 DAT and <0.01 ppm (<LOQ) at 10-13
DAT.

When the clothianidin (WDG) was applied as a single soil drench at
transplanting, residues were 0.025 and 0.028 ppm at 82 DAT and averaged
0.027 ppm, compared to an average residue of 0.036 ppm for samples
harvested at 7 DAT from the foliar applications at the same site.  When
the clothianidin (WDG) was applied via chemigation during fruit
development at 0.202 lb ai/A (1x rate), residues were <0.01 ppm for both
samples at 21 DAT, compared to an average residue of 0.024 ppm for
tomatoes harvested at 7 DAT from the foliar applications at the same
site.

Cucurbit Vegetables (Group 9)

were stored at ≤-20°C for up to 101 days prior to extraction for
analysis; these storage conditions and durations are supported by the
available storage stability data.

Residues of clothianidin in/on cantaloupes were determined using an
adequate LC/MS/MS method (Morse Method #164, modified).  The validated
LOQ is 0.01 ppm for cantaloupes; the LOD was not reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A (1x
rate), clothianidin residues were <0.01-0.037 ppm in/on 12 samples of
cantaloupe harvested at 7 DAT.  The average residue was 0.020 ppm and
the HAFT residue was 0.034 ppm.  When the clothianidin (WDG) was applied
as a single banded soil application at planting at 0.207 lb ai/A (1x
rate), residues were <0.01 ppm for both samples harvested at 92 DAT.  A
residue decline study was not conducted on cantaloupes.

Cucumber.  In six field trials conducted in the United States in Zones
2, 3, 5, and 6 during 2006 and 2007, clothianidin (50% WDG) was applied
to cucumbers as two broadcast foliar applications during fruit
development at rates of 0.097-0.102 lb ai/A/application (1.5x single
rate) and RTIs of 6-8 days, for a total of 0.199-0.203 lb ai/A (1x
seasonal rate).  At one field site, a separate plot was treated with
clothianidin (50% WDG) as a side-dress soil application during fruit
development at 0.207 lb ai/A (1x rate) for comparison with the foliar
applications.  All applications were made using ground equipment in
volumes of 10-42 gal/A, and no adjuvants were used.  Single control and
duplicate treated samples of cucumbers were harvested at commercial
maturity, 7 DAT for the foliar applications and at 21 DAT for the
side-dress soil application.  At one field trial location, samples were
collected at 1, 4, 7, 10 and 13 DAT to assess residues decline.
Cucumber samples were stored at ≤-20°C for up to 113 days prior to
extraction for analysis; these storage conditions and durations are
supported by the available storage stability data.

Residues of clothianidin in/on cucumbers were determined using an
adequate LC/MS/MS method (Morse Method #164, modified).  The validated
LOQ is 0.01 ppm for cucumbers; the LOD was not reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A (1x
rate), clothianidin residues were <0.01-0.017 ppm in/on 12 samples of
cucumber harvested at 7 DAT.  The average residue was 0.012 ppm and the
HAFT residue was 0.016 ppm for the foliar applications.  For the
side-dress soil application, clothianidin residues were 0.014 and 0.015
ppm in/on two samples collected at 21 DAT.  In the residue decline test,
average residues in/on cucumbers were 0.023 ppm at 1 DAT and declined to
≤0.01 ppm by 7 DAT.

Summer Squash.  In five field trials conducted in the United States in
Zones 1, 2, 3, 5, and 10 during 2006 and 2007, clothianidin (50% WDG)
was applied to summer squash as two broadcast foliar applications during
fruit development at rates of 0.096-0.105 lb ai/A/application (1.5x
single rate) and RTIs of 7 days, for a total of 0.195-0.209 lb ai/A (1x
seasonal rate).  At one field site, a separate plot was treated with
clothianidin (50% WDG) as an in-furrow application at planting at 0.207
lb ai/A for comparison with the foliar applications.  Applications were
made using ground equipment in volumes of 11-30 gal/A, and no adjuvants
were used.  Single control and duplicate treated samples of squash were
harvested at commercial maturity, 7 DAT for the foliar applications and
at 73 DAT for the soil application.  Samples of squash were stored at
≤-20°C for up to 225 days prior to extraction for analysis; these
storage conditions and durations are supported by the available storage
stability data.

Residues of clothianidin in/on squash were determined using an adequate
LC/MS/MS method (Morse Method #164, modified).  The validated LOQ is
0.01 ppm for squash; the LOD was not reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A (1x
rate), clothianidin residues were <0.01-0.043 ppm in/on 12 samples of
summer squash harvested at 7 DAT.  The average residue was 0.016 ppm and
the HAFT residue was 0.041 ppm.  When clothianidin (WDG) as applied as a
single in-furrow application at planting at 0.206 lb ai/A (1x rate),
residues were <0.01 ppm in/on both squash samples harvested at 73 DAT.
A residue decline study was not conducted on summer squash.

Stone Fruits (Group 12).

were stored at ≤-12°C for up to 497 days prior to extraction for
analysis; these storage conditions and durations are supported by the
available storage stability data.

Residues of clothianidin in/on peaches were determined using an adequate
LC/MS/MS method (Bayer Method 00552, modified).  The LLMV was 0.02 ppm
for peaches, and the statistically calculated LOQs were 0.011-0.017 ppm
and the LODs were 0.004-0.006 ppm.

Following a single foliar application at 0.19-0.21 lb ai/A (2x single
rate), clothianidin residues were 0.023-0.997 ppm in/on 32 samples of
peaches harvested at 6-7 DAT.  Clothianidin residues averaged 0.117 ppm
and the HAFT residue was 0.819 ppm.  Data from the residue decline test
indicates that clothianidin residues in/on peaches decreased steadily
over time, from 0.185 ppm at 0 DAT to 0.040 ppm at 14 DAT.

Low-growing Berry, except strawberry (Subgroup 13-07H)

were stored at ≤-10°C for up to 154 days prior to extraction for
analysis; these storage conditions and durations are supported by the
available storage stability data.

