Document ID: EPA-HQ-OPP-2006-0523-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-06-22T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	17 April 2007

	Subject:	Thiamethoxam.  Summary of Analytical Chemistry and Residue
Data.

		PC Code:  060109	40 CFR 180.565

		Chemical Class:  Neonicotinoid Insecticide (Group 4A)

		PP#0F6142.  Request for Amended Use Patterns for Actara® Insecticide
(EPA Reg. No. 100-938), Centric® 40WG Insecticide (EPA Reg. No.
100-1147), and Platinum® Insecticide (EPA Reg. No. 100-939) and to
Register Actara® 240 SC Insecticide (File Symbol No. 100-RELN). 

DP Numbers:	D281702, D325447	Decision Number:	363553

MRID Nos.:	44829301, 44939801, 44939802, 45086203, 45093301,
45093705-45093707, 45093709, 45093711, 45093713-45093716, 45108001,
45140901, 45499901-45499903,  45659201-45659206, 45701201,
45880901-45880903, 46724901-46724903

		Thiamethoxam.  PP#6E7060.  IR-4 Request to Add Uses on Artichoke,
Barley, and Caneberry to Actara® Insecticide (EPA Reg. No. 100-939) and
Uses on Hops to Platinum® Insecticide (EPA Reg. No. 100-939). 

DP Number:	D335847	Decision Number:	366608

MRID Nos.:	46801401-46801404

		Thiamethoxam.  PP#s3E6805, 9F5051, 3E6806, 3E6781, 2E6363, 3E6800,
3E6807, 4E6819, and 04CA0015.  Section 3 Registration for Seed Treatment
Uses on Legume Vegetables, Potato Seed Pieces, Oilseed Crops; and Foliar
Uses on Cranberry, Mint, Strawberry, Bushberry, and Root Vegetables
(Except Sugarbeet); and the Section 18 Emergency Exemption on Artichoke.

		DP Numbers:	292865, 296610, 297966, 298143, 298157, 300775

MRID Nos.:	45530901, 46114701, 46159201, 46162201, 46162501, 46162502,
46162503, 46162504, 46203601, 46203602

	To:	Dani Daniel/Venus Eagle, PM

		Insecticide/Rodenticide Branch

		Registration Division (7505P)

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

		Registration Action Branch 2

		Health Effects Division (7509P)

	Through:	William T. Drew, Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

		Richard A. Loranger, Ph.D., Branch Senior Scientist

		Registration Action Branch 2

		Health Effects Division (7509P)

This document was originally prepared under contract by Dynamac
Corporation (2275 Research Blvd, Suite 300; Rockville, MD 20850;
submitted 11/06/2006).  The document has been reviewed by the Health
Effects Division (HED) and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

  SEQ CHAPTER \h \r 1 Thiamethoxam [3-[(2-chloro-5-thiazolyl) methyl]
tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-imine] belongs to the
pesticide chemical class known as the neonicotinoids.  It is a
broad-spectrum, systemic insecticide with activity against sucking and
chewing insects on a wide variety of crops.  

Tolerances for residues of thiamethoxam are listed in 40 CFR 180.565 and
are expressed in terms of the combined residues of the insecticide
thiamethoxam and its metabolite CGA-322704.  The metabolite CGA-322704
is identical to the active ingredient clothianidin (PC Code 044309). The
established tolerances for plant commodities, under 180.565(a), range
from 0.02 ppm to 1.5 ppm; most of those tolerances are set at the
combined limit of quantitation (LOQ; 0.02 ppm) for thiamethoxam and
CGA-322704.  Tolerances have also been established, under 180.565(a) for
livestock commodities (milk, and meat and meat byproducts of cattle,
goat, hog, horse, and sheep), at 0.02 ppm each.  In addition,
time-limited tolerances for residues of thiamethoxam and CGA-322704 have
been established under 180.565(b) in connection with Section 18
emergency exemptions; these include tolerances for dried and succulent
bean at 0.02 ppm (12/31/06 expiration date) and cranberry at 0.02 ppm
(12/31/07 expiration date).  

Residue chemistry data to support these tolerances were submitted by
Syngenta Crop Protection, Inc. and reviewed by HED under PP#9F5046 (DP
Number D252021, 3/30/00, G.J. Herndon); PP#9F5051 (DP Number D265079,
5/8/00, G.J. Herndon; and DERs 44647906 and 44647907); PP#0F6142 (DP
Number D285545, 11/6/02, M. Doherty); and PP#3E6524, 2E6505, 1E6349, and
2E6508 (DP Number D286726, 12/23/03, Y. Donovan).  With the exception of
the 12/23/03 memo, data deficiencies were identified by HED as
conditions of registration; additional data were required pertaining to:

directions for use (Conclusion 2 of PP#9F5046 review, Conclusions 2b-2e
of D265079 PP#9F5051 review, and Conclusions 2a and 2b of D269520
PP#9F5051 review); 

plant metabolism (Conclusion 6c of PP#9F5046 review, Conclusion 6b of
D265079 PP#9F5051 review, and Conclusion 3 of D269520 PP#9F5051 review);

residue analytical methods (Conclusions 10b and 11a of PP#9F5046 review
and Conclusions 10a and 30g of D265079 PP#9F5051 review); 

storage stability (Conclusion 13a of PP#9F5046 review, Conclusions 12c
and 13 of D265079 PP#9F5051 review, only residue chemistry deficiency of
PP#0F6142 review, and Conclusions 8a and 8b of D269520 PP#9F5051
review); 

meat, milk, poultry, and eggs (Conclusion 30g of D265079 PP#9F5051
review); 

crop field trials (Conclusion 15 of D265079 PP#9F5051 review and
Conclusions 10a and 11a of D269520 PP#9F5051 review); 

processed food/feed (Conclusion 26 of PP#9F5051 review); and

field accumulation in rotational crops (Conclusions 34 and 36 of D265079
PP#9F5051 review).  

As part of PP#9F5051, Syngenta had proposed the establishment of
tolerances for residues of thiamethoxam and its major metabolite,
N-(2-chloro-thiazol-5-ylmethyl)-N’-methyl-N’-nitro-guanidine
(CGA-322704), converted to parent equivalents in/on the following
commodities:

	Leafy vegetables crop group (4)	2.0 ppm

	Head and stem Brassica crop subgroup (5A)	1.0 ppm

	Leafy Brassica greens crop subgroup (5B)	2.0 ppm

In review of PP#9F5051, HED recommended against these tolerances until
submission of additional plant metabolism data and supporting crop field
trial data.

Syngenta has now submitted residue chemistry data to satisfy the data
deficiencies identified in previous reviews.  Syngenta has also
proposed, in PP#0F6142, the establishment of a tolerance for 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’-nitroguanidine] in/on
the following raw agricultural commodities:  

	Grapes	0.15 ppm

	Grape, juice	0.20 ppm

	Raisins	0.30 ppm

Syngenta had also proposed tolerances for peanut commodities; however,
the proposal has since been withdrawn (letter from Fred Pearson,
Syngenta to Dan Kenny, EPA/RD, 4/26/04).  

In addition, Syngenta submitted a request to register a new thiamethoxam
product, Actara® 240 SC Insecticide (EPA File Symbol No. 100-RELN), a 2
lb/gal suspension concentrate (equivalent to a flowable concentrate;
FlC) formulation, for foliar uses on the bushberry subgroup, cranberry,
cotton, cucurbit vegetables, fruiting vegetables, juneberry,
lingonberry, mint, pecan, pome fruit, root vegetables subgroup, salal,
stone fruit, strawberry, tobacco, and tuberous and corm vegetables
subgroup.  Syngenta has submitted bridging crop field trial data for
selected crops to support the requested uses.  

Syngenta has also submitted amended labels for three products with
food/feed uses:  Actara® Insecticide (EPA Reg. No. 100-938), a 25%
water-dispersible granule (WG) formulation; Centric® 40WG Insecticide
(EPA Reg. No. 100-1147), a 40% WG formulation; and Platinum®
Insecticide (EPA Reg. No. 100-939), a 2 lb/gal FlC formulation.  For the
25% WG formulation, the petitioner has proposed:  to add uses on globe
artichoke, barley, caneberry, brassica leafy vegetables, grapes, and
leafy vegetables; to reinstate cucurbit vegetables and fruiting
vegetables to the label; and to increase the maximum seasonal rates for
bushberry, cranberry, cucurbit vegetables, fruiting vegetables, mint,
pome fruit, stone fruit, and strawberry.  For the 40% WG formulation,
the petitioner has proposed to increase the maximum seasonal rate to
cotton.  For the 2 lb/gal FlC formulation, the petitioner has proposed: 
to add uses on brassica leafy vegetables, grapes, hops, and leafy
vegetables; to increase the maximum application rate to bushberry,
cucurbit vegetables, fruiting vegetables, root vegetables subgroup 1B
(except sugarbeet), and strawberry; and to add an additional application
method for tuberous and corm vegetables.  

The   SEQ CHAPTER \h \r 1 Interregional Research Project No. 4 (IR-4)
has submitted a request for an amended registration of the end-use
product Actara® Insecticide to include new uses on artichoke (globe),
barley, and caneberry.  IR-4 has also requested to amend the
registration of Platinum® Insecticide to include new use of
thiamethoxam on hops.  Concurrently, IR-4 requests the establishment of
permanent tolerances for residues of the insecticide thiamethoxam   SEQ
CHAPTER \h \r 1
[3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-ox
adiazin-4-imine] and its CGA-322704  SEQ CHAPTER \h \r 1  metabolite
[N-(2-chloro-thiazol-5-ylmethyl)-N’-methyl-N’-nitro-guanidine]  SEQ
CHAPTER \h \r 1 , in/on the following raw agricultural commodities:  

	Artichoke, globe	0.40 ppm

	Barley, grain	0.30 ppm

	Barley, hay	0.40 ppm

	Barley, straw	0.40 ppm

	Caneberry subgroup 13A	0.30 ppm

	Hop, dried cones	0.10 ppm

Current thiamethoxam tolerances for barley grain, hay, and straw were
based on a seed-treatment use.  The petitioner has requested to add
foliar uses of thiamethoxam on barley to the label for the 25% WG
formulation, at a maximum seasonal rate of 0.094 lb ai/A with a 21-day
preharvest interval (PHI) and a retreatment interval (RTI) of 7 days.  

In addition, IR-4 proposes to add foliar uses of thiamethoxam on
artichoke and caneberry to the label for the 25% WG formulation, at a
maximum seasonal rate of 0.188 lb ai/A with a 7-day RTI, a 4-day PHI for
artichoke, and a 3-day PHI for caneberry.  IR-4 has proposed to add use
on hops to the label for the 2-lb/gal SC formulation as a single
soil-surface band treatment at a maximum application rate of 0.125 lb
ai/A with a 65-day PHI.  Applications to artichokes, barley, and
caneberry are to be made using ground or aerial equipment; applications
to hops are to be made using ground equipment only.

  SEQ CHAPTER \h \r 1 The nature of the residues of thiamethoxam has
been adequately delineated based on metabolism studies with corn,
cucumbers, pears, rice, wheat, goats, and hens.  The metabolism of
thiamethoxam in plants and livestock generally involves: (i) opening of
the oxadiazine ring by hydrolysis; (ii) loss of the nitro group; (iii)
hydrolysis of the guanidine moiety to urea derivatives; (iv) cleavage of
the N-C bridge between the two ring systems; and (v) N-demethylation of
the oxadiazine ring or its derivatives.  Initial hydrolysis of the
oxadiazine ring of thiamethoxam yields CGA-322704.  The residues of
concern for both the tolerance expression and risk assessment purposes
are the combined residues of thiamethoxam and CGA-322704.   New
metabolism studies with lettuce, potato and tobacco have been submitted
and the new studies indicate that the metabolism of thiamethoxam in
lettuce, potato and tobacco is similar to the metabolism observed in
corn, cucumbers, pears, rice, and wheat.

  SEQ CHAPTER \h \r 1 An adequate method is available to enforce the
established and proposed tolerances, HPLC Method AG-675.  The method may
be obtained from the Analytical Chemistry Branch of the Biological and
Economic Analysis Division (ACB/BEAD).  Briefly, the method consists of
extraction with aqueous acetonitrile (ACN), liquid-liquid partitioning
and solid-phase extraction cleanup, and analysis by HPLC with UV or MS
detection.  The LOQ is 0.01 ppm for each analyte in most commodities. 
The petitioner has submitted a modification of the method to add a
microwave extraction step for liver; the modification has been
adequately validated.  The petitioner should submit a revised version of
Method AG-675 which includes the full extraction steps for plant and
livestock commodities, including the microwave extraction step for
liver; the fulfillment of this data requirement may be considered a
condition of registration.

Adequate field trial data have been submitted to support the requested
new uses of the 25% WG formulation (EPA Reg. No. 100-938) and the 2
lb/gal FlC formulation (EPA Reg. No. 100-939) on brassica leafy
vegetables, grapes, and leafy vegetables.  Additional information,
pertaining to residues in/on untreated samples and product formulations,
should be submitted for one of the brassica leafy vegetable studies and
two of the leafy vegetable studies; fulfillment of these requirements
may be considered a condition of registration.  The submitted crop field
trial data were collected using the existing enforcement method and are
supported by adequate storage stability data.  The data indicate that
the proposed tolerances for grapes, head and stem brassica, leafy
brassica greens, and leafy vegetables are too low; tolerances of 0.20
ppm, 4.5 ppm, 3.0 ppm, and 4.0 ppm, respectively, are needed.  

Adequate crop field trial data have been submitted or are available to
support the amended use patterns of the 25% WG formulation (EPA Reg. No.
100-938) and the 2 lb/gal FlC formulation (EPA Reg. No. 100-939), with
the exception of the additional application method for tuberous and corm
vegetables proposed on the 2 lb/gal FlC formulation label.  The
submitted crop field trial data were collected using the existing
enforcement method and are supported by adequate storage stability data.
 The crop field trial data indicate that the established tolerance of
0.02 ppm for the root vegetable, except sugar beets, subgroup is too
low; an increased tolerance of 0.05 ppm is needed.  In addition, the
established tolerance for radish tops should be expanded to include the
leaves of root and tuber vegetables, except sugar beets.  The data
indicate that the established tolerance of 0.25 ppm for potato may be
reduced to 0.15 ppm.

Adequate processing data were submitted for grape, mint, and potato. 
These data indicate that a tolerance for raisins is necessary; the
proposed 0.30-ppm tolerance is appropriate.  The processing data also
indicate that no tolerances are needed for grape juice or the processed
commodities of mint and potato.  Additional information is needed to
support a previously submitted apple processing study.

Adequate data have been submitted to demonstrate that there are no
significant differences in residues as a result of treatment with the
2-lb/gal flowable concentrate formulation versus the 25%
water-dispersible granule formulation of thiamethoxam.  The bridging
data support registration of the SC formulation on those crops listed as
registered for the WG formulation.

Adequate field trial data have been submitted for globe artichoke,
caneberry, and hops.  A residue decline study is required to fulfill
data requirements for barley; this requirement may be considered a
condition of registration.  The submitted crop field trial data are
supported by an adequate analytical method and adequate storage
stability data.  The residue data have been evaluated using the NAFTA
tolerance harmonization methods.  Recommended tolerance levels are
summarized below and in Table 27.  Processing study results indicate
that tolerances for barley processed commodities are not required.  

The established 120-day plantback interval for crops without
thiamethoxam uses is tentatively supported by confined and field
rotational crop studies; additional information on sample storage
conditions for a potential rotational crop metabolite of concern
(CGA-265307) is required.  Fulfillment of this data requirement may be
considered a condition of registration.

There are livestock and poultry feed items associated with the proposed
and registered uses of thiamethoxam.  The calculated theoretical dietary
burdens (0.77 ppm for beef cattle and 0.98 ppm for dairy cattle)
resulting from the proposed and registered uses are supported by
previously submitted livestock feeding studies.  HED concludes that the
current tolerances for milk and the meat of cattle, goat, horse, and
sheep, and the meat byproducts of hog are adequate to cover the added
residues resulting from the proposed uses.  However, the available data
indicate that increased tolerances are needed for the meat byproducts of
cattle, goat, horse, and sheep, from 0.02 to 0.04 ppm.

Note to PM:  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 thiamethxoam 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:

′-methyl-N′′-nitro-guanidine], calculated as parent equivalents,
in connection with use of the pesticide under section 18 emergency
exemptions granted by EPA.”

Also, RD should ensure that the use restrictions listed on the Section
18 label that are in place to prevent transfer of residues to potable
water, fish, and irrigated crops that might otherwise result from the
use of thiamethoxam on cranberry are carried over to the Section 3
label.

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

HED has examined the residue chemistry database for thiamethoxam. 
Pending submission of a revised Section B (see requirements under
Directions for Use), a revised Section F (see requirements under
Proposed Tolerances), and a new certificate of analysis or new reference
standard for CGA-322704 (see requirements under Submittal of Analytical
Reference Standards), there are no residue chemistry issues that would
preclude granting a conditional registration for the requested uses of
thiamethoxam or establishment/revision of tolerances for combined
residues of thiamethoxam and CGA-322704.  In addition, there are no
residue chemistry issues that would preclude granting conditional
registration of the amended use directions for Actara® Insecticide (EPA
Reg. No. 100-938) and Platinum® Insecticide (EPA Reg. No. 100-939) as
specified on the amended labels received at EPA 8/2/06.  

The proposed/amended uses and the submitted data support the following
tolerances for the combined residues of thiamethoxam and CGA-322704,
expressed as thiamethoxam equivalents:

	Artichoke, globe	0.45	ppm

	Barley, grain	0.30	ppm

	Barley, hay	0.40	ppm

	Barley, straw	0.40	ppm

	Borage, seed 	0.02 	ppm

	Brassica, head and stem, subgroup 5A	4.50	 ppm	

	Brassica, leafy greens, subgroup 5B	3.0 	ppm

	Bushberry, subgroup 13B	0.20 	ppm

	Caneberry subgroup 13A	0.35	ppm

	Canola, seed	0.02 	ppm

	Cattle, meat	0.02 	ppm

	Cattle, meat byproducts	0.04 	ppm

	Cotton, gin byproducts	1.50 	ppm

	Cotton, undelinted seed	0.10 	ppm

	Crambe, seed	0.02 	ppm

	Cranberry	0.02 	ppm

	Flax, seed 	0.02 	ppm 

	Fruit, pome, group 11	0.20 	ppm

	Fruit, stone, group 12	0.50 	ppm

	Goat, meat	0.02 	ppm

	Goat, meat byproducts	0.04 	ppm

	Grape	0.20 	ppm

	Grape, raisin	0.30 	ppm

	Hog, meat byproducts	0.02 	ppm

	Hop	0.10	ppm

	Horse, meat	0.02 	ppm

	Horse, meat byproducts	0.04 	ppm

	Juneberry	0.20 	ppm

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

	Lingonberry	0.20 	ppm

	Milk	0.02 	ppm

	Mustard, seed 	0.02 	ppm 

	Peppermint	1.50 	ppm

	Potato 	0.15 	ppm

	Rapeseed, seed 	0.02 	ppm

	Safflower, seed 	0.02 	ppm

	Salal	0.20 	ppm

	Sheep, meat	0.02 	ppm

	Sheep, meat byproducts	0.04 	ppm

	Spearmint	1.50 	ppm

	Strawberry	0.30 	ppm

	Sunflower 	0.02 	ppm

	Tomato, paste	0.80 	ppm

	Vegetable, cucurbit, group 9 	0.02 	ppm

	Vegetable, fruiting, group 8	0.25 	ppm

	Vegetable, leafy, except brassica, group 4 	4.0 	ppm

	Vegetable, legume, group 6	0.02 	ppm

	Vegetable, root, except sugar beet, subgroup 1B	0.05 	ppm

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

There are no residue chemistry considerations that would preclude
establishment of permanent tolerances at the above levels.  There are
residue chemistry data gaps that HED believes should be filled and,
therefore, is recommending that any registrations for thiamethoxam be
made conditional upon resolution of the issues noted below.  A human
health risk assessment is forthcoming.

860.1200 Directions for Use

The following label amendments should be made for Actara® 240 SC:  

The Resistance Management section should be corrected to reflect the
fact that Actara® 240 SC is applied foliarly and is not applied to the
soil.  

The use directions for mint should be amended to specify a minimum
retreatment interval (RTI) of 14 days.

The proposed amended use directions for Actara® (EPA Reg. No. 100-938)
are supported by the available crop field trial, provided that the
petitioner makes the following amendments to the proposed label:

The label should clearly state that foliar applications of thiamethoxam
may not be made to any crop which was treated with thiamethoxam as a
soil application.

The proposed PHI for application to leafy vegetables should be revised
to 7 days.

The listing for “Spinach” in the crops included in the Leafy
Vegetables (except Brassica) group should be modified to state
“Spinach, including New Zealand and vine spinach” (the current
wording implies that the only types of spinach that may be treated are
New Zealand and vine spinach).

The proposed minimum RTI for strawberries should be modified from 7 days
to 10 days, the interval that is supported by the available crop field
trial data.

The proposed amended use directions for Platinum® (EPA Reg. No.
100-939) are supported by the available crop field trial, provided that
the petitioner makes the following amendments to the proposed label:

The label should clearly state that foliar applications of thiamethoxam
may not be made to any crop which was treated with thiamethoxam as a
soil application.

The proposed uses on leafy vegetables and brassica leafy vegetables
(head and stem brassica and leafy brassica greens) should be amended to
specify a PHI of 30 days.  

The proposed use on tuberous and corm vegetables as a broadcast soil
application during last hilling operation should be deleted from the
label as no crop field trial data were submitted to support this use.  

The proposed label for Actara® 240 SC and the current product labels
for Actara® (EPA Reg. No. 100-938) and Centric® 40WG (EPA Reg. No.
100-1147) recommend that spray adjuvants be used.  HED recommends that
statements indicating that use of a spray adjuvant may improve spray
coverage be removed from these labels.  The available crop field trial
data did not reflect use of adjuvants in the spray solutions.  HED
recommends such data be provided if the registrant desires statements on
the product labels indicating adjuvants may improve spray coverage.

The product label for EPA Reg. No. 100-941 specifies a seed treatment
rate for cotton in terms of mg ai per individual seed.  The label should
be amended to additionally include an application rate in terms of 100
lb of seed.  The available data support an application rate of 0.3 lb
ai/100 lb seed.

For products which include seed piece treatment for potatoes (EPA Reg.
Nos. 100-941 and 100-1249), a statement prohibiting the application of
thiamethoxam to potato plants grown from treated seed should be added to
the label.

For products which include seed treatment of soybeans (EPA Reg. Nos.
100-941 and 100-1247), a statement prohibiting the grazing, feeding, or
harvesting of treated soybean forage or hay for livestock should be
added to the label; no crop field trial data for soybean forage or hay
have been submitted.

Amendments to the proposed uses are required for the 25% WG formulation
(EPA Reg. No. 100-938) to reflect the parameters of field trial data for
artichoke, barley, and caneberry.

The use directions for artichoke, barley, and caneberry recommend that
spray adjuvants be used.  HED recommends that statements indicating that
use of a spray adjuvant may improve spray coverage be removed from these
labels.  The available crop field trial data did not reflect use of
adjuvants in the spray solutions.  HED recommends such data be provided
if the registrant desires statements on the product labels indicating
adjuvants may improve spray coverage.

For artichokes, the submitted label should be revised to specify a
maximum seasonal rate of 0.094 lb ai/A (6 oz product/A).  The proposed
single application rate, RTI, and PHI are supported by the submitted
crop field trial data.

For barley, the label should be revised to restrict use to barley grown
in the states of ID, ND, OR, SD, and WA.  The available data would
support an increase in the proposed application rate, to a maximum of
two applications at 0.063 lb ai/A/application (4 oz product/A) for a
maximum seasonal rate of 0.125 lb ai/A.  The proposed 7-day RTI and
21-day PHI are supported by the available data.

For caneberry, the label should be revised to specify a maximum single
application rate of 0.047 lb ai/A (3 oz product/A) and a maximum
seasonal rate of 0.094 lb ai/A (6 oz product/A).  The submitted crop
field trial data support the 7-day RTI and the 3-day PHI.

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

The analytical reference standard for thiamethoxam metabolite CGA-322704
currently available at the EPA National Pesticide Standards Repository
has expired.  The registrant should either recertify the lot in the
repository and send in an updated certificate of analysis, or submit a
new standard (different lot #) if the previous lot will not be
recertified.  

860.1550 Proposed Tolerances

The proposed tolerances for grapes, head and stem brassica, leafy
brassica greens, leafy vegetables, and raisins should be revised to
reflect the recommended tolerance levels and correct commodity
definitions as specified above and in Table 27.  In addition, the
tolerance for grape juice should be removed from the petition; the
available data indicate that a tolerance is not needed for grape juice.

HED recommends that conversion of conditional registration to
unconditional registration for the requested uses may be considered upon
submission of the outstanding residue chemistry data pertaining to
residue analytical methods; meat, milk, poultry, and eggs; crop field
trials; processed food and feed; and field accumulation in rotational
crops.

860.1340 Residue Analytical Methods

The petitioner should submit a revised version of Method AG-675 which
includes the full extraction steps for plant and livestock commodities,
including the microwave extraction step for liver.  The revised method
will then be forwarded to FDA for inclusion in PAM Vol. II.

860.1480 Meat, Milk, Poultry, Eggs

The petitioner should conduct a new poultry feeding study in which liver
samples are analyzed using the modified enforcement method, which
includes a microwave extraction step.  Liver samples should be analyzed
for residues of CGA-322704 and CGA-265307 as these metabolites were
found in significant quantities in the microwave hydrolysate in the
metabolism study.

860.1500 Crop Field Trials

A residue decline study is required to fulfill data requirements for
barley.

If the petitioner wishes to support soil applications to tuberous and
corm vegetables later than crop emergence, additional crop field trial
data are required.  

The petitioner should provide an explanation for the residues observed
in/on untreated leafy vegetable samples in the crop field trial study
reported in MRID 45880901.  

860.1520 Processed Food and Feed

The petitioner had previously been required to submit complete sample
history information including storage conditions for processed apple
commodities to support the apple processing study reported in MRID
44715134 (conclusion 26 of PP#9F5051 review, DP Number D265079, 5/8/00,
G.J. Herndon).  This information remains outstanding.

860.1900 Field Accumulation in Rotational Crops

The petitioner had previously been required to submit information
pertaining to sample storage conditions for rotational crop commodities
to support the field rotational crop study reported in MRID 44715106
(conclusion 34 of PP#9F5051 review, DP Number D265079, 5/8/00, G.J.
Herndon).  This information remains outstanding.

HED notes that the submitted data have resolved several previous data
deficiencies for thiamethoxam.  All data deficiencies specified in the
review for PP#9F5046 (DP Number D252021, 3/30/00, G.J. Herndon) have now
been resolved.  All data deficiencies, with the exception of those
specified in conclusions 26 and 34 (sample storage conditions only), of
the review for PP#9F5051 (DP Number D265079, 5/8/00, G.J. Herndon) have
now been resolved; and the only data deficiency specified in the review
for PP#0F6142 (DP Number D285545, 11/6/02, M. Doherty) has been
resolved.  All remaining data deficiencies have been reiterated above.

Background

Thiamethoxam is a broad-spectrum nitroguanidine insecticide which
belongs to the pesticidal class of compounds known as the neonicotinoids
(Group 4A; Insecticide Resistance Action Committee, Crop Life
International).  It has activity against sucking and chewing insects on
a wide variety of crops.  It appears to interfere with the nicotinic
acetyl choline receptors of the insect’s nervous system, but the
specific receptor site is unknown at this time.  It does not inhibit
cholinesterase or interfere with sodium channels and, therefore, has a
different mode of action than organophosphate, carbamate, and pyrethroid
insecticides.

The chemical structure and nomenclature of thiamethoxam and its
regulated metabolite CGA-322704 are presented in Table 1.  The
physicochemical properties of the technical grade of thiamethoxam are
presented in Table 2.

Table 1.		Thiamethoxam Nomenclature.

Chemical structure	

Common name	Thiamethoxam

Company experimental name	  SEQ CHAPTER \h \r 1 CGA 293343

IUPAC name	  SEQ CHAPTER \h \r 1
3-(2-chloro-1,3-thiazol-5-ylmethyl)-5-methyl-1,3,5-oxadiazinan-4-ylidene
(nitro)amine

CAS name	  SEQ CHAPTER \h \r 1
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxa
diazin-4-imine

CAS registry number	  SEQ CHAPTER \h \r 1 153719-23-4

End-use product (EP)	25% WG formulation (Actara® Insecticide; EPA Reg.
No. 100-938)

2 lb/gal FlC formulation (Platinum® Insecticide; EPA Reg. No. 100-939)

40% WG formulation (Centric® 40WG Insecticide; EPA Reg. No. 100-1147)

2 lb/gal FlC formulation (Actara® 240 SC Insecticide; EPA File Symbol
No. 100-RELN)

Chemical structure of CGA-322704 metabolite	

N-[(2-chloro-5-thiazoyl)methyl]-N’-methyl-N”-nitroguanidine

Table 2.		Physicochemical Properties of Thiamethoxam.  

Parameter	Value	Reference

Melting point/range	139.1 (C	PMRA Regulatory Note (REG2001-03) on
Thiamethoxam, 2/9/01

pH	4.7 (1% solution in water)

	Density	1.57 x 103 kg/m3

	Water solubility	4.1 g/L (25 °C)

	Solvent solubility	Solvent

acetone

dichloromethane

ethyl acetate

hexane

methanol

octanol

toluene	Solubility (g/L)

48

110

7.0

<1 mg/L

13

0.62

0.68

	Vapor pressure	2.7 x 10-9  Pa (20 (C)

6.6 x 10-9  Pa (25 (C)

	Dissociation constant, pKa	No dissociation within the pH range 2–12

	Octanol/water partition coefficient, Log(KOW)	0.13 ± 0.0017 (25 (C)

	UV/visible absorption spectrum	Not available

	

860.1200  Directions for Use

Syngenta has submitted a proposed label for a 2 lb/gal FlC formulation
(Actara® 240 SC Insecticide; EPA File Symbol No. 100-RELN) proposed for
foliar uses on the following crops:  bushberry subgroup; juneberry;
lingonberry; salal; cotton; cranberry; cucurbit vegetables; fruiting
vegetables; mint (peppermint and spearmint); pecan; pome fruit; root
vegetable subgroup, except sugar beets; stone fruit; strawberry;
tobacco; and tuberous and corm vegetables.  In addition, Syngenta has
submitted amended labels for three products:  Actara® Insecticide (EPA
Reg. No. 100-938), a 25% WG formulation; Centric® 40WG Insecticide (EPA
Reg. No. 100-1147), a 40% WG formulation; and Platinum® Insecticide
(EPA Reg. No. 100-939), a 2 lb/gal FlC formulation.

