Document ID: EPA-HQ-OPP-2010-0889-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-12-22T05:00Z

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<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

EPA Registration Division contact: Meredith Laws; (703) 308-7038 

<[Dow AgroSciences LLC]>

<[0F7777]>

<	EPA has received a pesticide petition (0F7777) from Dow AgroSciences
LLC, c/o Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN  46268
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of sulfoxaflor
(1-(6-trifluoromethylpyridin-3-yl)ethyl](methyl)-oxido-λ4-sulfanylidene
cyanamide) in or on the raw agricultural commodity carrot, roots at 0.05
parts per million (ppm); carrot, juice at 0.15 ppm; carrot, tops at 4
ppm; potato at 0.01 ppm; potato, wet peel at 0.02 ppm; potato, chips at
0.02 ppm; potato, dried at 0.02 ppm; potato, granules/flakes at 0.02
ppm; beet, sugar, roots at 0.03 ppm; beet, sugar, raw sugar at 0.04 ppm;
beet, sugar, molasses at 0.3 ppm; beet, sugar, thick juice at 0.15 ppm;
beet, sugar, dried pulp at 0.07 ppm; beet, sugar, tops at 3 ppm; radish,
roots at 0.05 ppm; radish, tops at 4 ppm; 1. Root and Tuber Vegetables
at 0.05 ppm; 2. Leaves of Root and Tuber Vegetables at 4 ppm; onion, dry
bulb at 0.01 ppm; onion, green at 0.06 ppm; 3-07A Bulb vegetables,
Onion, bulb, subgroup at 0.01 ppm; 3-07B Bulb Vegetables, Onion, green,
subgroup at 0.6 ppm; lettuce, leaf at 4 ppm; lettuce, head at 1.6 ppm;
spinach at 5 ppm; celery at 1 ppm; 4A. Leafy Vegetables (except
Brassica), Leafy greens, subgroup at 5 ppm; 4B. Leafy Vegetables (except
Brassica), Leafy petioles, subgroup at 1 ppm; cauliflower at 0.1 ppm;
broccoli at 0.45 ppm; cabbage at 1 ppm; mustard greens at 5 ppm; 5A.
Brassica Leafy Vegetables, head and stem (except cauliflower) at 1 ppm;
5B. Brassica Leafy Vegetables, leafy greens at 5 ppm; green bean, snap,
succulent at 0.8 ppm; beans, dry at 0.2 ppm; tomato at 0.35 ppm; tomato,
puree at 0.6 ppm; tomato, paste at 1.3 ppm; tomato, catsup at 0.6 ppm;
pepper, bell at 0.6 ppm;  8. Fruiting Vegetables (except cucurbits, plus
okra) at 0.6 ppm; cucumber at 0.3 ppm; melon at 0.3 ppm; squash at 0.03
ppm; 9. Cucurbit Vegetables (except squash) at 0.3 ppm; orange at 0.6
ppm; lemon at 0.6 ppm; grapefruit at 0.6 ppm; citrus, peel at 1 ppm;
citrus, dried pulp, at 0.9 ppm; 10. Citrus Fruits at 0.6 ppm; apple at
0.3 ppm; apple, dried pomace at 1.3 ppm; pear at 0.45 ppm; 11. Pome
Fruits at 0.45 ppm; cherry, pitted fruit at 2.5 ppm; cherry, dried
cherry at 15 ppm; nectarine, pitted fruit at 0.3 ppm; peach, pitted
fruit at 0.6 ppm; plum, pitted fruit at 0.25 ppm; 12. Stone Fruits
(except cherry) at 0.6 ppm; grape at 1.5 ppm; grape, raisins at 6 ppm;
strawberry, fruit at 0.6 ppm; 13-07F. Berry and Small Fruits, Grape at
1.5 ppm; 13-07G Berry and Small Fruits, Strawberry at .06 ppm; almond at
0.02 ppm; almond, hulls at 4 ppm; pistachio at 0.02 ppm;  pecan at 0.01
ppm; 14. Tree Nuts (plus pistachio) at 0.02 ppm; canola, seeds at 0.3
ppm; canola, meal at 0.7 ppm; 20-A. Rapeseed Subgroup at 0.3 PPM;
cotton, seed at 0.15 ppm; cotton, hulls at 0.3 ppm; cotton, gin
byproducts at 9.0 ppm; cotton, aspirated grain fractions at 3.5 ppm;
20-C. Cottonseed Subgroup at 0.15 ppm; wheat, grain at 0.06 ppm; wheat,
forage at 0.8 ppm; wheat, hay at 1.1 ppm; wheat, straw at  2 ppm;
barley, grain at 0.15 ppm; barley hay at  0.8 ppm; barley straw at  1.3
ppm; barley malt sprouts at  0.2 ppm; soybean, seed at 0.2 ppm; soybean
hay at 1.8 ppm; soybean, forage at 1.9 ppm; soybean hulls at 0.3 ppm;
soybean, meal, toasted at 0.3 ppm; soybean, aspirated grain fractions at
18 ppm.  Tolerances of unchanged parent, XDE-208 are also proposed for
milk at 0.09 ppm; fat of cattle, goat, horse and sheep at 0.04 ppm;
kidney of cattle, goat, horse and sheep at 0.2 ppm; meat of cattle,
goat, horse and sheep at 0.1 ppm; meat byproducts of cattle, goat, horse
and sheep at 0.3 ppm; fat and meat of hog at 0.01 ppm; meat byproducts
of hog at 0.4 ppm; egg at 0.01 ppm; fat and meat of poultry at 0.01 ppm;
meat byproduct of poultry at 0.03 ppm.  EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.>