Residues of clothianidin in/on cranberries were determined using an
adequate LC/MS/MS method (Bayer Method 00552, modified).  The LLMV was
0.01 ppm for cranberry, and the statistically calculated LOQ and LOD
were 0.004 and 0.001 ppm, respectively.

Following a single soil application at ~0.2 lb ai/A (1x rate),
clothianidin residues were <LOQ (<0.004 ppm) in/on all 10 samples of
cranberries harvested at 21-22 DAT.  Following the repeated foliar
applications totaling ~0.2 lb ai/A, clothianidin residues were
<004-0.006 ppm in/on 10 samples at 21-22 DAT, with 6 of the samples
having residues <LOQ.  The HAFT residues were <0.004 ppm for the soil
application and 0.005 ppm for foliar applications, and average residues
were 0.004 ppm for both the soil and foliar applications.

Tree Nuts (Group 14)

Almond.  In five field trials conducted in the United States in Zone 10
during 2007, clothianidin (50% WDG) was applied to almonds as two foliar
applications during nut development at rates of 0.096-0.109 lb
ai/A/application (1x single rate) and RTIs of 13-14 days, for a total of
0.194-0.207 lb ai/A (1x seasonal rate).  Applications were made using
ground equipment in volumes of 48-194 gal/A, and no adjuvants were used.
 Single control and duplicate treated samples of almonds (nutmeats and
hulls) were harvested from each test at commercial maturity, 21 DAT.  At
one site, samples were also harvested at 11, 16, 21, 26, and 31 DAT to
assess residue decline.  Samples of almond hulls and nutmeats were
stored at <-20°C for up to 52 days prior to extraction for analysis;
these storage conditions and durations are supported by the available
storage stability data.

Residues of clothianidin in/on nutmeats and hulls were determined using
an adequate LC/MS/MS method (Morse Method #164, modified).  The
validated LOQ is 0.01 ppm for both almond commodities; the LOD was not
reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A (1x
rate), clothianidin residues were 0.04-0.93 ppm in/on 10 samples of
almond hulls harvested at 21 DAT.  The average residue in/on hulls was
0.40 ppm and the HAFT residue was 0.83 ppm for hulls.  For almond
nutmeats, all samples harvested at 21 DAT had residues of ≤0.01 ppm.

Data from the residue decline test indicates that the residues in almond
hulls increased from 16 to 21 DAT, then decreased from 21 to 26 DAT.
For almond hulls, average residues were 0.59 ppm at 11 and 16 DAT,
increased to 0.86 ppm at 21 DAT, and then declined to 0.37 ppm at 26 DAT
and 0.30 ppm at 35 DAT.  The almond nutmeat residues decreased from
0.02-0.03 ppm at 11 DAT to <0.01 ppm (<LOQ) at 16-31 DAT.

Pecan.  In five field trials conducted in the United States in Zones 2,
4, 6, and 8 during 2006, clothianidin (50% WDG) was applied to pecans as
two foliar applications during nut development at rates of 0.097-0.102
lb ai/A/application (1x single rate) and RTIs of 14 days, for a total of
0.199-0.203 lb ai/A (1x seasonal  rate).  Applications were made using
ground equipment in volumes of 68-129 gal/A, and no adjuvants were used.
 Single control and duplicate treated samples of pecan nutmeats were
harvested at commercial maturity, 21-22 days DAT.  Samples of pecans
were stored at <-20°C for up to 113 days prior to extraction for
analysis; these storage conditions and durations are supported by the
available storage stability data.

Residues of clothianidin in/on nutmeats were determined using an
adequate LC/MS/MS method (Morse Method #164, modified).  The validated
LOQ is 0.01 ppm for pecans; the LOD was not reported.

Following two foliar applications at rates totaling ~0.2 lb ai/A,
clothianidin residues were <0.01 ppm (<LOQ) in/on all 10 samples of
pecan nutmeat harvested at 21-22 DAT.

Miscellaneous Crops

≤-20°C for up to 141 days and 172 days, respectively, prior to
extraction for analysis; these storage conditions and durations are
supported by the available storage stability data.

Residues of clothianidin in/on cottonseed and residues of clothianidin
and TMG in/on gin trash were determined using an adequate LC/MS/MS
method (Morse Method #164, modified).  The validated LOQ is 0.01 ppm for
clothianidin in each commodity and TMG in gin trash; the LOD was not
reported.

Following two foliar applications totaling 0.197-0.205 lb ai/A (1x
rate), clothianidin residues were <0.01-0.091 ppm in/on 24 samples of
cottonseed harvested at 19-22 DAT, with 5 samples having residues <LOQ.
The average clothianidin residue was 0.033 ppm in/on cottonseed, and the
HAFT residue was 0.080 ppm.  Data from the residue decline test
indicates that average clothianidin residues in/on cottonseed generally
decreased over time, from 0.088 ppm at 11 DAT to 0.017 ppm at 31 DAT.

For cotton gin trash, clothianidin residues were 0.49-2.48 ppm and TMG
residues were 0.048-0.138 ppm in/on 12 samples harvested at 19-22 DAT.
Average residues in/on gin trash were 1.35 ppm for clothianidin and
0.091 ppm for TMG, and the HAFT residues were 2.31 ppm for clothianidin
and 0.136 ppm for TMG.  Residues of clothianidin were 8-22x higher (avg.
15x) in gin trash samples than the associated TMG residues.  With
regards to the types of harvest procedures, residues of clothianidin and
TMG in/on gin trash were generally similar for picker and stripper
harvested cotton; however, clothianidin residues were slightly higher in
the gin trash from the picker harvested cotton (avg. 1.73 ppm) than from
the stripper harvested cotton (avg. 0.97 ppm).