HED notes that the proposed label for Actara® 240 SC and amended label
for Platinum® Insecticide (EPA Reg. No. 100-939) each state on the
front page of the label that the product is a “soluble concentrate,”
containing 2 lbs of thiamethoxam per gallon.  Based on the reported
water solubility of thiamethoxam, of 4.1 g/L (0.034 lb/gal; see Table
2), it seems unlikely that the products are soluble concentrates.  The
product labels specify, under Mixing Directions:  “Vigorous agitation
is necessary for proper dispersal of the product.  Maintain maximum
agitation throughout the spraying operation.”  Based on these
considerations, we concluded that the products are flowable concentrate
(i.e., suspension concentrate) formulations.

 

A summary of the products for which proposed/amended labels were
submitted is presented in Table 3.  A summary of the proposed/amended
use directions on these labels is presented in Table 4.  

Table 3.		Summary of Proposed/Registered End-Use Products.

Trade Name	Reg. No.	ai (% of formulation)	Formulation Type	Target Crops
Target Pests	Label Date

Actara® Insecticide	100-938	25.0	WG	Barley; Berries (caneberry
subgroup, bushberry subgroup, juneberry, lingonberry, salal); Brassica
leafy vegetables; Cranberry; Cucurbit vegetables; Fruiting vegetables;
Globe artichoke; Grapes; Leafy vegetables; Mint;  Pome fruit; Root
vegetable subgroup, (except sugar beets); Stone fruit; Strawberry;
Tobacco; and Tuberous and corm vegetables	A variety of sucking and
chewing insects	Undated

Actara® 240 SC Insecticide	100-RELN	21.6 (2 lb/gal)	FlC	Bushberry
subgroup; Juneberry; Lingonberry; Salal; Cotton; Cranberry; Cucurbit
vegetables; Fruiting vegetables; Mint; Pecan; Pome fruit; Root vegetable
subgroup, except sugar beets; Stone fruit; Strawberry; Tobacco; and
Tuberous and corm vegetables	A variety of sucking and chewing insects
12/19/05

Centric® 40WG Insecticide	100-1147	40.0	WG	Cotton; Pecan	A variety of
sucking and chewing insects	10/27/05

Platinum® Insecticide	100-939	21.6 (2 lb/gal)	FlC	Bushberry subgroup;
Juneberry; Lingonberry; Salal; Brassica leafy vegetables; Cucurbit
vegetables; Fruiting vegetables; Leafy vegetables; Grapes; Hops; Root
vegetable subgroup, except sugar beets; Strawberry; Tobacco; and
Tuberous and corm vegetables	A variety of sucking and chewing insects
Undated

Currently, several thiamethoxam products are registered for use on crops
associated with this review [canola; cotton; cranberry; mint;
strawberry; tobacco, and crop groups/subgroups 1B (root vegetables
except sugar beet), 1C (tuberous and corm vegetables), 6 (legume
vegetables), 8 (fruiting vegetables), 9 (cucurbit vegetables), 11 (pome
fruit), 12 (stone fruit), and 13B (bushberry)]:  

Helix XTra™ Insecticide with Fungicides (EPA Reg. No. 100-935), a 2.23
lb/gal ready-to-use (RTU) formulation; label dated 2/3/06;

Actara® Insecticide (EPA Reg. No. 100-938), a 25% WG formulation; label
dated 12/22/04;

Platinum® Insecticide (EPA Reg. No. 100-939), a 2 lb/gal FlC
formulation; label dated 7/9/05;

Cruiser® Insecticide (EPA Reg. No. 100-941), a 5 lb/gal FlC
formulation; label dated 2/3/06;

Centric® Insecticide (EPA Reg. No. 100-968), a 25% WG formulation;
label dated 12/11/03;

Helix™ Insecticide with Fungicides (EPA Reg. No. 100-973), a 1.12
lb/gal RTU formulation; label dated 2/3/06;

Platinum Ridomil Gold™ Insecticide/Fungicide (EPA Reg. No. 100-974), a
0.406 lb/gal FlC formulation; label dated 11/24/04;

Centric® 40WG Insecticide (EPA Reg. No. 100-1147), a 40% WG
formulation, label dated 10/15/03; 

CruiserMaxx™ Beans Insecticide Fungicide (EPA Reg. No. 100-1247), a
2.15 lb/gal EC formulation; label dated 5/24/06;

Adage®-Maxim® 4FS Twin Pack Insecticide-Fungicide (EPA Reg. No.
100-1249), a 5 lb/gal FlC formulation; label dated 4/14/06.

HED notes that EPA Reg. No. 100-974 (Platinum Ridomil Gold) is coded
incorrectly in PPLS as an emulsifiable concentrate formulation.  

Table 4. 	Summary of Proposed/Amended Directions for Use of
Thiamethoxam.

Formulation

[EPA Reg. No.]	Application Timing	Application Rate 

(lb ai/A)	Max. No. Applic. per Season	Minimum RTI1

(days)	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and other Limitations

Artichoke, Globe

25% WG

[100-938]	Foliar spray	0.047	4 (implied)	7	0.188	4	Applications are to
be made in a minimum of 10 gal/A using ground equipment or a minimum of
5 gal/A using aerial equipment.  

Barley

25% WG

[100-938]	Foliar spray	0.047	2 (implied)	7	0.094	21	Applications are to
be made in a minimum of 10 gal/A using ground equipment or a minimum of
5 gal/A using aerial equipment.  Application may not be made following a
long-residual seed or soil application of thiamethoxam.

Brassica (Cole) Leafy Vegetables:  Head and Stem Brassica [Broccoli,
Chinese Broccoli, Brussels Sprouts, Cabbage, Chinese Cabbage (Napa),
Chinese Mustard Cabbage, Cauliflower, Cavalo Broccolo, Kohlrabi]

2 lb/gal FlC

[100-939]	At or post planting or transplant	0.078-0.172	1	Not applicable
(NA)	0.172	14	Application is to be made: as an in-furrow spray during
planting; as a soil drench post seeding or transplant; in trickle or
drip irrigation water; or shanked into the root zone after establishment
or transplant.  Foliar applications of thiamethoxam may not be made
following a long-residual, soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.023-0.086	Not specified (NS)	7	0.172	0
Applications are to be made in a minimum of 10 gal/A using ground
equipment or a minimum of 5 gal/A using aerial equipment.  Application
may not be made following a long-residual seed or soil application of
thiamethoxam. 

Brassica (Cole) Leafy Vegetables:  Leafy Brassica Greens [Broccoli Raab,
Chinese Cabbage (Bok Choy), Collards, Kale, Mizuna, Mustard Greens,
Mustard Spinach, Rape Greens]

2 lb/gal FlC

[100-939]	At or post planting or transplant	0.078-0.172	1	Not applicable
(NA)	0.172	14	Application is to be made: as an in-furrow spray during
planting; as a soil drench post seeding or transplant; in trickle or
drip irrigation water; or shanked into the root zone after establishment
or transplant.  Foliar applications of thiamethoxam may not be made
following a long-residual, soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.023-0.086	NS	7	0.172	7	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  Application may not be made following a
long-residual seed or soil application of thiamethoxam.

Bushberry Subgroup [Blueberry (high and low bush), Currant, Elderberry,
Gooseberry, Huckleberry]; Juneberry; Lingonberry; Salal

2 lb/gal FlC

[100-939]	After bud break prior to beginning of bloom	0.078-0.188	1	NA
0.188	75	Application may be made as a surface band on each side of the
row out to the plant canopy drip line or within the vegetation-free
herbicide strip, in a minimum of 10 gal/A.  On the same day as
application, sufficient irrigation is to be applied following
application to incorporate the product into the plant’s root zone. 
Foliar applications of thiamethoxam may not be made following a
long-residual, soil application of thiamethoxam.

2 lb/gal FlC

[100-RELN]	Foliar spray	0.047-0.063	NS	7	0.125	3	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  Application may not be made following a
long-residual seed or soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.047-0.063	NS	7	0.188	3

	Caneberry [Blackberry, Loganberry, Red and Black Raspberry]

25% WG

[100-938]	Foliar spray	0.031-0.063	NS	7	0.188	3	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  

Cotton

2 lb/gal FlC

[100-RELN]	Foliar spray	0.031-0.047	NS	5	0.094	21	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 3
gal/A using aerial equipment.  Application within 45 days of planting is
prohibited if seeds were treated with a neonicotinoid product.

40% WG [100-1147]	Foliar spray	0.031-0.063	NS	5	0.125	21

	Cranberry

2 lb/gal FlC

[100-RELN]	Foliar spray	0.031-0.063	NS	7	0.125	30	Applications are to be
made in a minimum of 10 gal/A using ground equipment.  Aerial
application is prohibited.  .

25% WG

[100-938]	Foliar spray	0.031-0.063	NS	7	0.188	30

	Cucurbit Vegetables [Chayote, Chinese Waxgourd, Citron Melon, Cucumber,
Edible Gourd, Gherkin, Momordica species, Muskmelon, Pumpkin, Summer And
Winter Squash, Watermelon]

2 lb/gal FlC

[100-939]	At or post planting or transplant	0.078-0.172	1	NA	0.172	30
Application is to be made: as an in-furrow spray during planting; as a
soil drench post seeding or transplant; in trickle or drip irrigation
water; or shanked into the root zone after establishment or transplant. 
Foliar applications of thiamethoxam may not be made following a
long-residual, soil application of thiamethoxam.

2 lb/gal FlC

[100-RELN]	Foliar spray	0.031-0.063	NS	5	0.125	0	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  Application may not be made following an
in-furrow or soil application of thiamethoxam.  Application may not be
made following a long-residual seed or soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.023-0.086	NS	5	0.172	0

	Fruiting Vegetables [Eggplant, Ground Cherry, Pepino, Peppers (Bell,
Chili, Cooking, Pimento, and Sweet), Tomatillo, Tomato]

2 lb/gal FlC

[100-939]	At or post planting or transplant	0.078-0.172	1	NA	0.172	30
Application is to be made: as an in-furrow spray during planting; as a
soil drench post seeding or transplant; in trickle or drip irrigation
water; or shanked into the root zone after establishment or transplant. 
Foliar applications of thiamethoxam may not be made following a
long-residual, soil application of thiamethoxam.

2 lb/gal FlC

[100-RELN]	Foliar spray	0.031-0.063	NS	5	0.125	0	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  Application may not be made following a
long-residual seed or soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.031-0.086	NS	5	0.172	0

	Grapes

2 lb/gal FlC

[100-939]	Soil surface	0.125-0.266	1	NA	0.266	60	Application may be made
as a surface band on each side of the row out to the plant canopy drip
line or within the vegetation-free herbicide strip, in a minimum of 10
gal/A.  On the same day as application, sufficient irrigation is to be
applied following application to incorporate the product into the
plant’s root zone.  Foliar applications of thiamethoxam may not be
made following a long-residual, soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.023-0.055	NS	14	0.109	5	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  Application may not be made following a
long-residual seed or soil application of thiamethoxam.

Hops

2 lb/gal FlC

[100-939]	Soil surface	0.125	1	NA	0.125	65	Application may be made as a
surface band on each side of the row out to the plant canopy drip line
or within the vegetation-free herbicide strip.  On the same day as
application, apply sufficient irrigation following application to
incorporate the product into the plant’s root zone.

Leafy Vegetables (except Brassica) [Amaranth, Arugula, Cardoon, Celery,
Chinese Celery, Celtuce, Chervil, Chrysanthemum (edible-leaved and
garland), Corn salad, Cress (garden and upland), Dandelion, Dock,
Endive, Fennel, Lettuce (head and leaf), Orach, Parsley, Purslane
(garden and winter), Radicchio, Rhubarb, Spinach (New Zealand and vine),
Swiss chard]

2 lb/gal FlC

[100-939]	At or post planting or transplant	0.078-0.172	1	NA	0.172	14
Application is to be made: as an in-furrow spray during planting; as a
soil drench post seeding or transplant; in trickle or drip irrigation
water; or shanked into the root zone after establishment or transplant. 
Foliar applications of thiamethoxam may not be made following a
long-residual, soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.023-0.086	NS	7	0.172	3	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  Application may not be made following a
long-residual seed or soil application of thiamethoxam.

Mint [Peppermint and Spearmint]

2 lb/gal FlC

[100-RELN]	Foliar spray	0.023-0.063	NS	4	0.125	7	Applications are to be
made in a minimum of 10 gal/A using ground equipment.  Aerial
application is prohibited.  

25% WG

[100-938]	Foliar spray	0.023-0.063	NS	14	0.188	7	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment.  

Pecan

2 lb/gal FlC

[100-RELN]	Foliar spray	0.047-0.063	NS	7	0.125	14	Applications are to be
made in a minimum of 50 gal/A using ground equipment or a minimum of 20
gal/A using aerial equipment.  

40% WG

[100-1147]	Foliar spray	0.050-0.063	NS	7	0.125	14

	Pome Fruit [Apples, Crabapples, Loquat, Mayhaw, Quince, Pear, Oriental
Pear (Pyrus pyrifolia)]

2 lb/gal FlC

[100-RELN]	Prebloom foliar spray	0.070-0.086	1	10	0.125	35 or 14
Applications are to be made in a minimum of 50 gal/A using ground
equipment.  Aerial application is prohibited.  Applications to apples
are only to be made to apples produced east of the Mississippi River. 
Applications are not to be made to apples grown in NY except via SLN
NY020001.  A 35-day PHI has been proposed for applications >0.043 lb
ai/A.  A 14-day PHI has been proposed for applications ≤0.043 lb ai/A.
 Applications are not to be made to apples and pears after pre-bloom or
before post bloom. 

	Postbloom foliar spray	0.031-0.086	NS

25% WG

Applications are not to be made to apples grown in NY except via SLN
NY020001.  A 35-day PHI has been proposed for applications >0.043 lb
ai/A.  A 14-day PHI has been proposed for applications ≤0.043 lb ai/A.
 Applications are not to be made to apples and pears after pre-bloom or
before post bloom.  

	Postbloom foliar spray	0.031-0.086	NS

Root Vegetables Subgroup (Except Sugar beets) [Radish, Carrot, Celeriac,
Chicory, Edible Burdock, Garden Beet, Ginseng, Horseradish, Oriental
Radish, Parsnip, Rutabaga, Black Salsify, Spanish Salsify, Skirret,
Turnip, Turnip Rooted Chervil, Turnip Rooted Parsley]

2 lb/gal FlC

[100-939]	At seeding or within 24 hours of seeding	0.078-0.188	1	NA
0.102 for radish;

0.188 for all other crops	NS	Application is to be made: as an in-furrow
spray during planting; immediately after seeding using sufficient water
to incorporate into the seed zone; or in trickle or drip irrigation
water.  Foliar applications of thiamethoxam may not be made following a
long-residual, soil application of thiamethoxam.

2 lb/gal FlC

[100-RELN]

25% WG

[100-938]	Foliar spray	0.023-0.063	NS	7	0.063 for radish;

0.125 for all others	7	Applications are to be made in a minimum of 10
gal/A using ground equipment or a minimum of 5 gal/A using aerial
equipment.  Application may not be made following a long-residual seed
or soil application of thiamethoxam.

Stone Fruit [ Apricot, Chickasaw Plum, Damson Plum, Japanese Plum,
Nectarine, Peach, Plum, Plumcot, Prune (Fresh), Sweet and Tart Cherry]

2 lb/gal FlC

[100-RELN]	Foliar spray	0.031-0.086	2	7	0.125	14	Applications are to be
made as one pre-bloom and/or one post-bloom.  Applications are not to be
made after pre-bloom or before post bloom.  Applications are to be made
in a minimum of 50 gal/A using ground equipment.  Aerial application is
prohibited

25% WG

[100-938]	Foliar spray	0.031-0.086	NS	7	0.172	14	Applications are not to
be made after pre-bloom or before post bloom.  Applications are to be
made in a minimum of 50 gal/A using ground equipment.  Aerial
application is prohibited.  

Strawberry

2 lb/gal FlC

[100-939]	At or post planting, or prior to or at transplant	0.078-0.188
1	NA	0.188	50	Application is to be made: as an in-furrow spray during
planting; as a post transplant drench; in trickle or drip irrigation
water; or as a plant hole treatment just prior to or at transplant. 
Foliar applications of thiamethoxam may not be made following a
long-residual, soil application of thiamethoxam.

2 lb/gal FlC

[100-RELN]	Foliar spray	0.023-0.063	NS	7	0.125	3	Applications are to be
made in a minimum of 10 gal/A using ground equipment.  Aerial
application is prohibited.  Application may not be made following an
in-furrow or soil application of thiamethoxam.

25% WG

[100-938]	Foliar spray	0.023-0.063	NS	7	0.188	3	Applications are to be
made in a minimum of 50 gal/A using ground equipment.  Aerial
application is prohibited.  Application may not be made following a
long-residual seed or soil application of thiamethoxam.

Tobacco

2 lb/gal FlC

[100-939]	At transplant	0.008-0.02 lb/ 1,000 plants	1	NA	0.125	NS
Application is to be made at transplant to transplants in trays or as a
drench during transplanting.  Foliar applications of thiamethoxam may
not be made following a long-residual, soil application of thiamethoxam.

2 lb/gal FlC

[100-RELN]

25% WG

[100-938]	Foliar spray	0.031-0.047	NS	NS	0.047	14	Applications are to be
made in a minimum of 20 gal/A using ground equipment.  Application may
not be made following a long-residual seed or soil application of
thiamethoxam.

Tuberous And Corm Vegetables [Arracacha, Arrowroot, Canna, Bitter And
Sweet Cassava, Chayote (Root), Chinese Artichoke, Chufa, Dasheen,
Ginger, Jerusalem Artichoke, Leren, Potato, Sweet Potato, Tanier,
Turmeric, Yam Bean, Yams]

2 lb/gal FlC

[100-939]	Before planting, at planting, at emergence, or during last
hilling operation	0.078-0.125	1	NA	0.125	NS	Application is to be made:
as an in-furrow spray during planting; before or during planting
impregnated on granular fertilizer; at plant emergence as a directed
spray; or as a broadcast spray during last hilling operation.  Foliar
applications of thiamethoxam may not be made following a long-residual,
soil application of thiamethoxam.

2 lb/gal FlC

[100-RELN]

25% WG

[100-938]	Foliar spray	0.023-0.047	NS	7	0.094	14	Applications are to be
made in a minimum of 10 gal/A using ground equipment or a minimum of 5
gal/A using aerial equipment. Application may not be made following a
long-residual seed or soil application of thiamethoxam.

1  RTI = Retreatment interval

Applications are to be made before pests reach damaging levels.  A
restricted-entry interval (REI) of 12 hours is proposed.  The proposed
label for Actara( 240 SC and the current labels for Actara® (EPA Reg.
No. 100-938) and Centric® 40WG (EPA Reg. No. 100-1147) state that the
use of a spray adjuvant may improve spray coverage but is not required. 
Applications to cranberry may be made through sprinkler irrigation
equipment and applications to tuberous and corm vegetables may be made
using chemigation; application may not be made using irrigation
equipment physically connected to a public water system.

The following recommendations were made on the amended label for
Actara® (EPA Reg. No. 100-938) regarding resistance management:  avoid
using a block of more than three consecutive applications of Actara®
and/or other Group 4A insecticides; following a block of Group 4A
insecticides, rotate to a block of applications of effective products
with a different mode of action before using additional applications of
Group 4A insecticides; and foliar applications of Actara® or other
Group 4A insecticides may not be made following a long-residual soil
application of thiamethoxam or other seed- or soil-applied Group 4A
insecticides.

The following recommendations were made on the amended label for
Platinum® (EPA Reg. No. 100-939) regarding resistance management:  only
a single soil application of Platinum® may be made; and foliar
applications of Group 4A insecticides may not be made following a
long-residual soil application of thiamethoxam or other seed- or
soil-applied Group 4A insecticides.

The following recommendations were made on the proposed label for
Actara® 240 SC regarding resistance management:  only a single soil
application of Actara® 240 SC may be made; and foliar applications of
thiamethoxam or other Group 4A insecticides may not be made following a
long-residual soil application of Actara® 240 SC or other seed- or
soil-applied Group 4A insecticides.

With the exception of EPA Reg. Nos. 100-935, 100-973, and 100-974, the
following rotational crop restrictions are specified:  (i) treated areas
may be replanted immediately following harvest, or as soon as practical
following the last application, with any crop listed on the label and/or
 barley, brassica vegetables, canola, corn, cotton, cucurbit vegetables,
fruiting vegetables, leafy vegetables, legume vegetables, mint, oilseed
crops (rapeseed, Indian rapeseed, Indian mustard seed, field mustard
seed, black mustard seed, flax seed, safflower seed, crambe seed and
borage seed), root vegetables (except sugar beet), sorghum, strawberry,
sunflower, tobacco, tuberous and corm vegetables, and wheat; (ii) any
cover crop planted for erosion control or soil improvement may be
planted as soon as practical following last application, however, the
cover crop may not be grazed or harvested for food or feed; and (iii)
for all other crops, a 120-day plant-back interval (PBI) must be
observed.  HED notes that the amended labels for Actara® and Platinum®
(EPA Reg. Nos. 100-938 and 100-939) received for review did not contain
the rotational crop restrictions sections of the labels; rotational crop
restrictions were obtained from the current approved labels for these
products.

The product label for EPA Reg. No. 100-974 specifies more limiting
rotational crop restrictions than those listed above presumably because
the product also contains the active ingredient mefenoxam.

The following rotational crop restrictions are specified for EPA Reg.
Nos. 100-935 and 100-973:  treated areas may be replanted immediately
following harvest with canola or wheat, or as soon as practical
following the last application; all other crops may be planted 30 days
after the last application.

The proposed changes to the Actara® label (EPA Reg. No. 100-938) are
detailed below:

The resistance management section was expanded;

Uses on the following crops or crop groups were added:  artichoke
(globe); barley; caneberry; brassica leafy vegetables; grapes; and leafy
vegetables; 

Uses on the following crops, which had been voluntarily deleted to
address risk issues, were re-introduced:  cucurbit vegetables and the
fruiting vegetables eggplant, groundcherry, pepino, tomatillo, and
tomato; 

The maximum seasonal application rate was increased for the following
crops or crop groups:  bushberry; cranberry; cucurbit vegetables;
fruiting vegetables; mint; pome fruit; stone fruit; and strawberry;

The restriction to only make applications to mint using ground equipment
was deleted;

The restriction to only make applications to apples grown east of the
Mississippi River was deleted;

The restriction to only make one pre-bloom application to pome fruit was
deleted;

The restriction on the number of pre-bloom and post-bloom applications
to stone fruit was deleted.

The proposed changes to the Centric® 40WG label (EPA Reg. No. 100-1147)
are an increase in the maximum single and seasonal application rates to
cotton, and modification of the rotational crop restrictions to include
crops which have registered thiamethoxam uses on other Syngenta
products.  

The proposed changes to the Platinum® label (EPA Reg. No. 100-939) are
detailed below:

The resistance management section was expanded;

Uses on the following crops or crop groups were added:  brassica leafy
vegetables; grapes; hops; and leafy vegetables; 

The maximum single and seasonal application rates were increased for the
following crops or crop groups:  bushberry; cucurbit vegetables;
fruiting vegetables; root vegetables (except sugar beet) other than
radish; and strawberry;

An additional soil application method was added to the use direction for
tuberous and corm vegetables, to allow broadcast application to the soil
during the last hilling operation.

Conclusions.  The submitted labels are adequate to allow evaluation of
the residue data relative to the proposed/amended uses.  

The use directions for the following crops on the Actara® 240 SC
proposed label are identical to the use directions on the approved
product label for the 25% WG formulation (Actara®; EPA Reg. No.
100-938; label dated 12/22/04):  bushberry subgroup; juneberry;
lingonberry; salal; cranberry; peppers; pome fruit; root vegetable
subgroup, except sugar beets; stone fruit; strawberry; tobacco; and
tuberous and corm vegetables.  For mint, the use directions are
identical except that the Actara® 25% WG formulation specifies a 14-day
minimum RTI.  The current label for the Actara® 25% WG formulation does
not include use directions for cotton, cucurbit vegetables, or pecan.

The use directions for cotton and pecan on the Actara® 240 SC proposed
label are identical to the use directions for cotton and pecan on the
approved label for the 40% WG formulation (Centric® 40WG; EPA Reg. No.
100-1147; label dated 10/15/03).  

There are no registered thiamethoxam products with foliar uses on
cucurbit vegetables or on fruiting vegetables other than peppers. 
However, data to support foliar use of the 25% WG formulation on these
crops have been submitted previously (see 860.1500 – Crop Field
Trials).

The petitioner intends to rely on crop field trial data reflecting
foliar applications of the WG formulation to support foliar applications
of the FlC formulation to the same crops.  To support this translation
of data, the petitioner submitted bridging data reflecting side-by-side
treatments of the 2 lb/gal FlC formulation and the 25% WG formulation. 
Limited side-by-side field trial data were submitted for root vegetables
subgroup 1B (carrot and radish), leafy vegetables (head lettuce, leaf
lettuce, and spinach), brassica leafy vegetables (broccoli, cabbage, and
mustard greens), fruiting vegetables (tomatoes), and stone fruits
(plums); see 860.1500 – Crop Field Trials.  Of these crops, use of
Actara® 240 SC has only been proposed for use on fruiting vegetables,
root vegetables subgroup 1B, and stone fruits.  The side-by-side data
for leafy vegetables and root vegetables subgroup 1B indicated no
significant difference in residues between the two formulations;
however, the side-by-side data for brassica leafy vegetables and plums
indicated that residues resulting from use of the WG formulation were
slightly higher than those resulting from use of the FlC formulation. 
For tomatoes, the data indicate that foliar applications of the FlC
formulation may result in slightly higher residues in tomatoes than
applications of the 25% WG formulation; however, residues were low in/on
all samples.  Based on the overall results, HED has concluded (see
860.1200) 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.  

The following label amendments are needed for Actara® 240 SC:  

The Resistance Management section needs to be corrected to reflect the
fact that Actara® 240 SC is applied foliarly and is not applied to the
soil.  

The use directions for mint should be amended to specify a minimum RTI
of 14 days.

The proposed amended use directions for Actara® (EPA Reg. No. 100-938)
are supported by the available crop field trial, provided that the
petitioner makes the following amendments to the proposed label:

The label should clearly state that foliar applications of thiamethoxam
may not be made to any crop which was treated with thiamethoxam as a
soil application.

The proposed PHI for application to leafy vegetables should be revised
to 7 days.

The listing for “Spinach” in the crops included in the Leafy
Vegetables (except Brassica) group should be modified to state
“Spinach, including New Zealand and vine spinach” [the current
wording implies that the only types of spinach that may be treated are
New Zealand and vine spinach].

The proposed minimum RTI for strawberries should be modified from 7 days
to 10 days, the interval that is supported by the available crop field
trial data.

The proposed amended use directions for Platinum® (EPA Reg. No.
100-939) are supported by the available crop field trial, provided that
the petitioner makes the following amendments to the proposed label:

The label should clearly state that foliar applications of thiamethoxam
may not be made to any crop which was treated with thiamethoxam as a
soil application.

The proposed uses on leafy vegetables and brassica leafy vegetables
(head and stem brassica and leafy brassica greens) should be amended to
specify a PHI of 30 days.  

The proposed use on tuberous and corm vegetables as a broadcast soil
application during last hilling operation should be deleted from the
label as no crop field trial data were submitted to support this use.  

The proposed label for Actara® 240 SC and the current product labels
for Actara® (EPA Reg. No. 100-938) and Centric® 40WG (EPA Reg. No.
100-1147) recommend that spray adjuvants be used.  HED recommends that
statements indicating that use of a spray adjuvant may improve spray
coverage be removed from these labels.  The available crop field trial
data did not reflect use of adjuvants in the spray solutions.  HED
recommends such data be provided if the registrant desires statements on
the product labels indicating adjuvants may improve spray coverage.

The product label for EPA Reg. No. 100-941 specifies a seed treatment
rate for cotton in terms of mg ai per individual seed.  The label should
be amended to additionally include an application rate in terms of 100
lb of seed.

For products which include seed piece treatment for potatoes (EPA Reg.
Nos. 100-941 and 100-1249), a statement prohibiting the application of
thiamethoxam to potato plants grown from treated seed should be added to
the label.

For products which include seed treatment of soybeans (EPA Reg. Nos.
100-941 and 100-1247), a statement prohibiting the grazing, feeding, or
harvesting of treated soybean forage or hay for livestock should be
added to the label; no crop field trial data for soybean forage or hay
have been submitted.

The submitted labels are adequate to allow evaluation of the residue
data relative to the proposed uses on globe artichoke, barley,
caneberry, and hops.  Label amendments are required for the 25% WG
formulation (EPA Reg. No. 100-938) to reflect the parameters of field
trial data for artichoke, barley, and caneberry.

The use directions for artichoke, barley, and caneberry recommend that
spray adjuvants be used.  HED recommends that statements indicating that
use of a spray adjuvant may improve spray coverage be removed from these
labels.  The available crop field trial data did not reflect use of
adjuvants in the spray solutions.  HED recommends such data be provided
if the registrant desires statements on the product labels indicating
adjuvants may improve spray coverage.  

For artichokes, the submitted label should be revised to specify a
maximum seasonal rate of 0.094 lb ai/A (6 oz product/A).  The proposed
single application rate, RTI, and PHI are supported by the submitted
crop field trial data.  

For barley, the label should be revised to restrict use to barley grown
in the states of ID, ND, OR, SD, and WA.  The available data would
support an increase in the proposed application rate, to a maximum of
two applications at 0.063 lb ai/A/application (4 oz product/A) for a
maximum seasonal rate of 0.125 lb ai/A.  The proposed 7-day RTI and
21-day PHI are supported by the available data.

For caneberry, the label should be revised to specify a maximum single
application rate of 0.047 lb ai/A (3 oz product/A) and a maximum
seasonal rate of 0.094 lb ai/A (6 oz product/A).  The submitted crop
field trial data support the 7-day RTI and the 3-day PHI.  

The proposed use directions for hops are in agreement with the submitted
field trial parameters.