<A. Residue Chemistry>

<	1. Plant metabolism. [The nature of the residue in plants is
adequately understood for the purpose of these tolerances.  Based on the
findings from these metabolism studies, the residue of concern in plants
is the residue of XDE-208, expressed as the parent.]

>

	2. Analytical method. [The residue profile of sulfoxaflor is adequately
understood and an acceptable analytical method is available for
enforcement purposes.  Analytical method 091116, “Enforcement Method
for the Determination of Sulfoxaflor (XDE-208) and its Main Metabolites
in Agricultural Commodities using Offline Solid-Phase Extraction and
Liquid Chromatography with Tandem Mass Spectrometry Detection” was
validated on a variety of plant matrices.  The method was validated over
the concentration range of 0.010-5.0 mg/kg with validated limits of
detection (LOD) (LOQ) of 0.003 (except Australian studies with reported
LOQ of 0.005) and limit of quantitation of 0.010 mg/kg.]

<	3. Magnitude of residues. [The test material was GF-2032, a suspension
concentrate (SC) containing 240 g ai/L. In several MOR studies (leaf
lettuce, plum, soybean, wheat) GF-2732, a water dispersible granule (WG)
which contains 50% active ingredient was also used to generate bridging
data.

1. Almond: Magnitude of residues of XDE-208 was determined in almond
nutmeat and hulls, following two foliar applications targeted at 200 g
ai/ha each, made at weekly intervals, in spray volumes of 1000 – 4000
L/ha. Six trials were made in USA as the major producer and
representative geography for almonds in region 10. Residues of XDE-208
in almond nutmeat at PHI of 7 days ranged from ND (< 0.003 mg/kg) to
0.013 mg/kg with an average of 0.004.  Residues of XDE-208 in almond
hulls at PHI of 7 days ranged from 1.038 to 3.119 mg/kg, with an average
of 1.864 mg/kg. 

2. Apple: Magnitude of residues of XDE-208 was determined in apples on
16 trials in 3 representative geographies of apple production.  All
trials received two foliar applications targeted at 200 g ai/ha each,
made at weekly intervals, in spray volumes of 977 – 2272 L/ha. 
Recoveries of XDE-208 averaged 85-93% for apples.  Residues of XDE-208
in apples, fruit, at PHI of 7 days ranged from 0.021 mg/kg to 0.297
mg/kg, with an average of 0.091 mg/kg.  

3. Barley: Magnitude of residues of XDE-208 was determined in barley, on
20 trials in 2 representative geographies of barley production. All
trials received two foliar applications targeted at 50 g ai/ha each,
made at 14-day intervals, in spray volumes of 89-433 L/ha.  Recoveries
of XDE-208 averaged 83-101% for grain, 83-102% for straw, 100-101% for
hay, and 81-101% for forage. Residues were reported down to LOD level,
otherwise declared as non-detected (ND). Residues of XDE-208 in barley,
grain, at PHI of 14 days ranged from ND (<0.005 mg/kg) to 0.109 mg/kg,
with an average of 0.049 mg/kg.  Residues of XDE-208 in barley, straw,
at PHI of 14 days ranged from 0.012 mg/kg to 0.663 mg/kg, with an
average of 0.2 mg/kg.  Residues of XDE-208 in barley, hay, at a PHI of 7
days ranged from 0.029 mg/kg to 0.643 mg/kg, with an average of 0.251
mg/kg.  

4. Dry Beans: Magnitude of residues of XDE-208 was determined in dry
beans on 9 trials in 2 representative geographies of dry bean
production.  All trials received four foliar applications targeted at
100g ai/ha each, made at weekly intervals, in spray volumes of 200-500
L/ha.  Residues of XDE-208 in dry beans at PHI of 7 days ranged from
0.046 mg/kg to 0.094 mg/kg, with an average of 0.071 mg/kg.  

5. Succulent, Edible Podded Beans: Magnitude of residues of XDE-208 was
determined in succulent, edible podded beans, following four foliar
applications targeted at 100 g ai/ha each, made at weekly intervals, in
spray volumes of 408 – 511 L/ha.  Field samples were collected in
replicate samples at 7 days after last application.  Recoveries of
XDE-208 averaged 100% for succulent, edible podded beans.  Residues were
reported down to LOD level, otherwise declared as non-detected (ND).
Residues of XDE-208 in succulent, edible podded beans, whole pods, at
PHI of 7 days ranged from 0.028 mg/kg to 2.248 mg/kg, with an average of
0.579 mg/kg.

