commercial maturity, 72-94 days after treatment in the soil application
tests and 3 days after treatment in the foliar application tests.  At
two sites, additional samples from the foliar application tests were
collected at 7 and 10 days after treatment to examine residue decline.
Duplicate control and treated blueberry fruit samples were collected
from each test at each interval.

The HPLC/MS/MS method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on blueberry fruit was adequately
validated in conjunction with the sample analyses.  The LLMV for
residues of thiamethoxam and CGA-322704 was 0.01 ppm in/on blueberry
fruit.  Sample storage durations and conditions are reported in Table 5;
the storage conditions and durations are supported by adequate storage
stability data.

Following the single, banded soil application of the 2 lb/gal FlC
formulation at ~0.198 lb ai/A, residues of thiamethoxam and CGA-322704
were each <0.01 ppm (<LOQ) for combined residues of <0.02 ppm in/on 14
blueberry fruit samples harvested at 72-94 days after treatment.

Following the last of three foliar applications during fruit development
of the 25% WG formulation totaling ~0.197 lb ai/A, thiamethoxam residues
were <0.01-0.11 ppm and CGA-322704 residues were <0.01-0.05 ppm, for
combined residues of 0.02-0.12 ppm in/on 18 blueberry fruit samples
harvested at 3 days after treatment.

In the two decline tests, average combined residues were 0.08 and 0.09
ppm in samples collected 3 days after treatment and declined slightly to
0.03 and 0.06 ppm in samples collected 10 days after treatment.

Table 18.	Summary of Residue Data from Subgroup 13B Crop Field Trials
with Thiamethoxam.

Commodity	EP 1	Application Type	Total Rate

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

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

BUSHBERRY, JUNEBERRY, LINGONBERRY, SALAL (proposed use = 0.188 lb ai/A
total application rate, with a 3-day PHI for foliar application or a
75-day PHI for soil application)

Thiamethoxam Residues

Blueberry, fruit	25% WG	foliar during fruit development	0.196-0.204	3	18
<0.01	0.11	0.11	0.06	0.06	0.03

	2 lb/gal FlC	early-season soil application	0.187-0.218	72-94	14	<0.01
<0.01	<0.01	0.005	0.005	NA

CGA-322704 Residues

Blueberry, fruit	25% WG	foliar during fruit development	0.196-0.204	3	18
<0.01	0.05	0.05	0.01	0.01	0.01

	2 lb/gal FlC	early-season soil application	0.187-0.218	72-94	14	<0.01
<0.01	<0.01	0.005	0.005	NA

Combined Residues

Blueberry, fruit	25% WG	foliar during fruit development	0.196-0.204	3	18
<0.02	0.12	0.12	0.08	0.08	0.03

	2 lb/gal FlC	early-season soil application	0.187-0.218	72-94	14	<0.02
<0.02	<0.02	0.01	0.01	NA

1  EP = End-use product.

2  The LLMV was 0.01 ppm for each analyte.  In the calculation of the
median, mean, and standard deviation, 0.005 ppm (½LLMV) was used for
residues reported as <LOQ.  NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted blueberry crop field trial data are adequate
to satisfy data requirements for the bushberry crop subgroup.  The
petitioner has proposed to increase the maximum seasonal rate for use of
the 2 lb/gal FlC and 25% WG formulations on bushberry.  The available
data will support: a single banded soil application during the early
budding stage at 0.188 lb ai/A (1x the proposed maximum seasonal rate)
with a 75-day PHI; or three broadcast foliar applications of the 25% WG
formulation at 0.064 lb ai/A/application, for a total rate of 0.188 lb
ai/A (1x the proposed maximum seasonal rate), with a 7-day RTI and a
3-day PHI.

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for bushberry subgroup 13B.  The available
field trial data support the established tolerance for combined residues
of thiamethoxam and CGA-322704, expressed as thiamethoxam equivalents,
in/on bushberry, subgroup 13B, at 0.20 ppm.  HED has concluded
previously that crop field trial data for the bushberry subgroup may be
translated to support uses on juneberry, lingonberry, and salal; the
available bushberry data support the established 0.20-ppm tolerances for
the combined residues of thiamethoxam and CGA-322704 in/on juneberry,
lingonberry, and salal.

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on bushberries; HED has concluded (see 860.1200 –
Directions for Use) that sufficient bridging crop field trial data have
been submitted to allow translation of data for the 25% WG formulation
to support foliar uses of the 2 lb/gal FlC formulation.

Cranberry

DER Reference:	46114701.der.doc

IR-4 has submitted magnitude of the residue studies for cranberry.  The
results from these field trials are discussed below and summarized in
Table 19.

Six cranberry field trials were conducted during 2000 in Zones 1 (MA; 1
trial), 2 (NJ; 1 trial), 5 (WI; 2 trials), and 12 (OR; 2 trials).  A 25%
WG formulation of thiamethoxam was applied as three broadcast foliar
applications at 0.060-0.067 lb ai/A/application, for a total rate of
0.184-0.200 lb ai/A/season (~1x the proposed maximum seasonal rate).
Applications were made during the fruiting stage at RTIs of 6-7 days.
Cranberry fruit were harvested at commercial maturity 28-30 days after
the last treatment and duplicate control and treated cranberry fruit
samples were collected from each test.

The HPLC/MS/MS method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on cranberry fruit was adequately
validated in conjunction with the sample analyses.  The validated LOQ
was 0.01 ppm for thiamethoxam and its CGA-322704 in/on cranberry fruit;
the limit of detection (LOD) was 0.005 ppm for each analyte.  Sample
storage durations and conditions are reported in Table 5; the storage
conditions and durations are supported by adequate storage stability
data.

Following the last of three foliar applications of the 25% WG
formulation totaling ~0.197 lb ai/A, residues of thiamethoxam and
CGA-322704 were each <0.01 ppm (<LOQ) for combined residues of <0.02 ppm
in/on all cranberry fruit samples harvested at 28-30 days after
treatment.

Table 19.	Summary of Residue Data from Cranberry Crop Field Trials with
Thiamethoxam.

Commodity	EP 1	Total Rate

(lb ai/A) 	PHI

(days)	Residue Levels (ppm)2

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

CRANBERRY (proposed use = 0.188 lb ai/A total application rate with a
30-day PHI)

Thiamethoxam Residues

Cranberry, fruit	25% WG	0.184-0.200	28-30	12	<0.01	<0.01	<0.01	0.005
0.005	NA

CGA-322704 Residues

Cranberry, fruit	25% WG	0.184-0.200	28-30	12	<0.01	<0.01	<0.01	0.005
0.005	NA

Combined Residues

Cranberry, fruit	25% WG	0.184-0.200	28-30	12	<0.02	<0.02	<0.02	0.01	0.01
NA

1  EP = End-use product.

2  The LOQ was 0.01 ppm for each analyte.  In the calculation of the
median, mean, and standard deviation, 0.005 ppm (½LOQ) was used for
residues reported as <LOQ.  NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted cranberry crop field trial data are adequate
to satisfy data requirements.  The petitioner has proposed to increase
the maximum seasonal rate for use of the 25% WG formulation on
cranberry.  The available data will support three broadcast foliar
applications of the 25% WG formulation at 0.063 lb ai/A/application, for
a total rate of 0.188 lb ai/A (1x the proposed maximum seasonal rate),
with a 7-day RTI and a 30-day PHI.

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for cranberries.  The available field trial
data support the established tolerance for combined residues of
thiamethoxam and CGA-322704, expressed as thiamethoxam equivalents,
in/on cranberry at 0.02 ppm.

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on cranberries; HED has concluded (see 860.1200 –
Directions for Use) that sufficient bridging crop field trial data have
been submitted to allow translation of data for the 25% WG formulation
to support foliar uses of the 2 lb/gal FlC formulation.

Grape

DER Reference:	45093705.der.doc

Syngenta has submitted magnitude of the residue studies for grape.  The
results from these field trials are discussed below and summarized in
Table 20.

Twelve grape field trials were conducted in Zones 1 (NY and PA; 2
trials), 10 (CA; 8 trials), 11 (WA; 1 trial), and 12 (OR; 1 trial)
during the 1999 growing season.

At each field site, applications were made using three different
treatment regimes, as follows:

Treatment 2:  a single drench application of the 2 lb/gal FlC
formulation at 0.262 lb ai/A, directed to the base of the plant (1x the
proposed maximum rate for soil applications);

Treatment 5:  a single drench application of the 2 lb/gal FlC
formulation at 0.218 lb ai/A (0.8x) directed to the base of the plant
followed, 51-59 days later, by a single postemergence foliar broadcast
application of the 25% WG formulation at 0.045 lb ai/A (0.8x the maximum
single foliar application rate), for a total rate of 0.262 lb ai/A; and

Treatment 8:  two postemergence foliar broadcast applications, with a
13- to 15-day RTI, of the 25% WG formulation at 0.055 lb ai/A, for a
total rate of 0.11 lb ai/A (1x the proposed maximum rate for foliar
applications).

Additional, exaggerated-rate treatment regimes (Treatements 4, 7, and
10) were utilized to provide samples for a grape processing study.

Applications were made using ground equipment in 496-670 gal/A for
directed drench treatments and 40-178 gal/A for foliar treatments.  No
adjuvant was used for any of the applications.  For samples receiving
drench treatment only (Treatments 2 and 4), samples of grapes were
harvested 56-64 days after application.  For samples receiving foliar
applications (Treatment 5, 7, 8, and 10), mature samples of grapes were
harvested 5-6 days after the last foliar application.  At two trial
locations (CA and NY), grapes were collected at additional sampling
durations to evaluate residue decline:  grapes were collected 0, 39, 46,
53, and 65/66 days following drench application at 0.262 lb ai/A
(Treatment 2); and 0, 1, 3, and 12 days following the last foliar
application (Treatments 5 and 8).

The HPLC/MS/MS method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on grapes was adequately validated in
conjunction with the sample analyses.  The LOQ was 0.01 ppm for each
analyte.  Sample storage durations and conditions are reported in Table
5; the storage conditions and durations are supported by adequate
storage stability data.

Combined residues of thiamethoxam and CGA-322704 were below the combined
LOQ (<0.02 ppm) in/on all samples of grapes harvested 56-64 days
following a single directed drench application of the 2 lb/gal FlC
formulation at 0.262 lb ai/A (Treatment 2).  Individual residues of
thiamethoxam and CGA-322704 were <0.01 ppm and <0.01-0.01 ppm,
respectively, in/on these samples.

Maximum combined residues of thiamethoxam and CGA-322704 were <0.07 ppm
in/on grapes harvested 5-6 days following a single directed drench
application of the 2 lb/gal FlC formulation plus a single postemergence
foliar broadcast spray application of the 25% WG formulation at a total
rate of 0.262 lb ai/A (Treatment 5).   The maximum individual residues
of thiamethoxam and CGA-322704 were 0.06 ppm and <0.01 ppm,
respectively, in/on these samples.

Maximum combined residues of thiamethoxam and CGA-322704 were <0.13 ppm
in/on grapes harvested 5-6 days following two postemergence foliar
broadcast spray applications, with a 13- to 15-day RTI, of the 25% WG
formulation at a total rate of 0.110 lb ai/A (Treatment 8).  Maximum
individual residues of thiamethoxam and CGA-322704 were 0.12 ppm and
0.02 ppm, respectively, in/on these samples.

In the residue decline studies in which quantifiable residues were
observed, the decline data indicate no significant increase or decrease
in residues with increasing sampling durations.

Table 20.	Summary of Residue Data from Grape Crop Field Trials with
Thiamethoxam.

Commodity	Application Type1	Total Applic. Rate

(lb ai/A)	PHI

(days)	Residue Levels2

(ppm)

n	Min.	Max.	HAFT3	Median	Mean	Std. Dev.