860.1300 Nature of the Residue - Plants

DER Reference:	44939802.der.doc (Cucumber)

		45093709.der.doc (Tobacco)

		45093711.der.doc (Tobacco)

		45093713.der.doc (Potato)

		45093714.der.doc (Lettuce)

MRID 44939801 (summarized below; no DER prepared)

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

Metabolism studies with thiamethoxam have been submitted on corn,
cucumbers, pears, rice, and wheat; the studies on cucumbers, pears, and
rice reflected foliar applications, and the studies on corn and wheat
reflected seed treatment and/or soil drench applications.    SEQ CHAPTER
\h \r 1 The metabolism of thiamethoxam in crops generally involves:  (i)
opening of the oxadiazine ring by hydrolysis; (ii) loss of the nitro
group; (iii) hydrolysis of the guanidine moiety to urea derivatives;
(iv) cleavage of the N-C bridge between the two ring systems; and (v)
N-demethylation of the oxadiazine ring or its derivatives.  Initial
hydrolysis of the oxadiazine ring of thiamethoxam yields CGA-322704,
which is a major metabolite in corn, pears, rice and wheat.  CGA-322704
can then either:  (i) lose its nitro group to form NOA-421275 (a major
metabolite in corn); (ii) undergo N-demethylation to yield CGA-265307;
or (iii) be cleaved at the N-C bridge to form NOA-405217 and the
thiazole ring metabolites CGA-359683 and CGA-349208.  Alternatively,
thiamethoxam may initially lose its nitro group to form NOA-407475, and
then undergo hydrolysis of the oxadiazine ring to form NOA-421275, or
oxidation of the oxadiazine ring to form CGA-355190.  [For the chemical
names and structures of identified metabolites, see Appendix I.]

The Metabolism Assessment Review Committee (MARC) has determined that
the residues of concern for purposes of tolerance enforcement and risk
assessment are the combined residues of thiamethoxam and CGA-322704. 
Based on the uses requested under PP#9F5046 and 9F5051, the Committee
recommended that a new plant metabolism study be conducted on a leafy
vegetable (one of the representative commodities in either Crop Group 4
or 5).  Syngenta has now submitted the requested leafy vegetable
metabolism study.  Syngenta has also submitted an amendment to the
previously submitted cucumber metabolism study (reviewed under
PP#9F5046; DP Number D252021, 3/30/00, G.J. Herndon), a potato
metabolism study, and two metabolism studies for tobacco.  

In addition, Syngenta submitted (MRID 44939801) an amendment to the
previously submitted pear metabolism study (reviewed under PP#9F5046). 
The amendment contained additional data generated for pear leaves, and
amended results tables for pear fruit.  The data for pear leaves will
not be addressed herein.  Amended results tables for pear fruit were
presented to clarify results for the analysis of the aqueous fraction
from fruit treated with [14C-oxadiazine]thiamethoxam at the 16x rate;
however, the amended tables do not change any of the results that were
previously reported.  Therefore, the conclusions of the previous review
regarding the nature of the residue in pears do not need revision.

Cucumber:  Syngenta submitted an amendment to a previously submitted
cucumber metabolism study.  Samples of cucumber fruit were re-extracted
and analyzed to provide further metabolite
identification/characterization information.  In the previous study,
extractable organosoluble residues were analyzed by HPLC; however
studies in other crops indicated inconsistencies in the quantitation of
metabolite NOA-407475 by HPLC as a result of retention time dependency
on pH.  In the current submission, organosoluble residues were analyzed
by two-dimensional (2-D) TLC.

In the original study, [14C]thiamethoxam, separately labeled in the
thiazole (labeled at the 2- position) and oxadiazine (labeled at the 4-
position) rings, was applied to cucumbers twice foliarly at ~50 g
ai/ha/application, at a RTI of 10 days, for a total rate of ~100 g ai/ha
(0.09 lb ai/A/season; referred to as 0.5x rate).  Samples of mature
fruit were collected at 0 and 14 days after the last treatment, and
leaves were collected 14 days after the last treatment.  In addition, an
exaggerated rate study was conducted in which each test substance was
applied as a soil drench to seedlings at the first true-leaf stage at
~1500 g ai/ha (1.34 lb ai/A) followed 42 days later by a broadcast
foliar application at ~500 g ai/ha for a total rate of ~2000 g ai/ha
(1.78 lb ai/A/season; referred to as 10x rate).  Samples of leaves and
fruits were harvested prior to the foliar application at 42 days after
the last treatment to provide samples representing the early-season soil
application alone; samples of mature fruit, leaves, and roots and stems
were also collected 14 days after the foliar application.  

As reported in the previous review, following treatment with
thiazole-label and oxadiazine-label [14C]thiamethoxam, TRR were 0.035
and 0.031 ppm, respectively, in samples harvested 14 days following 0.5x
treatment, 0.280 and 0.383 ppm, respectively, in samples harvested 42
days following soil drench treatment, and 0.295 and 0.323 ppm,
respectively, in samples harvested 14 days following soil drench +
foliar treatment.  

For the current submission, subsamples of cucumber fruit from all
treatments were re-extracted using the same procedures as the original
study.  The petitioner reported that because the re-extractions of
cucumber fruit yielded very similar extraction profiles to those from
the original extractions, the original extraction balance values were
used to generate the quantitative distribution.  

The re-analysis data indicate that metabolite NOA-407475 is a
significant component of cucumber residues, at 11.9-19.5% TRR in
thiazole-label samples and 13.2-34.4% TRR in oxadiazine-label samples. 
NOA-407475 was only identified at low levels (up to 5.1% TRR) in the
original study.  The re-analysis yielded results similar to those from
the original study for levels of thiamethoxam and metabolites
CGA-322704, and CGA-355190 in cucumber fruit:  thiamethoxam was found at
9.2-28.0% TRR (0.003-0.103 ppm) and CGA-322704 and CGA-355190 were each
found at <7% TRR.  Levels of CGA-353968 were generally found to be lower
in the re-analyzed samples than in the original report:  0.5-2.4% TRR in
the re-analyzed samples versus 1.1-9.7% TRR in the original report. 
Individual unknowns were found to be ≤8.9% TRR (≤0.033 ppm) in the
re-analyzed samples.

Derivatization and HPLC analysis of two components (Peaks A and B) of
the aqueous extractable residues indicates that each peak is comprised
of multiple unknowns, each ≤6.6% TRR (≤0.02 ppm).  

Based on the results of the cucumber metabolism study, including
characterization and identification of residues in leaves (not reported
herein), the petitioner concluded that thiamethoxam is metabolized in
cucumber via one of two pathways.  The first pathway involves loss of
the nitro group to form NOA-407475, which then undergoes hydrolysis to
form CGA-355190.  Opening of the oxadiazine ring results in the
formation of CGA-353968, which then conjugates with glucose or undergoes
N-demethylation.  The second pathway involves opening of the oxadiazine
ring to form CGA-322704 followed by cleavage of the nitro group to form
NOA-421275.  CGA-322704 may also undergo N-demethylation, to form
CGA-265307, or conjugate with glucose to form the hydroxylamine
glucoside.  

No dates of extraction and/or analysis were provided for the current
submission.  Based on the completion date of the study in comparison
with the experimental termination date of the original study, samples
may have been stored frozen for up to an additional 17 months after the
completion of the original study.  No supporting storage stability data
were provided for the current study.  Because the petitioner used a
different method of analysis for extractable residues, the metabolite
profile of the re-extracted samples cannot be compared with the
metabolite profiles from the original samples to evaluate stability.  

Lettuce:  Syngenta submitted a study investigating the metabolism of
[thiazol-2-14C]thiamethoxam and [oxadiazin-4-14C]thiamethoxam (specific
activities 2.18 MBq/mg and 2.03 MBq/mg, respectively) in lettuce.  The
radiolabeled test substances were formulated as water-dispersible
granule formulations using formulation blank, diluted with water, and
applied to lettuce plants as three sequential foliar treatments at
0.046-0.048 lb ai/A or 0.445-0.480 lb ai/A.  The total application rates
were 0.137-0.144 lb ai/A, 0.8x the proposed maximum seasonal rate, and
1.35-1.43 lb ai/A, 8x the proposed maximum seasonal rate.  Samples were
collected 0, 3, 7, and 14 days following the final application (days
after treatment; DAT) from the 0.8x treatment plots, and 14 DAT from the
8x treatment plots.  

Total radioactive residues (TRR) in lettuce samples were 1.740, 1.023,
0.633, and 0.570 ppm in the 0-, 3-, 7-, and 14-DAT samples,
respectively, from the [thiazol-2-14C]thiamethoxam 0.8x treatment;
1.976, 1.501, 0.772, and 0.688 ppm in the 0-, 3-, 7-, and 14-DAT
samples, respectively, from the [oxadiazin-4-14C]thiamethoxam 0.8x
treatment; and 4.962 and 5.067 ppm in samples harvested 14 days
following the 8x treatments with [thiazol-2-14C]thiamethoxam and
[oxadiazin-4-14C]thiamethoxam, respectively.  

Extraction with 80% methanol in water released the majority of the
radioactivity (83-99%) from lettuce samples.  Soxhlet extraction
released a small amount of additional radioactivity (1.0-1.2%) from
14-DAT samples.  Additional radioactivity (12-15% in total) was released
from the nonextractable residues of 14-DAT samples, 0.8x treatment rate,
using sequential extractions at reflux with methanol/water, water, 1 N
HCl, and 1 N NaOH.  Remaining nonextractable residues in lettuce samples
from the 0.8x treatment accounted for 0.6-11.6% TRR.

These procedures adequately extracted the majority of residues from
lettuce; accountabilities were 98-108%.  Lettuce extracts were profiled
by TLC; metabolites were identified and/or confirmed by LC/MS analyses
of isolated fractions from the extracts of 8x treatment rate samples. 
Adequate storage stability data were submitted to support the storage
durations and conditions of samples from the study.

Approximately 74-95% TRR were identified in lettuce.  Thiamethoxam was
the major residue identified in all samples, at 78-83% TRR (1.4-1.9 ppm)
in 0-DAT samples, 66-70% TRR (0.67-1.1 ppm) in 3-DAT samples, 53-55% TRR
(0.35-0.41 ppm) in 7-DAT samples, and 38-42% TRR (0.24-0.26 ppm) in
14-DAT samples from the 0.8x treatment, and at 48-60% TRR (2.4-3.0 ppm)
in samples from the 8x treatment.  Metabolite CGA 322704 was found in
all samples, at levels ranging 2.1-5.8% TRR (0.022-0.049 ppm), with the
higher levels (in terms of % TRR) found at longer sampling durations. 
All other identified metabolites were found at <8% TRR; these included
NOA 407475, CGA 353042, CGA 382191, NOA 421275, NOA 424255, CGA 204261,
NOA 405217, CGA 265307, 1-(2-chloro-thiazol-5-yl)-urea, CGA 353968, CGA
359683, and CGA 355190, as well as the S-glucose conjugate of
3-(2-mercapto-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-one,
N-glucose conjugate of CGA 353968, O-glucose-conjugate of
(2-chloro-thiazol-5-yl)-methanol (CGA 349208), and O-glucose conjugate
of 1-(2-chloro-thiazol-5-ylmethyl)-1-hydroxymethyl-3-methyl-urea; refer
to Appendix I for the chemical structures of the identified metabolites.
 

Based on the results of the metabolism study, the petitioner proposed
that thiamethoxam is metabolized in lettuce via opening of the
oxadiazinan ring, loss of the nitro group followed by hydrolysis of the
resulting guanidine derivative to the corresponding urea compound,
demethylation, and cleavage of the nitrogen-carbon bridge between the
two rings, leading to oxadiazin- and thiazol-label specific metabolites.
 Metabolite CGA 349208 is sugar conjugated or oxidized to CGA 359683. 
Replacement of the chlorine atom by glutathione conjugation appeared to
occur as a very minor pathway, based on the identification of the
S-glucose conjugate.

Potato:  Syngenta has submitted a study investigating the metabolism of
[thiazol-2-14C]thiamethoxam and [oxadiazin-4-14C]thiamethoxam in
potatoes.  The radiolabeled test substances were formulated with
red-colored formulation blank (Cruiser WS 70), diluted with water, and
applied to potato seed pieces as a seed treatment on the day of planting
at 0.0061 and 0.0063 lb/100 lb seed pieces, respectively, for
[thiazol-2-14C]thiamethoxam and [oxadiazin-4-14C]thiamethoxam, or at
0.0264 and 0.0334 lb/100 lb seed pieces, respectively.  The petitioner
referred to the lower treatment rate as 1x and the higher treatment rate
as 5x; based on the registered potato seed treatment uses, the lower
treatment rates represent ~0.8x and the higher treatment rates represent
~3-4x the maximum seed application rate.  The specific activities of the
test substances were 60.1-60.2 μCi/mg for 1x treatments and 28.5-30.4
μCi/mg for 5x treatments. Samples of immature potato tubers (new
potatoes) and foliage were harvested 84 DAT, and mature potato tubers
and foliage were harvested 106 DAT.  

For tubers, TRR in the 84- and 106-DAT samples were 0.324 and 0.220 ppm,
respectively, from the [thiazol-2-14C]thiamethoxam 1x treatment; 1.163
and 0.853 ppm, respectively, from the [thiazol-2-14C]thiamethoxam 5x
treatment; 0.215 and 0.130 ppm, respectively, from the
[oxadiazin-4-14C]thiamethoxam 1x treatment; and 1.023 and 0.857 ppm,
respectively, from the [oxadiazin-4-14C]thiamethoxam 5x treatment.  For
foliage, TRR in the 84- and 106-DAT samples were 7.436 and 7.637 ppm,
respectively, from the [thiazol-2-14C]thiamethoxam 1x treatment; 42.036
and 41.916 ppm, respectively, from the [thiazol-2-14C]thiamethoxam 5x
treatment; 7.252 and 8.946 ppm, respectively, from the
[oxadiazin-4-14C]thiamethoxam 1x treatment; and 26.430 and 37.174 ppm,
respectively, from the [oxadiazin-4-14C]thiamethoxam 5x treatment.   

Extraction with ACN/water and methanol/water released the majority of
the radioactivity (64-92% TRR) from tubers and foliage.  Additional
residues were released using ACN/water at reflux (2-10% TRR) and water
at reflux (5-14% TRR); enzyme and mild or harsh chemical hydrolysis of
the remaining solids released small amounts of additional radioactivity.
 Remaining nonextractable residues accounted for 0.5-3.8% TRR.  These
procedures adequately extracted the majority of residues from potatoes;
accountabilities were 88-107%.  Metabolite identification and
quantification were conducted by 2-D TLC, with confirmation of
metabolite identification by HPLC.  Adequate storage stability data were
submitted to support the storage durations and conditions of samples
from the study.

 (≤2.5% TRR).  All other identified metabolites were found at <5% TRR;
these included CGA-353968, CGA-265307, CGA-349208, CGA-340575,
NOA-407475, CGA-353042, NOA-405217, N-desmethyl-CGA-353968, NOA-421275,
CGA-382191, and NOA-436944.  A total of 1.7-14.4% TRR was found to be
associated with polysaccharides, and 0.5-2.2% TRR was found to be
associated with lignins and cellulose in foliage.  Individual unknowns
in tubers were each <10% TRR (<0.07 ppm).  

Approximately 28-77% TRR were identified in foliage.  Thiamethoxam
comprised 8.3-13.8% TRR in 84-DAT samples and 1.5-3.3% TRR in 106-DAT
samples.  The metabolite CGA-322704 was found in all samples, at levels
ranging 0.7-3.4% TRR.  The hydroxylamine glucoside conjugate of
CGA-322704 was a major metabolite in immature foliage treated with
[oxadiazin-4-14C]thiamethoxam, at 16.6-20.0% TRR; the metabolite was
identified at 1.9-6.0% TRR in [thiazol-2-14C]thiamethoxam-treated
immature foliage and 3.4-4.5% TRR in
[oxadiazin-4-14C]thiamethoxam-treated mature foliage, and was not
identified in [thiazol-2-14C]thiamethoxam-treated mature foliage.  Other
major metabolites identified in foliage were:  NOA-407475 in all
samples, at 5.6-17.0% TRR; NOA-421275 in all samples, at 5.8-11.9% TRR;
the N-glucoside of CGA-353968 in foliage of
[oxadiazin-4-14C]thiamethoxam-treated immature tubers, at 4.8-12.6% TRR
(found at <2% TRR in other samples); and label-specific metabolites
CGA-353042 and NOA-436944 in foliage of
[oxadiazin-4-14C]thiamethoxam-treated mature tubers, at 9.4-12.1% TRR
and 13.2-14.7% TRR, respectively.  CGA-353042 and NOA-436944 were found
in the foliage of [oxadiazin-4-14C]thiamethoxam-treated immature tubers
at <1% TRR and 5.1-6.8% TRR, respectively.  All other identified
metabolites were found at <6% TRR; these included all metabolites except
CGA-282149 that were identified in tubers, as well as foliage
metabolites CGA-355190 and NOA-421276.  A total of 3.5-10.1% TRR was
found to be associated with polysaccharides, and 0.6-3.8% TRR was found
to be associated with lignins and cellulose.  Individual unknowns in
foliage were each <10% TRR (<3.9 ppm).  

HED notes that because the petitioner did not confirm the identification
of significant foliage metabolites hydroxylamine glucoside of
CGA-322704, NOA-407475, NOA-421275, N-glucoside of CGA-353968,
CGA-353042, and NOA-436944, the identifications of these metabolites in
foliage should be considered to be tentative.

Based on the results of the metabolism study, the petitioner proposes
that thiamethoxam is metabolized in potatoes via cleavage of the
oxadiazine ring to form CGA-322704 with subsequent hydrolysis of the
imine to form CGA-353968.  Thiamethoxam may also undergo bridge cleavage
to form CGA-349208, CGA-282149 and CGA-340575, with the latter two
metabolites being precursors of guanidine.  Alternatively, thiamethoxam
may lose the nitro group to form NOA-407475 which undergoes hydrolysis
of the imine to form CGA-355190.  CGA-322704 may also lose the nitro
group to form CGA-421275 and/or undergo oxidation to form the
hydroxylamine analog; the hydroxylamine analog and CGA-353968 may then
conjugate with glucose.  The petitioner noted that the glucose
conjugates were found to be present in higher quantities in foliage.

Tobacco:  Syngenta submitted a study investigating the metabolism of
[oxadiazin-4-14C]thiamethoxam in tobacco and the pyrolysis products of
[oxadiazin-4-14C]thiamethoxam-treated tobacco.  The test substance was
applied to tobacco plants using three treatment patterns.  Treatment 2
consisted of an in-furrow application at the time of transplanting at
0.132 lb ai/A (~1x the maximum rate for soil application) followed by a
foliar application at 0.058 lb ai/A (1.2x the maximum rate for foliar
application), for a total application rate of 0.189 lb ai/A.  Treatment
3 consisted of an in-furrow application at the time of transplanting at
1.35 lb ai/A (11x) followed by a foliar application at 0.57 lb ai/A
(12x), for a total application rate of 1.92 lb ai/A.  Treatment 4
consisted of a single application as an in-furrow application at the
time of transplanting at 0.186 lb ai/A (1.5x).  The specific activities
of the test substances were 40.8 (Ci/mg for Treatments 2 and 4 and 8.2
(Ci/mg for Treatment 3.  For the in-furrow applications, the
radiolabeled test substance was dissolved in ACN and then diluted with
water for application.  For the foliar applications, the test substance
was formulated as a wettable powder formulation using formulation blank
and then diluted with water for application.  HED notes that the current
and proposed labels prohibit foliar applications to tobacco if a soil
application was made.

Immature tobacco samples were collected prior to foliar application for
all three treatments (126 days after in-furrow treatment).  Mature
tobacco leaf samples were collected at three priming durations:  14, 28,
and 42 days following foliar application for Treatments 2 and 3, and
140, 154, and 168 days following Treatment 4.  Subsamples of mature
green foliage were flue-cured.  

TRR in tobacco matrices are presented in the table below.  The
petitioner noted that appreciable residues were observed in immature
samples, indicating significant uptake of radioactivity from the
in-furrow application.  In general, TRR in composite mature and cured
foliage from Treatment 3 were 10x greater than TRR in samples from
Treatment 2, which corresponds to the difference in the dose level.  TRR
in samples from Treatment 4 were slightly lower than TRR in samples from
Treatment 2, which further indicates that the parent compounds was
readily absorbed and distributed within the tobacco plants after
in-furrow treatment.

Matrix	Priming	ppm [oxadiazin-4-14C]thiamethoxam equivalents

Treatment 2	Treatment 3	Treatment 4

Immature foliage	--	0.875	20.611	1.757

Mature green foliage	First	3.798	27.569	1.592

	Second	0.747	8.819	0.568

	Third	1.026	11.045	0.452

	Composite sample	1.386	13.356	0.711

Cured foliage	First	18.125	176.635	12.383

	Second	17.901	166.413	9.952

	Third	12.739	119.192	10.079

	Composite sample	15.793	161.301	11.048

Extraction with ACN:water (8:2, v:v) released the majority of the
radioactivity from mature green foliage samples (78-87% TRR) and cured
foliage samples (67-73% TRR); immature foliage samples were not
subjected to extraction procedures.  Additional radioactivity (13-28%
TRR in total) was released from the nonextractable residues of Treatment
3 green foliage and Treatment 4 cured foliage using sequential
extractions/hydrolyses with 2-propanol/water, cellulase/cellobiase, 0.1N
HCl, 6 N HCl, 0.1 N NaOH, and 6 N NaOH.  Remaining nonextractable
residues in these tobacco samples were <1% TRR.  

These procedures adequately extracted the majority of residues from
tobacco matrices; accountabilities were 94-100%.  Extracts were profiled
by HPLC and TLC; metabolites were identified and/or confirmed by LC/MS,
LC/MS/MS, and/or 1H-NMR analyses of isolated fractions from the extracts
of Treatment 3 green foliage.  Adequate storage stability data were
submitted to support the storage durations and conditions of samples
from the study.

Approximately 55-65% TRR were identified in green foliage.  Thiamethoxam
was the major residue identified in all green foliage samples, at 14-25%
TRR (0.20 ppm in Treatment 2 foliage).  Metabolite CGA-322704 was found
in all green foliage samples at low levels (3.1-4.2% TRR; 0.049 ppm in
Treatment 2 foliage).  All other identified metabolites were found at
≤10% TRR; these included CGA-353042, CGA-382191, NOA-405217,
NOA-421275, NOA-407475, N-desmethyl-CGA-353968, CGA-353968, CGA-265307,
CGA-355190, guanidine, and the N-glycoside of CGA-353968.  

Approximately 49-58% TRR were identified in cured foliage.  Thiamethoxam
was found to account for a small proportion of the residue in cured
foliage, at 3.5-8.6% TRR (0.723 ppm in Treatment 2 cured foliage). 
Metabolite CGA-322704 was found in all cured foliage samples at slightly
higher levels than were observed in green foliage samples (7.2-8.5% TRR;
1.144 ppm in Treatment 2 cured foliage).  Metabolite NOA-407475 was
identified at 13.1% TRR (1.448 ppm) in Treatment 4 cured foliage, and at
lower levels in Treatment 2 and 3 cured foliage (6.4% and 7.6% TRR,
respectively).  All other identified metabolites were found at <9% TRR;
no metabolites were identified in cured foliage that were not identified
in green foliage.  

Cigarettes made from cured tobacco from each treatment were subjected to
pyrolysis.  The majority of the radioactivity was found in the extracts
and traps of side stream fractions, at 68.5-74.4% TRR, with the majority
of side stream radioactivity found in the traps designed to retain 14CO2
and [14C]methyl isocyanate (54.7-67.2% TRR).  The main stream extract
and trap fractions accounted for 10.0-17.7% TRR, with 3.0-8.3% TRR found
in the 14CO2 and [14C]methyl isocyanate traps.  Radioactivity remaining
in the filter pads, cigarette butt, and ash following extraction
accounted for a total of 5.5-8.6% TRR.  Approximately 71-77% TRR were
identified in the pyrolysis fractions of cigarettes.  Thiamethoxam and
CGA-322704 were found at low levels (0.7% TRR and 0.4-1.0% TRR,
respectively).  The majority of the radioactivity was attributed to
14CO2, at 61.4-69.2% TRR.  [14C]Methyl isocyanate was found to account
for ≤1.0% TRR.  All other identified metabolites were found at ≤2.0%
TRR, and no metabolites, other than methyl isocyanate, were identified
that had not been identified in cured tobacco foliage.  

Based on the results of the metabolism study, the petitioner proposed
that thiamethoxam is metabolized in tobacco via one of two major
pathways.  The first pathway involves loss of the nitro group to form
NOA-407475, which is then cleaved to form polar metabolite CGA-353042. 
CGA-353042 is then further metabolized to form N-methylguanidine and
guanidine, which are incorporated into natural products.  NOA-407475 may
also be oxidized to form urea analog CGA-355190, which undergoes ring
opening to form CGA-353968, its N-glycoside conjugate, and
N-desmethyl-CGA-353968, or may undergo ring opening to form NOA-421275. 
The second pathway involves ring opening of thiamethoxam to form
CGA-322704 which is then demethylated at a nitrogen to form CGA-265307. 
The petitioner noted that CGA-322704 and CGA-265307 were more abundant
in cured tobacco than uncured tobacco, indicating that they are
generated preferentially during the curing process.  NOA-421275 may also
form from CGA-322704 via loss of the nitro group, and then undergo
further metabolism to guanidine-related metabolites.

Syngenta also submitted a study investigating the metabolism of
[thiazol-2-14C]thiamethoxam in tobacco and the pyrolysis products of
[thiazol-2-14C]thiamethoxam-treated tobacco.  The test substance was
applied to tobacco plants using three treatment patterns.  Treatment 2
consisted of an in-furrow application at the time of transplanting at
0.128 lb ai/A (1x) followed by a foliar application at 0.058 lb ai/A
(1.2x), for a total application rate of 0.186 lb ai/A.  Treatment 3
consisted of an in-furrow application at the time of transplanting at
1.27 lb ai/A (10x) followed by a foliar application at 0.58 lb ai/A
(12x), for a total application rate of 1.85 lb ai/A.  Treatment 4
consisted of a single application as an in-furrow application at the
time of transplanting at 0.178 lb ai/A (1.4x).  The specific activities
of the test substances were 40.6 (Ci/mg for Treatments 2 and 4 and 8.0
(Ci/mg for Treatment 3.  For the first application, the radiolabeled
test substance was dissolved in ACN and then diluted with water for
application.  For the foliar applications, the test substance was
formulated as a wettable powder formulation using formulation blank and
then diluted with water for application.  

Immature tobacco samples were collected prior to foliar application for
all three treatments (71 days after in-furrow treatment).  Mature
tobacco leaf samples were collected at three priming durations:  14, 28,
and 42 days following foliar application for Treatments 2 and 3, and 85,
99, and 113 days following Treatment 4.  Subsamples of mature green
foliage were flue-cured.  

TRR in tobacco matrices are presented in the table below.  The
petitioner noted that TRR in composite foliage from Treatment 3 were
~14x greater than TRR in samples from Treatment 2.  TRR in samples from
Treatment 4 were comparable to TRR in samples from Treatment 2,
indicating that the parent compound was readily absorbed and distributed
within the tobacco plants after in-furrow treatment.

Matrix	Priming	ppm [thiazol-2-14C]thiamethoxam equivalents

Treatment 2	Treatment 3	Treatment 4

Immature foliage	--	5.757	55.230	2.777

Mature green foliage	First	2.900	28.329	2.382

	Second	1.633	33.117	1.462

	Third	1.322	21.435	0.924

	Composite sample	1.833	25.463	1.230

Cured foliage	First	16.095	228.634	12.945

	Second	16.636	156.337	12.591

	Third	11.309	122.976	8.949

	Composite sample	13.359	163.462	10.395

Extraction with ACN/water then methanol/water released the majority of
the radioactivity from mature green and cured foliage samples (65-79%
TRR); immature foliage samples were not subjected to extraction
procedures.  Additional radioactivity (16-18% TRR in total) was released
from the nonextractable residues of green foliage (all treatments) and
Treatment 2 cured foliage using extraction at reflux in ACN/water and
then water, followed by hydrolysis using 10% NaOH.  The remaining solid
residues in these tobacco samples were characterized as cellulose (≤2%
TRR).  

These procedures adequately extracted the majority of residues from
tobacco matrices; accountabilities were 94-100%.  Extracts were profiled
by HPLC and TLC.  Adequate storage stability data were submitted to
support the storage durations and conditions of samples from the study.

Approximately 66-77% TRR were identified in green foliage.  Thiamethoxam
was a major residue in all green foliage samples, at 15.3-18.2% TRR
(0.28 ppm in Treatment 2 foliage).  Metabolite NOA-407475 was identified
in all samples, at 13.0-17.0% TRR (0.24 ppm in Treatment 2 foliage), and
the N-glucoside of CGA-353968 was also found to be a major residue in
all samples, at 10.2-13.2% TRR (0.24 ppm in Treatment 2 foliage). 
Metabolite CGA-322704 was found in all green foliage samples at low
levels (2.6-3.7% TRR; 0.050 ppm in Treatment 2 foliage).  All other
identified metabolites were found at <9% TRR; these included
N-desmethyl-CGA-353968, CGA-353968, CGA-355190, CGA-265307, CGA-349208,
NOA-408445, and NOA-421275.  

Approximately 61-64% TRR were identified in cured foliage.  Thiamethoxam
was found to account for a small proportion of the residue in cured
foliage, at 2.1-6.7% TRR (0.278 ppm in Treatment 2 cured foliage). 
Metabolite CGA-322704 was found in all cured foliage samples at higher
levels than were observed in green foliage samples (8.9-11.0% TRR; 1.185
ppm in Treatment 2 cured foliage).  Metabolite NOA-407475 was identified
at 15.5-18.5%% TRR in all cured foliage samples (2.427 ppm in Treatment
2 foliage).  All other identified metabolites were found at <10% TRR; no
metabolites were identified in cured foliage that were not identified in
green foliage.  

The nonextractable residues of green foliage samples (all treatments)
and Treatment 2 cured foliage were subjected to additional extraction
procedures which indicated radioactivity associated with polysaccharides
(4.5-6.9% TRR), lignin (0.2-0.3% TRR in green foliage; 3.0% TRR in cured
foliage), and cellulose (0.4-1.5% TRR).