6. Broccoli: Magnitude of residues of XDE-208 was determined in
broccoli, on 13 trials in 3 representative geographies of broccoli
production.  All trials received four foliar applications targeted at
100 g ai/ha each, made at weekly intervals, in spray volumes of 190 –
500 L/ha.  Residues were reported down to LOD level, otherwise declared
as non-detected (ND). Residues of XDE-208 in broccoli, heads/stems, at
PHI of 3 days ranged from ND (<0.003 mg/kg) to 0.408 mg/kg, with an
average of 0.108 mg/kg. 

7. Cabbage: Magnitude of residues of XDE-208 was determined in cabbage
with wrapper leaves, on 14 trials in 3 representative geographies of
cabbage production.  All trials received four foliar applications on
cabbages targeted at 100 g ai/ha each, made at weekly intervals, in
spray volumes of 200 – 550 L/ha. Recoveries of XDE-208 averaged 79-96%
for cabbage with wrapper leaves.  Residues were reported down to LOD
level, otherwise declared as non-detected (ND).  Residues of XDE-208 in
cabbage with wrapper leaves at PHI of 3 days ranged from ND (<0.003
mg/kg) to 0.398 mg/kg, with an average of 0.093 mg/kg.

8. Canola: Magnitude of residues of XDE-208 was determined in canola, on
18 trials in 3 representative geographies of canola production.  All
trials received two foliar applications on canola targeted at 50 g ai/ha
each, made at 14-day intervals, in spray volumes of 89 – 522 L/ha.
Recoveries of XDE-208 averaged 90-94% for canola seed and 85-90% for
canola forage, and 101-103% for canola stubble.  Residues were reported
down to LOD level, otherwise declared as non-detected (ND). Residues of
XDE-208 in canola, seed, at PHI of 14 days ranged from ND in Australia
(<0.005 mg/kg) to 0.304 mg/kg, with an average of 0.057 mg/kg.  Residues
of XDE-208 in canola, forage/stubble, at PHI of 14 days ranged from
0.022 mg/kg to 1.493 mg/kg, with an average of 0.361 mg/kg.

9. Carrot: Magnitude of residues of XDE-208 was determined in carrots,
on 12 trials in 2 representative geographies of carrot production.  All
trials received four foliar applications on carrots, targeted at 100 g
ai/ha each, made at weekly intervals, in spray volumes of 200 – 550
L/ha. Recoveries of XDE-208 averaged 87-98% for carrot roots and tops.
Residues were reported down to LOD level, otherwise declared as
non-detected (ND). Residues of XDE-208 in carrot roots at PHI of 7 days
ranged from less than LOD to 0.032 mg/kg, with an average of 0.011
mg/kg.  Residues of XDE-208 in carrot tops at PHI of 7 days ranged from
0.3113 to 2.2834 mg/kg, with an average of 0.857 mg/kg.

10. Cauliflower: Magnitude of residues of XDE-208 was determined in
cauliflower following four foliar applications targeted at 100 g ai/ha
each, made at weekly intervals, in spray volumes of 292-535 L/ha.  Seven
trials were conducted in the major producers and representative
geographies for cauliflower. Recoveries for cauliflower averaged 93% for
XDE-208.  Residue results were reported down to the LOD level, otherwise
declared as non-detected (ND). Residues of XDE-208 in cauliflower at PHI
of 3 days ranged from ND in Australia (<0.005 mg/kg) to 0.031 mg/kg,
with an average of 0.022 mg/kg.  

>

11. Celery: Magnitude of residues of XDE-208 was determined in celery,
following four foliar applications targeted at 100 g ai/ha each, made at
weekly intervals, in spray volumes of 200-500 L/ha.  Recoveries for
celery averaged 83% for XDE-208. Residues of XDE-208 in celery at PHI of
3 days ranged from 0.058 mg/kg to 0.804 mg/kg, with an average of 0.229
mg/kg.

12. Cherry: Magnitude of residues of XDE-208 was determined in cherries,
on 8 trials in 2 representative geographies of cherry production.  All
trials received two foliar applications targeted at 200 g ai/ha each,
made at weekly intervals, in spray volumes of 950-2000 L/ha. Recoveries
of XDE-208 averaged 85-86% for cherries. Residues of XDE-208 in
cherries, pitted fruits, at PHI of 7 days ranged from 0.283 mg/kg to
1.773 mg/kg, with an average of 0.8 mg/kg.

13. Cotton: Magnitude of residues of XDE-208 was determined in cotton,
on 21 trials in 4 representative geographies of cotton production.  All
trials received four foliar applications on cotton targeted at 100 g
ai/ha each, made at weekly intervals, in spray volumes of 100 – 200
L/ha.  Recoveries of XDE-208 averaged 83-98% for cotton seed and gin
by-product.  Residues were reported down to LOD level, otherwise
declared as non-detected (ND). Residues of XDE-208 in cotton, seed, at
PHI of 14 days ranged from 0.004 mg/kg to 0.182 mg/kg, with an average
of 0.036 mg/kg.  Residues of XDE-208 in cotton, gin by-product, at PHI
of 14 days ranged from 0.037 mg/kg to 4.191 mg/kg, with an average of
0.931 mg/kg.  