GRAPE (proposed use = 0.266 lb ai/A total application rate for soil
surface application, with a 60-day PHI; or 0.109 lb ai/A total
application rate for foliar application, with a 5-day PHI)

Thiamethoxam Residues

Grape	Treatment 2	0.262	56-64	24	<0.01	<0.01	<0.01	0.005	0.005	NA

	Treatment 5	0.262	5-6	24	<0.01	0.06	0.05	0.02	0.02	0.02

	Treatment 8	0.110	5-6	24	<0.01	0.12	0.11	0.04	0.05	0.03

CGA-322704 Residues

Grape	Treatment 2	0.262	56-64	24	<0.01	0.01	<0.01	0.005	0.005	0.001

	Treatment 5	0.262	5-6	24	<0.01	<0.01	<0.01	0.005	0.005	NA

	Treatment 8	0.110	5-6	24	<0.01	0.02	<0.02	0.005	0.006	0.003

Combined Residues

Grape	Treatment 2	0.262	56-64	24	<0.02	<0.02	<0.02	0.01	0.01	0.001

	Treatment 5	0.262	5-6	24	<0.02	<0.07	<0.06	0.03	0.03	0.02

	Treatment 8	0.110	5-6	24	<0.02	<0.13	<0.12	0.05	0.06	0.03

1  The treatment regimes included the following:

Treatment 2 = Single directed drench application of the 2 lb/gal FlC
formulation at 0.262 lb ai/A

Treatment 5 = Single directed drench application of the 2 lb/gal FlC
formulation at 0.218 lb ai/A plus single foliar broadcast application of
the 25% WG formulation at 0.045 lb ai/A

Treatment 8 = Two foliar broadcast applications of the 25% WG
formulation at 0.055 lb ai/A/application

2  The LOQ was 0.01 ppm for each analyte.  In the calculation of the
median, mean, and standard deviation, 0.005 ppm (½LOQ) was used for
residues reported as <LOQ.  NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted grape crop field trial data are adequate to
support the proposed uses.  The available data will support:  a single
soil drench application of the 2 lb/gal FlC formulation at up to 0.266
lb ai/A with a 60-day PHI; or two broadcast foliar applications of the
25% WG formulation at 0.055 lb ai/A/application, for a total rate of
0.110 lb ai/A, with a 14-day RTI and a 5-day PHI.

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for grapes.  The available field trial data
will support a tolerance for combined residues of thiamethoxam and
CGA-322704, expressed as thiamethoxam equivalents, in/on grape at 0.20
ppm; the tolerance calculation for grapes is presented in Appendix II.

Strawberry

DER Reference:	46159201.der.doc

IR-4 has submitted magnitude of the residue studies for strawberry.  The
results from these field trials are discussed below and summarized in
Table 21.

Twenty-four tests were conducted during 2000-2001 on strawberries at 8
field sites examining three different treatment regimes.  In 8 tests
conducted in Zones 1 (NY; 1 test), 2 (NC; 1 test), 3 (Fl; 1 test), 5
(MI; 1 test), 10 (CA; 3 tests), and 12 (OR; 1 test), a 25% WG
formulation of thiamethoxam was applied as three broadcast foliar
applications to strawberry plants at 0.07 lb ai/A/application, for a
total rate of 0.21 lb ai/A/season (1.1x the proposed maximum rate for
foliar applications).  Applications were made during fruiting at RTIs of
8-12 days.  In an additional 16 tests at the same field sites (2 tests
per site), a 2 lb/gal FlC formulation of thiamethoxam was applied as a
single directed soil drench application at 0.20 lb ai/A (1.1x the
proposed maximum rate for soil applications) around the strawberry
plants at either 30 days (8 tests) or 50 days (8 tests) prior to normal
harvest.  For the foliar application tests, mature strawberry fruit were
harvested at four durations (0, 3, 7-8, and 9-11 days after treatment)
from 6 tests and at six durations (0, 3, 5, 7, 9-11, and 12 days after
treatment) from 2 tests.  In the soil drench tests, mature fruit were
harvested at either 29-32 days after treatment or 50-52 days after
treatment.  Four of the soil drench tests at two sites also examined
residue decline by collecting samples at approximately 10, 20, 30, and
40 days after treatment or 20, 30, 40, 50, and 60 days after treatment.
At each sampling interval, a single control and duplicate treated
strawberry fruit samples were collected in each test.

The HPLC/UV method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on strawberries was adequately validated
in conjunction with the sample analyses.  The LOQ for residues of
thiamethoxam and CGA-322704 was 0.01 ppm in/on strawberries for each
analyte.  Sample storage durations and conditions are reported in Table
5; the storage conditions and durations are supported by adequate
storage stability data.

Following the last of three foliar applications of the 25% WG
formulation totaling 0.21 lb ai/A,  residues of thiamethoxam were
0.03-0.36 ppm at 0 days after treatment, 0.01-0.26 ppm at 3 days after
treatment, 0.01-0.22 ppm at ~7 days after treatment, and <0.01-0.20 ppm
at ~10 days after treatment in/on 14-16 samples per interval.  At all
durations, residues of CGA-322704 were <0.01 ppm (<LOQ).  Combined
residues were 0.04-0.37 ppm at 0 days after treatment, 0.02-0.27 ppm at
3 days after treatment, 0.02-0.23 ppm at ~7 days after treatment, and
<0.02-0.21 ppm at ~10 days after treatment.

Following a single soil drench application of the 2 lb/gal FlC
formulation at 0.20 lb ai/A, residues of thiamethoxam were <0.01-0.11
ppm at 29-32 days after treatment and <0.01-0.05 ppm at 50-52 days after
treatment in/on 16 strawberry samples at each interval.  Residues of
CGA-322704 were <0.01 ppm (<LOQ) in/on all samples at each interval, and
combined residues were <0.02-0.12 ppm at ~30 days after treatment and
<0.02-0.06 ppm at ~50 days after treatment.

Residue decline studies from both types of application regimes showed
that residues of thiamethoxam in/on strawberries declined at longer
post-treatment durations.

Table 21.	Summary of Residue Data from Strawberry Crop Field Trials with
Thiamethoxam.

Commodity	EP 1	Total Rate

(lb ai/A) 	PHI

(days)	Residue Levels (ppm)2

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

STRAWBERRY (proposed use = 0.188 lb ai/A total application rate, with a
3-day PHI for foliar application or a 50-day PHI for soil application)

Thiamethoxam Residues

Strawberry, fruit	25% WG	0.21	3	16	0.01	0.26	0.26	0.05	0.09	0.08

	2 lb/gal FlC	0.20	50-52	16	<0.01	0.05	0.04	0.02	0.02	0.01

CGA-322704 Residues

Strawberry, fruit	25% WG	0.21	3	16	<0.01	<0.01	<0.01	0.005	0.005	NA

	2 lb/gal FlC	0.20	50-52	16	<0.01	<0.01	<0.01	0.005	0.005	NA

Combined Residues

Strawberry, fruit	25% WG	0.21	3	16	<0.02	<0.27	<0.27	0.06	0.10	0.08

	2 lb/gal FlC	0.20	50-52	16	<0.02	<0.06	<0.05	0.03	0.03	0.02

1  EP = End-use product.

2  The LOQ was 0.01 ppm for each analyte.  In the calculation of the
median, mean, and standard deviation, 0.005 ppm (½LOQ) was used for
residues reported as <LOQ.  NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted strawberry crop field trial data are
adequate to support the amended uses on strawberries, provided the
petitioner amends the recommended RTI for foliar applications.  The
petitioner has proposed to increase the maximum seasonal rate for use of
the 2 lb/gal FlC and 25% WG formulations on strawberry.  The available
data will support: a single banded soil application at 0.188 lb ai/A (1x
the proposed maximum seasonal rate) with a 50-day PHI; or three
broadcast foliar applications of the 25% WG formulation at 0.063 lb
ai/A/application, for a total rate of 0.188 lb ai/A (1x the proposed
maximum seasonal rate), with a 10-day RTI and a 3-day PHI.  The
petitioner should amend the RTI for foliar applications from 7 days to
10 days, the interval that is supported by the crop field trial data.

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for strawberry.  The available field trial data
support the established tolerance for combined residues of thiamethoxam
and CGA-322704, expressed as thiamethoxam equivalents, in/on strawberry
at 0.30 ppm.

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on strawberries; HED has concluded (see 860.1200 –
Directions for Use) that sufficient bridging crop field trial data have
been submitted to allow translation of data for the 25% WG formulation
to support foliar uses of the 2 lb/gal FlC formulation.

Pecan

See:    SEQ CHAPTER \h \r 1 Residue Chemistry Memo D286726, 12/23/03, Y.
Donovan (PP#s 3E6524, 2E6505, 1E6349, 2E6508)

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on pecan; no new crop field trial data for pecan were
submitted.  Adequate data are available to support use of the 40% WG
formulation on pecan (see DP Number D286726, 12/23/03, Y. Donovan).  HED
has concluded (see 860.1200 – Directions for Use) that sufficient
bridging crop field trial data have been submitted to allow translation
of data for the WG formulation to support foliar uses of the 2 lb/gal
FlC formulation.

Oilseed, group 20

Canola

DER Reference:	44829301.der.doc (Canola)

Syngenta has submitted an amendment to a previously submitted crop field
trial study for canola.  The original canola seed data (MRID 44703527)
were reviewed in conjunction with a petition on canola (PP#9F5046; DP
Number   SEQ CHAPTER \h \r 1 D252021, 3/30/00, G.J. Herndon).  The
Agency review concluded the following (conclusion 10b):

Based on achieving adequate recoveries on canola using the LC/MS method
(MRID# 447035-27), the petitioner has not adequately explained why the
majority of the canola field trial data were analyzed by a LC/MS/MS
method.  It appears that there may have been some interference problems
and, rather than modify or add clean-up steps to eliminate the
interference, the petitioner chose to eliminate 2 clean-up steps and use
a more selective detection system (LC/MS/MS using single ion
monitoring).  The LC/MS/MS [method] is the proposed enforcement method
for canola.  HED has reservations about proposing an enforcement method
which uses equipment most enforcement laboratories do not yet have
access to in lieu of better clean-up procedures.

In response, Syngenta has submitted additional residue data (MRID
44829301) from the reanalysis of canola seed samples using the HPLC
enforcement method, Method AG-675, with the full cleanup procedures.

In the original study, eight canola tests (one test per location) were
conducted between the 1997 and 1998 growing seasons in GA, ID, MN, MT,
ND, OR, SD, and WA.  Canola seed were treated using a ready-to-use (RTU)
formulation (CGA-293343 Combi FS-D) at a nominal rate of 0.5 lb/100 lb
(500 g ai/100 kg) of seed.  At the MN and ND test sites, two additional
tests were conducted in which canola seed were treated with the test
substance at 1.5 lb/100 lb (1500 g ai/100 kg) of seed.

In the original study, samples of canola seed were analyzed for residues
of thiamethoxam and CGA-322704 using a modification of HPLC Method
AG-675, the current tolerance enforcement method.  A different
extraction solvent (ACN/hexane) was used, two cleanup steps were
eliminated, and a more selective detection system (MS/MS using single
ion monitoring) was used.  The validated LOQ for each analyte in/on
canola seed was 0.01 ppm.  Samples were analyzed by Enviro-Test
Laboratories (Edmonton, Alberta, Canada).

In the current submission, samples of canola seed from the original
study were reanalyzed for residues of thiamethoxam and its metabolite
CGA-322704 using HPLC Method AG-675 with MS/MS detection; all extraction
and cleanup steps were followed as specified in the method.  Although
method recoveries from concurrent analysis of samples were marginal
(several recoveries were below the generally recognized acceptable range
of 70-120%), the range of recovery values was low; therefore, HED
concludes that the method is adequate for data collection.  The reported
LOQ for each analyte in/on canola seed was 0.01 ppm.  Samples were
reanalyzed by Novartis Human Safety Department (Greensboro, NC).

Sample storage durations and conditions are reported in Table 5; the
storage conditions and durations are supported by adequate storage
stability data.

Residues of thiamethoxam and its metabolite CGA-322704 were each below
the LOQ (<0.01 ppm) in/on all samples of canola seed grown from seed
treated with thiamethoxam at 0.5 lb ai/100 lb seed and harvested at
maturity, 87-190 days after planting; residues were also below the LOQ
in/on samples treated at 1.5 lb ai/100 lb of seed.  The data from the
reanalysis of canola seed using HPLC Method AG-675 with MS/MS detection
are consistent with the results from the original canola seed review.

Conclusions.  The submitted data are adequate and indicate that the
established tolerance of 0.02 ppm for canola seed is appropriate.

HED notes that the IR-4 has previously submitted adequate crop field
trial and processing data to support use of thiamethoxam as a seed
treatment for sunflower (DP Number D286726, 12/23/03, Y. Donovan).  HED
has recently established a new crop group for these commodities, the
oilseed crop group (group 20).  The members of the group are rapeseed,
seed; Indian rapeseed, seed; Indian mustard, seed: field mustard, seed;
black mustard, seed; flax, seed; sunflower, seed; safflower, seed; and
crambe, seed (see memo entitled “Reviewer's Guide and Summary of HED
ChemSAC Approvals for Amending Crop Group/Subgroups [40 CFR 180.411] and
Commodity Definitions [40 CFR 180.1 (h)]” from B. Schneider to B.
Madden dated 6/14/06).  Borage seed will also be added as a member if
Canada agrees to also add it to their Crop Group 20.  The representative
commodities are canola seed and sunflower seed.  Based on this new crop
group and the available crop field trial data for canola and sunflower,
tolerances were established, under PP#3E6806 in 2005 (see Federal
Register, Vol. 70, No. 3, 1/5/05, pages 708-720) for combined residues
of thiamethoxam and CGA-322704 at 0.02 ppm in/on the following
commodities:  borage, seed; crambe, seed; flax, seed; mustard, seed;
rapeseed, seed; and safflower, seed.