Fig.  In three field trials conducted in the United States in Zone 10
during 2008, clothianidin (2.13 lb/gal FlC) was applied to figs as two
foliar applications during fruit development at rates of 0.10 lb
ai/A/application (1x rate) and RTIs of 13-15 days, for a total of 0.20
lb ai/A/season (1x seasonal use rate).  Applications were made using
ground equipment in volumes of 109-120 gal/A, and included the use of a
nonionic surfactant (NIS) at 0.25% v/v.  Single control and duplicate
treated samples of figs were harvested from each test at commercial
maturity, 7 DAT.  Samples were also collected at 0, 7, 14 and 21 DAT in
one trial to assess residue decline.  Fig samples were stored at <-20°C
for up to 131 days prior to analysis.  This sample storage interval is
supported by the available storage stability data.

Residues of clothianidin in/on figs were determined using an adequate
the LC/MS/MS method (RM-39C-1).  The validated LOQ is 0.01 ppm, and the
LOD is 0.005 ppm.

Following two foliar applications of clothianidin (FlC) to figs at rates
totaling 0.20 lb ai/A, clothianidin residues were 0.015-0.031 ppm (<LOQ)
in/on the 6 samples of figs harvested at 7 DAT.  The average residue was
0.024 ppm and the HAFT residue was 0.029 ppm.  In the residue decline
trial, average residues declined rapidly from 0.087 ppm at 0 DAT to
0.027 ppm by 7 DAT, and then declined more slowly to 0.013 ppm by 21
DAT.

Pomegranate.  In three field trials conducted in the United States in
Zone 10 during 2008, clothianidin (2.13 lb/gal FlC) was applied to
pomegranates as two foliar applications during fruit development at
rates of 0.10 lb ai/A/application (1x rate) and RTIs of 13-14 days, for
a total of 0.20 lb ai/A/season (1x seasonal rate).  Applications were
made using ground equipment in volumes of 108-122 gal/A, and included
the use of a NIS at 0.25% v/v.  Single control and duplicate treated
samples of pomegranates were harvested from each test at commercial
maturity, 7 DAT.  Samples were also collected at 0, 7, 14 and 21 DAT in
one trial to assess residue decline. Pomegranate samples were stored at
<-20°C for up to 104 days prior to analysis.  This sample storage
interval is supported by the available storage stability data.

Residues of clothianidin in/on pomegranates were determined using an
adequate the LC/MS/MS method (RM-39C-1).  The validated LOQ is 0.01 ppm,
and the LOD is 0.005 ppm.

Following two foliar applications of clothianidin (FLC) to pomegranates
at rates totaling 0.20 lb ai/A (1x rate), clothianidin residues were
0.021-0.077 ppm in/on the 6 samples of pomegranates harvested at 7 DAT.
The average residue was 0.053 ppm and the highest average field trial
(HAFT) residue was 0.075 ppm.  In the residue decline trial, average
residues declined from 0.122 ppm at 0 DAT to 0.075 ppm by 7 DAT, and
then remained relatively steadily up to 21 DAT.

Conclusions.  The field trial data submitted by Valent supporting
repeated foliar applications of the 50% WDG or 2.13 lb/gal FlC
formulations of clothianidin are adequate, although the maximum single
application rate used in the field trials was higher (1.5x) than the
proposed rate, with the exceptions of the tree nut, fig and pomegranate
field trials.  For both the 50% WDG and 2.13 lb/gal FlC formulations,
the maximum proposed single foliar application rate is 0.05-0.067 lb
ai/A for all crops except tree nuts (0.1 lb ai/A), figs (0.09 lb ai/A)
and pomegranates (0.09 lb ai/A), and the maximum seasonal application
rate is 0.2 lb ai/A for all proposed crops.  However, in each trial, the
WDG or FLC formulation was applied twice at a rate of 0.1 lb ai/A (1.5x
proposed single rate for most crops) for a total of 0.2 lb ai/A (1x
proposed seasonal rate).  With the exceptions of the field trial data on
tree nuts, figs and pomegranates, the residue data from Valent’s
current field trials are likely to slightly over estimate clothianidin
residues.

For the proposed foliar applications, an adequate number of tests were
conducted using the 50% WDG or 2.13 lb/gal FlC formulation on the
required representative crops in the appropriate geographic regions at
~1x the proposed maximum seasonal rate, and the appropriate commodities
were collected from each test around the proposed PHIs.  Samples from
all the field trials were analyzed using adequate LC/MS/MS methods, and
the available storage stability data support the sample storage
durations and conditions.  As the proposed use directions are identical
for the 50% WDG and 2.13 lb/gal formulations, and the PHIs for the
foliar applications are >7 days, the residue data for the WDG or FlC
formulations will also support the use of either the FlC or WDG
formulations (per pending OECD residue chemistry guidelines) on
low-growing berries, tree nuts, cotton, and soybean.  For foliar
applications, HED will generally allow for translation of residue data
between water-diluted formulations (other than ECs, Mcap, and
oil-dispersion formulations) when the proposed PHI is >7 days and
residues are shown to decline at longer posttreatment intervals (per
draft, pending OECD guidelines).  Therefore, HED has no objections to
the translation of formulation data for the proposed uses on tuberous
and corm vegetables, cotton, berries, soybeans, and tree nuts.  However,
for the other crops HED is requesting that bridging trials be completed
and submitted in order to evaluate the residue levels resulting from
these two formulations for uses with a 7-day PHI.  Adequate residue data
were provided for TMG in/on leafy and Brassica vegetables commodities as
required.

In addition to the formulation issue, several other deficiencies were
noted in Valent’s field trial data.  First, with the exceptions of the
fig and pomegranate field trials, none of the other field trials
included the use of any adjuvants in the spray mix, although the
proposed labels allow for the use of spray adjuvants.  The foliar
applications were applied at a slightly exaggerated single rate (1.5x).
HED has evidence that adjuvants can have a significant impact on residue
levels, potentially increasing them by 4- to 5-fold relative to residues
resulting from the same use without adjuvants.  Therefore, the 1.5x
application rate is not sufficient to address the impact of adjuvants on
residue levels.  HED requests that bridging trials be conducted to show
the impact of adjuvants on residue levels (three trials per
representative crop) and that in the mean time, the proposed label be
revised to disallow the use of spray adjuvants with clothianidin foliar
treatments, with the exception of applications to figs, pomegranates,
and tree nuts except almonds (due to residues in/on almond hulls).