14. Cucumber: Magnitude of residues of XDE-208 was determined in
cucumbers/zucchini, on 16 trials in 3 representative geographies of
cucumber/zucchini production. All trials received four foliar
applications targeted at 100 g ai/ha each, made at weekly intervals, in
spray volumes of 188 to 889 L/ha. Recoveries of XDE-208 averaged 84-99%
for cucumbers/zucchinis.  Residues were reported down to LOD level,
otherwise declared as non-detected (ND). Residues of XDE-208 in
cucumbers/zucchinis at PHI of 1 day ranged from 0.004 mg/kg to 0.172
mg/kg, with an average of 0.054 mg/kg.  

15. Grape: Magnitude of residues of XDE-208 was determined in grapes, on
29 trials in 3 representative geographies of grape production.  All
trials received four foliar applications on grapes targeted at 100 g
ai/ha each, made at weekly intervals, in spray volumes of 287 – 1000
L/ha. Recoveries of XDE-208 averaged 71-105% for grapes.  Residues were
reported down to LOD level, otherwise declared as non-detected (ND).
Residues of XDE-208 in grapes at PHI of 7 days ranged from 0.012 mg/kg
to 1.942 mg/kg, with an average of 0.283 mg/kg.  

16. Head Lettuce: Magnitude of residues of XDE-208 was determined in
head lettuce, on 12 trials in 3 representative geographies of head
lettuce production.  All trials received four foliar application on head
lettuce targeted at 100 g ai/ha each, made at weekly intervals, in spray
volumes of 200 – 725 L/ha. Recoveries of XDE-208 averaged 96-102% for
head lettuce.  Residues were reported down to LOD level, otherwise
declared as non-detected (ND). Residues of XDE-208 in head lettuce,
leaves, at PHI of 3 days ranged from ND to 0.5 mg/kg, with an average of
0.11 mg/kg.

17. Leaf Lettuce: Magnitude of residues of XDE-208 was determined in
leaf lettuce, on 16 trials in 3 representative geographies of leaf
lettuce production.  All trials received four foliar application on leaf
lettuce targeted at 100 g ai/ha each, made at weekly intervals, in spray
volumes of 103 – 700 L/ha. Recoveries of XDE-208 averaged 89-102% for
leaf lettuce.  Residues were reported down to LOD level, otherwise
declared as non-detected (ND). Residues of XDE-208 in leaf lettuce,
leaves, at PHI of 3 days ranged from 0.052 mg/kg to 3.07 mg/kg, with an
average of 0.767 mg/kg.             

18. Melon: Magnitude of residues of XDE-208 was determined in melon on
14 trials in 3 representative geographies of melon production.  All
trials received four foliar applications targeted at 100 g ai/ha each,
made at weekly intervals, in spray volumes of 195 – 524 L/ha. 
Recoveries of XDE-208 averaged 84-100% for melons.  Residues were
reported down to LOD level, otherwise declared as non-detected (ND).
Residues of XDE-208 in melons at PHI of 1 day ranged from ND (<0.003
mg/kg) to 0.304 mg/kg, with an average of 0.045 mg/kg.  

19. Nectarine: Magnitude of residues of XDE-208 was determined in
nectarine, following two foliar applications targeted at 192 g ai/ha
each, made at weekly intervals, in spray volumes of 1000 – 2000 L/ha.
Recoveries for XDE-208 averaged 87-101% for nectarines.  Residues of
XDE-208 in Nectarines, pitted fruits, at PHI of 7 days ranged from 0.062
mg/kg to 0.2 mg/kg, with an average of 0.133 mg/kg.  

20. Bulb Onion: Magnitude of residues of XDE-208 was determined in bulb
onion,  following four foliar applications targeted at 100 g ai/ha each,
made at weekly intervals, in spray volumes of 200-500 L/ha. Recoveries
for bulb onion averaged 91% for XDE-208. Residue results were reported
down to the LOD level, otherwise declared as non-detected (ND). Residues
of XDE-208 in bulb onion at PHI of 7 days ranged from ND (<0.003 mg/kg)
to 0.0051 mg/kg (single sample with detectable amount, replicate was
ND), with an average of 0.003 mg/kg.  

21. Green Onion: Magnitude of residues of XDE-208 was determined in
green onion, following four foliar application targeted at 100 g ai/ha
each, made at weekly intervals, in spray volumes of 200-500 L/ha.  Six
trials were made in USA. Recoveries for green onion averaged 98% for
XDE-208. Residue results were reported down to the LOD level, otherwise
declared as non-detected (ND). Residues of XDE-208 in green onion at PHI
of 7 days ranged from ND (<0.003 mg/kg) to 0.4404 mg/kg, with an average
of 0.131 mg/kg.  