Miscellaneous commodities

Cotton

DER Reference:	45093707.der.doc

Syngenta   SEQ CHAPTER \h \r 1  has submitted field trial data for
thiamethoxam on cotton as a seed treatment.  The results from these
field trials are discussed below and summarized in Table 22.

Twelve cotton trials were conducted in Zones 2 (AL; 1 trial), 4 (AR, LA,
MS; 3 trials), 6 (TX; 1 trial), 8 (NM, OK, and TX; 4 trials), and 10 (AZ
and CA; 3 trials) during the 1996 growing season.  Since no quantifiable
residues resulted from the use of thiamethoxam as a seed treatment, the
number of field trials was reduced by 25 percent, and samples of cotton
seed from three field trials conducted in Zones 4 (LA), 8 (TX), and 10
(CA) were not analyzed.

A 70% wettable powder (WP) formulation (CGA-293343 70 WS) was applied to
cotton as a seed-treatment slurry at 0.3 lb ai/100 lb seed (300 g ai/100
kg of seed).  At two test sites (Fresno, CA and Tom Green, TX), two
additional tests were conducted to generate samples for processing;
cotton seed was treated with the test substance at an exaggerated rate
of 0.9 lb ai/100 lb of seed.  Treated cotton seeds were planted at the
field sites 9-94 days after treatment and samples of cotton seed were
harvested at maturity, 132-190 days after planting; samples of gin
byproducts were collected at six of the trials.  The treatment rates
correspond to ~1x and 3x (assuming 1 lb of cotton seeds contains 4,000
seeds).

The HPLC/MS method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on cotton commodities was adequately
validated in conjunction with the sample analyses.  The LOQ was 0.01 ppm
for each analyte.  Sample storage durations and conditions are reported
in Table 5; the storage conditions and durations are supported by
adequate storage stability data.

Residues of thiamethoxam and its metabolite CGA-322704 were below the
LOQ (<0.01 ppm each) in/on all samples of undelinted cotton seed and
cotton gin byproducts grown from seed treated with thiamethoxam at 0.3
lb ai/100 lb seed and harvested at maturity, 132-190 days after
planting.

In addition, residues of thiamethoxam and its metabolite CGA-322704 were
below the LOQ in/on all samples of undelinted cotton seed and gin
byproducts grown from seed treated with thiamethoxam at 0.9 lb/100 lb
seed and harvested at maturity, 163-189 days after planting.

Because the submitted data reflect seed treatment only, no residue
decline studies are required.

Table 22.	Summary of Residue Data from Cotton Crop Field Trials with
Thiamethoxam.

Matrix	Total Applic. Rate

(lb ai/100 lb seed)	PHI1

(days)	Residue Levels 2

(ppm)

	n	Min.	Max.	HAFT3	Median	Mean	Std. Dev.

COTTON (proposed/registered use = 0.34 mg/seed as a seed treatment;
0.125 lb ai/A total application rate for foliar application with 21-day
PHI)

Thiamethoxam Residues

Cotton, undelinted seed	0.3	132-190	18	<0.01	<0.01	<0.01	0.005	0.005	NA

	0.9	163-189	4	<0.01	<0.01	<0.01	0.005	0.005	NA

Cotton, gin byproducts	0.3	132-190	12	<0.01	<0.01	<0.01	0.005	0.005	NA

	0.9	163-189	4	<0.01	<0.01	<0.01	0.005	0.005	NA

CGA-322704 Residues

Cotton, undelinted seed	0.3	132-190	18	<0.01	<0.01	<0.01	0.005	0.005	NA

	0.9	163-189	4	<0.01	<0.01	<0.01	0.005	0.005	NA

Cotton, gin byproducts	0.3	132-190	12	<0.01	<0.01	<0.01	0.005	0.005	NA

	0.9	163-189	4	<0.01	<0.01	<0.01	0.005	0.005	NA

Combined Residues

Cotton, undelinted seed	0.3	132-190	18	<0.02	<0.02	<0.02	0.01	0.01	NA

	0.9	163-189	4	<0.02	<0.02	<0.02	0.01	0.01	NA

Cotton, gin byproducts	0.3	132-190	12	<0.02	<0.02	<0.02	0.01	0.01	NA

	0.9	163-189	4	<0.02	<0.02	<0.02	0.01	0.01	NA

1  PHI represents the number of days between the planting of treated
seed and harvest.

2  The LOQ was 0.01 ppm for each analyte.  In the calculation of the
median, mean, and standard deviation, 0.005 ppm (½LOQ) was used for
residues reported as <LOQ.  NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted cotton crop field trial data are adequate to
support use of thiamethoxam as a seed treatment to cotton.  The number
and locations of the field trials are in accordance with OPPTS Guideline
860.1500 for cotton.  Although no data were submitted reflecting seed
treatment of cotton followed by foliar applications (as allowed on
current labels), these data have been submitted previously (see D265079
PP#9F5051 review).  Combined residues of thiamethoxam and CGA-322704
were <0.02-<0.07 ppm in/on 26 samples of undelinted cottonseed grown
from seed treated at 0.30 lb ai/100 lb seed and harvested 20-28 days
following two foliar applications of the 25% WG formulation at a total
rate of 0.09 lb ai/A; combined residues of thiamethoxam were 0.06-1.10
ppm in/on 12 samples of cotton gin byproducts harvested 20-28 days
following treatment.  These data support the current tolerances of 0.10
ppm and 1.5 ppm for the combined residues of thiamethoxam and CGA-322704
in/on cotton seed and gin byproducts, respectively.

The petitioner has proposed to increase the maximum seasonal application
rate of the 40% WG formulation (EPA Reg. No. 100-1147), from 0.10 lb
ai/A to 0.125 lb ai/A.  No crop field trial data were submitted to
support this increased rate, and no crop field trial data are available
to support the increased rate.  If the petitioner wishes to support
applications to cotton at a total seasonal rate of 0.125 lb ai/A,
additional crop field trial data reflecting this use pattern should be
submitted.

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on cotton; HED has concluded (see 860.1200 –
Directions for Use) that sufficient bridging crop field trial data have
been submitted to allow translation of data for the 25% WG formulation
to support foliar uses of the 2 lb/gal FlC formulation.

Mint

DER Reference:	45530901.der1.doc

IR-4 has submitted magnitude of the residue studies for mint in support
of the requested new or amended uses on mint.  The results from these
field trials are discussed below and summarized in Table 23.

Five mint field trials were conducted during 1999 in Zone 5 (WI; 2
trials) and 11 (WA; 3 trials).  A 25% WG formulation of thiamethoxam was
applied as three broadcast foliar applications at 0.0645-0.0668 lb
ai/A/application, for a total rate of 0.196-0.198 lb ai/A/season (1x the
proposed maximum seasonal rate).  Applications were made during the
vegetative stage through early bud development at RTIs of 13-15 days.
Mint tops (leaves and stems) were harvested at commercial maturity 6-7
days after the last treatment and duplicate control and treated samples
of mint tops were collected from each test.

The HPLC/MS/MS method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on mint tops was adequately validated in
conjunction with the sample analyses.  The validated LOQ for residues of
thiamethoxam and its metabolite CGA-322704 was 0.05 ppm in/on mint tops;
the LOD was 0.025 ppm for each analyte.  Sample storage durations and
conditions are reported in Table 5; the storage conditions and durations
are supported by adequate storage stability data submitted concurrently
with the field trial data.

Six or seven days following the last of three foliar applications of the
25% WG formulation totaling ~0.197 lb ai/A, residues in/on 10 samples of
mint tops were 0.205-0.894 ppm for thiamethoxam and <0.05-0.128 ppm for
CGA-322704, for combined residues of 0.264-1.01 ppm.

Table 23.	Summary of Residue Data from Mint Crop Field Trials with
Thiamethoxam.

Commodity	EP 1	Total Rate

(lb ai/A) 	PHI

(days)	Residue Levels (ppm)2

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

MINT [Peppermint and Spearmint] (proposed use = 0.188 lb ai/A total
application rate with a 7-day PHI)

Thiamethoxam Residues

Mint, tops	25% WG	0.196-0.198	6-7	10	0.205	0.894	0.860	0.336	0.413	0.243

CGA-322704 Residues

Mint, tops	25% WG	0.196-0.198	6-7	10	<0.05	0.128	0.114	0.108	0.092	0.033

Combined Residues

Mint, tops	25% WG	0.196-0.198	6-7	10	0.264	1.012	0.973	0.435	0.505	0.262

1  EP = End-use product.

2  The LOQ was 0.05 ppm for each analyte.  In the calculation of the
median, mean, and standard deviation, 0.025 ppm (½LOQ) was used for
residues reported as <LOQ.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted mint crop field trial data are adequate to
support the amended uses on mint.  The petitioner has proposed to
increase the maximum seasonal rate for use of the 25% WG formulation on
mint.  The available data will support up to three broadcast foliar
applications of the 25% WG formulation to mint at 0.063 lb
ai/A/application, for a total rate of 0.188 lb ai/A (1x the proposed
maximum seasonal rate), with a 14-day RTI and a 7-day PHI.

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for mint.  The available field trial data
support the established tolerance for combined residues of thiamethoxam
and CGA-322704, expressed as thiamethoxam equivalents, in/on peppermint
and spearmint at 1.5 ppm.

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on mint; HED has concluded (see 860.1200 –
Directions for Use) that sufficient bridging crop field trial data have
been submitted to allow translation of data for the 25% WG formulation
to support foliar uses of the 2 lb/gal FlC formulation.

Tobacco

See:    SEQ CHAPTER \h \r 1 Residue Chemistry Memo D265079, 5/8/00, G.J.
Herndon (PP#9F5051)

The petitioner has proposed use of the new 2 lb/gal FlC formulation
(Actara® 240 SC) on tobacco, with the same use pattern as the existing
use pattern for the 25% WG formulation on tobacco.  Crop field trial
data for tobacco have been submitted and reviewed by HED (D265079
PP#9F5051 review).  At three tests, thiamethoxam (2 lb/gal FlC) was
applied to tobacco at planting as an in-furrow application at 0.13 lb
ai/A (1x the maximum rate for soil applications) followed by a single
broadcast foliar application of the 25% WG formulation at 0.056 lb ai/A
(1.2x the maximum rate for foliar applications), for a total rate of
0.18 lb ai/A.  Three tests were also conducted using 2 lb/gal FlC
formulation applied only at-planting as the in-furrow soil treatment at
0.13 lb ai/A.  Combined residues of thiamethoxam and CGA-322704 were
0.09-0.23 ppm and 0.6-0.8 ppm in/on six samples each of green and cured
leaves, respectively, harvested 14 days following the combination soil +
foliar treatment.  For the soil treatment alone, combined residues of
thiamethoxam and CGA-322704 were <0.02-0.13 ppm and <0.2-0.8 ppm in/on
six samples each of green and cured leaves, respectively.  Because
residues in/on cured tobacco were >0.1 ppm, the petitioner conducted
pyrolysis studies, which are discussed under 860.1300 – Nature of the
Residue.

Adequate residue data have been submitted to satisfy all data
requirements pertaining to tobacco.  The available data support the
following registered/proposed use patterns:  a single soil application
of the 2 lb/gal FlC formulation at 0.125 lb ai/A; or foliar application
of the 25% WG formulation at 0.047 lb ai/A with a 14-day PHI.  HED has
concluded (see 860.1200 – Directions for Use) that insufficient
bridging crop field trial data have been submitted to allow translation
of data for the 25% WG formulation to support foliar uses of the 2
lb/gal FlC formulation.

860.1520 Processed Food and Feed

DER Reference	46801401.de2.doc

Barley

  SEQ CHAPTER \h \r 1 IR-4 has submitted a processing study with
thiamethoxam on barley.    SEQ CHAPTER \h \r 1 In one trial conducted in
ID during the 2002 growing season, barley grain was harvested 21 days
following the last of two foliar broadcast applications of the 25% WG
formulation at 0.062 lb ai/A/application, for a total rate of 0.124 lb
ai/A (1.3x the proposed maximum seasonal rate).  Barley grain samples
were processed into pearled barley, bran, and flour using simulated
commercial procedures.

Samples of barley grain and its processed commodities (pearled barley,
bran, and flour) were analyzed for residues of   SEQ CHAPTER \h \r 1
thiamethoxam and its metabolite CGA-322704 using a modified version of
the current tolerance-enforcement method (Method AG-675).  This method
is adequate for data collection based on acceptable method recoveries.
The LLMV for this method was 0.01 ppm for both thiamethoxam and
CGA-322704 for all barley matrices.