Cigarettes made from cured tobacco from each treatment were subjected to
pyrolysis.  For the Treatment 2 and 4 cigarettes, the majority of the
radioactivity was found in the extracts and traps of side stream
fractions, at 41.9% and 55.1% TRR, respectively; the extracts and traps
of main stream fractions accounted for 31.4% TRR (Treatment 2) and 28.0%
TRR (Treatment 4).  For Treatment 3 cigarettes, approximately equal
amounts of radioactivity were found in the extracts/traps of main stream
and side stream fractions, at 38.4% and 35.9% TRR, respectively.  For
main stream fractions, the cigarette butt and the 40% KOH traps (which
would retain 14CO2) accounted for the largest portion of the
radioactivity, at 11.1-15.3% TRR and 13.6-17.5% TRR, respectively.  The
KOH traps accounted for the largest portion of the radioactivity in the
side stream fractions, at 29.6-47.5% TRR.  The 1,3-diaminopropane traps,
which would retain carbonyl sulfide (14COS), accounted for a minor
amount of radioactivity (<1.5% TRR).  Radioactivity remaining in the
filter pads, cigarette butt, and ash following extraction accounted for
a total of 10.9-15.1% TRR.  Approximately 61-77% TRR were identified in
the pyrolysis fractions of cigarettes.  Thiamethoxam and CGA-322704 were
found at low levels (0.2-1.1% TRR and 1.1-1.9% TRR, respectively).  The
majority of the radioactivity was attributed to 14CO2, at 47.1-61.1%
TRR.  All other identified metabolites were found at ≤6.8% TRR, and no
metabolites were identified that had not been identified in cured
tobacco foliage.  

Based on the results of the metabolism study, the petitioner proposed
that thiamethoxam is metabolized in tobacco via one of two pathways. 
The first pathway involves loss of the nitro group to form NOA-407475,
which then undergoes hydrolysis to form CGA-355190.  Opening of the
oxadiazine rings results in the formation of CGA-353968, which then
conjugates with glucose or undergoes N-demethylation.  The second
pathway involves opening of the oxadiazine ring to form CGA-322704
followed by cleavage of the nitro group to form NOA-421275.  NOA-421275
may then undergo bridge cleavage to form CGA-349208 and CGA-359683,
which conjugates with glycine to form NOA-408445.  CGA-322704 may also
undergo N-demethylation to form CGA-265307.  

Conclusions.  The submitted metabolism data for lettuce, potato and
tobacco are adequate to satisfy data requirements.  The available data
indicate that the metabolism of thiamethoxam in lettuce, potato and
tobacco is similar to that observed in other crops.  The nature of the
residue in thiamethoxam is now adequately understood.  The residues of
concern in plant commodities are thiamethoxam and CGA-322704.  

The submitted additional metabolism data for cucumber may not be used to
fulfill data requirements because no supporting storage stability data
were provided.  However, sufficient plant metabolism data are available
from other crops (corn, pears, rice, wheat, lettuce, potato and tobacco)
to fulfill data requirements for 860.1300 – Nature of the Residue for
thiamethoxam.

The submitted leafy vegetable metabolism study satisfies the data
requirements of the previous reviews pertaining to plant metabolism
(Conclusion 6c of PP#9F5046 review, Conclusion 6b of D265079 PP#9F5051
review, and Conclusion 3 of D269520 PP#9F5051 review).

Because combined residues of thiamethoxam and CGA-322704 exceeded 0.1
ppm in green tobacco, crop field trial data for tobacco are needed. 
Crop field trial data for tobacco have been submitted and reviewed by
HED (D265079 PP#9F5051 review); the data are discussed under 860.1500
– Crop Field Trials.  The crop field trial data indicate that combined
residues of thiamethoxam and CGA-322704 exceeded 0.1 ppm in cured
tobacco.  The petitioner has conducted the required pyrolysis studies
with thiamethoxam-treated tobacco.  In general, the pyrolysis of tobacco
treated with thiamethoxam labeled in the thiazolyl ring yielded similar
results to that for thiamethoxam labeled in the oxadiazine ring, with
14CO2 accounting for the majority of the radioactivity (~50-70% TRR). 
However, in the oxadiazine-ring label study, the majority of the
radioactivity was found in the side stream smoke fractions (70-75% TRR)
but the radioactivity was more evenly split between the main stream and
side stream fractions in the thiazole-ring study.

860.1300 Nature of the Residue - Livestock

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

The nature of the residue in livestock is adequately understood based on
acceptable goat and hen   SEQ CHAPTER \h \r 1 metabolism studies.  The
metabolism of thiamethoxam in ruminants and poultry is similar.  The
major metabolic pathway involves hydrolysis of the oxadiazine ring to
form CGA-322704 and subsequent demethylation to produce CGA-265307; loss
of the nitro group from these two metabolites also yields NOA-421275 and
NOA-421276.  Several major metabolites (MU3, L14, and MU12) in both
ruminants and poultry also result from the reduction of the nitro group
in thiamethoxam or CGA-265307 to a hydrazine, and subsequent conjugation
with acetic or 2-oxo-propionic acids.  Separation of the thiazole and
oxadiazine rings was only a minor pathway in ruminants and poultry. 
[For the chemical names and structures of identified metabolites, see
Appendix I and Residue Chemistry Memo D257676, 7/21/99, G.J. Herndon and
P. Hurley.]

The MARC has determined that the residues of concern for purposes of
tolerance enforcement and risk assessment are the combined residues of
thiamethoxam and CGA-322704, expressed as thiamethoxam.  The Committee
determined that ruminant metabolites MU12 and N-5 and poultry metabolite
MU3, which contain the chloro-thiazole ring but not the nitro group,
would not need to be included in the tolerance expression or
quantitatively used in a human health risk assessment.  

The MARC additionally concluded that in a laying hen feeding study for
thiamethoxam, the petitioner would need to analyze for the additional
metabolite CGA-265307 (in addition to the parent thiamethoxam and
CGA-322704 metabolites) based on it containing the N-nitro group and
being the major residue in eggs and fat.

860.1340 Residue Analytical Methods

DER Reference:	45140901.der.doc (also includes review of MRIDs 45499901
and 45499903)

		45659202.der.doc (also includes review of MRID 45659203)

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

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

Residue Chemistry Memo D271516, 5/29/01, M. Doherty

Enforcement method:  An   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 HPLC
method with UV or MS detection, Method AG-675, submitted in conjunction
with previous petitions (PP#9F5046 and PP#9F5051) is adequate for
collecting residue data and enforcing tolerances for residues of
thiamethoxam and CGA-322704 in/on crop and livestock commodities.  The
validated LOQ for each analyte is 0.01 ppm for all plant matrices with
the exception of fruit juices (0.005 ppm), grass (0.05 ppm), and cured
tobacco (0.1 ppm).  In livestock, the validated LOQ for residues of
thiamethoxam and CGA-322704 is 0.01 ppm each in meat, poultry, and eggs,
and 0.005 ppm each in milk.  

Briefly, samples are extracted with ACN:water (80:20, v:v), and the
extract is subjected to partitioning with toluene and hexane (livestock
commodity and oil samples only) and then cleaned up by solid-phase
extraction (SPE).  Residues of thiamethoxam and CGA-322704 are
determined in fruits, vegetables, oils, grains, and livestock
commodities using HPLC/UV.  HPLC/MS is used to determine residues in
cotton commodities, tobacco commodities, and the forage, fodder, and
straw of cereal grains and grasses to achieve the desired LOQs.  

Adequate method validation data have been submitted, and the method has
undergone a successful independent laboratory validation (ILV) and
Agency tolerance method validation (TMV).  The method includes a step in
the calculation to convert residues of CGA-322704 to thiamethoxam
equivalents.

This method has been adequately radiovalidated in crop and livestock
commodities, with the exception of liver.  As a condition of
registration under PP#9F5051, the petitioner was required to modify
Method AG-675 to add a microwave extraction step for liver, or propose a
new enforcement method for liver.  Radiovalidation data for the
revised/new method were also required.  

Syngenta has now submitted (MRID 45659202) a modification of Method
AG-675 to include a microwave extraction step for liver.  Liver samples
are first subjected to Polytron extraction using the procedures
described in Method AG-675, yielding the Polytron extract.  The
remaining solids are then subjected to microwave extraction in ACN:water
(8:2, v:v) using a temperature gradient of ambient temperature to 150 (C
over 60 minutes.  The extract is then cleaned up by liquid-liquid
partitioning with toluene and hexane, followed by SPE using strong anion
exchange and phenyl columns, additional partitioning with ethyl acetate,
and sequential SPE using amino and alumina columns.  Residues in the
Polytron extract and microwave extract are then separately determined by
HPLC/MS, and results are summed to determine total residues.  The
reported LOQ is 0.01 ppm.

The Polytron and microwave extraction procedures of the modified method
were adequately validated using fortified samples of goat and chicken
liver; samples were fortified prior to Polytron extraction, and the
solids remaining after Polytron extraction were fortified and subjected
to microwave extraction.  For Polytron extraction, recoveries of
thiamethoxam and CGA-322704 respectively averaged 84% with a standard
deviation of 6.0%, and 93% with a standard deviation of 6.8%, from
samples of goat and chicken liver fortified at 0.01 and 1.0 ppm.  For
microwave extraction, recoveries of thiamethoxam and CGA-322704
respectively averaged 81% with a standard deviation of 8.5%, and 100%
with a standard deviation of 12%, from samples of goat and chicken liver
fortified at 0.01 and 1.0 ppm.  

  SEQ CHAPTER \h \r 1 The fortification levels used in method validation
are adequate to bracket expected residue levels.  The microwave
extraction step is to be used only for analysis of liver samples.  No
confirmatory analysis procedures were included in the description of the
modified method; however, confirmatory analysis procedures, using
HPLC/MS/MS, are specified in the original Method AG-675.

Adequate radiovalidation data were submitted (MRID 45659203).  The
radiovalidation data indicate that the Polytron and microwave extraction
steps adequately extract aged residues of thiamethoxam and CGA-322704
from samples of chicken liver.  Aged residues of thiamethoxam were
adequately extracted from samples of goat liver; however, the extraction
efficiency for CGA-322704 averaged ~40% from goat liver.  The low
extraction efficiency will be considered when risk assessments are
conducted for thiamethoxam.

No ILV data were submitted; however, ILV data will not be required
because adequate ILV data were submitted for the original method.  

Data-collection method:  Samples of plant commodities from the storage
stability, crop field trial, and processing studies included in this
review were analyzed for residues of   SEQ CHAPTER \h \r 1 thiamethoxam
and its metabolite CGA-322704 using the current tolerance enforcement
method, Method AG-675 (with the exception of one storage stability study
discussed below).  For certain commodities (blueberry, canola,
cranberry, grape, and mint), the method was modified to use MS/MS
detection; additional minor modifications were made to remove or modify
sample cleanup steps.  Adequate method validation and concurrent method
recovery data were submitted with the crop field trial and processing
studies.  The LOQ or lowest level of method validation (LLMV) was 0.01
ppm for each analyte in each commodity, with the exception of mint tops
and oil, for which the LOQ was 0.05 ppm for each analyte, and
commodities included in the storage stability studies with plant and
animal commodities, for which the LOQ was reported to be 0.05 ppm for
each analyte.  

Samples of apple, tomato, potato, rapeseed, and corn grain from the
storage stability study with CGA-322704 (see 860.1380 – Storage
Stability) were analyzed for residues of CGA-322704 using HPLV/UV Method
REM 179.03.  This method was also used for the analysis of samples in
coffee crop field trial submissions (see DP Number D286726, 12/23/03, Y.
Donovan).  A description of this method was required in a previous
review (PP#9F5046 review; see conclusion 13a).  Syngenta has submitted
(MRIDs 45140901 and 45499903) a description and radiovalidation data for
Method REM 179.03 for the determination of residues of thiamethoxam and
CGA-322704 in plant commodities.  

Homogenized non-fatty plant samples are extracted with water/methanol,
and homogenized fatty crop samples are extracted with ACN; the extract
from fatty crop samples is partitioned with hexane, and the hexane phase
is discarded.  The extract is cleaned up by sequential SPE on phenyl and
ENVI-Carb columns prior to HPLC/UV analysis using column-switching.  The
reported LOQs are 0.02 ppm for each analyte in food commodities (edible
plant parts) and 0.05 ppm for each analyte in feedstuffs (non-edible
plant parts).  Residues of thiamethoxam and CGA-322704 may be confirmed
by LC/MS/MS, using electrospray ionization in the positive ion mode with
selected reaction monitoring.  

Although MRID 45140901 did not include full validation data for the
method, the representative chromatograms included in the submission
included recovery information; the source of these recovery data was not
specified.  Based on samples of melon fruit, sweet pepper fruit, maize
grain, tomato fruit, and rice grain fortified with each analyte at 0.02
and 0.2 ppm and samples of rice straw fortified with each analyte at
0.05 and 0.5 ppm, thiamethoxam recovery averaged 89% with a standard
deviation of 9% and CGA-322704 recovery averaged 84% with a standard
deviation of 10%.  Adequate method validation data for Method REM 179.03
were also included with studies in which the method was used for
analysis of samples. 

Adequate radiovalidation data have been submitted for pear fruit which
indicate that the method adequately extracts aged residues of
thiamethoxam and CGA-322704.  No ILV data have been submitted.  The
method has not been proposed for enforcement purposes; therefore, no ILV
data are needed.  

Conclusions.  The existing HPLC/UV (or MS) enforcement method, Method
AG-675, is adequate for collecting data on residues of thiamethoxam and
its metabolite CGA-322704 in/on plant commodities.  The method is
adequate for tolerance enforcement purposes for plant commodities.  

The modified version of Method AG-675, which includes a microwave
extraction step for liver, is adequate for data collection and tolerance
enforcement purposes for livestock commodities.  The petitioner should
submit a revised version of Method AG-675 which includes the full
extraction steps for plant and livestock commodities; including the
microwave extraction step for liver (the method submitted in MRID
45659202 only includes directions for the microwave extraction of liver
samples).  The revised method will then be forwarded to FDA for
inclusion in PAM Vol. II.

The submission of the modified version of Method AG-675 satisfies the
data requirements of the previous reviews pertaining to residue
analytical methods for livestock commodities (Conclusion 11a of
PP#9F5046 review and Conclusions 10a and 30g of D265079 PP#9F5051
review).

In the PP#9F5046 review, HED had made the following conclusion regarding
Method AG-675:

  

  SEQ CHAPTER \h \r 1 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 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 addition, no ILV
was submitted for the LC/MS/MS method.  However, HED will defer to the
Analytical Chemistry Branch (ACB) of BEAD for their recommendations
concerning this issue.

The issues raised in the conclusion have been addressed.  The petitioner
submitted data reflecting re-analysis of canola seed samples using
Method AG-675 with LC/MS/MS detection and with no elimination of cleanup
steps (see 860.1500 Crop Field Trials).  Adequate ILV data have been
submitted for the method and the method has undergone adequate
validation at ACB.  In addition, LC/MS/MS equipment is now available at
most enforcement laboratories.  HED concludes that this data requirement
has been satisfied.

860.1360 Multiresidue Methods

  SEQ CHAPTER \h \r 1 DER Reference:	None

See:  Residue Chemistry Memos D259838 and D259839, 9/28/99, G.J. Herndon

Residue Chemistry Memo D252021, 3/30/00, G.J. Herndon

FDA Pestrak Database, dated 6/05

The Agency has reviewed data concerning the recovery of residues of
thiamethoxam using FDA multiresidue method protocols of PAM Vol. I. 
Thiamethoxam was partially recovered (50-60%) using multiresidue method
Section 302 (Protocol D) but was not recovered using Sections 303 or 304
(Protocols E or F).  Metabolites CGA-322704 and CGA-265307 were tested
using Protocol C, but did not yield adequate responses; no further
testing was conducted for the metabolites.  The results of the
multiresidue testing were forwarded to FDA and ACB/BEAD.

860.1380 Storage Stability

Plant commodities

DER Reference:	45086203.der.doc (includes review of MRID 45108001)

		45659205.der.doc

Adequate storage stability data have been submitted previously for   SEQ
CHAPTER \h \r 1 thiamethoxam and CGA-322704 in/on apples, tomato,
potato, rape seed, and corn grain (PP#0F6142; DP Number   SEQ CHAPTER \h
\r 1 D285545, 11/6/02, M. Doherty).  The data indicate that when stored
at -18 (C, residues of thiamethoxam are stable in/on these commodities
for up to ca. 740 days, and residues of CGA-322704 are stable in/on
these commodities for up to 364 days; the reported results for
CGA-322704 were interim results.  

  SEQ CHAPTER \h \r 1 Syngenta has now submitted (MRID 45108001) the
final results of the storage stability study with CGA-322704 in apple,
tomato, potato, rapeseed, and corn grain stored frozen for up to 2
years.  Samples of apple, tomato, potato, rapeseed, and corn grain were
homogenized and fortified with CGA-322704 in water at 0.5 ppm and stored
at -18 ºC for a period up to 729 days (751 days for tomato).  Under
these conditions, residues of CGA-322704 appear to be stable in apple,
tomato, potato, rapeseed, and corn grain for up to 2 years.  Corrections
to residue data to account for in-storage dissipation during those time
periods will not be necessary.

  SEQ CHAPTER \h \r 1 The HPLC/UV method, REM 179.03, used to determine
residues of CGA-322704 in/on apple, tomato, potato, rapeseed, and corn
grain was adequately validated in conjunction with the sample analyses. 
The reported LOQ for this study was 0.05 ppm for all matrices.  

Syngenta has also submitted (MRID 45659205) the final results of a
storage stability study with thiamethoxam and its metabolite CGA-322704
in leaf lettuce, safflower seed, canola oil, corn meal, and tomato puree
stored frozen for 40-42 months.  The interim results of this study were
previously reported (MRID 44715113) and reviewed in conjunction with
PP#9F5046.    SEQ CHAPTER \h \r 1 

Samples of untreated leaf lettuce, safflower seed, canola oil, corn
meal, and tomato puree were fortified with thiamethoxam and CGA-322704
at 0.5 ppm each, and stored frozen at -20 ºC for up to approximately 40
months.  Under these conditions, r  SEQ CHAPTER \h \r 1 esidues of
thiamethoxam and CGA-322704 appear to be relatively stable in canola
oil, corn meal, leaf lettuce, safflower seed, and tomato puree for up to
approximately 40-42 months.  Corrections to residue values from the
residue trials to account for dissipation during storage are not
necessary.

The HPLC method, Method AG-675, used to determine residues of CGA-322704
in/on leaf lettuce, safflower seed, canola oil, corn meal, and tomato
puree was adequately validated in conjunction with the sample analyses. 
The reported LOQ was 0.05 ppm for each analyte in all matrices.

The petitioner conducted concurrent storage stability studies in
conjunction with the submitted crop field trial data for blueberry,
cranberry, and mint and the processing study with mint.  These data
indicate that residues of thiamethoxam and CGA-322704 are stable in
fortified samples of blueberry stored frozen up to 430 days, in
fortified samples of cranberry stored frozen for up to 110 days, in
fortified samples of mint tops stored frozen for up to 452 days, and in
fortified samples of mint oil stored frozen for up to 465 days.

The storage durations and conditions of samples from the crop field
trial and processing studies submitted to support this petition are
presented in Table 5.  

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

Matrix

[MRID]	Storage Temperature

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

Artichoke buds [46801402]	-20	224-231	Residues of thiamethoxam are
stable for up to 740 days, and residues of the metabolite CGA-322704 are
stable for up to 364 days in/on apples, tomato, potato, rape seed, and
corn grain stored frozen.

Barley bran [46801401]	-26 to -4 	91-93	Concurrent storage stability
data indicate that residues of thiamethoxam and CGA-322704 are stable
for up to 592 days in/on barley grain, 182 days in pearled barley, 170
days in barley bran, and 172 days in barley flour stored frozen.

Barley flour [46801401]	-26 to -4 	94-96	Concurrent storage stability
data indicate that residues of thiamethoxam and CGA-322704 are stable
for up to 592 days in/on barley grain, 182 days in pearled barley, 170
days in barley bran, and 172 days in barley flour stored frozen.

Barley grain [46801401]	-26 to -4 	196	Concurrent storage stability data
indicate that residues of thiamethoxam and CGA-322704 are stable for up
to 592 days in/on barley grain, 182 days in pearled barley, 170 days in
barley bran, and 172 days in barley flour stored frozen.

Barley grain [46801401]	-26 to -4 	201-611	Concurrent storage stability
data indicate that residues of thiamethoxam and CGA-322704 are stable
for up to 592 days in/on barley grain, 594 days in/on barley hay, and
599 days in/on barley straw stored frozen.

Barley hay [46801401]	-26 to -4 	203-616	Concurrent storage stability
data indicate that residues of thiamethoxam and CGA-322704 are stable
for up to 592 days in/on barley grain, 594 days in/on barley hay, and
599 days in/on barley straw stored frozen.

Barley straw [46801401]	-26 to -4 	205-618	Concurrent storage stability
data indicate that residues of thiamethoxam and CGA-322704 are stable
for up to 592 days in/on barley grain, 594 days in/on barley hay, and
599 days in/on barley straw stored frozen.

Bean, dry seed [46162502]	Frozen (unspecified temperature)	384-414	24
months

Blueberry [46162201]	<-4	430	Concurrent storage stability data indicate
that residues of thiamethoxam and CGA-322704 are stable for up to 430
days in/on blueberry.

Blueberry [46162201]	<-4	430	430 days for residues of thiamethoxam and
CGA-322704 in/on blueberry stored frozen

Broccoli, flower [45880902]	-29 to 1	21-114	24 months

Broccoli, head & stem [46724902]	-20	101-318	24 months

Cabbage head [45880902]	-29 to 1	43-47	24 months

Cabbage, with and without wrapper leaves [46724902]	-20	253-272	24
months

Caneberry [46801403]	-25 to -16	75-118	Residues of thiamethoxam are
stable for up to 740 days, and residues of the metabolite CGA-322704 are
stable for up to 364 days in/on apples, tomato, potato, rape seed, and
corn grain stored frozen.

Canola seed [44829301]	Frozen (unspecified temperature)	111-206	24
months

Carrot [46203602]	<0	28-455	Residues of thiamethoxam are stable for up
to 740 days, and residues of the metabolite CGA-322704 are stable for up
to 364 days in/on apples, tomato, potato, rape seed, and corn grain
stored frozen.

Carrot, roots [46203602]	<0	28-455	24 months

Celery stalks [45880901]	-29 to 1	72	24 months

Cotton, gin byproducts [45093707]	-20	855-963	40-42 months for
thiamethoxam and CGA-322704 in/on canola oil, leaf lettuce, safflower
seed, and tomato puree stored frozen.

Cotton, undelinted seed [45093707]	-20	863-954	40-42 months for
thiamethoxam and CGA-322704 in/on canola oil, leaf lettuce, safflower
seed, and tomato puree stored frozen.

Cranberry [46114701]	<0	120	110 days for residues of thiamethoxam and
CGA-322704 in/on cranberry stored frozen

Cranberry [46114701]	<0	120	Concurrent storage stability data indicate
that residues of thiamethoxam and CGA-322704 are stable for up to 110
days in/on cranberry.

Dry beans, dry and succulent beans [46162501-46162503] 	Frozen
(temperature unspecified)	197-517	Residues of thiamethoxam are stable
for up to 740 days, and residues of the metabolite CGA-322704 are stable
for up to 364 days in/on apples, tomato, potato, rape seed, and corn
grain stored frozen.

Grape [45093705]	-20	45-231	24 months

Grape, juice [45093705]	-20	75-136	40-42 months for thiamethoxam and
CGA-322704 in/on canola oil, corn meal, and tomato puree stored frozen.

Grape, raisin [45093705]	-20	84-117	40-42 months for thiamethoxam and
CGA-322704 in/on canola oil, corn meal, and tomato puree stored frozen.

Hops, dry cones [46801404]	<-20	treated:  56-68; control:  54-117
Concurrent storage stability data submitted in conjunction with the hops
field trials study indicate that residues of thiamethoxam and CGA-322704
are stable in/on dry hop cones stored frozen for up to 73 days.

Lettuce, head [45880901]	-29 to 1	76	24 months

Lettuce, head [46724901]	-20	46-54	24 months

Lettuce, leaf [45880901]	-29 to 1	105	24 months

Lettuce, leaf [46724901]	-20	359-366	24 months

Mint [45530901]	<0	443-502	Concurrent storage stability data indicate
that residues of thiamethoxam and CGA-322704 are stable for up to
approximately 465 days in/on mint tops and oil.

Mint, oil [45530901]	<0	463-502	465 days for residues of thiamethoxam
and CGA-322704 in mint oil stored frozen

Mint, tops [45530901]	<0	443-482	452 days for residues of thiamethoxam
and CGA-322704 in/on mint tops stored frozen

Mustard greens leaves [46724902]	-20	175-176	24 months

Pea, dry seed [46162501]	Frozen (unspecified temperature)	430-455	24
months

Pea, succulent pods [46162503]	Frozen (unspecified temperature)	197-517
24 months

Pea, succulent seed [46162503]	Frozen (unspecified temperature)	217-315
24 months

Pearled barley [46801401]	-26 to -4 	98	Concurrent storage stability
data indicate that residues of thiamethoxam and CGA-322704 are stable
for up to 592 days in/on barley grain, 182 days in pearled barley, 170
days in barley bran, and 172 days in barley flour stored frozen.

Potato, processed commodities (culls, wet peel and trimmings, flakes,
and chips) [45093706]	-20	3-43	40-42 months for thiamethoxam and
CGA-322704 in/on canola oil, corn meal, and tomato puree stored frozen.

Potato, processed commodities (wet peel and trimmings, flakes, and
chips) [45093301]	-20	245-448	40-42 months for thiamethoxam and
CGA-322704 in/on canola oil, corn meal, and tomato puree stored frozen.

Potato, seed pieces [45093301]	-20	111-670	24 months

Potato, seed pieces [45093706]	-20	82-184	24 months

Potato, tuber [45093301]	-20	18-557	24 months

Potato, tuber [45093706]	-20	3-79	24 months

Radish [46203601]	<-2	393-740	Residues of thiamethoxam are stable for up
to 740 days, and residues of the metabolite CGA-322704 are stable for up
to 364 days in/on apples, tomato, potato, rape seed, and corn grain
stored frozen.

Radish, roots [46203601]	<-2	393-740	24 months

Radish, tops [46203601]	<-2	563-748	24 months

Soybean [46162504	Frozen (temperature unspecified)	61-134	Residues of
thiamethoxam are stable for up to 740 days, and residues of the
metabolite CGA-322704 are stable for up to 364 days in/on apples,
tomato, potato, rape seed, and corn grain stored frozen.

Soybean, seed [46162504]	Frozen (unspecified temperature)	61-134 	24
months

Spinach [45880901]	-29 to 1	29-93	24 months

Spinach [46724901]	-20	424-473	24 months

Strawberry [46159201]	<-1	28	Concurrent storage stability data indicate
that residues of thiamethoxam and CGA-322704 are stable for up to 24
days in/on strawberry.

Strawberry [46159201]	<-1	850	40-42 months for thiamethoxam and
CGA-322704 in/on canola oil, leaf lettuce, safflower seed, and tomato
puree stored frozen.

Tomato, fruit [45880903]	-29 to 1	8-79	24 months

Tomato, fruit [46724903]	-20	135-201	24 months

Conclusions.  The submitted storage stability data are adequate to
fulfill data requirements. Adequate storage stability data are now
available on five crops indicating that residues of thiamethoxam and it
metabolite CGA-322704 are stable during up to ~24 months of frozen
storage in/on apples, tomato, potato, rapeseed, and corn grain.  In
addition, adequate storage stability data have been submitted indicating
that r  SEQ CHAPTER \h \r 1 esidues of thiamethoxam and CGA-322704 are
relatively stable in canola oil, corn meal, leaf lettuce, safflower
seed, and tomato puree for up to approximately 40-42 months at -20 ºC. 
These data together represent sufficient diverse crops (a root crop, a
leafy vegetable, a grain, an oilseed, a fruit, and a fruiting vegetable)
to allow determination that residues of thiamethoxam and CGA-322704 are
stable in/on all crops for at least 24 months.  

 ≤24 months prior to analysis.  Adequate data are available to support
these storage durations and conditions.  

The available data for canola oil, leaf lettuce, safflower seed, and
tomato puree may be translated to support the storage durations and
conditions of samples of cotton seed, cotton gin byproducts, and
strawberry from the crop field trials reported herein.  In addition, the
storage stability data for processed commodities canola oil, corn meal,
and tomato puree may be translated to support the storage durations and
conditions of the samples of processed commodities from the grape and
potato processing studies associated with this review.

The data requirements from previous reviews pertaining to storage
stability in plant commodities have now been satisfied.  In the
PP#9F5046 review, HED had required the petitioner to submit a detailed
description of Method REM 179.03, the method used to determine residues
of each analyte in some study samples (Conclusion 13a); this requirement
has been satisfied (see 860.1340 – Residue Analytical Method).  

In the D265079 PP#9F5051 review, HED had required that the storage
stability study be continued to cover the interval that the plant
commodity samples were stored frozen (Conclusion 12c).  In that review,
raw agricultural commodity (RAC) samples of potato, fruiting vegetables,
cucurbits, pome fruits, wheat and cotton were stored frozen for 14-27
months; samples of grain sorghum RACs were stored for up to 30 months,
although the majority of the samples were analyzed within ~24 months;
and processed commodity samples from the potato, tomato, apple, grain
sorghum, wheat, and cotton processing studies were stored frozen for
12-26 months from collection to analysis.  The available storage
stability data are adequate to support these sample storage durations
and conditions.

In the D269520 PP#9F5051 review, HED required the submission of the
ongoing storage stability study to support the storage durations of
samples from the crop field trials (Conclusions 8a and 8b).  In that
review, samples of leafy vegetable and brassica leafy vegetable
commodities were stored frozen for ~14-15 months prior to analysis.  The
available storage stability data are adequate to support these sample
storage durations and conditions.

Finally, in the PP#0F6142 review, HED required the submission of
sufficient storage stability to demonstrate the stability of CGA-322704
residues in/on corn commodities for up to 525 days (the only deficiency
of that review).  The available storage stability data are adequate to
support these sample storage durations and conditions.

Livestock commodities

DER Reference:	45499902.der.doc (includes review of MRID 45659204)

  SEQ CHAPTER \h \r 1 Syngenta has submitted the final results of a
storage stability study with thiamethoxam and its metabolites CGA-322704
and CGA-265307 in eggs, milk, and tissue samples stored frozen for up to
15-17 months.  The interim results of this study were previously
reported (MRID 44715114) and reviewed in conjunction with PP#9F5051 (DP
Number   SEQ CHAPTER \h \r 1 D265079, 5/8/00, G.J. Herndon).  The
petitioner has also submitted an amendment to MRID 45499902 to include
the results of a storage stability study with metabolite CGA-322704 in
beef liver stored frozen for up to approximately 47 months.

Samples of untreated eggs, milk, and beef muscle and liver were
fortified with thiamethoxam, CGA-322704, and CGA-265307 at 0.5 ppm each
and stored frozen at -20 ºC for up to approximately 15 months. 
Additional samples of fortified beef liver were analyzed for residues of
CGA-322704 at a storage interval of approximately 47 months.  Under
these conditions, residues of thiamethoxam, CGA-322704, and CGA-265307
appeared to be stable in eggs, milk, beef muscle, and beef liver for
15-17 months, and residues of CGA-322704 appear to be relatively stable
in beef liver stored frozen for up to 47.7 months.  Corrections to
residue data to account for in-storage dissipation during those time
periods will not be necessary.