22. Orange: Magnitude of residues of XDE-208 was determined in oranges
on 22 trials in 3 representative geographies of orange production.  All
trials received two foliar applications targeted at 200 g ai/ha each,
made at weekly intervals, in spray volumes of 950 – 4000 L/ha.
Recoveries of XDE-208 averaged 90-94% for oranges. Residues were
reported down to LOD level, otherwise declared as non-detected (ND).
Residues of XDE-208 in oranges, whole fruits, at PHI of 1 and 7 days
ranged from 0.009 mg/kg to 0.462 mg/kg, with an average of 0.184 mg/kg.

23. Peach: Magnitude of residues of XDE-208 was determined in peach, on
20 trials in 3 representative geographies of peach production.
Recoveries of XDE-208 averaged 85-105% for peaches.  Residues were
reported down to LOD level, otherwise declared as non-detected (ND).
Residues of XDE-208 in peaches, pitted fruits, at PHI of 7 days ranged
from ND in Australia (<0.005 mg/kg) to 0.637 mg/kg, with an average of
0.168 mg/kg.  Data from 2 trials on apricot in Australia has also been
included with peaches based on similarity of results.

24. Pears: Magnitude of residues of XDE-208 was determined in pears, on
12 trials in 3 representative geographies, of pome-fruits production.
All trials received two foliar applications on pear trees, targeted at
200 g ai/ha each, made at weekly intervals, in spray volumes of 500 –
3000 L/ha.  Recoveries of XDE-208 averaged 87-92% for pears. Residues of
XDE-208 in pears, whole fruits, at PHI of 7 days ranged from 0.044 mg/kg
to 0.267 mg/kg, with an average of 0.146 mg/kg.  

25. Pecans: Magnitude of residues of XDE-208 was determined in pecans
nutmeat raw agricultural commodity, following two foliar applications
targeted at 200 g ai/ha each, made at weekly intervals, in spray volumes
of 1000 – 4000 L/ha. Six trials were made in USA. Recoveries of
XDE-208 averaged 104% for nutmeat. Residues were reported down to LOD
level, otherwise declared as non-detected (ND). Residues of XDE-208 in
pecan nutmeat at PHI of 7 days ranged from ND (<0.003 mg/kg) to 0.0041
mg/kg, with an average of 0.003 mg/kg.  

26. Peppers: Magnitude of residues of XDE-208 was determined in bell
peppers on 6 trials in 2 representative geographies of pepper
production.   All trials received four applications targeted at 100 g
ai/ha each, made at weekly intervals, in spray volumes of 200 – 650
L/ha.  Recoveries of XDE-208 averaged 77-94% for peppers.  Residues were
reported down to LOD level, otherwise declared as non-detected (ND). 
Residues of XDE-208 in peppers, whole fruit, at PHI of 1 day ranged from
0.008 mg/kg to 0.262 mg/kg, with an average of 0.105 mg/kg.  

27. Plum: Magnitude of residues of XDE-208 was determined in plum, on 7
trials in 2 representative geographies of plum production.  All trials
received two foliar applications targeted at 200 g ai/ha each, made at
weekly intervals, in spray volumes of 957 – 3038 L/ha. Recoveries of
XDE-208 averaged 99-102% for plums.  Residues of XDE-208 in plums,
pitted fruits, at PHI of 7 days ranged from 0.014 mg/kg to 0.115 mg/kg,
with an average of 0.058 mg/kg.  

28. Potato: Magnitude of residues of XDE-208 was determined in potatoes,
on 15 trials in 2 representative geographies, of potato production.  All
trials received four foliar applications, targeted at 100 g ai/ha each,
made at weekly intervals, in spray volumes of 200 – 500 L/ha. 
Recoveries for potatoes averaged 90-96% for XDE-208. Residue results
were reported down to the LOD level, otherwise declared as non-detected
(ND). Residues of XDE-208 in potatoes at PHI of 7 days ranged from ND
(<0.003 mg/kg) to 0.009 mg/kg, with an average of 0.004 mg/kg.

29. Soybean: Magnitude of residues of XDE-208 was determined in soybean
forage, hay, and seed, during on 19 trials in 2 representative
geographies of soybean production.  All trials received four foliar
applications targeted at 100 g ai/ha each, made at weekly intervals, in
spray volumes of 188-500 L/ha. Recoveries for soybean forage, hay, and
seed averaged 84-95, 82-95, 83-93% for XDE-208, respectively. Residue
results were reported down to the LOD level, otherwise declared as
non-detected (ND). Residues of XDE-208 in soybean forage, at PHI of 7
days ranged from 0.015 mg/kg to 1.494 mg/kg, with an average of 0.353
mg/kg.  Residues of XDE-208 in soybean hay, at PHI of 7 days ranged from
0.060 mg/kg to 1.378 mg/kg, with an average of 0.658 mg/kg.  Residues of
XDE-208 in soybean seed, at PHI of 7 days ranged from ND (<0.003 mg/kg)
to 0.2128 mg/kg, with an average of 0.028 mg/kg.