Sample storage durations and conditions are reported in Table 4.  The
storage conditions and durations are supported by adequate storage
stability data generated concurrently with the processing study.    SEQ
CHAPTER \h \r 1

The results of the processing study are summarized in Table 7.  Residues
of thiamethoxam and CGA-322704 were 0.12 ppm and <0.01 ppm,
respectively, in/on barley grain raw agricultural commodity (RAC)
treated at 0.124 lb ai/A; the combined residues were <0.13 ppm in the
RAC.  The processing data indicate that residues of thiamethoxam may
reduce in pearled barley (0.03 ppm; 0.3x processing factor), bran (0.04
ppm; 0.3x processing factor), and flour (0.01 ppm; 0.1x processing
factor).  Processing factors for CGA-322704 could not be calculated
because residues were below the LLMV in/on the RAC and the processed
commodities.

The observed processing factors are less than the theoretical
concentration factors of 7.7x for barley bran and 1.2x for pearled
barley (based on separation into components; OPPTS 860.1520, Table 3).

  SEQ CHAPTER \h \r 1 Table 24.  Summary of Processing Factors for
Thiamethoxam.

RAC	Processed Commodity	Processing Factor

Thiamethoxam	CGA-322704	Combined

Barley	Pearled barley	0.3x	Not calculated (NC) 1	0.3x

	Bran	0.3x	NC	0.3x

	Flour	0.1x	NC	0.1x

1  Processing factor was not calculated because residues were <0.01 ppm
in the RAC and processed commodity.

Conclusions.  The submitted barley processing data are adequate to
satisfy data requirements.  The data indicate that combined residues of
thiamethoxam and CGA-332704 do not concentrate in pearled barley, barley
bran, or barley flour.  No tolerances are needed for barley processing
commodities.

Mint

In two tests conducted in WI and WA during 1999, thiamethoxam (25% DF)
was applied as three broadcast foliar applications at 0.322-342 lb
ai/A/application, for a total of 0.996-1.007 lb ai/A/season.
Applications were made during the vegetative stage through early bud
development at retreatment intervals (RTIs) of 13-14 days.  Duplicate
control and treated samples of mint tops were collected from each test
at commercial maturity, 7 days after treatment (DAT) and processed into
oil using simulated commercial procedures.  Prior to analysis, mint
(RAC) and processed mint oil samples were stored frozen for a maximum of
17 months, a duration supported by available stability data submitted
concurrently with the field tests.

The HPLC/MS/MS method (Method AG-675) used to determine residues of
thiamethoxam and CGA-322704 in/on mint tops was adequately validated in
conjunction with the sample analyses.   The validated LOQ for residues
of thiamethoxam and its metabolite CGA-322704 is 0.05 ppm in/on mint
tops and oil; the LOD was 0.025 ppm for each analyte.

Thiamethoxam residues were 1.380-2.360 ppm and CGA-322704 residues were
0.199-0.286 ppm for combined residues of 1.610-2.595 ppm in/on 4 samples
of unwashed mint tops (RAC) harvested at maturity.  Residues of
thiamethoxam and CGA-322704 were each <0.05 ppm (<LOQ) for combined
residues of <0.10 ppm in/on 4 samples of oil processed from treated
mint.  The processing factor for the average combined residues of
thiamethoxam and CGA-322704 was <0.05x in mint oil.  The maximum
theoretical concentration factor for mint is 330x.

Table 25.  Residue Data from Mint Processing Study with Thiamethoxam
(25% DF).

Trial ID (City, State, Year)	Processed Commodity	Total Rate

(lb ai/A)	PHI (days)	Residues (ppm) 1	Processing Factor 2

Thiamethoxam	CGA-322704	Combined

	Sullivan, WI, 1999	Mint tops (RAC)	1.007	7	1.745, 2.360	0.199, 0.235
1.944, 2.595	NA

	Mint Oil

	<0.05, <0.05	<0.05, <0.05	<0.10, <0.10	<0.04x

Prosser, WA, 1999	Mint tops (RAC)	0.996	7	1.380, 1.830	0.230, 0.286
1.610, 2.116	NA

	Mint Oil

	<0.05, <0.05	<0.05, <0.05	<0.10, <0.10	<0.05x

Conclusions.  The mint processing data are adequate.  Neither residues
of thiamethoxam nor of CGA-322704 concentrate in mint oil.  The
processing factor for the average combined residues of thiamethoxam and
CGA-322704 was <0.05x in mint oil.

DER Reference:	45093301.de2.doc (Potato)

		45093705.de2.doc (Grape)

		45093706.de2.doc (Potato)

		45530901.der2.doc (Mint)

See:    SEQ CHAPTER \h \r 1 Residue Chemistry Memo D265079, 5/8/00, G.J.
Herndon (PP#9F5051)

Syngenta submitted processing studies with grape and potato and IR-4
submitted a processing study with mint.  The results from these
processing studies are discussed below and the average processing
factors are summarized in Table 24.

Grape:  A grape processing study was conducted in conjunction with the
grape crop field trials.  Two trials were conducted in CA during the
1999 growing season.  At each trial site, thiamethoxam applications were
made using six different treatment regimes, as follows:

Treatment 2:  a single drench application of the 2 lb/gal FlC
formulation at 0.262 lb ai/A (1x the maximum proposed soil application
rate), directed to the base of the plant;

Treatment 4:  a single drench application of the 2 lb/gal FlC
formulation at 1.31 lb ai/A (4.9x) directed to the base of the plant;

Treatment 5:  a single drench application of the 2 lb/gal FlC
formulation at 0.218 lb ai/A (0.8x) directed to the base of the plant
followed, 51-59 days later, by a single postemergence foliar broadcast
application of the 25% WG formulation at 0.045 lb ai/A (0.8x the
proposed maximum single foliar application rate), for a total rate of
0.262 lb ai/A;

Treatment 7:  a single drench application of the 2 lb/gal FlC
formulation at 1.09 lb ai/A (4x) directed to the base of the plant
followed, 53-55 days later, by a single postemergence foliar broadcast
application of the 25% WG formulation at 0.223 lb ai/A (4x), for a total
rate of 1.31 lb ai/A;

Treatment 8:  two postemergence foliar broadcast applications, with a
13- to 15-day RTI, of the 25% WG formulation at 0.055 lb ai/A, for a
total rate of 0.11 lb ai/A (1x the proposed maximum foliar application
rate); and

Treatment 10:  two postemergence foliar broadcast applications, with a
14-day RTI, of the 25% WG formulation at 0.276 lb ai/A, for a total rate
of 0.55 lb ai/A (5x).

For samples receiving drench treatment only (Treatments 2 and 4),
samples of grapes were harvested 58-60 days after application.  For
samples receiving foliar applications (Treatment 5, 7, 8, and 10),
mature samples of grapes were harvested 5 days after the last foliar
application.  Raisins were generated at the field trial sites by field
drying grapes (still on the stem in bunches) for 19-25 days.  In
addition, samples of grapes were processed into juice within 5 days of
harvest using simulated commercial practices.

The HPLC/UV or HPLC/MS/MS method, Method AG-675, used to determine
residues of thiamethoxam and CGA-322704 in/on grape commodities was
adequately validated in conjunction with the sample analyses.  The LOQ
was 0.01 ppm for each analyte in grapes and raisins, and 0.005 ppm for
each analyte in juice.  Sample storage durations and conditions are
reported in Table 5; the storage conditions and durations are supported
by adequate storage stability data.

Residues of thiamethoxam and its metabolite CGA-322704 were below the
LOQ in/on all samples of grapes, raisins, and juice from the Treatment 2
plots, and were below the LOQ in/on all samples of grapes and juice from
the Treatment 4 plots.  Quantifiable residues of thiamethoxam were
observed in raisins from both Treatment 4 plots, at 0.02-0.04 ppm,
yielding processing factors of 1.5x and 2x.

Quantifiable residues of thiamethoxam in grapes and grape processing
commodities resulted after application of thiamethoxam using Treatments
5 and 7 (combination soil drench plus foliar broadcast application) and
Treatments 8 and 10 (two foliar broadcast applications).  Residues of
thiamethoxam in grape samples ranged 0.03-0.13 ppm in/on samples from
Treatments 5, 7, and 8, and 0.04-0.63 ppm in/on samples from Treatment
10; quantifiable residues of CGA-322704 were observed in/on one sample
of grapes from Treatment 10, at 0.01 ppm.

Residues of thiamethoxam in raisins ranged 0.03-0.40 ppm in samples from
Treatment 5, 7, and 8, and 0.48-1.1 ppm in samples from Treatment 10;
quantifiable residues of CGA-322704 were found in two samples of raisins
from Treatment 10, at 0.02 and 0.04 ppm.  Residues of thiamethoxam in
juice ranged 0.035-0.37 ppm in samples from Treatments 5, 7, and 8, and
0.65-0.69 ppm in samples from Treatment 10; quantifiable residues of
CGA-322704 were observed in juice samples from Treatment 10, at
0.008-0.009 ppm.  The processing factors from the processed commodity
samples ranged 1-4.3x for raisins and 0.8-3.1x for juice.

The observed processing factors for raisins are less than the
theoretical concentration factor of 4.7x for raisins (based on loss of
water; OPPTS Guideline 860.1520, Table 2); however, several of the
observed processing factors for juice are greater than the theoretical
concentration factor of 1.2x (based on separation into components; OPPTS
Guideline 860.1520, Table 3).  The average processing factor for raisins
was 2.3x.  The average processing factor for juice was calculated to be
1.1x, when a value of 1.2 was substituted for all processing factors
>1.2x [as specified in OPPTS Guideline 860.1520(f)(2)(i)].

Mint:  A mint processing study was conducted in conjunction with the
mint crop field trials. In two tests conducted in WI and WA during 1999,
the 25% WG formulation of thiamethoxam was applied as three broadcast
foliar applications at 0.322-342 lb ai/A/application (5x single rate),
for a total rate of 0.996-1.007 lb ai/A/season (8x maximum seasonal
rate).  Applications were made during the vegetative stage through early
bud development at RTIs of 13-14 days.  Duplicate control and treated
samples of mint tops were collected from each test at commercial
maturity, 7 days after treatment and processed into oil using simulated
commercial procedures.

The HPLC/MS/MS method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on mint tops was adequately validated in
conjunction with the sample analyses.  The validated LOQ for residues of
thiamethoxam and its metabolite CGA-322704 was 0.05 ppm for mint tops
and oil; the LOD was 0.025 ppm for each analyte.  Sample storage
durations and conditions are reported in Table 5; the storage conditions
and durations are supported by adequate storage stability data submitted
concurrently with the field trial data.

Thiamethoxam residues were 1.380-2.360 ppm and CGA-322704 residues were
0.199-0.286 ppm for combined residues of 1.610-2.595 ppm in/on 4 samples
of unwashed mint tops (RAC) treated at 8x and harvested at maturity.
Residues of thiamethoxam and CGA-322704 were each <0.05 ppm (<LOQ) for
combined residues of <0.10 ppm in/on 4 samples of oil processed from
8x-treated mint.  The processing factor for the average combined
residues of thiamethoxam and CGA-322704 was <0.05x in mint oil.  The
maximum theoretical concentration factor for mint is 330x (based on
separation into components; OPPTS Guideline 860.1520, Table 3).

Potato; MRID 45093301:  A potato processing study was conducted in
conjunction with the potato crop field trials reported in the same MRID.
 In one trial conducted in ID during the 1998 growing season, potato
tubers were harvested 14 days following the last of two broadcast foliar
applications of a 25% WG formulation at 0.09 or 0.44 lb
ai/A/application, for total rates of 0.18 and 0.88 lb ai/A (~2x and 9x
the registered maximum rate for foliar applications).  At separate plots
at the same site, potato seed pieces were treated with a 5 lb/gal FlC
formulation at a rate of 0.008 or 0.024 lb ai/100 lb seed pieces; based
on the planting rate, the seed piece treatment rate corresponded to 0.18
or 0.53 lb ai/A (1.4x and 4.2x the maximum registered seed treatment
rate).  Mature potato tubers were harvested from these plots 141 days
after planting.  Potato tuber samples from all treatment plots were
processed into wet peels (plus trimmings), flakes, and chips using
simulated commercial procedures.

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on potato commodities was adequately
validated in conjunction with the sample analyses.  The LOQ was 0.01 ppm
for each analyte.  Sample storage durations and conditions are reported
in Table 5; the storage conditions and durations are supported by
adequate storage stability data.

Following seed piece treatment using the 5 lb/gal FlC formulation at a
rate equivalent to 0.53 lb ai/A, combined residues of thiamethoxam and
CGA-322704 were 0.07 ppm in/on mature potato tubers.  The processing
data indicate that combined residues may concentrate in flakes (0.12
ppm; 1.7x processing factor) but reduce in wet peel (and trimmings;
<0.02 ppm; <0.3x processing factor) and chips (<0.02 ppm; <0.3x
processing factor).

Following application of the 25% WG formulation as two foliar
applications totaling 0.18 or 0.88 lb ai/A, residues of thiamethoxam and
CGA-322704 in/on potato tubers and all potato processed products were
below the LOQ; therefore, no processing factors can be calculated from
these trials.  Following seed piece treatment using the 5 lb/gal FlC
formulation at a rate equivalent to 0.18 lb ai/A, residues of
thiamethoxam and CGA-322704 were below the LOQ in/on potato tubers and
all potato processed products with the exception of flakes (0.03 ppm;
>1.5x processing factor).