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on livestock commodities was
adequately validated in conjunction with the sample analyses.  The
reported LOQ was 0.05 ppm for each analyte in meat, milk, and eggs.

Liver samples from the cattle feeding study amendment reported in this
review were stored frozen for approximately 60 months from collection to
re-analysis for CGA-322704; the original liver samples were stored
frozen for 8-12 months from collection to analysis.  The maximum storage
durations of poultry commodity samples from the poultry feeding study
reported in this review was 16.9 months for eggs and 14.9 months for
poultry tissues.  

Conclusions.  The submitted storage stability data for livestock
commodities are adequate and support the storage durations and
conditions of poultry commodities from the livestock feeding studies
reported in this review.  

The available data indicate that residues of CGA-322704 are stable in
beef liver during up to 48 months of frozen storage.  Although the
available storage stability data do no represent the full storage
interval of the cattle liver samples from the feeding study amendment,
no additional storage stability data will be required.  Residues of
CGA-322704 have been demonstrated to be stable in liver for an extended
storage period (~ 4 years) and it is unlikely that residues would begin
to decline at longer durations. 

The data requirements from previous reviews pertaining to storage
stability in livestock commodities have now been satisfied.  In the
D265079 PP#9F5051 review, HED had required additional data supporting
the storage durations reflected in the feeding study (Conclusion 13); in
that study, milk and tissue samples were stored at -20 C for up to 12
months prior to analysis.  The available data are adequate to support
these storage durations and conditions.

860.1400 Water, Fish, and Irrigated Crops

  SEQ CHAPTER \h \r 1 DER Reference:	None

See:  Residue Chemistry Memo D285545, 11/6/02, M. Doherty

Use of thiamethoxam on cranberries has been registered under Section 18
of FIFRA.  RD should ensure that the use restrictions listed on the
Section 18 label that are in place to prevent transfer of residues to
potable water, fish, and irrigated crops that might otherwise result
from the use of thiamethoxam on cranberry are carried over to the
Section 3 label.

860.1460 Food Handling

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

860.1480 Meat, Milk, Poultry, and Eggs

  SEQ CHAPTER \h \r 1 DER Reference:	45093715.der.doc (Poultry)

		45659206.der.doc (Cattle liver)

MRID 45093716 (summarized below; no DER prepared)

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

Thiamethoxam is currently used on several crops with associated
livestock feedstuffs.  The dietary burdens of thiamethoxam to livestock,
based on reasonably balanced diets, are presented in Table 6.  The
dietary burdens are 0.771 ppm for beef cattle, 0.977 ppm for dairy
cattle, 0.088 for swine and 0.232 for poultry.

  SEQ CHAPTER \h \r 1 The proposed uses for thiamethoxam include swine
and poultry feed items.  HED had previously concluded that there was no
expectation of quantifiable residues of thiamethoxam and CGA-322704 in
poultry or swine commodities [Category 180.6(a)(3)], based on a
calculated theoretical dietary burden (TDB) of 0.025 ppm for both swine
and poultry.  The proposed foliar uses on barley significantly increase
the TDB to swine and poultry, to 0.255 and 0.245 ppm, respectively.  The
lowest feeding level in the available ruminant feeding study was 2 ppm,
7.8x the maximum theoretical dietary burden to swine.  At that level,
combined residues of thiamethoxam and CGA-322704 were <0.02 ppm in
liver, kidney, and muscle samples; fat samples from the low and mid
dosing levels were not analyzed because combined residues in fat samples
were found to be below the LOQ in samples from the high dose level.  HED
concludes that the established tolerances of 0.02 ppm for hog meat and
meat byproducts are adequate to support the proposed use on barley.  

In the previously reviewed poultry metabolism study (  SEQ CHAPTER \h \r
1 DP Barcode D252021, 3/21/00, G.J. Herndon), hens were dosed at ~100
ppm, which is equivalent to ~400x the maximum dietary burden.  Based on
data from the metabolism study, residues of thiamethoxam and CGA-322704
in tissues and eggs would be expected to be <0.01 ppm even at a 10x
feeding level.  Therefore, a Category 180.6(a)(3) situation exists with
respect to thiamethoxam residues in poultry commodities, and tolerances
for residues in poultry commodities are not required.

Table 6.		Calculation of Maximum Theoretical Dietary Burdens of
Thiamethoxam to Livestock.

Feedstuff	% Dry Matter 1	% Diet 2	Reassessed Tolerance (ppm)	Dietary
Contribution (ppm) 3

Beef Cattle

Barley, grain	88	40	0.30	0.136

Cotton, gin byproducts	90	20	1.5	0.333

Cottonseed, meal	89	15	0.10	0.017

Wheat, forage	25	25	0.50	0.500

  TOTAL BURDEN

100

0.986

Dairy Cattle

Barley, grain	88	20	0.30	0.068

Cotton, gin byproducts	90	20	1.5	0.333

Cottonseed, meal	89	15	0.10	0.017

Wheat, forage	25	45	0.50	0.900

  TOTAL BURDEN

90

1.32

Swine

Barley, grain	N/A	80	0.30	0.240

Cottonseed, meal	N/A	15	0.10	0.015

  TOTAL BURDEN

95 3

0.255

Poultry

Barley, grain	N/A	75	0.30	0.225

Cottonseed, meal	N/A	20	0.10	0.02

  TOTAL BURDEN

95 3

0.245

1  Table 1 (OPPTS Guideline 860.1000).  

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

3  The remainder of the diet will be composed of feedstuffs derived from
crops that do not have thiamethoxam uses/tolerances proposed or
registered.

Ruminants:  A dairy cattle feeding study has been submitted previously
(PP#9F5051; D265079, 5/8/00, G. J. Herndon).  Three groups of three
Holstein cows each were dosed daily with thiamethoxam at 2, 6, or 20 ppm
via gelatin capsules for 28-30 days; the dosing levels are equivalent to
2x, 6x, and 20x the dietary burden for dairy cattle.  One dosed cow from
each dose group was sacrificed on Day 28, a second cow from each group
was sacrificed on Day 29, and the third cow was sacrificed on Day 30. 
Tissue samples were collected from each animal.  The combined residues
of thiamethoxam and CGA-322704 in milk plateaued between 7-14 days of
dosing for each group.  The maximum combined residues in milk from the
2-ppm dose group were 0.018 ppm on Day 7.  The combined residues in fat
were <LOQ from the 20x dose group.  Although residues of thiamethoxam
and CGA-322704 were <LOQ in meat, kidneys, and liver at the 2x dosing
level, residues of thiamethoxam were detected in muscle from the 6x and
20x dose groups and in kidneys from the 20x dose group.  

In the review of the livestock feeding study data, HED noted that there
were questions regarding the adequacy of Method AG-675 in determining
CGA-322704 residues in liver.  It was concluded that as a condition of
registration under PP#9F5051, the petitioner should modify Method AG-675
to add a microwave extraction step for liver, or propose a new
enforcement method for liver.  It was further concluded that the
petitioner should use this method to reanalyze the cow liver samples
from the feeding study and provide adequate storage stability data to
cover the period for which the samples were stored.  

Syngenta has responded to this data requirement with the submission of
an amendment to the original study.  In this amendment, samples of liver
were re-analyzed for residues of the thiamethoxam metabolite CGA-322704
using a revised version of the analytical method.  

The petitioner has revised the enforcement method, HPLC Method AG-675,
to include a microwave extraction step for liver (see 860.1340 –
Residue Analytical Method).  Samples of cattle liver from the original
feeding study were analyzed for   SEQ CHAPTER \h \r 1 residues of
CGA-322704 using the modified version of the HPLC/UV method.  Adequate
concurrent method recovery data were submitted for the method.  The
validated LOQ was 0.01 ppm for liver.  

Liver samples from the feeding study were stored frozen for
approximately 60 months from collection to re-analysis; the original
liver samples were stored frozen for 8-12 months from collection to
analysis.  Sample storage durations and conditions are supported by
adequate storage stability data.  

The results of the re-analysis of the liver samples indicate that
residues of CGA-322704 (as parent equivalents) were 0.05 ppm at the
2-ppm feeding level, 0.16 ppm at the 6-ppm feeding level, and 0.15 ppm
at the 20-ppm feeding level in liver collected following 28 days of
dosing.  Residues of CGA-322704 were 0.06 and 0.03 ppm at the 2-ppm
feeding level, 0.10 and 0.15 ppm at the 6-ppm feeding level, and 0.35
and 0.45 ppm at the 20-ppm feeding level in liver collected following 29
and 30 days of dosing, respectively.  In the previous review, residues
of thiamethoxam were found to be below the LOQ (<0.01 ppm) in the liver
samples from all feeding levels.

HED notes that in the review of the original cattle feeding study, it
was concluded that microwave extraction was required to release
bound/conjugated residues of thiamethoxam and CGA-322704 from liver. 
However, based on examination of the results of the goat metabolism
study, residues of thiamethoxam were not found in the microwave
hydrolysate of liver.  Therefore, the petitioner’s decision to
re-analyze liver samples for residues of metabolite CGA-322704 only is
appropriate.

Syngenta also submitted (MRID 45093716) a summary of the results of the
original cattle feeding study as well as estimates of the transfer of
thiamethoxam residues from crops to cattle commodities.  The estimates
were prepared using a diet which contained crops for which proposed use
has now been withdrawn (peanuts and peanut hay) and did not consider the
data from the re-analyzed liver samples.  Therefore, the summary is not
useful for tolerance assessment for livestock commodities.

Poultry:  Syngenta has submitted a poultry feeding study with
thiamethoxam.  Five treatment groups of fifteen laying hens each were
dosed with thiamethoxam at 0, 0.2, 0.6, 2 and 10 ppm in the feed for 28
consecutive days; the dosing levels represent 0.9x, 2.6x, 8.6x, and 43x
the dietary burden for poultry.  Eggs were collected daily; samples from
study days 0, 1, 3, 7, 14, 21, and 28 samples were analyzed.  Hens were
sacrificed 20-24 hours after the treated feed was replaced with
untreated feed, and composite samples of skin (with attached fat),
peritoneal fat, liver and muscle were collected.

The HPLC/UV method, Method AG-675, used to determine residues of
thiamethoxam, CGA-322704, and CGA-265307 in/on poultry commodities was
adequately validated in conjunction with the sample analyses.  The
validated LOQ was 0.01 ppm for each analyte in poultry matrices.  The
maximum storage interval from collection to analysis was 16.9 months for
eggs and 14.9 months for poultry tissues.  Adequate storage stability
data are available to support the storage durations and conditions of
the poultry feeding study samples.  

Following dosing at 10 ppm, residues of CGA-265307 were <0.01-0.028 ppm
in eggs; residues of thiamethoxam and CGA-322704 were below the LOQ
(<0.01 ppm each) in these samples.  Residues of thiamethoxam,
CGA-322704, and CGA-265307 were below the LOQ (<0.01 ppm each) in egg
samples from the 2-ppm dosing level.  Residues of thiamethoxam,
CGA-322704, and CGA-265307 were below the LOQ (<0.01 ppm each) in all
tissue samples (skin with attached fat, peritoneal fat, liver, and
muscle) from the 10-ppm dosing group.  Based on these results, the
petitioner did not analyze egg samples from the 0.2- and 0.6-ppm dosing
groups or tissue samples from the 0.2-, 0.6-, or 2-ppm dosing groups.

Based on the results from the goat and hen metabolism studies, HED had
previously concluded (PP#9F5051; DP Number D265079  SEQ CHAPTER \h \r 1
, 5/8/00, G.J. Herndon) that microwave extraction is required to release
bound/conjugated residues of thiamethoxam and its metabolite CGA-322704
from liver, which accounted for the majority of the radioactivity in
this organ.  The enforcement method used for analysis of samples in this
study, Method AG-675, does not include a microwave extraction step, and
therefore would not be capable of extracting bound/conjugated residues
of thiamethoxam and its CGA-322704 metabolite from liver.  The
petitioner has submitted a revised version of the method which includes
a microwave extraction step for liver (see 860.1340 – Residue
Analytical Method); however, this method was not used for the analysis
of liver samples in this study.

Conclusions.  The submitted cattle feeding study amendment is adequate. 
The data requirement specified in the D265079 PP#9F5051 review
pertaining to livestock commodities (conclusion 30g) has now been
satisfied.  Based on the available cattle feeding study data, the
established 0.02-ppm tolerance for the combined residues of thiamethoxam
and CGA-322704 in milk is appropriate.  As there is no reasonable
expectation of the transfer of thiamethoxam residues from feed items to
fat, tolerances are not required for residues in fat.  Although residues
of thiamethoxam and CGA-322704 were <LOQ in meat and kidneys at the 2x
dosing level, residues of thiamethoxam were detected in muscle from the
6x and 20x dose groups and in kidneys from the 20x dose group.  Based on
these data, tolerances should be set at the combined LOQ (0.02 ppm) for
residues of thiamethoxam and CGA-322704 in meat of cattle, goats,
horses, and sheep.  The data from the re-analysis of liver samples
indicate that combined residues of thiamethoxam and CGA-322704 were
≤0.07 ppm at the 2x dosing level, ≤0.17 ppm at the 6x dosing level,
and ≤0.46 ppm at the 20x dosing level.  These data indicate that a
tolerance of 0.04 ppm is needed for the combined residues of
thiamethoxam and CGA-322704 in the meat byproducts of cattle, goats,
horses, and sheep.  HED notes that the radiovalidation data for
CGA-322704 indicated that the extraction efficiency for goat liver using
the modified method was ~40%.

The poultry feeding study data are not adequate to satisfy data
requirements because the method used for analysis of liver was not
adequate to extract bound/conjugated residues.  Because it would be
impractical for the petitioner to re-analyze liver samples from this
study and generate supporting storage stability data (the study was
conducted in 1997), the study is not upgradeable.

The data for poultry commodities other than liver are adequate.  These
data indicate that combined residues of thiamethoxam and CGA-322704 were
below the LOQ in poultry eggs, fat, muscle, and skin with fat at the 43x
dosing level.  Quantifiable residues of CGA-265307 were observed in eggs
from the 43x dosing level (up to 0.03 ppm), but residues were <LOQ in
eggs at the 8.6x dosing level and in tissues at the 43x dosing level. 
These data indicate that there is no reasonable expectation of finite
residues of thiamethoxam, CGA-322704, or CGA-265307 in poultry eggs,
fat, or meat based on the existing uses of thiamethoxam.  No tolerances
for poultry eggs, fat, or meat are needed.  

In the poultry metabolism study, hens were dosed at ~100 ppm, which is
equivalent to ~430x the theoretical dietary burden.  In that study, the
maximum residues of thiamethoxam, CGA-322704, and CGA-265307 found in
liver were 0.022 ppm, 3.517 ppm, and 1.599 ppm, respectively.  Based on
these results, residues of both CGA-322704 and CGA-265307 would be
quantifiable at a 10x dosing level but <LOQ at a 1x dosing level. 
Therefore, the petitioner should conduct a new poultry feeding study in
which liver samples are analyzed using the modified enforcement method,
which includes a microwave extraction step.  Liver samples should be
analyzed for residues of CGA-322704 and CGA-265307 as these metabolites
were found in significant quantities in the microwave hydrolysate in the
metabolism study.  Given that the projected residues at the 1x feeding
level will be <LOQ, HED will assume for the time being that residues in
poultry liver remain a 180.6(a)(3) situation.  This conclusion will be
reevaluated upon receipt and review of new data for residues of
thiamethoxam, CGA-322704, and CGA-265307 in poultry liver.

860.1500 Crop Field Trials

DER Reference:	46801402 (Artichoke)	46114701 (Cranberry)	46203601
(Radish)

		46801401 (Barley)	46203602 (Carrot)	46162503 (Succulent peas)

		46801403 (Caneberry)	46162502 (Dry beans)	46162504 (Soybean)

		46801404 (Hops)		46162501 (Dry peas)	46159201 (Strawberry)

		46162201 (Blueberry) 	45530901 (Mint)

IR-4 has submitted magnitude of the residue studies for artichoke
(globe), barley, caneberries, and hops in support of the requested uses.
 The results from these field trials are discussed below and summarized
in Table 7.  

Table 7.		Summary of Residue Data from Crop Field Trials with
Thiamethoxam.

Total Applic. Rate

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

	n	Min.	Max.	HAFT a	Median b	Mean	Std. Dev.

Artichoke (proposed use = 0.188 lb ai/A total application rate, 4-day
PHI)

0.0929-0.0952	4	Thiamethoxam	6	0.080	0.244	0.197	0.166	0.171	0.060

CGA-322704	6	0.012	0.029	0.022	0.022	0.022	0.006

Combined	6	0.092	0.273	0.219	0.189	0.193	0.065

Barley (proposed use = 0.094 lb ai/A total application rate, 21-day PHI)

Barley hay

0.121-0.127	20-24	Thiamethoxam	16	<0.01	0.27	0.27	0.090	0.118	0.113

CGA-322704	16	<0.01	0.03	0.03	0.010	0.013	0.009

Combined	16	<0.02	<0.28	<0.28	0.103	0.131	0.115

Barley grain

0.121-0.127	20-24	Thiamethoxam	16	<0.01	0.21	0.20	0.065	0.079	0.078

CGA-322704	16	<0.01	0.02	0.02	0.005	0.008	0.005

Combined	16	<0.02	<0.22	<0.21	0.070	0.086	0.080

Barley straw

0.121-0.127	20-24	Thiamethoxam	16	<0.01	0.33	0.30	0.100	0.131	0.125

CGA-322704	16	<0.01	0.03	0.03	0.010	0.016	0.011

Combined	16	<0.02	<0.34	<0.31	0.120	0.147	0.125

Caneberry (proposed use = 0.188 lb ai/A total application rate, 3-day
PHI)

0.0947-0.0974	3	Thiamethoxam	12	0.01	0.20	0.19	0.10	0.11	0.07

CGA-322704	12	<0.01	0.04	0.04	0.015	0.016	0.011

Combined	12	<0.02	0.21	0.20	0.130	0.121	0.069

Hops (proposed use = 0.125 lb ai/A total application rate, 65-day PHI)

0.1188-0.1239	62-66	Thiamethoxam	5	<0.025	0.055	0.055	0.027	0.032	0.021

CGA-322704	5	<0.025	0.028	0.027	0.013	0.018	0.008

Combined	5	<0.050	0.083	0.082	0.039	0.051	0.029

Cranberry (proposed use = 0.125 lb ai/A total application rate, 30-day
PHI)

0.184-0.200	28-30	Thiamethoxam	12	<0.01	<0.01	<0.01	<0.01	0.01	0

CGA-322704	12	<0.01	<0.01	<0.01	<0.01	0.01	0

Combined	12	<0.02	<0.02	<0.02	<0.02	<0.02	0

Legume Vegetables (Proposed use = seed treatment at 0.05 lb ai/100 lb
seed)

0.05 lb ai/100 lb seed	55-100	Thiamethoxam	70b	<0.01	<0.01	<0.01	<0.01
0.01	0

CGA-322704	70b	<0.01	<0.01	<0.01	<0.01	0.01	0

Combined	70b	<0.02	<0.02	<0.02	<0.01	<0.01	0

Mint (proposed use = 0.125 lb ai/A total application rate, 7-day PHI)

0.196-0.198	6-7	Thiamethoxam	10	0.205	0.894	0.860	0.336	0.413	0.243

CGA-322704	10	0.049	0.128	0.118	0.108	0.094	0.028

Combined	10	0.264	1.010	0.972	0.435	0.507	0.259

a HAFT = Highest Average Field Trial

b For purposes of computing the median, mean, and standard deviation,
values reported as <0.01 ppm were treated as 0.01 ppm

b Combined for dry beans, dry peas, succulent peas (shelled and podded),
and soybean.

Artichoke, globe

IR-4 has submitted field trial data for thiamethoxam on artichoke. 
Three trials were conducted in Zone 10 (CA) during the 2002 growing
season.  

At each trial, two foliar broadcast applications of a 25% WG formulation
of thiamethoxam were made at ~0.047 lb ai/A/application with a 6- to
7-day RTI for a total rate of ~0.094 lb ai/A (0.5x the proposed maximum
seasonal rate).  Applications were made using ground equipment in spray
volumes of ~74-76 gal/A, without an adjuvant.  Duplicate control and
treated samples of artichoke buds (flower heads) were harvested from
each site four days after the last application.

Sample storage durations and conditions are reported in Table 4. 
Adequate storage stability data are available to support the storage
conditions and durations of samples from the artichoke field trials.

Samples of artichoke buds 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.  

The results of the crop field trials are reported in Table 6.  Maximum
combined residues of thiamethoxam and its metabolite CGA-322704 were
0.273 ppm in/on artichoke buds harvested four days following foliar
treatments with the 25% WG formulation at total seasonal rates of
0.093-0.095 lb ai/A.  Maximum individual average residues of
thiamethoxam and CGA-322704 were, respectively, 0.244 ppm and 0.030 ppm
in/on treated artichoke buds.

Conclusions.  The submitted artichoke crop field trial data are adequate
to support the proposed use, pending revision of the proposed use
pattern to match the use pattern used in the crop field trials (see
860.1200 Directions for Use).  The available data will support up to two
foliar broadcast applications of the 25% WG formulation at 0.047 lb
ai/A/application for a total seasonal rate of 0.094 lb ai/A, with a
7-day RTI and a 4-day PHI.

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for artichoke.  The available field trial data
will support a tolerance for residues of thiamethoxam and CGA-322704
in/on globe artichoke at 0.45 ppm; the tolerance calculation for
artichokes is presented in Appendix I.  

Barley

IR-4 has submitted field trial data for thiamethoxam on barley.  Eight
trials were conducted in the U.S. in Zones 5 (ND and SD; 4 trials), and
11 (ID and WA; 4 trials) during the 2001 and 2002 growing seasons.

At each trial, two foliar broadcast applications of a 25% WG formulation
of thiamethoxam were made at 0.059-0.064 lb ai/A/application with a 6-
to 8-day RTI for a total rate of 0.121-0.127 lb ai/A (1.3x the proposed
maximum seasonal rate).  Applications were made using ground equipment
in spray volumes of ~19-50 gal/A, without an adjuvant.  At each site,
grain, hay, and straw were harvested at barley maturity, 20-24 days
after the last application.  Hay samples were collected at the mature
grain stage instead of the milk to soft dough stage.  The petitioner
noted that this harvesting practice was accepted by EPA for this study
only, and included a copy of an e-mail between B. Schneider (HED) and J.
Corley (IR-4) approving of the harvesting procedure.  

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 field trials.    SEQ
CHAPTER \h \r 1  

Samples of barley matrices 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. 

The results of the crop field trials are reported in Table 6.  Maximum
combined residues of thiamethoxam and its metabolite CGA-322704 were
<0.28 ppm in/on barley hay, <0.22 ppm in/on barley grain, and <0.34 ppm
in/on barley straw harvested 20-24 days following foliar treatment with
the 25% WG formulation at total seasonal rates of 0.121-0.127 lb ai/A. 
Maximum individual residues of thiamethoxam were 0.27 ppm in/on treated
barley hay, 0.21 ppm in/on treated barley grain, and 0.33 ppm in/on
treated barley straw.  Maximum individual residues of CGA-322704 were
0.03 ppm in/on treated barley hay and straw, and 0.02 ppm in/on treated
barley grain.

No residue decline data were generated.  

Conclusions.  The submitted barley crop field trial are tentatively
adequate to support the proposed use.  The petitioner should revise the
proposed use pattern to restrict use to the states of ID, ND, OR, SD,
and WA (see 860.1200 Directions for Use).  In addition, a residue
decline study for barley should be submitted to confirm that residues of
thiamethoxam and its metabolite CGA-322704 do not increase in/on barley
matrices with later sampling durations; this study should be conducted
in Zone 7.  

The petitioner has conducted 8 field trials in Zones 5 (ND and SD; 4
trials), and 11 (ID and WA; 4 trials).  Of the requested states for
foliar use on barley, the states of ND and SD are in Zones 5 and 7, ID
is in Zone 11, and OR and WA are in Zones 11 and 12.  To support a full
registration on barley, OPPTS 860.1500 specifies that a total of 12
trials be conducted:  1 trial in Zone 1 or 2, 3 trials in Zone 5, 4
trials in Zone 7, 1 trial in Zone 9, 1 trial in Zone 10, and 2 in Zone
11.  IR-4 stated that the 4 trials conducted in Zone 5 should be
acceptable for the use in ND and SD because soil and climatic conditions
are very similar.  In addition, the 4 trials conducted in Zone 11 were
conducted over 2 years.  No significant differences were observed
between samples from Zone 11 and Zone 5.

HED agrees with IR-4 and concludes that the geographic representation of
barley crop field trial data is adequate to support the proposed use,
pending submission of the required residue decline study.  HED notes
that the crop field trial data would support an increase in the proposed
use pattern (see 860.1200 Directions for Use).  The available data
support tolerances for combined residues of thiamethoxam and CGA-322704
in/on barley grain at 0.30 ppm, barley hay at 0.40 ppm, and barley straw
at 0.40 ppm.

Caneberry subgroup 13A

IR-4 has submitted field trial data for thiamethoxam on caneberry (crop
subgroup 13A).  Six trials were conducted in Zones 2 (NJ; 1 trial), 5
(MI; 1 trial), 10 (CA; 1 trial), and 12 (OR and WA; 3 trials) during the
2002 growing season.  Blackberry, raspberry, and boysenberry varieties
were used in the study.

At each trial, two foliar-directed spray applications of a 25% WG
formulation of thiamethoxam were made at ~0.047 lb ai/A/application with
a 6- to 7-day RTI for a total rate of ~0.094 lb ai/A (0.5x the proposed
maximum seasonal rate).  Applications were made using ground equipment
in spray volumes of~21-78 gal/A, without an adjuvant.  Mature
caneberries were harvested three days after the last application.

Sample storage durations and conditions are reported in Table 4. 
Adequate storage stability data are available to support the storage
conditions and durations of samples from the caneberry field trials.

Samples of caneberries 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. 

The results of the crop field trials are reported in Table 6.  Maximum
combined residues of thiamethoxam and its metabolite CGA-322704 were
0.21 ppm in/on caneberries harvested three days following foliar
treatments with the 25% WG formulation at total seasonal rates of
0.095-0.097 lb ai/A.  Maximum individual residues of thiamethoxam and
CGA-322704 were, respectively, 0.20 ppm and 0.04 ppm in/on treated
caneberries.

No residue decline data were generated.  A residue decline study with
blueberries has been submitted separately (see DER for MRID 46162201)
which indicated that combined residues of thiamethoxam and CGA-322704
decreased slightly in blueberries with increasing sampling intervals (3,
7, and 10 days following application).  These data may be translated to
fulfill residue decline data requirements for the caneberry subgroup.

Conclusions.  The submitted caneberry crop field trial data are adequate
to support the proposed use, pending revision of the proposed use
pattern to match the use pattern used in the crop field trials (see
860.1200 Directions for Use).  The available data will support up to two
foliar broadcast applications of the 25% WG formulation at 0.047 lb
ai/A/application for a total seasonal rate of 0.094 lb ai/A, 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 caneberry subgroup 13A.  The available
field trial data will support a tolerance for residues of thiamethoxam
and CGA-322704 in/on caneberry at 0.35 ppm; the tolerance calculation
for caneberries is presented in Appendix I.  

Hop

IR-4 has submitted field trial data for thiamethoxam on dried hops. 
Three field trials were conducted in the U.S. during the 2002 growing
season in Zones 11 (ID and WA) and 12 (OR).

At each trial, a single soil surface application of a 2 lb/gal SC
formulation of thiamethoxam was made at ~0.125 lb ai/A (1x the proposed
maximum seasonal rate).  Applications were made using ground equipment
in spray volumes of ~29-45 gal/A, without an adjuvant.  Duplicate
control and treated samples of mature hop cones were harvested from the
OR and WA test sites 62-66 days after application.  Due to damage from a
wind and hail storm, only one sample per plot was harvested from the ID
test site, 64 days after application.

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 field trials. 

Samples of dried hop cones 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 0.025 ppm for both
thiamethoxam and CGA-322704.  

The results of the crop field trials are reported in Table 6.  Maximum
combined residues of thiamethoxam and its metabolite CGA-322704 were
0.0826 ppm in/on dried hop cones harvested 62-66 days following a soil
treatment with the 2 lb/gal SC formulation at 0.119-0.124 lb ai/A. 
Maximum individual residues of thiamethoxam and CGA-322704 were,
respectively, 0.0550 ppm and 0.0276 ppm in/on treated dried hop cones.

Conclusions.  The submitted hop crop field trial data are adequate to
support the proposed use.  The number and locations of the field trials
are in accordance with OPPTS Guideline 860.1500 for hops.  The available
data will support a single soil application of the 2 lb/gal SC
formulation to hops at 0.125 lb ai/A with a 65-day PHI.  

Table 8.  Summary of Residue Data from Blueberry Field Trials with
Thiamethoxam (25% DF or 2 lb/gal SC).

Analyte	Formulation	Application Type	Total Rate

(lb a.i./A) 	PHI (days)	Combined Residue Levels (ppm)1

	n	Min.	Max.	HAFT 2	Median (STMdR3)	Mean (STMR3)	Std. Dev.

Thiamethoxam	25% DF	foliar during fruit dev.	0.196-0.204	3	18	<0.01	0.11
0.105	0.06	0.053	0.025

	2 lb/gal SC	early-season soil application	0.187-0.218	72-94	14	<0.01
<0.01	0.005	0.005	0.005	0

CGA-322704	25% DF	foliar during fruit dev.	0.196-0.204	3	18	<0.01	0.05
0.045	0.01	0.013	0.012

	2 lb/gal SC	early-season soil application	0.187-0.218	72-94	14	<0.01
<0.01	0.005	0.005	0.005	0

Combined	25% DF	foliar during fruit dev.	0.196-0.204	3	18	<0.02	0.12
0.113	0.068	0.066	0.027

	2 lb/gal SC	early-season soil application	0.187-0.218	72-94	14	<0.02
<0.02	0.01	0.01	0.01	0

1	The LLMV is 0.01 ppm for each analyte in/on blueberry fruit. 

2 	HAFT = Highest Average Field Trial. 

3	STMdR = Supervised Trial Median Residue; STMR = Supervised Trial Mean
Residue.  To calculate HAFT, median and average residues, ½LLMV was
used for samples with residues <LLMV.