Second, no residue data were submitted on soybean forage and hay
following the proposed foliar applications, and no data were submitted
supporting the proposed application of the 5 lb/gal FlC formulation as a
seed treatment for soybeans.  The label should be revised to prohibit
the feeding of soybean forage and hay to livestock.

at ≥21 days following a single soil application at 0.2 lb ai/A are
likely to be less than or equal to the residues resulting from repeated
foliar applications totaling 0.2 lb ai/A, insufficient data are
available to make this determination.  Based on the submitted soil
application data, HED also assumes that the desired PHI for soil
applications is 21 days rather than the currently specified 7-day PHI.

Data are insufficient to support the soil application use patterns
requested. In order to support this use pattern, HED recommends bridging
studies be conducted to examine the effects of application mode (soil
vs. foliar) on residue levels.  Given the number of variables involved
with the requested uses (adjuvant use, formulation effects, and soil vs.
foliar application), HED further recommends that the design of these
trials be discussed with HED prior to their initiation.

Although no field trial data were submitted by Valent supporting the use
of the 5 lb/gal FlC formulation as a seed or seed-piece treatment on
soybeans and potatoes, no new residue data are required as the existing
residue data on soybeans and potatoes will support the proposed uses.
For potatoes, adequate field trial data are available supporting an
identical use for the 2.13 lb/gal FlC formulation (DP# 303164, W. Drew,
2/1/06); these data will support the same use for the 5 lb/gal FlC
formulation.

For soybeans, the submitted field trial data reflecting foliar
applications at up to 0.2 lb ai/A/season will cover the proposed seed
treatment use, as the proposed use rate from the seed treatment would
result in a worst-case field rate of 0.05 lb ai/A.  Given the longer
harvest interval and lower use rate for the seed treatment, and the fact
that residues in/on soybean seeds were detectable in only one soybean
seed sample (0.016 ppm) at 21 days following the foliar applications,
HED concludes that the proposed seed treatment is unlikely to result in
quantifiable residues in/on seeds at maturity.

Although additional field trial data are being required from Valent, the
available field trial data will support tolerances of clothianidin at
3.0 ppm on leafy vegetables, 1.9 ppm on Brassica vegetables, 0.2 ppm on
fruiting vegetables, undelinted cottonseed, and pomegranates, 0.06 ppm
on cucurbit vegetables, 0.05 ppm on figs, 0.01 ppm on tree nuts and
pistachios, 1.5 ppm on almond hulls, 4.5 ppm on cotton gin byproducts,
and 0.02 ppm on soybean seed.  (Note: although TMG residue data will be
used for risk assessment, the tolerance for primary crop uses will
continue to include only the parent compound for enforcement purposes)

The submitted residue data for TMG in/on leafy and Brassica vegetables
and cotton gin byproducts are adequate, and the ratio of clothianidin
residues to TMG residues was relatively consistent for a given crop.
Considering only samples having quantifiable residues of both analytes,
residues of clothianidin were 6x-23x higher than TMG residues in leafy
vegetable crops, with clothianidin residues averaging 17x higher in
celery and ~12x higher in head and leaf lettuce and spinach.  For
Brassica vegetables, clothianidin and TMG residues could not be compared
in cauliflower and cabbage as TMG residues were <LOQ in all but one
cabbage sample.  However, in mustard greens, clothianidin residues were
1.2-9.9x higher than the associated TMG residues, and averaged 4x
higher.  For cotton gin trash, residues of clothianidin were 8-22x
higher than the associated TMG residues, and averaged 15x higher.

The field trial data submitted by IR-4 supporting the use of
clothianidin (WDG) on peaches and low-growing berries (except
strawberry) are also adequate, although the peach field trials used an
exaggerated single application rate (2x).  An adequate number of tests
were conducted on peaches and cranberries using the WDG formulation in
the appropriate geographic regions at ~1x the proposed maximum seasonal
rate.  The appropriate commodities were collected from each test at the
proposed PHIs.  Samples from all the field trials were analyzed using an
adequate LC/MS/MS method, and the analyses are supported by the
available storage stability data.  Although no field trial data were
submitted supporting the use of the FlC formulation on berries, the
available residue data for the WDG formulation will be translated to
support the FlC formulation as the proposed PHI for the foliar
applications is 21 days for these crops.  However, bridging data are
required for use of the FlC product on peaches.

The available peach and cranberry field trial data support the proposed
tolerances of 0.70 ppm for peaches and 0.01 ppm for low-growing berries,
except strawberry (Subgroup 13-07H).

860.1520 Processed Food and Feed

47471607.de2.doc (Cotton)

47471613.de2.doc (Soybean)

47471616.de2.doc (Tomato)

In support of the proposed uses on cotton, soybeans and fruiting
vegetables, Valent has submitted processing studies on cotton, soybeans
and tomatoes.  The results of these studies are discussed below, and the
observed processing factors for the various processed commodities are
listed in Table 7.

Cotton.  In a field trial conducted in AR during 2006, clothianidin (50%
WDG) was applied to cotton as two broadcast foliar applications during
boll development at 0.496 and 0.505 lb ai/A with a 8-day RTI, for a
total rate of 1.0 lb ai/A (5x rate).  Applications were made using
ground equipment in volumes of 10 gal/A, and no adjuvants were used.
The cotton was harvested using a mechanical picker at maturity, 21 DAT,
and single control and treated bulk samples of undelinted cottonseed
were collected following ginning.  The cottonseeds were then processed
into hulls, meal, and refined oil using simulated commercial processing
procedures.  Samples of cottonseed, meal, hulls, and refined oil were
stored at <-20ºC for 91-112 days prior to analysis; these storage
conditions and durations are supported by the available storage
stability data.

Residues of clothianidin in/on cottonseed and its processed fractions
were determined using an adequate LC/MS/MS method (Morse Method #164,
modified).  The validated LOQ is 0.01 ppm for clothianidin in each
commodity; the LOD was not reported.