30. Spinach: Magnitude of residues of XDE-208 was determined in spinach,
on 8 trials in 2 representative geographies of spinach production.  All
trials received four foliar applications targeted at 100 g ai/ha each,
made at weekly intervals, in spray volumes of 199 – 460 L/ha. 
Recoveries of XDE-208 averaged 88-96% for spinach.  Residues of XDE-208
in spinach, leaves, at PHI of 7 days ranged from 0.039 mg/kg to 3.256
mg/kg, with an average of 1.077 mg/kg.  

31. Squash: Magnitude of residues of XDE-208 was determined in squash,
following four foliar applications targeted at 100 g ai/ha each, made at
weekly intervals, in spray volumes of 200-500 L/ha.  Six trials were
made in USA as one of the major producer and representative geography
for squash.  Recoveries for squash averaged 104-106% for XDE-208. 
Residue results were reported down to the LOD level, otherwise declared
as non-detected (ND). Residues of XDE-208 in squash at PHI of 1 day
ranged from ND (<0.003 mg/kg) to 0.0213 mg/kg, with an average of 0.007
mg/kg.  

32. Strawberry: Magnitude of residues of XDE-208 was determined in
strawberries, on 13 trials in 2 representative geographies of strawberry
production.  All trials received four applications targeted at 100 g
ai/ha each, made at weekly intervals, in spray volumes of 200-800 L/ha. 
Recoveries of XDE-208 averaged 85-100% for strawberries. Residues of
XDE-208 in strawberries, whole fruits, at PHI of 1 day ranged from 0.021
mg/kg to 0.496 mg/kg, with an average of 0.183 mg/kg.

33. Sugar beet: Magnitude of residues of XDE-208 was determined in sugar
beets on 13 trials in 2 representative geographies of sugar beet
production. All trials received four foliar application targeted at 100
g ai/ha each, made at weekly intervals, in spray volumes of 200 – 500
L/ha.  Recoveries of XDE-208 averaged 86-98% for sugar beet roots and
tops. Residues were reported down to LOD level, otherwise declared as
non-detected (ND). Residues of XDE-208 in sugar beet roots at PHI of 7
days ranged from ND (<0.003 mg/kg) to 0.025 mg/kg, with an average of
0.006 mg/kg.  Residues of XDE-208 in sugar beet tops at PHI of 7 days
ranged from 0.141 to 1.685 mg/kg, with an average of 0.744 mg/kg.  

34. Tomato: Magnitude of residues of XDE-208 was determined in tomatoes,
on 30 trials in 4 representative geographies of tomato production.  All
trials received four foliar applications targeted at 100 g ai/ha each,
made at weekly intervals in spray volumes of 192 to 1000 L/ha. 
Recoveries of XDE-208 averaged 82-94% for tomatoes. Residues were
reported down to LOD level, otherwise declared as non-detected (ND).
Residues of XDE-208 in tomatoes at PHI of 1 day ranged from 0.0041 to
0.451 mg/kg, with an average of 0.071 mg/kg.

35. Wheat: Magnitude of residues of XDE-208 was determined in wheat, on
40 trials in 4 representative geographies of wheat production.  All
trials received two foliar applications targeted at 50 g ai/ha each,
made at 14 day intervals, in spray volumes of 89-437 L/ha. Recoveries of
XDE-208 averaged 84-98% for grain, 81-101% for straw, 86-99% for hay,
and 85-101% for forage.  Residues were reported down to LOD level,
otherwise declared as non-detected (ND). Residues of XDE-208 in wheat,
grain, at PHI of 14 days ranged from ND (<0.003 mg/kg) to 0.067 mg/kg
with an average of 0.018 mg/kg.  Residues of XDE-208 in wheat, straw, at
PHI of 14 days ranged from 0.03 mg/kg to 1.641 mg/kg with an average of
0.42 mg/kg.  Residues of XDE-208 in wheat, hay, at PHI of 7 days ranged
from 0.024 mg/kg to 1.024 mg/kg with an average of 0.275 mg/kg. 
Residues of XDE-208 in wheat, forage, at PHI of 7 days ranged from 0.01
mg/kg to 1.34 mg/kg with an average of 0.163 mg/kg.]

<B. Toxicological Profile>

<	1. Acute toxicity.  [XDE-208 has low acute toxicity with an oral LD50
 750 mg/kg no dermal toxicity at the limit dose of 5000 mg/kg and no
inhalation toxicity at the highest achievable respirable concentration.
Skin and eye irritation was minimal and there was no skin sensitization
potential.]>

<	2. Genotoxicity. [A complete battery of in vitro and in vivo
genotoxicity studies was negative.]>

	3. Reproductive and developmental toxicity. [Standard regulatory
studies comprised a two-generation reproduction study in rats and a
developmental study in rats and rabbits. Mode of action studies
investigated effects seen in rats. No effects were seen in rabbits. With
the possible exception of a minimal delay in balano-preputial separation
in high dose level male rats, there were no reproduction or
developmental effects of relevance to humans.]