The blueberry field trial data are adequate.  The tests using the 2
lb/gal SC/L formulation reflect the use of a single, banded application
of thiamethoxam to the soil around blueberry plants during early budding
at ~0.198 lb ai/A/season.  The data support a 75-day PHI for this use. 
The tests using the 25% DF reflect the use of up to three foliar
applications of thiamethoxam to blueberry plants during fruit
development at ~0.066 lb ai/A/application and ~0.198 lb ai/A/season,
with a RTI of 7 days.  The data support a 3-day PHI for this use.

Table 9.  Summary of Residue Data from Carrot Field Trials with
Thiamethoxam (25% DF or 2 lb/gal SC)a.

Application Type	Total Rate

(lb a.i./A)	 PHI (days)	Analyte	Combined Residue Levels (ppm)1

n	Min.	Max.	HAFT 2	Median (STMdR3)	Mean (STMR3)	Std. Dev.

Foliar	0.124-0.129	7-8	Thiamethoxam	18	0.005	0.010	0.010	0.005	0.006
0.002

	CGA-322704	18	0.005	0.005	0.005	0.005	0.005	0.000

	Combined	18	0.010	0.010	0.010	0.010	0.010	0.000

Soil Banded	0.100-0.207	

70-136	Thiamethoxam	14	0.005	0.040	0.030	0.008	0.013	0.010

	CGA-322704	14	0.005	0.005	0.005	0.005	0.005	0.000

	Combined	14	0.010	0.010	0.010	0.010	0.010	0.000

a  Residues from the DF and SC formulation have been considered together
as there did not appear to be any differences in residues due to
formulation type.

1  The LLMV is 0.01 ppm for each analyte in/on blueberry fruit. 

2  HAFT = Highest Average Field Trial. 

3  STMdR = Supervised Trial Median Residue; STMR = Supervised Trial Mean
Residue.  To calculate HAFT, median and average residues ½LLMV was used
for samples with residues <LLMV.

The carrot field trial data are adequate and support the use of
thiamethoxam (SC/L or DF) on root vegetables (except sugar beets) as
either a banded or furrow application at planting at up to 0.2 lb ai/A,
or as two broadcast foliar applications during root development at up to
0.063 lb ai/A/application (0.125 lb ai/A/season), with a 7-day PHI. 
Combined residues in/on mature carrots were <0.05 ppm 70-136 days
following the at-planting soil application at 0.2 lb ai/A, and <0.02 ppm
7 days following the second of two foliar applications totaling 0.125 lb
ai/A.

Table 10.  Summary of Residue Data from Radish Field Trials using
Thiamethoxam as a Soil Treatment at Planting (2 lb/gal SC/L) or as Two
Late Season Foliar Applications (25% DF). 

Commodity	

Formulation	

Application Type	

Total Rate

(lb a.i./A) 	

PHI (days) 1	

Residue Levels (ppm)2

	

n	

Min.	

Max.	

HAFT 3	

Median (STMdR4)	

Mean (STMR4)	

Std. Dev.

Thiamethoxam Residues

Radish tops	

2 lb/gal SC/L	

Soil at planting 5	

0.098-0.099	

27-43	

8	

<0.01	

0.37	

0.36	

0.08	

0.13	

0.14

	

0.197-0.200	

37-41	

4	

0.22	

0.40	

0.36	

0.27	

0.29	

0.09

Broadcast foliar	

0.063-0.1235	

7	

4	

0.07	

0.10	

0.08	

0.08	

0.08	

0.01

	

25% DF	

Broadcast  foliar	

0.062-0.1265	

6-8	

12	

0.06	

0.64	

0.61	

0.15	

0.21	

0.20

Radish roots	

2 lb/gal SC/L	

Soil at planting 5	

0.098-0.099	

27-43	

8	

<0.01	

0.02	

0.02	

0.01	

0.005	

0.007

	

0.197-0.200	

37-41	

4	

0.02	

0.08	

0.08	

0.05	

0.05	

0.03

Broadcast foliar	

0.063-0.1235	

7	

4	

<0.01	

0.01	

0.01	

0.01	

0.005	

0.006

	

25% DF	

Broadcast  foliar	

0.062-0.1265	

6-8	

12	

<0.01	

0.01	

0.01	

0.01	

0.005	

0.003

CGA-322704 Residues

Radish tops	

2 lb/gal SC/L	

Soil at planting 5	

0.098-0.099	

27-43	

8	

<0.01	

0.09	

0.09	

0.02	

0.03	

0.04

	

0.197-0.200	

37-41	

4	

0.04	

0.08	

0.07	

0.06	

0.06	

0.02

Broadcast foliar	

0.063-0.1235	

7	

4	

0.01	

0.02	

0.02	

0.02	

0.02	

0.004

	

25% DF	

Broadcast  foliar	

0.062-0.1265	

6-8	

11	

0.02	

0.13	

0.10	

0.03	

0.04	

0.03

Radish roots	

2 lb/gal SC/L	

Soil at planting 5	

0.098-0.099	

27-43	

8	

<0.01	

<0.01	

<0.01	

<0.01	

0.005	

0

	

0.197-0.200	

37-41	

4	

<0.01	

<0.01	

<0.01	

<0.01	

0.005	

0

Broadcast foliar	

0.063-0.1235	

7	

4	

<0.01	

<0.01	

<0.01	

<0.01	

0.005	

0

	

25% DF	

Broadcast  foliar	

0.062-0.1265	

6-8	

12	

<0.01	

<0.01	

<0.01	

<0.01	

0.005	

0

Combined Residues

Radish tops	

2 lb/gal SC/L	

Soil at planting	

0.098-0.099	

27-43	

8	

<0.02	

0.46	

0.45	

0.09	

0.17	

0.18

	

0.197-0.200	

37-41	

4	

0.25	

0.48	

0.43	

0.32	

0.34	

0.11

Broadcast foliar	

0.063-0.1235	

7	

4	

0.09	

0.11	

0.10	

0.09	

0.10	

0.01

	

25% DF	

Broadcast  foliar	

0.062-0.1265	

6-8	

11-12	

0.09	

0.66	

0.63	

0.19	

0.26	

0.21

Radish roots	

2 lb/gal SC/L	

Soil at planting	

0.098-0.099	

27-43	

8	

<0.02	

0.03	

0.03	

0.02	

0.01	

0.004

	

0.197-0.200	

37-41	

4	

0.03	

0.09	

0.09	

0.06	

0.06	

0.03

Broadcast foliar	

0.063-0.1235	

7	

4	

<0.02	

<0.02	

<0.02	

<0.02	

0.01	

0

	

25% DF	

Broadcast  foliar	

0.062-0.1265	

6-8	

12	

<0.02	

<0.02	

<0.02	

<0.02	

0.01	

0

1	PHI - preharvest interval; none is proposed.

2	The LOQ is 0.01 ppm for each analyte in/on radish matrices.

3 	HAFT = Highest Average Field Trial. 

4	STMdR = Supervised Trial Median Residue; STMR = Supervised Trial Mean
Residue.  To calculate combined mean residues, ½LOQ was used for
samples with residues <LOQ.

5	Two broadcast foliar applications were made at 0.060-0.063 lb ai/A for
a total of 0.123-0.126 lb ai/A/season at one test site in FL.  For all
other tests, a single broadcast foliar application was made at
0.061-0.064 lb ai/A.  Residues from the tests receiving two foliar
applications (2x) did not differ significantly from the other tests,
therefore the data are included in the summary table.

The radish field trial data are adequate and support the use of
thiamethoxam (SC/L or DF) on root vegetables (except sugar beets) as
either a banded or furrow application at planting at up to 0.1 lb ai/A,
or as a single broadcast foliar application during root development at
up to 0.063 lb ai/A, with a 7-day PHI.  Following a at-planting soil
application of thiamethoxam (2 lb/gal SC/L) at ~0.1 lb ai/A, combined
residues were <0.02-0.46 ppm in/on mature radish tops and <0.02-0.03 ppm
in/on radish roots harvested 27-43 DAT.  Following a single foliar
application of thiamethoxam (25% DF) at 0.061-0.064 lb ai/A, combined
residues were 0.09-0.66 ppm in/on mature radish tops and <0.02 ppm in/on
radish roots harvested 6-8 DAT.

Table 11.  Summary of Residue Data from Strawberry Field Trials Using
Thiamethoxam (DF or  SC) as a Foliar or Soil Drench Application(s).

Commodity	Formulation	Total Rate

(lb a.i./A)	PHI (days)1	Residue Levels (ppm)2

n	Min.	Max.	HAFT3	Median

(STMdR4)	Median

(STMR4)	Std.

Dev.

Strawberry Fruit

	25% DF

	0.21	Thiamethoxam

	0	16	0.030	0.360	0.305	0.110	0.139	0.097

	3	16	0.010	0.260	0.260	0.050	0.090	0.085

	7-8	14	0.010	0.220	0.190	0.040	0.074	0.074

	9-12	20	0.005	0.200	0.170	0.035	0.052	0.053

	CGA-322704

	

0	

16	

0.005	0.005	0.005	0.005	0.005	0.000

	3	16	0.005	0.005	0.005	0.005	0.005	0.000

	7-8	14	0.005	0.005	0.005	0.005	0.005	0.000

	9-12	20	0.005	0.005	0.005	0.005	0.005	0.000

	Combined

	0	16	0.035	0.365	0.310	0.115	0.144	0.097

	3	16	0.015	0.265	0.265	0.055	0.095	0.085

	7-8	14	0.015	0.225	0.195	0.045	0.079	0.074

	9-12	20	0.010	0.205	0.175	0.040	0.057	0.053

Strawberry Fruit	2 lb/gal SC	0.20	Thiamethoxam

	29-32	20	0.005	0.110	0.100	0.020	0.039	0.038

	40-60	28	0.005	0.060	0.050	0.020	0.020	0.015

	CGA-322704

	29-32	20	0.005	0.005	0.005	0.005	0.005	0.000

	40-60	28	0.005	0.005	0.005	0.005	0.005	0.000

	Combined

	29-32	20	0.010	0.115	0.105	0.025	0.044	0.038

	40-60	28	0.010	0.065	0.055	0.025	0.025	0.015

1	The proposed PHIs for strawberry are 3 days using the 25% DF
formulation and 50 days using the 2 lb/gal SC formulation.

2	The LOQ is 0.01 ppm for each analyte in/on strawberry fruit. 

3 	HAFT = Highest Average Field Trial. 

4	STMdR = Supervised Trial Median Residue; STMR = Supervised Trial Mean
Residue.  To calculate average residues ½LOQ was used for samples with
residues <LOQ.

The strawberry field trial data are scientifically adequate.  The tests
using the 25% DF formulation will support the use of up to three foliar
applications of thiamethoxam (DF) to strawberry plants during fruiting
at 0.07 lb ai/A/application for 0.21 lb ai/A/season, with a RTI of 8-12
days.  Adequate data are available to support PHIs ranging from 0-10
days.  The tests using the 2 lb/gal SC formulation will support the use
of a single directed soil drench application of thiamethoxam (SC) to the
soil around strawberry plants at up to 0.20 lb ai/A.  Adequate data are
available to support a PHI of either 30 or 50 days.

Root vegetable, except sugar beet, subgroup 1B

DER Reference:	46203601.der.doc (Radish)

		46203602.der.doc (Carrot)

IR-4 has submitted magnitude of the residue studies for carrot and
radish, the representative crops of subgroup 1B.  The results from these
field trials are discussed below and summarized in Table 12.  

Carrot:  Sixteen field tests at 7 sites were conducted on carrots during
the 2000-2001 growing season.  Tests were conducted in Zones 3 (FL; 1
trial), 5 (OH; 1 trial), 6 (TX; 1 trial), 10 (CA; 3 trials), and 11 (WA;
1 trial).  Thiamethoxam was applied to carrots as either (i) a single,
banded, soil application at planting using the 2 lb/gal FlC formulation
at 0.200-0.207 lb ai/A (6 tests; 1.1x the proposed maximum rate); or
(ii) two broadcast, foliar applications during root development using
the 25% WG formulation at 0.062-0.066 lb ai/A/application, with RTIs of
6-7 days, for a total rate of 0.124-0.129 lb ai/A (7 tests; 1x the
maximum foliar application rate).  Two of the sites also included plots
that received two broadcast, foliar applications of the 2 lb/gal FlC
formulation at 0.062-0.063 lb ai/A/application with a RTI of 7 days, for
a total rate of 0.124-0.126 lb ai/A (2 tests; 1x).  A single control and
duplicate treated samples of carrots were collected from each treatment
at normal crop maturity, either 70-136 days after the soil treatment or
7-8 days after the second foliar application.  

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

Following a single, banded soil application of the 2 lb/gal FlC
formulation at planting at 0.200-0.207 lb ai/A, residues of thiamethoxam
were <0.01-0.04 ppm and residues of CGA-322704 were <0.01 ppm in/on 12
samples of mature carrots harvested 70-136 days post-treatment.  For the
soil application, combined residues were <0.02-<0.05 ppm.

Seven days following the second of two broadcast foliar applications of
the 25% WG formulation totaling 0.125-0.129 lb ai/A, residues of
thiamethoxam were ≤0.01 ppm and residues of CGA-322704 were <0.01 ppm
in/on all 14 root samples.  For the foliar applications, combined
residues were <0.02 ppm.

The data from the side-by-side plots reflecting foliar application of
the 2 lb/gal FlC or 25% WG formulation indicate that combined residues
of thiamethoxam and CGA-322704 were the same in/on samples treated with
either formulation.  

Radish:  Fourteen tests were conducted on radish at 6 field sites during
2000.  Tests were conducted in Zones 1 (NY; 1 trial), 2, (MD; 1 trial),
3 (FL; 2 trials), 5 (OH; 1 trial), and 10 (CA; 1 trial).  At each field
site, thiamethoxam was applied to radish plots as either (i) a single,
banded, soil application at planting using the 2 lb/gal FlC formulation
at 0.098-0.099 lb ai/A (4 tests; 1x the maximum rate) or 0.197-0.200 lb
ai/A (2 tests; 2x); or (ii) as broadcast, foliar applications during
root development using the 25% WG formulation as either a single
application at 0.062-0.064 lb ai/A (5 tests; 1x the maximum foliar
application rate), or as two applications at 0.060-0.063 lb
ai/A/application with a RTI of 7 days, for a total rate of 0.123 lb ai/A
(1 test; 2x).  Two of the field sites also included plots that received
broadcast, foliar applications of the 2 lb/gal FlC formulation using
either a single application at 0.061 lb ai/A (1x) or two applications at
0.063 lb ai/A/application with a RTI of 7 days, for a total rate of
0.126 lb ai/A/season (2x).  Duplicate control and treated samples of
radish tops and roots were collected from each test at normal crop
maturity.  Post-treatment durations were 27-43 days for the soil
application at planting and 6-8 days for the foliar applications.  

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

Following a single, banded soil application of the 2 lb/gal FlC
formulation at planting at 0.098-0.099 lb ai/A (1x rate), residues of
thiamethoxam were <0.01-0.37 ppm in/on 8 top samples and <0.01-0.02 ppm
in/on 8 root samples harvested 27-43 days after treatment; residues of
metabolite CGA-322704 were <0.01-0.09 ppm in/on 8 top samples and were
<0.01 ppm in/on all 8 root samples.  Combined residues were <0.02-0.46
ppm in/on radish tops and <0.02-0.03 ppm in/on radish roots.

Six to eight days following a single broadcast foliar application of the
25% WG formulation at 0.061-0.064 lb ai/A (1x rate), residues of
thiamethoxam were 0.06-0.64 ppm in/on 12 top samples and ≤0.01 ppm
in/on 12 root samples; residues of metabolite CGA-322704 were 0.02-0.13
ppm in/on 11 top samples and were <0.01 ppm in/on all 12 root samples. 
Combined residues were 0.09-0.66 ppm in/on radish tops and <0.02 ppm
in/on radish roots.

The data from the side-by-side plots reflecting foliar application of
the 2 lb/gal FlC or 25% WG formulation indicate that combined residues
of thiamethoxam and CGA-322704 were similar or slightly higher in/on
samples treated with the 25% WG formulation than in/on samples treated
with the 2 lb/gal FlC formulation.

Table 12.	Summary of Residue Data from Subgroup 1B Crop Field Trials
with Thiamethoxam. 

Commodity	EP 1	Application Type	Total Rate

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

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

CARROT (proposed use = 0.188 lb ai/A total application rate for at
planting application; 0.125 lb ai/A for foliar application with 7-day
PHI)

Thiamethoxam Residues

Carrot, root	2 lb/gal FlC	Soil at planting 4	0.200-0.206	70-136	12	<0.01
0.04	0.03	0.01	0.01	0.01

Broadcast foliar	0.124-0.216	7	4	<0.01	<0.01	<0.01	0.005	0.005	NA

	25% WG	Broadcast  foliar	0.125-0.129	7-8	14	<0.01	0.01	0.01	0.005	0.006
0.002

CGA-322704 Residues

Carrot, root	2 lb/gal FlC	Soil at planting 4	0.200-0.206	70-136	12	<0.01
<0.01	<0.01	0.005	0.005	NA

Broadcast foliar	0.124-0.216	7	4	<0.01	<0.01	<0.01	0.005	0.005	NA

	25% WG	Broadcast  foliar	0.125-0.129	7-8	14	<0.01	<0.01	<0.01	0.005
0.005	NA

Combined Residues

Carrot, root	2 lb/gal FlC	Soil at planting 4	0.200-0.206	70-136	12	<0.02
<0.05	<0.04	0.02	0.02	0.01

Broadcast foliar	0.124-0.216	7	4	<0.02	<0.02	<0.02	0.01	0.01	NA

	25% WG	Broadcast  foliar	0.125-0.129	7-8	14	<0.02	<0.02	<0.02	0.01	0.01
0.002

RADISH (registered use = 0.102 lb ai/A total application rate for at
planting application; 0.063 lb ai/A for foliar application with 7-day
PHI)

Thiamethoxam Residues

Radish, tops	2 lb/gal FlC	Soil at planting	0.098-0.099	27-43	8	<0.01
0.37	0.36	0.08	0.13	0.15

	0.197-0.200	37-41	4	0.22	0.40	0.36	0.27	0.29	0.09

Broadcast foliar	0.063-0.1235	7	4	0.07	0.09	0.08	0.08	0.08	0.01

	25% WG	Broadcast  foliar	0.062-0.1265	6-8	12	0.06	0.64	0.61	0.15	0.21
0.20

Radish, roots	2 lb/gal FlC	Soil at planting	0.098-0.099	27-43	8	<0.01
0.02	0.02	0.005	0.008	0.005

	0.197-0.200	37-41	4	0.02	0.08	0.08	0.05	0.05	0.03

Broadcast foliar	0.063-0.1235	7	4	<0.01	0.01	0.01	0.01	0.01	0.003

	25% WG	Broadcast  foliar	0.062-0.1265	6-8	12	<0.01	0.01	0.01	0.005
0.005	0.001

CGA-322704 Residues

Radish, tops	2 lb/gal FlC	Soil at planting	0.098-0.099	27-43	8	<0.01
0.09	0.09	0.01	0.03	0.04

	0.197-0.200	37-41	4	0.03	0.08	0.07	0.05	0.05	0.02

Broadcast foliar	0.063-0.1235	7	4	0.01	0.02	0.02	0.02	0.02	0.005

	25% WG	Broadcast  foliar	0.062-0.1265	6-8	11	0.02	0.13	0.11	0.03	0.04
0.03

Radish, roots	2 lb/gal FlC	Soil at planting	0.098-0.099	27-43	8	<0.01
<0.01	<0.01	0.005	0.005	NA

	0.197-0.200	37-41	4	<0.01	<0.01	<0.01	0.005	0.005	NA

Broadcast foliar	0.063-0.1235	7	4	<0.01	<0.01	<0.01	0.005	0.005	NA

	25% WG	Broadcast  foliar	0.062-0.1265	6-8	12	<0.01	<0.01	<0.01	0.005
0.005	NA

Combined Residues

Radish, tops	2 lb/gal FlC	Soil at planting	0.098-0.099	27-43	8	<0.02
0.46	0.45	0.09	0.16	0.18

	0.197-0.200	37-41	4	0.25	0.48	0.43	0.32	0.34	0.11

Broadcast foliar	0.063-0.1235	7	4	0.09	0.11	0.10	0.09	0.10	0.01

	25% WG	Broadcast  foliar	0.062-0.1265	6-8	11	0.09	0.66	0.63	0.19	0.26
0.21

Radish, roots	2 lb/gal FlC	Soil at planting	0.098-0.099	27-43	8	<0.02
<0.03	<0.03	0.01	0.01	0.005

	0.197-0.200	37-41	4	<0.03	<0.09	<0.09	0.05	0.05	0.03

Broadcast foliar	0.063-0.1235	7	4	<0.02	<0.02	<0.02	0.01	0.01	NA

	25% WG	Broadcast  foliar	0.062-0.1265	6-8	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. 

4  Data from the test reflecting soil treatment at 0.100 lb ai/A was
excluded from the data summary.

5  Results from the samples receiving two foliar applications did not
differ significantly from the samples receiving a single foliar
application; therefore, the data are included in the summary table.

Conclusions.  The submitted carrot and radish crop field trial data are
adequate to fulfill data requirements.  The petitioner has proposed to
increase the maximum seasonal rate for use of the 2 lb/gal FlC
formulation, as a soil application, on all crops in this subgroup except
radish.  The available data will support: a single at-planting
application of the 2 lb/gal FlC formulation at 0.1 lb ai/A for radish
and 0.188 lb ai/A for other crops in the subgroup (1x the maximum
seasonal rate); or two foliar applications of the 25% WG formulation at
a total rate of 0.063 lb ai/A for radish and 0.125 lb ai/A for other
crops in the subgroup, with a 7-day RTI and a 7-day PHI.  

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for root vegetables subgroup 1B.  The available
field trial data will support a tolerance for combined residues of
thiamethoxam and CGA-322704, expressed as thiamethoxam equivalents,
in/on root vegetables, except sugar beets, subgroup 1B, at 0.05 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.  

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on root vegetables except sugar beets; 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.  

Tuberous and corm vegetables, subgroup 1C

DER Reference:	45093301.de1.doc (Potato; also includes MRID 45701201)

		45093706.de1.doc (Potato)

Syngenta has submitted magnitude of the residue studies for potato in
support of seed treatment uses on potatoes.  The results from these
field trials are discussed below and summarized in Table 13.  

MRID 45093301:  Eighteen potato field trials were conducted in Zones 1
(ME and NY; 2 trials), 2 (NC; 1 trial), 3 (FL; 2 trials), 5 (MI, MN, ND,
and WI; 4 trials), 9 (CO; 1 trial), 10 (CA; 2 trials), and 11 (ID, OR,
and WA; 6 trials) during the 1998 growing season.

At each trial, potato seed pieces were treated with a 5 lb/gal FlC
formulation (product identified as CGA-293343 5FS; no EPA Reg. No.
provided) at a rate of 0.008 lb ai/100 lb seed pieces (8 g ai/100 kg);
based on the planting rate, the seed piece treatment rate corresponded
to 0.18 lb ai/A (1.4x the current maximum seed piece treatment rate). 
At 16 of the trials, a separate plot of potato plants received two
broadcast foliar applications, with a 7-day RTI, of a 25% WG formulation
(product identified as CGA-293343 25WG; no EPA Reg. No. provided) at
0.09 lb ai/A/application for a total rate of 0.18 lb ai/A (2x the
maximum foliar application rate).  In addition, at two of the trials, a
separate plot was planted with potato seed pieces which had received
seed piece treatment of a 1.6% dust (D) formulation (product identified
as CGA-293343 1.6DS; no EPA Reg. No. provided) at a rate equivalent to
0.18 lb ai/A; and at one trial, a separate plot was planted with potato
seed pieces receiving seed piece treatment of the 5 lb/gal FlC
formulation at 0.13 lb ai/A, and the resulting plants received a foliar
application of the 25% WG formulation at 0.07 lb ai/A, for a total rate
of 0.20 lb ai/A.  

Treated seed pieces were planted within one day following application. 
Foliar applications were made using ground equipment in ~10-30 gal/A,
with the exception of two trials (FL) in which applications were made at
5 gal/A to simulate aerial applications.  No adjuvant was used in the
spray mixtures.  Following seed treatments, seed pieces were collected
following application, and mature tubers were harvested 90-143 days
after planting; at two trials, tuber samples were collected at
additional sampling durations to evaluate residue decline.  Potatoes
receiving foliar application were harvested 14-15 days after last
application; at three locations, samples were collected 0, 2, 6, 10, and
18 days following the last foliar application to evaluate residue
decline.

The HPLC/UV method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on potato tubers 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
6; the storage conditions and durations are supported by adequate
storage stability data.

Maximum combined residues of thiamethoxam and its metabolite CGA-322704
were 0.12 ppm in/on potato tubers harvested at maturity following seed
piece treatment with the 5 lb/gal FlC formulation at 0.18 lb ai/A. 
Maximum individual residues of thiamethoxam and CGA-322704 were 0.08 and
0.06 ppm, respectively, in/on potato tubers grown from treated seed
pieces.  Following two broadcast foliar applications of the 25% WG
formulation, at a total rate of 0.18 lb ai/A, thiamethoxam residues were
<0.01-0.02 ppm and CGA-322704 residues were <0.01 ppm; combined residues
were <0.02-<0.03 ppm.  

In the two trials in which side-by-side plots were planted with seed
pieces receiving application of the 5 lb/gal FlC formulation or the 1.6%
D formulation, the D formulation yielded higher residues than the FlC
formulation in both trials:  in tubers harvested at maturity, combined
residues were 0.20-0.42 ppm for samples treated with the D formulation
and 0.06-0.12 ppm for samples treated with the FlC formulation.   

Combined residues in potato tubers harvested 14 days following the
foliar application were higher in samples receiving combined seed
treatment and foliar application, at a total rate of 0.20 lb ai/A, than
in samples receiving only foliar applications, at a total rate of 0.18
lb ai/A:  combined residues were 0.09 ppm in/on two samples receiving
combined applications and were <0.02 ppm in/on two samples from the same
site receiving only foliar application.  

Residue decline data indicate no noticeable increase or decrease in
residues with increasing sampling durations.  

The petitioner additionally analyzed potato seed pieces immediately
after application, which confirmed thiamethoxam application.

MRID 45093706:  Sixteen potato field trials were conducted in Zones 1
(ME and NY; 2 trials), 2 (NC; 1 trial), 3 (FL; 1 trial), 5 (MI, MN, ND,
and WI; 4 trials), 9 (CO; 1 trial), 10 (CA; 1 trial), and 11 (ID, OR,
and WA; 6 trials) during the 1999 growing season.  

At each trial, potato seed pieces were treated with a 1.6% D formulation
(product identified as CGA-293343 1.6DS; no EPA Reg. No. provided) at a
rate of 0.008 lb ai/100 lb seed pieces (8 g ai/100 kg).  Seed potatoes
were planted at a rate of 2,200 lb seed pieces/A; therefore, the seed
piece treatment rate corresponded to 0.18 lb ai/A (1.4x the current
maximum seed piece treatment rate).  Potatoes then received two
postemergence broadcast foliar applications of a 25% WG formulation
(product identified as CGA-293343 25WG; no EPA Reg. No. provided) at
0.044 lb ai/A/application (0.5x the maximum foliar application rate),
for a total application rate of 0.26 lb ai/A.  The foliar applications
were made with a RTI of ~7 days.  Foliar applications were made using
ground equipment in ~10-35 gal/A, without an adjuvant.  At two field
trials, test plots were treated with concentrated foliar spray
applications (~5 gal/A) in order to simulate aerial applications. 
Potatoes were harvested 12-15 days after last application at all
locations.  At one location, potato tubers were also harvested 2, 6, 10,
and 18 days following last application to evaluate residue decline.  

At two locations, additional plots received exaggerated rate treatments:
 seed piece treatment at 0.024 lb ai/100 lb seed pieces (equivalent to
0.53 lb ai/A) plus two postemergence foliar applications at 0.22 lb
ai/A/application, for a total rate of 0.97 lb ai/A.  

The HPLC/UV method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on potato tubers 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.

Maximum combined residues of thiamethoxam and its metabolite CGA-322704
were 0.83 ppm in/on potato tubers harvested 12-15 days following
application of thiamethoxam at a total rate of 0.26-0.29 lb ai/A. 
Maximum individual residues of thiamethoxam and CGA-322704 were,
respectively, 0.74 ppm and 0.08 ppm in/on treated potato tubers.

Residue decline data indicate no noticeable increase or decrease in
residues with increasing sampling durations.  

The petitioner additionally analyzed potato seed pieces immediately
after application, which confirmed thiamethoxam application.

Table 13.	Summary of Residue Data from Subgroup 1C Crop Field Trials
with Thiamethoxam. 

Commodity	EP 1	Application Type	Total Rate

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

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

POTATO (registered use = 0.125 lb ai/A total application rate for seed
piece treatment; 0.125 lb ai/A total application rate for soil
application; 0.094 lb ai/A total application rate for foliar application
with 14-day PHI)

Thiamethoxam Residues

Potato tubers	5 lb/gal FlC	Seed piece treatment	0.18	90-143	36	<0.01
0.08	0.06	0.005	0.01	0.02

	1.6% D	Seed piece treatment	0.18	90-99	4	0.15	0.21	0.18	0.18	0.18	0.03

	25% WG	Two foliar applications	0.18	14-15	32	<0.01	0.02	0.02	0.005
0.006	0.004

Potato Tubers	1.6% D + 25% WG	Seed piece + two foliar applications
0.26-0.29 	12-15	31	<0.01	0.74	0.68	0.02	0.07	0.16

	0.97	12-14	2	0.02	0.06	0.06	NC	NC	NC

CGA-322704 Residues

Potato tubers	5 lb/gal FlC	Seed piece treatment	0.18	90-143	36	<0.01
0.06	0.05	0.005	0.008	0.01

	1.6% D	Seed piece treatment	0.18	90-99	4	0.04	0.18	0.16	0.09	0.10	0.07

	25% WG	Two foliar applications	0.18	14-15	32	<0.01	<0.01	<0.01	0.005
0.005	NA

Potato Tubers	1.6% D + 25% WG	Seed piece + two foliar applications
0.26-0.29 	12-15	31	<0.01	0.08	0.08	0.005	0.01	0.02

	0.97	12-14	2	<0.01	0.01	0.01	NC	NC	NC

Combined Residues

Potato tubers	5 lb/gal FlC	Seed piece treatment	0.18	90-143	36	<0.02
0.12	0.12	0.01	0.02	0.03

	1.6% D	Seed piece treatment	0.18	90-99	4	0.20	0.42	0.36	0.28	0.29	0.09

	25% WG	Two foliar applications	0.18	14-15	32	<0.02	<0.03	<0.03	0.01
0.01	0.004

Potato Tubers	1.6% D + 25% WG	Seed piece + two foliar applications
0.26-0.29 	12-15	31	<0.02	0.83	0.77	0.03	0.08	0.18

	0.97	12-14	2	<0.03	0.07	0.07	NC	NC	NC

1  EP = End-use product.

2  The reported residue results were corrected by the petitioner for
concurrent method recovery <100%.  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. 
Median, mean, and standard deviation were not calculated (NC) for n=2. 
NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted potato crop field trial data are adequate to
support the seed piece treatment uses on potato, provided the petitioner
modifies the appropriate labels to specify that soil and foliar
applications may not be made to potatoes following seed piece treatment.
 The available data will support:  a single seed piece treatment of the
5 lb/gal FlC formulation at a rate equivalent to 0.18 lb ai/A; or two
broadcast foliar applications, with a 7-day RTI, of the 25% WG
formulation at 0.09 lb ai/A/application for a total rate of 0.18 lb
ai/A, with a 14-day PHI.  No data are available reflecting seed piece
treatment with the FlC formulation in combination with soil or foliar
applications; therefore, all product labels with uses on potato should
specify that no soil or foliar applications may be made to potatoes that
received seed piece treatment with thiamethoxam.