Potato; MRID 45093706:  A potato processing study was conducted in
conjunction with the potato crop field trials reported in same MRID.  In
two trials conducted in ID and ND during the 1999 growing season, potato
seed pieces were treated with a 1.6% D formulation at a rate of 0.008 lb
ai/100 lb seed pieces; based on the planting rate, the seed piece
treatment rate corresponded to 0.18 lb ai/A (1.4x the maximum registered
seed treatment rate).  Potato plants then received two postemergence
broadcast foliar applications of a 25% WG formulation at 0.044 lb
ai/A/application (~1x the maximum single foliar application rate), for a
total application rate of 0.26 lb ai/A.  At each trial site, an
additional plot received exaggerated rate treatment:  seed piece
treatment at 0.024 lb ai/100 lb seed pieces (equivalent to 0.53 lb ai/A;
4.2x) plus two postemergence foliar applications at 0.22 lb
ai/A/application (4.7x), for a total rate of 0.97 lb ai/A.  Mature
potato tubers were harvested 14 days (ID trial) and 12 days (ND trial)
after the last foliar application, and processed into culls, wet peels
and trimmings, flakes, and chips using simulated commercial procedures.

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on potato commodities was adequately
validated in conjunction with the sample analyses.  The LOQ was 0.01 ppm
for each analyte.  Sample storage durations and conditions are reported
in Table 5; the storage conditions and durations are supported by
adequate storage stability data.

Samples of potato tubers from the exaggerated rate treatment in ID were
the only samples in which quantifiable residues of both thiamethoxam and
CGA-322704 were obtained, at 0.06 and 0.01 ppm, respectively.  Based on
the processing data from this trial, combined residues of thiamethoxam
and CGA-322704 may concentrate in flakes (0.15 ppm; 2.2x processing
factor) but do not concentrate in wet peel (and trimmings; 0.05 ppm;
0.7x processing factor) and chips (<0.07 ppm; <1x processing factor).
In two other trials (0.26 lb ai/A treatment rate in ID and 0.97 lb ai/A
treatment rate in ND), in which samples bore quantifiable residues of
thiamethoxam but non-quantifiable residues of CGA-322704, the processing
data indicate that residues may concentrate in flakes (1.3x and 2x
processing factors) and possibly chips (processing factors of <1x and
~1.3x were observed) but do not concentrate in wet peel (processing
factors of <0.5x and ~0.7x).  The processing data from these three
trials also indicate that combined residues do not concentrate in cull
potatoes (processing factors of ≤1x).

In the fourth trial (0.26 lb ai/A treatment rate from ND), residues of
thiamethoxam and CGA-322704 were below the LOQ in/on all samples.

The observed processing factors are less than the theoretical
concentration factors of 4.7x for dried potatoes (flakes, granules;
based on loss of water, OPPTS Guideline 860.1520, Table 2) and 4.0x for
processed potato waste (based on separation into components; OPPTS
Guideline 860.1520, Table 3).

Potato; MRID 44715110:  Syngenta had previously submitted a processing
study with potato (see D265079 PP#9F5051 review).  In two tests
conducted in ID and ND, thiamethoxam (FlC and WG formulations) was
applied to potatoes at rates totaling 0.04, 0.17, 0.51, and 0.85 lb ai/A
(0.3x, 1.4x, 4x, and 7x the maximum seasonal rate, respectively).
Potatoes were harvested 14 days following last application and processed
using simulated commercial practices into culls, wet peels and
trimmings, granules, and chips.  In the study conducted in ID, residues
of thiamethoxam and CGA-322704 were each <0.01 ppm in/on one composite
potato sample treated at 4x and 7x, and residues did not concentrate
appreciably in any of the processed potato commodities.  In the ND
study, combined residues were 0.037 ppm and 0.035 ppm in/on potato RAC
samples after 4x and 7x treatments, respectively.  Residues did not
concentrate appreciably in culls, wet peels and trimmings or granules.
In chips, residues were found to reduce in the 4x samples (0.8x
processing factor) but concentrate in the 7x samples (2.9x processing
factor).

  SEQ CHAPTER \h \r 1 Table 26.		Summary of Processing Factors for
Thiamethoxam.

RAC	Processed Commodity	Average Processing Factor

Grape	Juice	1.1x

	Raisin	2.3x

Mint	Oil	0.05x

Potato	Chips	1.2x

	Flakes	1.7x

	Wet peel	<0.6x

Conclusions.  The submitted processing data are adequate to satisfy data
requirements.  The potato and mint processing data indicate that
combined residues of thiamethoxam and CGA-332704 do not concentrate in
mint oil or potato wet peel.  No tolerances are needed for mint
processed commodities or for processed potato waste.

The processing data indicate that combined residues of thiamethoxam and
CGA-322704 concentrate in grape juice and raisins.  Based on the HAFT
residue for grapes (0.12 ppm) and the average processing factors for
juice (1.1x) and raisins (2.3x), expected residues in juice would be
0.13 ppm and expected residues in raisins would be 0.28 ppm.  Because
expected juice residues are less than the recommended 0.20-ppm tolerance
for grapes, a separate tolerance for grape juice is not needed.  The
proposed 0.30-ppm tolerance for raisins is appropriate.

The processing data indicate that combined residues of thiamethoxam and
CGA-322704 may concentrate in potato chips and flakes.  Based on the
HAFT residue for potatoes (0.12 ppm) and the average processing factors
for chips (1.2x) and flakes (1.7x), expected residues in chips would be
0.14 ppm and expected residues in flakes would be 0.20 ppm.  Because
expected residues in chips and flakes are not significantly higher than
the recommended 0.15-ppm tolerance for potatoes, separate tolerances for
potato chips and flakes are not needed.

In conjunction with the cotton crop field trials reported in this
review, the petitioner treated cotton seed at an exaggerated rate (3x
the field trial rate); the harvested seed was processed into hulls,
meal, and oil.  However, residues of thiamethoxam and CGA-322704 were
found to be <LOQ in/on all samples of cotton seed, including samples
grown from seed treated at an exaggerated rate.  Therefore, the
processed commodity samples were not analyzed.

Processing studies for crops associated with this review, apple, canola,
cotton, plum, and tomato, have been submitted previously (see PP#9F5046
review for canola data, and D265079 PP#9F5051 review for apple, cotton,
and tomato; and DP Number D286726, 12/23/03, Y. Donovan for plum data).
The processing data indicated that combined residues of thiamethoxam and
CGA-322704:  concentrate slightly in apple wet pomace (1.6x); reduce on
average in apple juice (0.75x); do not concentrate in cottonseed meal,
hulls, or refined oil; do not concentrate in prunes; and concentrate in
tomato puree and paste (1.7x and 3.8x, respectively).  Residues of
thiamethoxam and CGA-322704 were found to be <LOQ in/on canola seed
treated at 3x; therefore, no further processing data were required for
canola.  Based on these data, it was concluded that no tolerances were
needed for apple, canola, cotton, and plum processed commodities, and
that a tolerance of 0.80 ppm was appropriate for tomato paste.

For the apple, cotton, potato, and tomato studies, HED concluded that
the processing data were adequate to fulfill data requirements provided
adequate supporting storage stability data were submitted (conclusion
12c of D265079 PP#9F5051 review); as stated under 860.1380 – Storage
Stability, storage stability data requirements have been fulfilled.  For
the apple processing study, complete sample history including storage
conditions for processed apple commodities was also required (conclusion
26); these data remain outstanding.

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

Analytical reference standards for thiamethoxam and its metabolite
CGA-322704 are currently available at the EPA National Pesticide
Standards Repository; however, the standard for the metabolite
CGA-322704 has expired (personal communication with Dallas Wright, ACB,
7/13/06).  The registrant should either recertify the lot in the
repository and send in an updated certificate of analysis (COA), or
submit a new standard (different lot #) if the previous lot will not be
recertified.  If a new COA is being submitted, it should be faxed to the
repository at<PHONE_NUMBER>.

If a new standard is being submitted, it should be sent to the
Analytical Chemistry Lab, which is located at Fort Meade, to the
attention of either Theresa Cole or Frederic Siegelman, at the following
address:

	USEPA

	National Pesticide Standards Repository/Analytical Chemistry Branch/OPP

	701 Mapes Road

	Fort George G. Meade, MD  20755-5350

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

860.1850 Confined Accumulation in Rotational Crops

  SEQ CHAPTER \h \r 1 DER Reference:	None

See:    SEQ CHAPTER \h \r 1 MARC Decision Memo:  D258614, 8/31/99, G.J.
Herndon

Residue Chemistry Memo D252021, 3/30/00, G.J. Herndon (PP#9F5046)

  SEQ CHAPTER \h \r 1 Confined rotational crop studies were previously
reviewed in conjunction with the petition for thiamethoxam use on canola
(PP#9F5046).  These studies indicated that limited field rotational crop
studies are necessary to support the proposed 120-day PBI for rotational
crops, and that the metabolism of [14C]thiamethoxam in rotational crops
is similar to the metabolism observed in primary crops.

In a meeting held on 7/28/99, the MARC determined that the major
residues from the confined rotational crop studies were the parent
thiamethoxam and its CGA-322704 metabolite.  In animal feedstuffs,
CGA-265307, a metabolite containing the N-nitro group, was found to be a
major residue.  The MARC recommended that all three compounds be
analyzed in field rotational crop studies.

860.1900 Field Accumulation in Rotational Crops

DER Reference:	45659201.der.doc

See:  Residue Chemistry Memo D265079, 5/8/00, G.J. Herndon (PP#9F5051)

Field rotational crop studies were reviewed in conjunction with the
petition for thiamethoxam on various crops (PP#9F5051).  HED concluded
that the limited field rotational crop study would be considered
adequate, provided that questions were resolved concerning the analysis
for metabolite CGA-265307 and the storage stability of residues in/on
lettuce and turnip tops, and a description of the storage conditions at
the analytical facility was submitted.

Analysis of several samples from the 30-day PBI indicated that residues
of each analyte were <0.01 ppm (<LOQ) to 0.02 ppm in/on turnip tops and
wheat forage.  Secondary crop samples from the 120-day PBI from three
different test sites were also analyzed, and residues of thiamethoxam
and CGA-322704 were each <0.01 ppm in/on all representative rotational
crops (leaf lettuce, turnip tops and roots, and wheat grain, forage, hay
and straw).

In the studies, the rotational crop commodities were not analyzed for
the metabolite CGA-265307.  In the D265079 PP#9F5051 review, HED
concluded that analysis for this metabolite could be deferred as a
condition of registration.  As a condition of registration, the
petitioner was required to either reanalyze the limited rotational crop
study samples for the CGA-265307 metabolite and provide adequate storage
stability data to cover the period the samples were stored, or to
conduct a new field rotational crop study examining the samples for
residues of thiamethoxam, CGA-322704, and CGA-265307.

Syngenta   SEQ CHAPTER \h \r 1 has submitted the required additional
data, as an amendment to the previously submitted limited field
rotational crop study.  In this amendment, samples of rotational crop
commodities from the 120-day PBI were analyzed for residues of the
thiamethoxam metabolite CGA-265307.

In the original study, field rotational crop trials were conducted in
CA, FL, and IL, with peppers, leaf lettuce, and mustard greens planted
as the primary crops.  At each test site, a FlC formulation of
thiamethoxam was applied to the primary crop as an in-furrow application
at planting (leaf lettuce and mustard greens) or as a transplant drench
(peppers) at 0.134 lb ai/A followed 30-51 days later by a broadcast
foliar application of a 25% WG formulation at 0.04 lb ai/A, for a total
rate of 0.179 lb ai/A (~1x the maximum seasonal rate of 0.188 lb ai/A to
rotatable crops).  At the CA and FL sites, leaf lettuce and peppers were
allowed to mature and desiccate, and were cultivated into the soil on
the day of planting of the rotational crops; mustard greens at the IL
sites were clean cut and removed ~1 day after the last application, and
the plots were rototilled.  At each test site, single control and
duplicate treated plots were planted with leaf lettuce, turnips, and
wheat as representative rotational crops at PBIs of approximately 30,
120, and 180 days after the final application of thiamethoxam.  Samples
of lettuce, turnip roots and tops, and wheat forage, hay, straw, and
grain were harvested at maturity or the appropriate crop growth stage.

The HPLC/UV or HPLC/MS method, Method AG-675, used for determination of
CGA-265307 residues in/on rotational crop commodities was adequately
validated in conjunction with the sample analyses.  The validated LOQ
was 0.01 ppm for each commodity.