<	4. Subchronic toxicity. [In rat and mouse subchronic toxicity studies,
the primary target organ was the liver.  In the dog, the only effects
were decreases in feed consumption and body weight gain. In a rat 28-day
dermal toxicity study there were no effects at the limit dose of 1000
mg/kg/day.] 

>

	5. Chronic toxicity. [Carcinogenicity was assessed in rats and mice.
Treatment-related liver tumors occurred in high dose male rats and male
and female mice. These effects have been shown not to be relevant to
humans.]

<	6. Animal metabolism. [XDE-208 has negligible metabolism in rats,
mice, dogs and rabbits.]>

<	7. Metabolite toxicology. [All environmental metabolites have
significantly lower toxicity than the parent molecule.]>

	8. Endocrine disruption. [A minimal delay in balano-preputial
separation and effects on interstitial cells were seen in rats but not
mice.]

 

<C. Aggregate Exposure>

<	1. Dietary exposure. [Dietary exposures associated with the proposed
uses of sulfoxaflor have been estimated using DEEM-FCID™ and
conservative assumptions.  The Tier 1 acute assessment assumes residues
at MRL levels and 100% crop treated.   The chronic assessment assumes
residues at average values from field trials with processing factors,
average estimated residues in meat, milk, poultry and egg commodities,
and 100% crop treated.  Acute and chronic dietary (food + water)
exposures are below the aPAD and cPAD, respectively, for all
subpopulations.  Exposures below the aPAD and cPAD indicate a reasonable
certainty of no harm associated with the proposed uses of sulfoxaflor.>

	   

Acute Dietary Exposure.  For acute dietary sulfoxaflor exposures, the
NOAEL selected by DAS is 25 mg/kg/d from the acute neurotoxicity study
in rats.  With the 100X uncertainty factor, the acute population
adjusted dose (aPAD) is 0.25 mg/kg/d. Acute dietary exposures associated
with the proposed uses of sulfoxaflor were assessed using DEEM-FCID™
and consumption data derived from the 1994-1998 USDA Continuing Surveys
of Food Intake by Individuals (CSFII).  For this conservative Tier 1
acute dietary exposure assessment, residues in commodities were assumed
at the MRLs proposed by DAS for all commodities, and 100% crop treated
was assumed for all commodities.  Processing factors were used when
necessary for processed commodities not otherwise covered by a specific
tolerance.  Drinking water was included directly in the acute dietary
risk assessment at an adjusted parent-equivalent residue of 18.21 µg/L,
based on water modeling conducted by DAS.  Acute dietary exposures at
the 95th percentile (the appropriate level for a Tier 1 assessment)
range from 0.014932 mg/kg/d (5.97% aPAD) for adults 50+ years old to
0.051964 mg/kg/d (20.79% aPAD) for children aged 1-2 years, the most
highly exposed subpopulation.  The 95th percentile acute dietary
exposure for the U.S. population is 0.019809 mg/kg/d (7.92% aPAD). 
Thus, acute dietary exposures correspond to 20.79% of the acute
population adjusted dose or less for all population subgroups. 

Chronic Dietary Exposure. For chronic dietary sulfoxaflor exposures, the
NOAEL selected by DAS is 1 mg/kg/d from the chronic rat bioassay.  With
the 100X uncertainty factor, the chronic population adjusted dose (cPAD)
is 0.01 mg/kg/d.

Chronic dietary exposures associated with the proposed uses of
sulfoxaflor were assessed using DEEM-FCID™ and consumption data
derived from the 1994-1998 USDA Continuing Surveys of Food Intake by
Individuals (CSFII).  For this refined chronic dietary exposure
assessment, residues in commodities were assumed at the average residues
from field trials as calculated by DAS or at anticipated residues for
meat, milk, poultry and eggs as calculated by DAS.  Average residues
from field trials are more reflective of potential exposures over time,
so they result in a more representative yet conservative estimate of
chronic dietary exposures than the use of MRLs.  Also, 100% crop treated
was assumed for all commodities.  Processing factors were used to
reflect the concentration or reduction of residues in processed
commodities.  Drinking water was included directly in the chronic
dietary risk assessment at an adjusted parent-equivalent residue of 9.54
µg/L, based on water modeling conducted by DAS.  Chronic dietary
exposures range from 0.000782 mg/kg/d (7.8% cPAD) for youth 13-19 years
old to 0.003582 mg/kg/d (35.8% cPAD) for children aged 1-2 years, the
most highly exposed subpopulation.  The chronic dietary exposure for the
U.S. population is 0.001097 mg/kg/d (11.0% cPAD).  Thus, chronic dietary
exposures correspond to 35.8% of the chronic population adjusted dose or
less for all population subgroups.] 