The number and locations of the field trials are in accordance with
OPPTS Guideline 860.1500 for potato.  Because the available data
indicate that seed treatment with a D formulation will generally yield
higher residues than seed treatment with a FlC formulation, and only FlC
formulations are registered for seed piece treatments, only the FlC
formulation data will be used for tolerance assessment.  The available
field trial data will support a tolerance for combined residues of
thiamethoxam and CGA-322704, expressed as thiamethoxam equivalents,
in/on potato at 0.20 ppm.  A tolerance had previously been established
for tuberous and corm vegetables subgroup 1C, based on crop field trial
for potato, the representative crop of subgroup 1C.  When Syngenta
established seed treatment uses on potatoes (and not on other members of
subgroup 1C), a separate tolerance was established for potatoes and the
subgroup 1C tolerance was revised to tuberous and corm vegetables
subgroup 1D.  Adequate data are available (see DP Number D265079,
5/8/00, G.J. Herndon) to support the established 0.02-ppm tolerance for
crop subgroup 1D.  These data are also adequate to support early season
soil applications to potato.

The petitioner has proposed to amend the label for the 2 lb/gal FlC
formulation (EPA Reg. No. 100-939) to expand the use on tuberous and
corm vegetables to include a broadcast soil application during the last
hilling operation; no PHI was proposed.  The available crop field trial
data for the tuberous and corm subgroup reflected treatments consisting
of an in-furrow application at planting followed by two foliar broadcast
applications; no data reflecting soil application later in the season
have been submitted.  If the petitioner wishes to support soil
applications to tuberous and corm vegetables later than crop emergence,
additional crop field trial data are required.  

The petitioner has proposed foliar uses of the 2 lb/gal FlC formulation
(Actara® 240 SC) on tuberous and corm vegetables; 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.  

Leafy vegetable, except brassica, group 4

DER Reference:	45880901.der.doc (Celery, head and leaf lettuce, spinach)

		46724901.der.doc (Head and leaf lettuce, spinach)

Syngenta has submitted magnitude of the residue studies for celery, head
lettuce, leaf lettuce, and spinach.  The results from these field trials
are discussed below and summarized in Table 14.  

MRID 45880901:  Eight field trials were conducted during the 2002
growing season.  One trial was conducted on celery in Zone 3 (FL); one
trial was conducted on head lettuce in Zone 10 (CA); one trial was
conducted on leaf lettuce in Zone 10 (CA); and five trials were
conducted on spinach in Zones 1 (NY; 1 trial), 2 (NJ; 1 trial), 6 (TX; 1
trial), 9 (CO; 1 trial), and 10 (CA; 1 trial).  

At each field site, a single soil application of a 2 lb/gal FlC
formulation was applied at a target rate of 0.17 lb ai/A (1x the maximum
proposed soil application rate).  Applications were made as a single
in-furrow application at planting (one head lettuce and two spinach
trials), a single post seeding, transplant, or hill drench application
(one head lettuce and one spinach trial), or a single application
shanked into the root zone (one celery, one leaf lettuce, and two
spinach trials).  Applications were made using ground equipment in
~15-120 gal/A, without an adjuvant.  Samples of celery leaf stalks, head
lettuce (with and without wrapper leaves and wrapper leaves alone), leaf
lettuce leaves, and spinach leaves were harvested 49-68 days following
in-furrow application, 30-32 days following drench application, and
30-33 days following shanked application.  

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on leafy vegetable 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 CGA-322704 were below the LOQ (<0.01 ppm
each) in/on all head lettuce samples.  Combined residues of thiamethoxam
and CGA-322704 were <0.02  and 0.28 ppm in/on two samples of celery and
<0.11 and 0.15 ppm in/on two samples of leaf lettuce harvested 30 days
following a single soil application, shanked into the root zone, at
0.169-0.190 lb ai/A.  Combined residues were <0.02-0.41 ppm in/on four
samples of spinach harvested 49-63 days following a single in-furrow
soil application at planting at 0.172-0.176 lb ai/A; <0.05 and <0.08 ppm
in/on two samples harvested 30 days following a single soil drench
application at 0.179 lb ai/A; and <0.08-<0.43 ppm in/on four samples
harvested 30-33 days following a single soil application, shanked into
the root zone, at 0.170-0.175 lb ai/A.  

No residue decline studies were included in the submission.  Because the
use patterns tested reflected soil applications at least 30 days prior
to harvest of mature crop, no residue decline studies are required.

Quantifiable residues of thiamethoxam and CGA-322704 were observed in/on
untreated samples of celery, head lettuce, leaf lettuce, and spinach, at
0.01-0.08 ppm.  These residues were often greater than residues observed
in treated samples from the same trial site.  No explanation for
quantifiable residues was provided by the petitioner.

MRID 46724901:  Syngenta Crop Protection   SEQ CHAPTER \h \r 1 has
submitted side-by-side field trial data on head lettuce, leaf lettuce,
and spinach, representative crops of crop group 4, following two
broadcast foliar applications of thiamethoxam formulated as a 2 lb/gal
FlC formulation or 25% WG formulation.  Four side-by-side field trials
were conducted during the 2000 and 2001 growing seasons:  one trial was
conducted on head lettuce in Zone 10 (CA); one trial was conducted on
leaf lettuce in Zone 10 (CA); and two trials were conducted on spinach
in Zones 6 (TX; 1 trial) and 10 (CA; 1 trial).

Each field test consisted of one untreated plot and two treated plots. 
At each trial, two foliar broadcast applications of the 2 lb/gal FlC and
25% WG formulations were made, in separate plots, at 0.088 lb
ai/A/application, with a 7- to 8-day RTI, for a total rate of 0.176 lb
ai/A.  Applications were made using ground equipment in ~20-25 gal/A,
without an adjuvant.  Samples of head lettuce (with and without wrapper
leaves and wrapper leaves alone), leaf lettuce leaves, and spinach
leaves were harvested 0 and 6-7 days after the last application.  

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on leafy vegetable 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.

The results of this side-by-side study are not summarized in Table 14. 
Combined residues of thiamethoxam and its metabolite CGA-322704 were
<0.82-<1.01 and <0.11-<0.13 ppm in/on two samples of head lettuce (with
wrapper leaves) harvested 0 and 6 days, respectively, following the last
application of the 2 lb/gal FlC formulation at a total rate of 0.176 lb
ai/A and were <0.74-<1.01 and <0.17-0.21 ppm in/on two samples of head
lettuce harvested 0 and 6 days, respectively, following the last
application of the 25% WG formulation at a total rate of 0.176 lb ai/A. 
Combined residues of thiamethoxam and CGA-322704 were <0.90-1.5 and
0.22-0.23 ppm in/on two samples of leaf lettuce harvested 0 and 7 days,
respectively, following treatment with the 2 lb/gal FlC formulation and
were <0.53-<0.61 and <0.08-<0.14 ppm in/on two samples of leaf lettuce
harvested 0 and 7 days, respectively, following treatment with the 25%
WG formulation.  Combined residues of thiamethoxam and CGA-322704 were
0.75-4.8 and 0.10-0.92 ppm in/on four samples of spinach harvested 0 and
7 days, respectively, following treatment with the 2 lb/gal FlC
formulation and were 0.64-5.0 and 0.13-0.91 ppm in/on four samples of
spinach harvested 0 and 7 days, respectively, following treatment with
the 25% WG formulation.  These data indicate that there is no
significant difference in combined residues in leafy vegetable
commodities following foliar applications of the 2 lb/gal FlC
formulation or the 25% WG formulation.

The residue data also indicate that combined residues of thiamethoxam
and CGA-322704 decline in head lettuce, leaf lettuce, and spinach from
the 0-day sampling interval to the 6/7-day sampling interval.

Table 14.	Summary of Residue Data from Crop Group 4 Crop Field Trials
with Thiamethoxam. 

Commodity	Application Type1	Total Rate

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

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

LEAFY VEGETABLES (proposed use = 0.172 lb ai/A total application rate
for soil application with a 14-day PHI; or 0.172 lb ai/A total
application rate for foliar application with 3-day PHI)

Thiamethoxam Residues

Celery, leaf stalks	Treatment 4	0.190	30	2	<0.01	0.26	0.14	NC	NC	NC

Head lettuce, with wrapper leaves	Treatment 2	0.176	68	2	<0.01	<0.01
<0.01	NC	NC	NC

	Treatment 3	0.172	32	2	<0.01	<0.01	<0.01	NC	NC	NC

Leaf lettuce, leaves	Treatment 4	0.169	30	2	0.10	0.14	0.12	NC	NC	NC

Spinach, leaves	Treatment 2	0.172-0.176	49-63	4	<0.01	0.05	0.04	0.01
0.02	0.02

	Treatment 3	0.179	30	2	<0.01	<0.01	<0.01	NC	NC	NC

	Treatment 4	0.170-0.175	30-33	4	<0.01	<0.01	<0.01	0.005	0.005	NA

CGA-322704 Residues

Celery, leaf stalks	Treatment 4	0.190	30	2	<0.01	0.02	0.015	NC	NC	NC

Head lettuce, with wrapper leaves	Treatment 2	0.176	68	2	<0.01	<0.01
<0.01	NC	NC	NC

	Treatment 3	0.172	32	2	<0.01	<0.01	<0.01	NC	NC	NC

Leaf lettuce, leaves	Treatment 4	0.169	30	2	<0.01	0.01	0.01	NC	NC	NC

Spinach, leaves	Treatment 2	0.172-0.176	49-63	4	<0.01	0.31	0.22	0.07
0.11	0.14

	Treatment 3	0.179	30	2	0.03	0.06	0.05	NC	NC	NC

	Treatment 4	0.170-0.175	30-33	4	0.06	0.36	0.26	0.12	0.16	0.14

Combined Residues

Celery, leaf stalks	Treatment 4	0.190	30	2	<0.02	0.28	0.15	NC	NC	NC

Head lettuce, with wrapper leaves	Treatment 2	0.176	68	2	<0.02	<0.02
<0.02	NC	NC	NC

	Treatment 3	0.172	32	2	<0.02	<0.02	<0.02	NC	NC	NC

Leaf lettuce, leaves	Treatment 4	0.169	30	2	<0.11	0.15	0.13	NC	NC	NC

Spinach, leaves	Treatment 2	0.172-0.176	49-63	4	<0.02	0.41	0.29	0.09
0.15	0.19

	Treatment 3	0.179	30	2	<0.05	<0.08	<0.07	NC	NC	NC

	Treatment 4	0.170-0.175	30-33	4	<0.08	0.43	0.31	0.14	0.19	0.16

1  The treatment regimes were:  

Treatment 2 = Single application as in-furrow spray at planting

Treatment 3 = Single post seeding, transplant, or hill drench
application

Treatment 4 = Single application shanked into the root zone

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.  Median, mean, and standard deviation were
not calculated (NC) for n=2.  NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted leafy vegetables crop field trial data
reflecting soil application, when considered on their own, are not
adequate to support the proposed soil applications to leafy vegetables
because geographic representation was inadequate.  Twenty-four crop
field trials (6 each for celery, head lettuce, leaf lettuce, and
spinach) are required to support use on the leafy vegetables, except
brassica, crop group; only 8 field trials reflecting soil application
were conducted.  

Syngenta had previously submitted residue data for thiamethoxam on leafy
vegetables in conjunction with a previous petition (PP#9F5051).  These
studies reflected side-by-side plots in which leafy vegetables received
either (i) two foliar applications of thiamethoxam (25% WG) at 0.088 lb
ai/A/application with a 7-day RTI, for a total seasonal rate of 0.17 lb
ai/A (1x the proposed maximum rate for foliar applications); or (ii) a
single soil application of thiamethoxam (unidentified formulation
referred to as 4L) at 0.126 lb ai/A, as either an in-furrow spray at
planting, a narrow surface band application incorporated at planting, or
a soil drench at transplanting, plus a single broadcast foliar
application of thiamethoxam (25% WG) at 0.044 lb ai/A/application, for a
total rate of 0.17 lb ai/A.  Combined residues of thiamethoxam and
CGA-322704 were <0.02-<0.31 ppm in/on 12 samples of head lettuce,
<0.17-1.9 ppm in/on 12 samples of leaf lettuce, <0.09-0.42 ppm in/on 12
samples of celery, and <0.22-1.5 ppm in/on 12 samples of spinach
harvested 7 days following the last of two foliar applications; and were
<0.04-<0.38 ppm in/on 12 samples of head lettuce, <0.04-0.56 ppm in/on
16 samples of leaf lettuce, <0.02-0.28 ppm in/on 12 samples of celery,
and <0.08-1.1 ppm in/on 12 samples of spinach harvested 7 days following
the combination soil + foliar application.  Comparison of the residues
in side-by-side plots indicates that combined residues resulting from
soil + foliar application were lower than combined residues resulting
from two foliar applications at almost every site.

HED had concluded that the residue data were adequate pending submission
and review of:  (i) supporting storage stability data; (ii) amended use
directions to match the application rates used in the field trials; and
(iii) information on the type of formulation used for the soil
applications.  The supporting storage stability data and amended use
directions have been submitted.  Currently, the petitioner has proposed
the following use patterns for leafy vegetables:  (i) a single soil
application of the 2 lb/gal FlC formulation at up to 0.172 lb ai/A, made
as an in-furrow spray at planting, a soil drench post-seeding or
-transplant, in trickle or drip irrigation water, or shanked into the
root zone after establishment or transplant, with a 14-day PHI; or (ii)
foliar applications of the 25% WG formulation at a total rate of up to
0.172 lb ai/A with a 7-day RTI and a 3-day PHI.  Information on the type
of formulation used for soil applications in the data previously
reported remains outstanding.

In consideration of the available side-by-side trial data, HED concludes
that the limited field trial data reflecting soil-only applications are
adequate to support the requested soil application uses, provided that
the petitioner modifies the PHI for soil applications to 30 days and
submits an explanation for the residues observed in/on untreated
samples.  The available data indicate that it is unlikely that soil-only
applications will yield higher residues than foliar applications.  The
available field trial data will support the following use patterns for
leafy vegetables:  (i) a single soil application of the 2 lb/gal FlC
formulation at up to 0.172 lb ai/A, made as an in-furrow spray at
planting, a soil drench post seeding or transplant, in trickle or drip
irrigation water, or shanked into the root zone after establishment or
transplant, with a 30-day PHI; or (ii) foliar applications of the 25% WG
formulation at a total rate of up to 0.172 lb ai/A with a 7-day RTI and
a 7-day PHI.  Provided the petitioner amends the proposed use pattern to
specify a 30-day PHI for soil applications and a 7-day PHI for foliar
applications, the available data will support a tolerance for combined
residues of thiamethoxam and CGA-322704, expressed as thiamethoxam
equivalents, in/on leafy vegetables at 4.0 ppm; the tolerance
calculation for leafy vegetables is presented in Appendix II.  

The submitted crop field trial data reflecting foliar applications of
the 25% WG and 2 lb/gal FlC formulations in side-by-side plots are
adequate to demonstrate that foliar applications of the FlC formulation
will not result in higher residues in leafy vegetable commodities than
applications of the 25% WG formulation.

Brassica leafy vegetable, group 5

DER Reference:	45880902.der.doc (Broccoli, cabbage)

		46724902.der.doc (Broccoli, cabbage, mustard greens)

Syngenta has submitted magnitude of the residue studies for broccoli,
cabbage, and mustard greens in support of the requested new or amended
uses on Brassica leafy vegetables.  The results from these field trials
are discussed below and summarized in Table 15.  

MRID 45880902:  Syngenta submitted field trial data for thiamethoxam on
broccoli and cabbage, the representative crops of crop subgroup 5A, head
and stem brassica.   Seven field trials were conducted during the 2002
growing season.  Five trials were conducted on broccoli in Zones 6 (TX;
1 trial), 10 (CA; 3 trials), and 12 (WA; 1 trial), and two trials were
conducted on cabbage in Zones 1 (NY; 1 trial) and 2 (NC; 1 trial).

At each field site, a single soil application of a 2 lb/gal FlC
formulation was applied at a target rate of 0.17 lb ai/A (1x the
proposed maximum soil rate).  Applications were made as a single
in-furrow application at planting (two broccoli and one cabbage trials),
a single post-seeding, -transplant, or hill drench application (one
broccoli and one cabbage trial), or a single application shanked into
the root zone (two broccoli and one cabbage trials).  Applications were
made using ground equipment in ~21-87 gal/A, without an adjuvant. 
Samples of broccoli flowers (head and stem) and cabbage (with and
without wrapper leaves and wrapper leaves alone) were harvested 71-84
days following in-furrow application, 33 days following drench
application to broccoli, 84 days following drench application to
cabbage, and 31-34 days following shanked application; at one broccoli
trial, samples of flowers were also collected 14 days following shanked
application.

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on broccoli and cabbage 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 CGA-322704 were below the LOQ (<0.01 ppm
each) in/on 4 samples of broccoli harvested 71 or 84 days following a
single in-furrow soil application at planting at 0.169-0.170 lb ai/A. 
Combined residues of thiamethoxam and CGA-322704 were <0.03 ppm in/on
two samples of broccoli harvested 33 days following a single soil drench
application at 0.175 lb ai/A, and were <0.02-0.03 ppm in/on two samples
of broccoli harvested 14 days and four samples of broccoli harvested
31-33 days following a single soil application, shanked into the root
zone, at 0.170-0.172 lb ai/A.

Combined residues of thiamethoxam and CGA-322704 were 0.05 ppm in/on 2
samples of cabbage (head with wrapper leaves) harvested 84 days
following a single in-furrow soil application at planting at 0.178 lb
ai/A; <0.02 and <0.03 ppm in/on two samples harvested 84 days following
a single soil drench application at 0.171 lb ai/A; and 0.12 and 0.23 ppm
in/on two samples harvested 34 days following a single soil application,
shanked into the root zone, at 0.173 lb ai/A.    

No residue decline studies were included in the submission.  Because the
use patterns tested reflected soil applications at least 30 days prior
to harvest of mature crop, no residue decline studies are required.

MRID 46724902:  Syngenta Crop Protection   SEQ CHAPTER \h \r 1 has
submitted side-by-side field trial data on broccoli, cabbage, and
mustard greens, the representative crops of crop group 5, brassica leafy
vegetables, following two broadcast foliar applications of thiamethoxam
formulated as a 2 lb/gal FlC formulation or 25% WG formulation.  Four
side-by-side field trials were conducted during the 2000 and 2001
growing seasons:  two trials were conducted on broccoli in Zones 6 (TX;
1 trial) and 10 (CA; 1 trial); one trial was conducted on cabbage in
Zone 1 (NY); and one trial was conducted on mustard greens in Zone 10
(CA).

Each field test consisted of one untreated plot and two treated plots. 
At each trial, two foliar broadcast applications of the 2 lb/gal FlC and
25% WG formulations were made, in separate plots, at 0.088 lb
ai/A/application, with a 7-day RTI, for a total rate of 0.176 lb ai/A. 
Applications were made using ground equipment in ~10-50 gal/A, without
an adjuvant.  Samples of broccoli flower (head and stem) and cabbage
(heads with and without wrapper leaves, and wrapper leaves alone) were
harvested 0 days after the last application, and samples of mustard
green leaves were harvested 7 days after last application.  

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on brassica leafy vegetable
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.

Maximum combined residues of thiamethoxam and its metabolite CGA-322704
were 0.46 ppm in/on broccoli harvested on the day of the last
application of the 2 lb/gal FlC formulation and 0.51 ppm in/on broccoli
harvested on the day of the last application of the 25% WG formulation. 
Maximum combined residues of thiamethoxam and its metabolite CGA-322704
were 0.62 ppm in/on cabbage (with wrapper leaves) harvested on the day
of the last application of the 2 lb/gal FlC formulation and 0.74 ppm
in/on cabbage harvested on the day of the last application of the 25% WG
formulation.  Maximum combined residues of thiamethoxam and its
metabolite CGA-322704 were 0.83 ppm in/on mustard greens harvested 7
days following the last application of the 2 lb/gal FlC formulation and
1.0 ppm in/on mustard greens harvested 7 days following the last
application of the 25% WG formulation.  

Overall, the maximum combined residues of thiamethoxam and CGA-322704
were slightly higher in/on samples treated with the 25% WG formulation
than in/on samples treated with the 2 lb/gal FlC formulation.  

No residue decline studies were included in the submission.  Residue
decline data have been submitted previously for brassica leafy
vegetables which indicate that combined residues of thiamethoxam and
CGA-322704 decrease with increasing sampling durations (from 0 days to 9
days following last application of a 25% WG formulation).  

Table 15.	Summary of Residue Data from Crop Group 5 Crop Field Trials
with Thiamethoxam. 

Commodity	Application Type1	Total Rate

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

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

BRASSICA LEAFY VEGETABLES (proposed use = 0.172 lb ai/A total
application rate for soil application with a 14-day PHI; or 0.172 lb
ai/A total application rate for foliar application with 0-day PHI for
head and stem brassica and a 7-day PHI for leafy brassica greens)

Thiamethoxam Residues

Broccoli, head and stem	Treatment 2	0.169-0.170	71-84	4	<0.01	<0.01
<0.01	0.005	0.005	NA

	Treatment 3	0.175	33	2	0.02	0.02	0.02	NC	NC	NC

	Treatment 4	0.170-0.172	31-33	4	<0.01	0.02	0.02	0.008	0.01	0.01

Cabbage, head with wrapper leaves	Treatment 2	0.178	84	2	0.04	0.04	0.04
NC	NC	NC

	Treatment 3	0.179	30	2	0.01	0.02	0.015	NC	NC	NC

	Treatment 4	0.170-0.175	30-33	2	0.10	0.18	0.14	NC	NC	NC

Broccoli, head and stem	2 lb/gal FlC	0.176	0	4	0.34	0.41	0.40	0.38	0.38
0.03

	25% WG	0.176	0	4	0.32	0.49	0.47	0.39	0.40	0.08

Cabbage, head with wrapper leaves	2 lb/gal FlC	0.176	0	2	0.15	0.57	0.36
NC	NC	NC

	25% WG	0.176	0	2	0.58	0.69	0.64	NC	NC	NC

Mustard greens	2 lb/gal FlC	0.176	7	2	0.60	0.69	0.65	NC	NC	NC

	25% WG	0.176	7	2	0.69	0.75	0.72	NC	NC	NC

CGA-322704 Residues

Broccoli, head and stem	Treatment 2	0.169-0.170	71-84	4	<0.01	0.01	0.01
0.005	0.006	0.003

	Treatment 3	0.175	33	2	<0.01	<0.01	<0.01	NC	NC	NC

	Treatment 4	0.170-0.172	31-33	4	<0.01	<0.01	<0.01	0.005	0.005	NA

Cabbage, head with wrapper leaves	Treatment 2	0.178	84	2	0.01	0.01	0.01
NC	NC	NC

	Treatment 3	0.179	30	2	<0.01	<0.01	<0.01	NC	NC	NC

	Treatment 4	0.170-0.175	30-33	2	0.02	0.04	0.03	NC	NC	NC

Broccoli, head and stem	2 lb/gal FlC	0.176	0	4	0.01	0.04	0.03	0.02	0.02
0.01

	25% WG	0.176	0	4	0.02	0.03	0.03	0.02	0.02	0.01

Cabbage, head with wrapper leaves	2 lb/gal FlC	0.176	0	2	<0.01	0.04	0.03
NC	NC	NC

	25% WG	0.176	0	2	0.04	0.05	0.05	NC	NC	NC

Mustard greens	2 lb/gal FlC	0.176	7	2	0.11	0.12	0.12	NC	NC	NC

	25% WG	0.176	7	2	0.18	0.23	0.21	NC	NC	NC

Combined Residues

Broccoli, head and stem	Treatment 2	0.169-0.170	71-84	4	<0.02	<0.02
<0.02	0.01	0.01	0.003

	Treatment 3	0.175	33	2	<0.03	<0.03	<0.03	NC	NC	NC

	Treatment 4	0.170-0.172	31-33	4	<0.02	<0.03	0.03	0.01	0.02	0.01

Cabbage, head with wrapper leaves	Treatment 2	0.178	84	2	0.05	0.05	0.05
NC	NC	NC

	Treatment 3	0.179	30	2	<0.02	<0.03	0.03	NC	NC	NC

	Treatment 4	0.170-0.175	30-33	2	0.12	0.23	0.18	NC	NC	NC

Broccoli, head and stem	2 lb/gal FlC	0.176	0	4	0.35	0.46	0.43	0.39	0.40
0.04

	25% WG	0.176	0	4	0.36	0.51	0.49	0.41	0.42	0.08

Cabbage, head with wrapper leaves	2 lb/gal FlC	0.176	0	2	<0.16	0.61	0.39
NC	NC	NC

	25% WG	0.176	0	2	0.64	0.74	0.69	NC	NC	NC

Mustard greens	2 lb/gal FlC	0.176	7	2	0.73	0.83	0.78	NC	NC	NC

	25% WG	0.176	7	2	0.90	1.0	0.95	NC	NC	NC

1  The treatment regimes were:  

Treatment 2 = Single application of 2 lb/gal FlC as in-furrow spray at
planting/transplant

Treatment 3 = Single post seeding, transplant, or hill drench
application of 2 lb/gal FlC

Treatment 4 = Single application of 2 lb/gal FlC shanked into the root
zone

2 lb/gal FlC = 2 foliar applications of 2 lb/gal FlC

25% WG = 2 foliar applications of 25% WG

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.  Median, mean, and standard deviation were
not calculated (NC) for n=2.  NA = Not applicable.

3  HAFT = Highest Average Field Trial.

Conclusions.  The submitted brassica leafy vegetables crop field trial
data, when considered on their own, are not adequate to support the
proposed soil applications to brassica leafy vegetables because
geographic representation was inadequate.  Seventeen crop field trials
(6 each for broccoli/cauliflower and cabbage, and 5 for mustard greens)
are required to support use on the brassica leafy vegetables crop group;
only 7 field trials reflecting soil application were conducted.

Syngenta had submitted residue data for thiamethoxam on leafy vegetables
in conjunction with a previous petition.  These studies reflected
side-by-side plots in which brassica leafy vegetables received either
(i) two foliar applications of thiamethoxam (25% WG) at 0.088 lb
ai/A/application with a 7-day RTI, for a total seasonal rate of 0.17 lb
ai/A (1x the proposed maximum rate for foliar applications); or (ii) a
single soil application of thiamethoxam (unidentified formulation
referred to as 4L) at 0.126 lb ai/A, as either an in-furrow spray at
planting, a narrow surface band application incorporated at planting, or
a soil drench at transplanting, plus a single broadcast foliar
application of thiamethoxam (25% WG) at 0.044 lb ai/A/application, for a
total rate of 0.17 lb ai/A.  Combined residues of thiamethoxam and
CGA-322704 were <0.12-1.12 ppm in/on 12 samples of broccoli, <0.27-3.08
ppm in/on 12 samples of cabbage (with wrapper leaves), and 2.9-6.4 ppm
in/on 10 samples of mustard greens harvested 0 days following the last
of two foliar applications; residues were <0.03-0.20 ppm in/on 12
samples of broccoli, <0.06-0.79 ppm in/on 12 samples of cabbage, and
0.35-2.0 ppm in/on 10 samples of mustard greens harvested 7 days
following foliar-only treatment.  Combined residues were <0.05-<0.57 ppm
in/on 12 samples of broccoli, 0.11-0.70 ppm in/on 12 samples of cabbage,
and 1.2-3.0 ppm in/on 20 samples of mustard greens harvested 0 days
following the combination soil + foliar application; residues were
<0.02-0.14 ppm in/on 12 samples of broccoli, <0.02-0.16 ppm in/on 12
samples of cabbage, and 0.19-1.2 in/on 20 samples of mustard greens
harvested 7 days following combination treatment.  Comparison of the
residues in side-by-side plots indicates that combined residues
resulting from soil + foliar application were lower than combined
residues resulting from two foliar applications at almost every site.

HED had concluded that the residue data were adequate pending submission
and review of:  (i) supporting storage stability data; (ii) amended use
directions to match the application rates used in the field trials; and
(iii) information on the type of formulation used for the soil
applications.  The supporting storage stability data and amended use
directions have been submitted.  Currently, the petitioner has proposed
the following use patterns for brassica leafy vegetables:  (i) a single
soil application of the 2 lb/gal FlC formulation at up to 0.172 lb ai/A,
made as an in-furrow spray at planting, a soil drench post-seeding or
-transplant, in trickle or drip irrigation water, or shanked into the
root zone after establishment or transplant, with a 30-day PHI; or (ii)
foliar applications of the 25% WG formulation at a total rate of up to
0.172 lb ai/A with a 7-day RTI, a 0-day PHI for head and stem brassica,
and a 7-day PHI for leafy brassica greens.  HED notes that in the
previous petition, a PHI of 7 days had been proposed for head and stem
brassica and a PHI of 0 days had been proposed for leafy brassica
greens.  Information on the type of formulation used for soil
applications in the data reported previously remain outstanding.