Samples had been stored frozen for 25.3-38.3 months prior to analysis
for CGA-265307 residues.  To support the sample storage durations, the
petitioner conducted a supporting storage stability study using samples
of wheat forage and straw from a previously submitted wheat metabolism
study (see DP Number D265079  SEQ CHAPTER \h \r 1 , 5/8/00, G.J.
Herndon).  These data are adequate to support the storage conditions and
durations of samples from the field rotational crop re-analysis study.

Residues of CGA-265307 were below the LOQ (<0.01 ppm) in/on six samples
each of leaf lettuce, turnip roots, turnip tops, wheat hay, wheat straw,
and wheat grain and eight samples of wheat forage grown from crops
planted 115-125 days following final application of thiamethoxam to a
primary crop at a total rate of 0.179 lb ai/A.

Conclusions.  The submitted field rotational crop data are adequate to
fulfill the data requirements of the previous review (conclusions 34 and
36 of the D265079 PP#9F5051 review) with the exception of the
requirement to submit information pertaining to the storage conditions
at the analytical facility.  Adequate data for metabolite CGA-265307
have been submitted; the data indicate that quantifiable residues of
CGA-265307 are not expected in rotational crop commodities from a
120-day PBI.  Rotational crop commodity samples from the original study
were stored frozen for up to 9 months prior to analysis; adequate
storage stability data are now available to support these storage
durations.

Pending submission of required information pertaining to storage
conditions, the existing 120-day plantback restriction for crops without
thiamethoxam uses is adequate.

Two product labels specify a lower PBI, 30 days, for crops without
thiamethoxam uses; EPA Reg. Nos. 100-935 and 100-973.  The only uses on
these labels are seed treatment of canola.  HED had previously concluded
that a 30-day PBI was appropriate for seed treatment of canola, due to
the low treatment rate (calculated to equivalent to ~0.04 lb ai/A; see
PP#9F5046 review).

860.1550 Proposed Tolerances

The tolerance definition for thiamethoxam, as determined by the MARC, is
the combined residues of the insecticide thiamethoxam and its metabolite
CGA-322704.  The tolerance expression for thiamethoxam listed in 40 CFR
180.565(a) and 180.565(b) should be revised to reflect the fact that the
enforcement method reports combined residues of thiamethoxam and
CGA-322704 in terms of parent equivalents.  The expression in 180.565(a)
should be revised to:

“A tolerance is established for the combined residues of the
insecticide thiamethoxam
[3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-ox
adiazin-4-imine] (CAS Reg. No. 153719–23–4) and its metabolite
[N-(2-chloro-thiazol-5-ylmethyl)-N′-methyl-N′′-nitro-guanidine],
calculated as parent equivalents, in or on the following raw
agricultural commodities:”

The expression in 180.565(b) should be revised to:

“Time-limited tolerances are established for the combined residues of
the insecticide thiamethoxam
[3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-ox
adiazin-4-imine] and its metabolite CGA-322704, calculated as parent
equivalents, in connection with use of the pesticide under section 18
emergency exemptions granted by EPA.”

There are no Codex or Mexican MRLs established for residues of
thiamethoxam in crops associated with this review.  Canada has
established a 0.01-ppm MRL for milk and a 0.02-ppm MRL for all food
crops, eggs, meat, and meat by-products of cattle, hogs, poultry, and
sheep.  The existing and proposed U.S. tolerances cannot be harmonized
with the Canadian MRL for all commodities, as higher residues were
observed in the crop field trials for some commodities, and feeding
study data indicate that higher tolerances are needed for milk and the
meat byproducts of cattle, goat, horse, and sheep.

A summary of the recommended tolerances for the petition are listed in
Table 27.  The Agency’s Guidance for Setting Pesticide Tolerances
Based on Field Trial Data was utilized for determining appropriate
tolerance levels for artichoke, caneberry (subgroup 13A), grapes, leafy
vegetable crop group, head and stem brassica subgroup, and leafy
brassica greens subgroup; see Appendix II for tolerance calculations.
The combined residue levels of thiamethoxam and CGA-322704 in/on these
commodities were readily quantifiable; <10% of the residue values were
below the LOQ.  Based on these calculations, revised tolerances should
be proposed for globe artichoke (0.45 ppm), canberries (0.35 ppm), grape
(0.20 ppm), head and stem brassica (4.5 ppm), leafy brassica greens
(3.0), and leafy vegetables (4.0).

Residue data for barley hay, barley grain, barley straw, and hops were
not entered into the tolerance spreadsheet because >15% of residue
values were below the LOQ.   The available data support the proposed
tolerances for barley grain, barley hay, barley straw, and hops.

The harmonization guidance was not used to determine appropriate
tolerance levels for legume vegetables, potato seed pieces, oilseed
crops; and foliar uses on cranberry, mint, strawberry, bushberry, and
root vegetables (except sugarbeet).  Residue data on these commodities
were received and reviewed, and tolerances established prior to
institution of the current policy.  Tolerances for these commodities
were established in the Federal Register [January 5, 2005 (Volume 70,
Number 3)].

The available crop field trial data indicate that the established
tolerance of 0.02 ppm for the root vegetable, except sugar beets,
subgroup is too low and should be increased to 0.05 ppm.  The data also
indicate that the established tolerance of 0.25 ppm for potato should be
reduced to 0.15 ppm.

Currently, a tolerance exists for combined residues of thiamethoxam and
CGA-322704 in/on radish tops, at 0.80 ppm.  This tolerance is not
sufficient to cover potential residues in/on the leaves of all
commodities in subgroup 1B.  A tolerance should be established for
leaves of root and tuber vegetables, except sugar beets, at 0.80 ppm.

Time-limited tolerances for dried bean, succulent bean, and cranberry
currently exist under 40 CFR 180.565(b).  Because permanent tolerances
have been established under 40 CFR 180.565(a) for cranberries and the
legume vegetable group, the time-limited tolerances are no longer needed
and should be removed.  In addition, a tolerance for succulent bean
currently exists under 40 CFR 180.565(a); the tolerance should be
removed because this commodity is now covered by the crop group
tolerance for legume vegetables.  Time-limited tolerances for artichoke
and hops currently exist under 40 CFR 180.565(b).  Because these
tolerances will no longer be associated with Section 18 emergency
exemptions, the tolerances should be moved to 40 CFR 180.565(a).

The available processing data indicate that no tolerances are needed for
mint, barley, or potato processed commodities.  The grape processing
data indicate that the proposed tolerance of 0.30 ppm is appropriate for
raisins but that no tolerance is needed for grape juice.  The proposed
tolerance for grape juice should be removed from the petition.

The established tolerances for livestock commodities, at 0.02 ppm for
combined residues of thiamethoxam and CGA-322704 in milk, the meat of
cattle, goat, horse, and sheep, and the meat byproducts of hog are
adequate; no revision to these tolerances is needed as a result of the
requested amended uses.  However, the available feeding study data
indicate that increased tolerances are needed for the meat byproducts of
cattle, goat, horse, and sheep, from 0.02 to 0.04 ppm.  The available
data also indicate that a tolerance for hog meat is not needed; this
tolerance should be removed.

The proposed tolerances should be revised to reflect the recommended
tolerance levels and correct commodity definitions as specified in Table
27.

Table 27.  Tolerance Summary for Thiamethoxam.

Commodity	Established Tolerance  (ppm)	Proposed Tolerance (ppm)
Recommended Tolerance (ppm)	Comments; Correct Commodity Definition

Tolerances listed under 40 CFR 180.565(a):

Barley, grain		0.02		0.30		0.30	The recommended tolerance is contingent
on label revisions to restrict foliar use of thiamethoxam to barley
grown in the states of ID, ND, OR, SD, and WA.

Barley, hay		0.05		0.40		0.40

	Barley, straw		0.03		0.40		0.40

	Bean, succulent		0.02		--		Remove	This commodity is covered by the
existing tolerance for “Vegetable, legume, group 6”

Borage, seed		0.02		--		0.02

	Bushberry, subgroup 13B		0.20		--		0.20

	Canola, seed		0.02		--		0.02

	Cattle, meat byproducts		0.02		--		0.04	The available data indicate
that the tolerance should be increased.

Cattle, meat		0.02		--		0.02

	Cotton, gin byproducts		1.5		--		1.5

	Cotton, undelinted seed		0.10		--		0.10

	Crambe, seed		0.02		--		0.02

	Cranberry		0.02		--		0.02

	Flax, seed		0.02		--		0.02

	Fruit, pome, group 11		0.2		--		0.20

	Fruit, stone, group 12		0.5		--		0.50

	Goat, meat byproducts		0.02		--		0.04	The available data indicate that
the tolerance should be increased.

Goat, meat		0.02		--		0.02

	Hog, meat byproducts		0.02		--		0.02

	Hog, meat		0.02		--		0.02

	Horse, meat byproducts		0.02		--		0.04	The available data indicate that
the tolerance should be increased.

Horse, meat		0.02		--		0.02

	Juneberry		0.20		--		0.20

	Lingonberry	0.20		--		0.20

	Milk	0.02		--		0.02

	Mustard, seed	0.02		--		0.02

	Peppermint	1.5		--		1.5

	Potato	0.25		--		0.15	The available data indicate that the established
tolerance may be reduced.

Radish, tops	0.80		--		Remove	This commodity will be covered by the new
tolerance for Leaves of root and tuber vegetables, except sugar beets

Rapeseed, seed	0.02		--		0.02

	Safflower, seed	0.02		--		0.02

	Salal	0.20		--		0.20

	Sheep, meat byproducts	0.02		--		0.04	The available data indicate that
the tolerance shoould be increased.

Sheep, meat	0.02		--		0.02

	Spearmint	1.5		--		1.5

	Strawberry	0.3		--		0.30

	Sunflower	0.02		--		0.02	Sunflower, seed

Tomato, paste	0.80		--		0.80

	Vegetable, cucurbit, group 9	0.2		--		0.20

	Vegetable, fruiting, group 8	0.25		--		0.25

	Vegetable, legume, group 6	0.02		--		0.02

	Vegetable, root, except sugar beet, subgroup 1B	0.02		--		0.05	The
available crop field trial data indicate that the tolerance should be
increased.

Vegetable, tuberous and corm, except potato, subgroup 1D	0.02		--		0.02

	Tolerances listed under 40 CFR 180.565(b):

Artichoke, globe		0.40 3		0.40		Move	Tolerance listing should be moved
from 180.565(b) to 180.565(a).

Hop, dried cone		0.10 1		0.10		Move	Tolerance listing should be moved
from 180.565(b) to 180.565(a).

Bean, dried		0.021		--		Remove	This commodity is covered by the existing
tolerance for “Vegetable, legume, group 6”

Bean, succulent		0.021		--		Remove	This commodity is covered by the
existing tolerance for “Vegetable, legume, group 6”

Cranberry		0.022		--		Remove	Permanent tolerance has been established
for cranberry under 180.565(a)

Tolerances to be listed under 40 CFR 180.565(a):

Artichoke, globe		0.40

[180.565 (b)]		0.40		0.45	The recommended tolerance is contingent on
label revisions to specify up to two foliar applications of the 25% WG
formulation at 0.047 lb ai/A/application, with a 7-day RTI, for a total
rate of 0.094 lb ai/A, with a 4-day PHI.

Caneberry subgroup 13A	None established		0.30		0.35	The recommended
tolerance is contingent on label revisions to specify up to two foliar
applications of the 25% WG formulation at 0.047 lb ai/A/application,
with a 7-day RTI, for a total rate of 0.094 lb ai/A, with a 3-day PHI.

Hop, dried cone	0.10

[180.565 (b)]		0.10		0.10	Hop

Grapes	--		0.15		0.20	Grape

Grape, juice	--		0.20		--	HED has concluded that a separate tolerance
for grape juice is not needed.

Head and stem Brassica crop subgroup (5A)	--		1.0		4.54	Brassica, head
and stem, subgroup 5A

Leafy Brassica greens crop subgroup (5B)	--		2.0		3.05	Brassica, leafy
greens, subgroup 5B

Leafy vegetables crop group (4)	--		2.0		4.0	Vegetable, leafy, except
brassica, group 4

Leaves of root and tuber vegetables, except sugar beets	--		--		0.80

	Raisins	--		0.30		0.30	Grape, raisin

1  Time-limited tolerance with expiration/revocation date of 12/31/06.

2  Time-limited tolerance with expiration/revocation date of 12/31/07.

3  Time-limited tolerance with expiration/revocation date of 6/30/08

4  Recommended tolerance for a 0-day PHI; if the petitioner wishes to
support a 7-day PHI, a tolerance of 1.4 ppm is recommended.

5  Recommended tolerance for a 7-day PHI; if the petitioner wishes to
support a 0-day PHI, a tolerance of 9.0 ppm is recommended.