Following two foliar applications at a 5x rate, clothianidin residues
were 0.131 ppm in/on undelinted cottonseed.  After processing, average
clothianidin residues were 0.013 ppm in meal, 0.099 ppm in/on hulls, and
<0.01 ppm in refined oil.  The data indicate that residues of
clothianidin were reduced in cottonseed hulls (0.76x), meal (0.10x), and
refined oil (<0.08x).  The theoretical processing factors for cottonseed
are 2.2x for meal, 3.8x for hulls, and 6.3x for refined oil.

Soybean.  In a field trial conducted in AR during 2007, clothianidin
(50% WDG) was applied to soybeans as two broadcast foliar sprays during
pod fill at 0.501 lb ai/A/application with a 7-day RTI, for a total rate
of 1.0 lb ai/A (5x rate).  Applications were made using ground equipment
in a volume of 20 gal/A, and no adjuvants were used.  Single control and
treated bulk samples of soybean seeds were harvested at maturity, 21
DAT.  Seeds were then processed into hulls, meal, and refined oil using
simulated commercial processing procedures.  Samples of soybean seed,
hulls, meal, and refined oil were stored at <-20ºC for 17-23 days prior
to analysis; these storage conditions and durations are supported by the
available storage stability data.

Residues of clothianidin in/on soybeans and its processed fractions were
determined using an adequate LC/MS/MS method (Morse Method #164,
modified).  The validated LOQ is 0.01 ppm for clothianidin in each
commodity; the LOD was not reported.

Following two foliar applications at 5x rates, clothianidin residues
were <0.01 ppm (<LOQ) in/on the soybean seed sample used for processing.
 After processing, clothianidin residues were <0.01 ppm in/on two
samples each of meal and oil, and <0.01 and 0.015 ppm in/on two samples
of hulls.  Although soybean aspirated grain fractions (AGF) were
generated during the processing study, samples of AGF were not collected
and analyzed.  Processing factors for clothianidin in soybean matrices
could not be calculated as residues were <LOQ in/on seed; however, there
did appear to be a slight concentration in soybeans hulls (1.3x), but
not in meal or refined oil (<1x).  The theoretical concentration factors
are 11.3x for hulls, 2.2x for meal and 12.0x for refined oil.

Tomato.  In a field trial conducted in NY during 2007, clothianidin (50%
WDG) was applied to tomatoes during fruit development as two broadcast
foliar applications at 0.502 and 0.505 lb ai/A with a 7-day RTI, for a
total rate of 1.01 lb ai/A (5x rate).  Applications were made using
ground equipment in a volume of 30 gal/A, and no adjuvants were used.
Control and treated bulk samples of tomato fruits were harvested at 7
DAT, and were processed into paste and puree using simulated commercial
processing procedures.  Samples of tomato fruit, paste and puree were
stored at ≤-20°C for up to 56 days prior to extraction for analysis;
these storage conditions and durations are supported by the available
storage stability data.

Residues of clothianidin in/on tomato and its processed fractions were
determined using an adequate LC/MS/MS method (Morse Method #164,
modified).  The validated LOQ is 0.01 ppm for clothianidin in each
commodity; the LOD was not reported.

Clothianidin residues averaged 0.026 ppm in/on whole fruit, 0.031 ppm in
paste and 0.020 ppm in puree, for processing factors of 1.2x for paste
and 0.8x for puree.  The theoretical concentration factors are 5.5x for
tomato paste and 1.4x for tomato puree.

  SEQ CHAPTER \h \r 1 Table 7.	Summary of Processing Factors for
Clothianidin.

RAC	Processed Commodity	Processing Factor

Cotton	Hulls	0.76x

	Meal	0.10x

	Refined Oil	<0.08x

Soybean	Hulls	NC 1

	Meal 	NC

	Refined oil	NC

Tomato	Tomato Paste	1.2x

	Tomato Puree	0.8x

1	NC = not calculated; residues were <LOQ in the soybean RAC following
applications totaling a 5x rate.

Conclusions.  The submitted cotton, soybean and tomato processing
studies are adequate.  As processing reduced clothianidin residues in
cotton hulls, meal and refined oil, and in tomato puree, separate
tolerances are not required for these commodities.  A separate tolerance
is also not required for tomato paste, although residues were shown to
concentrate slightly (1.2x).  Based the 1.2x processing factor for
tomato paste and the HAFT residue of 0.036 ppm for tomatoes treated at a
1x rate, the maximum expected residues in paste (0.043 ppm) are well
below the recommended tolerance for fruiting vegetables (0.2 ppm).

pm) in/on seeds, meal, and refined oil, and ≤0.015 ppm in hulls
following applications at a 5x exaggerated rate.  Therefore, separate
tolerances are not required for any soybean processed commodities.  In
addition, given the low levels of residues detected in soybean hulls
(≤0.015 ppm), quantifiable residues of clothianidin are also unlikely
to occur in soybean AGF following a 1x application.  Therefore, a
tolerance for grain AGF is also not required at the current time.

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

An analytical standard for clothianidin, with an expiration date of
12/14/2013, is currently available in the EPA National Pesticide
Standards Repository (personal communication with Dallas Wright, ACB,
9/15/08).

860.1850 Confined Accumulation in Rotational Crops

DP# D282446, Y. Donovan, 5/1/03

An adequate confined rotational crop study is available and was reviewed
in conjunction with the petition for use on canola and corn (DP#
D282446).  Rotational crops of turnips, Swiss chard, and wheat were
planted approximately 1, 5, and 10 months following a single soil
application of [14C]-clothianidin at the rate of 0.293 lb ai/A (1.5x
rate) and samples of the appropriate RACs were harvested at maturity.
The metabolism of clothianidin in rotational crops was similar to the
primary crops and the MARC concluded that parent, TZNG and MNG are the
residues of concern in rotational crops and that only parent needs to be
included in the tolerance expression.  The clothianidin risk assessment
team concurs with these findings.