In consideration of the available side-by-side trial data, HED concludes
that the limited field trial data reflecting soil-only applications are
adequate to support the requested soil application uses, provided that
the petitioner modifies the PHI for soil applications to 30 days.  The
available data indicate that it is unlikely that soil-only applications
will yield higher residues than foliar applications.  The available
field trial data will support the following use patterns for brassica
leafy vegetables:  (i) a single soil application of the 2 lb/gal FlC
formulation at up to 0.172 lb ai/A, made as an in-furrow spray at
planting, a soil drench post seeding or transplant, in trickle or drip
irrigation water, or shanked into the root zone after establishment or
transplant, with a 14-day PHI; or (ii) foliar applications of the 25% WG
formulation at a total rate of up to 0.172 lb ai/A with a 7-day RTI, a
0-day PHI for head and stem brassica, and a 7-day PHI for leafy brassica
greens.  Provided the petitioner amends the proposed use pattern to
specify a PHI of 30 days for soil applications, the available data will
support a tolerance for combined residues of thiamethoxam and
CGA-322704, expressed as thiamethoxam equivalents, in/on head and stem
brassica at 4.5 ppm for a 0-day PHI or 1.4 ppm for a 7-day PHI.  The
available data will also support a tolerance for combined residues of
thiamethoxam and CGA-322704 in/on leafy brassica greens at 9.0 ppm for a
0-day PHI or 3.0 ppm for a 7-day PHI.  The tolerance calculations are
presented in Appendix II.

The submitted crop field trial data reflecting foliar applications of
the 25% WG and 2 lb/gal FlC formulations in side-by-side plots
demonstrate that foliar applications of the 25% WG formulation may
result in higher residues in brassica leafy vegetable commodities than
applications of the FlC formulation.  The petitioner has not proposed
foliar applications of the 2 lb/gal FlC formulation to brassica leafy
vegetables.

HED notes that the submitted leafy vegetable and brassica leafy
vegetable crop field trial data satisfy the data requirement pertaining
to crop field trials in the D265079 PP#9F5051 review (conclusion 15).

Legume vegetable, group 6

DER Reference:	46162501.der.doc (Dry pea)

		46162502.der.doc (Dry bean)

		46162503.der.doc (Succulent pea)

		46162504.der.doc (Soybean)

IR-4 has submitted magnitude of the residue studies for dry beans, dry
and succulent peas, and soybeans in support of the requested new or
amended uses on legume vegetables.  The results from these field trials
are discussed below and summarized in Table 16.  

Bean, dry:  Nine field trials were conducted during 2000 on dry beans. 
Tests were conducted in Zones 1 (NY; 1 trial), 5, (WI; 2 trials), 7 (ND;
2 trials), 8 (CO; 1 trial), 9 (CO; 1 trial), 10 (CA; 1 trial), and 11
(WA; 1 trial).  Seeds were treated once with an aqueous slurry of a 5
lb/gal FlC formulation of thiamethoxam at a rate of 0.05 or 0.14 lb
ai/100 lb seed (1x and 2.8x the maximum rate) using a seed treater. 
Seeds were shipped to the field sites and planted 3-54 days after
treatment.  A single control and duplicate treated samples of dry beans
were collected from each test at normal crop maturity, 86-121 days after
planting.  

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

Following a seed treatment with the 5 lb/gal FlC formulation at 0.05 or
0.14 lb ai/100 lb seed (1x and 2.8x), residues of both thiamethoxam and
CGA-322704 were each <0.01 ppm in/on all samples of dry beans (n=18 per
rate) harvested at commercial maturity, for combined residues of <0.02
ppm. 

Pea, dry:  Five field trials were conducted during 2000 on dry peas. 
Tests were conducted in Zones 7 (ND; 2 trials) and 11 (ID and WA; 3
trials).  Seeds were treated once with an aqueous slurry of a 5 lb/gal
FlC formulation of thiamethoxam at a rate of 0.05 or 0.14 lb ai/100 lb
seed (1x and 2.8x the maximum rate) using a seed treater.  Seeds were
shipped to the field sites and planted within 24 days of treatment.  A
single control and duplicate treated samples of dry peas were collected
from each test at normal crop maturity, 77-100 days after planting.  

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

Following a seed treatment with the 5 lb/gal FlC formulation at 0.05 lb
ai/100 lb seed (1x), residues of both thiamethoxam and CGA-322704 were
each <0.01 ppm (<LLMV) in/on all 10 samples of dry peas harvested at
commercial maturity, for combined residues of <0.02 ppm.  Following the
0.14 lb ai/100 lb seed application rate (2.8x), residues of thiamethoxam
were also <0.01 ppm in/on all dry pea samples and residues of CGA-322704
were <0.01-0.02 ppm, for combined residues of <0.02-<0.03 ppm.  

Pea, succulent:  Ten field trials were conducted during 2000 on
succulent shelled (7 tests) and podded (3 tests) peas.  Tests on
succulent shelled peas were conducted in Zones 2 (NJ; 1 trial), 5 (IN,
OH, and WI; 4 trials), 10 (CA; 1 trial), and 11 (WA; 1 trial), and tests
on succulent podded peas were conducted in Zones 10 (CA; 2 trials) and
12 (OR; 1 trial).  Seeds were treated once with an aqueous slurry of a 5
lb/gal FlC formulation of thiamethoxam at a rate of 0.05 or 0.14 lb
ai/100 lb seed (1x and 2.8x the maximum rate) using a seed treater. 
Seeds were shipped to the field sites and planted within 25 days of
treatment.  A single control and duplicate treated samples of succulent
shelled or podded peas were collected from each test at normal crop
maturity, 55-77 days after planting.  

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

at 0.05 or 0.14 lb ai/100 lb seed (1x and 2.8x), residues of both
thiamethoxam and CGA-322704 were each ≤0.01 ppm (≤LLMV) in/on all
samples of succulent podded and shelled peas harvested at maturity, for
combined residues of <0.02 ppm.  

Soybean:  Fifteen field trials conducted during 2002 on soybeans.  Tests
were conducted in Zones 2 (NC and VA; 2 trials); 4 (AR and MS; 2
trials), and 5 (IL, IN, IA, KS, MI, MN, MO, NE, ND, OH, and SD; 11
trials).  Seeds were treated once with an aqueous slurry of a 5 lb/gal
FlC formulation of thiamethoxam at a rate of 0.05 lb ai/100 lb seed (1x
the maximum rate) using a seed treater and shipped to the field sites
for planting.  A single control and duplicate treated samples of
soybeans were collected from each test at normal crop maturity, 117-192
days after planting.  Samples of forage and hay were not collected.  

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

Following a seed treatment with the 5 lb/gal FlC formulation at 0.05 lb
ai/100 lb seed (1x), residues of both thiamethoxam and CGA-322704 were
each <0.01 ppm in/on all 30 samples of soybean seeds harvested at
commercial maturity, for combined residues of <0.02 ppm.  

Table 16.	Summary of Residue Data from Group 6 Crop Field Trials with
Thiamethoxam.

Commodity	EP1	Total Rate

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

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

BEAN (registered use = seed treatment at 0.05 lb ai/100 lb of seed)

Thiamethoxam Residues

Bean, dry seeds 	5 lb/gal FlC	0.05	86-121	10	<0.01	<0.01	<0.01	0.005
0.005	NA

0.14

10	<0.01	<0.01	<0.01	0.005	0.005	NA

CGA-322704 Residues

Bean, dry seeds 	5 lb/gal FlC	0.05	86-121	10	<0.01	<0.01	<0.01	0.005
0.005	NA

0.14

10	<0.01	<0.01	<0.01	0.005	0.005	NA

Combined Residues

Bean, dry seeds 	5 lb/gal FlC	0.05	86-121	10	<0.02	<0.02	<0.02	0.01	0.01
NA

0.14

10	<0.02	<0.02	<0.02	0.01	0.01	NA

PEA (registered use = seed treatment at 0.05 lb ai/100 lb of seed)

Thiamethoxam Residues

Pea, dry seeds 	5 lb/gal FlC	0.05	77-100	10	<0.01	<0.01	<0.01	0.005
0.005	NA

0.14

10	<0.01	<0.01	<0.01	0.005	0.005	NA

Pea, succulent shelled	5 lb/gal FlC	0.05	55-77	14	<0.01	<0.01	<0.01
0.005	0.005	NA

0.14

14	<0.01	0.01	0.01	0.005	0.006	0.002

Pea, succulent pods	5 lb/gal FlC	0.05	65	6	<0.01	<0.01	<0.01	0.005	0.005
NA

0.14

6	<0.01	0.01	0.01	0.005	0.006	0.002

CGA-322704 Residues

Pea, dry seeds 	5 lb/gal FlC	0.05	77-100	10	<0.01	<0.01	<0.01	0.005
0.005	NA

0.14

10	<0.01	0.02	0.02	0.005	0.01	0.01

Pea, succulent shelled	5 lb/gal FlC	0.05	55-77	14	<0.01	<0.01	<0.01
0.005	0.005	NA

0.14

14	<0.01	<0.01	<0.01	0.005	0.005	NA

Pea, succulent pods	5 lb/gal FlC	0.05	65	6	<0.01	<0.01	<0.01	0.005	0.005
NA

0.14

6	<0.01	<0.01	<0.01	0.005	0.005	NA

Combined Residues

Pea, dry seeds 	5 lb/gal FlC	0.05	77-100	10	<0.02	<0.02	<0.02	0.01	0.01
NA

0.14

10	<0.02	<0.03	<0.03	0.01	0.02	0.01

Pea, succulent shelled	5 lb/gal FlC	0.05	55-77	14	<0.02	<0.02	<0.02	0.01
0.01	NA

0.14

14	<0.02	<0.02	<0.02	0.01	0.01	0.002

Pea, succulent pods	5 lb/gal FlC	0.05	65	6	<0.02	<0.02	<0.02	0.01	0.01
NA

0.14

6	<0.02	<0.02	<0.02	0.01	0.01	0.002

SOYBEAN (registered use = seed treatment at 0.05 lb ai/100 lb of seed)

Thiamethoxam Residues

Soybean, seed 	5 lb/gal FlC	0.05	117-192	30	<0.01	<0.01	<0.01	0.005
0.005	NA

CGA-322704 Residues

Soybean, seed 	5 lb/gal FlC	0.05	117-192	30	<0.01	<0.01	<0.01	0.005
0.005	NA

Combined Residues

Soybean, seed 	5 lb/gal FlC	0.05	117-192	30	<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 bean, pea, and soybean crop field trial data
are adequate to support the registered uses on the legume vegetable
group, provided feeding restrictions for soybean forage and hay are
placed on the label.  The available data will support seed treatment of
legume vegetable seeds at 0.05 lb ai/100 lb of seed.  

The number and locations of the dry bean, dry pea, succulent pea, and
soybean field trials are adequate to support a crop group tolerance, in
consideration with the available crop field trial data for succulent
bean (DP Number D286726, 12/23/03, Y. Donovan).  The available field
trial data will support a tolerance for combined residues of
thiamethoxam and CGA-322704, expressed as thiamethoxam equivalents,
in/on legume vegetables at 0.02 ppm.  

Fruiting vegetable, group 8

DER Reference:	45880903.der.doc (Tomato)

		46724903.der.doc (Tomato)

Syngenta has submitted magnitude of the residue studies for tomatoes. 
The results from these field trials are discussed below and summarized
in Table 17.  

MRID 45880903:  Twelve tomato field trials were conducted in Zones 1
(PA; 1 trial), 2 (SC; 1 trial), 3 (FL; 2 trials), 5 (OH, 1 trial), and
10 (CA; 7 trials) during the 2002 growing season.

At each field site, a single soil application of a 2 lb/gal FlC
formulation was applied at a target rate of 0.17 lb ai/A (1x the
proposed maximum rate for soil applications).  Applications were made as
a single in-furrow application at planting or transplant (four trials),
a single post-seeding, -transplant, or hill drench application (four
trials), or a single application shanked into the root zone (four
trials).  Applications were made using ground equipment in ~14-114
gal/A, without an adjuvant.  Samples of tomato fruit were harvested
60-131 days after the in-furrow application, and 29-31 days following
drench or shanked application.  At two trial locations, one trial with
drench application and one trial with shanked application, tomato
samples were collected at 2, 9, 16, 23, 30, and 37 days following
application to evaluate residue decline.  

The HPLC/UV method, Method AG-675, used to determine residues of
thiamethoxam and CGA-322704 in/on tomatoes 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 CGA-322704 were below the LOQ (<0.01 ppm
each) in/on all tomato samples harvested 29-30 days following a single
soil application, shanked into the root zone, at 0.173-0.180 lb ai/A. 
Maximum combined residues of thiamethoxam and its metabolite CGA-322704
were 0.05 ppm in/on tomato fruit harvested 60-131 days following a
single in-furrow application, at planting/transplant, at 0.167-0.184 lb
ai/A, and were 0.03 ppm in/on samples harvested 29-31 days following a
single drench application at 0.172-0.187 lb ai/A.  Maximum individual
residues of thiamethoxam and CGA-322704 were 0.03 and 0.02 ppm,
respectively, in/on samples receiving in-furrow application, and 0.02
and 0.01 ppm, respectively, in/on samples receiving drench application. 

oxam and CGA-322704 were too low (≤0.04 ppm each) in/on all samples
from the residue decline trials to determine a pattern of decline;
however, the data indicate that residues do not generally increase in/on
tomato fruit with sampling durations ≥16 days. 

MRID 46724903:  Syngenta Crop Protection   SEQ CHAPTER \h \r 1 has
submitted side-by-side field trial data on tomato, a representative crop
of crop group 8, fruiting vegetables, following two broadcast foliar
applications of thiamethoxam formulated as a 2 lb/gal FlC formulation or
25% WG formulation.  Two side-by-side field trials were conducted on
tomato in Zones 3 (FL; 1 trial) and 10 (CA; 1 trial) during the 2000
growing season.

Each field test consisted of one untreated plot and two treated plots. 
At each trial, two foliar broadcast applications of the 2 lb/gal FlC and
25% WG formulations were made, in separate plots, at 0.088 lb
ai/A/application, with a 7- to 8-day RTI, for a total rate of 0.176 lb
ai/A (~1x the maximum proposed rate for foliar applications). 
Applications were made using ground equipment in ~20-84 gal/A, without
an adjuvant.  Samples of tomato were harvested 0 and 2/4 days following
last application.

The HPLC/UV or HPLC/MS method, Method AG-675, used to determine residues
of thiamethoxam and CGA-322704 in/on tomatoes 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.

Maximum combined residues of thiamethoxam and its metabolite CGA-322704
were <0.11 ppm in/on tomato harvested on the day of the last application
of the 2 lb/gal FlC formulation, and <0.07 ppm in/on tomato harvested on
the day of the last application of the 25% WG formulation.  Maximum
individual residues of thiamethoxam and CGA-322704 were 0.10 and 0.01
ppm, respectively, in/on tomato treated with the 2 lb/gal FlC
formulation and 0.06 and 0.01 ppm in/on tomato treated with the 25% WG
formulation.  A comparison of residues in/on tomato fruit from the
side-by-side plots indicates that residues were slightly higher in/on
samples treated with the FlC formulation than in/on samples treated with
the WG formulation; however, individual residues were ≤0.10 ppm in/on
all samples.  

The residue data also indicate that combined residues decline from the
0-day sampling interval to the 2/4-day sampling interval.

Table 17.	Summary of Residue Data from Tomato Crop Field Trials with
Thiamethoxam.

Matrix	Application Type1	Total Applic. Rate

(lb ai/A)	PHI

(days)	Residue Levels 2

(ppm)

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

FRUITING VEGETABLES (proposed use = 0.172 lb ai/A total application rate
for soil application with a 30-day PHI; or 0.172 lb ai/A total
application rate for foliar application with 0-day PHI)

Thiamethoxam Residues

Tomato	Treatment 2	0.167-0.184	60-131	8	<0.01	0.03	0.03	0.005	0.01	0.01

	Treatment 3	0.172-0.187	29-31	8	<0.01	0.02	0.02	0.005	0.009	0.01

	Treatment 4	0.172-0.180	29-30	8	<0.01	<0.01	<0.01	0.005	0.005	NA

Tomato	2 lb/gal FlC	0.176	0	4	0.03	0.10	0.09	0.08	0.07	0.03

	25% WG	0.176	0	4	0.02	0.06	0.06	0.06	0.05	0.02

	2 lb/gal FlC	0.176	2-4	4	<0.01	0.04	0.04	0.03	0.02	0.01

	25% WG	0.176	2-4	4	<0.01	0.02	0.02	0.02	0.02	0.008

CGA-322704 Residues

Tomato	Treatment 2	0.167-0.184	60-131	8	<0.01	0.02	0.02	0.005	0.01	0.01

	Treatment 3	0.172-0.187	29-31	8	<0.01	0.01	0.01	0.005	0.007	0.003

	Treatment 4	0.172-0.180	29-30	8	<0.01	<0.01	<0.01	0.005	0.005	NA

Tomato	2 lb/gal FlC	0.176	0	4	<0.01	0.01	0.01	0.005	0.006	0.003

	25% WG	0.176	0	4	<0.01	<0.01	<0.01	0.005	0.005	NA

	2 lb/gal FlC	0.176	2-4	4	<0.01	0.02	0.02	0.005	0.009	0.008

	25% WG	0.176	2-4	4	<0.01	0.01	0.01	0.008	0.008	0.003

Combined Residues

Tomato	Treatment 2	0.167-0.184	60-131	8	<0.02	0.05	0.05	0.01	0.02	0.02

	Treatment 3	0.172-0.187	29-31	8	<0.02	0.03	0.03	0.01	0.02	0.01

	Treatment 4	0.172-0.180	29-30	8	<0.02	<0.02	<0.02	0.01	0.01	NA

Tomato	2 lb/gal FlC	0.176	0	4	<0.04	<0.11	0.10	0.08	0.08	0.03

	25% WG	0.176	0	4	<0.03	<0.07	0.07	0.06	0.05	0.02

	2 lb/gal FlC	0.176	2-4	4	<0.02	<0.05	0.05	0.04	0.03	0.02

	25% WG	0.176	2-4	4	<0.02	0.03	0.03	0.03	0.02	0.009

1  The treatment regimes were:  

Treatment 2 = Single application of 2 lb/gal FlC as in-furrow spray at
planting/transplant

Treatment 3 = Single post seeding, transplant, or hill drench
application of 2 lb/gal FlC

Treatment 4 = Single application of 2 lb/gal FlC shanked into the root
zone

2 lb/gal FlC = 2 foliar applications of 2 lb/gal FlC

25% WG = 2 foliar applications of 25% WG

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 tomato crop field trial data, when
considered on their own, are not adequate to support soil applications
to fruiting vegetables because geographic representation was inadequate.
 Twenty-one crop field trials (12 for tomato, 6 for bell pepper, and 3
for non-bell pepper) are required to support use on the fruiting
vegetables crop group; trials reflecting soil application were only
conducted with tomato.  

The petitioner has proposed to increase the maximum seasonal rate for
use of the 2 lb/gal FlC and 25% WG formulations on fruiting vegetables,
from 0.125 lb ai/A to 0.172 lb ai/A.  The petitioner has also proposed
to reinstate the fruiting vegetables eggplant, groundcherry, pepino,
tomatillo, and tomato to the label for the 25% WG formulation.

Syngenta had previously submitted residue data for thiamethoxam on
fruiting vegetables in conjunction with a previous petition (PP#9F5051;
DP Number D265079, 5/8/00, G.J. Herndon).  These studies reflected
side-by-side plots, at most sites, in which fruiting vegetables received
either (i) two foliar applications of thiamethoxam (25% WG) at 0.088 lb
ai/A/application with a 5-day RTI, for a total seasonal rate of 0.17 lb
ai/A (1x the proposed maximum rate for foliar applications); or (ii) a
single at-planting in-furrow, surface-banded, or transplant-drench
application of thiamethoxam (FlC formulation) at 0.125 lb ai/A, plus a
single broadcast foliar application of thiamethoxam (25% WG) at 0.044 lb
ai/A/application, for a total rate of 0.17 lb ai/A.  Combined residues
of thiamethoxam and CGA-322704 were <0.02-<0.15 ppm in/on 26 samples of
tomato, <0.02-<0.18 ppm in/on 12 samples of bell peppers, and <0.04-0.24
ppm in/on 6 samples of hot peppers harvested 0 days following the last
of two foliar applications; and combined residues were <0.02-<0.09 ppm
in/on 28 samples of tomato, <0.03-0.11 ppm in/on 10 samples of bell
peppers, and <0.03-<0.10 ppm in/on 8 samples of hot peppers harvested 0
days following combination soil + foliar application.  Comparison of the
residues in side-by-side plots indicates that combined residues
resulting from soil + foliar application were lower than combined
residues resulting from two foliar applications at almost every site.

HED concludes that the limited field trial data reflecting soil-only
applications are adequate to support the requested soil application
uses.  The available data indicate that it is unlikely that soil-only
applications will yield higher residues than foliar applications.  The
available field trial data will support the following use patterns for
fruiting vegetables:  (i) a single soil application of the 2 lb/gal FlC
formulation at up to 0.172 lb ai/A, made as an in-furrow spray at
planting, a soil drench post-seeding or -transplant, in trickle or drip
irrigation water, or shanked into the root zone after establishment or
transplant, with a 30-day PHI; or (ii) foliar applications of the 25% WG
formulation at a total rate of up to 0.172 lb ai/A with a 5-day RTI and
a 0-day PHI.  The available data indicate that the established 0.25-ppm
tolerance for fruiting vegetables is appropriate.

The submitted crop field trial data reflecting foliar applications of
the 25% WG and 2 lb/gal FlC formulations in side-by-side plots
demonstrate that foliar applications of the FlC formulation may result
in slightly higher residues in tomatoes than applications of the 25% WG
formulation; however, residues were low in/on all samples.  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.

Cucurbit vegetables, group 9

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

The petitioner has proposed reinstating use of the 25% WG formulation
(EPA Reg. No. 100-938) on the cucurbit vegetable group, at a higher
maximum seasonal rate, and has proposed increasing the maximum single
and seasonal application rates of the 2 lb/gal FlC formulation (EPA Reg.
No. 100-939) to the cucurbit vegetable group, and has proposed use of
the new 2 lb/gal FlC formulation (Actara® 240 SC) for foliar
applications to cucurbit vegetables.  No new crop field trial data were
submitted to support these amended use requests.  HED has concluded (see
860.1200) 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.

The proposed uses of thiamethoxam on cucurbits are: (i) a single soil
application of the 2 lb/gal FlC formulation at up to 0.172 lb ai/A, made
as an in-furrow spray at planting, a soil drench post seeding or
transplant, in trickle or drip irrigation water, or shanked into the
root zone after establishment or transplant, with a 30-day PHI; (ii)
foliar applications of the 2 lb/gal FlC formulation at a total rate of
0.125 lb ai/A with a 5-day RTI and a 0-day PHI; or (iii) foliar
applications of the 25% WG formulation at a total rate of 0.172 lb ai/A
with a 5-day RTI and a 0-day PHI.  

Syngenta had previously submitted residue data for thiamethoxam on
cucurbit vegetables in conjunction with a previous petition (PP#9F5051;
DP Number D265079, 5/8/00, G.J. Herndon).  These studies reflected
side-by-side plots, at most sites, in which cucurbit vegetables received
either (i) two foliar applications of thiamethoxam (25% WG) at 0.088 lb
ai/A/application with a 4- to 6-day RTI, for a total seasonal rate of
0.176 lb ai/A (1x the proposed maximum rate for foliar applications); or
(ii) a single in-furrow or banded application of thiamethoxam (FlC
formulation) at 0.13 lb ai/A, plus a single broadcast foliar application
of thiamethoxam (25% WG) at 0.044 lb ai/A/application, for a total rate
of 0.174 lb ai/A.  Residues of thiamethoxam per se were 0.01-0.10 ppm
in/on 16 samples of cucumber, 0.01-0.14 ppm in/on 12 samples of
cantaloupe, and <0.01-0.13 ppm in/on 10 samples of summer squash
harvested 0 days following two foliar applications, and residues were
<0.01-0.03 in/on 20 samples of cucumber, <0.01-0.05 ppm in/on 16 samples
of cantaloupe, and <0.01-0.11 ppm in/on 14 samples of summer squash
harvested 0 days following combination soil + foliar application. 
Residues of CGA-322704 were <0.01 ppm in/on all treated samples. 
Comparison of the residues in side-by-side plots indicates that combined
residues resulting from soil + foliar application were lower than
combined residues resulting from two foliar applications at almost every
site.  HED had concluded that the data were adequate to support the
0.2-ppm tolerance for cucurbit vegetables provided supporting storage
stability data were submitted; the storage stability data requirement
has been fulfilled (see 860.1380 – Storage Stability).  

Based on the side-by-side crop field trial data for cucurbits and the
available soil application data for leafy vegetables, brassica leafy
vegetables, and tomatoes, HED concludes that it is unlikely that
soil-only applications to cucurbit vegetables at a total rate of 0.172
lb ai/A will yield higher residues than foliar applications at a total
rate of 0.172 lb ai/A.  The available data will support the following
uses on cucurbit vegetables:  (i) a single soil application of the 2
lb/gal FlC formulation at up to 0.172 lb ai/A, made as an in-furrow
spray at planting, a soil drench post seeding or transplant, in trickle
or drip irrigation water, or shanked into the root zone after
establishment or transplant, with a 30-day PHI; or (ii) foliar
applications of the 25% WG formulation at a total rate of 0.172 lb ai/A
with a 5-day RTI and a 0-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.  

Pome fruit, group 11

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

The petitioner has proposed amending the current use directions for the
25% WG formulation (EPA Reg. No. 100-938) on pome fruit to remove the
restriction to apply only to apples grown east of the Mississippi River,
to remove the restriction to only make one prebloom application, and to
increase the maximum seasonal rate.  The petitioner has also proposed
use of the new 2 lb/gal FlC formulation (Actara® 240 SC) for foliar
applications to pome fruit.  No new crop field trial data were submitted
to support these amended use requests.  HED has concluded (see 860.1200)
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.

ations ≤0.043 lb ai/A or a 35-day PHI for applications >0.043 lb ai/A.

Syngenta had previously submitted residue data for thiamethoxam on pome
fruit in conjunction with a previous petition (PP#9F5051; DP Number
D265079, 5/8/00, G.J. Herndon).  In a total of 13 apple tests and 6 pear
tests, thiamethoxam (25% WG) was applied as four successive foliar
applications at 0.088+0.088+0.044+0.044 lb ai/A, with RTIs of 7-10 days,
for a total rate of 0.26 lb ai/A/season (1x the proposed maximum
seasonal rate).  The number and locations of the field trials are in
accordance with OPPTS Guideline 860.1500 for the pome fruit group.  The
combined residues of thiamethoxam and CGA-322704 were <0.03-<0.12 ppm
in/on 26 samples of apples and <0.03-0.09 ppm in/on 12 samples of pears
harvested ~14 days following the last of application.  HED had concluded
that the data were adequate to support the 0.2-ppm tolerance for pome
fruit provided supporting storage stability data were submitted; the
storage stability data requirement has been fulfilled (see 860.1500).  

HED concludes that the available pome fruit data support the proposed
increased use pattern for the 25% WG formulation on pome fruit.  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.  

Stone fruit, group 12

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 amending the current use directions for the
25% WG formulation (EPA Reg. No. 100-938) on stone fruit to remove the
restriction to only make one prebloom and one postbloom application and
to increase the maximum seasonal rate.  The petitioner has also proposed
use of the new 2 lb/gal FlC formulation (Actara® 240 SC) for foliar
applications to stone fruit.  No new crop field trial data were
submitted to support these amended use requests.  HED has concluded (see
860.1200) 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.

The proposed uses of thiamethoxam on stone fruit are: (i) foliar
applications of the 25% WG formulation at 0.031-0.086 lb
ai/A/application made during the pre-bloom or postbloom growth stages,
with a total seasonal rate of 0.172 lb ai/A, a 7-day RTI, and a 14-day
PHI; or (ii) foliar applications of the 2 lb/gal FlC formulation at
0.031-0.086 lb ai/A/application made as one pre-bloom and/or one
postbloom application, with a total seasonal rate of 0.125 lb ai/A, a
7-day RTI, and a 14-day PHI.  

Syngenta had previously submitted residue data for thiamethoxam on stone
fruit in conjunction with a previous petition (DP Number D286726,
12/23/03, Y. Donovan).  In a total of 4 sweet cherry, 4 tart cherry, 9
peach, and 6 plum trials, the 25% WG formulation of thiamethoxam was
applied as two foliar applications at 0.086 lb ai/A/application, with a
RTI of ~10 days, for a total rate of 0.172 lb ai/A/season (1x the
proposed maximum seasonal rate).  Side-by-side trials were conducted for
two of the plum trials; an additional plot was treated with the 2 lb/gal
FlC formulation.  The combined residues of thiamethoxam and CGA-322704
were 0.13-0.30 ppm in/on 16 samples of cherries, <0.02-0.31 ppm in/on 18
samples of peaches, and <0.02-0.04 ppm in/on 12 samples of plums
harvested ~14 days following the last foliar application with the WG
formulation.  The combined residues of thiamethoxam and CGA-322704 were
<0.02 ppm in/on 4 samples of plums harvested 14 days following the last
foliar application with the FlC formulation.  HED had concluded that the
data were adequate to support the 0.5-ppm tolerance for stone fruit. 
The available stone fruit data support the proposed increased use
pattern for the 25% WG formulation on stone fruit. 

The data from the side-by-side plots reflecting foliar application of
the 2 lb/gal FlC or 25% WG formulation indicate that combined residues
of thiamethoxam and CGA-322704 were higher in/on plum samples treated
with the 25% WG formulation than in/on plum samples treated with the 2
lb/gal FlC formulation.  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.  

Berry and small fruit, group 13

Bushberry, subgroup 13B

DER Reference:	46162201.der.doc (Blueberry)

IR-4 has submitted magnitude of the residue studies for blueberries. 
The results from these field trials are discussed below and summarized
in Table 18.  

Sixteen blueberry field trials were conducted at 9 field sites during
2001 in Zones 1 (ME; 1 trial), 2 (NJ and NC; 4 trials), 5 (MI; 3
trials), and 12 (OR; 1 trial).  In 7 tests, a 2 lb/gal FlC formulation
of thiamethoxam was applied once as a banded soil application around
blueberry plants during the early budding stage at 0.187-0.218 lb ai/A
(~1x the proposed maximum rate for soil applications).  In another 9
tests, a 25% WG formulation of thiamethoxam was applied as three
broadcast foliar applications to blueberry plants during fruit
development at 0.064-0.069 lb ai/A/application, for a total rate of
0.197-0.204 lb ai/A/season (~1x the proposed maximum rate for foliar
applications), at RTIs of 6-7 days.  Blueberry fruit were harvested at
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 410-305-2999.

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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F 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
leafy vegetables.  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-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.  

Page   PAGE  1  of   NUMPAGES  137 

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

Page   PAGE  137  of   NUMPAGES  137