References

DP Number:	D257676

Subject:	PP#9F5046 and 9F5051. Thiamethoxam on Canola, Barley, Sorghum,
Wheat, Cotton, Tuberous and Corm Vegetables, Leafy Vegetables, Brassica
Vegetables, Fruiting Vegetables, Cucurbit Vegetables, Pome Fruits, and
Tobacco.  Memo to the Metabolism Assessment Review Committee (MARC) for
Meeting to be Held on 7/28/99.

From:		G.J. Herndon and P. Hurley

To:		G. Kramer

Dated:		7/21/99

MRID(s):	None

DP Number:	D258614

Subject:	Thiamethoxam.  Results of the HED Metabolism Assessment Review
Committee Meeting Held on 7/28/99.

From:		G.J. Herndon

To:		G. Kramer

Dated:		8/31/99

MRID(s):	None

DP Number:	D259838

Subject:	Multi-Residue Method Testing of Thiamethoxam (CGA-293343) and
Its Metabolite CGA-322704.  PC Code 060109

From:		G.J. Herndon

To:		F. Griffith

Dated:		9/28/99

MRID(s):	44703523

DP Number:	D259839

Subject:	Multiresidue Test information for the updating of PAM I

From:		G.J. Herndon

To:		M. Wirtz

Dated:		9/28/99

MRID(s):	44703523

DP Number:	D252021

Subject:	PP#9F5046.  Thiamethoxam on Canola.  Section 3 Registration and
Permanent Tolerance Request for Use of Thiamethoxam (Helix Formulation)
for Use as a Seed Treatment on Canola Seed Prior to Planting.  First
Food Use.  Residue Chemistry Review:  Evaluation of Analytical Method
and Residue Data.

From:		G.J. Herndon

To:		T. Levine/H. Daniel

Dated:		3/30/00

MRID(s):	44703510-44703512, 44703515, 44703516, 44703520-44703531,
44703534-44703536, 44715106, 44715113, 44715114, 44715116, and 44715117

DP Number:	D265079

Subject:	PP#9F5051.  Thiamethoxam on Various Crops.  Section 3
Registration and Permanent Tolerance Request for Use of Thiamethoxam as
a Seed Treatment, Soil Treatment, or Foliar Use on Barley, Brassica
(Cole) Leafy Vegetables, Cotton, Cucurbit Vegetables, Fruiting (except
Cucurbit) Vegetables, Leafy (except Brassica) Vegetables, Pome Fruit,
Tuberous and Corm Vegetables, Sorghum, and Wheat.  Section 3
Registration for Tobacco.  Residue Chemistry Review:  Evaluation of
Analytical Method and Residue Data.

From:		G.J. Herndon

To:		T. Levine/H. Daniel

Dated:		5/8/00

MRID(s):	44715103-44715114, and 44715134

DP Number:	D271516

Subject:	PP#95046/95051.  Thiamethoxam on Canola, Barley, Sorghum,
Wheat, Cotton, Tuberous and Corm Vegetables, Leafy Vegetables, Brassica
Vegetables, Fruiting Vegetables, Cucurbit Vegetables, Pome Fruits, and
Tobacco.  Results of Petition Method Validation.

From:		M. Doherty

To:		T. Levine/D. Daniel

Dated:		5/29/01

MRID(s):	None

DP Number:	D285545

Subject:	PP#0F06142.  Thiamethoxam.  Section 3 Registration for Use as a
Corn Seed Treatment.  Summary of Analytical Chemistry and Residue Data.

From:		M. Doherty

To:		M. Laws/D. Daniel

Dated:		11/06/02

MRID(s):	44703525, 45093708

DP Number:	D286726

Subject:	PP# 3E06524, 2E06505, 1E06349, 2E6508.  Thiamethoxam.  Section
3 Registration for Use on Stone Fruit, Coffee, Pecan, and as a Seed
Treatment on Sunflower and Succulent beans.  Summary of Analytical
Chemistry and Residue Data.

From:		Y. Donovan

To:		M. Laws/D. Daniel

Dated:		12/23/03

MRID(s):	45091002, 45499904-45499913, 45757501, 45757701-45757703,
45793401

  SEQ CHAPTER \h \r 1 Attachments:

International Residue Limit Status sheet

Appendix I - Chemical Names and Structures of Thiamethoxam and
Metabolites

Appendix II - Tolerance Assessment Calculations

Template Version September 2005

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:
(3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-ox
adiazin-4-imine)	Common Name:

Thiamethoxam	X Proposed tolerance

( Reevaluated tolerance

( Other	Date: 7/12/06

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

X No Codex proposal step 6 or above

Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#0F6142

DP Numbers:  D281702, D335847

Other Identifier:

Residue definition (step 8/CXL):  N/A	Reviewer/Branch:  M. Doherty/C.
Swartz/RAB2

	Residue definition:    SEQ CHAPTER \h \r 1 combined residues of the
insecticide thiamethoxam
[3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-ox
adiazin-4-imine] and its metabolite
[N-(2-chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine]  SEQ
CHAPTER \h \r 1

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

Grape	0.15

Grape, juice	0.20

Raisins	0.30

Head and stem Brassica crop subgroup (5A)	1.0

Leafy vegetables crop group (4)	2.0

Leafy Brassica greens crop subgroup (5B)	2.0

	Limits for Canada	Limits for Mexico

   No Limits

   No Limits for the crops requested	 No Limits

X   No Limits for the crops requested

Residue definition  Parent including the metabolite
(E)-N-[(2-chloro-5-thiazolyl)methyl]-N’-methyl-N”-nitro-guanidine
Residue definition:  thiametoxam

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

All food crops, eggs, meat, and meat by-products of cattle, hogs,
poultry, and sheep	0.02	Tomato	0.2

Milk	0.01	Melon	0.2

Cucumber	0.2

Watermelon	0.2

Cotton	0.10

Eggplant	0.25

Chile pepper	0.25

Notes/Special Instructions:  S. Funk, Jul 13, 2006.

APPENDIX I.	Chemical Names and Structures of Thiamethoxam and
Metabolites.

Common name; Company code

Matrix	Chemical name	Chemical structure

Thiamethoxam;

CGA-293343

Cucumber fruit

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxa
diazin-4-imine

CGA-322704

Cucumber fruit

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage
N-[(2-chloro-5-thiazoyl)methyl]-N’-methyl-N”-nitroguanidine

CGA-204261

Lettuce	methyl urea

CGA-265307

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage
N-(2-chloro-thiazol-5-ylmethyl)-N’-nitro-guanidine

CGA-282149

Potato tuber	2H-1,3,5-oxadiazin-4-amine, 3,6-dihydro-3-methyl-N-nitro

CGA-340575

Potato tuber and foliage	2H-1,3,5-oxadiazin-4-amine, 3,6-dihydro-N-nitro

CGA-349208

Potato tuber and foliage

Cured tobacco foliage	5-thiazolemethanol, 2-chloro

CGA-353042

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage
3-methyl-[1,3,5]oxadiazinan-4-ylideneamine

CGA-353968

Cucumber fruit

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage
1-(2-chloro-thiazol-5-ylmethyl)-3-methyl-urea

CGA-355190

Cucumber fruit

Lettuce

Potato foliage

Green and cured tobacco foliage
3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-one

CGA-382191

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage	N-methylguanidine

Guanidine

Green and cured tobacco foliage	Guanidine

Hydroxylamine glucoside of CGA-322704

Potato tuber and foliage

I13

Lettuce	Mixture of O-glucose-conjugate of
(2-chloro-thiazol-5-yl)-methanol and O-glucose conjugate of
1-(2-chloro-thiazol-5-ylmethyl)-1-hydroxymethyl-3-methyl-urea

I13b

Lettuce 1	S-glucose conjugate of
3-(2-mercapto-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-one

I15a;

N-desmethyl-CGA-353968

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage	1-(2-chloro-thiazol-5-yl)-urea

N-glucoside of CGA-353968

Potato tuber and foliage

Green and cured tobacco foliage

NOA-405217

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage	N-methyl-N’-nitroguanidine

NOA-407475

Cucumber fruit

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage
3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylideneami
ne

NOA-408445

Green and cured tobacco foliage
{[(2-chloro-1,3-thiazol-5-yl)carbonyl]amino}acetic acid

NOA-421275

Lettuce

Potato tuber and foliage

Green and cured tobacco foliage
N-(2-chloro-thiazol-5-ylmethyl)-N’-methyl-guanidine

NOA-421276

Potato foliage	N-[(2-chloro-1,3-thiazol-5-yl)methyl]guanidine
hydrochloride

NOA-424255

Lettuce	N-nitro-guanidine

NOA-436944

Potato tuber and foliage	carbonic acid compound with guanidine (1:2)

1  Tentative structure assignment.

Appendix II.  Tolerance Assessment Calculations.

Artichoke

The dataset used to establish a tolerance for combined residues of
thiamethoxam and CGA-322704 in/on artichoke consisted of field trial
data representing application rates of 0.093-0.095 lb ai/A (2
applications at 0.046-0.048 lb ai/A/application) with a 4-day PHI.
Although the crop field trial data are not within 25% of the maximum
label application rate and minimum label PHI, respectively, it is
assumed that the product label will be amended to reflect the use
pattern of the crop field trials.  The residue values used to calculate
the tolerance are provided in Table I-1.

All 6 field trial sample results were above the LOQ.  Since there were
no values reported below the LOQ, maximum likelihood estimation (MLE)
procedures were not needed to impute censored values.

The thiamethoxam on artichoke dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure I-1) indicates that the dataset is reasonably lognormal, and the
result from the approximate Shapiro-Francia test statistic (Figure I-2)
confirmed that the assumption of lognormality should not be rejected.

Since the field trial data for thiamethoxam on artichoke represent a
small dataset (i.e., less than 15 samples) and are reasonably lognormal,
the upper bound estimate of the 95th percentile based on the median
residue value was compared to the minimum of the 95% upper confidence
limit (UCL) on the 95th percentile and the point estimate of the 99th
percentile, and the minimum value was selected as the tolerance value.
Using the rounding procedure as outlined in the Guidance for Setting
Pesticide Tolerances Based on Field Trial Data SOP, the point estimate
of the 99th percentile rounds to the value 0.45 ppm (Figure II-2).
Because this value was the minimum value, 0.45 ppm is the recommended
tolerance level for thiamethoxam on artichoke.

Table I-1.	Residue data used to calculate tolerances for thiamethoxam.

Regulator:	EPA	EPA

Chemical:	Thiamethoxam	Thiamethoxam

Crop:	Artichoke	Caneberry

PHI:	4 Days	3 Days

App. Rate:	2 at 0.0462-0.0477 lb ai/A/application	2 at 0.046-0.051 lb
ai/A

Submitter:	IR-4	IR-4

MRID Citation:	MRID 46801402	MRID 46801403

	Combined Residues of Thiamethoxam and CGA-322704 (ppm)

	0.1874	0.11

	0.2511	0.14

	0.1620	0.06

	0.1914	0.07

	0.0916	0.19

	0.2728	0.21

0.12

0.14

0.18

0.21

0.02

0.02

Figure I-  SEQ Figure \* ARABIC  1 :  Lognormal probability plot of
thiamethoxam residues in artichoke.

Figure I-  SEQ Figure \* ARABIC  2 :  Data summary table for residues of
thiamethoxam in artichoke.

Caneberry

The dataset used to establish a tolerance for combined residues of
thiamethoxam and CGA-322704 in/on caneberry consisted of field trial
data representing application rates of 0.095-0.097 lb ai/A (2
applications at 0.046-0.051 lb ai/A/application) with a 3-day PHI.
Although the crop field trial data are not within 25% of the maximum
label application rate and minimum label PHI, respectively, it is
assumed that the product label will be amended to reflect the use
pattern of the crop field trials.  The residue values used to calculate
the tolerance are provided in Table I-1.

Residues of thiamethoxam were above the LOQ in/on all samples.  However,
residues of CGA-322704 were below the LOQ in 4 of the 12 samples; these
samples are indicated in red font in Table I-1.  Since there were no
thiamethoxam values reported below the LOQ, MLE procedures were not
needed to impute censored values.

The result from the approximate Shapiro-Francia test statistic (Figure
I-4) indicated that the assumption of lognormality should be rejected.
Visual inspection of the lognormal probability plot (Figure I-3)
provided in the spreadsheet confirmed that the dataset is not lognormal.

Since the field trial data for thiamethoxam on caneberry are not
lognormal, the upper bound on the 89th percentile should be selected as
the tolerance value (distribution-free method).  Using the rounding
procedure as outlined in the Guidance for Setting Pesticide Tolerances
Based on Field Trial Data SOP, the upper bound on the 89th percentile
rounds to the value 0.35 ppm.  Therefore, 0.35 ppm is the recommended
tolerance level for thiamethoxam on caneberry.

Figure I-  SEQ Figure \* ARABIC  3 :  Lognormal probability plot for
residues of thiamethoxam in caneberry.

Figure I-  SEQ Figure \* ARABIC  4 :  Data summary table for residues of
thiamethoxam in caneberry.