  SEQ CHAPTER \h \r 1 860.1900 Field Accumulation in Rotational Crops

DP# D282446, Y. Donovan, 5/1/03

Adequate limited field rotational crop studies are available and were
reviewed in conjunction with the petition for seed treatment uses on
canola and corn (DP# D282446).  In these studies, 10-11 trials were
conducted in which mustard greens, turnips, and wheat were planted 1, 4,
8, and 12 months following a single seed treatment to corn at rates
equivalent to 0.144 to 0.171 lb ai/A).  Although the rates used in these
field rotational crop studies are slightly below (0.7x-0.9x rate) the
maximum seasonal rate being proposed by Valent on field and vegetable
crops (0.2 lb ai/A), the existing data are acceptable for supporting the
proposed field and vegetable crop uses.

Based on the residue data from the field rotational crop field trails,
tolerances were established for clothianidin residues at 0.02 ppm in/on
non-grass animal feeds (Group 18), the forage, fodder and straw of
cereal grains (Group 16), grass forage, fodder and hay (Group 17), and
soybean forage and hay.  These tolerances and the available rotational
crop residue data support rotational crop restrictions of 30 days for
the above crop/crop groups and a 1-year restriction for any other crops
without registered clothianidin uses.

The proposed labels for the 50% WDG and the 2.13 lb/gal FlC do not
contain any rotational crop restrictions.  Therefore, the use directions
for both labels must be amended to include rotational crop restrictions.
 The available residue data will support immediate replanting of the
following crops following the last application of clothianidin:  corn,
sorghum, rapeseed, canola, sugar beets and all crops listed on the
label, except soybeans.  Other cereal grains, soybeans, dried beans and
peas may be replanted 30 days following the last application, and all
other crops not listed on the label may be replanted 1 year after
application.

860.1550 Proposed Tolerances

For purposes of setting tolerances, the Agency has determined that only
clothianidin needs to be included in the tolerance expression for both
primary and rotational crops and for animal commodities.  The submitted
data for the metabolite TMG will not be included in the tolerance
expression, but will be used for risk assessment.

Permanent tolerances are established for residues of clothianidin in/on
a variety of plant commodities at levels ranging from 0.01 ppm in/on a
number of plant commodities to 1.0 ppm in/on pome fruits [40 CFR
§180.586(a)].  Tolerances for clothianidin have also been established
in milk at 0.01 ppm.  Time-limited tolerances have been established at
0.02 ppm in/on sugar beet roots and tops [40 CFR §180.586(b)]; these
tolerances are set to expire on 12/31/09.  In addition, tolerances for
indirect or inadvertent residues have been established for clothianidin
at 0.02 ppm in/on non-grass animal feeds, the forage, fodder and straw
of cereal grains, grass forage, fodder and hay, and soybean forage and
hay [40 CFR §180.586(d)].  The proposed and recommended tolerances for
this petition are listed in Table 8.

The recommended tolerances for the leafy, Brassica, cucurbit and
fruiting vegetable crop groups, peaches, figs, pomegranates, almonds
hull, and cotton seed and gin trash were determined using the Agency’s
SOP “Guidelines for Setting Pesticide Tolerances Based on Field Trial
Data” and the tolerance harmonization spreadsheet (Appendix I).
Calculating possible tolerances for each of the representative crops
separately, the recommended crop group tolerances are 3.0 ppm for leafy
vegetables, 1.9 ppm for Brassica vegetables, 0.2 ppm for fruiting
vegetables, and 0.06 ppm for cucurbit vegetables.  For the individual
crops, the calculated tolerances are 0.70 ppm for peaches, 0.20 ppm of
pomegranates, 0.05 ppm for figs, 1.5 ppm for almond hulls, 0.2 ppm for
cottonseed, and 4.5 ppm for gin trash.

The tolerance spreadsheet could not be used to calculate possible
tolerances for the tree nuts crop group, the low-growing berry subgroup,
or soybean seeds due to the large number of samples from these crops
with residue values <LOQ.  For tree nuts, clothianidin residues were
<LOQ in/on all samples of pecan nutmeats and were <LOQ in/on all but one
sample of almond nutmeats (0.01 ppm).  For the low-growing berries
(subgroup13-07H), clothianidin residues were <LOQ in/on 6 out of the 10
samples of cranberries following foliar applications.  For soybean
seeds, residues were <LOQ in/on all but one sample (0.016 ppm).
Therefore, the tolerances for these crop groups/commodities are based on
the maximum observed residues.  The recommended tolerances are 0.01 ppm
for tree nuts (Group 14) and low-growing berries, except strawberry
(Subgroup 13-07H), and 0.02 ppm for soybean seed.  As the proposed use
on tree nuts includes pistachios, a separate tolerance of 0.01 ppm
should also be established on pistachio, as this crop has not yet been
officially included in the tree nuts group.

For the proposed tolerance on tuberous and corm vegetables (Subgroup
1C), the existing residue data and tolerance (0.05 ppm) on potatoes will
support the proposed tolerance, as potato is the representative crop for
this subgroup.  Canada has recently established MRLs for potato
commodities.  For harmonization purposes, the tolerances being
recommended by HED are in accord with the Canadian MRLs.  Once the
tolerance is established for the tuberous and corm vegetable Subgroup
1C, the existing tolerance on potato can be deleted.

Based on the adequate cotton and tomato processing studies, clothianidin
residues were either reduced or concentrated only slightly (1.2x in
tomato paste) in cotton and tomato processed commodities.  Considering
the observed processing factors and the HAFT residues in/on cottonseed
and tomatoes, separate tolerances are not required for tomato and cotton
processed commodities.  In the soybean processing study, clothianidin
residues were <LOQ in/on soybean seed following an application at 5x,
and were <LOQ in the associated meal and oil fractions and ≤0.015 ppm
in hulls.  These data indicate that quantifiable residues of
clothianidin are unlikely to occur in soybean meal, hulls, and refined
oil following applications at the 1x rate; therefore separate tolerances
are also not required for any soybean processed fractions.  In addition,
the residue data on soybean hulls indicate that quantifiable residues of
clothianidin are also unlikely to occur in soybean AGF following a 1x
application; therefore, a tolerance on grain AGF is not required at the
present time.