<	i. Food. [NA – remove]>

<	ii. Drinking water. [DAS has concluded that the residues of concern in
water include the parent molecule as well as a metabolite known as
X11719474. Based on a review of the extensive toxicity testing of the
metabolite, DAS has concluded that it is at least 7-fold less toxic than
the parent molecule.  Therefore, this toxicity adjustment factor (TAF)
is used to express estimated concentrations of the metabolite in water
in terms of sulfoxaflor parent equivalents. The environmental behavior
of parent sulfoxaflor and its primary metabolite X11719474 were
initially modeled with the screening-level SCI-GROW  for groundwater and
with the Tier 2 PRZM/EXAMS models for surface water, followed by the
refined groundwater assessment with PRZM following USEPA’s PRZM-GW
methodology.  Maximum seasonal application rates, combined with
worst-case application intervals and timings, yielded conservative
estimates for a variety of crops proposed for treatment with
sulfoxaflor.

As they are higher than the groundwater results, surface water-derived
values are the appropriate EDWC values for input into dietary
assessments, and were used as appropriate refined EDWC values for input
into dietary assessment:

Total parent-equivalent concentrations are calculated by applying the
toxicity adjustment factor of 7X to the modeled metabolite
concentrations and then summing with the modeled concentration of
sulfoxaflor. Based on the estimated refined concentrations, an estimated
parent-equivalent residue of 18.21 µg/L is assumed in the acute dietary
assessment, and an estimated parent-equivalent residue of 9.54 µg/L is
assumed in the chronic dietary assessment.]

>

<	2. Non-dietary exposure. [Sulfoxaflor is currently not registered for
any residential non-food site.  Thus, the risk from non-dietary exposure
to sulfoxaflor residues is considered negligible.] >

<D. Cumulative Effects>

<	[At this time, EPA does not have available data to determine whether
sulfoxaflor has a common mechanism of toxicity with other substances. 
Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, sulfoxaflor does not
appear to produce a toxic metabolite generated by other substances.  For
purposes of this assessment, therefore, it is assumed that sulfoxaflor
does not have a mechanism of toxicity common with other substances and
no cumulative risk assessment is required.]>

<E. Safety Determination>

	1. U.S. population. [Using the above conservative exposure assumptions,
and based on the completeness and reliability of proposed tolerances in
fruit and vegetable commodities will utilize 11% or less of the chronic
population adjusted does, cPAD, for the general U. S. population.  The
population subgroup with the highest exposure of 35.8% of the cPAD is
children (1-2 yrs old).  Generally, EPA has no concern for exposures
below 100% of the cPAD because the cPAD represents the level at or below
which daily aggregate dietary exposures over a lifetime will not pose
appreciable risks to human health.  Additionally, the potential
contribution of XDE-208 residues in drinking water to aggregate exposure
is expected to be minimal.  Drinking water was included directly in the
chronic dietary risk assessment at an adjusted parent-equivalent residue
of 9.54 µg/L, based on water modeling conducted by DAS.  Short-term and
intermediate-term risks are considered to be negligible because of lack
of significant toxicological effects.  Therefore, based on these risk
assessments, Dow AgroSciences concludes that there is reasonable
certainty that no harm will result to the U. S. population from
aggregate exposure to XDE-208 residues.]

<	2. Infants and children. [In assessing the potential for additional
sensitivity of infants and children to residues of XDE-208, data from
developmental toxicity studies in rats and rabbits and a
multi-generation reproduction study in the rat are considered.  The
developmental toxicity studies are designed to evaluate adverse effects
on the developing organism resulting from pesticide exposure during
prenatal development.  Reproduction studies provide information relating
to effects from exposure of both parents to the pesticide on the
reproductive capability and potential systemic toxicity of mating
animals and on various parameters associated with the well being of
offspring.

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ffects in rats were shown to be due to XDE-208 agonism to the fetal rat
muscle nicotinic acetylcholine receptor. XDE-208 has also been shown not
to have any agonism to the corresponding human receptors whereby it is
possible to conclude that the effects in rats are not relevant to humans
and therefore, do not trigger retention of the FQPA safety factor. 

In addition, the NOEL in the chronic rat study (1 mg/kg/day), used to
calculate the chronic RfD (0.01 mg/kg/day), is already lower than the
acute NOEL from the acute neurotoxicity study in rats (25 mg/kg/day). 
Therefore, an additional FQPA uncertainty factor is not needed and the
RfD at 0.01 mg/kg/day is appropriate for assessing risk to infants and
children.

Using the conservative exposure assumptions, the percent RfD utilized by
the potential exposure to residues of XDE-208 on a wide variety of fruit
and vegetable crops and animal commodities is <35.8% for children 1-2
years, the population subgroup predicted to be potentially the most
highly exposed.  Risk for developmental toxicity from acute exposure to
XDE-208 was evaluated for females (13-49 years old).  The high-end MOE
value of >1600 (6.2% of aRfD) is well above the acceptable 100. 
Therefore, based on the completeness and reliability of the toxicity
data and the conservative exposure assessment, Dow AgroSciences
concludes with reasonable certainty that no harm will result to infants
and children, females 13+ years old and the prenatal development of
infants from the aggregate exposure to XDE-208 residues.]

>

<F. International Tolerances>

<	[There are no Maximum Residue Limits (MRL) established for residues on
any food or feed crop. International harmonization is therefore not an
issue for this notification.]

>

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