Grapes

The dataset used to establish a tolerance for combined residues of
thiamethoxam and CGA-322704 on grapes consisted of field trial data
representing two foliar applications at 0.055 lb ai/A/application for a
total rate of 0.110 lb ai/A, with a 5-day PHI.  As specified by the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP,
the field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively.  The residue
values used to calculate the tolerance are provided in Table II-1.
Grape crop field trial representing soil applications at the maximum
proposed rate were also submitted; because the foliar application data
yielded higher residues than the soil application data, the foliar
application data were used for tolerance calculations.

All but two of the 24 field trial sample results had thiamethoxam
residues above the LOQ; residues of CGA-322704 were below the LOQ in/on
all samples except one.  Because the number of values with combined
residues below the combined LOQ was less than 10%, maximum likelihood
estimation (MLE) procedures were not needed to impute censored values.

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

Since the field trial data for thiamethoxam on grapes represent a large
dataset (i.e., more than 15 samples) and are reasonably lognormal, the
minimum of the 95% upper confidence limit (UCL) on the 95th percentile
and the point estimate of the 99th percentile should be selected as the
tolerance value.  Using the rounding procedure as outlined in the
Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP,
the 95% UCL on the 95th percentile and the point estimate of the 99th
percentile rounds to the value 0.20 ppm (Figure II-2).  Therefore, 0.20
ppm is the recommended tolerance level for combined residues of
thiamethoxam and CGA-322704 in/on grapes.

Head and stem brassica, subgroup 5A

The dataset used to establish a tolerance for combined residues of
thiamethoxam and CGA-322704 in/on head and stem brassica consisted of
field trial data representing two foliar applications at 0.088 lb
ai/A/application for a total rate of 0.17 lb ai/A, with a 0-day PHI.
The field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively.  The
representative commodities of the head and stem brassica subgroup are
broccoli (or cauliflower) and cabbage.  Because the cabbage field trials
yielded higher residues than the broccoli field trials, the cabbage
field trials were used for tolerance calculations.  In addition, the
crop field trial data representing combination soil + foliar
applications were not used for tolerance calculations because the
proposed use pattern prohibits combination soil + foliar applications to
head and stem brassica.  The residue values used to calculate the
tolerance are provided in Table II-1.

All 12 field trial sample results had thiamethoxam residues above the
LOQ; residues of CGA-322704 were above the LOQ in/on 10 of the 12
samples.  Because no samples had combined residues below the combined
LOQ, MLE procedures were not needed to impute censored values.

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

Since the field trial data for thiamethoxam on cabbage represent a small
dataset (i.e., less than 15 samples) and are reasonably lognormal, the
upper bound estimate of the 95th percentile based on the median residue
value was compared to the minimum of the 95% UCL on the 95th percentile
and the point estimate of the 99th percentile, and the minimum value was
selected as the tolerance value.  Using the rounding procedure as
outlined in the guidance, the point estimate of the 99th percentile
rounds to the value 4.5 ppm (Figure II-4).  Because this value was the
minimum value, 4.5 ppm is the recommended tolerance level for combined
residues of thiamethoxam and CGA-322704 in/on head and stem brassica,
subgroup 5A.

Broccoli data were also entered into the spreadsheet to compare the
recommended tolerance with that of cabbage; because the recommended
tolerance for cabbage was <5x the recommended tolerance for broccoli
(3.0 ppm), a crop subgroup tolerance is appropriate.

Leafy brassica greens, subgroup 5B

The dataset used to establish a tolerance for combined residues of
thiamethoxam and CGA-322704 in/on leafy brassica greens consisted of
field trial data representing two foliar applications at 0.088 lb
ai/A/application for a total rate of 0.17 lb ai/A, with a 7-day PHI.
The field trial application rates and PHIs are within 25% of the maximum
label application rate and minimum label PHI, respectively. The
representative commodity of the leafy brassica greens brassica subgroup
is mustard greens.  The crop field trial data for mustard greens
representing combination soil + foliar applications were not used for
tolerance calculations because the proposed use pattern prohibits
combination soil + foliar applications to leafy brassica greens.  The
residue values used to calculate the tolerance are provided in Table
II-1.

All 10 field trial sample results had thiamethoxam and CGA-322704
residues above the LOQ; therefore, MLE procedures were not needed to
impute censored values.

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

Since the field trial data for thiamethoxam on mustard greens represent
a small dataset and are reasonably lognormal, the upper bound estimate
of the 95th percentile based on the median residue value was compared to
the minimum of the 95% UCL on the 95th percentile and the point estimate
of the 99th percentile.  Using the rounding procedure as outlined in the
guidance, the point estimate of the 99th percentile rounds to the value
3.0 ppm (Figure II-6).  Because this value was the minimum value, 3.0
ppm is the recommended tolerance level for combined residues of
thiamethoxam and CGA-322704 in/on leafy brassica greens, subgroup 5B.

Leafy vegetables, group 4

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crop field trial data representing combination soil + foliar
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All 12 field trial sample results had thiamethoxam residues above the
LOQ; residues of CGA-322704 were above the LOQ in/on 10 of the 12
samples.  Because no samples had combined residues below the combined
LOQ, MLE procedures were not needed to impute censored values.

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

Since the field trial data for thiamethoxam on leaf lettuce represent a
small dataset and are reasonably lognormal, the upper bound estimate of
the 95th percentile based on the median residue value was compared to
the minimum of the 95% UCL on the 95th percentile and the point estimate
of the 99th percentile.  Using the rounding procedure as outlined in the
guidance, upper bound estimate of the 95th percentile based on the
median residue value rounds to the value 4.0 ppm (Figure II-8).  Because
this value was the minimum value, 4.0 ppm is the recommended tolerance
level for combined residues of thiamethoxam and CGA-322704 in/on leafy
vegetables, group 4.

 the recommended tolerance with that of leaf lettuce; because the
recommended tolerance for leaf lettuce was ≤5x the recommended
tolerances for celery (0.80 ppm), head lettuce (0.80 ppm), and spinach
(3.0 ppm), a crop group tolerance is appropriate.

Table II-1.	Residue data used to calculate tolerance for combined
residues of thiamethoxam and CGA-322704 in/on grapes, head and stem
brassica, leafy brassica greens, and leafy vegetables.

Regulator:	EPA	EPA	EPA	EPA

Chemical:	Thiamethoxam	Thiamethoxam	Thiamethoxam	Thiamethoxam

Crop:	Grapes	Cabbage	Mustard greens	Leaf lettuce

PHI:	5 days	0 days	7 days	7 days

App. Rate:	2 at 0.055 lb ai/A/application	2 at 0.088 lb ai/A/application
2 at 0.088 lb ai/A/application	2 at 0.088 lb ai/A/application

Submitter:	Syngenta Crop Protection	Syngenta Crop Protection	Syngenta
Crop Protection	Syngenta Crop Protection

MRID Citation:	MRID 45093705	MRID 44647906	MRID 44647906	MRID 44647907

	Combined Residues of Thiamethoxam and CGA-322704 (ppm)

	<0.03	2.07	0.94	0.89

	<0.05	3.08	0.91	0.76

	<0.04	<0.27	0.50	<0.17

	<0.04	0.93	0.39	0.26

	<0.05	0.68	0.35	1.90

	0.10	0.26	0.45	0.22

	<0.08	0.68	0.58	0.08

	<0.13	0.80	0.43	<0.06

	<0.11	1.13	1.60	0.92

	<0.13	0.81	2.00	0.85

	<0.05	0.62

0.42

	<0.06	<0.42

0.58

	<0.03

<0.03

<0.06

<0.09

<0.04

<0.06

<0.05

<0.10

<0.05

<0.05

<0.02

<0.02

Figure II-   SEQ Figure_II- \* ARABIC  1 .  Lognormal probability plot
of thiamethoxam field trial data for grapes.

Figure II- 2.   Tolerance spreadsheet summary of thiamethoxam field
trial data for grapes.

Figure II- 3.  Lognormal probability plot of thiamethoxam field trial
data for cabbage with 0-day PHI.

Figure II- 4.   Tolerance spreadsheet summary of thiamethoxam field
trial data for cabbage with 0-day PHI.

Figure II- 5.  Lognormal probability plot of thiamethoxam field trial
data for mustard greens with 7-day PHI.

Figure II- 6.  Tolerance spreadsheet summary of thiamethoxam field trial
data for mustard greens with 7-day PHI.

Figure II- 7.  Lognormal probability plot of thiamethoxam field trial
data for leaf lettuce.

Figure II- 8.   Tolerance spreadsheet summary of thiamethoxam field
trial data for leaf lettuce.

Alternate tolerance calculations

In their current submission, Syngenta has proposed PHIs of 0 days for
the head and stem brassica subgroup and 7 days for the leafy brassica
greens subgroup.  In their original submission requesting these uses,
the petitioner had proposed PHIs of 7 days for head and stem brassica
vegetables and 0 days for leafy brassica greens.  The recommended
tolerances for these two subgroups have calculated for these alternate
PHIs.

Head and stem brassica, subgroup 5A

A recommended tolerance for head and stem brassica was calculated using
field trial data representing two foliar applications at 0.088 lb
ai/A/application for a total rate of 0.17 lb ai/A, with a 7-day PHI.
Because the cabbage field trials yielded higher residues than the
broccoli field trials, the cabbage field trials were used for tolerance
calculations.  The residue values used to calculate the tolerance are
provided in Table II-2.

All 12 field trial sample results had thiamethoxam residues above the
LOQ; residues of CGA-322704 were above the LOQ in/on 11 of the 12
samples.  Because no samples had combined residues below the combined
LOQ, MLE procedures were not needed to impute censored values.

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

Using the rounding procedure as outlined in the guidance, the point
estimate of the 99th percentile rounds to the value 1.4 ppm (Figure
II-10).  Because this value was the minimum value, 1.4 ppm is the
recommended tolerance level for combined residues of thiamethoxam and
CGA-322704 in/on head and stem brassica, subgroup 5A with a 7-day PHI.

Broccoli data were also entered into the spreadsheet to compare the
recommended tolerance with that of cabbage; because the recommended
tolerance for cabbage was <5x the recommended tolerance for broccoli
(0.35 ppm), a crop subgroup tolerance is appropriate.

Leafy brassica greens, subgroup 5B

A recommended tolerance for leafy brassica greens was calculated using
field trial data representing two foliar applications at 0.088 lb
ai/A/application for a total rate of 0.17 lb ai/A, with a 0-day PHI.
The residue values used to calculate the tolerance are provided in Table
II-2.

All 10 field trial sample results had thiamethoxam and CGA-322704
residues above the LOQ; therefore, MLE procedures were not needed to
impute censored values.

The thiamethoxam-mustard greens dataset was entered into the tolerance
spreadsheet.  Visual inspection of the lognormal probability plot
(Figure II-11) provided in the spreadsheet indicates that the dataset is
reasonably lognormal and the result from the approximate Shapiro-Francia
test statistic (Figure II-12) confirmed that the assumption of
lognormality should not be rejected.

Using the rounding procedure as outlined in the guidance, the point
estimate of the 99th percentile rounds to the value 9.0 ppm (Figure
II-12).  Because this value was the minimum value, 9.0 ppm is the
recommended tolerance level for combined residues of thiamethoxam and
CGA-322704 in/on leafy brassica greens, subgroup 5B with a 0-day PHI.

Table II-2.	Residue data used to calculate tolerance for combined
residues of thiamethoxam and CGA-322704 in/on head and stem brassica and
leafy brassica greens with alternate PHIs.

Regulator:	EPA	EPA

Chemical:	Thiamethoxam	Thiamethoxam

Crop:	Cabbage	Mustard greens

PHI:	7 days	0 days

App. Rate:	2 at 0.088 lb ai/A/application	2 at 0.088 lb ai/A/application

Submitter:	Syngenta Crop Protection	Syngenta Crop Protection

MRID Citation:	MRID 44647906	MRID 44647906

	Combined Residues of Thiamethoxam and CGA-322704 (ppm)

	0.79	6.3

	0.71	5.7

	0.07	3.8

	<0.06	3.3

	0.12	5.4

	0.16	4.0

	0.32	6.4

	0.26	5.8

	0.29	2.9

	0.25	3.9

	0.19

0.16

Figure II- 9.  Lognormal probability plot of thiamethoxam field trial
data for cabbage with 7-day PHI.

Figure II- 10.   Tolerance spreadsheet summary of thiamethoxam field
trial data for cabbage with 7-day PHI.

Figure II- 11.  Lognormal probability plot of thiamethoxam field trial
data for mustard greens with 0-day PHI.

Figure II- 12.   Tolerance spreadsheet summary of thiamethoxam field
trial data for mustard greens with 0-day PHI.

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Thiamethoxam	Summary of Analytical Chemistry and Residue Data	DP
Numbers:  D281702, D325447

Page   PAGE  137  of   NUMPAGES  137