As the proposed uses will not increase the dietary exposure of livestock
to clothianidin residues, the current 0.01 ppm tolerance for milk is
adequate and tolerances are not required for eggs or fat, meat, and meat
byproducts of cattle, goats, hogs, horses, sheep and poultry.

Except for potatoes and peach/stone fruit there are currently no
established or proposed Codex, Canadian, or Mexican maximum residue
limits (MRLs) for clothianidin on the requested crops/crop groups.  For
potato and peach/stone fruit commodities, HED’s recommended tolerances
are in accord with established/recommended Canadian MRLs.    Therefore,
harmonization with international MRLs is not an issue with this
petition.  An International Residue Limit Status Sheet is attached.

Table 8. 	Tolerance Summary for Clothianidin

Commodity	Proposed/Existing

Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;

Correct Commodity Definition

Leafy vegetables, Crop Group 4	3.5	3.0	Adequate data from the foliar
application use are available on lettuce (head and leaf), celery and
spinach.

Vegetable, leafy, except Brassica, Group 4

Brassica (Cole) vegetables, Crop Group 5	3.0	1.9	Adequate data from the
foliar application use are available on cabbage, cauliflower and mustard
greens.

Vegetable, Brassica, leafy, Group 4

Fruiting vegetables, Crop Group 8	0.25	0.20	Adequate data from the
foliar application use are available on tomatoes and peppers (Bell and
non-Bell).

Vegetable, fruiting, Group 8

Cucurbits vegetables, Crop Group 9	0.05	0.06	Adequate data from the
foliar application use are available on cucumbers, cantaloupes and
summer squash.

Vegetable, cucurbits, Group 9

Crop Sub-Group 13-07H	0.01	0.01	Adequate data are available on
cranberries.

Berry, low-growing, except strawberry, Subgroup 13-07H

Tree nuts, Crop Group 14	0.01	0.01	Adequate data are available on
almonds and pecans.  Nut, tree, Group 14.

A separate tolerance is also required for Pistachio.

Pistachio	None	0.01

	Almond, hulls	1.5	1.5	Adequate data are available on almonds.

Fig	0.05	0.05	Adequate data are available on figs.

Pomegranate	0.20	0.20	Adequate data are available on pomegranates.

Peach	0.70	0.80	Adequate data are available on peaches.  0.8 ppm is
being recommended for harmonization purposes.

Cotton, seed	0.25	0.20	Adequate data are available on cotton.

Cotton, undelinted seed

Cotton, gin byproducts

Cotton, gin byproducts	4.5	4.5

	Cotton, meal	0.25	None	Adequate cotton seed processing data are
available.  As residues were reduced in meal, hulls and oil, separate
tolerances are not required.

Cotton, hulls	0.25	None

	Cotton, refined oil	0.01	None

	Soybean, seed	0.03	0.02	Adequate data are available

Soybean, hulls	0.35	None	Adequate soybean processing data are available
indicating that quantifiable residues are unlikely to occur in soybean
processed fractions

Soybean, meal	0.07	None

	Soybean, oil	0.01	None

	Tomato, paste	0.08	None	Adequate processing data are available on
tomato indicating that separate tolerances are not required for tomato
puree and paste.

Tomato, puree	0.07	None

	Vegetable, tuberous and corm, Subgroup 1C	0.05	0.3	Adequate residue
data are available on potatoes to support a subgroup tolerance on
tuberous and corm vegetables.

Once the subgroup tolerance is established the separate tolerance on
potatoes can be deleted.  The recommended tolerances are harmonized with
current and/or pending MRLs in Canada, and are based on seed piece
treatments.  That use produces the highest residue.

Potato	0.05	delete

	Potato, chips	None	0.6

	Potato, granules/flakes	None	1.5

References

DP Number:	D282446

Subject:	PP# 1F06315. TI-435 (Clothianidin) on Corn and Canola.  Summary
of Analytical Chemistry and Residue Data.

From:		Y. Donovan

To:		D. Kenny/M. Laws

Dated:		5/01/03

MRID(s):	45422527-35, 45422305-06, and 45422610-19

DP Numbers:	 D303164, D309473, D309474, D312449, D314533, and D318496

Subject:	Clothianidin.  Tolerance Petition Requesting Food Use of the
Insecticide Clothianidin on Grapes, Potatoes, Sorghum, and Cotton
(Section 3 Registration).  Summary of Analytical Chemistry and Residue
Data.

From:		W. Drew

To:		K. Davis/D. Kenny

Dated:		2/1/06

MRID(s):	46346801, 46346802, 46357301, 46357302, 46144901, 46144901,
46482308, 46482309

DP Number:	D35355

Subject:	Clothianidin.  Tolerance Petition Requesting the Establishment
of Permanent Tolerances (Associated with Section 3 Registration) for
Food/Feed Use of the Insecticide as a Seed Treatment on Sugar Beets.
Resolution of Rotational Crop Data Deficiency.  Summary of Analytical
Chemistry and Residue Data.

From:		W. Drew

To:		K. Davis/V. Eagle

Dated:		10/16/2007

MRID(s):	47007809, 47007810, 46826901

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Tolerance Assessment Calculations

Template Version April 2008

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:
(E)-N-[(2-Chloro-5-thiazolyl)methyl]-N’-methyl-N”-nitroguanidine
Common Name: Clothianidin	X Proposed tolerances

 Reevaluated tolerance

 Other	Date: 2/16/09

Codex Status (Maximum Residue Limits)	U. S. Tolerances

X No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested 	Petition
Numbers: 8F7395, 8E7460,  and 9F7530

DP Numbers: 355896, 360842, and 362499

Other Identifier: PC Code 044309

Residue definition (step 8/CXL):  NA	Reviewer/Branch: M. Doherty

	Residue definition: Clothianidin

Crop (s)1	MRL (mg/kg)	Crop(s) 	Recommended Tolerance (ppm)

Vegetable, leafy, except Brassica, Group 4	3.0

Vegetable, Brassica, leafy, Group 5	1.9

Vegetable, fruiting, Group 8	0.2

Vegetable, cucurbits, Group 9	0.06

Fig	0.05

Nut, tree nuts, Group 14	0.01

Pistachio	0.01

Pomegranate	0.20

Almond, hulls	1.5

Cotton, undelinted seed	0.20

Cotton, gin byproducts	4.5

Soybean, seed	0.02

Peach	0.80

Berry, low-growing, except strawberry, Subgroup 13-07H	0.01

	Limits for Canada	Limits for Mexico

( No Limits

X No Limits for the crops requested	X  No Limits

(   No Limits for the crops requested

Residue definition: Clothianidin	Residue definition:  NA

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

  SEQ CHAPTER \h \r 1 Field corn grain	0.01

Popcorn grain	0.01

Rapeseed (canola)	0.01

Sweet corn kernel plus cob with husk removed	0.01

Milk	0.01

	Notes/Special Instructions:  Potato commodities were recently given
MRLs by Canada, as follows:  Tubers (0.3 ppm), chips (0.6 ppm), and
granules/flakes (1.5 ppm).  PMRA (Canada) is currently reviewing a
petition to establish tolerances on stone fruit, which includes peaches.

Appendix I.  Tolerance Assessment Calculations.

sets that were small (≤15 samples) and 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.  For datasets that were not lognormal,
the upper bound on the 89th percentile was selected as the tolerance
value (distribution-free method).  The rounding procedures specified in
the SOP were also used.

Leafy Vegetables, Crop Group 4

The datasets used to establish a tolerance for clothianidin on the leafy
vegetables crop group consisted of field trial data for celery, leaf
lettuce, head lettuce, and spinach (the representative crops of leafy
vegetables), representing foliar application rates of 0.2 lb ai/A/season
(2 applications at 0.1 lb ai/A/application) with a 7-day PHI.  As
specified by the SOP, 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 I-1.

All field trial sample results for head lettuce, leaf lettuce, and
spinach were above the LOQ (0.01 ppm), and all but one of the celery
sample results were above the LOQ.  The celery, leaf lettuce, head
lettuce, and spinach datasets were small (12 samples each).  The dataset
for each crop was entered into the tolerance spreadsheet.  Visual
inspection of the lognormal probability plots for celery, leaf lettuce,
head lettuce, and spinach (Figures I-1, I-3, I-5, and I-7 respectively)
provided in the spreadsheet indicated that the leaf lettuce, head
lettuce, and spinach datasets were reasonably lognormal, but that the
celery dataset was not.  The results from the approximate
Shapiro-Francia test statistic (Figures I-2, I-4, I-6, and I-8)
confirmed that the assumption of lognormality should not be rejected for
leaf lettuce, head lettuce, and spinach, but should be rejected for
celery.

Using the tolerance spreadsheet, the recommended tolerances are 1.6 ppm
for both celery and head lettuce, 2.0 ppm for leaf lettuce, and 3.0 ppm
for spinach.  Because the minimum and maximum recommended tolerances
differ by less than 5x, a crop group tolerance is appropriate for leafy
vegetables.  The recommended value is 3.0 ppm, the maximum of the
recommended individual tolerances.

Table I-1.	Residue data used to calculate tolerance for Clothianidin on
Leafy Vegetables.

Regulator:	EPA	EPA	EPA	EPA

Chemical:	Clothianidin	Clothianidin	Clothianidin	Clothianidin

Crop:	Celery	Head Lettuce	Leaf Lettuce	Spinach

PHI:	7 days 	7 days 	7 days 	6-7 days

App. Rate:	 0.198-0.206 lb ai/A	0.197-0.204 lb ai/A	0.198-0.202 lb ai/A
0.193-0.204 lb ai/A

Submitter:	Valent	Valent	Valent	Valent

MRID Citation:	MRID 47471606	MRID 47471609	MRID 47471610	MRID 47471614

	Residues of Clothianidin (ppm)

	0.023	0.010	0.195	0.077

	0.030	0.014	0.232	0.082

	0.036	0.056	0.269	0.152

	0.050	0.110	0.275	0.158

	0.362	0.133	0.286	0.288

	0.433	0.197	0.341	0.31

	0.437	0.303	0.615	0.631

	0.558	0.423	0.643	0.651

	0.778	0.431	0.717	0.886

	0.879	0.465	0.731	0.936

	0.907	0.559	0.986	1.65

	0.941	0.589	1.210	1.81

1	Residue values <LOQ (0.01 ppm) are listed in bold.

Figure I-1.  Lognormal probability plot of Clothianidin field trial
data for Celery.

Figure I-2.   Tolerance spreadsheet summary of Clothianidin field trial
data for Celery.

Figure I-3.  Lognormal probability plot of Clothianidin field trial data
for Head Lettuce.

Figure I-4.   Tolerance spreadsheet summary of Clothianidin field trial
data for Head Lettuce.

Figure I-5.  Lognormal probability plot of Clothianidin field trial data
for Leaf Lettuce.

Figure I-6.   Tolerance spreadsheet summary of Clothianidin field trial
data for Leaf Lettuce.

Figure I-7.  Lognormal probability plot of Clothianidin field trial data
for Spinach.

Figure I-8.   Tolerance spreadsheet summary of Clothianidin field trial
data for Spinach.

Brassica Leafy Vegetables, Crop Group 5

The datasets used to establish a tolerance for clothianidin on the
Brassica vegetables crop group consisted of field trial data on cabbage,
cauliflower and mustard greens (the representative crops for Brassica
vegetables), representing seasonal foliar application rates of 0.2 lb
ai/A (2 applications at 0.1 lb ai/A/application) with a 7-day PHI.  As
specified by the SOP, 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 I-2.

All field trial sample results for cabbage, cauliflower and mustard
greens were above the LOQ (0.01 ppm).  The cabbage, cauliflower and
mustard greens datasets were small (10-12 samples each).  The dataset